For 12-18 months following a preeclamptic pregnancy, cardiovascular abnormalities persist in some women and appear to raise their risk for recurrent preeclampsia in a subsequent pregnancy, according to a case-control study published online Feb. 22 in Hypertension.

If these findings are confirmed in further studies, it might become possible to identify women at high risk for recurrent preeclampsia by performing a cardiovascular assessment before they attempt a second pregnancy, said Dr. Herbert Valensise of the department of obstetrics and gynecology, Tor Vergata University, Rome, and his associates.

©Jupiterimages/Thinkstock.com

An estimated 3%-8% of pregnancies are complicated by preeclampsia, and women who have preeclampsia once are seven times more likely to have a recurrence in subsequent pregnancies than are women who never had the disorder. At present, it is difficult to predict which women will have a recurrence. The investigators assessed cardiac function in women who had completed a first pregnancy and had not yet attempted a second pregnancy; 75 of these women had early preeclampsia during their initial pregnancies and were compared with 147 control subjects who did not. All these study participants were then followed through their second pregnancies to determine whether preeclampsia recurred.

The 22 women who had recurrent preeclampsia in their second pregnancies showed several cardiovascular abnormalities during the nonpregnant state, compared with the control subjects and the 53 women who did not develop preeclampsia in their second pregnancies. The affected women had lower stroke volume (63 mL vs. 73 mL and 70 mL, respectively), elevated total vascular resistance (1,638 vs. 1,341 and 1,383 dyne·s⁻¹·cm⁻⁵), lower cardiac output (4.6 vs. 5.3 and 5.2 L), higher diastolic blood pressure (77 vs. 68 and 69 mm Hg), greater thickness of the left-ventricular wall (35 vs. 28 and 33), and “a tendency to a concentric geometry of the left ventricle,” Dr. Valensise and his associates said. All differences were statistically significant at P less than .05 (Hypertension. 2016 Feb 22. doi: 10.1161/HYPERTENSIONAHA.115.06674).

These findings “suggest that cardiac dysfunction and cardiovascular maladaptation precede the appearance of a recurrent preeclampsia months before a second pregnancy,” they said.

The preeclampsia during the first pregnancy was no more severe among women who had a recurrence than it was among the women who did not, so the severity of the first episode was not a useful guide for predicting recurrence, the investigators added.

No funding source was identified for this study. Dr. Valensise and his associates reported having no relevant financial disclosures.

For 12-18 months following a preeclamptic pregnancy, cardiovascular abnormalities persist in some women and appear to raise their risk for recurrent preeclampsia in a subsequent pregnancy, according to a case-control study published online Feb. 22 in Hypertension.

If these findings are confirmed in further studies, it might become possible to identify women at high risk for recurrent preeclampsia by performing a cardiovascular assessment before they attempt a second pregnancy, said Dr. Herbert Valensise of the department of obstetrics and gynecology, Tor Vergata University, Rome, and his associates.

©Jupiterimages/Thinkstock.com

An estimated 3%-8% of pregnancies are complicated by preeclampsia, and women who have preeclampsia once are seven times more likely to have a recurrence in subsequent pregnancies than are women who never had the disorder. At present, it is difficult to predict which women will have a recurrence. The investigators assessed cardiac function in women who had completed a first pregnancy and had not yet attempted a second pregnancy; 75 of these women had early preeclampsia during their initial pregnancies and were compared with 147 control subjects who did not. All these study participants were then followed through their second pregnancies to determine whether preeclampsia recurred.

The 22 women who had recurrent preeclampsia in their second pregnancies showed several cardiovascular abnormalities during the nonpregnant state, compared with the control subjects and the 53 women who did not develop preeclampsia in their second pregnancies. The affected women had lower stroke volume (63 mL vs. 73 mL and 70 mL, respectively), elevated total vascular resistance (1,638 vs. 1,341 and 1,383 dyne·s⁻¹·cm⁻⁵), lower cardiac output (4.6 vs. 5.3 and 5.2 L), higher diastolic blood pressure (77 vs. 68 and 69 mm Hg), greater thickness of the left-ventricular wall (35 vs. 28 and 33), and “a tendency to a concentric geometry of the left ventricle,” Dr. Valensise and his associates said. All differences were statistically significant at P less than .05 (Hypertension. 2016 Feb 22. doi: 10.1161/HYPERTENSIONAHA.115.06674).

These findings “suggest that cardiac dysfunction and cardiovascular maladaptation precede the appearance of a recurrent preeclampsia months before a second pregnancy,” they said.

The preeclampsia during the first pregnancy was no more severe among women who had a recurrence than it was among the women who did not, so the severity of the first episode was not a useful guide for predicting recurrence, the investigators added.

No funding source was identified for this study. Dr. Valensise and his associates reported having no relevant financial disclosures.

For 12-18 months following a preeclamptic pregnancy, cardiovascular abnormalities persist in some women and appear to raise their risk for recurrent preeclampsia in a subsequent pregnancy, according to a case-control study published online Feb. 22 in Hypertension.

If these findings are confirmed in further studies, it might become possible to identify women at high risk for recurrent preeclampsia by performing a cardiovascular assessment before they attempt a second pregnancy, said Dr. Herbert Valensise of the department of obstetrics and gynecology, Tor Vergata University, Rome, and his associates.

©Jupiterimages/Thinkstock.com

An estimated 3%-8% of pregnancies are complicated by preeclampsia, and women who have preeclampsia once are seven times more likely to have a recurrence in subsequent pregnancies than are women who never had the disorder. At present, it is difficult to predict which women will have a recurrence. The investigators assessed cardiac function in women who had completed a first pregnancy and had not yet attempted a second pregnancy; 75 of these women had early preeclampsia during their initial pregnancies and were compared with 147 control subjects who did not. All these study participants were then followed through their second pregnancies to determine whether preeclampsia recurred.

The 22 women who had recurrent preeclampsia in their second pregnancies showed several cardiovascular abnormalities during the nonpregnant state, compared with the control subjects and the 53 women who did not develop preeclampsia in their second pregnancies. The affected women had lower stroke volume (63 mL vs. 73 mL and 70 mL, respectively), elevated total vascular resistance (1,638 vs. 1,341 and 1,383 dyne·s⁻¹·cm⁻⁵), lower cardiac output (4.6 vs. 5.3 and 5.2 L), higher diastolic blood pressure (77 vs. 68 and 69 mm Hg), greater thickness of the left-ventricular wall (35 vs. 28 and 33), and “a tendency to a concentric geometry of the left ventricle,” Dr. Valensise and his associates said. All differences were statistically significant at P less than .05 (Hypertension. 2016 Feb 22. doi: 10.1161/HYPERTENSIONAHA.115.06674).

These findings “suggest that cardiac dysfunction and cardiovascular maladaptation precede the appearance of a recurrent preeclampsia months before a second pregnancy,” they said.

The preeclampsia during the first pregnancy was no more severe among women who had a recurrence than it was among the women who did not, so the severity of the first episode was not a useful guide for predicting recurrence, the investigators added.

No funding source was identified for this study. Dr. Valensise and his associates reported having no relevant financial disclosures.

Despite an abundance of peer-reviewed resources, there is wide variation in the surgical management of shoulder instability.^1,2 Current American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines regarding the shoulder address only generalized shoulder pain, glenohumeral osteoarthritis, and rotator cuff injuries,^3,4 and treatment algorithms focus on conservative treatment, rather than surgical recommendations.^4-7

Shoulder instability most commonly results from 1 or more of 4 common lesions (capsular laxity, glenoid bone loss, humeral bone loss, and capsulolabral insufficiency).⁸ While it is a relatively common condition that represents 1% to 2% of all athletic injuries,^9,10 little consensus exists about surgical indications, ideal treatment algorithms, or optimal operative technique. This is a critical issue because more than 50% of patients with glenohumeral instability will undergo surgical intervention.¹¹ Chahal and associates⁶ surveyed 44 shoulder experts and reported strong consensus about diagnosis, but little agreement regarding surgical management. Owens and colleagues¹ have also evaluated current trends for surgical treatment of this pathology. Randelli and associates⁵ attempted to categorize operative management based upon case-specific shoulder scenarios through online surveys. Their survey, however, covered a broad range of shoulder injuries rather than instability in particular. In this study, we assess trends for surgical management of glenohumeral instability in a case-based survey of shoulder experts.

Materials and Methods

Survey Information

An online survey (Survey Monkey) of 417 active members of the American Shoulder and Elbow Surgeons (ASES) was administered on May 1, 2014. Respondents were blinded to the institution and co-investigators conducting the survey. The survey link was distributed via email because it has been shown to be a more efficacious conduit than standard postal mail.¹² The case-based, 25-question survey (Appendix) was designed to assess respondents’ selection of surgical intervention. Section 1 determined member demographics, including fellowship training, arthroscopy experience, and years of practice. Section 2 involved the presentation of 5 case scenarios. For each case, respondents were asked to identify the optimal surgical procedure in both primary and revision settings. Section 3 posed several general questions regarding shoulder-instability management.

Statistical Analysis

Data were stored using Microsoft Excel (Microsoft) and analyzed using SAS Software version 9.3 (SAS Institute, Inc.). Demographic survey responses were reported using descriptive statistics. Responses to clinical survey questions were reported using frequencies and percentages. To identify when a majority consensus was achieved for a given question, responses were flagged as reaching consensus when more than 50% of participants gave the same response.¹³In the event that only 2 response options were available, reaching consensus required 67% of respondents to choose a single answer (since, by default, a consensus would be reached with only 2 response options). Because this was an analysis of all respondents, an a priori power calculation was not performed. Associations between training and practice demographics and responses to clinical questions were investigated using chi-square analyses. All comparative analyses were two-tailed and used P = .05 as the threshold for statistical significance.

Results

Demographics

One hundred and twenty-five (29.9%) ASES members responded to the survey. Of the respondents, 71.2% reported at least 15 years of experience, and 71% performed more than 150 shoulder cases annually. Surgeons came from academic institutions (41.6%), private practice (24.8%), or mixed (33.6%). The majority of respondents were fellowship-trained in shoulder/elbow surgery (52.8%), while fewer had completed a sports-medicine fellowship (24.0%). For arthroscopic procedures, responses were nearly divided between those who preferred beach-chair positioning (47.2%) and those who preferred the lateral decubitus position (46.4%). The majority (70.4%) of respondents practiced in the United States and with a relatively even distribution among states and region. The remaining 29.6% of those surveyed practiced abroad.

Degree of Consensus Responses and Cases

Of the 25 survey questions, 6 questions were omitted from consensus calculations because these were designed for demographic categorization rather than professional opinion (questions 1-5, 8). Thirteen of the remaining 19 questions (68%) reached consensus response. All clinical case scenarios (5 of 5) reached consensus for selection of technique for the primary procedure; however, only 40% (2 of 5) of cases had a consensus in the revision setting.

In case 1, a young soccer player (noncontact athlete) with negligible bone loss, arthroscopic Bankart repair was recommended by 81.6% of respondents. In the event of revision surgery, only 22.4% recommended arthroscopic Bankart repair, and the remainder split between open Bankart repair with possible capsular shift (36%) or Latarjet procedure (32.8%).

In case 2, a college American football player (contact athlete) with negligible bone loss, arthroscopic Bankart repair was recommended by 56.8%. In the event of revision surgery, a majority of members (51.2%) suggested a Latarjet procedure.

In case 3, the weekend warrior with significant bone loss, most respondents recommended a Latarjet procedure for both primary (72.8%) and revision surgery (79.0%).

In case 4, a weekend warrior with multidirectional instability, 60% of respondents suggested arthroscopic Bankart repair, 21.6% recommended rotator interval closure, and 10.4% chose a capsular shift. As a revision procedure, there was less agreement, with a split between open Bankart repair (39.2%) and capsular shift only (39.2%).

In case 5, the weekend warrior with large engaging Hill-Sachs lesions, 60% of respondent selected a remplissage procedure. If revision was required, a Latarjet procedure was the choice of 48.8% of respondents (Table).

General Questions

For contact athletes, most respondents (87.2%) would allow return to play in the same season and recommended surgery after the end of the season. After surgical intervention, 56.8% prescribed 4 weeks of immobilization. When counseling a return to contact sports, 51.2% recommended waiting for 4 to 6 months.

The ASES members were divided on conservative management of instability injuries. Responses included immobilization in internal rotation (39.2%), no immobilization (39.2%), and external-rotation bracing (21.6%).

Finally, members thought the most important factor in choosing surgical technique was the patient’s pathology, then age; the least influential criteria was the patient’s sports participation.

Analysis of Training Demographics and Surgical Technique Preferences

Chi-square analyses demonstrated that respondents who completed a sports fellowship were more likely to do at least 50% of cases arthroscopically (odds ratio [OR], 15.3; P < .001) and were more likely to use the lateral decubitus position (OR, 2.8; P < .021). Furthermore, American respondents had a higher likelihood of having completed either a sports fellowship (OR, 12.8; P < .001) or a shoulder/elbow fellowship (OR, 4.6; P = .002) when compared with foreign respondents.

Discussion

In the absence of formal clinical practice guidelines, most surgeons formulate treatment strategy based upon a combination of experience and peer-reviewed evidence. The cohort analyzed in the current study was highly experienced, with more than 70% performing 150 shoulder cases annually and having more than 15 years of experience. We found a consensus response in 68% of questions and all primary surgical techniques for our shoulder instability scenarios. While expert consensus reported here is not equivalent to evidence-based clinical practice guidelines, it does provide important information to consider when treating anterior shoulder instability.

Specific responses to our case scenarios invite further reflection. Considering young (both noncontact and contact) athletes without bony pathology (cases 1 and 2, respectively), the ASES surgeons recommended arthroscopic Bankart repair for both. Randelli and associates5 found 71% of survey respondents recommended arthroscopic Bankart repair in a similar setting. It is interesting to note that consensus persisted regardless of the sport in which they engaged. Contact athletes have the highest rates of dislocation (up to 7 times higher incidence) compared with the general population.¹⁴ In addition, they have a higher recurrence rate after surgery.¹⁵ It should be noted, however, that although both cases reached consensus, the percentage of experts who recommended an arthroscopic procedure fell from 82% in the noncontact athlete to 57% in the contact athlete. This concurs with a recent review by Harris and Romeo,¹⁶ who recommended similar treatments for athletes without bony defects. In an older patient population with recurrent instability (case 3), responses varied more widely but still reached a consensus on primary surgical techniques. Respondents agreed that, even for patients with multidirectional instability, initial management should consist of arthroscopic capsulolabral repair. Overall, the agreement for arthroscopy for cases 1 through 3 mimics recent US practice patterns, showing 90% of stabilizations are being performed arthroscopically.¹⁷ Additionally, a recent meta-analysis by Harris and associates18 favored arthroscopic Bankart repair, showing no significant difference vs open stabilization even on long-term follow-up.

Glenoid bone loss is a difficult clinical scenario and that is reflected in this study’s findings. The literature suggests that arthroscopic Bankart repair, in this setting, is usually not sufficient and may result in a recurrence rate up to 75%, if bone loss greater than 20% is unaddressed.¹⁹ Our study supports this trend because ASES members recommended a Latarjet procedure when there is substantial bone loss.

While open Latarjet procedure was the consensus for dealing with glenoid bone loss, arthroscopic techniques were strongly favored for humeral head defects. This change in practice patterns results from the introduction of the arthroscopic remplissage technique.²⁰ Two recent systemic reviews have supported this technique, reporting good functional outcomes for engaging Hill-Sachs lesions.^21,22 Our study had similar agreement, with most respondents recommending remplissage for these patients.

This study found the lowest rates of expert consensus in the setting of revision surgery, likely caused, in part, by the paucity of available large cohort studies. This is a major void in the literature, and more studies are needed to help guide surgeons on the best techniques to deal with this difficult patient population.

Conservative bracing technique was 1 of the survey questions lacking a consensus response. Interestingly, 39% of members recommended no immobilization after an instability event. This contrasts with recent literature concerning the best position for bracing. We also found twice as many surgeons recommended internal rotation immobilization over external rotation. This is a subject of debate, with some studies stating improvement with external rotation immobilization,²³ while other studies reported no difference.²⁴ Overall, recommendations regarding type of immobilization are unclear, which will likely continue until larger studies can be performed.

The literature describing surgical trends in the treatment of shoulder instability is sparse and variable. With regard to other shoulder etiologies, only rotator cuff pathology has used expert consensus. Acevedo and colleagues¹³ reported agreement of ASES members surveyed regarding rotator cuff management. There was no consensus among surgeons in more than 50% of questions, despite AAOS published guidelines for rotator cuff treatment.²⁵ Despite the lack of guidelines for our topic, we found a consensus among respondents with 68% of survey questions.

To date, only 2 studies of shoulder instability management have elicited the opinion of experts in shoulder surgery. Chahal and associates⁶ surveyed 42 members of ASES and JOINTS (Joined Orthopaedic Initiatives for National Trials of the Shoulder) Canada on shoulder instability cases and found substantial agreement on diagnosis but little consensus regarding surgical technique. This lack of agreement on procedures differs from our findings and may be related to their complicated case scenarios that generated a wide array of treatment recommendations. Randelli and colleagues⁵ surveyed more than 1000 European Society of Sports Traumatology, Knee Surgery, and Arthroscopy members and reported similar agreement on arthroscopic Bankart repair in young male shoulder-dislocation patients, although no other instability scenarios were investigated. Our study is the first to report responses from expert shoulder surgeons on surgical-treatment strategies for an array of common shoulder instability pathologies.

This study had several limitations. First, while our study suffered from a low response rate (29.9%), it was similar to other published studies.^5,13 Second, because the case series included in the survey attempted to capture the most common instability scenarios, they were limited in their scope and failed to address additional etiologies or pathologic permutations. We believe, however, that a more comprehensive survey would have resulted in respondent fatigue and lowered the response rate. It is unlikely that any survey could capture all variables that come into play during clinical decision-making, and we sought to evaluate the most common shoulder instability scenarios. Third, 30% of respondents were from outside the United States, where the Latarjet procedure is much more popular. While this was not a majority, Latarjet’s regional preference may have decreased the consensus response in some scenarios if only the United States was included. Finally, there is inherent bias in a respondent pool that is heavily weighted to shoulder-surgery experts (ASES members) and does not consider the responses of the general orthopedic surgery community as have other studies.⁷

Conclusion

This study demonstrates that expert shoulder surgeons often agreed on shoulder-treatment principles for anterior shoulder instability. In the setting of primary repair, arthroscopic Bankart repair was favored in the absence of bony pathology, regardless of age (20 to 35 years) or nature of sport (contact versus noncontact). Latarjet procedures were favored in the setting of glenoid bone loss, and remplissage for an engaging Hill-Sachs lesion. Less agreement was observed for revision stabilization. It should be noted that, while consensus was often reached for our cases, there was a wide distribution of technical considerations and surgical preferences even among those who are fellowship-trained and high-volume surgeons, and who can be considered experts in the field of shoulder surgery.

Despite an abundance of peer-reviewed resources, there is wide variation in the surgical management of shoulder instability.^1,2 Current American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines regarding the shoulder address only generalized shoulder pain, glenohumeral osteoarthritis, and rotator cuff injuries,^3,4 and treatment algorithms focus on conservative treatment, rather than surgical recommendations.^4-7

Shoulder instability most commonly results from 1 or more of 4 common lesions (capsular laxity, glenoid bone loss, humeral bone loss, and capsulolabral insufficiency).⁸ While it is a relatively common condition that represents 1% to 2% of all athletic injuries,^9,10 little consensus exists about surgical indications, ideal treatment algorithms, or optimal operative technique. This is a critical issue because more than 50% of patients with glenohumeral instability will undergo surgical intervention.¹¹ Chahal and associates⁶ surveyed 44 shoulder experts and reported strong consensus about diagnosis, but little agreement regarding surgical management. Owens and colleagues¹ have also evaluated current trends for surgical treatment of this pathology. Randelli and associates⁵ attempted to categorize operative management based upon case-specific shoulder scenarios through online surveys. Their survey, however, covered a broad range of shoulder injuries rather than instability in particular. In this study, we assess trends for surgical management of glenohumeral instability in a case-based survey of shoulder experts.

Materials and Methods

Survey Information

An online survey (Survey Monkey) of 417 active members of the American Shoulder and Elbow Surgeons (ASES) was administered on May 1, 2014. Respondents were blinded to the institution and co-investigators conducting the survey. The survey link was distributed via email because it has been shown to be a more efficacious conduit than standard postal mail.¹² The case-based, 25-question survey (Appendix) was designed to assess respondents’ selection of surgical intervention. Section 1 determined member demographics, including fellowship training, arthroscopy experience, and years of practice. Section 2 involved the presentation of 5 case scenarios. For each case, respondents were asked to identify the optimal surgical procedure in both primary and revision settings. Section 3 posed several general questions regarding shoulder-instability management.

Statistical Analysis

Data were stored using Microsoft Excel (Microsoft) and analyzed using SAS Software version 9.3 (SAS Institute, Inc.). Demographic survey responses were reported using descriptive statistics. Responses to clinical survey questions were reported using frequencies and percentages. To identify when a majority consensus was achieved for a given question, responses were flagged as reaching consensus when more than 50% of participants gave the same response.¹³In the event that only 2 response options were available, reaching consensus required 67% of respondents to choose a single answer (since, by default, a consensus would be reached with only 2 response options). Because this was an analysis of all respondents, an a priori power calculation was not performed. Associations between training and practice demographics and responses to clinical questions were investigated using chi-square analyses. All comparative analyses were two-tailed and used P = .05 as the threshold for statistical significance.

Results

Demographics

One hundred and twenty-five (29.9%) ASES members responded to the survey. Of the respondents, 71.2% reported at least 15 years of experience, and 71% performed more than 150 shoulder cases annually. Surgeons came from academic institutions (41.6%), private practice (24.8%), or mixed (33.6%). The majority of respondents were fellowship-trained in shoulder/elbow surgery (52.8%), while fewer had completed a sports-medicine fellowship (24.0%). For arthroscopic procedures, responses were nearly divided between those who preferred beach-chair positioning (47.2%) and those who preferred the lateral decubitus position (46.4%). The majority (70.4%) of respondents practiced in the United States and with a relatively even distribution among states and region. The remaining 29.6% of those surveyed practiced abroad.

Degree of Consensus Responses and Cases

Of the 25 survey questions, 6 questions were omitted from consensus calculations because these were designed for demographic categorization rather than professional opinion (questions 1-5, 8). Thirteen of the remaining 19 questions (68%) reached consensus response. All clinical case scenarios (5 of 5) reached consensus for selection of technique for the primary procedure; however, only 40% (2 of 5) of cases had a consensus in the revision setting.

In case 1, a young soccer player (noncontact athlete) with negligible bone loss, arthroscopic Bankart repair was recommended by 81.6% of respondents. In the event of revision surgery, only 22.4% recommended arthroscopic Bankart repair, and the remainder split between open Bankart repair with possible capsular shift (36%) or Latarjet procedure (32.8%).

In case 2, a college American football player (contact athlete) with negligible bone loss, arthroscopic Bankart repair was recommended by 56.8%. In the event of revision surgery, a majority of members (51.2%) suggested a Latarjet procedure.

In case 3, the weekend warrior with significant bone loss, most respondents recommended a Latarjet procedure for both primary (72.8%) and revision surgery (79.0%).

In case 4, a weekend warrior with multidirectional instability, 60% of respondents suggested arthroscopic Bankart repair, 21.6% recommended rotator interval closure, and 10.4% chose a capsular shift. As a revision procedure, there was less agreement, with a split between open Bankart repair (39.2%) and capsular shift only (39.2%).

In case 5, the weekend warrior with large engaging Hill-Sachs lesions, 60% of respondent selected a remplissage procedure. If revision was required, a Latarjet procedure was the choice of 48.8% of respondents (Table).

General Questions

For contact athletes, most respondents (87.2%) would allow return to play in the same season and recommended surgery after the end of the season. After surgical intervention, 56.8% prescribed 4 weeks of immobilization. When counseling a return to contact sports, 51.2% recommended waiting for 4 to 6 months.

The ASES members were divided on conservative management of instability injuries. Responses included immobilization in internal rotation (39.2%), no immobilization (39.2%), and external-rotation bracing (21.6%).

Finally, members thought the most important factor in choosing surgical technique was the patient’s pathology, then age; the least influential criteria was the patient’s sports participation.

Analysis of Training Demographics and Surgical Technique Preferences

Chi-square analyses demonstrated that respondents who completed a sports fellowship were more likely to do at least 50% of cases arthroscopically (odds ratio [OR], 15.3; P < .001) and were more likely to use the lateral decubitus position (OR, 2.8; P < .021). Furthermore, American respondents had a higher likelihood of having completed either a sports fellowship (OR, 12.8; P < .001) or a shoulder/elbow fellowship (OR, 4.6; P = .002) when compared with foreign respondents.

Discussion

In the absence of formal clinical practice guidelines, most surgeons formulate treatment strategy based upon a combination of experience and peer-reviewed evidence. The cohort analyzed in the current study was highly experienced, with more than 70% performing 150 shoulder cases annually and having more than 15 years of experience. We found a consensus response in 68% of questions and all primary surgical techniques for our shoulder instability scenarios. While expert consensus reported here is not equivalent to evidence-based clinical practice guidelines, it does provide important information to consider when treating anterior shoulder instability.

Specific responses to our case scenarios invite further reflection. Considering young (both noncontact and contact) athletes without bony pathology (cases 1 and 2, respectively), the ASES surgeons recommended arthroscopic Bankart repair for both. Randelli and associates5 found 71% of survey respondents recommended arthroscopic Bankart repair in a similar setting. It is interesting to note that consensus persisted regardless of the sport in which they engaged. Contact athletes have the highest rates of dislocation (up to 7 times higher incidence) compared with the general population.¹⁴ In addition, they have a higher recurrence rate after surgery.¹⁵ It should be noted, however, that although both cases reached consensus, the percentage of experts who recommended an arthroscopic procedure fell from 82% in the noncontact athlete to 57% in the contact athlete. This concurs with a recent review by Harris and Romeo,¹⁶ who recommended similar treatments for athletes without bony defects. In an older patient population with recurrent instability (case 3), responses varied more widely but still reached a consensus on primary surgical techniques. Respondents agreed that, even for patients with multidirectional instability, initial management should consist of arthroscopic capsulolabral repair. Overall, the agreement for arthroscopy for cases 1 through 3 mimics recent US practice patterns, showing 90% of stabilizations are being performed arthroscopically.¹⁷ Additionally, a recent meta-analysis by Harris and associates18 favored arthroscopic Bankart repair, showing no significant difference vs open stabilization even on long-term follow-up.

Glenoid bone loss is a difficult clinical scenario and that is reflected in this study’s findings. The literature suggests that arthroscopic Bankart repair, in this setting, is usually not sufficient and may result in a recurrence rate up to 75%, if bone loss greater than 20% is unaddressed.¹⁹ Our study supports this trend because ASES members recommended a Latarjet procedure when there is substantial bone loss.

While open Latarjet procedure was the consensus for dealing with glenoid bone loss, arthroscopic techniques were strongly favored for humeral head defects. This change in practice patterns results from the introduction of the arthroscopic remplissage technique.²⁰ Two recent systemic reviews have supported this technique, reporting good functional outcomes for engaging Hill-Sachs lesions.^21,22 Our study had similar agreement, with most respondents recommending remplissage for these patients.

This study found the lowest rates of expert consensus in the setting of revision surgery, likely caused, in part, by the paucity of available large cohort studies. This is a major void in the literature, and more studies are needed to help guide surgeons on the best techniques to deal with this difficult patient population.

Conservative bracing technique was 1 of the survey questions lacking a consensus response. Interestingly, 39% of members recommended no immobilization after an instability event. This contrasts with recent literature concerning the best position for bracing. We also found twice as many surgeons recommended internal rotation immobilization over external rotation. This is a subject of debate, with some studies stating improvement with external rotation immobilization,²³ while other studies reported no difference.²⁴ Overall, recommendations regarding type of immobilization are unclear, which will likely continue until larger studies can be performed.

The literature describing surgical trends in the treatment of shoulder instability is sparse and variable. With regard to other shoulder etiologies, only rotator cuff pathology has used expert consensus. Acevedo and colleagues¹³ reported agreement of ASES members surveyed regarding rotator cuff management. There was no consensus among surgeons in more than 50% of questions, despite AAOS published guidelines for rotator cuff treatment.²⁵ Despite the lack of guidelines for our topic, we found a consensus among respondents with 68% of survey questions.

To date, only 2 studies of shoulder instability management have elicited the opinion of experts in shoulder surgery. Chahal and associates⁶ surveyed 42 members of ASES and JOINTS (Joined Orthopaedic Initiatives for National Trials of the Shoulder) Canada on shoulder instability cases and found substantial agreement on diagnosis but little consensus regarding surgical technique. This lack of agreement on procedures differs from our findings and may be related to their complicated case scenarios that generated a wide array of treatment recommendations. Randelli and colleagues⁵ surveyed more than 1000 European Society of Sports Traumatology, Knee Surgery, and Arthroscopy members and reported similar agreement on arthroscopic Bankart repair in young male shoulder-dislocation patients, although no other instability scenarios were investigated. Our study is the first to report responses from expert shoulder surgeons on surgical-treatment strategies for an array of common shoulder instability pathologies.

This study had several limitations. First, while our study suffered from a low response rate (29.9%), it was similar to other published studies.^5,13 Second, because the case series included in the survey attempted to capture the most common instability scenarios, they were limited in their scope and failed to address additional etiologies or pathologic permutations. We believe, however, that a more comprehensive survey would have resulted in respondent fatigue and lowered the response rate. It is unlikely that any survey could capture all variables that come into play during clinical decision-making, and we sought to evaluate the most common shoulder instability scenarios. Third, 30% of respondents were from outside the United States, where the Latarjet procedure is much more popular. While this was not a majority, Latarjet’s regional preference may have decreased the consensus response in some scenarios if only the United States was included. Finally, there is inherent bias in a respondent pool that is heavily weighted to shoulder-surgery experts (ASES members) and does not consider the responses of the general orthopedic surgery community as have other studies.⁷

Conclusion

This study demonstrates that expert shoulder surgeons often agreed on shoulder-treatment principles for anterior shoulder instability. In the setting of primary repair, arthroscopic Bankart repair was favored in the absence of bony pathology, regardless of age (20 to 35 years) or nature of sport (contact versus noncontact). Latarjet procedures were favored in the setting of glenoid bone loss, and remplissage for an engaging Hill-Sachs lesion. Less agreement was observed for revision stabilization. It should be noted that, while consensus was often reached for our cases, there was a wide distribution of technical considerations and surgical preferences even among those who are fellowship-trained and high-volume surgeons, and who can be considered experts in the field of shoulder surgery.

Despite an abundance of peer-reviewed resources, there is wide variation in the surgical management of shoulder instability.^1,2 Current American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines regarding the shoulder address only generalized shoulder pain, glenohumeral osteoarthritis, and rotator cuff injuries,^3,4 and treatment algorithms focus on conservative treatment, rather than surgical recommendations.^4-7

Shoulder instability most commonly results from 1 or more of 4 common lesions (capsular laxity, glenoid bone loss, humeral bone loss, and capsulolabral insufficiency).⁸ While it is a relatively common condition that represents 1% to 2% of all athletic injuries,^9,10 little consensus exists about surgical indications, ideal treatment algorithms, or optimal operative technique. This is a critical issue because more than 50% of patients with glenohumeral instability will undergo surgical intervention.¹¹ Chahal and associates⁶ surveyed 44 shoulder experts and reported strong consensus about diagnosis, but little agreement regarding surgical management. Owens and colleagues¹ have also evaluated current trends for surgical treatment of this pathology. Randelli and associates⁵ attempted to categorize operative management based upon case-specific shoulder scenarios through online surveys. Their survey, however, covered a broad range of shoulder injuries rather than instability in particular. In this study, we assess trends for surgical management of glenohumeral instability in a case-based survey of shoulder experts.

Materials and Methods

Survey Information

An online survey (Survey Monkey) of 417 active members of the American Shoulder and Elbow Surgeons (ASES) was administered on May 1, 2014. Respondents were blinded to the institution and co-investigators conducting the survey. The survey link was distributed via email because it has been shown to be a more efficacious conduit than standard postal mail.¹² The case-based, 25-question survey (Appendix) was designed to assess respondents’ selection of surgical intervention. Section 1 determined member demographics, including fellowship training, arthroscopy experience, and years of practice. Section 2 involved the presentation of 5 case scenarios. For each case, respondents were asked to identify the optimal surgical procedure in both primary and revision settings. Section 3 posed several general questions regarding shoulder-instability management.

Statistical Analysis

Data were stored using Microsoft Excel (Microsoft) and analyzed using SAS Software version 9.3 (SAS Institute, Inc.). Demographic survey responses were reported using descriptive statistics. Responses to clinical survey questions were reported using frequencies and percentages. To identify when a majority consensus was achieved for a given question, responses were flagged as reaching consensus when more than 50% of participants gave the same response.¹³In the event that only 2 response options were available, reaching consensus required 67% of respondents to choose a single answer (since, by default, a consensus would be reached with only 2 response options). Because this was an analysis of all respondents, an a priori power calculation was not performed. Associations between training and practice demographics and responses to clinical questions were investigated using chi-square analyses. All comparative analyses were two-tailed and used P = .05 as the threshold for statistical significance.

Results

Demographics

One hundred and twenty-five (29.9%) ASES members responded to the survey. Of the respondents, 71.2% reported at least 15 years of experience, and 71% performed more than 150 shoulder cases annually. Surgeons came from academic institutions (41.6%), private practice (24.8%), or mixed (33.6%). The majority of respondents were fellowship-trained in shoulder/elbow surgery (52.8%), while fewer had completed a sports-medicine fellowship (24.0%). For arthroscopic procedures, responses were nearly divided between those who preferred beach-chair positioning (47.2%) and those who preferred the lateral decubitus position (46.4%). The majority (70.4%) of respondents practiced in the United States and with a relatively even distribution among states and region. The remaining 29.6% of those surveyed practiced abroad.

Degree of Consensus Responses and Cases

Of the 25 survey questions, 6 questions were omitted from consensus calculations because these were designed for demographic categorization rather than professional opinion (questions 1-5, 8). Thirteen of the remaining 19 questions (68%) reached consensus response. All clinical case scenarios (5 of 5) reached consensus for selection of technique for the primary procedure; however, only 40% (2 of 5) of cases had a consensus in the revision setting.

In case 1, a young soccer player (noncontact athlete) with negligible bone loss, arthroscopic Bankart repair was recommended by 81.6% of respondents. In the event of revision surgery, only 22.4% recommended arthroscopic Bankart repair, and the remainder split between open Bankart repair with possible capsular shift (36%) or Latarjet procedure (32.8%).

In case 2, a college American football player (contact athlete) with negligible bone loss, arthroscopic Bankart repair was recommended by 56.8%. In the event of revision surgery, a majority of members (51.2%) suggested a Latarjet procedure.

In case 3, the weekend warrior with significant bone loss, most respondents recommended a Latarjet procedure for both primary (72.8%) and revision surgery (79.0%).

In case 4, a weekend warrior with multidirectional instability, 60% of respondents suggested arthroscopic Bankart repair, 21.6% recommended rotator interval closure, and 10.4% chose a capsular shift. As a revision procedure, there was less agreement, with a split between open Bankart repair (39.2%) and capsular shift only (39.2%).

In case 5, the weekend warrior with large engaging Hill-Sachs lesions, 60% of respondent selected a remplissage procedure. If revision was required, a Latarjet procedure was the choice of 48.8% of respondents (Table).

General Questions

For contact athletes, most respondents (87.2%) would allow return to play in the same season and recommended surgery after the end of the season. After surgical intervention, 56.8% prescribed 4 weeks of immobilization. When counseling a return to contact sports, 51.2% recommended waiting for 4 to 6 months.

The ASES members were divided on conservative management of instability injuries. Responses included immobilization in internal rotation (39.2%), no immobilization (39.2%), and external-rotation bracing (21.6%).

Finally, members thought the most important factor in choosing surgical technique was the patient’s pathology, then age; the least influential criteria was the patient’s sports participation.

Analysis of Training Demographics and Surgical Technique Preferences

Chi-square analyses demonstrated that respondents who completed a sports fellowship were more likely to do at least 50% of cases arthroscopically (odds ratio [OR], 15.3; P < .001) and were more likely to use the lateral decubitus position (OR, 2.8; P < .021). Furthermore, American respondents had a higher likelihood of having completed either a sports fellowship (OR, 12.8; P < .001) or a shoulder/elbow fellowship (OR, 4.6; P = .002) when compared with foreign respondents.

Discussion

In the absence of formal clinical practice guidelines, most surgeons formulate treatment strategy based upon a combination of experience and peer-reviewed evidence. The cohort analyzed in the current study was highly experienced, with more than 70% performing 150 shoulder cases annually and having more than 15 years of experience. We found a consensus response in 68% of questions and all primary surgical techniques for our shoulder instability scenarios. While expert consensus reported here is not equivalent to evidence-based clinical practice guidelines, it does provide important information to consider when treating anterior shoulder instability.

Specific responses to our case scenarios invite further reflection. Considering young (both noncontact and contact) athletes without bony pathology (cases 1 and 2, respectively), the ASES surgeons recommended arthroscopic Bankart repair for both. Randelli and associates5 found 71% of survey respondents recommended arthroscopic Bankart repair in a similar setting. It is interesting to note that consensus persisted regardless of the sport in which they engaged. Contact athletes have the highest rates of dislocation (up to 7 times higher incidence) compared with the general population.¹⁴ In addition, they have a higher recurrence rate after surgery.¹⁵ It should be noted, however, that although both cases reached consensus, the percentage of experts who recommended an arthroscopic procedure fell from 82% in the noncontact athlete to 57% in the contact athlete. This concurs with a recent review by Harris and Romeo,¹⁶ who recommended similar treatments for athletes without bony defects. In an older patient population with recurrent instability (case 3), responses varied more widely but still reached a consensus on primary surgical techniques. Respondents agreed that, even for patients with multidirectional instability, initial management should consist of arthroscopic capsulolabral repair. Overall, the agreement for arthroscopy for cases 1 through 3 mimics recent US practice patterns, showing 90% of stabilizations are being performed arthroscopically.¹⁷ Additionally, a recent meta-analysis by Harris and associates18 favored arthroscopic Bankart repair, showing no significant difference vs open stabilization even on long-term follow-up.

Glenoid bone loss is a difficult clinical scenario and that is reflected in this study’s findings. The literature suggests that arthroscopic Bankart repair, in this setting, is usually not sufficient and may result in a recurrence rate up to 75%, if bone loss greater than 20% is unaddressed.¹⁹ Our study supports this trend because ASES members recommended a Latarjet procedure when there is substantial bone loss.

While open Latarjet procedure was the consensus for dealing with glenoid bone loss, arthroscopic techniques were strongly favored for humeral head defects. This change in practice patterns results from the introduction of the arthroscopic remplissage technique.²⁰ Two recent systemic reviews have supported this technique, reporting good functional outcomes for engaging Hill-Sachs lesions.^21,22 Our study had similar agreement, with most respondents recommending remplissage for these patients.

This study found the lowest rates of expert consensus in the setting of revision surgery, likely caused, in part, by the paucity of available large cohort studies. This is a major void in the literature, and more studies are needed to help guide surgeons on the best techniques to deal with this difficult patient population.

Conservative bracing technique was 1 of the survey questions lacking a consensus response. Interestingly, 39% of members recommended no immobilization after an instability event. This contrasts with recent literature concerning the best position for bracing. We also found twice as many surgeons recommended internal rotation immobilization over external rotation. This is a subject of debate, with some studies stating improvement with external rotation immobilization,²³ while other studies reported no difference.²⁴ Overall, recommendations regarding type of immobilization are unclear, which will likely continue until larger studies can be performed.

The literature describing surgical trends in the treatment of shoulder instability is sparse and variable. With regard to other shoulder etiologies, only rotator cuff pathology has used expert consensus. Acevedo and colleagues¹³ reported agreement of ASES members surveyed regarding rotator cuff management. There was no consensus among surgeons in more than 50% of questions, despite AAOS published guidelines for rotator cuff treatment.²⁵ Despite the lack of guidelines for our topic, we found a consensus among respondents with 68% of survey questions.

To date, only 2 studies of shoulder instability management have elicited the opinion of experts in shoulder surgery. Chahal and associates⁶ surveyed 42 members of ASES and JOINTS (Joined Orthopaedic Initiatives for National Trials of the Shoulder) Canada on shoulder instability cases and found substantial agreement on diagnosis but little consensus regarding surgical technique. This lack of agreement on procedures differs from our findings and may be related to their complicated case scenarios that generated a wide array of treatment recommendations. Randelli and colleagues⁵ surveyed more than 1000 European Society of Sports Traumatology, Knee Surgery, and Arthroscopy members and reported similar agreement on arthroscopic Bankart repair in young male shoulder-dislocation patients, although no other instability scenarios were investigated. Our study is the first to report responses from expert shoulder surgeons on surgical-treatment strategies for an array of common shoulder instability pathologies.

This study had several limitations. First, while our study suffered from a low response rate (29.9%), it was similar to other published studies.^5,13 Second, because the case series included in the survey attempted to capture the most common instability scenarios, they were limited in their scope and failed to address additional etiologies or pathologic permutations. We believe, however, that a more comprehensive survey would have resulted in respondent fatigue and lowered the response rate. It is unlikely that any survey could capture all variables that come into play during clinical decision-making, and we sought to evaluate the most common shoulder instability scenarios. Third, 30% of respondents were from outside the United States, where the Latarjet procedure is much more popular. While this was not a majority, Latarjet’s regional preference may have decreased the consensus response in some scenarios if only the United States was included. Finally, there is inherent bias in a respondent pool that is heavily weighted to shoulder-surgery experts (ASES members) and does not consider the responses of the general orthopedic surgery community as have other studies.⁷

Conclusion

This study demonstrates that expert shoulder surgeons often agreed on shoulder-treatment principles for anterior shoulder instability. In the setting of primary repair, arthroscopic Bankart repair was favored in the absence of bony pathology, regardless of age (20 to 35 years) or nature of sport (contact versus noncontact). Latarjet procedures were favored in the setting of glenoid bone loss, and remplissage for an engaging Hill-Sachs lesion. Less agreement was observed for revision stabilization. It should be noted that, while consensus was often reached for our cases, there was a wide distribution of technical considerations and surgical preferences even among those who are fellowship-trained and high-volume surgeons, and who can be considered experts in the field of shoulder surgery.

Disagreement over quality measures regarding hypertension has led the American College of Cardiology and the American Heart Association to withhold their imprimatur from the Core Quality Measures Collaborative.

The collaborative ultimately chose to endorse two hypertension measures and will allow physicians to report on either. A measure put forward by the National Quality Forum defines adequate blood pressure control as less than 140/90 mm Hg while a measure from the Healthcare Effectiveness Data and Information Set (HEDIS 2016) defines adequate control as less than 150/90 mm Hg for patients over 60 years of age without diabetes or chronic kidney disease.

©Ingram Publishing/thinkstockphotos.com

“AHA and ACC have concerns with the inclusion of the HEDIS 2016 measure in these core measure sets because of its likelihood to increase the number of inadequately treated patients with high [blood pressure], who would be at greater risk for heart disease and stroke,” Dr. Richard Chazal, ACC president-elect, and Dr. Mark Creager, AHA president, wrote in an editorial published Feb. 16 in Hypertension (2016 Feb 18. doi: 10.1161/HYP.0000000000000043).

The Core Quality Measures Collaborative is led by the Centers for Medicare & Medicaid Services and America’s Health Insurance Plans, with input from the National Quality Forum, medical societies, employer groups, and consumer groups, with the goal of building a uniform set of quality measures to be used by both public and private payers in value-based payment structures.

The first seven sets of measures under the collaborative were announced Feb. 16; cardiology measures were included in this limited release.

For cardiology, the quality measures span a number of areas, including chronic cardiovascular condition measures (including congestive heart failure, hypertension, ischemic heart disease/coronary heart disease, atrial fibrillation, and prevention) and acute cardiovascular condition measures (including acute myocardial infarction, angioplasty and stents, implantable cardiac defibrillators, cardiac catheterization, and pediatric heart surgery).

A number of measures were identified for future inclusion, including proportion of days covered; defect-free care for acute MI; clinician-level companion measure to hospital risk-standardized complication rate following implantation of implantable cardioverter-defibrillator; postdischarge appointment for heart failure patients; and cardiac stress imaging not meeting appropriate use criteria: routine testing after percutaneous coronary intervention.

Beyond the concerns with the hypertension measure, nothing in particular was left out of the first set of measures, Dr. Paul Casale, a member of the ACC board of trustees, said in an interview. He added that he expects to see more outcomes-related measures in the future.

“There is always the tension between current measures that we can collect more easily, which tend to be some of the more process-related measures, versus the outcomes measures, which everyone would like to see more of,” Dr. Casale said. “But we are challenged, particularly around collection, so I think moving forward we’ll look for opportunities for that.”

The set also identified a few other areas where measures are expected to be developed, including a number around heart failure, renal function measures for hypertension, and others.

According to the editorial in Hypertension, both the ACC and the AHA expect the current hypertension measures to change as new evidence is brought forward.

“AHA and ACC are currently in the process of developing a guideline for [high blood pressure] treatment that will evaluate the full span of evidence, including the endpoint of stroke,” Dr. Chazal and Dr. Creager wrote, noting that the guideline is expected to be released later this year. “Until the new guideline is published, we urge, as we did in an advisory along with the Centers for Disease Control and Prevention in 2014, all health care providers and patients to strive to reach a BP target of less than 140/90 mmHg.”

[email protected]

Disagreement over quality measures regarding hypertension has led the American College of Cardiology and the American Heart Association to withhold their imprimatur from the Core Quality Measures Collaborative.

The collaborative ultimately chose to endorse two hypertension measures and will allow physicians to report on either. A measure put forward by the National Quality Forum defines adequate blood pressure control as less than 140/90 mm Hg while a measure from the Healthcare Effectiveness Data and Information Set (HEDIS 2016) defines adequate control as less than 150/90 mm Hg for patients over 60 years of age without diabetes or chronic kidney disease.

©Ingram Publishing/thinkstockphotos.com

“AHA and ACC have concerns with the inclusion of the HEDIS 2016 measure in these core measure sets because of its likelihood to increase the number of inadequately treated patients with high [blood pressure], who would be at greater risk for heart disease and stroke,” Dr. Richard Chazal, ACC president-elect, and Dr. Mark Creager, AHA president, wrote in an editorial published Feb. 16 in Hypertension (2016 Feb 18. doi: 10.1161/HYP.0000000000000043).

The Core Quality Measures Collaborative is led by the Centers for Medicare & Medicaid Services and America’s Health Insurance Plans, with input from the National Quality Forum, medical societies, employer groups, and consumer groups, with the goal of building a uniform set of quality measures to be used by both public and private payers in value-based payment structures.

The first seven sets of measures under the collaborative were announced Feb. 16; cardiology measures were included in this limited release.

For cardiology, the quality measures span a number of areas, including chronic cardiovascular condition measures (including congestive heart failure, hypertension, ischemic heart disease/coronary heart disease, atrial fibrillation, and prevention) and acute cardiovascular condition measures (including acute myocardial infarction, angioplasty and stents, implantable cardiac defibrillators, cardiac catheterization, and pediatric heart surgery).

A number of measures were identified for future inclusion, including proportion of days covered; defect-free care for acute MI; clinician-level companion measure to hospital risk-standardized complication rate following implantation of implantable cardioverter-defibrillator; postdischarge appointment for heart failure patients; and cardiac stress imaging not meeting appropriate use criteria: routine testing after percutaneous coronary intervention.

Beyond the concerns with the hypertension measure, nothing in particular was left out of the first set of measures, Dr. Paul Casale, a member of the ACC board of trustees, said in an interview. He added that he expects to see more outcomes-related measures in the future.

“There is always the tension between current measures that we can collect more easily, which tend to be some of the more process-related measures, versus the outcomes measures, which everyone would like to see more of,” Dr. Casale said. “But we are challenged, particularly around collection, so I think moving forward we’ll look for opportunities for that.”

The set also identified a few other areas where measures are expected to be developed, including a number around heart failure, renal function measures for hypertension, and others.

According to the editorial in Hypertension, both the ACC and the AHA expect the current hypertension measures to change as new evidence is brought forward.

“AHA and ACC are currently in the process of developing a guideline for [high blood pressure] treatment that will evaluate the full span of evidence, including the endpoint of stroke,” Dr. Chazal and Dr. Creager wrote, noting that the guideline is expected to be released later this year. “Until the new guideline is published, we urge, as we did in an advisory along with the Centers for Disease Control and Prevention in 2014, all health care providers and patients to strive to reach a BP target of less than 140/90 mmHg.”

[email protected]

Disagreement over quality measures regarding hypertension has led the American College of Cardiology and the American Heart Association to withhold their imprimatur from the Core Quality Measures Collaborative.

The collaborative ultimately chose to endorse two hypertension measures and will allow physicians to report on either. A measure put forward by the National Quality Forum defines adequate blood pressure control as less than 140/90 mm Hg while a measure from the Healthcare Effectiveness Data and Information Set (HEDIS 2016) defines adequate control as less than 150/90 mm Hg for patients over 60 years of age without diabetes or chronic kidney disease.

©Ingram Publishing/thinkstockphotos.com

“AHA and ACC have concerns with the inclusion of the HEDIS 2016 measure in these core measure sets because of its likelihood to increase the number of inadequately treated patients with high [blood pressure], who would be at greater risk for heart disease and stroke,” Dr. Richard Chazal, ACC president-elect, and Dr. Mark Creager, AHA president, wrote in an editorial published Feb. 16 in Hypertension (2016 Feb 18. doi: 10.1161/HYP.0000000000000043).

The Core Quality Measures Collaborative is led by the Centers for Medicare & Medicaid Services and America’s Health Insurance Plans, with input from the National Quality Forum, medical societies, employer groups, and consumer groups, with the goal of building a uniform set of quality measures to be used by both public and private payers in value-based payment structures.

The first seven sets of measures under the collaborative were announced Feb. 16; cardiology measures were included in this limited release.

For cardiology, the quality measures span a number of areas, including chronic cardiovascular condition measures (including congestive heart failure, hypertension, ischemic heart disease/coronary heart disease, atrial fibrillation, and prevention) and acute cardiovascular condition measures (including acute myocardial infarction, angioplasty and stents, implantable cardiac defibrillators, cardiac catheterization, and pediatric heart surgery).

A number of measures were identified for future inclusion, including proportion of days covered; defect-free care for acute MI; clinician-level companion measure to hospital risk-standardized complication rate following implantation of implantable cardioverter-defibrillator; postdischarge appointment for heart failure patients; and cardiac stress imaging not meeting appropriate use criteria: routine testing after percutaneous coronary intervention.

Beyond the concerns with the hypertension measure, nothing in particular was left out of the first set of measures, Dr. Paul Casale, a member of the ACC board of trustees, said in an interview. He added that he expects to see more outcomes-related measures in the future.

“There is always the tension between current measures that we can collect more easily, which tend to be some of the more process-related measures, versus the outcomes measures, which everyone would like to see more of,” Dr. Casale said. “But we are challenged, particularly around collection, so I think moving forward we’ll look for opportunities for that.”

The set also identified a few other areas where measures are expected to be developed, including a number around heart failure, renal function measures for hypertension, and others.

According to the editorial in Hypertension, both the ACC and the AHA expect the current hypertension measures to change as new evidence is brought forward.

“AHA and ACC are currently in the process of developing a guideline for [high blood pressure] treatment that will evaluate the full span of evidence, including the endpoint of stroke,” Dr. Chazal and Dr. Creager wrote, noting that the guideline is expected to be released later this year. “Until the new guideline is published, we urge, as we did in an advisory along with the Centers for Disease Control and Prevention in 2014, all health care providers and patients to strive to reach a BP target of less than 140/90 mmHg.”

[email protected]

Although recent clinical results of arthroscopic rotator cuff repair (RCR) have been encouraging, achieving anatomical healing of full-thickness rotator cuff tears remains a challenge.^1-4 Several factors influence rotator cuff healing after repair.^1,3-8 Patient-related factors include advanced patient age, tear size, tear chronicity, and amount of fatty infiltration.^1,3,5,6,8-10 Tension applied to the repair construct is a significant factor as well.^11,12

In the literature, limited consideration has been given to repair tension.¹³ The majority of studies have focused on other factors, mainly repair technique. Some surgeons advocate use of a double-row repair construct in which the rotator cuff tendon is pulled to the lateral margin of the footprint.^14-19 Double-row techniques, which include the transosseous-equivalent (TOE) construct, are biomechanically superior to other repairs.^20-26 Another purported benefit of double-row repair is more complete restoration and pressurization of the rotator cuff footprint.^21,24,27,28

Rotator cuff tears typically occur near the dysvascular region of the diseased musculotendinous unit, often leaving a stump of tissue attached to the tuberosity and ultimately a shortened tendon.²⁹ In addition, full-thickness tears often retract over time. Meyer and colleagues²⁹ recently demonstrated that this shortening is irreversible. Snyder³⁰ and Sostak and colleagues³¹ suggested that pulling a shortened, degenerative rotator cuff tendon to the lateral margin of the footprint results in increased tissue tension compared with that produced with a more medially based repair just off the articular margin. In our opinion, the possible increase in tension during a laterally based repair, whether single- or double-row, may place excessive strain on the diseased tissue as well as the surgical construct, potentially contributing to repair failure.

We conducted a study to evaluate the difference, if any, in tension applied to the rotator cuff tendon positioned at the medial versus lateral margin of the footprint during arthroscopic RCR. We hypothesized significantly more tension would be placed on the rotator cuff tendon when positioned at the lateral versus medial footprint.

Methods

After obtaining Institutional Review Board approval for this study, we collected data on a consecutive series of patients who underwent arthroscopic RCR performed by Dr. Getelman at a single institution. Only patients with primary full-thickness tears of the supraspinatus and/or infraspinatus were included. Exclusion criteria included revision rotator cuff surgeries, partial-thickness tears, concurrent subscapularis tears requiring anchor fixation, and any tears that could not be mobilized to the lateral footprint without interval slides or margin convergence. The 20 identified patients constituted the study group.

Demographic factors, including age and preoperative length of symptoms, were recorded after chart review. Magnetic resonance imaging (MRI) was performed for all patients before surgery and was retrospectively reviewed. Dr. Getelman assigned each patient a modified Goutallier score, based on MRI, to assess for fatty infiltration/atrophy.³² Each patient was placed in the lateral decubitus position with the operative arm in balanced suspension at 70° of abduction. Standard glenohumeral and subacromial diagnostic arthroscopy was performed. The rotator cuff tear was gently debrided back to a healthy-appearing margin in preparation for repair. The tear was then measured in the anterior-posterior (A-P) and medial-lateral (M-L) planes using a premeasured, marked suture, as previously described.33 Complete bursal and articular-sided releases were performed to allow for appropriate mobilization of the tendon. The tear was classified as crescent-shaped, U-shaped, or L-shaped.

Viewing from the posterior portal, the surgeon inserted a tissue grasper through the lateral portal. The tendon was grasped at multiple points along its edge, anterior to posterior, and was translated laterally to assess its reducibility; the apex of the tear correlated with the point of maximal excursion and coverage of the footprint. Once confirmed, the rotator cuff tear apex was clamped with a tissue grasper. After placement in a sterile arthroscopic camera sleeve (DeRoyal camera drape with perforated tip), a calibrated digital weigh scale (American Weigh Scales model H22 portable electronic hanging scale, with accuracy of 0.01 lb) was attached to the tissue grasper with an S-hook (Figure 1). The tendon edge was first translated about 3 mm lateral to the articular margin (the medial footprint position), and tension was recorded (Figures 2A, 2B). After a 1-minute relaxation period, the tendon edge was translated to the lateral edge of the rotator cuff footprint (the lateral footprint position), and tension was recorded again (Figures 2C, 2D). A medially based single-row RCR with triple-loaded sutures and bone marrow vents placed in the lateral tuberosity was then completed, regardless of tension, tear size, or tear morphology.³¹ Typically, 1 anchor was used for every 10 to 15 mm of A-P tear length.

SAS software was used for statistical analysis, the Wilcoxon signed rank test for continuous or ordinal data comparisons between paired groups, and the Mann-Whitney test for continuous or ordinal data comparisons between independent, unmatched groups. One-way analysis of variance (ANOVA) was used to compare means among the 3 groups of morphology subtypes. Linear regression was performed to assess the simultaneous relationship between potential predictors (age, sex, length of symptoms, Goutallier score, tear size) and medial or lateral tension, where medial tension was included as an additional potential predictor for lateral tension. Restricted cubic splines were fit to assess linearity. Predictors were retained in multivariate regression using backward variable retention. Because of inadequate sample size, additivity was assumed except for sex. Statistical significance was set at P < .05.

Results

Of the 20 rotator cuff tears evaluated (Table 1), 13 were crescent-shaped, 5 were U-shaped, and 2 were L-shaped. Mean (SD) A-P tear size was 17.7 (5.8) mm, and mean (SD) M-L tear size was 19.1 (8.6) mm. Mean age of the 20 patients (15 men, 5 women) was 57.9 years (range, 44-72 years). Mean (SD) length of symptoms was 12.9 (12.4) months (range, 3-48 months). Mean (SD) modified Goutallier score was 1.4 (0.7; range, 0-3).

Mean (SD) rotator cuff tension for all tears approximated to the medial footprint was 0.41 (0.33) pound, and mean (SD) cuff tension for all tears approximated to the lateral footprint was 2.21 (1.20) pounds—representing a 5.4-fold difference (P < .0001).

No statistically significant differences were detected in the ANOVA comparing tensions at medial and lateral positions among tear morphologic subtypes (all Ps >.05).

Subgroup analysis (Table 2) was performed for smaller (≤20 mm A-P) and larger (>20 mm A-P) tears. For smaller tears, mean (SD) tension was 0.27 (0.24) pound applied with the cuff tendon pulled to the medial footprint and 2.06 (1.06) pounds applied with the tendon pulled to the lateral footprint—a 7.6-fold difference (P < .0018). For larger tears, mean (SD) tension was 0.58 (0.37) pound applied with the tendon pulled to the medial footprint and 2.38 (1.4) pounds applied with the tendon pulled to the lateral footprint—a 4.1-fold difference (P < .005).

A statistically significant difference in tensions was found between small and large cuff tears positioned at the medial footprint (0.27 vs 0.58 lb; P = .0367); no difference was found between groups with the tendon at the lateral footprint (2.06 vs 2.38 lb; P = .284).

Univariate and multivariate analyses were performed using linear regression analysis (Table 3). During univariate analysis for medial footprint position, A-P tear size and Goutallier score both positively correlated with increasing tension; for lateral footprint position, no factors statistically correlated with lateral tension, though there was a positive trend for medial tension and female sex. During multivariate analysis for medial footprint position, only A-P tear size positively correlated with increasing tension; for lateral footprint position, both age (in nonlinear fashion as function of age + age²) and medial tension positively correlated with increasing tension.

Discussion

Our results indicated that significantly more tension is placed on the torn rotator cuff tendon when it is reduced across the footprint from a medial to a more lateral position in vivo. More tension was required for all tears to be reduced to the lateral footprint compared with the medial footprint. As expected, compared with smaller tears, larger tears required significantly more tension in order to be reduced to the medial footprint. Interestingly, no statistical difference was found between tensions required to reduce either small or large tears to the lateral footprint, which suggests that, regardless of tear size, more force must be applied to reduce the torn tendon to the lateral footprint compared with the medial footprint.

Hersche and Gerber³⁴ were the first to report rotator cuff tension measurements in vivo. Although their study did not specifically compare cuff tensions reducing the tear to the medial versus lateral footprint, it did examine tension at displacement of 10 and 20 mm. Tension increased from 27 N to 60 N, correlating with a 2.2-fold difference between the 2 distances. Domb and colleagues35 also compared in vivo rotator cuff tension differences between the medial footprint and the lateral footprint in 4 patients. Mean tension applied to the cuff during reduction to the articular margin was 27 N, or 6 pounds. Mean tension needed to reduce the cuff to the lateral tuberosity was 76 N, or 17 pounds, for a 2.8-fold difference. Tears were not measured but were described as massive and retracted.

Although repair tension has long been recognized as a crucial factor in RCR healing, little clinical research has focused on the effects of excess tension. Davidson and Rivenburgh11 prospectively followed the clinical outcomes of 67 consecutive cuff repairs after intraoperative tension measurement and found that high-tension repairs (>8 lb) had significantly lower clinical outcome measures. However, the authors did not report on correlations with radiologic healing and stated, “Functional outcome is inversely proportional to rotator cuff repair tension.” Further study of the in vivo effects of increased tension on clinical and radiologic outcomes is needed.

Several animal studies have been conducted on the effects of tension on RCRs. Gerber and colleagues36 reported that the force needed to produce 1 cm of sheep supraspinatus tendon excursion increased 7-fold, from 6.8 N to 47.8 N, after 40 weeks of tendon tear. Coleman and colleagues³⁷ compared the modulus of elasticity in sheep supraspinatus tendon after 6 weeks and 18 weeks of detachment and reported increases of 60% and 70%, respectively. Gimbel and colleagues³⁸ showed that, in a rat model, “repair tension rapidly increased initially after injury followed by a progressive, but less dramatic, increase with additional time.” Of note, we did not identify any correlation between chronicity of symptoms and the tension needed to reduce the tendon medially or to a more lateral position on the footprint.

In acute tears, the cuff tissue is more compliant and mobile and can be pulled laterally across its anatomical footprint with minimal tension.³⁹ In contrast, cuff tissue in the more commonly encountered chronic tear is less compliant and is not mobile enough to be pulled to the lateral margin of the footprint without added stress.^30,34,35 In large, acute tears in which there are minimal tissue degeneration and retraction, a laterally based footprint-restoring technique may be performed with minimal tension. This technique may have advantages over a medially based repair. In the literature, more attention needs to be directed toward the biomechanics and biology of chronic rotator cuff tears, as these are more commonly encountered.

Almost all of the prospective studies that have compared single- and double-row RCR have found no significant differences in MRI healing rates or clinical results at follow-up up to 2 years.^14,16,40-45 Detailed analysis of the surgical techniques used in all these studies revealed that the rotator cuff tendons were repaired back to the lateral footprint in both the single- and double-row constructs.^14,16,40-45 Although no clinical studies have compared medially and laterally based single-row repairs, our data suggest that medially based repairs have lower tensions and therefore should not be considered equivalent. Sostak and colleagues³¹ and Murray and colleagues⁴⁶ have shown that a medially based single-row RCR can achieve excellent clinical and anatomical results, likely partly because of the lower tension applied to the torn cuff tissue.^31,46 Studies are needed to compare medially and laterally based repairs, including single- and double-row repairs.

The vast majority of recent research has aimed to counteract construct tension with stronger biomechanical constructs.^20-26 Surgeons have also aimed to improve biological healing by pulling the tendon laterally across the footprint to achieve complete footprint coverage, ultimately increasing the surface area for tendon–bone healing. This has led to the development of various double-row repair techniques, in which the cuff tendon is pulled to the lateral margin of its footprint. One row of anchors is placed in the medial aspect of the footprint, while a second is placed in the lateral aspect; the cuff is reduced and compressed to the tuberosity with various suture configurations. The TOE technique was developed to improve pressurization of the cuff tendon across the footprint by linking the 2 rows with bridging sutures. In doing so, however, the potentially deleterious effects of increased tension introduced by pulling the tendon laterally may have been overlooked. Nevertheless, the biomechanics and stress distribution likely differ between single-row repair and TOE repairs, and direct comparisons cannot be made at this time. The medial row of a double-row or TOE construct may stress-shield or “unload” the more lateral tissue. Studies are needed in order to better understand the tension differential and stress distribution of various double-row constructs.

Recognizing tear morphology is crucial in maximizing chances of healing after cuff repair. For example, a crescent-shaped tear is reduced to the tuberosity with direct lateral translation of the apex of the tear, which is also the deepest or most displaced part of the tear. On the other hand, reducing an L- or reverse L-shaped tear to the tuberosity is not as direct; reducing the deepest or most displaced part of the tear would lead to overreduction and overtensioning of the tendon. However, often the exact “elbow” of the tear is not obvious and appears more rounded; therefore, it is crucial for the surgeon to examine the mobility of the torn tendon along its entire length to minimize tension. Study is needed to assess tension along the entire length of the tear for different tear morphologies and sizes.

Although our results showed that increased tension was needed to reduce a torn tendon to its lateral footprint, no study has indicated exactly how much is “too much” tension. As stated earlier, use of stronger biomechanical constructs, including TOE constructs, may overcome the increased tension associated with laterally based repairs. In addition, laterally based repairs, either single- or double-row, may be best suited for tears with lower tension, whereas medially based repairs may be best suited for higher tension tears. It is also possible that the difference in tensions noted in this study is not significant enough to have a clinical impact on choice of construct or on anatomical healing. We need studies that correlate anatomical healing rates with repair tension in order to better guide surgeons on when to use a medially or laterally based repair.

Other possible effects of increased tension associated with laterally based repairs, including beneficial effects, must be considered as well. Viscoelastic properties of human rotator cuff tendon may dissipate increased tension over time through a variety of mechanisms. Stress relaxation, gap formation, creep, and the hysteresis effect, all associated with cyclical loading in the early healing period, may lead to dissipation of force over time.^47,48 These more complex biomechanical properties of RCR constructs are yet to be clearly defined.

This study had several weaknesses. Its data represent a static measurement of time-zero rotator cuff tension, which greatly simplifies the biomechanics of the torn rotator cuff and repair construct as well as changes that occur with healing. During cuff repair, forces typically are distributed through several fixation points in stepwise process and are not focused on a single point of tissue with a grasper. Therefore, the findings of this study may not directly correlate with medially versus laterally based repairs in vivo. Furthermore, as this is a time-zero measurement, we could not determine whether the tension differential between the 2 repair positions remained static over time. Current literature suggests that muscle atrophy, fatty infiltration, and loss of elasticity of the musculotendinous unit are relatively irreversible.^35,37,49 In addition, determining the precise apex of a cuff tear can be difficult, so error may have been introduced during this process. Last, although placement of the cuff tissue at the medial or lateral footprint position was based on visual estimation by an experienced and skilled arthroscopist, error may have been introduced based on this imprecise technique.

Conclusion

This study demonstrated a significant, 5.4-fold increase in in vivo time-zero rotator cuff tension with the tendon edge reduced to the lateral footprint rather than the medial footprint.

Although recent clinical results of arthroscopic rotator cuff repair (RCR) have been encouraging, achieving anatomical healing of full-thickness rotator cuff tears remains a challenge.^1-4 Several factors influence rotator cuff healing after repair.^1,3-8 Patient-related factors include advanced patient age, tear size, tear chronicity, and amount of fatty infiltration.^1,3,5,6,8-10 Tension applied to the repair construct is a significant factor as well.^11,12

In the literature, limited consideration has been given to repair tension.¹³ The majority of studies have focused on other factors, mainly repair technique. Some surgeons advocate use of a double-row repair construct in which the rotator cuff tendon is pulled to the lateral margin of the footprint.^14-19 Double-row techniques, which include the transosseous-equivalent (TOE) construct, are biomechanically superior to other repairs.^20-26 Another purported benefit of double-row repair is more complete restoration and pressurization of the rotator cuff footprint.^21,24,27,28

Rotator cuff tears typically occur near the dysvascular region of the diseased musculotendinous unit, often leaving a stump of tissue attached to the tuberosity and ultimately a shortened tendon.²⁹ In addition, full-thickness tears often retract over time. Meyer and colleagues²⁹ recently demonstrated that this shortening is irreversible. Snyder³⁰ and Sostak and colleagues³¹ suggested that pulling a shortened, degenerative rotator cuff tendon to the lateral margin of the footprint results in increased tissue tension compared with that produced with a more medially based repair just off the articular margin. In our opinion, the possible increase in tension during a laterally based repair, whether single- or double-row, may place excessive strain on the diseased tissue as well as the surgical construct, potentially contributing to repair failure.

We conducted a study to evaluate the difference, if any, in tension applied to the rotator cuff tendon positioned at the medial versus lateral margin of the footprint during arthroscopic RCR. We hypothesized significantly more tension would be placed on the rotator cuff tendon when positioned at the lateral versus medial footprint.

Methods

After obtaining Institutional Review Board approval for this study, we collected data on a consecutive series of patients who underwent arthroscopic RCR performed by Dr. Getelman at a single institution. Only patients with primary full-thickness tears of the supraspinatus and/or infraspinatus were included. Exclusion criteria included revision rotator cuff surgeries, partial-thickness tears, concurrent subscapularis tears requiring anchor fixation, and any tears that could not be mobilized to the lateral footprint without interval slides or margin convergence. The 20 identified patients constituted the study group.

Demographic factors, including age and preoperative length of symptoms, were recorded after chart review. Magnetic resonance imaging (MRI) was performed for all patients before surgery and was retrospectively reviewed. Dr. Getelman assigned each patient a modified Goutallier score, based on MRI, to assess for fatty infiltration/atrophy.³² Each patient was placed in the lateral decubitus position with the operative arm in balanced suspension at 70° of abduction. Standard glenohumeral and subacromial diagnostic arthroscopy was performed. The rotator cuff tear was gently debrided back to a healthy-appearing margin in preparation for repair. The tear was then measured in the anterior-posterior (A-P) and medial-lateral (M-L) planes using a premeasured, marked suture, as previously described.33 Complete bursal and articular-sided releases were performed to allow for appropriate mobilization of the tendon. The tear was classified as crescent-shaped, U-shaped, or L-shaped.

Viewing from the posterior portal, the surgeon inserted a tissue grasper through the lateral portal. The tendon was grasped at multiple points along its edge, anterior to posterior, and was translated laterally to assess its reducibility; the apex of the tear correlated with the point of maximal excursion and coverage of the footprint. Once confirmed, the rotator cuff tear apex was clamped with a tissue grasper. After placement in a sterile arthroscopic camera sleeve (DeRoyal camera drape with perforated tip), a calibrated digital weigh scale (American Weigh Scales model H22 portable electronic hanging scale, with accuracy of 0.01 lb) was attached to the tissue grasper with an S-hook (Figure 1). The tendon edge was first translated about 3 mm lateral to the articular margin (the medial footprint position), and tension was recorded (Figures 2A, 2B). After a 1-minute relaxation period, the tendon edge was translated to the lateral edge of the rotator cuff footprint (the lateral footprint position), and tension was recorded again (Figures 2C, 2D). A medially based single-row RCR with triple-loaded sutures and bone marrow vents placed in the lateral tuberosity was then completed, regardless of tension, tear size, or tear morphology.³¹ Typically, 1 anchor was used for every 10 to 15 mm of A-P tear length.

SAS software was used for statistical analysis, the Wilcoxon signed rank test for continuous or ordinal data comparisons between paired groups, and the Mann-Whitney test for continuous or ordinal data comparisons between independent, unmatched groups. One-way analysis of variance (ANOVA) was used to compare means among the 3 groups of morphology subtypes. Linear regression was performed to assess the simultaneous relationship between potential predictors (age, sex, length of symptoms, Goutallier score, tear size) and medial or lateral tension, where medial tension was included as an additional potential predictor for lateral tension. Restricted cubic splines were fit to assess linearity. Predictors were retained in multivariate regression using backward variable retention. Because of inadequate sample size, additivity was assumed except for sex. Statistical significance was set at P < .05.

Results

Of the 20 rotator cuff tears evaluated (Table 1), 13 were crescent-shaped, 5 were U-shaped, and 2 were L-shaped. Mean (SD) A-P tear size was 17.7 (5.8) mm, and mean (SD) M-L tear size was 19.1 (8.6) mm. Mean age of the 20 patients (15 men, 5 women) was 57.9 years (range, 44-72 years). Mean (SD) length of symptoms was 12.9 (12.4) months (range, 3-48 months). Mean (SD) modified Goutallier score was 1.4 (0.7; range, 0-3).

Mean (SD) rotator cuff tension for all tears approximated to the medial footprint was 0.41 (0.33) pound, and mean (SD) cuff tension for all tears approximated to the lateral footprint was 2.21 (1.20) pounds—representing a 5.4-fold difference (P < .0001).

No statistically significant differences were detected in the ANOVA comparing tensions at medial and lateral positions among tear morphologic subtypes (all Ps >.05).

Subgroup analysis (Table 2) was performed for smaller (≤20 mm A-P) and larger (>20 mm A-P) tears. For smaller tears, mean (SD) tension was 0.27 (0.24) pound applied with the cuff tendon pulled to the medial footprint and 2.06 (1.06) pounds applied with the tendon pulled to the lateral footprint—a 7.6-fold difference (P < .0018). For larger tears, mean (SD) tension was 0.58 (0.37) pound applied with the tendon pulled to the medial footprint and 2.38 (1.4) pounds applied with the tendon pulled to the lateral footprint—a 4.1-fold difference (P < .005).

A statistically significant difference in tensions was found between small and large cuff tears positioned at the medial footprint (0.27 vs 0.58 lb; P = .0367); no difference was found between groups with the tendon at the lateral footprint (2.06 vs 2.38 lb; P = .284).

Univariate and multivariate analyses were performed using linear regression analysis (Table 3). During univariate analysis for medial footprint position, A-P tear size and Goutallier score both positively correlated with increasing tension; for lateral footprint position, no factors statistically correlated with lateral tension, though there was a positive trend for medial tension and female sex. During multivariate analysis for medial footprint position, only A-P tear size positively correlated with increasing tension; for lateral footprint position, both age (in nonlinear fashion as function of age + age²) and medial tension positively correlated with increasing tension.

Discussion

Our results indicated that significantly more tension is placed on the torn rotator cuff tendon when it is reduced across the footprint from a medial to a more lateral position in vivo. More tension was required for all tears to be reduced to the lateral footprint compared with the medial footprint. As expected, compared with smaller tears, larger tears required significantly more tension in order to be reduced to the medial footprint. Interestingly, no statistical difference was found between tensions required to reduce either small or large tears to the lateral footprint, which suggests that, regardless of tear size, more force must be applied to reduce the torn tendon to the lateral footprint compared with the medial footprint.

Hersche and Gerber³⁴ were the first to report rotator cuff tension measurements in vivo. Although their study did not specifically compare cuff tensions reducing the tear to the medial versus lateral footprint, it did examine tension at displacement of 10 and 20 mm. Tension increased from 27 N to 60 N, correlating with a 2.2-fold difference between the 2 distances. Domb and colleagues35 also compared in vivo rotator cuff tension differences between the medial footprint and the lateral footprint in 4 patients. Mean tension applied to the cuff during reduction to the articular margin was 27 N, or 6 pounds. Mean tension needed to reduce the cuff to the lateral tuberosity was 76 N, or 17 pounds, for a 2.8-fold difference. Tears were not measured but were described as massive and retracted.

Although repair tension has long been recognized as a crucial factor in RCR healing, little clinical research has focused on the effects of excess tension. Davidson and Rivenburgh11 prospectively followed the clinical outcomes of 67 consecutive cuff repairs after intraoperative tension measurement and found that high-tension repairs (>8 lb) had significantly lower clinical outcome measures. However, the authors did not report on correlations with radiologic healing and stated, “Functional outcome is inversely proportional to rotator cuff repair tension.” Further study of the in vivo effects of increased tension on clinical and radiologic outcomes is needed.

Several animal studies have been conducted on the effects of tension on RCRs. Gerber and colleagues36 reported that the force needed to produce 1 cm of sheep supraspinatus tendon excursion increased 7-fold, from 6.8 N to 47.8 N, after 40 weeks of tendon tear. Coleman and colleagues³⁷ compared the modulus of elasticity in sheep supraspinatus tendon after 6 weeks and 18 weeks of detachment and reported increases of 60% and 70%, respectively. Gimbel and colleagues³⁸ showed that, in a rat model, “repair tension rapidly increased initially after injury followed by a progressive, but less dramatic, increase with additional time.” Of note, we did not identify any correlation between chronicity of symptoms and the tension needed to reduce the tendon medially or to a more lateral position on the footprint.

In acute tears, the cuff tissue is more compliant and mobile and can be pulled laterally across its anatomical footprint with minimal tension.³⁹ In contrast, cuff tissue in the more commonly encountered chronic tear is less compliant and is not mobile enough to be pulled to the lateral margin of the footprint without added stress.^30,34,35 In large, acute tears in which there are minimal tissue degeneration and retraction, a laterally based footprint-restoring technique may be performed with minimal tension. This technique may have advantages over a medially based repair. In the literature, more attention needs to be directed toward the biomechanics and biology of chronic rotator cuff tears, as these are more commonly encountered.

Almost all of the prospective studies that have compared single- and double-row RCR have found no significant differences in MRI healing rates or clinical results at follow-up up to 2 years.^14,16,40-45 Detailed analysis of the surgical techniques used in all these studies revealed that the rotator cuff tendons were repaired back to the lateral footprint in both the single- and double-row constructs.^14,16,40-45 Although no clinical studies have compared medially and laterally based single-row repairs, our data suggest that medially based repairs have lower tensions and therefore should not be considered equivalent. Sostak and colleagues³¹ and Murray and colleagues⁴⁶ have shown that a medially based single-row RCR can achieve excellent clinical and anatomical results, likely partly because of the lower tension applied to the torn cuff tissue.^31,46 Studies are needed to compare medially and laterally based repairs, including single- and double-row repairs.

The vast majority of recent research has aimed to counteract construct tension with stronger biomechanical constructs.^20-26 Surgeons have also aimed to improve biological healing by pulling the tendon laterally across the footprint to achieve complete footprint coverage, ultimately increasing the surface area for tendon–bone healing. This has led to the development of various double-row repair techniques, in which the cuff tendon is pulled to the lateral margin of its footprint. One row of anchors is placed in the medial aspect of the footprint, while a second is placed in the lateral aspect; the cuff is reduced and compressed to the tuberosity with various suture configurations. The TOE technique was developed to improve pressurization of the cuff tendon across the footprint by linking the 2 rows with bridging sutures. In doing so, however, the potentially deleterious effects of increased tension introduced by pulling the tendon laterally may have been overlooked. Nevertheless, the biomechanics and stress distribution likely differ between single-row repair and TOE repairs, and direct comparisons cannot be made at this time. The medial row of a double-row or TOE construct may stress-shield or “unload” the more lateral tissue. Studies are needed in order to better understand the tension differential and stress distribution of various double-row constructs.

Recognizing tear morphology is crucial in maximizing chances of healing after cuff repair. For example, a crescent-shaped tear is reduced to the tuberosity with direct lateral translation of the apex of the tear, which is also the deepest or most displaced part of the tear. On the other hand, reducing an L- or reverse L-shaped tear to the tuberosity is not as direct; reducing the deepest or most displaced part of the tear would lead to overreduction and overtensioning of the tendon. However, often the exact “elbow” of the tear is not obvious and appears more rounded; therefore, it is crucial for the surgeon to examine the mobility of the torn tendon along its entire length to minimize tension. Study is needed to assess tension along the entire length of the tear for different tear morphologies and sizes.

Although our results showed that increased tension was needed to reduce a torn tendon to its lateral footprint, no study has indicated exactly how much is “too much” tension. As stated earlier, use of stronger biomechanical constructs, including TOE constructs, may overcome the increased tension associated with laterally based repairs. In addition, laterally based repairs, either single- or double-row, may be best suited for tears with lower tension, whereas medially based repairs may be best suited for higher tension tears. It is also possible that the difference in tensions noted in this study is not significant enough to have a clinical impact on choice of construct or on anatomical healing. We need studies that correlate anatomical healing rates with repair tension in order to better guide surgeons on when to use a medially or laterally based repair.

Other possible effects of increased tension associated with laterally based repairs, including beneficial effects, must be considered as well. Viscoelastic properties of human rotator cuff tendon may dissipate increased tension over time through a variety of mechanisms. Stress relaxation, gap formation, creep, and the hysteresis effect, all associated with cyclical loading in the early healing period, may lead to dissipation of force over time.^47,48 These more complex biomechanical properties of RCR constructs are yet to be clearly defined.

This study had several weaknesses. Its data represent a static measurement of time-zero rotator cuff tension, which greatly simplifies the biomechanics of the torn rotator cuff and repair construct as well as changes that occur with healing. During cuff repair, forces typically are distributed through several fixation points in stepwise process and are not focused on a single point of tissue with a grasper. Therefore, the findings of this study may not directly correlate with medially versus laterally based repairs in vivo. Furthermore, as this is a time-zero measurement, we could not determine whether the tension differential between the 2 repair positions remained static over time. Current literature suggests that muscle atrophy, fatty infiltration, and loss of elasticity of the musculotendinous unit are relatively irreversible.^35,37,49 In addition, determining the precise apex of a cuff tear can be difficult, so error may have been introduced during this process. Last, although placement of the cuff tissue at the medial or lateral footprint position was based on visual estimation by an experienced and skilled arthroscopist, error may have been introduced based on this imprecise technique.

Conclusion

This study demonstrated a significant, 5.4-fold increase in in vivo time-zero rotator cuff tension with the tendon edge reduced to the lateral footprint rather than the medial footprint.

Although recent clinical results of arthroscopic rotator cuff repair (RCR) have been encouraging, achieving anatomical healing of full-thickness rotator cuff tears remains a challenge.^1-4 Several factors influence rotator cuff healing after repair.^1,3-8 Patient-related factors include advanced patient age, tear size, tear chronicity, and amount of fatty infiltration.^1,3,5,6,8-10 Tension applied to the repair construct is a significant factor as well.^11,12

In the literature, limited consideration has been given to repair tension.¹³ The majority of studies have focused on other factors, mainly repair technique. Some surgeons advocate use of a double-row repair construct in which the rotator cuff tendon is pulled to the lateral margin of the footprint.^14-19 Double-row techniques, which include the transosseous-equivalent (TOE) construct, are biomechanically superior to other repairs.^20-26 Another purported benefit of double-row repair is more complete restoration and pressurization of the rotator cuff footprint.^21,24,27,28

Rotator cuff tears typically occur near the dysvascular region of the diseased musculotendinous unit, often leaving a stump of tissue attached to the tuberosity and ultimately a shortened tendon.²⁹ In addition, full-thickness tears often retract over time. Meyer and colleagues²⁹ recently demonstrated that this shortening is irreversible. Snyder³⁰ and Sostak and colleagues³¹ suggested that pulling a shortened, degenerative rotator cuff tendon to the lateral margin of the footprint results in increased tissue tension compared with that produced with a more medially based repair just off the articular margin. In our opinion, the possible increase in tension during a laterally based repair, whether single- or double-row, may place excessive strain on the diseased tissue as well as the surgical construct, potentially contributing to repair failure.

We conducted a study to evaluate the difference, if any, in tension applied to the rotator cuff tendon positioned at the medial versus lateral margin of the footprint during arthroscopic RCR. We hypothesized significantly more tension would be placed on the rotator cuff tendon when positioned at the lateral versus medial footprint.

Methods

After obtaining Institutional Review Board approval for this study, we collected data on a consecutive series of patients who underwent arthroscopic RCR performed by Dr. Getelman at a single institution. Only patients with primary full-thickness tears of the supraspinatus and/or infraspinatus were included. Exclusion criteria included revision rotator cuff surgeries, partial-thickness tears, concurrent subscapularis tears requiring anchor fixation, and any tears that could not be mobilized to the lateral footprint without interval slides or margin convergence. The 20 identified patients constituted the study group.

Demographic factors, including age and preoperative length of symptoms, were recorded after chart review. Magnetic resonance imaging (MRI) was performed for all patients before surgery and was retrospectively reviewed. Dr. Getelman assigned each patient a modified Goutallier score, based on MRI, to assess for fatty infiltration/atrophy.³² Each patient was placed in the lateral decubitus position with the operative arm in balanced suspension at 70° of abduction. Standard glenohumeral and subacromial diagnostic arthroscopy was performed. The rotator cuff tear was gently debrided back to a healthy-appearing margin in preparation for repair. The tear was then measured in the anterior-posterior (A-P) and medial-lateral (M-L) planes using a premeasured, marked suture, as previously described.33 Complete bursal and articular-sided releases were performed to allow for appropriate mobilization of the tendon. The tear was classified as crescent-shaped, U-shaped, or L-shaped.

Viewing from the posterior portal, the surgeon inserted a tissue grasper through the lateral portal. The tendon was grasped at multiple points along its edge, anterior to posterior, and was translated laterally to assess its reducibility; the apex of the tear correlated with the point of maximal excursion and coverage of the footprint. Once confirmed, the rotator cuff tear apex was clamped with a tissue grasper. After placement in a sterile arthroscopic camera sleeve (DeRoyal camera drape with perforated tip), a calibrated digital weigh scale (American Weigh Scales model H22 portable electronic hanging scale, with accuracy of 0.01 lb) was attached to the tissue grasper with an S-hook (Figure 1). The tendon edge was first translated about 3 mm lateral to the articular margin (the medial footprint position), and tension was recorded (Figures 2A, 2B). After a 1-minute relaxation period, the tendon edge was translated to the lateral edge of the rotator cuff footprint (the lateral footprint position), and tension was recorded again (Figures 2C, 2D). A medially based single-row RCR with triple-loaded sutures and bone marrow vents placed in the lateral tuberosity was then completed, regardless of tension, tear size, or tear morphology.³¹ Typically, 1 anchor was used for every 10 to 15 mm of A-P tear length.

SAS software was used for statistical analysis, the Wilcoxon signed rank test for continuous or ordinal data comparisons between paired groups, and the Mann-Whitney test for continuous or ordinal data comparisons between independent, unmatched groups. One-way analysis of variance (ANOVA) was used to compare means among the 3 groups of morphology subtypes. Linear regression was performed to assess the simultaneous relationship between potential predictors (age, sex, length of symptoms, Goutallier score, tear size) and medial or lateral tension, where medial tension was included as an additional potential predictor for lateral tension. Restricted cubic splines were fit to assess linearity. Predictors were retained in multivariate regression using backward variable retention. Because of inadequate sample size, additivity was assumed except for sex. Statistical significance was set at P < .05.

Results

Of the 20 rotator cuff tears evaluated (Table 1), 13 were crescent-shaped, 5 were U-shaped, and 2 were L-shaped. Mean (SD) A-P tear size was 17.7 (5.8) mm, and mean (SD) M-L tear size was 19.1 (8.6) mm. Mean age of the 20 patients (15 men, 5 women) was 57.9 years (range, 44-72 years). Mean (SD) length of symptoms was 12.9 (12.4) months (range, 3-48 months). Mean (SD) modified Goutallier score was 1.4 (0.7; range, 0-3).

Mean (SD) rotator cuff tension for all tears approximated to the medial footprint was 0.41 (0.33) pound, and mean (SD) cuff tension for all tears approximated to the lateral footprint was 2.21 (1.20) pounds—representing a 5.4-fold difference (P < .0001).

No statistically significant differences were detected in the ANOVA comparing tensions at medial and lateral positions among tear morphologic subtypes (all Ps >.05).

Subgroup analysis (Table 2) was performed for smaller (≤20 mm A-P) and larger (>20 mm A-P) tears. For smaller tears, mean (SD) tension was 0.27 (0.24) pound applied with the cuff tendon pulled to the medial footprint and 2.06 (1.06) pounds applied with the tendon pulled to the lateral footprint—a 7.6-fold difference (P < .0018). For larger tears, mean (SD) tension was 0.58 (0.37) pound applied with the tendon pulled to the medial footprint and 2.38 (1.4) pounds applied with the tendon pulled to the lateral footprint—a 4.1-fold difference (P < .005).

A statistically significant difference in tensions was found between small and large cuff tears positioned at the medial footprint (0.27 vs 0.58 lb; P = .0367); no difference was found between groups with the tendon at the lateral footprint (2.06 vs 2.38 lb; P = .284).

Univariate and multivariate analyses were performed using linear regression analysis (Table 3). During univariate analysis for medial footprint position, A-P tear size and Goutallier score both positively correlated with increasing tension; for lateral footprint position, no factors statistically correlated with lateral tension, though there was a positive trend for medial tension and female sex. During multivariate analysis for medial footprint position, only A-P tear size positively correlated with increasing tension; for lateral footprint position, both age (in nonlinear fashion as function of age + age²) and medial tension positively correlated with increasing tension.

Discussion

Our results indicated that significantly more tension is placed on the torn rotator cuff tendon when it is reduced across the footprint from a medial to a more lateral position in vivo. More tension was required for all tears to be reduced to the lateral footprint compared with the medial footprint. As expected, compared with smaller tears, larger tears required significantly more tension in order to be reduced to the medial footprint. Interestingly, no statistical difference was found between tensions required to reduce either small or large tears to the lateral footprint, which suggests that, regardless of tear size, more force must be applied to reduce the torn tendon to the lateral footprint compared with the medial footprint.

Hersche and Gerber³⁴ were the first to report rotator cuff tension measurements in vivo. Although their study did not specifically compare cuff tensions reducing the tear to the medial versus lateral footprint, it did examine tension at displacement of 10 and 20 mm. Tension increased from 27 N to 60 N, correlating with a 2.2-fold difference between the 2 distances. Domb and colleagues35 also compared in vivo rotator cuff tension differences between the medial footprint and the lateral footprint in 4 patients. Mean tension applied to the cuff during reduction to the articular margin was 27 N, or 6 pounds. Mean tension needed to reduce the cuff to the lateral tuberosity was 76 N, or 17 pounds, for a 2.8-fold difference. Tears were not measured but were described as massive and retracted.

Although repair tension has long been recognized as a crucial factor in RCR healing, little clinical research has focused on the effects of excess tension. Davidson and Rivenburgh11 prospectively followed the clinical outcomes of 67 consecutive cuff repairs after intraoperative tension measurement and found that high-tension repairs (>8 lb) had significantly lower clinical outcome measures. However, the authors did not report on correlations with radiologic healing and stated, “Functional outcome is inversely proportional to rotator cuff repair tension.” Further study of the in vivo effects of increased tension on clinical and radiologic outcomes is needed.

Several animal studies have been conducted on the effects of tension on RCRs. Gerber and colleagues36 reported that the force needed to produce 1 cm of sheep supraspinatus tendon excursion increased 7-fold, from 6.8 N to 47.8 N, after 40 weeks of tendon tear. Coleman and colleagues³⁷ compared the modulus of elasticity in sheep supraspinatus tendon after 6 weeks and 18 weeks of detachment and reported increases of 60% and 70%, respectively. Gimbel and colleagues³⁸ showed that, in a rat model, “repair tension rapidly increased initially after injury followed by a progressive, but less dramatic, increase with additional time.” Of note, we did not identify any correlation between chronicity of symptoms and the tension needed to reduce the tendon medially or to a more lateral position on the footprint.

In acute tears, the cuff tissue is more compliant and mobile and can be pulled laterally across its anatomical footprint with minimal tension.³⁹ In contrast, cuff tissue in the more commonly encountered chronic tear is less compliant and is not mobile enough to be pulled to the lateral margin of the footprint without added stress.^30,34,35 In large, acute tears in which there are minimal tissue degeneration and retraction, a laterally based footprint-restoring technique may be performed with minimal tension. This technique may have advantages over a medially based repair. In the literature, more attention needs to be directed toward the biomechanics and biology of chronic rotator cuff tears, as these are more commonly encountered.

Almost all of the prospective studies that have compared single- and double-row RCR have found no significant differences in MRI healing rates or clinical results at follow-up up to 2 years.^14,16,40-45 Detailed analysis of the surgical techniques used in all these studies revealed that the rotator cuff tendons were repaired back to the lateral footprint in both the single- and double-row constructs.^14,16,40-45 Although no clinical studies have compared medially and laterally based single-row repairs, our data suggest that medially based repairs have lower tensions and therefore should not be considered equivalent. Sostak and colleagues³¹ and Murray and colleagues⁴⁶ have shown that a medially based single-row RCR can achieve excellent clinical and anatomical results, likely partly because of the lower tension applied to the torn cuff tissue.^31,46 Studies are needed to compare medially and laterally based repairs, including single- and double-row repairs.

The vast majority of recent research has aimed to counteract construct tension with stronger biomechanical constructs.^20-26 Surgeons have also aimed to improve biological healing by pulling the tendon laterally across the footprint to achieve complete footprint coverage, ultimately increasing the surface area for tendon–bone healing. This has led to the development of various double-row repair techniques, in which the cuff tendon is pulled to the lateral margin of its footprint. One row of anchors is placed in the medial aspect of the footprint, while a second is placed in the lateral aspect; the cuff is reduced and compressed to the tuberosity with various suture configurations. The TOE technique was developed to improve pressurization of the cuff tendon across the footprint by linking the 2 rows with bridging sutures. In doing so, however, the potentially deleterious effects of increased tension introduced by pulling the tendon laterally may have been overlooked. Nevertheless, the biomechanics and stress distribution likely differ between single-row repair and TOE repairs, and direct comparisons cannot be made at this time. The medial row of a double-row or TOE construct may stress-shield or “unload” the more lateral tissue. Studies are needed in order to better understand the tension differential and stress distribution of various double-row constructs.

Recognizing tear morphology is crucial in maximizing chances of healing after cuff repair. For example, a crescent-shaped tear is reduced to the tuberosity with direct lateral translation of the apex of the tear, which is also the deepest or most displaced part of the tear. On the other hand, reducing an L- or reverse L-shaped tear to the tuberosity is not as direct; reducing the deepest or most displaced part of the tear would lead to overreduction and overtensioning of the tendon. However, often the exact “elbow” of the tear is not obvious and appears more rounded; therefore, it is crucial for the surgeon to examine the mobility of the torn tendon along its entire length to minimize tension. Study is needed to assess tension along the entire length of the tear for different tear morphologies and sizes.

Although our results showed that increased tension was needed to reduce a torn tendon to its lateral footprint, no study has indicated exactly how much is “too much” tension. As stated earlier, use of stronger biomechanical constructs, including TOE constructs, may overcome the increased tension associated with laterally based repairs. In addition, laterally based repairs, either single- or double-row, may be best suited for tears with lower tension, whereas medially based repairs may be best suited for higher tension tears. It is also possible that the difference in tensions noted in this study is not significant enough to have a clinical impact on choice of construct or on anatomical healing. We need studies that correlate anatomical healing rates with repair tension in order to better guide surgeons on when to use a medially or laterally based repair.

Other possible effects of increased tension associated with laterally based repairs, including beneficial effects, must be considered as well. Viscoelastic properties of human rotator cuff tendon may dissipate increased tension over time through a variety of mechanisms. Stress relaxation, gap formation, creep, and the hysteresis effect, all associated with cyclical loading in the early healing period, may lead to dissipation of force over time.^47,48 These more complex biomechanical properties of RCR constructs are yet to be clearly defined.

This study had several weaknesses. Its data represent a static measurement of time-zero rotator cuff tension, which greatly simplifies the biomechanics of the torn rotator cuff and repair construct as well as changes that occur with healing. During cuff repair, forces typically are distributed through several fixation points in stepwise process and are not focused on a single point of tissue with a grasper. Therefore, the findings of this study may not directly correlate with medially versus laterally based repairs in vivo. Furthermore, as this is a time-zero measurement, we could not determine whether the tension differential between the 2 repair positions remained static over time. Current literature suggests that muscle atrophy, fatty infiltration, and loss of elasticity of the musculotendinous unit are relatively irreversible.^35,37,49 In addition, determining the precise apex of a cuff tear can be difficult, so error may have been introduced during this process. Last, although placement of the cuff tissue at the medial or lateral footprint position was based on visual estimation by an experienced and skilled arthroscopist, error may have been introduced based on this imprecise technique.

Conclusion

This study demonstrated a significant, 5.4-fold increase in in vivo time-zero rotator cuff tension with the tendon edge reduced to the lateral footprint rather than the medial footprint.

Transforaminal lumbar interbody fusion (TLIF) has become an increasingly popular method of lumbar fusion, since its introduction by Harms and Rolinger in 1982.¹ The procedure allows for a circumferential fusion through a posterior-only approach, with improved sagittal alignment² and minimal risk for iatrogenic nerve injury. In the past decade, a minimally invasive surgical method of TLIF (MIS TLIF) has been introduced^3-5 and involves neural decompression and interbody fusion through a tubular retractor, and percutaneous placement of pedicle-screw instrumentation. This technique uses muscle dilation rather than large-scale detachment of muscle. Proponents of the MIS technique have postulated that decreased muscle damage would lead to better short-term, and possibly long-term, clinical outcomes, because of less iatrogenic soft-tissue damage.

Studies that have compared results of MIS TLIF with open TLIF have shown improved perioperative outcomes, but most have shown similar intermediate-term clinical outcomes.6 In the short term, multiple studies demonstrate that MIS TLIF is associated with decreased blood loss, less postoperative pain and narcotic requirements, and shorter hospital length of stay.^7-13 However, changes in pain score and disease-specific and generic health-related quality of life measures have been similar for the 2 procedures, beyond 6 months postoperatively.^10,13-15 These studies have generally involved retrospective reviews of unmatched patient groups, with small sample sizes and significant heterogeneity in surgical indications and case complexity. In our study, we compared intermediate-term clinical outcomes of MIS TLIF with open TLIF, using propensity matching to optimize baseline similarity of the groups.

Methods

This retrospective study was conducted after receiving approval from the Institutional Review Board. Surgical and clinical databases of 2 centers from 2008 to 2012 were reviewed for eligible subjects. Cases in 2007 were excluded because this was the year that MIS was introduced as a new technique in the practice. Inclusion criteria consisted of patients who underwent 1- to 2-level MIS TLIF and had complete baseline, 1- and 2-year postoperative outcome measures. Patients who had surgery for trauma, tumor, or osteomyelitis were excluded. Outcome measures collected and reviewed in this study included the Oswestry Disability Index (ODI),^16,17 the Medical Outcomes Study Short-Form 36 (SF-36),¹⁸ and numeric rating scales for back and leg pain (0-100 scale).¹⁹ The Physical Composite Summary (PCS) and Mental Composite Summary of the SF-36 were reviewed separately. We recorded the following patient demographic data: age, gender, American Society of Anesthesiologists (ASA) grade, body mass index, indication for surgery, workers’ compensation, and smoking status. Surgical data included number of levels fused, operative time, estimated blood loss, and length of hospital stay.

Propensity-scoring technique^20,21 was used to match the MIS TLIF patients to a control group of patients who underwent TLIF using an open approach (open TLIF), matching for multiple characteristics to produce 2 similar comparison groups. Propensity matching was performed to control for bias. In controlling for known confounders or biases, propensity matching, in theory, should also control for unknown confounders. Gender, age, body mass index, smoking status, indication for fusion, as well as preoperative ODI, SF-36 PCS, SF-36 Mental Composite Summary, and pain scores were used to generate a control open TLIF group.

MIS TLIF Surgical Technique

Patients in the MIS TLIF group underwent neural decompression and interbody fusion through a tubular retractor system (METRx, Medtronic Inc.), followed by percutaneous pedicle-screw fixation under fluoroscopic guidance (Sextant, Medtronic Inc.). After successful induction of general endotracheal anesthesia, patients were positioned prone on a radiolucent table. Posteroanterior (PA) and lateral fluoroscopic images were used to localize 2 paramedian incisions, approximately 3-cm to 5-cm lateral to midline, over the pedicles of interest. Modified Jamshidi needles (Medtronic Inc.) were used to cannulate the pedicles under PA, posterior-oblique, PA, and lateral fluoroscopic guidance. The pedicles were tapped with a cannulated tap. Pedicle screws and rods were introduced on the side contralateral to the TLIF and were used as needed to maintain intradiscal distraction during the TLIF portion of the procedure.

Decompression and TLIF were carried out on the side of the patient’s radicular pain or bilaterally, according to the surgeon’s discretion. A K-wire was advanced to the facet joint complex, after which sequential dilators were used to dilate through the muscles to establish an intramuscular corridor to the facet. A 26-mm fixed tubular retractor was docked over the facet and locked in place, using a post attached to the operating room table. Neural decompression was obtained by removal of the entire facet-joint complex and lamina to the base of the spinous process, using a combination of high-speed drills and Kerrison rongeurs. The ligamentum flavum was completely resected. The superior articular process of the caudal vertebra was removed all the way to the pedicle below. Ball-tipped probes were used to confirm that traversing and exiting nerve roots were completely free. An annulotomy was performed, and all disc material was removed from the disc through a combination of rotating shavers, serrated curettes, endplate scrapers, and rasps. Bone graft was placed anterior and contralateral to the interbody cage. (Bone grafts included autogenous iliac crest, local bone obtained from the decompression, recombinant human bone morphogenetic protein 2, or allograft demineralized bone matrix at the surgeon’s discretion.) After placement of the interbody cage, the ipsilateral pedicle-screw instrumentation was put over the remaining guide wires and compression applied across the construct to lock the interbody cage and restore lordosis. Wounds were closed without drains.

Open TLIF Surgical Technique

In patients undergoing open TLIF, a midline incision was made over the vertebrae of interest, and paraspinal muscles were subperiosteally dissected to the tips of the transverse processes. The appropriate level was confirmed with intraoperative radiograph. Pedicle screws were placed free-hand using anatomic landmarks, and appropriate placement was confirmed with intraoperative radiograph and evoked electromyography stimulation. Laminectomy and facetectomy were performed, and the disc was entered on the side of the facetectomy. After thorough disc-space preparation, bone graft and an interbody cage were placed, rods inserted, and compression carried out. A supplemental posterolateral fusion was also performed after decortication of the transverse processes and cartilaginous surface of the contralateral facet. Layered wound closure was performed over drains.

Analysis

Statistical analysis was carried out using SPSS Statistics version 17.0 (IBM) with significance set at the P < .01 level. A small, conservative P-value threshold was used to minimize type II error that resulted from the multiple comparisons performed. Student t test was used to determine any significant differences between continuous demographic variables, and to compare preoperative and postoperative outcome measure scores within and between study groups. Fisher’s exact test was used to compare categorical variables between the 2 groups.

Results

The MIS TLIF group consisted of 64 patients (average age, 52 years), and included 22 patients with degenerative spondylolisthesis, 33 with disc pathology, 8 with postdecompression, and 1 non-union patient. The open TLIF group consisted of 64 patients (average age, 54 years), and included 39 degenerative spondylolisthesis, 15 disc pathology, 7 postdecompression, and 3 nonunion patients (Table 1). All 64 open and 19 MIS cases were from a spine practice with 6 surgeons, and 45 MIS cases came from a spine practice with 2 surgeons. There was also an unequal distribution of the specific levels fused between the open and MIS groups.

Although the operative time was similar in both groups, the MIS TLIF group had a statistically significantly lower blood loss compared with the open TLIF group (Table 2). Both MIS TLIF and open TLIF lead to significant improvements in pain, ODI, and SF-36 PCS (P < .01) (Table 3). At 1 year, both groups had similar improvements in pain (36.9 vs 30.8, P = .178) and SF-36 PCS (9.9 vs 7.5, P = .231), but the MIS TLIF group had a statistically significantly greater improvement in ODI compared with the open TLIF group (30.4 vs 15.1, P < .000). At 2 years, both groups had similar improvements in SF-36 PCS (12.1 vs 7.5, P = .033), but the MIS TLIF group had a statistically significantly greater improvement in pain (40.2 vs 27.0, P = .005) and ODI (33.1 vs 15.4, P < .000) compared with the open TLIF group (Table 4).

Discussion

The current study compared intermediate-term clinical outcomes of MIS TLIF to open TLIF. We used propensity matching to identify a control group of open TLIFs that were comparable to the MIS TLIF group across a variety of covariates that are known to influence the results of lumbar fusion. This created comparison groups that were as closely matched at baseline as possible. We found that, at 2-year follow-up, MIS TLIF patients had less pain and less low-back pain–related disability as measured by ODI. There was also a trend toward better generic health-related quality of life in the MIS TLIF group.

These data suggest that the decreased soft-tissue trauma of the minimally invasive surgical technique, which leads to improved perioperative parameters in the short term, may also lead to some advantages that translate to improved intermediate-term clinical outcomes. Traditional lumbar fusion procedures have shown excellent clinical results when used for accepted clinical indications.²² However, the procedure requires extensive dissection of the paraspinal muscles, which causes significant muscle damage as evidenced by muscle breakdown products that can be detected in the bloodstream postoperatively.^23,24 The lateral dissection also transects the dorsal ramus of the segmental nerves, which innervate the paraspinal muscles, leading to significant scarring and atrophy on postoperative imaging studies.²³ Some authors have used the term “fusion disease” to describe the constellation of soft-tissue degradation seen after open lumbar fusion.⁵

An MIS version of the TLIF procedure that was described in 2003³ avoids much of this iatrogenic soft-tissue trauma. It involves intramuscular dilation to approach the spine and to carry out neural decompression and interbody fusion, in conjunction with percutaneous pedicle-screw instrumentation. Proponents of this technique point to diminished iatrogenic soft-tissue and muscle damage as an advantage. Multiple studies have, in fact, confirmed improved short-term perioperative parameters, such as less blood loss, lower narcotic requirements, and decreased length-of-hospital stay.²⁵ Economic analyses have also shown lower direct and indirect costs with the MIS technique.²⁶

Several studies have compared patient-reported outcome measures of MIS and open TLIF, and the results have been mixed. Most of these studies have shown similar improvement in clinical outcomes between the 2 procedures, but the MIS technique demonstrated short-term perioperative advantages, such as lower blood loss, less narcotic requirements, and shorter length of stay.^7-15 The authors of these studies conclude that the MIS technique can provide similar long-term results with lower short-term morbidity when compared with open TLIF. In contrast, some studies have shown better short- and intermediate-term clinical outcomes with the MIS technique.^23,27-29 As a whole, the literature comparing the 2 procedures consists of mostly small retrospective studies with nonrandomized patient samples, heterogeneous surgical indications, and differing surgical techniques, making it difficult to draw conclusions.

The current study suggests that MIS TLIF may lead to improved clinical results at 2-year follow-up, compared with open TLIF. Our study used propensity-score matching to minimize the effects of nonrandom assignment of subjects to MIS TLIF or open TLIF. A limitation of observational studies is that bias in assignment of subjects to treatment groups can lead to overestimation or underestimation of the effect of the treatment itself. Propensity-score matching attempts to reduce this bias by accounting for several covariates that predict whether a subject will receive a certain treatment. These covariates are used in a logistic regression to produce a propensity score, which can be used to match subjects to controls across multiple dimensions, thus ensuring groups are as comparable as possible at baseline.

Our study still has several limitations. Sample size is relatively small, and follow-up is still only intermediate, at 2 years. There was unequal distribution of specific levels of surgery. Because patients were not blinded to the treatment they received, it is possible that patient perception of receiving a newer, less-invasive treatment method may influence their subjective improvement. The study sample was drawn from 2 different centers, with one center providing mostly MIS cases and the other providing mostly open cases. Because of this, undetected differences in how patients were selected for surgery could also affect outcomes. Any latent confounding variables, which are not identified a priori, will not be accounted for in the matching process. Only a prospective, randomized study with large numbers can control for observed and unobserved confounding patient characteristics.

In summary, our study shows that MIS TLIF is associated with improved low back pain and low back–related disability at 2 years compared with open TLIF. Other studies comparing the 2 techniques have come to different conclusions regarding whether the short-term benefits of MIS TLIF translate into long-term differences in clinical outcome. This study adds to this evidence and suggests there may be longer term advantages to the MIS approach, but prospective randomized trials are needed to confirm this finding and determine the true magnitude of these differences.

Transforaminal lumbar interbody fusion (TLIF) has become an increasingly popular method of lumbar fusion, since its introduction by Harms and Rolinger in 1982.¹ The procedure allows for a circumferential fusion through a posterior-only approach, with improved sagittal alignment² and minimal risk for iatrogenic nerve injury. In the past decade, a minimally invasive surgical method of TLIF (MIS TLIF) has been introduced^3-5 and involves neural decompression and interbody fusion through a tubular retractor, and percutaneous placement of pedicle-screw instrumentation. This technique uses muscle dilation rather than large-scale detachment of muscle. Proponents of the MIS technique have postulated that decreased muscle damage would lead to better short-term, and possibly long-term, clinical outcomes, because of less iatrogenic soft-tissue damage.

Studies that have compared results of MIS TLIF with open TLIF have shown improved perioperative outcomes, but most have shown similar intermediate-term clinical outcomes.6 In the short term, multiple studies demonstrate that MIS TLIF is associated with decreased blood loss, less postoperative pain and narcotic requirements, and shorter hospital length of stay.^7-13 However, changes in pain score and disease-specific and generic health-related quality of life measures have been similar for the 2 procedures, beyond 6 months postoperatively.^10,13-15 These studies have generally involved retrospective reviews of unmatched patient groups, with small sample sizes and significant heterogeneity in surgical indications and case complexity. In our study, we compared intermediate-term clinical outcomes of MIS TLIF with open TLIF, using propensity matching to optimize baseline similarity of the groups.

Methods

This retrospective study was conducted after receiving approval from the Institutional Review Board. Surgical and clinical databases of 2 centers from 2008 to 2012 were reviewed for eligible subjects. Cases in 2007 were excluded because this was the year that MIS was introduced as a new technique in the practice. Inclusion criteria consisted of patients who underwent 1- to 2-level MIS TLIF and had complete baseline, 1- and 2-year postoperative outcome measures. Patients who had surgery for trauma, tumor, or osteomyelitis were excluded. Outcome measures collected and reviewed in this study included the Oswestry Disability Index (ODI),^16,17 the Medical Outcomes Study Short-Form 36 (SF-36),¹⁸ and numeric rating scales for back and leg pain (0-100 scale).¹⁹ The Physical Composite Summary (PCS) and Mental Composite Summary of the SF-36 were reviewed separately. We recorded the following patient demographic data: age, gender, American Society of Anesthesiologists (ASA) grade, body mass index, indication for surgery, workers’ compensation, and smoking status. Surgical data included number of levels fused, operative time, estimated blood loss, and length of hospital stay.

Propensity-scoring technique^20,21 was used to match the MIS TLIF patients to a control group of patients who underwent TLIF using an open approach (open TLIF), matching for multiple characteristics to produce 2 similar comparison groups. Propensity matching was performed to control for bias. In controlling for known confounders or biases, propensity matching, in theory, should also control for unknown confounders. Gender, age, body mass index, smoking status, indication for fusion, as well as preoperative ODI, SF-36 PCS, SF-36 Mental Composite Summary, and pain scores were used to generate a control open TLIF group.

MIS TLIF Surgical Technique

Patients in the MIS TLIF group underwent neural decompression and interbody fusion through a tubular retractor system (METRx, Medtronic Inc.), followed by percutaneous pedicle-screw fixation under fluoroscopic guidance (Sextant, Medtronic Inc.). After successful induction of general endotracheal anesthesia, patients were positioned prone on a radiolucent table. Posteroanterior (PA) and lateral fluoroscopic images were used to localize 2 paramedian incisions, approximately 3-cm to 5-cm lateral to midline, over the pedicles of interest. Modified Jamshidi needles (Medtronic Inc.) were used to cannulate the pedicles under PA, posterior-oblique, PA, and lateral fluoroscopic guidance. The pedicles were tapped with a cannulated tap. Pedicle screws and rods were introduced on the side contralateral to the TLIF and were used as needed to maintain intradiscal distraction during the TLIF portion of the procedure.

Decompression and TLIF were carried out on the side of the patient’s radicular pain or bilaterally, according to the surgeon’s discretion. A K-wire was advanced to the facet joint complex, after which sequential dilators were used to dilate through the muscles to establish an intramuscular corridor to the facet. A 26-mm fixed tubular retractor was docked over the facet and locked in place, using a post attached to the operating room table. Neural decompression was obtained by removal of the entire facet-joint complex and lamina to the base of the spinous process, using a combination of high-speed drills and Kerrison rongeurs. The ligamentum flavum was completely resected. The superior articular process of the caudal vertebra was removed all the way to the pedicle below. Ball-tipped probes were used to confirm that traversing and exiting nerve roots were completely free. An annulotomy was performed, and all disc material was removed from the disc through a combination of rotating shavers, serrated curettes, endplate scrapers, and rasps. Bone graft was placed anterior and contralateral to the interbody cage. (Bone grafts included autogenous iliac crest, local bone obtained from the decompression, recombinant human bone morphogenetic protein 2, or allograft demineralized bone matrix at the surgeon’s discretion.) After placement of the interbody cage, the ipsilateral pedicle-screw instrumentation was put over the remaining guide wires and compression applied across the construct to lock the interbody cage and restore lordosis. Wounds were closed without drains.

Open TLIF Surgical Technique

In patients undergoing open TLIF, a midline incision was made over the vertebrae of interest, and paraspinal muscles were subperiosteally dissected to the tips of the transverse processes. The appropriate level was confirmed with intraoperative radiograph. Pedicle screws were placed free-hand using anatomic landmarks, and appropriate placement was confirmed with intraoperative radiograph and evoked electromyography stimulation. Laminectomy and facetectomy were performed, and the disc was entered on the side of the facetectomy. After thorough disc-space preparation, bone graft and an interbody cage were placed, rods inserted, and compression carried out. A supplemental posterolateral fusion was also performed after decortication of the transverse processes and cartilaginous surface of the contralateral facet. Layered wound closure was performed over drains.

Analysis

Statistical analysis was carried out using SPSS Statistics version 17.0 (IBM) with significance set at the P < .01 level. A small, conservative P-value threshold was used to minimize type II error that resulted from the multiple comparisons performed. Student t test was used to determine any significant differences between continuous demographic variables, and to compare preoperative and postoperative outcome measure scores within and between study groups. Fisher’s exact test was used to compare categorical variables between the 2 groups.

Results

The MIS TLIF group consisted of 64 patients (average age, 52 years), and included 22 patients with degenerative spondylolisthesis, 33 with disc pathology, 8 with postdecompression, and 1 non-union patient. The open TLIF group consisted of 64 patients (average age, 54 years), and included 39 degenerative spondylolisthesis, 15 disc pathology, 7 postdecompression, and 3 nonunion patients (Table 1). All 64 open and 19 MIS cases were from a spine practice with 6 surgeons, and 45 MIS cases came from a spine practice with 2 surgeons. There was also an unequal distribution of the specific levels fused between the open and MIS groups.

Although the operative time was similar in both groups, the MIS TLIF group had a statistically significantly lower blood loss compared with the open TLIF group (Table 2). Both MIS TLIF and open TLIF lead to significant improvements in pain, ODI, and SF-36 PCS (P < .01) (Table 3). At 1 year, both groups had similar improvements in pain (36.9 vs 30.8, P = .178) and SF-36 PCS (9.9 vs 7.5, P = .231), but the MIS TLIF group had a statistically significantly greater improvement in ODI compared with the open TLIF group (30.4 vs 15.1, P < .000). At 2 years, both groups had similar improvements in SF-36 PCS (12.1 vs 7.5, P = .033), but the MIS TLIF group had a statistically significantly greater improvement in pain (40.2 vs 27.0, P = .005) and ODI (33.1 vs 15.4, P < .000) compared with the open TLIF group (Table 4).

Discussion

The current study compared intermediate-term clinical outcomes of MIS TLIF to open TLIF. We used propensity matching to identify a control group of open TLIFs that were comparable to the MIS TLIF group across a variety of covariates that are known to influence the results of lumbar fusion. This created comparison groups that were as closely matched at baseline as possible. We found that, at 2-year follow-up, MIS TLIF patients had less pain and less low-back pain–related disability as measured by ODI. There was also a trend toward better generic health-related quality of life in the MIS TLIF group.

These data suggest that the decreased soft-tissue trauma of the minimally invasive surgical technique, which leads to improved perioperative parameters in the short term, may also lead to some advantages that translate to improved intermediate-term clinical outcomes. Traditional lumbar fusion procedures have shown excellent clinical results when used for accepted clinical indications.²² However, the procedure requires extensive dissection of the paraspinal muscles, which causes significant muscle damage as evidenced by muscle breakdown products that can be detected in the bloodstream postoperatively.^23,24 The lateral dissection also transects the dorsal ramus of the segmental nerves, which innervate the paraspinal muscles, leading to significant scarring and atrophy on postoperative imaging studies.²³ Some authors have used the term “fusion disease” to describe the constellation of soft-tissue degradation seen after open lumbar fusion.⁵

An MIS version of the TLIF procedure that was described in 2003³ avoids much of this iatrogenic soft-tissue trauma. It involves intramuscular dilation to approach the spine and to carry out neural decompression and interbody fusion, in conjunction with percutaneous pedicle-screw instrumentation. Proponents of this technique point to diminished iatrogenic soft-tissue and muscle damage as an advantage. Multiple studies have, in fact, confirmed improved short-term perioperative parameters, such as less blood loss, lower narcotic requirements, and decreased length-of-hospital stay.²⁵ Economic analyses have also shown lower direct and indirect costs with the MIS technique.²⁶

Several studies have compared patient-reported outcome measures of MIS and open TLIF, and the results have been mixed. Most of these studies have shown similar improvement in clinical outcomes between the 2 procedures, but the MIS technique demonstrated short-term perioperative advantages, such as lower blood loss, less narcotic requirements, and shorter length of stay.^7-15 The authors of these studies conclude that the MIS technique can provide similar long-term results with lower short-term morbidity when compared with open TLIF. In contrast, some studies have shown better short- and intermediate-term clinical outcomes with the MIS technique.^23,27-29 As a whole, the literature comparing the 2 procedures consists of mostly small retrospective studies with nonrandomized patient samples, heterogeneous surgical indications, and differing surgical techniques, making it difficult to draw conclusions.

The current study suggests that MIS TLIF may lead to improved clinical results at 2-year follow-up, compared with open TLIF. Our study used propensity-score matching to minimize the effects of nonrandom assignment of subjects to MIS TLIF or open TLIF. A limitation of observational studies is that bias in assignment of subjects to treatment groups can lead to overestimation or underestimation of the effect of the treatment itself. Propensity-score matching attempts to reduce this bias by accounting for several covariates that predict whether a subject will receive a certain treatment. These covariates are used in a logistic regression to produce a propensity score, which can be used to match subjects to controls across multiple dimensions, thus ensuring groups are as comparable as possible at baseline.

Our study still has several limitations. Sample size is relatively small, and follow-up is still only intermediate, at 2 years. There was unequal distribution of specific levels of surgery. Because patients were not blinded to the treatment they received, it is possible that patient perception of receiving a newer, less-invasive treatment method may influence their subjective improvement. The study sample was drawn from 2 different centers, with one center providing mostly MIS cases and the other providing mostly open cases. Because of this, undetected differences in how patients were selected for surgery could also affect outcomes. Any latent confounding variables, which are not identified a priori, will not be accounted for in the matching process. Only a prospective, randomized study with large numbers can control for observed and unobserved confounding patient characteristics.

In summary, our study shows that MIS TLIF is associated with improved low back pain and low back–related disability at 2 years compared with open TLIF. Other studies comparing the 2 techniques have come to different conclusions regarding whether the short-term benefits of MIS TLIF translate into long-term differences in clinical outcome. This study adds to this evidence and suggests there may be longer term advantages to the MIS approach, but prospective randomized trials are needed to confirm this finding and determine the true magnitude of these differences.

Transforaminal lumbar interbody fusion (TLIF) has become an increasingly popular method of lumbar fusion, since its introduction by Harms and Rolinger in 1982.¹ The procedure allows for a circumferential fusion through a posterior-only approach, with improved sagittal alignment² and minimal risk for iatrogenic nerve injury. In the past decade, a minimally invasive surgical method of TLIF (MIS TLIF) has been introduced^3-5 and involves neural decompression and interbody fusion through a tubular retractor, and percutaneous placement of pedicle-screw instrumentation. This technique uses muscle dilation rather than large-scale detachment of muscle. Proponents of the MIS technique have postulated that decreased muscle damage would lead to better short-term, and possibly long-term, clinical outcomes, because of less iatrogenic soft-tissue damage.

Studies that have compared results of MIS TLIF with open TLIF have shown improved perioperative outcomes, but most have shown similar intermediate-term clinical outcomes.6 In the short term, multiple studies demonstrate that MIS TLIF is associated with decreased blood loss, less postoperative pain and narcotic requirements, and shorter hospital length of stay.^7-13 However, changes in pain score and disease-specific and generic health-related quality of life measures have been similar for the 2 procedures, beyond 6 months postoperatively.^10,13-15 These studies have generally involved retrospective reviews of unmatched patient groups, with small sample sizes and significant heterogeneity in surgical indications and case complexity. In our study, we compared intermediate-term clinical outcomes of MIS TLIF with open TLIF, using propensity matching to optimize baseline similarity of the groups.

Methods

This retrospective study was conducted after receiving approval from the Institutional Review Board. Surgical and clinical databases of 2 centers from 2008 to 2012 were reviewed for eligible subjects. Cases in 2007 were excluded because this was the year that MIS was introduced as a new technique in the practice. Inclusion criteria consisted of patients who underwent 1- to 2-level MIS TLIF and had complete baseline, 1- and 2-year postoperative outcome measures. Patients who had surgery for trauma, tumor, or osteomyelitis were excluded. Outcome measures collected and reviewed in this study included the Oswestry Disability Index (ODI),^16,17 the Medical Outcomes Study Short-Form 36 (SF-36),¹⁸ and numeric rating scales for back and leg pain (0-100 scale).¹⁹ The Physical Composite Summary (PCS) and Mental Composite Summary of the SF-36 were reviewed separately. We recorded the following patient demographic data: age, gender, American Society of Anesthesiologists (ASA) grade, body mass index, indication for surgery, workers’ compensation, and smoking status. Surgical data included number of levels fused, operative time, estimated blood loss, and length of hospital stay.

Propensity-scoring technique^20,21 was used to match the MIS TLIF patients to a control group of patients who underwent TLIF using an open approach (open TLIF), matching for multiple characteristics to produce 2 similar comparison groups. Propensity matching was performed to control for bias. In controlling for known confounders or biases, propensity matching, in theory, should also control for unknown confounders. Gender, age, body mass index, smoking status, indication for fusion, as well as preoperative ODI, SF-36 PCS, SF-36 Mental Composite Summary, and pain scores were used to generate a control open TLIF group.

MIS TLIF Surgical Technique

Patients in the MIS TLIF group underwent neural decompression and interbody fusion through a tubular retractor system (METRx, Medtronic Inc.), followed by percutaneous pedicle-screw fixation under fluoroscopic guidance (Sextant, Medtronic Inc.). After successful induction of general endotracheal anesthesia, patients were positioned prone on a radiolucent table. Posteroanterior (PA) and lateral fluoroscopic images were used to localize 2 paramedian incisions, approximately 3-cm to 5-cm lateral to midline, over the pedicles of interest. Modified Jamshidi needles (Medtronic Inc.) were used to cannulate the pedicles under PA, posterior-oblique, PA, and lateral fluoroscopic guidance. The pedicles were tapped with a cannulated tap. Pedicle screws and rods were introduced on the side contralateral to the TLIF and were used as needed to maintain intradiscal distraction during the TLIF portion of the procedure.

Decompression and TLIF were carried out on the side of the patient’s radicular pain or bilaterally, according to the surgeon’s discretion. A K-wire was advanced to the facet joint complex, after which sequential dilators were used to dilate through the muscles to establish an intramuscular corridor to the facet. A 26-mm fixed tubular retractor was docked over the facet and locked in place, using a post attached to the operating room table. Neural decompression was obtained by removal of the entire facet-joint complex and lamina to the base of the spinous process, using a combination of high-speed drills and Kerrison rongeurs. The ligamentum flavum was completely resected. The superior articular process of the caudal vertebra was removed all the way to the pedicle below. Ball-tipped probes were used to confirm that traversing and exiting nerve roots were completely free. An annulotomy was performed, and all disc material was removed from the disc through a combination of rotating shavers, serrated curettes, endplate scrapers, and rasps. Bone graft was placed anterior and contralateral to the interbody cage. (Bone grafts included autogenous iliac crest, local bone obtained from the decompression, recombinant human bone morphogenetic protein 2, or allograft demineralized bone matrix at the surgeon’s discretion.) After placement of the interbody cage, the ipsilateral pedicle-screw instrumentation was put over the remaining guide wires and compression applied across the construct to lock the interbody cage and restore lordosis. Wounds were closed without drains.

Open TLIF Surgical Technique

In patients undergoing open TLIF, a midline incision was made over the vertebrae of interest, and paraspinal muscles were subperiosteally dissected to the tips of the transverse processes. The appropriate level was confirmed with intraoperative radiograph. Pedicle screws were placed free-hand using anatomic landmarks, and appropriate placement was confirmed with intraoperative radiograph and evoked electromyography stimulation. Laminectomy and facetectomy were performed, and the disc was entered on the side of the facetectomy. After thorough disc-space preparation, bone graft and an interbody cage were placed, rods inserted, and compression carried out. A supplemental posterolateral fusion was also performed after decortication of the transverse processes and cartilaginous surface of the contralateral facet. Layered wound closure was performed over drains.

Analysis

Statistical analysis was carried out using SPSS Statistics version 17.0 (IBM) with significance set at the P < .01 level. A small, conservative P-value threshold was used to minimize type II error that resulted from the multiple comparisons performed. Student t test was used to determine any significant differences between continuous demographic variables, and to compare preoperative and postoperative outcome measure scores within and between study groups. Fisher’s exact test was used to compare categorical variables between the 2 groups.

Results

The MIS TLIF group consisted of 64 patients (average age, 52 years), and included 22 patients with degenerative spondylolisthesis, 33 with disc pathology, 8 with postdecompression, and 1 non-union patient. The open TLIF group consisted of 64 patients (average age, 54 years), and included 39 degenerative spondylolisthesis, 15 disc pathology, 7 postdecompression, and 3 nonunion patients (Table 1). All 64 open and 19 MIS cases were from a spine practice with 6 surgeons, and 45 MIS cases came from a spine practice with 2 surgeons. There was also an unequal distribution of the specific levels fused between the open and MIS groups.

Although the operative time was similar in both groups, the MIS TLIF group had a statistically significantly lower blood loss compared with the open TLIF group (Table 2). Both MIS TLIF and open TLIF lead to significant improvements in pain, ODI, and SF-36 PCS (P < .01) (Table 3). At 1 year, both groups had similar improvements in pain (36.9 vs 30.8, P = .178) and SF-36 PCS (9.9 vs 7.5, P = .231), but the MIS TLIF group had a statistically significantly greater improvement in ODI compared with the open TLIF group (30.4 vs 15.1, P < .000). At 2 years, both groups had similar improvements in SF-36 PCS (12.1 vs 7.5, P = .033), but the MIS TLIF group had a statistically significantly greater improvement in pain (40.2 vs 27.0, P = .005) and ODI (33.1 vs 15.4, P < .000) compared with the open TLIF group (Table 4).

Discussion

The current study compared intermediate-term clinical outcomes of MIS TLIF to open TLIF. We used propensity matching to identify a control group of open TLIFs that were comparable to the MIS TLIF group across a variety of covariates that are known to influence the results of lumbar fusion. This created comparison groups that were as closely matched at baseline as possible. We found that, at 2-year follow-up, MIS TLIF patients had less pain and less low-back pain–related disability as measured by ODI. There was also a trend toward better generic health-related quality of life in the MIS TLIF group.

These data suggest that the decreased soft-tissue trauma of the minimally invasive surgical technique, which leads to improved perioperative parameters in the short term, may also lead to some advantages that translate to improved intermediate-term clinical outcomes. Traditional lumbar fusion procedures have shown excellent clinical results when used for accepted clinical indications.²² However, the procedure requires extensive dissection of the paraspinal muscles, which causes significant muscle damage as evidenced by muscle breakdown products that can be detected in the bloodstream postoperatively.^23,24 The lateral dissection also transects the dorsal ramus of the segmental nerves, which innervate the paraspinal muscles, leading to significant scarring and atrophy on postoperative imaging studies.²³ Some authors have used the term “fusion disease” to describe the constellation of soft-tissue degradation seen after open lumbar fusion.⁵

An MIS version of the TLIF procedure that was described in 2003³ avoids much of this iatrogenic soft-tissue trauma. It involves intramuscular dilation to approach the spine and to carry out neural decompression and interbody fusion, in conjunction with percutaneous pedicle-screw instrumentation. Proponents of this technique point to diminished iatrogenic soft-tissue and muscle damage as an advantage. Multiple studies have, in fact, confirmed improved short-term perioperative parameters, such as less blood loss, lower narcotic requirements, and decreased length-of-hospital stay.²⁵ Economic analyses have also shown lower direct and indirect costs with the MIS technique.²⁶

Several studies have compared patient-reported outcome measures of MIS and open TLIF, and the results have been mixed. Most of these studies have shown similar improvement in clinical outcomes between the 2 procedures, but the MIS technique demonstrated short-term perioperative advantages, such as lower blood loss, less narcotic requirements, and shorter length of stay.^7-15 The authors of these studies conclude that the MIS technique can provide similar long-term results with lower short-term morbidity when compared with open TLIF. In contrast, some studies have shown better short- and intermediate-term clinical outcomes with the MIS technique.^23,27-29 As a whole, the literature comparing the 2 procedures consists of mostly small retrospective studies with nonrandomized patient samples, heterogeneous surgical indications, and differing surgical techniques, making it difficult to draw conclusions.

The current study suggests that MIS TLIF may lead to improved clinical results at 2-year follow-up, compared with open TLIF. Our study used propensity-score matching to minimize the effects of nonrandom assignment of subjects to MIS TLIF or open TLIF. A limitation of observational studies is that bias in assignment of subjects to treatment groups can lead to overestimation or underestimation of the effect of the treatment itself. Propensity-score matching attempts to reduce this bias by accounting for several covariates that predict whether a subject will receive a certain treatment. These covariates are used in a logistic regression to produce a propensity score, which can be used to match subjects to controls across multiple dimensions, thus ensuring groups are as comparable as possible at baseline.

Our study still has several limitations. Sample size is relatively small, and follow-up is still only intermediate, at 2 years. There was unequal distribution of specific levels of surgery. Because patients were not blinded to the treatment they received, it is possible that patient perception of receiving a newer, less-invasive treatment method may influence their subjective improvement. The study sample was drawn from 2 different centers, with one center providing mostly MIS cases and the other providing mostly open cases. Because of this, undetected differences in how patients were selected for surgery could also affect outcomes. Any latent confounding variables, which are not identified a priori, will not be accounted for in the matching process. Only a prospective, randomized study with large numbers can control for observed and unobserved confounding patient characteristics.

In summary, our study shows that MIS TLIF is associated with improved low back pain and low back–related disability at 2 years compared with open TLIF. Other studies comparing the 2 techniques have come to different conclusions regarding whether the short-term benefits of MIS TLIF translate into long-term differences in clinical outcome. This study adds to this evidence and suggests there may be longer term advantages to the MIS approach, but prospective randomized trials are needed to confirm this finding and determine the true magnitude of these differences.

The optimal management strategy for acute fractures of the metadiaphyseal fifth metatarsal (Jones fractures) is controversial. Patients can be successfully treated nonoperatively with non-weight-bearing and immobilization in a short leg cast^1-7 or operatively with placement of an intramedullary screw.^8-10 The primary advantage of nonoperative treatment is avoiding the risks and discomfort of surgery; disadvantages include the need for prolonged immobilization and protected weight-bearing as well as a decreased union rate.^8,9 Advantages of operative treatment include accelerated functional recovery and an improved union rate; disadvantages include exposure to the risks, inconvenience, and discomfort of surgery. Clear, definitive evidence for guiding treatment is not available in the orthopedic literature, and treatment strategies vary substantially according to surgeon and patient preference.

Expected-value decision analysis, a research tool that helps guide decision-making in situations of uncertainty, has been effectively applied to other areas of uncertainty in the orthopedic literature.^11-14 Borrowed from gaming theory, the technique involves creating a decision tree to define the clinical problem, determining outcome probabilities and utilities, performing a fold-back analysis to determine the optimal decision-making strategy, and performing a sensitivity analysis to model the effect of varying outcome probabilities and utilities on decision-making. Decision analysis may therefore allow the clinician and the patient to optimize decision-making based on best available evidence and patient preferences. It also helps determine the most important factors affecting management strategies and the decision-making process, which may not always be intuitive.

In the present study, we used expected-value decision analysis to determine the optimal management strategy, operative or nonoperative, for acute Jones fracture. We also explored factors with the most influence on the model and identified important questions for future research.

Materials and Methods

Institutional review board approval was obtained for this study. Analysis was performed with Treeage Pro statistical software (Treeage Software).

Outcome Probabilities

Outcome probabilities were determined by reviewing the literature for articles on Jones fractures. This body of literature was summarized in a comprehensive review by Dean and colleagues¹⁵, who extracted data from 19 studies: 1 randomized controlled trial, 1 prospective case series, and 17 retrospective case series.¹⁵ We used data from these studies to determine outcome probabilities (Table).

Outcome Utilities

Utilities represent patient preferences for various disease states. Outcome utility values were obtained from 32 adults (25 women, 7 men) with no history of foot injury. Mean age was 32.4 years (range, 20-69 years). The questionnaire presented scenarios for the different outcomes and asked patients to rate these outcomes on a scale ranging from 0 (worst possible outcome) to 10 (best possible outcome). The Sports subscale of the Foot and Ankle Ability Measure (FAAM) 16 was used to quantify patient activity level.

Decision Tree and Fold-Back Analysis

A decision tree was constructed with 1 decision node, 4 chance nodes, and 7 terminal nodes (Figure 1). The decision tree demonstrates 2 different strategies for managing a Jones fracture. The decision node divides the tree into 2 branches: initial operative or nonoperative treatment. Both branches are followed by various chance nodes, each terminating in a discrete clinical outcome. Per convention, utility data were placed to the right of the terminal nodes, and probability data were placed under the terminal nodes.

Fold-back analysis was performed to identify the optimal strategy. Fold-back analysis involves multiplying each outcome utility by its associated probability, thereby providing an “expected value” for each clinical endpoint. Then, the expected values for each endpoint can be summed for a given management strategy, and the ultimate expected values of the different strategies can be compared. The management strategy associated with the highest expected value is optimal for the given outcome utilities and probabilities.

Sensitivity Analysis

One-way sensitivity analysis was performed to model the effect on decision-making of changing the values for utility for uncomplicated surgery, utility for healing with nonoperative treatment, utility for uncomplicated treatment of nonunion, likelihood of healing with nonoperative treatment, likelihood of healing with surgery, and likelihood of minor complication with surgery. These were the variables found to affect the decision-making strategy within their clinically plausible ranges.

Results

Outcome Probabilities and Utilities

Outcome probabilities and utilities are illustrated in Figure 1. By convention, probabilities appear below the corresponding branches of the decision tree, and utilities appear at the end of each branch. Mean (SD) FAAM Sports subscale score was 84.6 (27.4). This subscale is scored as a percentage from 0% to 100%, with higher scores indicating a higher level of physical function.

Decision Analysis

The expected value for nonoperative treatment was 7.74, and the expected value for intramedullary screw fixation was 7.88 (Figure 1). Therefore, operative treatment was identified as the optimal treatment strategy.

Sensitivity analyses revealed that the optimal decision making strategy was very sensitive to small changes in several variables. Nonoperative treatment becomes the preferred strategy when the utility value for uncomplicated surgery falls below 8.04 (Figure 2), when the utility for healing with nonoperative treatment rises above 8.49 (Figure 3), when the likelihood of healing with nonoperative treatment rises above 82% (Figure 4), or when the probability of healing after surgery falls below 92% (Figure 5). Nonoperative treatment is also favored when the probability of minor complication with surgery is above 17% (Figure 6) and when utility for a successfully treated nonunion is higher than 6.9 (Figure 7).

Discussion

Optimal management of a metadiaphyseal fracture of the fifth metatarsal (Jones fracture) remains controversial. The decision between initial operative or nonoperative treatment lends itself to expected-value decision analysis because of well-defined treatment options and relatively discrete outcomes. The principal advantages of nonoperative treatment are that it allows the patient to avoid the risks and discomfort of surgery, and the principal advantages of operative treatment are that it maximizes the chance of fracture union and may accelerate functional recovery.

Our decision analysis determined that operative fixation is the optimal decision path, given the outcome probabilities derived from the literature and the utilities obtained from surveys. This finding is in accordance with several expert opinions in foot and ankle fracture surgery.^17,18 However, the expected values of the operative and nonoperative treatment strategies differed by only 0.3 on a 10-point scale. Such similar expected values in our model are not surprising given the controversy surrounding clinical decision making in the treatment of these fractures.¹⁹

In addition, our analysis identified the important variables in the decision-making process. Patients averse to surgery, patients not averse to successful nonoperative treatment, and patients who view successful nonunion surgery after initial nonoperative treatment as a relatively positive outcome may be best treated nonoperatively. These findings emphasize the importance of patient preferences and shared decision-making. Higher rates of healing with nonoperative treatment, lower rates of healing with surgery, and higher complication rates with surgery also favor nonoperative management. It would therefore be valuable to identify risk factors for nonunion with nonoperative treatment and to identify the technical details of surgery that maximize rates of healing and minimize the risk of complications.

The limitations of decision analysis involve the methods by which probabilities and utilities are obtained. In general, the most accurate, stable, and robust estimates of outcome probabilities are derived from a meta-analytic synthesis of randomized clinical trials, the highest level of clinical evidence. In our model, data were extracted primarily from level IV studies; only 1 level III study²⁰ and 1 level II study²¹ were available for analysis. Thus, as is the case with many foot and ankle disorders²², the information on treatment of Jones fractures is very limited in its level of clinical evidence.

Determination of outcome utility also has limitations. Utility is a subjective value that an individual places on a specific outcome. This can be very difficult to quantify. In general, the most robust estimates of patient-derived utilities are derived from complex qualitative methods, such as the standard reference gamble or time trade-offs, in which patients are asked to gamble or choose between health states usually referenced to death. In this study, we determined patient-derived utility values from a direct scaling method using a Likert scale because of the complexity of the standard reference gamble and the difficulty of referencing to death for metatarsal fracture. Although use of a direct scale to determine utility values is less rigorous than the standard reference gamble, this technique has been corroborated methodologically,²³ is advantageous in terms of feasibility and reliability,²⁴ and has been successfully used in other orthopedic decision analysis models.^12,25,26 In our estimation, generally active patients without a history of foot pathology constituted a sample of convenience but also were representative of individuals at risk for Jones fracture. Although specific scenarios were presented, the patients who completed the questionnaire may not have had deep insights into the subtleties and implications of the various disease states and treatments. Regardless of how outcome probabilities and utilities are determined, they are considered point estimates in decision analysis, and sensitivity analyses are therefore performed to assess how decision making changes over a range of values.

Conclusion

The results of this study may help optimize the process of deciding between operative and nonoperative treatment for Jones fracture. For a given patient, the optimal strategy depends not only on the probabilities of the various outcomes but also on personal preference. Thus, there may not be one right answer for all patients. Patients who value a higher chance of fracture healing with initial treatment or an earlier return to sports are best treated operatively, whereas patients who are risk-averse and place a high value on fracture healing without surgery should be managed nonoperatively. We therefore advocate a model of shared medical decision-making in which the physician and the patient are jointly involved, considering both outcome probabilities and patient preferences. Ongoing research efforts should focus on predictors of nonunion with nonoperative treatment.

The optimal management strategy for acute fractures of the metadiaphyseal fifth metatarsal (Jones fractures) is controversial. Patients can be successfully treated nonoperatively with non-weight-bearing and immobilization in a short leg cast^1-7 or operatively with placement of an intramedullary screw.^8-10 The primary advantage of nonoperative treatment is avoiding the risks and discomfort of surgery; disadvantages include the need for prolonged immobilization and protected weight-bearing as well as a decreased union rate.^8,9 Advantages of operative treatment include accelerated functional recovery and an improved union rate; disadvantages include exposure to the risks, inconvenience, and discomfort of surgery. Clear, definitive evidence for guiding treatment is not available in the orthopedic literature, and treatment strategies vary substantially according to surgeon and patient preference.

Expected-value decision analysis, a research tool that helps guide decision-making in situations of uncertainty, has been effectively applied to other areas of uncertainty in the orthopedic literature.^11-14 Borrowed from gaming theory, the technique involves creating a decision tree to define the clinical problem, determining outcome probabilities and utilities, performing a fold-back analysis to determine the optimal decision-making strategy, and performing a sensitivity analysis to model the effect of varying outcome probabilities and utilities on decision-making. Decision analysis may therefore allow the clinician and the patient to optimize decision-making based on best available evidence and patient preferences. It also helps determine the most important factors affecting management strategies and the decision-making process, which may not always be intuitive.

In the present study, we used expected-value decision analysis to determine the optimal management strategy, operative or nonoperative, for acute Jones fracture. We also explored factors with the most influence on the model and identified important questions for future research.

Materials and Methods

Institutional review board approval was obtained for this study. Analysis was performed with Treeage Pro statistical software (Treeage Software).

Outcome Probabilities

Outcome probabilities were determined by reviewing the literature for articles on Jones fractures. This body of literature was summarized in a comprehensive review by Dean and colleagues¹⁵, who extracted data from 19 studies: 1 randomized controlled trial, 1 prospective case series, and 17 retrospective case series.¹⁵ We used data from these studies to determine outcome probabilities (Table).

Outcome Utilities

Utilities represent patient preferences for various disease states. Outcome utility values were obtained from 32 adults (25 women, 7 men) with no history of foot injury. Mean age was 32.4 years (range, 20-69 years). The questionnaire presented scenarios for the different outcomes and asked patients to rate these outcomes on a scale ranging from 0 (worst possible outcome) to 10 (best possible outcome). The Sports subscale of the Foot and Ankle Ability Measure (FAAM) 16 was used to quantify patient activity level.

Decision Tree and Fold-Back Analysis

A decision tree was constructed with 1 decision node, 4 chance nodes, and 7 terminal nodes (Figure 1). The decision tree demonstrates 2 different strategies for managing a Jones fracture. The decision node divides the tree into 2 branches: initial operative or nonoperative treatment. Both branches are followed by various chance nodes, each terminating in a discrete clinical outcome. Per convention, utility data were placed to the right of the terminal nodes, and probability data were placed under the terminal nodes.

Fold-back analysis was performed to identify the optimal strategy. Fold-back analysis involves multiplying each outcome utility by its associated probability, thereby providing an “expected value” for each clinical endpoint. Then, the expected values for each endpoint can be summed for a given management strategy, and the ultimate expected values of the different strategies can be compared. The management strategy associated with the highest expected value is optimal for the given outcome utilities and probabilities.

Sensitivity Analysis

One-way sensitivity analysis was performed to model the effect on decision-making of changing the values for utility for uncomplicated surgery, utility for healing with nonoperative treatment, utility for uncomplicated treatment of nonunion, likelihood of healing with nonoperative treatment, likelihood of healing with surgery, and likelihood of minor complication with surgery. These were the variables found to affect the decision-making strategy within their clinically plausible ranges.

Results

Outcome Probabilities and Utilities

Outcome probabilities and utilities are illustrated in Figure 1. By convention, probabilities appear below the corresponding branches of the decision tree, and utilities appear at the end of each branch. Mean (SD) FAAM Sports subscale score was 84.6 (27.4). This subscale is scored as a percentage from 0% to 100%, with higher scores indicating a higher level of physical function.

Decision Analysis

The expected value for nonoperative treatment was 7.74, and the expected value for intramedullary screw fixation was 7.88 (Figure 1). Therefore, operative treatment was identified as the optimal treatment strategy.

Sensitivity analyses revealed that the optimal decision making strategy was very sensitive to small changes in several variables. Nonoperative treatment becomes the preferred strategy when the utility value for uncomplicated surgery falls below 8.04 (Figure 2), when the utility for healing with nonoperative treatment rises above 8.49 (Figure 3), when the likelihood of healing with nonoperative treatment rises above 82% (Figure 4), or when the probability of healing after surgery falls below 92% (Figure 5). Nonoperative treatment is also favored when the probability of minor complication with surgery is above 17% (Figure 6) and when utility for a successfully treated nonunion is higher than 6.9 (Figure 7).

Discussion

Optimal management of a metadiaphyseal fracture of the fifth metatarsal (Jones fracture) remains controversial. The decision between initial operative or nonoperative treatment lends itself to expected-value decision analysis because of well-defined treatment options and relatively discrete outcomes. The principal advantages of nonoperative treatment are that it allows the patient to avoid the risks and discomfort of surgery, and the principal advantages of operative treatment are that it maximizes the chance of fracture union and may accelerate functional recovery.

Our decision analysis determined that operative fixation is the optimal decision path, given the outcome probabilities derived from the literature and the utilities obtained from surveys. This finding is in accordance with several expert opinions in foot and ankle fracture surgery.^17,18 However, the expected values of the operative and nonoperative treatment strategies differed by only 0.3 on a 10-point scale. Such similar expected values in our model are not surprising given the controversy surrounding clinical decision making in the treatment of these fractures.¹⁹

In addition, our analysis identified the important variables in the decision-making process. Patients averse to surgery, patients not averse to successful nonoperative treatment, and patients who view successful nonunion surgery after initial nonoperative treatment as a relatively positive outcome may be best treated nonoperatively. These findings emphasize the importance of patient preferences and shared decision-making. Higher rates of healing with nonoperative treatment, lower rates of healing with surgery, and higher complication rates with surgery also favor nonoperative management. It would therefore be valuable to identify risk factors for nonunion with nonoperative treatment and to identify the technical details of surgery that maximize rates of healing and minimize the risk of complications.

The limitations of decision analysis involve the methods by which probabilities and utilities are obtained. In general, the most accurate, stable, and robust estimates of outcome probabilities are derived from a meta-analytic synthesis of randomized clinical trials, the highest level of clinical evidence. In our model, data were extracted primarily from level IV studies; only 1 level III study²⁰ and 1 level II study²¹ were available for analysis. Thus, as is the case with many foot and ankle disorders²², the information on treatment of Jones fractures is very limited in its level of clinical evidence.

Determination of outcome utility also has limitations. Utility is a subjective value that an individual places on a specific outcome. This can be very difficult to quantify. In general, the most robust estimates of patient-derived utilities are derived from complex qualitative methods, such as the standard reference gamble or time trade-offs, in which patients are asked to gamble or choose between health states usually referenced to death. In this study, we determined patient-derived utility values from a direct scaling method using a Likert scale because of the complexity of the standard reference gamble and the difficulty of referencing to death for metatarsal fracture. Although use of a direct scale to determine utility values is less rigorous than the standard reference gamble, this technique has been corroborated methodologically,²³ is advantageous in terms of feasibility and reliability,²⁴ and has been successfully used in other orthopedic decision analysis models.^12,25,26 In our estimation, generally active patients without a history of foot pathology constituted a sample of convenience but also were representative of individuals at risk for Jones fracture. Although specific scenarios were presented, the patients who completed the questionnaire may not have had deep insights into the subtleties and implications of the various disease states and treatments. Regardless of how outcome probabilities and utilities are determined, they are considered point estimates in decision analysis, and sensitivity analyses are therefore performed to assess how decision making changes over a range of values.

Conclusion

The results of this study may help optimize the process of deciding between operative and nonoperative treatment for Jones fracture. For a given patient, the optimal strategy depends not only on the probabilities of the various outcomes but also on personal preference. Thus, there may not be one right answer for all patients. Patients who value a higher chance of fracture healing with initial treatment or an earlier return to sports are best treated operatively, whereas patients who are risk-averse and place a high value on fracture healing without surgery should be managed nonoperatively. We therefore advocate a model of shared medical decision-making in which the physician and the patient are jointly involved, considering both outcome probabilities and patient preferences. Ongoing research efforts should focus on predictors of nonunion with nonoperative treatment.

The optimal management strategy for acute fractures of the metadiaphyseal fifth metatarsal (Jones fractures) is controversial. Patients can be successfully treated nonoperatively with non-weight-bearing and immobilization in a short leg cast^1-7 or operatively with placement of an intramedullary screw.^8-10 The primary advantage of nonoperative treatment is avoiding the risks and discomfort of surgery; disadvantages include the need for prolonged immobilization and protected weight-bearing as well as a decreased union rate.^8,9 Advantages of operative treatment include accelerated functional recovery and an improved union rate; disadvantages include exposure to the risks, inconvenience, and discomfort of surgery. Clear, definitive evidence for guiding treatment is not available in the orthopedic literature, and treatment strategies vary substantially according to surgeon and patient preference.

Expected-value decision analysis, a research tool that helps guide decision-making in situations of uncertainty, has been effectively applied to other areas of uncertainty in the orthopedic literature.^11-14 Borrowed from gaming theory, the technique involves creating a decision tree to define the clinical problem, determining outcome probabilities and utilities, performing a fold-back analysis to determine the optimal decision-making strategy, and performing a sensitivity analysis to model the effect of varying outcome probabilities and utilities on decision-making. Decision analysis may therefore allow the clinician and the patient to optimize decision-making based on best available evidence and patient preferences. It also helps determine the most important factors affecting management strategies and the decision-making process, which may not always be intuitive.

In the present study, we used expected-value decision analysis to determine the optimal management strategy, operative or nonoperative, for acute Jones fracture. We also explored factors with the most influence on the model and identified important questions for future research.

Materials and Methods

Institutional review board approval was obtained for this study. Analysis was performed with Treeage Pro statistical software (Treeage Software).

Outcome Probabilities

Outcome probabilities were determined by reviewing the literature for articles on Jones fractures. This body of literature was summarized in a comprehensive review by Dean and colleagues¹⁵, who extracted data from 19 studies: 1 randomized controlled trial, 1 prospective case series, and 17 retrospective case series.¹⁵ We used data from these studies to determine outcome probabilities (Table).

Outcome Utilities

Utilities represent patient preferences for various disease states. Outcome utility values were obtained from 32 adults (25 women, 7 men) with no history of foot injury. Mean age was 32.4 years (range, 20-69 years). The questionnaire presented scenarios for the different outcomes and asked patients to rate these outcomes on a scale ranging from 0 (worst possible outcome) to 10 (best possible outcome). The Sports subscale of the Foot and Ankle Ability Measure (FAAM) 16 was used to quantify patient activity level.

Decision Tree and Fold-Back Analysis

A decision tree was constructed with 1 decision node, 4 chance nodes, and 7 terminal nodes (Figure 1). The decision tree demonstrates 2 different strategies for managing a Jones fracture. The decision node divides the tree into 2 branches: initial operative or nonoperative treatment. Both branches are followed by various chance nodes, each terminating in a discrete clinical outcome. Per convention, utility data were placed to the right of the terminal nodes, and probability data were placed under the terminal nodes.

Fold-back analysis was performed to identify the optimal strategy. Fold-back analysis involves multiplying each outcome utility by its associated probability, thereby providing an “expected value” for each clinical endpoint. Then, the expected values for each endpoint can be summed for a given management strategy, and the ultimate expected values of the different strategies can be compared. The management strategy associated with the highest expected value is optimal for the given outcome utilities and probabilities.

Sensitivity Analysis

One-way sensitivity analysis was performed to model the effect on decision-making of changing the values for utility for uncomplicated surgery, utility for healing with nonoperative treatment, utility for uncomplicated treatment of nonunion, likelihood of healing with nonoperative treatment, likelihood of healing with surgery, and likelihood of minor complication with surgery. These were the variables found to affect the decision-making strategy within their clinically plausible ranges.

Results

Outcome Probabilities and Utilities

Outcome probabilities and utilities are illustrated in Figure 1. By convention, probabilities appear below the corresponding branches of the decision tree, and utilities appear at the end of each branch. Mean (SD) FAAM Sports subscale score was 84.6 (27.4). This subscale is scored as a percentage from 0% to 100%, with higher scores indicating a higher level of physical function.

Decision Analysis

The expected value for nonoperative treatment was 7.74, and the expected value for intramedullary screw fixation was 7.88 (Figure 1). Therefore, operative treatment was identified as the optimal treatment strategy.

Sensitivity analyses revealed that the optimal decision making strategy was very sensitive to small changes in several variables. Nonoperative treatment becomes the preferred strategy when the utility value for uncomplicated surgery falls below 8.04 (Figure 2), when the utility for healing with nonoperative treatment rises above 8.49 (Figure 3), when the likelihood of healing with nonoperative treatment rises above 82% (Figure 4), or when the probability of healing after surgery falls below 92% (Figure 5). Nonoperative treatment is also favored when the probability of minor complication with surgery is above 17% (Figure 6) and when utility for a successfully treated nonunion is higher than 6.9 (Figure 7).

Discussion

Optimal management of a metadiaphyseal fracture of the fifth metatarsal (Jones fracture) remains controversial. The decision between initial operative or nonoperative treatment lends itself to expected-value decision analysis because of well-defined treatment options and relatively discrete outcomes. The principal advantages of nonoperative treatment are that it allows the patient to avoid the risks and discomfort of surgery, and the principal advantages of operative treatment are that it maximizes the chance of fracture union and may accelerate functional recovery.

Our decision analysis determined that operative fixation is the optimal decision path, given the outcome probabilities derived from the literature and the utilities obtained from surveys. This finding is in accordance with several expert opinions in foot and ankle fracture surgery.^17,18 However, the expected values of the operative and nonoperative treatment strategies differed by only 0.3 on a 10-point scale. Such similar expected values in our model are not surprising given the controversy surrounding clinical decision making in the treatment of these fractures.¹⁹

In addition, our analysis identified the important variables in the decision-making process. Patients averse to surgery, patients not averse to successful nonoperative treatment, and patients who view successful nonunion surgery after initial nonoperative treatment as a relatively positive outcome may be best treated nonoperatively. These findings emphasize the importance of patient preferences and shared decision-making. Higher rates of healing with nonoperative treatment, lower rates of healing with surgery, and higher complication rates with surgery also favor nonoperative management. It would therefore be valuable to identify risk factors for nonunion with nonoperative treatment and to identify the technical details of surgery that maximize rates of healing and minimize the risk of complications.

The limitations of decision analysis involve the methods by which probabilities and utilities are obtained. In general, the most accurate, stable, and robust estimates of outcome probabilities are derived from a meta-analytic synthesis of randomized clinical trials, the highest level of clinical evidence. In our model, data were extracted primarily from level IV studies; only 1 level III study²⁰ and 1 level II study²¹ were available for analysis. Thus, as is the case with many foot and ankle disorders²², the information on treatment of Jones fractures is very limited in its level of clinical evidence.

Determination of outcome utility also has limitations. Utility is a subjective value that an individual places on a specific outcome. This can be very difficult to quantify. In general, the most robust estimates of patient-derived utilities are derived from complex qualitative methods, such as the standard reference gamble or time trade-offs, in which patients are asked to gamble or choose between health states usually referenced to death. In this study, we determined patient-derived utility values from a direct scaling method using a Likert scale because of the complexity of the standard reference gamble and the difficulty of referencing to death for metatarsal fracture. Although use of a direct scale to determine utility values is less rigorous than the standard reference gamble, this technique has been corroborated methodologically,²³ is advantageous in terms of feasibility and reliability,²⁴ and has been successfully used in other orthopedic decision analysis models.^12,25,26 In our estimation, generally active patients without a history of foot pathology constituted a sample of convenience but also were representative of individuals at risk for Jones fracture. Although specific scenarios were presented, the patients who completed the questionnaire may not have had deep insights into the subtleties and implications of the various disease states and treatments. Regardless of how outcome probabilities and utilities are determined, they are considered point estimates in decision analysis, and sensitivity analyses are therefore performed to assess how decision making changes over a range of values.

Conclusion

The results of this study may help optimize the process of deciding between operative and nonoperative treatment for Jones fracture. For a given patient, the optimal strategy depends not only on the probabilities of the various outcomes but also on personal preference. Thus, there may not be one right answer for all patients. Patients who value a higher chance of fracture healing with initial treatment or an earlier return to sports are best treated operatively, whereas patients who are risk-averse and place a high value on fracture healing without surgery should be managed nonoperatively. We therefore advocate a model of shared medical decision-making in which the physician and the patient are jointly involved, considering both outcome probabilities and patient preferences. Ongoing research efforts should focus on predictors of nonunion with nonoperative treatment.

The beach-chair position (BCP) is commonly used for both arthroscopic and open shoulder surgery. This technique positions the shoulder in an anatomical upright position, facilitating shoulder access and visualization.¹ Compared with the lateral decubitus position, the BCP also improves airway access, reduces bleeding, and lessens the risk for brachial plexus injury.²

Despite the advantages of using the BCP, there have been multiple reports of catastrophic neurologic complications, including severe brain damage and death, in relatively healthy patients without any known risk factors.^3-6 The definitive etiology of these complications remains unclear, but it has been hypothesized that BCP use may be an independent risk factor for cerebrovascular ischemia,^1,5-16 as the upright position can cause hypotension leading to increased risk for cerebral hypoperfusion.^7-11,17 Reducing cerebral perfusion pressure below critical thresholds may result in permanent neurologic injury.^4-6,14 Therefore, monitoring of cerebral perfusion and optimization of intraoperative cerebral oxygenation have been recommended to help avoid potential neurologic complications. However, a direct relationship between intraoperative cerebral desaturation events (CDEs) and postoperative neurocognitive deficits has not been definitively established.^1,9-12

To put into perspective the importance of detecting and preventing CDEs and neurologic complications, we can consider the incidence of fatal pulmonary embolism associated with total joint arthroplasty. Although the incidence is very low, about 0.1% to 2.0%, some form of venous thromboembolism prophylaxis is the standard of care for helping prevent this serious complication. Similarly, catastrophic neurologic complications of upright shoulder arthroscopy are very rare, but it is still important to consider measures that help minimize them.

We reviewed the literature for the incidence of postoperative neurocognitive deficits, number of reported neurocognitive complications, and incidence of intraoperative CDEs in patients who underwent arthroscopic shoulder surgery in the BCP.

Methods

Dr. Salazar and Dr. Hazel independently searched the Medline, Cochrane, and Embase databases for case series, prospective studies, and cohort studies that reported neurocognitive complications associated with the BCP and the incidence of intraoperative CDEs. The authors used beach chair, desaturation, near infrared spectroscopy, and shoulder as medical subject headings (MeSH). In addition, bibliographies of retrieved articles were checked for studies that the search terms may have missed. Eighty-one publications were identified and reviewed for possible inclusion.

Next, the same 2 authors reviewed the titles and abstracts for relevance and determined which articles had potential to contribute to the study. Only English-language publications were considered for inclusion. To review the incidence of postoperative neurocognitive deficits, we included only those studies with more than 25 patients, documentation of postoperative complications, and arthroscopic shoulder surgery performed with the patient in the seated, semi-upright, or BCP. Only studies with at least 25 patients were used in order to increase the power and improve the level of evidence. To review reported cases of neurocognitive complications, we included all relevant case reports and case series. To review the incidence of intraoperative CDEs and investigate their relationship with postoperative neurocognitive deficits, we included studies that reported on use of intraoperative cerebral perfusion monitoring. Modalities used in these studies included near infrared spectroscopy, electroencephalography, and invasive blood pressure monitoring calculated at the brain level. Studies were excluded if they did not involve arthroscopic shoulder surgery or were not conducted with human subjects.

Information recorded for each study included general information such as author and publication year, type of study, number of patients enrolled, type of intraoperative monitoring, anesthesia protocol, number of patients with CDEs, and number of patients with neurocognitive complications after surgery.

Results

Our search identified 81 publications for potential inclusion. Our first aim was to identify the overall incidence of reported neurocognitive deficits after arthroscopic shoulder surgery with the patient in the BCP. We identified 10 studies (Table 1) that met the inclusion criteria. Among the 24,701 patients in these 10 studies, there was only 1 reported case of neurocognitive deficit after surgery, in a mixed prospective-retrospective study of 15,014 cases by Rohrbaugh and colleagues.18 The deficit they reported was an ischemic cerebral vascular accident. The 0.0067% incidence in their study demonstrates how rare the complication is. Two large retrospective studies (Ns = 4169 and 5177 patients) found no postoperative neurocognitive complications.^19,20 Only 3 studies performed formal postoperative cognitive testing. Salazar and colleagues²¹ used the Repeatable Battery for the Assessment of Neuropsychological Status before and after surgery, and Gillespie and colleagues⁸ and Lee and colleagues¹⁰ used the Mini–Mental State Examination before and after surgery. Total incidence of reported neurocognitive deficits from our review was 0.004% (1/24,701).

Our second aim was to review all reported cases of neurocognitive complications after arthroscopic shoulder surgery with the patient in the BCP. We identified 4 publications that fit our inclusion criteria (Table 2). Pohl and Cullen6 described 4 cases of ischemic brain injury after arthroscopic shoulder surgery with the patient in the BCP. Age range was 47 to 57 years. Specific intraoperative cerebral monitoring was not used. However, these patients had several episodes of intraoperative hypotension (systolic blood pressures, 80-90 mm Hg), measured with a traditional blood pressure cuff on the arm. In general, these patients had minimal cerebrovascular risk factors and no known preexisting cerebrovascular disease. Drummond and colleagues²² described an ischemic stroke in a 50-year-old man after arthroscopic subacromial decompression and open rotator cuff repair that resulted in unresolved right hemiplegia. Subsequent diagnostic investigation revealed an asymmetry of the circle of Willis resulting in limited flow to the left anterior and middle cerebral artery distributions. Bhatti and Enneking³ reported the case of a 64-year-old man who lost vision in the right eye immediately after arthroscopic rotator cuff repair. His vision improved spontaneously the next morning and continued to improve over the next 6 months—he regained 20/20 vision with some residual optic neuropathy.

Our third aim was to determine the incidence of intraoperative CDEs during arthroscopic shoulder surgery with the patient in the BCP. Incidence of CDEs varied widely among the 7 studies reviewed (Table 3). Minimum incidence of intraoperative CDE was 0% in a cohort of 30 patients,¹ and maximum incidence was 80% in a study of 61 patients,¹² all of whom underwent elective arthroscopic shoulder surgery in the BCP. Although there was wide variability in CDE incidence, the studies were consistent with respect to their definition of a CDE. Most authors used a decrease in regional cerebral tissue oxygen saturation of 20% or more from baseline, or an absolute value up to 55%, to define a CDE. None of the 7 studies reviewed reported a clinically significant adverse neurocognitive event.

Discussion

Of concern, there have been several surveys, case reports, and small case series of previously healthy patients who had no known risk factors, underwent arthroscopic shoulder surgery in the BCP, and developed unanticipated postoperative neurologic complications.^4-6,14 Beach-chair positioning during surgical procedures has been implicated as a contributing factor leading to cerebral hypoperfusion with potential for cerebral ischemia.^1,12,23 These changes in cerebral perfusion pressure are thought to be the major determinant of poor neurologic outcomes. Such reports have exposed the potential need for heightened vigilance, alternative anesthesia techniques, and improved monitoring, though the exact etiology of the central nervous system injuries in this patient population is incompletely understood and is likely multifactorial. Therefore, in this study we wanted to determine the incidence of postoperative neurocognitive deficits and review all reported cases of neurocognitive complications in patients who have undergone arthroscopic shoulder surgery in the BCP. In addition, we wanted to define the incidence of intraoperative CDEs and investigate their relationship with postoperative neurocognitive complications.

According to our review, the incidence of postoperative neurocognitive complications after surgery in the BCP is 0.004% (1/24,701). However, this finding is based only on what has been reported; the true incidence is not known. It is also important to note that the incidence of neurocognitive deficits after many other types of surgery is not known and that surgery itself may be a risk factor for postoperative neurocognitive deficits.²⁴ In their retrospective review of 15,014 patients who underwent arthroscopic shoulder surgery in the BCP at a single institution over an 11-year period, Rohrbaugh and colleagues18 found an overall postoperative complication rate of 0.37% and a 0.0067% incidence of neurocognitive deficits. One patient in the series was given a diagnosis of ischemic stroke on the basis of neurologic deficits that occurred 24 hours after surgery. Yadeau and colleagues²⁰ found no postoperative neurocognitive complications in a mixed prospective-retrospective study of 4169 patients—3000 identified retrospectively, 1169 prospectively—who underwent arthroscopic shoulder surgery in the BCP at an ambulatory surgery center. Pin-on and colleagues¹⁹ reported on a series of 5177 orthopedic and neurosurgical patients who underwent surgery in the BCP. In those who had arthroscopic shoulder surgery, intraoperative systolic blood pressures obtained from an arterial line referenced to heart level decreased a mean (SD) of 14.4% (12.7%), whereas in those whose pressures were obtained from a noninvasive blood pressure cuff referenced to heart level decreased 19.3% (12.6%). However, the authors reported no incidence of postoperative stroke or neurologic deficits.

Although uncommon, perioperative cerebral ischemic accidents are potentially devastating for patients, their families, and the health care professionals involved. These events have tremendous economic, social, professional, and medicolegal implications, with perioperative stroke being particularly morbid. Perioperative stroke has a mortality rate of 60%, versus 15% to 46% for stroke in general.^25,26 In 2005, Pohl and Cullen⁶ published a landmark article on a series of 4 relatively healthy middle-aged patients who were at low risk for stroke but had catastrophic neurocognitive complications (including 1 death) after arthroscopic shoulder surgery in the BCP. Bhatti and Enneking³ described a case of acute postoperative vision loss and ophthalmoplegia attributed to intraoperative hypotension leading to ischemia in a patient who underwent an elective shoulder arthroscopic procedure in the BCP. These reports prompted multiple investigations into the physiologic hemodynamic changes associated with surgery in the BCP and the treatment strategies used to improve patient safety.

In the normal physiologic state, the sympathetic nervous system is activated when a person assumes the seated position. The result is increased systemic vascular resistance and heart rate alterations to maintain cardiac output and mean arterial pressure. In anesthetized patients, this response is blunted by the vasodilatory effects of intravenous and volatile anesthetics. Multiple studies have demonstrated substantial hemodynamic changes in both awake and anesthetized patients during the maneuver from the supine position to the seated position^1,27,28; these changes include diminished cardiac index, stroke volume, and arterial pressure.¹⁷ The data underscore the need for attentiveness and accurate monitoring of cerebral perfusion when the transition is made from the supine position to the BCP, particularly in the early phase of surgery and in high-risk patients.

Knowledge of these hemodynamic changes has led several authors to recommend additional intraoperative monitoring of cerebral perfusion. Monitoring techniques have included use of invasive blood pressure monitoring adjusted to brain level, cerebral oximetry using near infrared spectroscopy, and electroencephalography. However, the clinical relevance of intraoperative CDEs in isolation is not well understood.^1,6,7,23 In addition, cost and availability of additional advanced monitoring likely factor into why it is not more commonly used. For this patient population, the severity, frequency, and duration of desaturation that causes cerebral ischemia and the relationship with postoperative neurocognitive deficits remain undefined.

The incidence of CDEs in patients being monitored with near infrared spectroscopy while undergoing elective arthroscopic shoulder surgery in the BCP varies widely, from 0% to 80% (mean, 41%).^{1,4,7,10,12,21} Magnitude and duration of cerebral ischemia required to produce neurocognitive dysfunction in this patient population remain unidentified as well. In conscious patients, a 20% reduction in frontal lobe oxygenation is associated with clinical manifestations of cerebral hypoperfusion, such as syncope.^15,29 As none of the patients in the studies we reviewed experienced any sort of deficit, we cannot definitively state there is a correlation between CDE occurrence and neurocognitive deficit.

One limitation of our investigation is that it was a systemic review, and thus there was substantial heterogeneity in the methods and designs of the studies included in the analysis. Among the different series, there was variability in multiple aspects of the study design, including type of anesthetic, patient inclusion criteria, type of surgery, type of intraoperative cerebral perfusion monitoring, and type of neurocognitive testing. As a result, comparing the groups was difficult, and the generalizability of our findings may be limited. In addition, it is difficult to accurately establish incidence and comprehensively review these events because of the paucity of literature.

Conclusion

Neurocognitive complications after shoulder arthroscopy with the patient in the BCP are extremely rare but potentially devastating events that can affect healthy patients with no preexisting cerebrovascular risk factors. Our review indicated the incidence of permanent neurologic deficit after arthroscopy in the BCP may be as low as 0.004%. The exact etiology of such complications is not clear. Basic science research and large prospective studies are needed to identify the clinically relevant thresholds of magnitude, duration, and frequency of intraoperative CDEs in order to establish their relationship with postoperative neurocognitive complications. Such large studies may also elucidate modifiable patient-specific risk factors and establish the most sensitive, safe, and cost-effective intraoperative monitoring tools. Current literature suggests that accurate intraoperative monitoring of cerebral perfusion, alternatives to general anesthesia, and prudent use of intraoperative blood pressure control may improve patient safety.

The beach-chair position (BCP) is commonly used for both arthroscopic and open shoulder surgery. This technique positions the shoulder in an anatomical upright position, facilitating shoulder access and visualization.¹ Compared with the lateral decubitus position, the BCP also improves airway access, reduces bleeding, and lessens the risk for brachial plexus injury.²

Despite the advantages of using the BCP, there have been multiple reports of catastrophic neurologic complications, including severe brain damage and death, in relatively healthy patients without any known risk factors.^3-6 The definitive etiology of these complications remains unclear, but it has been hypothesized that BCP use may be an independent risk factor for cerebrovascular ischemia,^1,5-16 as the upright position can cause hypotension leading to increased risk for cerebral hypoperfusion.^7-11,17 Reducing cerebral perfusion pressure below critical thresholds may result in permanent neurologic injury.^4-6,14 Therefore, monitoring of cerebral perfusion and optimization of intraoperative cerebral oxygenation have been recommended to help avoid potential neurologic complications. However, a direct relationship between intraoperative cerebral desaturation events (CDEs) and postoperative neurocognitive deficits has not been definitively established.^1,9-12

To put into perspective the importance of detecting and preventing CDEs and neurologic complications, we can consider the incidence of fatal pulmonary embolism associated with total joint arthroplasty. Although the incidence is very low, about 0.1% to 2.0%, some form of venous thromboembolism prophylaxis is the standard of care for helping prevent this serious complication. Similarly, catastrophic neurologic complications of upright shoulder arthroscopy are very rare, but it is still important to consider measures that help minimize them.

We reviewed the literature for the incidence of postoperative neurocognitive deficits, number of reported neurocognitive complications, and incidence of intraoperative CDEs in patients who underwent arthroscopic shoulder surgery in the BCP.

Methods

Dr. Salazar and Dr. Hazel independently searched the Medline, Cochrane, and Embase databases for case series, prospective studies, and cohort studies that reported neurocognitive complications associated with the BCP and the incidence of intraoperative CDEs. The authors used beach chair, desaturation, near infrared spectroscopy, and shoulder as medical subject headings (MeSH). In addition, bibliographies of retrieved articles were checked for studies that the search terms may have missed. Eighty-one publications were identified and reviewed for possible inclusion.

Next, the same 2 authors reviewed the titles and abstracts for relevance and determined which articles had potential to contribute to the study. Only English-language publications were considered for inclusion. To review the incidence of postoperative neurocognitive deficits, we included only those studies with more than 25 patients, documentation of postoperative complications, and arthroscopic shoulder surgery performed with the patient in the seated, semi-upright, or BCP. Only studies with at least 25 patients were used in order to increase the power and improve the level of evidence. To review reported cases of neurocognitive complications, we included all relevant case reports and case series. To review the incidence of intraoperative CDEs and investigate their relationship with postoperative neurocognitive deficits, we included studies that reported on use of intraoperative cerebral perfusion monitoring. Modalities used in these studies included near infrared spectroscopy, electroencephalography, and invasive blood pressure monitoring calculated at the brain level. Studies were excluded if they did not involve arthroscopic shoulder surgery or were not conducted with human subjects.

Information recorded for each study included general information such as author and publication year, type of study, number of patients enrolled, type of intraoperative monitoring, anesthesia protocol, number of patients with CDEs, and number of patients with neurocognitive complications after surgery.

Results

Our search identified 81 publications for potential inclusion. Our first aim was to identify the overall incidence of reported neurocognitive deficits after arthroscopic shoulder surgery with the patient in the BCP. We identified 10 studies (Table 1) that met the inclusion criteria. Among the 24,701 patients in these 10 studies, there was only 1 reported case of neurocognitive deficit after surgery, in a mixed prospective-retrospective study of 15,014 cases by Rohrbaugh and colleagues.18 The deficit they reported was an ischemic cerebral vascular accident. The 0.0067% incidence in their study demonstrates how rare the complication is. Two large retrospective studies (Ns = 4169 and 5177 patients) found no postoperative neurocognitive complications.^19,20 Only 3 studies performed formal postoperative cognitive testing. Salazar and colleagues²¹ used the Repeatable Battery for the Assessment of Neuropsychological Status before and after surgery, and Gillespie and colleagues⁸ and Lee and colleagues¹⁰ used the Mini–Mental State Examination before and after surgery. Total incidence of reported neurocognitive deficits from our review was 0.004% (1/24,701).

Our second aim was to review all reported cases of neurocognitive complications after arthroscopic shoulder surgery with the patient in the BCP. We identified 4 publications that fit our inclusion criteria (Table 2). Pohl and Cullen6 described 4 cases of ischemic brain injury after arthroscopic shoulder surgery with the patient in the BCP. Age range was 47 to 57 years. Specific intraoperative cerebral monitoring was not used. However, these patients had several episodes of intraoperative hypotension (systolic blood pressures, 80-90 mm Hg), measured with a traditional blood pressure cuff on the arm. In general, these patients had minimal cerebrovascular risk factors and no known preexisting cerebrovascular disease. Drummond and colleagues²² described an ischemic stroke in a 50-year-old man after arthroscopic subacromial decompression and open rotator cuff repair that resulted in unresolved right hemiplegia. Subsequent diagnostic investigation revealed an asymmetry of the circle of Willis resulting in limited flow to the left anterior and middle cerebral artery distributions. Bhatti and Enneking³ reported the case of a 64-year-old man who lost vision in the right eye immediately after arthroscopic rotator cuff repair. His vision improved spontaneously the next morning and continued to improve over the next 6 months—he regained 20/20 vision with some residual optic neuropathy.

Our third aim was to determine the incidence of intraoperative CDEs during arthroscopic shoulder surgery with the patient in the BCP. Incidence of CDEs varied widely among the 7 studies reviewed (Table 3). Minimum incidence of intraoperative CDE was 0% in a cohort of 30 patients,¹ and maximum incidence was 80% in a study of 61 patients,¹² all of whom underwent elective arthroscopic shoulder surgery in the BCP. Although there was wide variability in CDE incidence, the studies were consistent with respect to their definition of a CDE. Most authors used a decrease in regional cerebral tissue oxygen saturation of 20% or more from baseline, or an absolute value up to 55%, to define a CDE. None of the 7 studies reviewed reported a clinically significant adverse neurocognitive event.

Discussion

Of concern, there have been several surveys, case reports, and small case series of previously healthy patients who had no known risk factors, underwent arthroscopic shoulder surgery in the BCP, and developed unanticipated postoperative neurologic complications.^4-6,14 Beach-chair positioning during surgical procedures has been implicated as a contributing factor leading to cerebral hypoperfusion with potential for cerebral ischemia.^1,12,23 These changes in cerebral perfusion pressure are thought to be the major determinant of poor neurologic outcomes. Such reports have exposed the potential need for heightened vigilance, alternative anesthesia techniques, and improved monitoring, though the exact etiology of the central nervous system injuries in this patient population is incompletely understood and is likely multifactorial. Therefore, in this study we wanted to determine the incidence of postoperative neurocognitive deficits and review all reported cases of neurocognitive complications in patients who have undergone arthroscopic shoulder surgery in the BCP. In addition, we wanted to define the incidence of intraoperative CDEs and investigate their relationship with postoperative neurocognitive complications.

According to our review, the incidence of postoperative neurocognitive complications after surgery in the BCP is 0.004% (1/24,701). However, this finding is based only on what has been reported; the true incidence is not known. It is also important to note that the incidence of neurocognitive deficits after many other types of surgery is not known and that surgery itself may be a risk factor for postoperative neurocognitive deficits.²⁴ In their retrospective review of 15,014 patients who underwent arthroscopic shoulder surgery in the BCP at a single institution over an 11-year period, Rohrbaugh and colleagues18 found an overall postoperative complication rate of 0.37% and a 0.0067% incidence of neurocognitive deficits. One patient in the series was given a diagnosis of ischemic stroke on the basis of neurologic deficits that occurred 24 hours after surgery. Yadeau and colleagues²⁰ found no postoperative neurocognitive complications in a mixed prospective-retrospective study of 4169 patients—3000 identified retrospectively, 1169 prospectively—who underwent arthroscopic shoulder surgery in the BCP at an ambulatory surgery center. Pin-on and colleagues¹⁹ reported on a series of 5177 orthopedic and neurosurgical patients who underwent surgery in the BCP. In those who had arthroscopic shoulder surgery, intraoperative systolic blood pressures obtained from an arterial line referenced to heart level decreased a mean (SD) of 14.4% (12.7%), whereas in those whose pressures were obtained from a noninvasive blood pressure cuff referenced to heart level decreased 19.3% (12.6%). However, the authors reported no incidence of postoperative stroke or neurologic deficits.

Although uncommon, perioperative cerebral ischemic accidents are potentially devastating for patients, their families, and the health care professionals involved. These events have tremendous economic, social, professional, and medicolegal implications, with perioperative stroke being particularly morbid. Perioperative stroke has a mortality rate of 60%, versus 15% to 46% for stroke in general.^25,26 In 2005, Pohl and Cullen⁶ published a landmark article on a series of 4 relatively healthy middle-aged patients who were at low risk for stroke but had catastrophic neurocognitive complications (including 1 death) after arthroscopic shoulder surgery in the BCP. Bhatti and Enneking³ described a case of acute postoperative vision loss and ophthalmoplegia attributed to intraoperative hypotension leading to ischemia in a patient who underwent an elective shoulder arthroscopic procedure in the BCP. These reports prompted multiple investigations into the physiologic hemodynamic changes associated with surgery in the BCP and the treatment strategies used to improve patient safety.

In the normal physiologic state, the sympathetic nervous system is activated when a person assumes the seated position. The result is increased systemic vascular resistance and heart rate alterations to maintain cardiac output and mean arterial pressure. In anesthetized patients, this response is blunted by the vasodilatory effects of intravenous and volatile anesthetics. Multiple studies have demonstrated substantial hemodynamic changes in both awake and anesthetized patients during the maneuver from the supine position to the seated position^1,27,28; these changes include diminished cardiac index, stroke volume, and arterial pressure.¹⁷ The data underscore the need for attentiveness and accurate monitoring of cerebral perfusion when the transition is made from the supine position to the BCP, particularly in the early phase of surgery and in high-risk patients.

Knowledge of these hemodynamic changes has led several authors to recommend additional intraoperative monitoring of cerebral perfusion. Monitoring techniques have included use of invasive blood pressure monitoring adjusted to brain level, cerebral oximetry using near infrared spectroscopy, and electroencephalography. However, the clinical relevance of intraoperative CDEs in isolation is not well understood.^1,6,7,23 In addition, cost and availability of additional advanced monitoring likely factor into why it is not more commonly used. For this patient population, the severity, frequency, and duration of desaturation that causes cerebral ischemia and the relationship with postoperative neurocognitive deficits remain undefined.

The incidence of CDEs in patients being monitored with near infrared spectroscopy while undergoing elective arthroscopic shoulder surgery in the BCP varies widely, from 0% to 80% (mean, 41%).^{1,4,7,10,12,21} Magnitude and duration of cerebral ischemia required to produce neurocognitive dysfunction in this patient population remain unidentified as well. In conscious patients, a 20% reduction in frontal lobe oxygenation is associated with clinical manifestations of cerebral hypoperfusion, such as syncope.^15,29 As none of the patients in the studies we reviewed experienced any sort of deficit, we cannot definitively state there is a correlation between CDE occurrence and neurocognitive deficit.

One limitation of our investigation is that it was a systemic review, and thus there was substantial heterogeneity in the methods and designs of the studies included in the analysis. Among the different series, there was variability in multiple aspects of the study design, including type of anesthetic, patient inclusion criteria, type of surgery, type of intraoperative cerebral perfusion monitoring, and type of neurocognitive testing. As a result, comparing the groups was difficult, and the generalizability of our findings may be limited. In addition, it is difficult to accurately establish incidence and comprehensively review these events because of the paucity of literature.

Conclusion

Neurocognitive complications after shoulder arthroscopy with the patient in the BCP are extremely rare but potentially devastating events that can affect healthy patients with no preexisting cerebrovascular risk factors. Our review indicated the incidence of permanent neurologic deficit after arthroscopy in the BCP may be as low as 0.004%. The exact etiology of such complications is not clear. Basic science research and large prospective studies are needed to identify the clinically relevant thresholds of magnitude, duration, and frequency of intraoperative CDEs in order to establish their relationship with postoperative neurocognitive complications. Such large studies may also elucidate modifiable patient-specific risk factors and establish the most sensitive, safe, and cost-effective intraoperative monitoring tools. Current literature suggests that accurate intraoperative monitoring of cerebral perfusion, alternatives to general anesthesia, and prudent use of intraoperative blood pressure control may improve patient safety.

The beach-chair position (BCP) is commonly used for both arthroscopic and open shoulder surgery. This technique positions the shoulder in an anatomical upright position, facilitating shoulder access and visualization.¹ Compared with the lateral decubitus position, the BCP also improves airway access, reduces bleeding, and lessens the risk for brachial plexus injury.²

Despite the advantages of using the BCP, there have been multiple reports of catastrophic neurologic complications, including severe brain damage and death, in relatively healthy patients without any known risk factors.^3-6 The definitive etiology of these complications remains unclear, but it has been hypothesized that BCP use may be an independent risk factor for cerebrovascular ischemia,^1,5-16 as the upright position can cause hypotension leading to increased risk for cerebral hypoperfusion.^7-11,17 Reducing cerebral perfusion pressure below critical thresholds may result in permanent neurologic injury.^4-6,14 Therefore, monitoring of cerebral perfusion and optimization of intraoperative cerebral oxygenation have been recommended to help avoid potential neurologic complications. However, a direct relationship between intraoperative cerebral desaturation events (CDEs) and postoperative neurocognitive deficits has not been definitively established.^1,9-12

To put into perspective the importance of detecting and preventing CDEs and neurologic complications, we can consider the incidence of fatal pulmonary embolism associated with total joint arthroplasty. Although the incidence is very low, about 0.1% to 2.0%, some form of venous thromboembolism prophylaxis is the standard of care for helping prevent this serious complication. Similarly, catastrophic neurologic complications of upright shoulder arthroscopy are very rare, but it is still important to consider measures that help minimize them.

We reviewed the literature for the incidence of postoperative neurocognitive deficits, number of reported neurocognitive complications, and incidence of intraoperative CDEs in patients who underwent arthroscopic shoulder surgery in the BCP.

Methods

Dr. Salazar and Dr. Hazel independently searched the Medline, Cochrane, and Embase databases for case series, prospective studies, and cohort studies that reported neurocognitive complications associated with the BCP and the incidence of intraoperative CDEs. The authors used beach chair, desaturation, near infrared spectroscopy, and shoulder as medical subject headings (MeSH). In addition, bibliographies of retrieved articles were checked for studies that the search terms may have missed. Eighty-one publications were identified and reviewed for possible inclusion.

Next, the same 2 authors reviewed the titles and abstracts for relevance and determined which articles had potential to contribute to the study. Only English-language publications were considered for inclusion. To review the incidence of postoperative neurocognitive deficits, we included only those studies with more than 25 patients, documentation of postoperative complications, and arthroscopic shoulder surgery performed with the patient in the seated, semi-upright, or BCP. Only studies with at least 25 patients were used in order to increase the power and improve the level of evidence. To review reported cases of neurocognitive complications, we included all relevant case reports and case series. To review the incidence of intraoperative CDEs and investigate their relationship with postoperative neurocognitive deficits, we included studies that reported on use of intraoperative cerebral perfusion monitoring. Modalities used in these studies included near infrared spectroscopy, electroencephalography, and invasive blood pressure monitoring calculated at the brain level. Studies were excluded if they did not involve arthroscopic shoulder surgery or were not conducted with human subjects.

Information recorded for each study included general information such as author and publication year, type of study, number of patients enrolled, type of intraoperative monitoring, anesthesia protocol, number of patients with CDEs, and number of patients with neurocognitive complications after surgery.

Results

Our search identified 81 publications for potential inclusion. Our first aim was to identify the overall incidence of reported neurocognitive deficits after arthroscopic shoulder surgery with the patient in the BCP. We identified 10 studies (Table 1) that met the inclusion criteria. Among the 24,701 patients in these 10 studies, there was only 1 reported case of neurocognitive deficit after surgery, in a mixed prospective-retrospective study of 15,014 cases by Rohrbaugh and colleagues.18 The deficit they reported was an ischemic cerebral vascular accident. The 0.0067% incidence in their study demonstrates how rare the complication is. Two large retrospective studies (Ns = 4169 and 5177 patients) found no postoperative neurocognitive complications.^19,20 Only 3 studies performed formal postoperative cognitive testing. Salazar and colleagues²¹ used the Repeatable Battery for the Assessment of Neuropsychological Status before and after surgery, and Gillespie and colleagues⁸ and Lee and colleagues¹⁰ used the Mini–Mental State Examination before and after surgery. Total incidence of reported neurocognitive deficits from our review was 0.004% (1/24,701).

Our second aim was to review all reported cases of neurocognitive complications after arthroscopic shoulder surgery with the patient in the BCP. We identified 4 publications that fit our inclusion criteria (Table 2). Pohl and Cullen6 described 4 cases of ischemic brain injury after arthroscopic shoulder surgery with the patient in the BCP. Age range was 47 to 57 years. Specific intraoperative cerebral monitoring was not used. However, these patients had several episodes of intraoperative hypotension (systolic blood pressures, 80-90 mm Hg), measured with a traditional blood pressure cuff on the arm. In general, these patients had minimal cerebrovascular risk factors and no known preexisting cerebrovascular disease. Drummond and colleagues²² described an ischemic stroke in a 50-year-old man after arthroscopic subacromial decompression and open rotator cuff repair that resulted in unresolved right hemiplegia. Subsequent diagnostic investigation revealed an asymmetry of the circle of Willis resulting in limited flow to the left anterior and middle cerebral artery distributions. Bhatti and Enneking³ reported the case of a 64-year-old man who lost vision in the right eye immediately after arthroscopic rotator cuff repair. His vision improved spontaneously the next morning and continued to improve over the next 6 months—he regained 20/20 vision with some residual optic neuropathy.

Our third aim was to determine the incidence of intraoperative CDEs during arthroscopic shoulder surgery with the patient in the BCP. Incidence of CDEs varied widely among the 7 studies reviewed (Table 3). Minimum incidence of intraoperative CDE was 0% in a cohort of 30 patients,¹ and maximum incidence was 80% in a study of 61 patients,¹² all of whom underwent elective arthroscopic shoulder surgery in the BCP. Although there was wide variability in CDE incidence, the studies were consistent with respect to their definition of a CDE. Most authors used a decrease in regional cerebral tissue oxygen saturation of 20% or more from baseline, or an absolute value up to 55%, to define a CDE. None of the 7 studies reviewed reported a clinically significant adverse neurocognitive event.

Discussion

Of concern, there have been several surveys, case reports, and small case series of previously healthy patients who had no known risk factors, underwent arthroscopic shoulder surgery in the BCP, and developed unanticipated postoperative neurologic complications.^4-6,14 Beach-chair positioning during surgical procedures has been implicated as a contributing factor leading to cerebral hypoperfusion with potential for cerebral ischemia.^1,12,23 These changes in cerebral perfusion pressure are thought to be the major determinant of poor neurologic outcomes. Such reports have exposed the potential need for heightened vigilance, alternative anesthesia techniques, and improved monitoring, though the exact etiology of the central nervous system injuries in this patient population is incompletely understood and is likely multifactorial. Therefore, in this study we wanted to determine the incidence of postoperative neurocognitive deficits and review all reported cases of neurocognitive complications in patients who have undergone arthroscopic shoulder surgery in the BCP. In addition, we wanted to define the incidence of intraoperative CDEs and investigate their relationship with postoperative neurocognitive complications.

According to our review, the incidence of postoperative neurocognitive complications after surgery in the BCP is 0.004% (1/24,701). However, this finding is based only on what has been reported; the true incidence is not known. It is also important to note that the incidence of neurocognitive deficits after many other types of surgery is not known and that surgery itself may be a risk factor for postoperative neurocognitive deficits.²⁴ In their retrospective review of 15,014 patients who underwent arthroscopic shoulder surgery in the BCP at a single institution over an 11-year period, Rohrbaugh and colleagues18 found an overall postoperative complication rate of 0.37% and a 0.0067% incidence of neurocognitive deficits. One patient in the series was given a diagnosis of ischemic stroke on the basis of neurologic deficits that occurred 24 hours after surgery. Yadeau and colleagues²⁰ found no postoperative neurocognitive complications in a mixed prospective-retrospective study of 4169 patients—3000 identified retrospectively, 1169 prospectively—who underwent arthroscopic shoulder surgery in the BCP at an ambulatory surgery center. Pin-on and colleagues¹⁹ reported on a series of 5177 orthopedic and neurosurgical patients who underwent surgery in the BCP. In those who had arthroscopic shoulder surgery, intraoperative systolic blood pressures obtained from an arterial line referenced to heart level decreased a mean (SD) of 14.4% (12.7%), whereas in those whose pressures were obtained from a noninvasive blood pressure cuff referenced to heart level decreased 19.3% (12.6%). However, the authors reported no incidence of postoperative stroke or neurologic deficits.

Although uncommon, perioperative cerebral ischemic accidents are potentially devastating for patients, their families, and the health care professionals involved. These events have tremendous economic, social, professional, and medicolegal implications, with perioperative stroke being particularly morbid. Perioperative stroke has a mortality rate of 60%, versus 15% to 46% for stroke in general.^25,26 In 2005, Pohl and Cullen⁶ published a landmark article on a series of 4 relatively healthy middle-aged patients who were at low risk for stroke but had catastrophic neurocognitive complications (including 1 death) after arthroscopic shoulder surgery in the BCP. Bhatti and Enneking³ described a case of acute postoperative vision loss and ophthalmoplegia attributed to intraoperative hypotension leading to ischemia in a patient who underwent an elective shoulder arthroscopic procedure in the BCP. These reports prompted multiple investigations into the physiologic hemodynamic changes associated with surgery in the BCP and the treatment strategies used to improve patient safety.

In the normal physiologic state, the sympathetic nervous system is activated when a person assumes the seated position. The result is increased systemic vascular resistance and heart rate alterations to maintain cardiac output and mean arterial pressure. In anesthetized patients, this response is blunted by the vasodilatory effects of intravenous and volatile anesthetics. Multiple studies have demonstrated substantial hemodynamic changes in both awake and anesthetized patients during the maneuver from the supine position to the seated position^1,27,28; these changes include diminished cardiac index, stroke volume, and arterial pressure.¹⁷ The data underscore the need for attentiveness and accurate monitoring of cerebral perfusion when the transition is made from the supine position to the BCP, particularly in the early phase of surgery and in high-risk patients.

Knowledge of these hemodynamic changes has led several authors to recommend additional intraoperative monitoring of cerebral perfusion. Monitoring techniques have included use of invasive blood pressure monitoring adjusted to brain level, cerebral oximetry using near infrared spectroscopy, and electroencephalography. However, the clinical relevance of intraoperative CDEs in isolation is not well understood.^1,6,7,23 In addition, cost and availability of additional advanced monitoring likely factor into why it is not more commonly used. For this patient population, the severity, frequency, and duration of desaturation that causes cerebral ischemia and the relationship with postoperative neurocognitive deficits remain undefined.

The incidence of CDEs in patients being monitored with near infrared spectroscopy while undergoing elective arthroscopic shoulder surgery in the BCP varies widely, from 0% to 80% (mean, 41%).^{1,4,7,10,12,21} Magnitude and duration of cerebral ischemia required to produce neurocognitive dysfunction in this patient population remain unidentified as well. In conscious patients, a 20% reduction in frontal lobe oxygenation is associated with clinical manifestations of cerebral hypoperfusion, such as syncope.^15,29 As none of the patients in the studies we reviewed experienced any sort of deficit, we cannot definitively state there is a correlation between CDE occurrence and neurocognitive deficit.

One limitation of our investigation is that it was a systemic review, and thus there was substantial heterogeneity in the methods and designs of the studies included in the analysis. Among the different series, there was variability in multiple aspects of the study design, including type of anesthetic, patient inclusion criteria, type of surgery, type of intraoperative cerebral perfusion monitoring, and type of neurocognitive testing. As a result, comparing the groups was difficult, and the generalizability of our findings may be limited. In addition, it is difficult to accurately establish incidence and comprehensively review these events because of the paucity of literature.

Conclusion

Neurocognitive complications after shoulder arthroscopy with the patient in the BCP are extremely rare but potentially devastating events that can affect healthy patients with no preexisting cerebrovascular risk factors. Our review indicated the incidence of permanent neurologic deficit after arthroscopy in the BCP may be as low as 0.004%. The exact etiology of such complications is not clear. Basic science research and large prospective studies are needed to identify the clinically relevant thresholds of magnitude, duration, and frequency of intraoperative CDEs in order to establish their relationship with postoperative neurocognitive complications. Such large studies may also elucidate modifiable patient-specific risk factors and establish the most sensitive, safe, and cost-effective intraoperative monitoring tools. Current literature suggests that accurate intraoperative monitoring of cerebral perfusion, alternatives to general anesthesia, and prudent use of intraoperative blood pressure control may improve patient safety.

A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.

The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.

Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).

In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.

Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.

Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.

“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.

“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.

The authors reported that they had no conflicts of interest.

A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).

[email protected]

A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.

The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.

Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).

In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.

Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.

Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.

“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.

“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.

The authors reported that they had no conflicts of interest.

A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).

[email protected]

A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.

The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.

Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).

In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.

Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.

Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.

“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.

“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.

The authors reported that they had no conflicts of interest.

A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).

[email protected]

LOS ANGELES – The equipoise between carotid stenting and endarterectomy received a further boost in 10-year results from the landmark Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) that compared the two options head-to-head.

Reported the day after results from another big trial that pitted carotid stenting against surgery, the Asymptomatic Carotid Trial (ACT I), the new long-term results from the CREST study mean that deciding among the options relies largely on patient preference although individual clinical characteristics might favor one approach or the other, experts said.

Mitchel L. Zoler/Frontline Medical News

The big remaining unknown and wild card is whether doing no procedural intervention at all and relying entirely on optimal, contemporary medical treatment works just as well as endarterectomy or carotid stenting. The role for stand-alone medical therapy against carotid surgery or stenting (on top of medical therapy) is currently undergoing a formal, direct comparison in the randomized Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2).

Taking the 5-year outcome results from ACT I and the 10-year outcome results from CREST both into account, “we now have a lot of evidence that both carotid stenting and surgery are safe and durable. The results support both options” for either patients with symptomatic carotid artery stenosis or asymptomatic patients with carotid stenosis as extensive as in the patients enrolled in these trials, said Dr. Thomas G. Brott at the International Stroke Conference.

“In routine practice, we lay out the options of endarterectomy, carotid stenting, or no intervention with just medical treatment to patients and let them decide,” noted Dr. Brott, professor of neurology and director of research at the Mayo Clinic in Jacksonville, Fla.

CREST randomized 2,502 symptomatic or asymptomatic patients with significant carotid stenosis during 2000-2008 at 117 U.S. and Canadian centers. From this group, 1,607 consented and were available for long-term follow-up, done at a median of 7.4 years and as long as 10 years after follow-up.

The study’s primary, long-term endpoint was stroke, MI, or death during the periprocedural period (30 days after treatment or 36 days after enrollment depending on when the procedural intervention occurred) plus the rate of ipsilateral stroke during up to 10 years of follow-up. This combined endpoint occurred in 10% of the patients who underwent endarterectomy and in 12% of those who had stenting, a difference that was not statistically significant, Dr. Brott reported. Concurrent with his presentation at the meeting, sponsored by the American Heart Association, the results also were published online (N Engl J Med. 2016 Feb 18. doi: 10.1056/NEJMoa1505215).

The results included a secondary endpoint that showed a significant benefit for endarterectomy. The tally of periprocedural strokes or deaths plus ipsilateral strokes during 10-year follow-up was 8% for the surgical group and 11% for those who received a stent, a 37% excess hazard with stenting.

Dr. Brott attributed this secondary difference between the two arms of the study to a statistically significant excess of stroke or death during the periprocedural period in the patients treated by stenting, and more specifically an excess of strokes. The rate of total periprocedural strokes was 4% with stenting and 2% with endarterectomy, a statistically significant difference. Although an embolic protection device was used “when feasible” during stenting, this protection can be fallible, Dr. Brott noted. In contrast, the results from the ACT I trial showed no statistically significant difference in the rate of periprocedural total strokes between the stented and endarterectomy patients.

Dr. Brott had no relevant disclosures. The CREST trial received partial funding from Abbott Vascular.

[email protected]

On Twitter @mitchelzoler

LOS ANGELES – The equipoise between carotid stenting and endarterectomy received a further boost in 10-year results from the landmark Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) that compared the two options head-to-head.

Reported the day after results from another big trial that pitted carotid stenting against surgery, the Asymptomatic Carotid Trial (ACT I), the new long-term results from the CREST study mean that deciding among the options relies largely on patient preference although individual clinical characteristics might favor one approach or the other, experts said.

Mitchel L. Zoler/Frontline Medical News

The big remaining unknown and wild card is whether doing no procedural intervention at all and relying entirely on optimal, contemporary medical treatment works just as well as endarterectomy or carotid stenting. The role for stand-alone medical therapy against carotid surgery or stenting (on top of medical therapy) is currently undergoing a formal, direct comparison in the randomized Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2).

Taking the 5-year outcome results from ACT I and the 10-year outcome results from CREST both into account, “we now have a lot of evidence that both carotid stenting and surgery are safe and durable. The results support both options” for either patients with symptomatic carotid artery stenosis or asymptomatic patients with carotid stenosis as extensive as in the patients enrolled in these trials, said Dr. Thomas G. Brott at the International Stroke Conference.

“In routine practice, we lay out the options of endarterectomy, carotid stenting, or no intervention with just medical treatment to patients and let them decide,” noted Dr. Brott, professor of neurology and director of research at the Mayo Clinic in Jacksonville, Fla.

CREST randomized 2,502 symptomatic or asymptomatic patients with significant carotid stenosis during 2000-2008 at 117 U.S. and Canadian centers. From this group, 1,607 consented and were available for long-term follow-up, done at a median of 7.4 years and as long as 10 years after follow-up.

The study’s primary, long-term endpoint was stroke, MI, or death during the periprocedural period (30 days after treatment or 36 days after enrollment depending on when the procedural intervention occurred) plus the rate of ipsilateral stroke during up to 10 years of follow-up. This combined endpoint occurred in 10% of the patients who underwent endarterectomy and in 12% of those who had stenting, a difference that was not statistically significant, Dr. Brott reported. Concurrent with his presentation at the meeting, sponsored by the American Heart Association, the results also were published online (N Engl J Med. 2016 Feb 18. doi: 10.1056/NEJMoa1505215).

The results included a secondary endpoint that showed a significant benefit for endarterectomy. The tally of periprocedural strokes or deaths plus ipsilateral strokes during 10-year follow-up was 8% for the surgical group and 11% for those who received a stent, a 37% excess hazard with stenting.

Dr. Brott attributed this secondary difference between the two arms of the study to a statistically significant excess of stroke or death during the periprocedural period in the patients treated by stenting, and more specifically an excess of strokes. The rate of total periprocedural strokes was 4% with stenting and 2% with endarterectomy, a statistically significant difference. Although an embolic protection device was used “when feasible” during stenting, this protection can be fallible, Dr. Brott noted. In contrast, the results from the ACT I trial showed no statistically significant difference in the rate of periprocedural total strokes between the stented and endarterectomy patients.

Dr. Brott had no relevant disclosures. The CREST trial received partial funding from Abbott Vascular.

[email protected]

On Twitter @mitchelzoler

LOS ANGELES – The equipoise between carotid stenting and endarterectomy received a further boost in 10-year results from the landmark Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) that compared the two options head-to-head.

Reported the day after results from another big trial that pitted carotid stenting against surgery, the Asymptomatic Carotid Trial (ACT I), the new long-term results from the CREST study mean that deciding among the options relies largely on patient preference although individual clinical characteristics might favor one approach or the other, experts said.

Mitchel L. Zoler/Frontline Medical News

The big remaining unknown and wild card is whether doing no procedural intervention at all and relying entirely on optimal, contemporary medical treatment works just as well as endarterectomy or carotid stenting. The role for stand-alone medical therapy against carotid surgery or stenting (on top of medical therapy) is currently undergoing a formal, direct comparison in the randomized Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2).

Taking the 5-year outcome results from ACT I and the 10-year outcome results from CREST both into account, “we now have a lot of evidence that both carotid stenting and surgery are safe and durable. The results support both options” for either patients with symptomatic carotid artery stenosis or asymptomatic patients with carotid stenosis as extensive as in the patients enrolled in these trials, said Dr. Thomas G. Brott at the International Stroke Conference.

“In routine practice, we lay out the options of endarterectomy, carotid stenting, or no intervention with just medical treatment to patients and let them decide,” noted Dr. Brott, professor of neurology and director of research at the Mayo Clinic in Jacksonville, Fla.

CREST randomized 2,502 symptomatic or asymptomatic patients with significant carotid stenosis during 2000-2008 at 117 U.S. and Canadian centers. From this group, 1,607 consented and were available for long-term follow-up, done at a median of 7.4 years and as long as 10 years after follow-up.

The study’s primary, long-term endpoint was stroke, MI, or death during the periprocedural period (30 days after treatment or 36 days after enrollment depending on when the procedural intervention occurred) plus the rate of ipsilateral stroke during up to 10 years of follow-up. This combined endpoint occurred in 10% of the patients who underwent endarterectomy and in 12% of those who had stenting, a difference that was not statistically significant, Dr. Brott reported. Concurrent with his presentation at the meeting, sponsored by the American Heart Association, the results also were published online (N Engl J Med. 2016 Feb 18. doi: 10.1056/NEJMoa1505215).

The results included a secondary endpoint that showed a significant benefit for endarterectomy. The tally of periprocedural strokes or deaths plus ipsilateral strokes during 10-year follow-up was 8% for the surgical group and 11% for those who received a stent, a 37% excess hazard with stenting.

Dr. Brott attributed this secondary difference between the two arms of the study to a statistically significant excess of stroke or death during the periprocedural period in the patients treated by stenting, and more specifically an excess of strokes. The rate of total periprocedural strokes was 4% with stenting and 2% with endarterectomy, a statistically significant difference. Although an embolic protection device was used “when feasible” during stenting, this protection can be fallible, Dr. Brott noted. In contrast, the results from the ACT I trial showed no statistically significant difference in the rate of periprocedural total strokes between the stented and endarterectomy patients.

Dr. Brott had no relevant disclosures. The CREST trial received partial funding from Abbott Vascular.

[email protected]

On Twitter @mitchelzoler

To improve patient care and outcomes, leading dermatologists offered their recommendations on facial sunscreens. Consideration must be given to:

• Anthelios SX
  La Roche-Posay Laboratoire Dermatologique
  "This medium-weight facial moisturizing cream with broad-spectrum sunscreen seems to be a widely accepted option for daily patient use, and I use it myself.”
  —Lorraine L. Rosamilia, MD, State College, Pennsylvania

• Anthelios 50
  La Roche-Posay Laboratoire Dermatologique
  Recommended by Gary Goldenberg, MD, New York, New York

• Elizabeth Arden Pro Triple Protection Factor SPF 50
  Elizabeth Arden, Inc.
  “This is a tinted, chemical-free SPF 50 sunscreen that looks, feels, and smells like its made by a cosmetic company that understands what people want in a skin care product. Additionally, it has several antioxidants and DNA repair enzyme. So not only is it protecting the skin from UV damage, but it’s trying to reverse some of that damage as well.”
  —Mark G. Rubin, MD, Beverly Hills, California

• EltaMD UV Clear Broad-Spectrum SPF 46
  EltaMD
  “This sunscreen has an elegant feel upon application and leaves little residue, making it a nice product for daily facial application.”
  —Neil Fernandes, MD, Phoenix, Arizona

• Neutrogena Age Shield Face Lotion Sunscreen
  Johnson & Johnson Consumer Inc
  “This sunscreen has broad UV spectrum coverage that blocks against harmful UVA and UVB rays. It has the added benefit of having antioxidants that may slow and reverse photoaging.”
  —Shari Lipner, MD, PhD, New York, New York

• Sheer Physical UV Defense SPF 50
  SkinCeuticals
  “It is very lightweight, especially for a physical block, and is noncomedogenic and sheer but still provides broad-spectrum coverage with both titanium dioxide and zinc oxide. There is a tinted version as well that I often recommend for women.”
  —Monica Schadlow, MD, New York, New York

Cutis invites readers to send us their recommendations. Hand creams, scar treatments, and body scrubs will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on facial sunscreens. Consideration must be given to:

• Anthelios SX
  La Roche-Posay Laboratoire Dermatologique
  "This medium-weight facial moisturizing cream with broad-spectrum sunscreen seems to be a widely accepted option for daily patient use, and I use it myself.”
  —Lorraine L. Rosamilia, MD, State College, Pennsylvania

• Anthelios 50
  La Roche-Posay Laboratoire Dermatologique
  Recommended by Gary Goldenberg, MD, New York, New York

• Elizabeth Arden Pro Triple Protection Factor SPF 50
  Elizabeth Arden, Inc.
  “This is a tinted, chemical-free SPF 50 sunscreen that looks, feels, and smells like its made by a cosmetic company that understands what people want in a skin care product. Additionally, it has several antioxidants and DNA repair enzyme. So not only is it protecting the skin from UV damage, but it’s trying to reverse some of that damage as well.”
  —Mark G. Rubin, MD, Beverly Hills, California

• EltaMD UV Clear Broad-Spectrum SPF 46
  EltaMD
  “This sunscreen has an elegant feel upon application and leaves little residue, making it a nice product for daily facial application.”
  —Neil Fernandes, MD, Phoenix, Arizona

• Neutrogena Age Shield Face Lotion Sunscreen
  Johnson & Johnson Consumer Inc
  “This sunscreen has broad UV spectrum coverage that blocks against harmful UVA and UVB rays. It has the added benefit of having antioxidants that may slow and reverse photoaging.”
  —Shari Lipner, MD, PhD, New York, New York

• Sheer Physical UV Defense SPF 50
  SkinCeuticals
  “It is very lightweight, especially for a physical block, and is noncomedogenic and sheer but still provides broad-spectrum coverage with both titanium dioxide and zinc oxide. There is a tinted version as well that I often recommend for women.”
  —Monica Schadlow, MD, New York, New York

Cutis invites readers to send us their recommendations. Hand creams, scar treatments, and body scrubs will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on facial sunscreens. Consideration must be given to:

• Anthelios SX
  La Roche-Posay Laboratoire Dermatologique
  "This medium-weight facial moisturizing cream with broad-spectrum sunscreen seems to be a widely accepted option for daily patient use, and I use it myself.”
  —Lorraine L. Rosamilia, MD, State College, Pennsylvania

• Anthelios 50
  La Roche-Posay Laboratoire Dermatologique
  Recommended by Gary Goldenberg, MD, New York, New York

• Elizabeth Arden Pro Triple Protection Factor SPF 50
  Elizabeth Arden, Inc.
  “This is a tinted, chemical-free SPF 50 sunscreen that looks, feels, and smells like its made by a cosmetic company that understands what people want in a skin care product. Additionally, it has several antioxidants and DNA repair enzyme. So not only is it protecting the skin from UV damage, but it’s trying to reverse some of that damage as well.”
  —Mark G. Rubin, MD, Beverly Hills, California

• EltaMD UV Clear Broad-Spectrum SPF 46
  EltaMD
  “This sunscreen has an elegant feel upon application and leaves little residue, making it a nice product for daily facial application.”
  —Neil Fernandes, MD, Phoenix, Arizona

• Neutrogena Age Shield Face Lotion Sunscreen
  Johnson & Johnson Consumer Inc
  “This sunscreen has broad UV spectrum coverage that blocks against harmful UVA and UVB rays. It has the added benefit of having antioxidants that may slow and reverse photoaging.”
  —Shari Lipner, MD, PhD, New York, New York

• Sheer Physical UV Defense SPF 50
  SkinCeuticals
  “It is very lightweight, especially for a physical block, and is noncomedogenic and sheer but still provides broad-spectrum coverage with both titanium dioxide and zinc oxide. There is a tinted version as well that I often recommend for women.”
  —Monica Schadlow, MD, New York, New York

Cutis invites readers to send us their recommendations. Hand creams, scar treatments, and body scrubs will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.