Background: Communication among team members within hospitals is typically fragmented. Bedside interdisciplinary rounds (IDR) have the potential to improve communication and outcomes through enhanced structure and patient engagement.

Objective: To decrease length of stay (LOS) and complications through the transformation of daily IDR to a bedside model.

Results: There was no difference in LOS (6.6 vs. 7.0 days, P = .17, for the MICRO and control groups, respectively) or clinical deterioration (7.7% vs. 9.3%, P = .46). LOS was reduced for patients transferred to the study unit (10.4 vs. 14.0 days, P = .02, for the MICRO and control groups, respectively). Nurses and hospitalists gave significantly higher scores for patient safety climate and the efficiency of rounds after implementation of the MICRO model.

Limitations: The trial was performed at a single hospital.

Conclusions:  Bedside IDR did not reduce overall LOS or clinical deterioration. Future studies should examine whether comprehensive transformation of medical units, including co-leadership, geographic cohorting of teams, and bedside interdisciplinary rounding, improves clinical outcomes compared to units without these features.

Also in the Journal of Hospital Medicine …

Standardized Attending Rounds to Improve the Patient Experience: A Pragmatic Cluster Randomized Controlled Trial

Authors: Bradley Monash, MD, Nader Najafi, MD, Michelle Mourad, MD, Alvin Rajkomar, MD, Sumant R. Ranji, MD, Margaret C. Fang, MD, MPH, FHM, Marcia Glass, MD, Dimiter Milev, MPH, Yile Ding, MD, Andy Shen, BA, Bradley A. Sharpe, MD, FACP, SFHM, James D Harrison, MPH, PhD

All Together Now: Impact of a Regionalization and Bedside Rounding Initiative on the Efficiency and Inclusiveness of Clinical Rounds

Authors: Kristin T. L. Huang, MD, Jacquelyn Minahan, Patricia Brita-Rossi, RN, MSN, MBA, Patricia Aylward, RN, MSN, Joel T. Katz, MD, SFHM, Christopher Roy, MD, Jeffrey L. Schnipper, MD, MPH, FHM, Robert Boxer, MD, PhD

Family Report Compared to Clinician-Documented Diagnoses for Psychiatric Conditions Among Hospitalized Children

Authors: Stephanie K. Doupnik, MD, Chris Feudtner, MD, PhD, MPH, Steven C. Marcus, PhD

Perceived Safety and Value of Inpatient ‘Very Important Person’ Services

Authors: Joshua Allen-Dicker, MD, MPH, Andrew Auerbach, MD, MPH, SFHM, Shoshana J. Herzig, MD, MPH

A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories

Authors: Caroline B. Nguyen, PharmD, BCPS, Rita Shane, PharmD, FASHP, FCSHP, Douglas S. Bell, MD, PhD, Galen Cook-Wiens, MS, Joshua M. Pevnick, MD, MSHS

Background: Communication among team members within hospitals is typically fragmented. Bedside interdisciplinary rounds (IDR) have the potential to improve communication and outcomes through enhanced structure and patient engagement.

Objective: To decrease length of stay (LOS) and complications through the transformation of daily IDR to a bedside model.

Results: There was no difference in LOS (6.6 vs. 7.0 days, P = .17, for the MICRO and control groups, respectively) or clinical deterioration (7.7% vs. 9.3%, P = .46). LOS was reduced for patients transferred to the study unit (10.4 vs. 14.0 days, P = .02, for the MICRO and control groups, respectively). Nurses and hospitalists gave significantly higher scores for patient safety climate and the efficiency of rounds after implementation of the MICRO model.

Limitations: The trial was performed at a single hospital.

Conclusions:  Bedside IDR did not reduce overall LOS or clinical deterioration. Future studies should examine whether comprehensive transformation of medical units, including co-leadership, geographic cohorting of teams, and bedside interdisciplinary rounding, improves clinical outcomes compared to units without these features.

Also in the Journal of Hospital Medicine …

Standardized Attending Rounds to Improve the Patient Experience: A Pragmatic Cluster Randomized Controlled Trial

Authors: Bradley Monash, MD, Nader Najafi, MD, Michelle Mourad, MD, Alvin Rajkomar, MD, Sumant R. Ranji, MD, Margaret C. Fang, MD, MPH, FHM, Marcia Glass, MD, Dimiter Milev, MPH, Yile Ding, MD, Andy Shen, BA, Bradley A. Sharpe, MD, FACP, SFHM, James D Harrison, MPH, PhD

All Together Now: Impact of a Regionalization and Bedside Rounding Initiative on the Efficiency and Inclusiveness of Clinical Rounds

Authors: Kristin T. L. Huang, MD, Jacquelyn Minahan, Patricia Brita-Rossi, RN, MSN, MBA, Patricia Aylward, RN, MSN, Joel T. Katz, MD, SFHM, Christopher Roy, MD, Jeffrey L. Schnipper, MD, MPH, FHM, Robert Boxer, MD, PhD

Family Report Compared to Clinician-Documented Diagnoses for Psychiatric Conditions Among Hospitalized Children

Authors: Stephanie K. Doupnik, MD, Chris Feudtner, MD, PhD, MPH, Steven C. Marcus, PhD

Perceived Safety and Value of Inpatient ‘Very Important Person’ Services

Authors: Joshua Allen-Dicker, MD, MPH, Andrew Auerbach, MD, MPH, SFHM, Shoshana J. Herzig, MD, MPH

A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories

Authors: Caroline B. Nguyen, PharmD, BCPS, Rita Shane, PharmD, FASHP, FCSHP, Douglas S. Bell, MD, PhD, Galen Cook-Wiens, MS, Joshua M. Pevnick, MD, MSHS

Background: Communication among team members within hospitals is typically fragmented. Bedside interdisciplinary rounds (IDR) have the potential to improve communication and outcomes through enhanced structure and patient engagement.

Objective: To decrease length of stay (LOS) and complications through the transformation of daily IDR to a bedside model.

Results: There was no difference in LOS (6.6 vs. 7.0 days, P = .17, for the MICRO and control groups, respectively) or clinical deterioration (7.7% vs. 9.3%, P = .46). LOS was reduced for patients transferred to the study unit (10.4 vs. 14.0 days, P = .02, for the MICRO and control groups, respectively). Nurses and hospitalists gave significantly higher scores for patient safety climate and the efficiency of rounds after implementation of the MICRO model.

Limitations: The trial was performed at a single hospital.

Conclusions:  Bedside IDR did not reduce overall LOS or clinical deterioration. Future studies should examine whether comprehensive transformation of medical units, including co-leadership, geographic cohorting of teams, and bedside interdisciplinary rounding, improves clinical outcomes compared to units without these features.

Also in the Journal of Hospital Medicine …

Standardized Attending Rounds to Improve the Patient Experience: A Pragmatic Cluster Randomized Controlled Trial

Authors: Bradley Monash, MD, Nader Najafi, MD, Michelle Mourad, MD, Alvin Rajkomar, MD, Sumant R. Ranji, MD, Margaret C. Fang, MD, MPH, FHM, Marcia Glass, MD, Dimiter Milev, MPH, Yile Ding, MD, Andy Shen, BA, Bradley A. Sharpe, MD, FACP, SFHM, James D Harrison, MPH, PhD

All Together Now: Impact of a Regionalization and Bedside Rounding Initiative on the Efficiency and Inclusiveness of Clinical Rounds

Authors: Kristin T. L. Huang, MD, Jacquelyn Minahan, Patricia Brita-Rossi, RN, MSN, MBA, Patricia Aylward, RN, MSN, Joel T. Katz, MD, SFHM, Christopher Roy, MD, Jeffrey L. Schnipper, MD, MPH, FHM, Robert Boxer, MD, PhD

Family Report Compared to Clinician-Documented Diagnoses for Psychiatric Conditions Among Hospitalized Children

Authors: Stephanie K. Doupnik, MD, Chris Feudtner, MD, PhD, MPH, Steven C. Marcus, PhD

Perceived Safety and Value of Inpatient ‘Very Important Person’ Services

Authors: Joshua Allen-Dicker, MD, MPH, Andrew Auerbach, MD, MPH, SFHM, Shoshana J. Herzig, MD, MPH

A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories

Authors: Caroline B. Nguyen, PharmD, BCPS, Rita Shane, PharmD, FASHP, FCSHP, Douglas S. Bell, MD, PhD, Galen Cook-Wiens, MS, Joshua M. Pevnick, MD, MSHS

A nationwide shortage of intensivists has more hospitalists stepping into the critical care arena, but not all with the level of preparation and comfort of David Aymond, MD, a Louisiana-based hospitalist trained in family medicine (HTFM).

Dr. Aymond gained his ICU experience in a fellowship with the University of Alabama, where hospitalists also “were responsible for ICU patients,” he said. Years later, as an employee of both small and large hospitals with busy ICU services, and a faculty member for a family medicine residency with a busy ICU, Dr. Aymond moves seamlessly between roles.

“I am currently practicing as a full time intensivist and take consults from other providers, yet I only have a certificate from fellowship, no formal board certification in critical care,” noted a survey respondent.

Other participants stated, “it makes perfect sense to have a pathway to critical care if both family medicine and internal medicine coexist as hospitalists,” that certification is “imperative at rural and underserved hospitals,” and also “helpful for those …who work in larger hospitals and take care of critically ill patients.” More than half of those surveyed want the Family Medicine Committee to work with ABFM to create the pathway.

The majority (87%) of the HTFM survey respondents are certified by the ABFM, and 8% have attained Recognition of Focused Practice in Hospital Medicine. Common pathways for additional credentialing include SHM’s Fellow of Hospital Medicine program (38%), a fellowship in hospital medicine (19%), and certification in hospice and palliative care (15%). More than 38% reported “other qualifications,” such as years of work experience, certification by the American Osteopathic Board of Family Physicians, and prior training in internal medicine.

The survey also found that certification differences in internal medicine and family medicine hospitalists, which may have posed employment obstacles in the past for HTFM, are not as much of an issue.

“The critical care pathway is the bigger concern,” Dr. Aymond said.

SHM’s Family Medicine Committee will be working on a proposal to ABFM to create the training pathway in the coming months. Dr. Aymond wants intensivists to know that this not an attempt to encroach on their professional domain, “but an opportunity to fill the existing professional gap.

Family medicine physicians are already providing critical care services, so a pathway to obtain formal training makes sense,” he adds. “If a family medicine doc completes the fellowship and takes it back to a residency program [the residents] will be more prepared for their potential careers in hospital and ICU medicine and much more comfortable with high-acuity patients.”

Claudia Stahl is SHM’s content manager.

A nationwide shortage of intensivists has more hospitalists stepping into the critical care arena, but not all with the level of preparation and comfort of David Aymond, MD, a Louisiana-based hospitalist trained in family medicine (HTFM).

Dr. Aymond gained his ICU experience in a fellowship with the University of Alabama, where hospitalists also “were responsible for ICU patients,” he said. Years later, as an employee of both small and large hospitals with busy ICU services, and a faculty member for a family medicine residency with a busy ICU, Dr. Aymond moves seamlessly between roles.

“I am currently practicing as a full time intensivist and take consults from other providers, yet I only have a certificate from fellowship, no formal board certification in critical care,” noted a survey respondent.

Other participants stated, “it makes perfect sense to have a pathway to critical care if both family medicine and internal medicine coexist as hospitalists,” that certification is “imperative at rural and underserved hospitals,” and also “helpful for those …who work in larger hospitals and take care of critically ill patients.” More than half of those surveyed want the Family Medicine Committee to work with ABFM to create the pathway.

The majority (87%) of the HTFM survey respondents are certified by the ABFM, and 8% have attained Recognition of Focused Practice in Hospital Medicine. Common pathways for additional credentialing include SHM’s Fellow of Hospital Medicine program (38%), a fellowship in hospital medicine (19%), and certification in hospice and palliative care (15%). More than 38% reported “other qualifications,” such as years of work experience, certification by the American Osteopathic Board of Family Physicians, and prior training in internal medicine.

The survey also found that certification differences in internal medicine and family medicine hospitalists, which may have posed employment obstacles in the past for HTFM, are not as much of an issue.

“The critical care pathway is the bigger concern,” Dr. Aymond said.

SHM’s Family Medicine Committee will be working on a proposal to ABFM to create the training pathway in the coming months. Dr. Aymond wants intensivists to know that this not an attempt to encroach on their professional domain, “but an opportunity to fill the existing professional gap.

Family medicine physicians are already providing critical care services, so a pathway to obtain formal training makes sense,” he adds. “If a family medicine doc completes the fellowship and takes it back to a residency program [the residents] will be more prepared for their potential careers in hospital and ICU medicine and much more comfortable with high-acuity patients.”

Claudia Stahl is SHM’s content manager.

A nationwide shortage of intensivists has more hospitalists stepping into the critical care arena, but not all with the level of preparation and comfort of David Aymond, MD, a Louisiana-based hospitalist trained in family medicine (HTFM).

Dr. Aymond gained his ICU experience in a fellowship with the University of Alabama, where hospitalists also “were responsible for ICU patients,” he said. Years later, as an employee of both small and large hospitals with busy ICU services, and a faculty member for a family medicine residency with a busy ICU, Dr. Aymond moves seamlessly between roles.

“I am currently practicing as a full time intensivist and take consults from other providers, yet I only have a certificate from fellowship, no formal board certification in critical care,” noted a survey respondent.

Other participants stated, “it makes perfect sense to have a pathway to critical care if both family medicine and internal medicine coexist as hospitalists,” that certification is “imperative at rural and underserved hospitals,” and also “helpful for those …who work in larger hospitals and take care of critically ill patients.” More than half of those surveyed want the Family Medicine Committee to work with ABFM to create the pathway.

The majority (87%) of the HTFM survey respondents are certified by the ABFM, and 8% have attained Recognition of Focused Practice in Hospital Medicine. Common pathways for additional credentialing include SHM’s Fellow of Hospital Medicine program (38%), a fellowship in hospital medicine (19%), and certification in hospice and palliative care (15%). More than 38% reported “other qualifications,” such as years of work experience, certification by the American Osteopathic Board of Family Physicians, and prior training in internal medicine.

The survey also found that certification differences in internal medicine and family medicine hospitalists, which may have posed employment obstacles in the past for HTFM, are not as much of an issue.

“The critical care pathway is the bigger concern,” Dr. Aymond said.

SHM’s Family Medicine Committee will be working on a proposal to ABFM to create the training pathway in the coming months. Dr. Aymond wants intensivists to know that this not an attempt to encroach on their professional domain, “but an opportunity to fill the existing professional gap.

Family medicine physicians are already providing critical care services, so a pathway to obtain formal training makes sense,” he adds. “If a family medicine doc completes the fellowship and takes it back to a residency program [the residents] will be more prepared for their potential careers in hospital and ICU medicine and much more comfortable with high-acuity patients.”

Claudia Stahl is SHM’s content manager.

ORLANDO – Janus kinase inhibitors are “currently the most promising treatments” for alopecia areata, but they are expensive, are not approved for this indication, and so getting insurance coverage for these treatments can be difficult, Carolyn Goh, MD, said at the annual meeting of the American Academy of Dermatology.

In a video interview at the meeting, Dr. Goh of the department of dermatology, University of California, Los Angeles, shares the latest treatment algorithms that include these novel therapies, and thoughts on how to work with patients to increase their likelihood of getting insurance coverage for these treatments. Referring to the Janus kinase inhibitors, also known as JAK inhibitors, she said, “I think they would be very helpful for all patients with alopecia areata, but really given their side effect profile and risks involved, they should be reserved for more extensive disease.”

In the interview, Dr. Goh also discusses screening for thyroid disease in this patient population.

She had no disclosures.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Janus kinase inhibitors are “currently the most promising treatments” for alopecia areata, but they are expensive, are not approved for this indication, and so getting insurance coverage for these treatments can be difficult, Carolyn Goh, MD, said at the annual meeting of the American Academy of Dermatology.

In a video interview at the meeting, Dr. Goh of the department of dermatology, University of California, Los Angeles, shares the latest treatment algorithms that include these novel therapies, and thoughts on how to work with patients to increase their likelihood of getting insurance coverage for these treatments. Referring to the Janus kinase inhibitors, also known as JAK inhibitors, she said, “I think they would be very helpful for all patients with alopecia areata, but really given their side effect profile and risks involved, they should be reserved for more extensive disease.”

In the interview, Dr. Goh also discusses screening for thyroid disease in this patient population.

She had no disclosures.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Janus kinase inhibitors are “currently the most promising treatments” for alopecia areata, but they are expensive, are not approved for this indication, and so getting insurance coverage for these treatments can be difficult, Carolyn Goh, MD, said at the annual meeting of the American Academy of Dermatology.

In a video interview at the meeting, Dr. Goh of the department of dermatology, University of California, Los Angeles, shares the latest treatment algorithms that include these novel therapies, and thoughts on how to work with patients to increase their likelihood of getting insurance coverage for these treatments. Referring to the Janus kinase inhibitors, also known as JAK inhibitors, she said, “I think they would be very helpful for all patients with alopecia areata, but really given their side effect profile and risks involved, they should be reserved for more extensive disease.”

In the interview, Dr. Goh also discusses screening for thyroid disease in this patient population.

She had no disclosures.

[email protected]

On Twitter @whitneymcknight

Adjuvant sunitinib or sorafenib show no significant advantages in disease-free or overall survival over placebo in patients with high-risk clear cell renal cancer, according to secondary analysis of data from the ASSURE trial.

The primary analysis of data from the ASSURE trial, which included patients with all types of renal cell carcinoma, had failed to show a benefit in disease-free survival.

“Given recently published results of a 750-patient randomized trial, S-TRAC, (sunitinib 50 mg daily [4/2 schedule] vs placebo in clear cell predominant pT3-4 or node-positive disease) that show improved [disease-free survival], the appropriate adjuvant strategy for high-risk patients is unclear,” Naomi B. Haas, MD, and coauthors wrote (JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0076).

Therefore, the investigators focused on a subset of patients from the ASSURE trial with high-risk clear cell renal cancer to determine if there might be a benefit in this group.

The secondary analysis involved 1,069 participants with pT3 and higher or node-positive renal cancer with clear cell histology who were randomized to receive 54 weeks of sunitinib (50mg, oral daily for 28 of 42 days per cycle), sorafenib (400 mg, oral twice daily continuously), or placebo.

The 5-year disease-free survival rate was 47.7% for patients in the sunitinib arm, 49.9% for those taking sorafenib, and 50% for placebo, with no statistically significant difference between the three groups. The 5-year overall survival rate was 75.2% for the sunitinib arm, 80.2% in the sorafenib arm, and 76.5% for those on placebo, with no statistically significant differences between the groups, reported Dr. Haas of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, and colleagues.

“This high-risk population had a better 5-year recurrence-free rate (around 50%) than expected (41.9% for high-risk disease and 36.0% for node-positive disease), possibly a result of better surgical technique, more accurate staging, or unknown biologic factors,” the authors wrote.

When the researchers analyzed disease-free survival according to quartiles of total dose per 6-week cycle, they also found no differences between each quartile of average dose per cycle.

There was, however, a significantly higher rate of grade 3 or higher adverse events in the sunitinib arm (66%) and sorafenib group (72%), compared with placebo (22%).

“Based on this analysis, a rationale for adjuvant therapy in this high-risk population is not elucidated,” Dr. Haas and colleagues said.

The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.

Adjuvant sunitinib or sorafenib show no significant advantages in disease-free or overall survival over placebo in patients with high-risk clear cell renal cancer, according to secondary analysis of data from the ASSURE trial.

The primary analysis of data from the ASSURE trial, which included patients with all types of renal cell carcinoma, had failed to show a benefit in disease-free survival.

“Given recently published results of a 750-patient randomized trial, S-TRAC, (sunitinib 50 mg daily [4/2 schedule] vs placebo in clear cell predominant pT3-4 or node-positive disease) that show improved [disease-free survival], the appropriate adjuvant strategy for high-risk patients is unclear,” Naomi B. Haas, MD, and coauthors wrote (JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0076).

Therefore, the investigators focused on a subset of patients from the ASSURE trial with high-risk clear cell renal cancer to determine if there might be a benefit in this group.

The secondary analysis involved 1,069 participants with pT3 and higher or node-positive renal cancer with clear cell histology who were randomized to receive 54 weeks of sunitinib (50mg, oral daily for 28 of 42 days per cycle), sorafenib (400 mg, oral twice daily continuously), or placebo.

The 5-year disease-free survival rate was 47.7% for patients in the sunitinib arm, 49.9% for those taking sorafenib, and 50% for placebo, with no statistically significant difference between the three groups. The 5-year overall survival rate was 75.2% for the sunitinib arm, 80.2% in the sorafenib arm, and 76.5% for those on placebo, with no statistically significant differences between the groups, reported Dr. Haas of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, and colleagues.

“This high-risk population had a better 5-year recurrence-free rate (around 50%) than expected (41.9% for high-risk disease and 36.0% for node-positive disease), possibly a result of better surgical technique, more accurate staging, or unknown biologic factors,” the authors wrote.

When the researchers analyzed disease-free survival according to quartiles of total dose per 6-week cycle, they also found no differences between each quartile of average dose per cycle.

There was, however, a significantly higher rate of grade 3 or higher adverse events in the sunitinib arm (66%) and sorafenib group (72%), compared with placebo (22%).

“Based on this analysis, a rationale for adjuvant therapy in this high-risk population is not elucidated,” Dr. Haas and colleagues said.

The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.

Adjuvant sunitinib or sorafenib show no significant advantages in disease-free or overall survival over placebo in patients with high-risk clear cell renal cancer, according to secondary analysis of data from the ASSURE trial.

The primary analysis of data from the ASSURE trial, which included patients with all types of renal cell carcinoma, had failed to show a benefit in disease-free survival.

“Given recently published results of a 750-patient randomized trial, S-TRAC, (sunitinib 50 mg daily [4/2 schedule] vs placebo in clear cell predominant pT3-4 or node-positive disease) that show improved [disease-free survival], the appropriate adjuvant strategy for high-risk patients is unclear,” Naomi B. Haas, MD, and coauthors wrote (JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0076).

Therefore, the investigators focused on a subset of patients from the ASSURE trial with high-risk clear cell renal cancer to determine if there might be a benefit in this group.

The secondary analysis involved 1,069 participants with pT3 and higher or node-positive renal cancer with clear cell histology who were randomized to receive 54 weeks of sunitinib (50mg, oral daily for 28 of 42 days per cycle), sorafenib (400 mg, oral twice daily continuously), or placebo.

The 5-year disease-free survival rate was 47.7% for patients in the sunitinib arm, 49.9% for those taking sorafenib, and 50% for placebo, with no statistically significant difference between the three groups. The 5-year overall survival rate was 75.2% for the sunitinib arm, 80.2% in the sorafenib arm, and 76.5% for those on placebo, with no statistically significant differences between the groups, reported Dr. Haas of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, and colleagues.

“This high-risk population had a better 5-year recurrence-free rate (around 50%) than expected (41.9% for high-risk disease and 36.0% for node-positive disease), possibly a result of better surgical technique, more accurate staging, or unknown biologic factors,” the authors wrote.

When the researchers analyzed disease-free survival according to quartiles of total dose per 6-week cycle, they also found no differences between each quartile of average dose per cycle.

There was, however, a significantly higher rate of grade 3 or higher adverse events in the sunitinib arm (66%) and sorafenib group (72%), compared with placebo (22%).

“Based on this analysis, a rationale for adjuvant therapy in this high-risk population is not elucidated,” Dr. Haas and colleagues said.

The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.

Take-Home Points

• Lateral patella dislocation is sufficiently treated with modern versions of patellofemoral surgery.
• Comprehensive assessment for underlying osseous pathology is paramount (torsional abnormalities of the femur or tibia, trochlea dysplasia, patella alta, etc).
• In such cases, isolated medial patellofemoral ligament reconstructions will fail. Instead, the underlying osseous abnormalities must be addressed during concomitant procedures (derotational osteotomy, tibial tubercle transfer, trochleoplasty, etc).

The incidence of patellar instability is high, particularly in young females. In principle, cases of patellar instability can be classified as traumatic (dislocation is caused by external, often direct forces) or nontraumatic (anatomy predisposes to instability).^1-4

Anatomy Predisposing to Patella Dislocation

Most patients present with specific anatomical factors that predispose to patellar instability (isolated or combined).

Of the osteochondral factors, dysplasia of the femoral trochlea (trochlea groove [TG]) is most important. In healthy patients, the concave trochlea stabilizes the patella in knee flexion angles above 20°. In particular, the lateral facet of the trochlea plays a key role in withstanding the lateralizing quadriceps vector. The dysplastic trochlea, which has a flat or even a convex surface, destabilizes the patella (Figure 1). Moreover, patella alta is a pivotal factor in the development of LPD.

Diagnostics

Physical Examination

It is recommended that the physician starts the examination by assessing the walking and standing patient while focusing on torsional malalignment of the lower extremities (increased antetorsion of the femur, increased external torsion of the tibia), which is often indicated by squinting patellae.^8,27,28

Imaging

Radiographs are the basis for each patient’s imaging analysis. For a patient with valgus or varus clinical appearance, a weight-bearing whole-leg radiograph is used to precisely assess the degree of deformity in the frontal plane. A true lateral radiograph (congruent posterior condyles) provides information about patellar height (patella alta/infera). Most indices that quantify patellar height use the tibia as reference (eg, tuberosity, anterior aspect of articulation surface).

MRI is the gold standard for LPD diagnosis—it can be used to easily identify soft-tissue lesions and establish their patellar or femoral location (eg, MPFL rupture). MRI also provides information on potential pathologies of quadriceps tendon, patella tendon, and infrapatellar fat pad. Compared with radiographs, MRI is more sensitive in detecting osteochondral lesions in LPD.

Treatment

MPFL Reconstruction

Isolated MPFL reconstruction is commonly regarded as a standard, straightforward procedure.

Trochleoplasty

In cases of recurrent LPD or a flat or convex trochlea (Dejour type B, C, or D dysplasia), deepening trochleoplasty should be considered.

Osteotomy

The most popular type of osteotomy in the setting of LPD is the transfer of the TT (TTT).

Derotational osteotomies of the femur (externally rotating) provide good outcomes in patients with LPD and associated torsional deformities,^61-63 though the literature is incongruent with respect to whether rotational osteotomies of the femur should be performed at the proximal or distal aspect.^64-67 In the majority of our LPD cases, we combine femoral derotation with MPFL reconstruction.

Treatment Algorithms

We suggest using different algorithms for primary LPD (Figure 22, Tables 1-2) and recurrent LPD (Figure 23).

Conclusion

In skeletally mature patients, LPD is sufficiently treated with modern versions of patellofemoral surgery. Comprehensive assessment for underlying pathology is paramount as preparation for developing an appropriate surgical plan for the patient.

Am J Orthop. 2017;46(2):E86-E96. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Lateral patella dislocation is sufficiently treated with modern versions of patellofemoral surgery.
• Comprehensive assessment for underlying osseous pathology is paramount (torsional abnormalities of the femur or tibia, trochlea dysplasia, patella alta, etc).
• In such cases, isolated medial patellofemoral ligament reconstructions will fail. Instead, the underlying osseous abnormalities must be addressed during concomitant procedures (derotational osteotomy, tibial tubercle transfer, trochleoplasty, etc).

The incidence of patellar instability is high, particularly in young females. In principle, cases of patellar instability can be classified as traumatic (dislocation is caused by external, often direct forces) or nontraumatic (anatomy predisposes to instability).^1-4

Anatomy Predisposing to Patella Dislocation

Most patients present with specific anatomical factors that predispose to patellar instability (isolated or combined).

Of the osteochondral factors, dysplasia of the femoral trochlea (trochlea groove [TG]) is most important. In healthy patients, the concave trochlea stabilizes the patella in knee flexion angles above 20°. In particular, the lateral facet of the trochlea plays a key role in withstanding the lateralizing quadriceps vector. The dysplastic trochlea, which has a flat or even a convex surface, destabilizes the patella (Figure 1). Moreover, patella alta is a pivotal factor in the development of LPD.

Diagnostics

Physical Examination

It is recommended that the physician starts the examination by assessing the walking and standing patient while focusing on torsional malalignment of the lower extremities (increased antetorsion of the femur, increased external torsion of the tibia), which is often indicated by squinting patellae.^8,27,28

Imaging

Radiographs are the basis for each patient’s imaging analysis. For a patient with valgus or varus clinical appearance, a weight-bearing whole-leg radiograph is used to precisely assess the degree of deformity in the frontal plane. A true lateral radiograph (congruent posterior condyles) provides information about patellar height (patella alta/infera). Most indices that quantify patellar height use the tibia as reference (eg, tuberosity, anterior aspect of articulation surface).

MRI is the gold standard for LPD diagnosis—it can be used to easily identify soft-tissue lesions and establish their patellar or femoral location (eg, MPFL rupture). MRI also provides information on potential pathologies of quadriceps tendon, patella tendon, and infrapatellar fat pad. Compared with radiographs, MRI is more sensitive in detecting osteochondral lesions in LPD.

Treatment

MPFL Reconstruction

Isolated MPFL reconstruction is commonly regarded as a standard, straightforward procedure.

Trochleoplasty

In cases of recurrent LPD or a flat or convex trochlea (Dejour type B, C, or D dysplasia), deepening trochleoplasty should be considered.

Osteotomy

The most popular type of osteotomy in the setting of LPD is the transfer of the TT (TTT).

Derotational osteotomies of the femur (externally rotating) provide good outcomes in patients with LPD and associated torsional deformities,^61-63 though the literature is incongruent with respect to whether rotational osteotomies of the femur should be performed at the proximal or distal aspect.^64-67 In the majority of our LPD cases, we combine femoral derotation with MPFL reconstruction.

Treatment Algorithms

We suggest using different algorithms for primary LPD (Figure 22, Tables 1-2) and recurrent LPD (Figure 23).

Conclusion

In skeletally mature patients, LPD is sufficiently treated with modern versions of patellofemoral surgery. Comprehensive assessment for underlying pathology is paramount as preparation for developing an appropriate surgical plan for the patient.

Am J Orthop. 2017;46(2):E86-E96. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Lateral patella dislocation is sufficiently treated with modern versions of patellofemoral surgery.
• Comprehensive assessment for underlying osseous pathology is paramount (torsional abnormalities of the femur or tibia, trochlea dysplasia, patella alta, etc).
• In such cases, isolated medial patellofemoral ligament reconstructions will fail. Instead, the underlying osseous abnormalities must be addressed during concomitant procedures (derotational osteotomy, tibial tubercle transfer, trochleoplasty, etc).

The incidence of patellar instability is high, particularly in young females. In principle, cases of patellar instability can be classified as traumatic (dislocation is caused by external, often direct forces) or nontraumatic (anatomy predisposes to instability).^1-4

Anatomy Predisposing to Patella Dislocation

Most patients present with specific anatomical factors that predispose to patellar instability (isolated or combined).

Of the osteochondral factors, dysplasia of the femoral trochlea (trochlea groove [TG]) is most important. In healthy patients, the concave trochlea stabilizes the patella in knee flexion angles above 20°. In particular, the lateral facet of the trochlea plays a key role in withstanding the lateralizing quadriceps vector. The dysplastic trochlea, which has a flat or even a convex surface, destabilizes the patella (Figure 1). Moreover, patella alta is a pivotal factor in the development of LPD.

Diagnostics

Physical Examination

It is recommended that the physician starts the examination by assessing the walking and standing patient while focusing on torsional malalignment of the lower extremities (increased antetorsion of the femur, increased external torsion of the tibia), which is often indicated by squinting patellae.^8,27,28

Imaging

Radiographs are the basis for each patient’s imaging analysis. For a patient with valgus or varus clinical appearance, a weight-bearing whole-leg radiograph is used to precisely assess the degree of deformity in the frontal plane. A true lateral radiograph (congruent posterior condyles) provides information about patellar height (patella alta/infera). Most indices that quantify patellar height use the tibia as reference (eg, tuberosity, anterior aspect of articulation surface).

MRI is the gold standard for LPD diagnosis—it can be used to easily identify soft-tissue lesions and establish their patellar or femoral location (eg, MPFL rupture). MRI also provides information on potential pathologies of quadriceps tendon, patella tendon, and infrapatellar fat pad. Compared with radiographs, MRI is more sensitive in detecting osteochondral lesions in LPD.

Treatment

MPFL Reconstruction

Isolated MPFL reconstruction is commonly regarded as a standard, straightforward procedure.

Trochleoplasty

In cases of recurrent LPD or a flat or convex trochlea (Dejour type B, C, or D dysplasia), deepening trochleoplasty should be considered.

Osteotomy

The most popular type of osteotomy in the setting of LPD is the transfer of the TT (TTT).

Derotational osteotomies of the femur (externally rotating) provide good outcomes in patients with LPD and associated torsional deformities,^61-63 though the literature is incongruent with respect to whether rotational osteotomies of the femur should be performed at the proximal or distal aspect.^64-67 In the majority of our LPD cases, we combine femoral derotation with MPFL reconstruction.

Treatment Algorithms

We suggest using different algorithms for primary LPD (Figure 22, Tables 1-2) and recurrent LPD (Figure 23).

Conclusion

In skeletally mature patients, LPD is sufficiently treated with modern versions of patellofemoral surgery. Comprehensive assessment for underlying pathology is paramount as preparation for developing an appropriate surgical plan for the patient.

Am J Orthop. 2017;46(2):E86-E96. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Surgical intervention for cervical spondylosis and radiculopathy classically involves either an anterior or posterior approach for adequate decompression of the spinal cord and associated nerve roots.
• Combined anterior-posterior surgery for cervical spondylotic myelopathy is a relatively new technique that has previously been used for disorders of the thoracolumbar spine.
• Combined anterior-posterior cervical decompression and fusion for the treatment of cervical spondylotic myelopathy is associated with minor complications and excellent neurologic outcomes.
• Combined surgery can either be performed in a single day or in a staged manner, with current literature showing that same-day surgery is superior with respect to estimated blood loss and length of stay.

Cervical spondylotic myelopathy (CSM) is a degenerative disease characterized by progressive compression of the spinal cord. CSM has been found to be the most common cause of spinal impairment as well as the most frequently acquired cause of spinal dysfunction in people over 55 years of age.^1,2 If left untreated, this condition can reduce manual dexterity and cause gait disturbances, dysesthesias, and weakness in the extremities. When conservative treatments fail, surgical intervention often becomes the preferred course of action for CSM and/or myeloradiculopathy.

The surgical approach for CSM and other advanced cervical spine (CS) deformities varies and is often a source of debate. Being a relatively safe and effective procedure, anterior decompression with fusion is optimal in treating discogenic lesions causing myelopathy but is less effective in multilevel disease.^3,4 When pseudarthrosis, adjacent segment degeneration (ASD), and hardware failure are of concern, posterior decompressive laminectomy with instrumentation is a promising option.⁵ However, this method is less effective in restoring lordosis and can increase the risk for later clinical deterioration.⁶ There is a select subset of patients for whom a combined anterior-posterior approach is ideal.^7-9In cases in which a combined anterior-posterior approach is identified as the best treatment option, whether to perform the operation in a sequential or staged manner must be decided, and this question is another source of debate. Single-day surgery is sometimes anecdotally criticized as posing a greater risk to the patient. On the other hand, some comparative studies have shown no statistically significant difference in major complication rates between the 2 options.^10,11 More descriptive studies of combined anterior-posterior decompression and fusion (CAPDF) are needed to explore the efficacy of the procedure. In this article, we describe a study we conducted to characterize the operative data, perioperative complications, and short-term outcomes associated with CAPDF for the treatment of CSM in a select group of patients.

Methods

After receiving Institutional Review Board approval for this study (formal consent was not required), we retrospectively reviewed the charts of 21 patients who underwent CAPDF for CSM at our institution. All patients underwent surgery between February 2010 and March 2015. Criteria for inclusion in the study included same-day CAPDF for CSM. Staged procedures were excluded, as were combined procedures for the treatment of other diseases (eg, malignancies). All patients were operated on by the same primary surgeon (Dr. Davis) and co-surgeon (Dr. Labiak). The 1 patient who was lost to follow-up was excluded from the postoperative outcome analysis.

We reviewed the patients’ medical records for surgical consultations, operative reports, intraoperative reports, progress notes, and postoperative office visit reports. Demographic information included age, sex, body mass index, and preoperative risk factors, such as diabetes and tobacco use. All patients had been diagnosed with myelopathy. Clinical data included previous history of CS surgery, levels fused (and number of levels fused) anteriorly and posteriorly, operative time, estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Short-term (3-month follow-up) neurologic improvement was determined both objectively, with the Nurick grading system,¹² and subjectively, with determination of patient quality of life before and after surgery and with neurologic examination.

Operative Technique: Anterior Approach

All operations were performed with continuous somatosensory evoked potential monitoring of both upper and lower extremities. Each patient, positioned supine with the head in a neutral position, underwent standard endotracheal intubation. Intubation was followed by a transverse incision and dissection down to the deep cervical fascia with maintenance of the carotid sheath laterally and tracheoesophageal complex medially. Interspaces were identified and later were confirmed with lateral radiographs. Discectomy, osteophytectomy, and removal of hypertrophied or calcified ligament were then performed until decompression was satisfactory. Corpectomies were not performed. Polyetheretherketone interbody spacers (Stryker) were used with autograft harvested from vertebral body resection. Low-profile screw-plate systems were placed. After completion of the anterior procedure, the patient was placed prone, with the head fixed in a Mayfield clamping device in neutral position and with all pressure points carefully padded.

Operative Technique: Posterior Approach

A midline incision was made through the skin and subcutaneous tissue to the level of the deep cervical fascia. Then, dissection was performed to the tips of the lateral masses. Instrumentation and fusion preceded spinal decompression. This order, chosen to preserve bony landmarks for guidance during instrumentation, did not interfere with subsequent decompression. Segmental spinal instrumentation was placed using lateral mass screw-rod fixation. After the laminae and ligamenta flava were bilaterally mobilized, the entire bony ligamentous complex spanning the area of fusion was removed en masse (most commonly C3–C7) in order to decrease the number of instrument passes near the spinal cord. Next, a modest foraminotomy was performed to extend the opening laterally and ensure adequate decompression of the nerve roots. Autograft harvested from the spinous processes and laminae was used. The posterior portion of the operation contributed significantly to blood loss and postoperative pain during the perioperative period. We recommend performing a very meticulous dissection to minimize these consequences. No patient in this study required a halo orthosis.

Results

Twenty-one patients with CSM were treated with CAPDF between February 2010 and March 2015 (Table 1).

Table 2 summarizes the operative data. Mean number of levels fused was 2 (range, 1-3) anteriorly and 3 (range, 1-4) posteriorly.

Representative Case

Patient 15, a 53-year-old man, presented with complaints of dysesthesias of the hands. Focused neurologic evaluation at the time revealed limited CS range of motion on extension. The patient (Figures 2A-2D) was diffusely hyperreflexic and had pathologic spread in the upper extremities.

Discussion

Cervical myelopathy is a common yet frequently underdiagnosed disease, owing to the fact that many patients remain asymptomatic even after experiencing degenerative changes in the spinal column.^14-16 The additive effects of spondylosis, osteophyte formation, ligamentous hypertrophy, and listhesis lead to progressive canal and intervertebral foraminal compromise, ultimately producing the clinical syndromes of myelopathy and radiculopathy.¹⁷ The characteristic symptoms of CSM are known to have an insidious onset. In the early stages, patients note a subtle gait disturbance and later experience manual dexterity reductions and upper extremity dysesthesias.¹⁸ As the condition progresses and conservative management fails, surgical intervention is sought.

Nevertheless, the pursuit of surgical treatment for CSM remains somewhat controversial. Some authors have found no statistically significant difference between conservative and surgical management of mild to moderate CSM,¹⁹ whereas others have found that surgically treated patients had much better outcomes than their medically treated counterparts.²⁰ In 2010, Scardino and colleagues²¹ reported that CSM patients who were bedridden and/or wheelchair-bound with seemingly irreversible myelopathy were capable of neurologic improvement after surgical intervention. At the very least, what remains clear is that untreated CSM is known to follow an unpredictable course, with the condition deteriorating faster for some patients than others.²²Traditional anterior or posterior approaches, which can be used in the majority of cases of cervical spondylosis and/or radiculopathy, have been compared extensively.^23,24 The inverse relationship concerning the integrity of an anterior construct and the number of levels fused is a well-established clinical finding.^3,4,8,25-28 Laminectomy with fusion is not without its disadvantages: Cervical instability secondary to mechanical loss of posterior cervical support, and subsequent post-laminectomy kyphosis, is a common complication.²³ In cases in which more stability is required, the combined anterior-posterior approach is more promising than either approach alone. This technique has its roots in the treatment of several thoracolumbar spine disorders, including infections, scoliosis, trauma, and tumors.^29-31 More recently, the technique has been applied to CS disorders.

In 2008, Gok and colleagues³² retrospectively compared the results of anterior-only fusion and CAPDF for CSM. Forty-six patients underwent anterior surgery only, and 21 underwent CAPDF. The groups’ complication rates were similar: 28.6% (anterior only) and 24% (CAPDF); the incidence of ASD was lower in the combined group. Song and colleagues³³ conducted a similar study in 2010. They compared anterior fusion alone and CAPDF in treating degenerative cervical kyphosis. Results were strongly in favor of the combined technique, as it led to “greater correction of sagittal alignment, a better maintenance of correction angle, a higher rate of fusion, a lower rate of subsidence and lower complications.” Both studies established that, in a select group of patients, the benefits of CAPDF outweighed the risks. These findings, combined with our study’s findings of no major complications and the transience of minor complications, suggest CAPDF should not be considered too invasive or risky.

The results of our study also mirror those of 3 other studies on the use of CAPDF for CS disorders. In 1995, McAfee and colleagues³⁴ reported on a group of 100 patients with follow-up of 2 years or more. In most cases, the surgical indication was trauma, but neoplasm, infection, rheumatoid arthritis, and CSM were found as well. Outcomes were very favorable: improvement in a previous neurologic deficit (57/75 patients), ability to walk again (21/35 patients), no new neurologic deficits, and no hardware failures. In 2000, Schultz and colleagues³⁵ retrospectively reviewed the cases of 72 patients who underwent CAPDF for a variety of complex CS disorders. Two of the 72 experienced transient neurologic deficits, and, though the immediate complication rate was relatively high (32%), the long-term complication rate was down to 5%. In 2009, Konya and colleagues³⁶ retrospectively reviewed the cases of 40 patients who underwent CAPDF, primarily for CSM. Within 1 week after surgery, neurologic deficits were reduced in 36 patients; by 1 year after surgery, neurologic deficits were reduced in all 40 patients, and fusion was achieved in 39. These 3 studies^34-36 helped establish CAPDF of the CS as a viable and effective procedure that can be performed within a single day.

Although many physicians have achieved favorable results with single-day surgery, the decision to operate in a sequential or staged manner remains controversial. Some anecdotally claim CAPDF poses a greater operative risk to the patient. In 1991, the continuous procedure was found to involve less blood loss and shorter LOS while providing for better correction of severe spinal deformity in patients with scoliosis and rigid kyphosis.³⁷ Three more recent comparative studies examining the same issue in the treatment of CS diseases found staging did not reduce the complication rate and may in fact have been associated with higher complication rates, more blood loss, and longer total operative time and LOS.^10,11,38 Our study’s lower blood loss, shorter LOS, and lower major complication rate relative to the combined groups in all 3 of those studies are most likely attributable to our operating on a lower mean number of spinal levels and our restricting the surgical indication to CSM. The positive short-term outcomes and low rate of long-term complications in our study, combined with the data from these 3 comparative studies, suggest that same-day surgery is superior to staged surgery. A staged operation should be considered only if the patient cannot tolerate long periods under general anesthesia.

Many have advocated extending fusion down to T1 to prevent ASD at the C7–T1 disk space.^35,39,40 We decided against this approach for 2 reasons. First, at C7, lateral mass screws were always chosen over pedicle screws. When possible, shorter lateral mass screws were used at this level, making C7 much less rigid. Second, the C7–T1 facet capsule was maintained to preserve joint integrity. We suggest extending fusion down to T1 only if there is prior evidence of spinal disease and/or listhesis at C7–T1. Although long-term (many-year) follow-up is often desired, we specifically assessed short-term (3-month) outcomes. We have anecdotally found that degree of improvement often follows a predictable course after 3-month follow-up. If myelopathy resolves even to a small extent during the first 3 postoperative months, later improvement will likely follow an upward course. Conversely, if myelopathy does not improve during the first 3 months, further improvement is much less likely.

This trend in neurologic improvement likely is directly related to degree of myelopathy before surgery. Patients with CSM generally experience symptoms over an extended period and try conservative management before any surgical consultation. Although spinal ischemia is often resolved by decompression, permanent ischemic damage to the cord is not uncommon. In this setting, postoperative neurologic improvement is minimal or even nonexistent, and decompression is preventive rather than curative. In our study, 1 patient had no subjective improvement after surgery. At 3-month follow-up, magnetic resonance imaging showed notable myelomalacia without residual spinal cord compression. We attribute the failure of the ischemic changes to resolve to long-standing preoperative damage to the cord. Nevertheless, surgery stabilized the myelopathy and prevented further ischemic damage and clinical deterioration.

As is the case with any operation, patients must be carefully selected for CAPDF. Indications for CAPDF, as described by Kim and Alexander,⁷ include acute spinal trauma, post-laminectomy kyphosis, kyphotic deformity with intact posterior tension band, multilevel spondylosis and OPLL, and preexisting risk factors for pseudarthrosis. Clearly, the severity of each varies, and the pathologies are not mutually exclusive. We emphasize that these indications provide only a guideline for performing CAPDF, and patients must be selected on a case-by-case basis. All the patients in our study were symptomatic and exhibited significant compression of the spinal cord anteriorly and posteriorly at multiple levels. Several presented with concomitant pathologies, such as cervical kyphotic deformity, congenital spinal stenosis, and OPLL. In each case, the indication for surgical intervention was undoubted. We sought both to improve the patient’s baseline symptoms and to prevent further damage to the spinal cord.

This study had its limitations. First, its retrospective design predisposed it to a higher degree of bias. Second, because CAPDF is not commonly performed, the sample size was relatively small. Third, although it provided a descriptive analysis of CAPDF for CSM, the study did not use a direct comparison group to establish whether treatment within a single day or staged treatment was more beneficial for our cohort in particular. On the basis of prior experience and observation, we think performing the operation within a single day is much more beneficial for the patient. Our discussion of studies that have compared same-day and staged surgery supports this observation. Therefore, staged treatment was not recommended to our patients.

Conclusion

Few descriptive studies have explored CAPDF for CSM. Our study’s results showed the procedure was associated with minor complications and provided symptomatic relief for a majority of patients as early as 3 months after surgery. In addition, CAPDF can be successfully performed sequentially within a single day. As such, it represents an excellent option for treating multilevel symptomatic CSM cases that require more extensive spinal decompression and more stability.

Am J Orthop. 2017;46(2):E97-E104. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Surgical intervention for cervical spondylosis and radiculopathy classically involves either an anterior or posterior approach for adequate decompression of the spinal cord and associated nerve roots.
• Combined anterior-posterior surgery for cervical spondylotic myelopathy is a relatively new technique that has previously been used for disorders of the thoracolumbar spine.
• Combined anterior-posterior cervical decompression and fusion for the treatment of cervical spondylotic myelopathy is associated with minor complications and excellent neurologic outcomes.
• Combined surgery can either be performed in a single day or in a staged manner, with current literature showing that same-day surgery is superior with respect to estimated blood loss and length of stay.

Cervical spondylotic myelopathy (CSM) is a degenerative disease characterized by progressive compression of the spinal cord. CSM has been found to be the most common cause of spinal impairment as well as the most frequently acquired cause of spinal dysfunction in people over 55 years of age.^1,2 If left untreated, this condition can reduce manual dexterity and cause gait disturbances, dysesthesias, and weakness in the extremities. When conservative treatments fail, surgical intervention often becomes the preferred course of action for CSM and/or myeloradiculopathy.

The surgical approach for CSM and other advanced cervical spine (CS) deformities varies and is often a source of debate. Being a relatively safe and effective procedure, anterior decompression with fusion is optimal in treating discogenic lesions causing myelopathy but is less effective in multilevel disease.^3,4 When pseudarthrosis, adjacent segment degeneration (ASD), and hardware failure are of concern, posterior decompressive laminectomy with instrumentation is a promising option.⁵ However, this method is less effective in restoring lordosis and can increase the risk for later clinical deterioration.⁶ There is a select subset of patients for whom a combined anterior-posterior approach is ideal.^7-9In cases in which a combined anterior-posterior approach is identified as the best treatment option, whether to perform the operation in a sequential or staged manner must be decided, and this question is another source of debate. Single-day surgery is sometimes anecdotally criticized as posing a greater risk to the patient. On the other hand, some comparative studies have shown no statistically significant difference in major complication rates between the 2 options.^10,11 More descriptive studies of combined anterior-posterior decompression and fusion (CAPDF) are needed to explore the efficacy of the procedure. In this article, we describe a study we conducted to characterize the operative data, perioperative complications, and short-term outcomes associated with CAPDF for the treatment of CSM in a select group of patients.

Methods

After receiving Institutional Review Board approval for this study (formal consent was not required), we retrospectively reviewed the charts of 21 patients who underwent CAPDF for CSM at our institution. All patients underwent surgery between February 2010 and March 2015. Criteria for inclusion in the study included same-day CAPDF for CSM. Staged procedures were excluded, as were combined procedures for the treatment of other diseases (eg, malignancies). All patients were operated on by the same primary surgeon (Dr. Davis) and co-surgeon (Dr. Labiak). The 1 patient who was lost to follow-up was excluded from the postoperative outcome analysis.

We reviewed the patients’ medical records for surgical consultations, operative reports, intraoperative reports, progress notes, and postoperative office visit reports. Demographic information included age, sex, body mass index, and preoperative risk factors, such as diabetes and tobacco use. All patients had been diagnosed with myelopathy. Clinical data included previous history of CS surgery, levels fused (and number of levels fused) anteriorly and posteriorly, operative time, estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Short-term (3-month follow-up) neurologic improvement was determined both objectively, with the Nurick grading system,¹² and subjectively, with determination of patient quality of life before and after surgery and with neurologic examination.

Operative Technique: Anterior Approach

All operations were performed with continuous somatosensory evoked potential monitoring of both upper and lower extremities. Each patient, positioned supine with the head in a neutral position, underwent standard endotracheal intubation. Intubation was followed by a transverse incision and dissection down to the deep cervical fascia with maintenance of the carotid sheath laterally and tracheoesophageal complex medially. Interspaces were identified and later were confirmed with lateral radiographs. Discectomy, osteophytectomy, and removal of hypertrophied or calcified ligament were then performed until decompression was satisfactory. Corpectomies were not performed. Polyetheretherketone interbody spacers (Stryker) were used with autograft harvested from vertebral body resection. Low-profile screw-plate systems were placed. After completion of the anterior procedure, the patient was placed prone, with the head fixed in a Mayfield clamping device in neutral position and with all pressure points carefully padded.

Operative Technique: Posterior Approach

A midline incision was made through the skin and subcutaneous tissue to the level of the deep cervical fascia. Then, dissection was performed to the tips of the lateral masses. Instrumentation and fusion preceded spinal decompression. This order, chosen to preserve bony landmarks for guidance during instrumentation, did not interfere with subsequent decompression. Segmental spinal instrumentation was placed using lateral mass screw-rod fixation. After the laminae and ligamenta flava were bilaterally mobilized, the entire bony ligamentous complex spanning the area of fusion was removed en masse (most commonly C3–C7) in order to decrease the number of instrument passes near the spinal cord. Next, a modest foraminotomy was performed to extend the opening laterally and ensure adequate decompression of the nerve roots. Autograft harvested from the spinous processes and laminae was used. The posterior portion of the operation contributed significantly to blood loss and postoperative pain during the perioperative period. We recommend performing a very meticulous dissection to minimize these consequences. No patient in this study required a halo orthosis.

Results

Twenty-one patients with CSM were treated with CAPDF between February 2010 and March 2015 (Table 1).

Table 2 summarizes the operative data. Mean number of levels fused was 2 (range, 1-3) anteriorly and 3 (range, 1-4) posteriorly.

Representative Case

Patient 15, a 53-year-old man, presented with complaints of dysesthesias of the hands. Focused neurologic evaluation at the time revealed limited CS range of motion on extension. The patient (Figures 2A-2D) was diffusely hyperreflexic and had pathologic spread in the upper extremities.

Discussion

Cervical myelopathy is a common yet frequently underdiagnosed disease, owing to the fact that many patients remain asymptomatic even after experiencing degenerative changes in the spinal column.^14-16 The additive effects of spondylosis, osteophyte formation, ligamentous hypertrophy, and listhesis lead to progressive canal and intervertebral foraminal compromise, ultimately producing the clinical syndromes of myelopathy and radiculopathy.¹⁷ The characteristic symptoms of CSM are known to have an insidious onset. In the early stages, patients note a subtle gait disturbance and later experience manual dexterity reductions and upper extremity dysesthesias.¹⁸ As the condition progresses and conservative management fails, surgical intervention is sought.

Nevertheless, the pursuit of surgical treatment for CSM remains somewhat controversial. Some authors have found no statistically significant difference between conservative and surgical management of mild to moderate CSM,¹⁹ whereas others have found that surgically treated patients had much better outcomes than their medically treated counterparts.²⁰ In 2010, Scardino and colleagues²¹ reported that CSM patients who were bedridden and/or wheelchair-bound with seemingly irreversible myelopathy were capable of neurologic improvement after surgical intervention. At the very least, what remains clear is that untreated CSM is known to follow an unpredictable course, with the condition deteriorating faster for some patients than others.²²Traditional anterior or posterior approaches, which can be used in the majority of cases of cervical spondylosis and/or radiculopathy, have been compared extensively.^23,24 The inverse relationship concerning the integrity of an anterior construct and the number of levels fused is a well-established clinical finding.^3,4,8,25-28 Laminectomy with fusion is not without its disadvantages: Cervical instability secondary to mechanical loss of posterior cervical support, and subsequent post-laminectomy kyphosis, is a common complication.²³ In cases in which more stability is required, the combined anterior-posterior approach is more promising than either approach alone. This technique has its roots in the treatment of several thoracolumbar spine disorders, including infections, scoliosis, trauma, and tumors.^29-31 More recently, the technique has been applied to CS disorders.

In 2008, Gok and colleagues³² retrospectively compared the results of anterior-only fusion and CAPDF for CSM. Forty-six patients underwent anterior surgery only, and 21 underwent CAPDF. The groups’ complication rates were similar: 28.6% (anterior only) and 24% (CAPDF); the incidence of ASD was lower in the combined group. Song and colleagues³³ conducted a similar study in 2010. They compared anterior fusion alone and CAPDF in treating degenerative cervical kyphosis. Results were strongly in favor of the combined technique, as it led to “greater correction of sagittal alignment, a better maintenance of correction angle, a higher rate of fusion, a lower rate of subsidence and lower complications.” Both studies established that, in a select group of patients, the benefits of CAPDF outweighed the risks. These findings, combined with our study’s findings of no major complications and the transience of minor complications, suggest CAPDF should not be considered too invasive or risky.

The results of our study also mirror those of 3 other studies on the use of CAPDF for CS disorders. In 1995, McAfee and colleagues³⁴ reported on a group of 100 patients with follow-up of 2 years or more. In most cases, the surgical indication was trauma, but neoplasm, infection, rheumatoid arthritis, and CSM were found as well. Outcomes were very favorable: improvement in a previous neurologic deficit (57/75 patients), ability to walk again (21/35 patients), no new neurologic deficits, and no hardware failures. In 2000, Schultz and colleagues³⁵ retrospectively reviewed the cases of 72 patients who underwent CAPDF for a variety of complex CS disorders. Two of the 72 experienced transient neurologic deficits, and, though the immediate complication rate was relatively high (32%), the long-term complication rate was down to 5%. In 2009, Konya and colleagues³⁶ retrospectively reviewed the cases of 40 patients who underwent CAPDF, primarily for CSM. Within 1 week after surgery, neurologic deficits were reduced in 36 patients; by 1 year after surgery, neurologic deficits were reduced in all 40 patients, and fusion was achieved in 39. These 3 studies^34-36 helped establish CAPDF of the CS as a viable and effective procedure that can be performed within a single day.

Although many physicians have achieved favorable results with single-day surgery, the decision to operate in a sequential or staged manner remains controversial. Some anecdotally claim CAPDF poses a greater operative risk to the patient. In 1991, the continuous procedure was found to involve less blood loss and shorter LOS while providing for better correction of severe spinal deformity in patients with scoliosis and rigid kyphosis.³⁷ Three more recent comparative studies examining the same issue in the treatment of CS diseases found staging did not reduce the complication rate and may in fact have been associated with higher complication rates, more blood loss, and longer total operative time and LOS.^10,11,38 Our study’s lower blood loss, shorter LOS, and lower major complication rate relative to the combined groups in all 3 of those studies are most likely attributable to our operating on a lower mean number of spinal levels and our restricting the surgical indication to CSM. The positive short-term outcomes and low rate of long-term complications in our study, combined with the data from these 3 comparative studies, suggest that same-day surgery is superior to staged surgery. A staged operation should be considered only if the patient cannot tolerate long periods under general anesthesia.

Many have advocated extending fusion down to T1 to prevent ASD at the C7–T1 disk space.^35,39,40 We decided against this approach for 2 reasons. First, at C7, lateral mass screws were always chosen over pedicle screws. When possible, shorter lateral mass screws were used at this level, making C7 much less rigid. Second, the C7–T1 facet capsule was maintained to preserve joint integrity. We suggest extending fusion down to T1 only if there is prior evidence of spinal disease and/or listhesis at C7–T1. Although long-term (many-year) follow-up is often desired, we specifically assessed short-term (3-month) outcomes. We have anecdotally found that degree of improvement often follows a predictable course after 3-month follow-up. If myelopathy resolves even to a small extent during the first 3 postoperative months, later improvement will likely follow an upward course. Conversely, if myelopathy does not improve during the first 3 months, further improvement is much less likely.

This trend in neurologic improvement likely is directly related to degree of myelopathy before surgery. Patients with CSM generally experience symptoms over an extended period and try conservative management before any surgical consultation. Although spinal ischemia is often resolved by decompression, permanent ischemic damage to the cord is not uncommon. In this setting, postoperative neurologic improvement is minimal or even nonexistent, and decompression is preventive rather than curative. In our study, 1 patient had no subjective improvement after surgery. At 3-month follow-up, magnetic resonance imaging showed notable myelomalacia without residual spinal cord compression. We attribute the failure of the ischemic changes to resolve to long-standing preoperative damage to the cord. Nevertheless, surgery stabilized the myelopathy and prevented further ischemic damage and clinical deterioration.

As is the case with any operation, patients must be carefully selected for CAPDF. Indications for CAPDF, as described by Kim and Alexander,⁷ include acute spinal trauma, post-laminectomy kyphosis, kyphotic deformity with intact posterior tension band, multilevel spondylosis and OPLL, and preexisting risk factors for pseudarthrosis. Clearly, the severity of each varies, and the pathologies are not mutually exclusive. We emphasize that these indications provide only a guideline for performing CAPDF, and patients must be selected on a case-by-case basis. All the patients in our study were symptomatic and exhibited significant compression of the spinal cord anteriorly and posteriorly at multiple levels. Several presented with concomitant pathologies, such as cervical kyphotic deformity, congenital spinal stenosis, and OPLL. In each case, the indication for surgical intervention was undoubted. We sought both to improve the patient’s baseline symptoms and to prevent further damage to the spinal cord.

This study had its limitations. First, its retrospective design predisposed it to a higher degree of bias. Second, because CAPDF is not commonly performed, the sample size was relatively small. Third, although it provided a descriptive analysis of CAPDF for CSM, the study did not use a direct comparison group to establish whether treatment within a single day or staged treatment was more beneficial for our cohort in particular. On the basis of prior experience and observation, we think performing the operation within a single day is much more beneficial for the patient. Our discussion of studies that have compared same-day and staged surgery supports this observation. Therefore, staged treatment was not recommended to our patients.

Conclusion

Few descriptive studies have explored CAPDF for CSM. Our study’s results showed the procedure was associated with minor complications and provided symptomatic relief for a majority of patients as early as 3 months after surgery. In addition, CAPDF can be successfully performed sequentially within a single day. As such, it represents an excellent option for treating multilevel symptomatic CSM cases that require more extensive spinal decompression and more stability.

Am J Orthop. 2017;46(2):E97-E104. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Surgical intervention for cervical spondylosis and radiculopathy classically involves either an anterior or posterior approach for adequate decompression of the spinal cord and associated nerve roots.
• Combined anterior-posterior surgery for cervical spondylotic myelopathy is a relatively new technique that has previously been used for disorders of the thoracolumbar spine.
• Combined anterior-posterior cervical decompression and fusion for the treatment of cervical spondylotic myelopathy is associated with minor complications and excellent neurologic outcomes.
• Combined surgery can either be performed in a single day or in a staged manner, with current literature showing that same-day surgery is superior with respect to estimated blood loss and length of stay.

Cervical spondylotic myelopathy (CSM) is a degenerative disease characterized by progressive compression of the spinal cord. CSM has been found to be the most common cause of spinal impairment as well as the most frequently acquired cause of spinal dysfunction in people over 55 years of age.^1,2 If left untreated, this condition can reduce manual dexterity and cause gait disturbances, dysesthesias, and weakness in the extremities. When conservative treatments fail, surgical intervention often becomes the preferred course of action for CSM and/or myeloradiculopathy.

The surgical approach for CSM and other advanced cervical spine (CS) deformities varies and is often a source of debate. Being a relatively safe and effective procedure, anterior decompression with fusion is optimal in treating discogenic lesions causing myelopathy but is less effective in multilevel disease.^3,4 When pseudarthrosis, adjacent segment degeneration (ASD), and hardware failure are of concern, posterior decompressive laminectomy with instrumentation is a promising option.⁵ However, this method is less effective in restoring lordosis and can increase the risk for later clinical deterioration.⁶ There is a select subset of patients for whom a combined anterior-posterior approach is ideal.^7-9In cases in which a combined anterior-posterior approach is identified as the best treatment option, whether to perform the operation in a sequential or staged manner must be decided, and this question is another source of debate. Single-day surgery is sometimes anecdotally criticized as posing a greater risk to the patient. On the other hand, some comparative studies have shown no statistically significant difference in major complication rates between the 2 options.^10,11 More descriptive studies of combined anterior-posterior decompression and fusion (CAPDF) are needed to explore the efficacy of the procedure. In this article, we describe a study we conducted to characterize the operative data, perioperative complications, and short-term outcomes associated with CAPDF for the treatment of CSM in a select group of patients.

Methods

After receiving Institutional Review Board approval for this study (formal consent was not required), we retrospectively reviewed the charts of 21 patients who underwent CAPDF for CSM at our institution. All patients underwent surgery between February 2010 and March 2015. Criteria for inclusion in the study included same-day CAPDF for CSM. Staged procedures were excluded, as were combined procedures for the treatment of other diseases (eg, malignancies). All patients were operated on by the same primary surgeon (Dr. Davis) and co-surgeon (Dr. Labiak). The 1 patient who was lost to follow-up was excluded from the postoperative outcome analysis.

We reviewed the patients’ medical records for surgical consultations, operative reports, intraoperative reports, progress notes, and postoperative office visit reports. Demographic information included age, sex, body mass index, and preoperative risk factors, such as diabetes and tobacco use. All patients had been diagnosed with myelopathy. Clinical data included previous history of CS surgery, levels fused (and number of levels fused) anteriorly and posteriorly, operative time, estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Short-term (3-month follow-up) neurologic improvement was determined both objectively, with the Nurick grading system,¹² and subjectively, with determination of patient quality of life before and after surgery and with neurologic examination.

Operative Technique: Anterior Approach

All operations were performed with continuous somatosensory evoked potential monitoring of both upper and lower extremities. Each patient, positioned supine with the head in a neutral position, underwent standard endotracheal intubation. Intubation was followed by a transverse incision and dissection down to the deep cervical fascia with maintenance of the carotid sheath laterally and tracheoesophageal complex medially. Interspaces were identified and later were confirmed with lateral radiographs. Discectomy, osteophytectomy, and removal of hypertrophied or calcified ligament were then performed until decompression was satisfactory. Corpectomies were not performed. Polyetheretherketone interbody spacers (Stryker) were used with autograft harvested from vertebral body resection. Low-profile screw-plate systems were placed. After completion of the anterior procedure, the patient was placed prone, with the head fixed in a Mayfield clamping device in neutral position and with all pressure points carefully padded.

Operative Technique: Posterior Approach

A midline incision was made through the skin and subcutaneous tissue to the level of the deep cervical fascia. Then, dissection was performed to the tips of the lateral masses. Instrumentation and fusion preceded spinal decompression. This order, chosen to preserve bony landmarks for guidance during instrumentation, did not interfere with subsequent decompression. Segmental spinal instrumentation was placed using lateral mass screw-rod fixation. After the laminae and ligamenta flava were bilaterally mobilized, the entire bony ligamentous complex spanning the area of fusion was removed en masse (most commonly C3–C7) in order to decrease the number of instrument passes near the spinal cord. Next, a modest foraminotomy was performed to extend the opening laterally and ensure adequate decompression of the nerve roots. Autograft harvested from the spinous processes and laminae was used. The posterior portion of the operation contributed significantly to blood loss and postoperative pain during the perioperative period. We recommend performing a very meticulous dissection to minimize these consequences. No patient in this study required a halo orthosis.

Results

Twenty-one patients with CSM were treated with CAPDF between February 2010 and March 2015 (Table 1).

Table 2 summarizes the operative data. Mean number of levels fused was 2 (range, 1-3) anteriorly and 3 (range, 1-4) posteriorly.

Representative Case

Patient 15, a 53-year-old man, presented with complaints of dysesthesias of the hands. Focused neurologic evaluation at the time revealed limited CS range of motion on extension. The patient (Figures 2A-2D) was diffusely hyperreflexic and had pathologic spread in the upper extremities.

Discussion

Cervical myelopathy is a common yet frequently underdiagnosed disease, owing to the fact that many patients remain asymptomatic even after experiencing degenerative changes in the spinal column.^14-16 The additive effects of spondylosis, osteophyte formation, ligamentous hypertrophy, and listhesis lead to progressive canal and intervertebral foraminal compromise, ultimately producing the clinical syndromes of myelopathy and radiculopathy.¹⁷ The characteristic symptoms of CSM are known to have an insidious onset. In the early stages, patients note a subtle gait disturbance and later experience manual dexterity reductions and upper extremity dysesthesias.¹⁸ As the condition progresses and conservative management fails, surgical intervention is sought.

Nevertheless, the pursuit of surgical treatment for CSM remains somewhat controversial. Some authors have found no statistically significant difference between conservative and surgical management of mild to moderate CSM,¹⁹ whereas others have found that surgically treated patients had much better outcomes than their medically treated counterparts.²⁰ In 2010, Scardino and colleagues²¹ reported that CSM patients who were bedridden and/or wheelchair-bound with seemingly irreversible myelopathy were capable of neurologic improvement after surgical intervention. At the very least, what remains clear is that untreated CSM is known to follow an unpredictable course, with the condition deteriorating faster for some patients than others.²²Traditional anterior or posterior approaches, which can be used in the majority of cases of cervical spondylosis and/or radiculopathy, have been compared extensively.^23,24 The inverse relationship concerning the integrity of an anterior construct and the number of levels fused is a well-established clinical finding.^3,4,8,25-28 Laminectomy with fusion is not without its disadvantages: Cervical instability secondary to mechanical loss of posterior cervical support, and subsequent post-laminectomy kyphosis, is a common complication.²³ In cases in which more stability is required, the combined anterior-posterior approach is more promising than either approach alone. This technique has its roots in the treatment of several thoracolumbar spine disorders, including infections, scoliosis, trauma, and tumors.^29-31 More recently, the technique has been applied to CS disorders.

In 2008, Gok and colleagues³² retrospectively compared the results of anterior-only fusion and CAPDF for CSM. Forty-six patients underwent anterior surgery only, and 21 underwent CAPDF. The groups’ complication rates were similar: 28.6% (anterior only) and 24% (CAPDF); the incidence of ASD was lower in the combined group. Song and colleagues³³ conducted a similar study in 2010. They compared anterior fusion alone and CAPDF in treating degenerative cervical kyphosis. Results were strongly in favor of the combined technique, as it led to “greater correction of sagittal alignment, a better maintenance of correction angle, a higher rate of fusion, a lower rate of subsidence and lower complications.” Both studies established that, in a select group of patients, the benefits of CAPDF outweighed the risks. These findings, combined with our study’s findings of no major complications and the transience of minor complications, suggest CAPDF should not be considered too invasive or risky.

The results of our study also mirror those of 3 other studies on the use of CAPDF for CS disorders. In 1995, McAfee and colleagues³⁴ reported on a group of 100 patients with follow-up of 2 years or more. In most cases, the surgical indication was trauma, but neoplasm, infection, rheumatoid arthritis, and CSM were found as well. Outcomes were very favorable: improvement in a previous neurologic deficit (57/75 patients), ability to walk again (21/35 patients), no new neurologic deficits, and no hardware failures. In 2000, Schultz and colleagues³⁵ retrospectively reviewed the cases of 72 patients who underwent CAPDF for a variety of complex CS disorders. Two of the 72 experienced transient neurologic deficits, and, though the immediate complication rate was relatively high (32%), the long-term complication rate was down to 5%. In 2009, Konya and colleagues³⁶ retrospectively reviewed the cases of 40 patients who underwent CAPDF, primarily for CSM. Within 1 week after surgery, neurologic deficits were reduced in 36 patients; by 1 year after surgery, neurologic deficits were reduced in all 40 patients, and fusion was achieved in 39. These 3 studies^34-36 helped establish CAPDF of the CS as a viable and effective procedure that can be performed within a single day.

Although many physicians have achieved favorable results with single-day surgery, the decision to operate in a sequential or staged manner remains controversial. Some anecdotally claim CAPDF poses a greater operative risk to the patient. In 1991, the continuous procedure was found to involve less blood loss and shorter LOS while providing for better correction of severe spinal deformity in patients with scoliosis and rigid kyphosis.³⁷ Three more recent comparative studies examining the same issue in the treatment of CS diseases found staging did not reduce the complication rate and may in fact have been associated with higher complication rates, more blood loss, and longer total operative time and LOS.^10,11,38 Our study’s lower blood loss, shorter LOS, and lower major complication rate relative to the combined groups in all 3 of those studies are most likely attributable to our operating on a lower mean number of spinal levels and our restricting the surgical indication to CSM. The positive short-term outcomes and low rate of long-term complications in our study, combined with the data from these 3 comparative studies, suggest that same-day surgery is superior to staged surgery. A staged operation should be considered only if the patient cannot tolerate long periods under general anesthesia.

Many have advocated extending fusion down to T1 to prevent ASD at the C7–T1 disk space.^35,39,40 We decided against this approach for 2 reasons. First, at C7, lateral mass screws were always chosen over pedicle screws. When possible, shorter lateral mass screws were used at this level, making C7 much less rigid. Second, the C7–T1 facet capsule was maintained to preserve joint integrity. We suggest extending fusion down to T1 only if there is prior evidence of spinal disease and/or listhesis at C7–T1. Although long-term (many-year) follow-up is often desired, we specifically assessed short-term (3-month) outcomes. We have anecdotally found that degree of improvement often follows a predictable course after 3-month follow-up. If myelopathy resolves even to a small extent during the first 3 postoperative months, later improvement will likely follow an upward course. Conversely, if myelopathy does not improve during the first 3 months, further improvement is much less likely.

This trend in neurologic improvement likely is directly related to degree of myelopathy before surgery. Patients with CSM generally experience symptoms over an extended period and try conservative management before any surgical consultation. Although spinal ischemia is often resolved by decompression, permanent ischemic damage to the cord is not uncommon. In this setting, postoperative neurologic improvement is minimal or even nonexistent, and decompression is preventive rather than curative. In our study, 1 patient had no subjective improvement after surgery. At 3-month follow-up, magnetic resonance imaging showed notable myelomalacia without residual spinal cord compression. We attribute the failure of the ischemic changes to resolve to long-standing preoperative damage to the cord. Nevertheless, surgery stabilized the myelopathy and prevented further ischemic damage and clinical deterioration.

As is the case with any operation, patients must be carefully selected for CAPDF. Indications for CAPDF, as described by Kim and Alexander,⁷ include acute spinal trauma, post-laminectomy kyphosis, kyphotic deformity with intact posterior tension band, multilevel spondylosis and OPLL, and preexisting risk factors for pseudarthrosis. Clearly, the severity of each varies, and the pathologies are not mutually exclusive. We emphasize that these indications provide only a guideline for performing CAPDF, and patients must be selected on a case-by-case basis. All the patients in our study were symptomatic and exhibited significant compression of the spinal cord anteriorly and posteriorly at multiple levels. Several presented with concomitant pathologies, such as cervical kyphotic deformity, congenital spinal stenosis, and OPLL. In each case, the indication for surgical intervention was undoubted. We sought both to improve the patient’s baseline symptoms and to prevent further damage to the spinal cord.

This study had its limitations. First, its retrospective design predisposed it to a higher degree of bias. Second, because CAPDF is not commonly performed, the sample size was relatively small. Third, although it provided a descriptive analysis of CAPDF for CSM, the study did not use a direct comparison group to establish whether treatment within a single day or staged treatment was more beneficial for our cohort in particular. On the basis of prior experience and observation, we think performing the operation within a single day is much more beneficial for the patient. Our discussion of studies that have compared same-day and staged surgery supports this observation. Therefore, staged treatment was not recommended to our patients.

Conclusion

Few descriptive studies have explored CAPDF for CSM. Our study’s results showed the procedure was associated with minor complications and provided symptomatic relief for a majority of patients as early as 3 months after surgery. In addition, CAPDF can be successfully performed sequentially within a single day. As such, it represents an excellent option for treating multilevel symptomatic CSM cases that require more extensive spinal decompression and more stability.

Am J Orthop. 2017;46(2):E97-E104. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

AT 2017 AAAAI ANNUAL MEETING

ATLANTA – Long-term walnut oral immunotherapy induces clinically relevant treatment response in children with tree nut allergy, results from a small ongoing study showed.

“Tree nut allergy is a generally life-long and potentially life-threatening disorder without an active therapy,” study author Amy M. Scurlock, MD, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “Significant clinical, immunologic, and serologic cross reactivity has been described among tree nut families. Multi–tree nut allergen sensitization is common with 46% reporting allergy to more than one tree nut.”

[email protected]

AT 2017 AAAAI ANNUAL MEETING

ATLANTA – Long-term walnut oral immunotherapy induces clinically relevant treatment response in children with tree nut allergy, results from a small ongoing study showed.

“Tree nut allergy is a generally life-long and potentially life-threatening disorder without an active therapy,” study author Amy M. Scurlock, MD, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “Significant clinical, immunologic, and serologic cross reactivity has been described among tree nut families. Multi–tree nut allergen sensitization is common with 46% reporting allergy to more than one tree nut.”

[email protected]

AT 2017 AAAAI ANNUAL MEETING

ATLANTA – Long-term walnut oral immunotherapy induces clinically relevant treatment response in children with tree nut allergy, results from a small ongoing study showed.

“Tree nut allergy is a generally life-long and potentially life-threatening disorder without an active therapy,” study author Amy M. Scurlock, MD, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “Significant clinical, immunologic, and serologic cross reactivity has been described among tree nut families. Multi–tree nut allergen sensitization is common with 46% reporting allergy to more than one tree nut.”

[email protected]

ORLANDO – Azacitadine and valproic acid can be safely coadministered as maintenance therapy after allogeneic stem cell transplantation in patients with high-risk acute myelogenous leukemia (AML), according to interim findings from an investigator-initiated phase II study.

One-year relapse-free and overall survival rates were about 80%, and no significant toxicities were reported in 28 such patients who began the treatment at least 40 days after transplant and were treated for 4 months, Patrick A. Hagen, MD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.

The Armed Forces Institute of Pathology/Public Domain

[email protected]

ORLANDO – Azacitadine and valproic acid can be safely coadministered as maintenance therapy after allogeneic stem cell transplantation in patients with high-risk acute myelogenous leukemia (AML), according to interim findings from an investigator-initiated phase II study.

One-year relapse-free and overall survival rates were about 80%, and no significant toxicities were reported in 28 such patients who began the treatment at least 40 days after transplant and were treated for 4 months, Patrick A. Hagen, MD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.

The Armed Forces Institute of Pathology/Public Domain

[email protected]

ORLANDO – Azacitadine and valproic acid can be safely coadministered as maintenance therapy after allogeneic stem cell transplantation in patients with high-risk acute myelogenous leukemia (AML), according to interim findings from an investigator-initiated phase II study.

One-year relapse-free and overall survival rates were about 80%, and no significant toxicities were reported in 28 such patients who began the treatment at least 40 days after transplant and were treated for 4 months, Patrick A. Hagen, MD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.

The Armed Forces Institute of Pathology/Public Domain

[email protected]

About 1 in 4 American adults who say they have good or excellent hearing has hearing damage. According to a Vital Signs report, much of the damage is due to everyday loud sounds, such as leaf blowers, concerts, even portable devices. The rumble of a washing machine approaches the 85 decibels at which extended exposure can cause hearing damage. Sixty seconds of listening to a nearby siren (120 dB) also can cause hearing damage.

CDC researchers analyzed > 3,500 hearing tests conducted on adult participants in the 2012 National Health and Nutrition Examination Survey. Of those participants, 20% who reported no job-related noise exposure nonetheless had hearing damage in a pattern usually caused by noise.

People may delay reporting hearing loss because they don’t know or won’t admit they have a problem, the CDC says. Only 46% of adults who reported having trouble hearing saw a health care provider (HCP) for their hearing in the past 5 years. But chronic noise exposure has been associated with worsening heart disease, increased blood pressure, and other adverse health effects.

The CDC suggests HCPs ask patients (even those as young as 20) about their hearing. For instance, they can ask, “Do you find it difficult to follow a conversation if there is background noise?” and “Can you usually hear and understand what someone says in a normal tone of voice when you can’t see that person’s face?”

At routine health care visits, the CDC suggests HCPs explain to patients how noise exposure can permanently damage hearing. They also suggest recommending earplugs or noise-canceling headphones. About 70% of people exposed to loud noise never or seldom wear hearing protection, CDC says.  The CDC suggests advising patients to turn down the volume when watching TV, listening to music, and using earbuds or headphones, as well as asking whether patients are taking medicines that increase the risk of hearing damage. If patients show or report hearing problems, the CDC suggests HCPs examine their hearing or refer them to a hearing specialist.

About 1 in 4 American adults who say they have good or excellent hearing has hearing damage. According to a Vital Signs report, much of the damage is due to everyday loud sounds, such as leaf blowers, concerts, even portable devices. The rumble of a washing machine approaches the 85 decibels at which extended exposure can cause hearing damage. Sixty seconds of listening to a nearby siren (120 dB) also can cause hearing damage.

CDC researchers analyzed > 3,500 hearing tests conducted on adult participants in the 2012 National Health and Nutrition Examination Survey. Of those participants, 20% who reported no job-related noise exposure nonetheless had hearing damage in a pattern usually caused by noise.

People may delay reporting hearing loss because they don’t know or won’t admit they have a problem, the CDC says. Only 46% of adults who reported having trouble hearing saw a health care provider (HCP) for their hearing in the past 5 years. But chronic noise exposure has been associated with worsening heart disease, increased blood pressure, and other adverse health effects.

The CDC suggests HCPs ask patients (even those as young as 20) about their hearing. For instance, they can ask, “Do you find it difficult to follow a conversation if there is background noise?” and “Can you usually hear and understand what someone says in a normal tone of voice when you can’t see that person’s face?”

At routine health care visits, the CDC suggests HCPs explain to patients how noise exposure can permanently damage hearing. They also suggest recommending earplugs or noise-canceling headphones. About 70% of people exposed to loud noise never or seldom wear hearing protection, CDC says.  The CDC suggests advising patients to turn down the volume when watching TV, listening to music, and using earbuds or headphones, as well as asking whether patients are taking medicines that increase the risk of hearing damage. If patients show or report hearing problems, the CDC suggests HCPs examine their hearing or refer them to a hearing specialist.

About 1 in 4 American adults who say they have good or excellent hearing has hearing damage. According to a Vital Signs report, much of the damage is due to everyday loud sounds, such as leaf blowers, concerts, even portable devices. The rumble of a washing machine approaches the 85 decibels at which extended exposure can cause hearing damage. Sixty seconds of listening to a nearby siren (120 dB) also can cause hearing damage.

CDC researchers analyzed > 3,500 hearing tests conducted on adult participants in the 2012 National Health and Nutrition Examination Survey. Of those participants, 20% who reported no job-related noise exposure nonetheless had hearing damage in a pattern usually caused by noise.

People may delay reporting hearing loss because they don’t know or won’t admit they have a problem, the CDC says. Only 46% of adults who reported having trouble hearing saw a health care provider (HCP) for their hearing in the past 5 years. But chronic noise exposure has been associated with worsening heart disease, increased blood pressure, and other adverse health effects.

The CDC suggests HCPs ask patients (even those as young as 20) about their hearing. For instance, they can ask, “Do you find it difficult to follow a conversation if there is background noise?” and “Can you usually hear and understand what someone says in a normal tone of voice when you can’t see that person’s face?”

At routine health care visits, the CDC suggests HCPs explain to patients how noise exposure can permanently damage hearing. They also suggest recommending earplugs or noise-canceling headphones. About 70% of people exposed to loud noise never or seldom wear hearing protection, CDC says.  The CDC suggests advising patients to turn down the volume when watching TV, listening to music, and using earbuds or headphones, as well as asking whether patients are taking medicines that increase the risk of hearing damage. If patients show or report hearing problems, the CDC suggests HCPs examine their hearing or refer them to a hearing specialist.

Photo courtesy of Biogen

Interim results from the B-YOND trial suggest prophylactic treatment with a recombinant factor IX Fc fusion protein (rFIXFc) can provide long-term safety and efficacy, according to researchers.

B-YOND is an extension study for adults and adolescents who completed the B-LONG study and children who completed the Kids B-LONG study.

In both trials, researchers tested rFIXFc in patients with hemophilia B.

The median duration of rFIXFc treatment has surpassed 3 years for the adults and adolescents enrolled in B-YOND and exceeded 1.5 years for children in this trial.

Researchers said the median annualized bleeding rates (ABRs) have been low in these patients, and none of the patients have developed inhibitors.

“The interim data from B-YOND confirm the safety profile of [rFIXFc] and show that adult, adolescent, and pediatric subjects maintained low annual bleed rates with prophylactic dosing of [rFIXFc] every 1 to 2 weeks,” said principal investigator John Pasi, MD, PhD, of Barts and the London School of Medicine and Dentistry in London, UK.

“These results come from the longest-term study of an extended half-life therapy for hemophilia B and provide physicians across the globe with important insights and information about the treatment of hemophilia B.”

The results were published in Thrombosis and Haemostasis.

The research was sponsored by Bioverativ Therapeutics Inc., the company developing rFIXFc (also known as eftrenonacog alfa and by the brand name Alprolix) in collaboration with Sobi. rFIXFc is approved to treat hemophilia B in the US, European Union, and other countries.

Treatment

B-YOND has enrolled 116 patients with hemophilia B who completed B-LONG (n=93) or Kids B-LONG (n=23). The patients were placed in 1 of 4 treatment groups (but could change at any point):

• Weekly prophylaxis—20 to 100 IU/kg every 7 days (50 adults/adolescents, 19 children)
• Individualized prophylaxis—100 IU/kg every 8 to 16 days (30 adults/adolescents, 5 children)
• Modified prophylaxis, which was defined as further dosing personalization to optimize prophylaxis (13 adults/adolescents, 1 child)
• Episodic treatment, which was available only to adults and adolescents (n=15).

In the weekly prophylaxis group, the median dosing interval was 7.0 days for adults, adolescents, and children. The average weekly prophylactic dose was 49.5 IU/kg in adults/adolescents, 64.4 IU/kg in kids younger than 6, and 63.1 IU/kg in kids ages 6 to 11.

In the individualized prophylaxis group, the median dosing interval was 13.7 days for adults and adolescents and 10.0 days in pediatric patients (ages 6 to 11 only). The average weekly prophylactic dose was 50.2 IU/kg in adults/adolescents, and 66.6 IU/kg in kids ages 6 to 11.

In the modified prophylaxis group, the median dosing interval was 6.9 days for adults and adolescents and 4.1 days in the single pediatric patient (who was older than 6). The average weekly prophylactic dose was 61.7 IU/kg in adults/adolescents and 157.9 IU/kg in the pediatric patient.

From the start of B-LONG to the B-YOND interim data cut, adults/adolescents had a median of 39.5 months of cumulative rFIXFc treatment and a median of 162 cumulative exposure days.

From the start of Kids B-LONG to the data cut, pediatric patients had a median of 21.9 months of cumulative rFIXFc treatment and a median of 94 cumulative exposure days.

ABRs

As of the interim data cut, the overall median ABR was 2.3 for adults/adolescents in both the weekly and individualized prophylaxis groups.

The median ABR was 2.4 for adults/adolescents in the modified prophylaxis group and 11.3 for those receiving on-demand treatment.

Among children under age 6 (n=9), the median ABR in the weekly prophylaxis group was 0. (None of the younger children had individualized or modified prophylaxis.)

For children ages 6 to 11, the median ABR was 2.7 in the weekly prophylaxis group (n=10) and 2.4 in the individualized prophylaxis group (n=5). The patient in the modified prophylaxis group had an ABR of 3.1.

Safety

The researchers said rFIXFc was well-tolerated, and the adverse events (AEs) reported were typical of the population studied.

AEs were reported in 75.9% of patients. The most common were headache (n=14, 12.1%) and common cold (n=13, 11.2%), and the majority of AEs were considered unrelated to rFIXFc.

Three adult/adolescent patients experienced AEs during B-YOND that were considered treatment-related, including noncardiac chest pain, hematuria, and obstructive uropathy. All 3 events resolved.

One patient experienced breath odor during B-LONG that was considered treatment-related. And 1 patient reported decreased appetite during Kids B-LONG that was considered treatment-related. Neither of these events resolved.

There were 39 serious AEs in 23 patients (19.8%). All but 1 of these events were considered unrelated to rFIXFc.

The treatment-related serious AE was renal colic in a patient originally enrolled in the B-LONG study. The patient had a medical history of previous clot colic. The event resolved and did not lead to study discontinuation.

There have been no reports of serious allergic reactions or anaphylaxis associated with rFIXFc, no vascular thrombotic events, and no deaths.

Photo courtesy of Biogen

Interim results from the B-YOND trial suggest prophylactic treatment with a recombinant factor IX Fc fusion protein (rFIXFc) can provide long-term safety and efficacy, according to researchers.

B-YOND is an extension study for adults and adolescents who completed the B-LONG study and children who completed the Kids B-LONG study.

In both trials, researchers tested rFIXFc in patients with hemophilia B.

The median duration of rFIXFc treatment has surpassed 3 years for the adults and adolescents enrolled in B-YOND and exceeded 1.5 years for children in this trial.

Researchers said the median annualized bleeding rates (ABRs) have been low in these patients, and none of the patients have developed inhibitors.

“The interim data from B-YOND confirm the safety profile of [rFIXFc] and show that adult, adolescent, and pediatric subjects maintained low annual bleed rates with prophylactic dosing of [rFIXFc] every 1 to 2 weeks,” said principal investigator John Pasi, MD, PhD, of Barts and the London School of Medicine and Dentistry in London, UK.

“These results come from the longest-term study of an extended half-life therapy for hemophilia B and provide physicians across the globe with important insights and information about the treatment of hemophilia B.”

The results were published in Thrombosis and Haemostasis.

The research was sponsored by Bioverativ Therapeutics Inc., the company developing rFIXFc (also known as eftrenonacog alfa and by the brand name Alprolix) in collaboration with Sobi. rFIXFc is approved to treat hemophilia B in the US, European Union, and other countries.

Treatment

B-YOND has enrolled 116 patients with hemophilia B who completed B-LONG (n=93) or Kids B-LONG (n=23). The patients were placed in 1 of 4 treatment groups (but could change at any point):

• Weekly prophylaxis—20 to 100 IU/kg every 7 days (50 adults/adolescents, 19 children)
• Individualized prophylaxis—100 IU/kg every 8 to 16 days (30 adults/adolescents, 5 children)
• Modified prophylaxis, which was defined as further dosing personalization to optimize prophylaxis (13 adults/adolescents, 1 child)
• Episodic treatment, which was available only to adults and adolescents (n=15).

In the weekly prophylaxis group, the median dosing interval was 7.0 days for adults, adolescents, and children. The average weekly prophylactic dose was 49.5 IU/kg in adults/adolescents, 64.4 IU/kg in kids younger than 6, and 63.1 IU/kg in kids ages 6 to 11.

In the individualized prophylaxis group, the median dosing interval was 13.7 days for adults and adolescents and 10.0 days in pediatric patients (ages 6 to 11 only). The average weekly prophylactic dose was 50.2 IU/kg in adults/adolescents, and 66.6 IU/kg in kids ages 6 to 11.

In the modified prophylaxis group, the median dosing interval was 6.9 days for adults and adolescents and 4.1 days in the single pediatric patient (who was older than 6). The average weekly prophylactic dose was 61.7 IU/kg in adults/adolescents and 157.9 IU/kg in the pediatric patient.

From the start of B-LONG to the B-YOND interim data cut, adults/adolescents had a median of 39.5 months of cumulative rFIXFc treatment and a median of 162 cumulative exposure days.

From the start of Kids B-LONG to the data cut, pediatric patients had a median of 21.9 months of cumulative rFIXFc treatment and a median of 94 cumulative exposure days.

ABRs

As of the interim data cut, the overall median ABR was 2.3 for adults/adolescents in both the weekly and individualized prophylaxis groups.

The median ABR was 2.4 for adults/adolescents in the modified prophylaxis group and 11.3 for those receiving on-demand treatment.

Among children under age 6 (n=9), the median ABR in the weekly prophylaxis group was 0. (None of the younger children had individualized or modified prophylaxis.)

For children ages 6 to 11, the median ABR was 2.7 in the weekly prophylaxis group (n=10) and 2.4 in the individualized prophylaxis group (n=5). The patient in the modified prophylaxis group had an ABR of 3.1.

Safety

The researchers said rFIXFc was well-tolerated, and the adverse events (AEs) reported were typical of the population studied.

AEs were reported in 75.9% of patients. The most common were headache (n=14, 12.1%) and common cold (n=13, 11.2%), and the majority of AEs were considered unrelated to rFIXFc.

Three adult/adolescent patients experienced AEs during B-YOND that were considered treatment-related, including noncardiac chest pain, hematuria, and obstructive uropathy. All 3 events resolved.

One patient experienced breath odor during B-LONG that was considered treatment-related. And 1 patient reported decreased appetite during Kids B-LONG that was considered treatment-related. Neither of these events resolved.

There were 39 serious AEs in 23 patients (19.8%). All but 1 of these events were considered unrelated to rFIXFc.

The treatment-related serious AE was renal colic in a patient originally enrolled in the B-LONG study. The patient had a medical history of previous clot colic. The event resolved and did not lead to study discontinuation.

There have been no reports of serious allergic reactions or anaphylaxis associated with rFIXFc, no vascular thrombotic events, and no deaths.

Photo courtesy of Biogen

Interim results from the B-YOND trial suggest prophylactic treatment with a recombinant factor IX Fc fusion protein (rFIXFc) can provide long-term safety and efficacy, according to researchers.

B-YOND is an extension study for adults and adolescents who completed the B-LONG study and children who completed the Kids B-LONG study.

In both trials, researchers tested rFIXFc in patients with hemophilia B.

The median duration of rFIXFc treatment has surpassed 3 years for the adults and adolescents enrolled in B-YOND and exceeded 1.5 years for children in this trial.

Researchers said the median annualized bleeding rates (ABRs) have been low in these patients, and none of the patients have developed inhibitors.

“The interim data from B-YOND confirm the safety profile of [rFIXFc] and show that adult, adolescent, and pediatric subjects maintained low annual bleed rates with prophylactic dosing of [rFIXFc] every 1 to 2 weeks,” said principal investigator John Pasi, MD, PhD, of Barts and the London School of Medicine and Dentistry in London, UK.

“These results come from the longest-term study of an extended half-life therapy for hemophilia B and provide physicians across the globe with important insights and information about the treatment of hemophilia B.”

The results were published in Thrombosis and Haemostasis.

The research was sponsored by Bioverativ Therapeutics Inc., the company developing rFIXFc (also known as eftrenonacog alfa and by the brand name Alprolix) in collaboration with Sobi. rFIXFc is approved to treat hemophilia B in the US, European Union, and other countries.

Treatment

B-YOND has enrolled 116 patients with hemophilia B who completed B-LONG (n=93) or Kids B-LONG (n=23). The patients were placed in 1 of 4 treatment groups (but could change at any point):

• Weekly prophylaxis—20 to 100 IU/kg every 7 days (50 adults/adolescents, 19 children)
• Individualized prophylaxis—100 IU/kg every 8 to 16 days (30 adults/adolescents, 5 children)
• Modified prophylaxis, which was defined as further dosing personalization to optimize prophylaxis (13 adults/adolescents, 1 child)
• Episodic treatment, which was available only to adults and adolescents (n=15).

In the weekly prophylaxis group, the median dosing interval was 7.0 days for adults, adolescents, and children. The average weekly prophylactic dose was 49.5 IU/kg in adults/adolescents, 64.4 IU/kg in kids younger than 6, and 63.1 IU/kg in kids ages 6 to 11.

In the individualized prophylaxis group, the median dosing interval was 13.7 days for adults and adolescents and 10.0 days in pediatric patients (ages 6 to 11 only). The average weekly prophylactic dose was 50.2 IU/kg in adults/adolescents, and 66.6 IU/kg in kids ages 6 to 11.

In the modified prophylaxis group, the median dosing interval was 6.9 days for adults and adolescents and 4.1 days in the single pediatric patient (who was older than 6). The average weekly prophylactic dose was 61.7 IU/kg in adults/adolescents and 157.9 IU/kg in the pediatric patient.

From the start of B-LONG to the B-YOND interim data cut, adults/adolescents had a median of 39.5 months of cumulative rFIXFc treatment and a median of 162 cumulative exposure days.

From the start of Kids B-LONG to the data cut, pediatric patients had a median of 21.9 months of cumulative rFIXFc treatment and a median of 94 cumulative exposure days.

ABRs

As of the interim data cut, the overall median ABR was 2.3 for adults/adolescents in both the weekly and individualized prophylaxis groups.

The median ABR was 2.4 for adults/adolescents in the modified prophylaxis group and 11.3 for those receiving on-demand treatment.

Among children under age 6 (n=9), the median ABR in the weekly prophylaxis group was 0. (None of the younger children had individualized or modified prophylaxis.)

For children ages 6 to 11, the median ABR was 2.7 in the weekly prophylaxis group (n=10) and 2.4 in the individualized prophylaxis group (n=5). The patient in the modified prophylaxis group had an ABR of 3.1.

Safety

The researchers said rFIXFc was well-tolerated, and the adverse events (AEs) reported were typical of the population studied.

AEs were reported in 75.9% of patients. The most common were headache (n=14, 12.1%) and common cold (n=13, 11.2%), and the majority of AEs were considered unrelated to rFIXFc.

Three adult/adolescent patients experienced AEs during B-YOND that were considered treatment-related, including noncardiac chest pain, hematuria, and obstructive uropathy. All 3 events resolved.

One patient experienced breath odor during B-LONG that was considered treatment-related. And 1 patient reported decreased appetite during Kids B-LONG that was considered treatment-related. Neither of these events resolved.

There were 39 serious AEs in 23 patients (19.8%). All but 1 of these events were considered unrelated to rFIXFc.

The treatment-related serious AE was renal colic in a patient originally enrolled in the B-LONG study. The patient had a medical history of previous clot colic. The event resolved and did not lead to study discontinuation.

There have been no reports of serious allergic reactions or anaphylaxis associated with rFIXFc, no vascular thrombotic events, and no deaths.