U.S. military veterans living in rural areas who engage in evidence-based psychotherapy and telemedicine-based collaborative care can significantly increase their chances of improving outcomes related to posttraumatic stress disorder, according to a new study.

“Although psychotherapy and pharmacotherapy treatments for PTSD have proven to be efficacious in randomized clinical trials and have been disseminated widely by the [Veterans Health Administration], stigma and geographic barriers often prevent rural veterans from engaging in these evidence-based treatments,” says the study, published in JAMA (2014 Nov. 19 [doi.101001/jamapsychiatry.2014.1575]) and led by John C. Fortney, Ph.D., of the University of Washington’s department of psychiatry and behavioral sciences in Seattle, and his associates.

In a pragmatic, randomized effectiveness trial, Dr. Fortney and his associates recruited outpatients from 11 Department of Veterans Affairs (VA) community-based outpatient clinics (CBOCs) in predominantly rural areas of the United States over the course of 22 months. A total of 265 patients completed baseline interviews and randomization after meeting eligibility criteria, which consisted of meeting diagnostic standards for PTSD; having no medical history of schizophrenia, bipolar disorder, substance dependence, or hearing impairment; having a telephone; not having a life-threatening illness; and lacking capacity to consent.

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The 265 subjects were randomized into one of two groups: those receiving usual care (UC), or those receiving the Telemedicine Outreach for PTSD (TOP) treatment developed by the investigators. Patients were mostly unemployed, middle-aged men with severe PTSD symptoms and “other mental health coexisting illnesses,” according to a press release.

Subjects in the UC group received certain health care services, such as psychotropic medications for PTSD prescribed by psychiatrists, evidence-based psychotherapy for PTSD delivered by psychologists or social workers, supportive PTSD-focused therapy delivered by psychologists or social workers (individual and group), and supportive therapy delivered by social workers (individual and group), among others. Subjects in the TOP group, however, received the attention of telephone nurse care managers, including PTSD symptom monitoring and medication regimen adherence monitoring and promotion. In addition, those in the TOP group received access to a telephone pharmacist and telepsychologist.

Subjects were enrolled in a series of 12 cognitive processing therapy sessions for the duration of the study, from Nov. 23, 2009, through Sept. 28, 2011, and attendance was taken at each session. After the sessions concluded, subjects were then followed up on for 12 months.

During that follow-up period after treatments ended, patients who received TOP had significantly larger decreases in Posttraumatic Diagnostic Scale (PDS) scores (from 35.0 to 29.1), compared with those from the UC group (from 33.5 to 32.1) at 6 months (beta = −3.81; P = .002) and 12 months (beta = −2.49; P = .04). At 12 months, TOP subjects also had significantly larger decreases in PDS scores (from 35.0 to 30.1), compared with those who received UC (from 33.5 to 29.1) .

Subjects who attended at least eight cognitive processing therapy sessions were more likely to improve their PDS scores (beta = −3.86 [95% confidence interval, −7.19 to −0.54]; P = .02). However, the authors noted that there were “no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens” was not significant.

“This trial introduces a promising model for managing PTSD in a treatment-resistant population,” Dr. Fortney and his associates wrote. “Findings suggest that telemedicine-based collaborative care can successfully engage this population in evidence-based psychotherapy for PTSD, thereby improving clinical outcomes.”

Among the study limitations cited by the investigators is that the PDS was administered to assess PTSD, rather than the Clinician-Administered PTSD Scale, which is the reference standard.

The authors reported no relevant financial conflicts of interest.

[email protected]

U.S. military veterans living in rural areas who engage in evidence-based psychotherapy and telemedicine-based collaborative care can significantly increase their chances of improving outcomes related to posttraumatic stress disorder, according to a new study.

“Although psychotherapy and pharmacotherapy treatments for PTSD have proven to be efficacious in randomized clinical trials and have been disseminated widely by the [Veterans Health Administration], stigma and geographic barriers often prevent rural veterans from engaging in these evidence-based treatments,” says the study, published in JAMA (2014 Nov. 19 [doi.101001/jamapsychiatry.2014.1575]) and led by John C. Fortney, Ph.D., of the University of Washington’s department of psychiatry and behavioral sciences in Seattle, and his associates.

In a pragmatic, randomized effectiveness trial, Dr. Fortney and his associates recruited outpatients from 11 Department of Veterans Affairs (VA) community-based outpatient clinics (CBOCs) in predominantly rural areas of the United States over the course of 22 months. A total of 265 patients completed baseline interviews and randomization after meeting eligibility criteria, which consisted of meeting diagnostic standards for PTSD; having no medical history of schizophrenia, bipolar disorder, substance dependence, or hearing impairment; having a telephone; not having a life-threatening illness; and lacking capacity to consent.

© Dron - Fotolia.com

The 265 subjects were randomized into one of two groups: those receiving usual care (UC), or those receiving the Telemedicine Outreach for PTSD (TOP) treatment developed by the investigators. Patients were mostly unemployed, middle-aged men with severe PTSD symptoms and “other mental health coexisting illnesses,” according to a press release.

Subjects in the UC group received certain health care services, such as psychotropic medications for PTSD prescribed by psychiatrists, evidence-based psychotherapy for PTSD delivered by psychologists or social workers, supportive PTSD-focused therapy delivered by psychologists or social workers (individual and group), and supportive therapy delivered by social workers (individual and group), among others. Subjects in the TOP group, however, received the attention of telephone nurse care managers, including PTSD symptom monitoring and medication regimen adherence monitoring and promotion. In addition, those in the TOP group received access to a telephone pharmacist and telepsychologist.

Subjects were enrolled in a series of 12 cognitive processing therapy sessions for the duration of the study, from Nov. 23, 2009, through Sept. 28, 2011, and attendance was taken at each session. After the sessions concluded, subjects were then followed up on for 12 months.

During that follow-up period after treatments ended, patients who received TOP had significantly larger decreases in Posttraumatic Diagnostic Scale (PDS) scores (from 35.0 to 29.1), compared with those from the UC group (from 33.5 to 32.1) at 6 months (beta = −3.81; P = .002) and 12 months (beta = −2.49; P = .04). At 12 months, TOP subjects also had significantly larger decreases in PDS scores (from 35.0 to 30.1), compared with those who received UC (from 33.5 to 29.1) .

Subjects who attended at least eight cognitive processing therapy sessions were more likely to improve their PDS scores (beta = −3.86 [95% confidence interval, −7.19 to −0.54]; P = .02). However, the authors noted that there were “no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens” was not significant.

“This trial introduces a promising model for managing PTSD in a treatment-resistant population,” Dr. Fortney and his associates wrote. “Findings suggest that telemedicine-based collaborative care can successfully engage this population in evidence-based psychotherapy for PTSD, thereby improving clinical outcomes.”

Among the study limitations cited by the investigators is that the PDS was administered to assess PTSD, rather than the Clinician-Administered PTSD Scale, which is the reference standard.

The authors reported no relevant financial conflicts of interest.

[email protected]

U.S. military veterans living in rural areas who engage in evidence-based psychotherapy and telemedicine-based collaborative care can significantly increase their chances of improving outcomes related to posttraumatic stress disorder, according to a new study.

“Although psychotherapy and pharmacotherapy treatments for PTSD have proven to be efficacious in randomized clinical trials and have been disseminated widely by the [Veterans Health Administration], stigma and geographic barriers often prevent rural veterans from engaging in these evidence-based treatments,” says the study, published in JAMA (2014 Nov. 19 [doi.101001/jamapsychiatry.2014.1575]) and led by John C. Fortney, Ph.D., of the University of Washington’s department of psychiatry and behavioral sciences in Seattle, and his associates.

In a pragmatic, randomized effectiveness trial, Dr. Fortney and his associates recruited outpatients from 11 Department of Veterans Affairs (VA) community-based outpatient clinics (CBOCs) in predominantly rural areas of the United States over the course of 22 months. A total of 265 patients completed baseline interviews and randomization after meeting eligibility criteria, which consisted of meeting diagnostic standards for PTSD; having no medical history of schizophrenia, bipolar disorder, substance dependence, or hearing impairment; having a telephone; not having a life-threatening illness; and lacking capacity to consent.

© Dron - Fotolia.com

The 265 subjects were randomized into one of two groups: those receiving usual care (UC), or those receiving the Telemedicine Outreach for PTSD (TOP) treatment developed by the investigators. Patients were mostly unemployed, middle-aged men with severe PTSD symptoms and “other mental health coexisting illnesses,” according to a press release.

Subjects in the UC group received certain health care services, such as psychotropic medications for PTSD prescribed by psychiatrists, evidence-based psychotherapy for PTSD delivered by psychologists or social workers, supportive PTSD-focused therapy delivered by psychologists or social workers (individual and group), and supportive therapy delivered by social workers (individual and group), among others. Subjects in the TOP group, however, received the attention of telephone nurse care managers, including PTSD symptom monitoring and medication regimen adherence monitoring and promotion. In addition, those in the TOP group received access to a telephone pharmacist and telepsychologist.

Subjects were enrolled in a series of 12 cognitive processing therapy sessions for the duration of the study, from Nov. 23, 2009, through Sept. 28, 2011, and attendance was taken at each session. After the sessions concluded, subjects were then followed up on for 12 months.

During that follow-up period after treatments ended, patients who received TOP had significantly larger decreases in Posttraumatic Diagnostic Scale (PDS) scores (from 35.0 to 29.1), compared with those from the UC group (from 33.5 to 32.1) at 6 months (beta = −3.81; P = .002) and 12 months (beta = −2.49; P = .04). At 12 months, TOP subjects also had significantly larger decreases in PDS scores (from 35.0 to 30.1), compared with those who received UC (from 33.5 to 29.1) .

Subjects who attended at least eight cognitive processing therapy sessions were more likely to improve their PDS scores (beta = −3.86 [95% confidence interval, −7.19 to −0.54]; P = .02). However, the authors noted that there were “no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens” was not significant.

“This trial introduces a promising model for managing PTSD in a treatment-resistant population,” Dr. Fortney and his associates wrote. “Findings suggest that telemedicine-based collaborative care can successfully engage this population in evidence-based psychotherapy for PTSD, thereby improving clinical outcomes.”

Among the study limitations cited by the investigators is that the PDS was administered to assess PTSD, rather than the Clinician-Administered PTSD Scale, which is the reference standard.

The authors reported no relevant financial conflicts of interest.

[email protected]

With the first cases described in 1977, ischiofemoral impingement (IFI) is a relatively recently discovered and less known potential cause of hip pain caused by compression on the quadratus femoris muscle (QFM).^1-10 These first patients, who were treated with surgical excision of the lesser trochanter, experienced symptom improvement in all 3 cases.^5,7 The most widely accepted diagnostic criteria use a combination of clinical and imaging findings.^1-10 Criteria most often cited in the literature include isolated edema-like signal in the QFM on magnetic resonance imaging (MRI) and ipsilateral hip pain without a known cause, such as recent trauma or infection.^4,5 All studies describe QFM compression occurring as the muscle passes between the lesser trochanter of the femur and the origin of the ischial tuberosity/hamstring tendons.^1-10

Several authors have sought to improve diagnostic accuracy by providing various measurements to quantify the probability of impingement.^5,7,9 Although groups have proposed different thresholds, our institution currently uses values reported by Tosun and colleagues⁵ because theirs is the most robust sample size to date and included 50 patients with IFI.^7,9 Although 5 different measurements were proposed, 2 are more commonly cited. The first is the ischiofemoral space (IFS), which is the most narrow distance between the cortex of the lesser trochanter and the cortex of the ischial tuberosity. This space should normally be greater than 1.8 cm.⁵ The second measurement is called the quadratus femoris space (QFS) and is the most narrow distance between the hamstring tendons and either the iliopsoas tendon or the cortex of the lesser trochanter. The QFS should normally be greater than 1.0 cm.⁵ However, because these measurements may depend on the hip position during imaging, full-range-of-motion (FROM) MRI may increase diagnostic yield. At our institution, patients are usually imaged supine in neutral position (with respect to internal or external rotation).

In this article, we briefly review IFI, provide an example of how FROM MRI can improve diagnostic accuracy, describe our FROM protocol, and propose an expanded definition of the impingement criteria. The patient provided written informed consent for print and electronic publication of the case details and images.  

Full–Range-of-Motion MRI Technique

A 58-year-old woman with no surgical history or diagnosed inflammatory arthropathy presented to the department of physical medicine and rehabilitation with left-buttock pain radiating down the left thigh. Despite nonsurgical management with nonsteroidal anti-inflammatory medication, exercise therapy, use of a transcutaneous electrical nerve stimulator unit, and oral corticosteroid therapy, the pain continued. The patient was referred for MRI, and routine static imaging of the pelvis was performed. Although edema-like signal was present in both QFMs (Figure 1), left more than right, the measurement of the QFS and IFS did not meet all criteria for narrowing as described in previous studies. On the symptomatic left side, the IFS measured 1.5 cm and the QFS measured 1.4 cm (Figure 2). On the same side, the distance between the cortex of the greater trochanter and the cortex of the ischial tuberosity, proposed adapted IFS, measured 1.4 cm, and the distance between the cortex of the greater trochanter and the hamstring tendons origin, proposed adapted QFS, measured 1.1 cm (Figure 3). However, because of the isolated QFM edema, refractory buttock and thigh pain, and exclusion of other diagnoses (such as labral tear, bone marrow edema/stress reaction in the hip, or MRI findings of sciatic neuropathy), we determined that the patient needed evaluation of the QFS and the IFS through a full range of motion. The patient returned for the FROM MRI 16 days after the initial static MRI.

Our FROM MRI was performed on a Magnetom Skyra 3 Tesla magnet (Seimens Healthcare Global, Munich, Germany), using a body array 18-channel coil and a table spine coil. In a supine position, the patient’s imaging started with the hip in extension, adduction, and approximately 20º of internal rotation. During imaging acquisition, the patient was maintained in adduction and extension while the hip was passively externally rotated (Figure 3). A technologist assisted the patient in maintaining the position through a 60º arc of external rotation, while an axial-gradient echo sequence was used to obtain sequential images through the entire arc. Selected parameters are listed in the Table. Acquisition of the arc of motion in the axial plane requires approximately 3 minutes per hip to generate between 8 and 10 images.

With the patient’s hip in internal rotation, narrowing between the ischium or hamstring tendons and the lesser trochanter did not meet all of the criteria described by Tosun and colleagues⁵ or Torriani and colleagues.⁷ However, when the patient shifted into external rotation, the distance between the ischial tuberosity and the greater trochanter, and between the hamstring tendons origin and the greater trochanter, significantly narrowed. The adapted IFS decreased from 3.4 cm to 1.5 cm, and the adapted QFS decreased from 3.2 cm to 0.9 cm, accounting for a 54% and 72% reduction of the adapted IFS and QFS, respectively, with maximum external rotation (Figures 4, 5).

Discussion

While femoroacetabular impingement is a widely recognized and sometimes surgically treated syndrome, IFI may be overlooked as a cause of hip pain. Although IFI is traditionally described as mass effect on the QFM by the ischium/hamstring tendons origin and the lesser trochanter, we propose expansion of this criteria to include narrowing resulting from the greater trochanter in external rotation as a potential source of impingement. By use of FROM MRI, we adapted measurements previously described for IFI to evaluate for compression of the QFM by adjacent osseous and tendinous structures throughout the full range of internal/external hip rotation. In this case, FROM imaging provided evidence of possible anatomical narrowing caused by the greater trochanter, in addition to that caused by the lesser trochanter. Given that impingement may be caused by either the greater or lesser trochanters, it is prudent to perform FROM MRI in evaluating patients with suspected IFI. If FROM imaging is not feasible, static imaging in both maximal internal and external rotation may allow for better assessment. There have been no large studies conducted to assess the normal interval between the ischial tuberosity/hamstring origins and the greater trochanter.

The purpose of this report is to call attention to a source of impingement that may be undetected with static MRI, possibly leading to a missed diagnosis. While we believe this to be the first reported example of impingement involving the greater trochanter, larger studies should be conducted to explore this possible source of impingement. Information about the incidence of greater trochanteric impingement could lead to changes in our understanding of this syndrome and its management.

With the first cases described in 1977, ischiofemoral impingement (IFI) is a relatively recently discovered and less known potential cause of hip pain caused by compression on the quadratus femoris muscle (QFM).^1-10 These first patients, who were treated with surgical excision of the lesser trochanter, experienced symptom improvement in all 3 cases.^5,7 The most widely accepted diagnostic criteria use a combination of clinical and imaging findings.^1-10 Criteria most often cited in the literature include isolated edema-like signal in the QFM on magnetic resonance imaging (MRI) and ipsilateral hip pain without a known cause, such as recent trauma or infection.^4,5 All studies describe QFM compression occurring as the muscle passes between the lesser trochanter of the femur and the origin of the ischial tuberosity/hamstring tendons.^1-10

Several authors have sought to improve diagnostic accuracy by providing various measurements to quantify the probability of impingement.^5,7,9 Although groups have proposed different thresholds, our institution currently uses values reported by Tosun and colleagues⁵ because theirs is the most robust sample size to date and included 50 patients with IFI.^7,9 Although 5 different measurements were proposed, 2 are more commonly cited. The first is the ischiofemoral space (IFS), which is the most narrow distance between the cortex of the lesser trochanter and the cortex of the ischial tuberosity. This space should normally be greater than 1.8 cm.⁵ The second measurement is called the quadratus femoris space (QFS) and is the most narrow distance between the hamstring tendons and either the iliopsoas tendon or the cortex of the lesser trochanter. The QFS should normally be greater than 1.0 cm.⁵ However, because these measurements may depend on the hip position during imaging, full-range-of-motion (FROM) MRI may increase diagnostic yield. At our institution, patients are usually imaged supine in neutral position (with respect to internal or external rotation).

In this article, we briefly review IFI, provide an example of how FROM MRI can improve diagnostic accuracy, describe our FROM protocol, and propose an expanded definition of the impingement criteria. The patient provided written informed consent for print and electronic publication of the case details and images.  

Full–Range-of-Motion MRI Technique

A 58-year-old woman with no surgical history or diagnosed inflammatory arthropathy presented to the department of physical medicine and rehabilitation with left-buttock pain radiating down the left thigh. Despite nonsurgical management with nonsteroidal anti-inflammatory medication, exercise therapy, use of a transcutaneous electrical nerve stimulator unit, and oral corticosteroid therapy, the pain continued. The patient was referred for MRI, and routine static imaging of the pelvis was performed. Although edema-like signal was present in both QFMs (Figure 1), left more than right, the measurement of the QFS and IFS did not meet all criteria for narrowing as described in previous studies. On the symptomatic left side, the IFS measured 1.5 cm and the QFS measured 1.4 cm (Figure 2). On the same side, the distance between the cortex of the greater trochanter and the cortex of the ischial tuberosity, proposed adapted IFS, measured 1.4 cm, and the distance between the cortex of the greater trochanter and the hamstring tendons origin, proposed adapted QFS, measured 1.1 cm (Figure 3). However, because of the isolated QFM edema, refractory buttock and thigh pain, and exclusion of other diagnoses (such as labral tear, bone marrow edema/stress reaction in the hip, or MRI findings of sciatic neuropathy), we determined that the patient needed evaluation of the QFS and the IFS through a full range of motion. The patient returned for the FROM MRI 16 days after the initial static MRI.

Our FROM MRI was performed on a Magnetom Skyra 3 Tesla magnet (Seimens Healthcare Global, Munich, Germany), using a body array 18-channel coil and a table spine coil. In a supine position, the patient’s imaging started with the hip in extension, adduction, and approximately 20º of internal rotation. During imaging acquisition, the patient was maintained in adduction and extension while the hip was passively externally rotated (Figure 3). A technologist assisted the patient in maintaining the position through a 60º arc of external rotation, while an axial-gradient echo sequence was used to obtain sequential images through the entire arc. Selected parameters are listed in the Table. Acquisition of the arc of motion in the axial plane requires approximately 3 minutes per hip to generate between 8 and 10 images.

With the patient’s hip in internal rotation, narrowing between the ischium or hamstring tendons and the lesser trochanter did not meet all of the criteria described by Tosun and colleagues⁵ or Torriani and colleagues.⁷ However, when the patient shifted into external rotation, the distance between the ischial tuberosity and the greater trochanter, and between the hamstring tendons origin and the greater trochanter, significantly narrowed. The adapted IFS decreased from 3.4 cm to 1.5 cm, and the adapted QFS decreased from 3.2 cm to 0.9 cm, accounting for a 54% and 72% reduction of the adapted IFS and QFS, respectively, with maximum external rotation (Figures 4, 5).

Discussion

While femoroacetabular impingement is a widely recognized and sometimes surgically treated syndrome, IFI may be overlooked as a cause of hip pain. Although IFI is traditionally described as mass effect on the QFM by the ischium/hamstring tendons origin and the lesser trochanter, we propose expansion of this criteria to include narrowing resulting from the greater trochanter in external rotation as a potential source of impingement. By use of FROM MRI, we adapted measurements previously described for IFI to evaluate for compression of the QFM by adjacent osseous and tendinous structures throughout the full range of internal/external hip rotation. In this case, FROM imaging provided evidence of possible anatomical narrowing caused by the greater trochanter, in addition to that caused by the lesser trochanter. Given that impingement may be caused by either the greater or lesser trochanters, it is prudent to perform FROM MRI in evaluating patients with suspected IFI. If FROM imaging is not feasible, static imaging in both maximal internal and external rotation may allow for better assessment. There have been no large studies conducted to assess the normal interval between the ischial tuberosity/hamstring origins and the greater trochanter.

The purpose of this report is to call attention to a source of impingement that may be undetected with static MRI, possibly leading to a missed diagnosis. While we believe this to be the first reported example of impingement involving the greater trochanter, larger studies should be conducted to explore this possible source of impingement. Information about the incidence of greater trochanteric impingement could lead to changes in our understanding of this syndrome and its management.

With the first cases described in 1977, ischiofemoral impingement (IFI) is a relatively recently discovered and less known potential cause of hip pain caused by compression on the quadratus femoris muscle (QFM).^1-10 These first patients, who were treated with surgical excision of the lesser trochanter, experienced symptom improvement in all 3 cases.^5,7 The most widely accepted diagnostic criteria use a combination of clinical and imaging findings.^1-10 Criteria most often cited in the literature include isolated edema-like signal in the QFM on magnetic resonance imaging (MRI) and ipsilateral hip pain without a known cause, such as recent trauma or infection.^4,5 All studies describe QFM compression occurring as the muscle passes between the lesser trochanter of the femur and the origin of the ischial tuberosity/hamstring tendons.^1-10

Several authors have sought to improve diagnostic accuracy by providing various measurements to quantify the probability of impingement.^5,7,9 Although groups have proposed different thresholds, our institution currently uses values reported by Tosun and colleagues⁵ because theirs is the most robust sample size to date and included 50 patients with IFI.^7,9 Although 5 different measurements were proposed, 2 are more commonly cited. The first is the ischiofemoral space (IFS), which is the most narrow distance between the cortex of the lesser trochanter and the cortex of the ischial tuberosity. This space should normally be greater than 1.8 cm.⁵ The second measurement is called the quadratus femoris space (QFS) and is the most narrow distance between the hamstring tendons and either the iliopsoas tendon or the cortex of the lesser trochanter. The QFS should normally be greater than 1.0 cm.⁵ However, because these measurements may depend on the hip position during imaging, full-range-of-motion (FROM) MRI may increase diagnostic yield. At our institution, patients are usually imaged supine in neutral position (with respect to internal or external rotation).

In this article, we briefly review IFI, provide an example of how FROM MRI can improve diagnostic accuracy, describe our FROM protocol, and propose an expanded definition of the impingement criteria. The patient provided written informed consent for print and electronic publication of the case details and images.  

Full–Range-of-Motion MRI Technique

A 58-year-old woman with no surgical history or diagnosed inflammatory arthropathy presented to the department of physical medicine and rehabilitation with left-buttock pain radiating down the left thigh. Despite nonsurgical management with nonsteroidal anti-inflammatory medication, exercise therapy, use of a transcutaneous electrical nerve stimulator unit, and oral corticosteroid therapy, the pain continued. The patient was referred for MRI, and routine static imaging of the pelvis was performed. Although edema-like signal was present in both QFMs (Figure 1), left more than right, the measurement of the QFS and IFS did not meet all criteria for narrowing as described in previous studies. On the symptomatic left side, the IFS measured 1.5 cm and the QFS measured 1.4 cm (Figure 2). On the same side, the distance between the cortex of the greater trochanter and the cortex of the ischial tuberosity, proposed adapted IFS, measured 1.4 cm, and the distance between the cortex of the greater trochanter and the hamstring tendons origin, proposed adapted QFS, measured 1.1 cm (Figure 3). However, because of the isolated QFM edema, refractory buttock and thigh pain, and exclusion of other diagnoses (such as labral tear, bone marrow edema/stress reaction in the hip, or MRI findings of sciatic neuropathy), we determined that the patient needed evaluation of the QFS and the IFS through a full range of motion. The patient returned for the FROM MRI 16 days after the initial static MRI.

Our FROM MRI was performed on a Magnetom Skyra 3 Tesla magnet (Seimens Healthcare Global, Munich, Germany), using a body array 18-channel coil and a table spine coil. In a supine position, the patient’s imaging started with the hip in extension, adduction, and approximately 20º of internal rotation. During imaging acquisition, the patient was maintained in adduction and extension while the hip was passively externally rotated (Figure 3). A technologist assisted the patient in maintaining the position through a 60º arc of external rotation, while an axial-gradient echo sequence was used to obtain sequential images through the entire arc. Selected parameters are listed in the Table. Acquisition of the arc of motion in the axial plane requires approximately 3 minutes per hip to generate between 8 and 10 images.

With the patient’s hip in internal rotation, narrowing between the ischium or hamstring tendons and the lesser trochanter did not meet all of the criteria described by Tosun and colleagues⁵ or Torriani and colleagues.⁷ However, when the patient shifted into external rotation, the distance between the ischial tuberosity and the greater trochanter, and between the hamstring tendons origin and the greater trochanter, significantly narrowed. The adapted IFS decreased from 3.4 cm to 1.5 cm, and the adapted QFS decreased from 3.2 cm to 0.9 cm, accounting for a 54% and 72% reduction of the adapted IFS and QFS, respectively, with maximum external rotation (Figures 4, 5).

Discussion

While femoroacetabular impingement is a widely recognized and sometimes surgically treated syndrome, IFI may be overlooked as a cause of hip pain. Although IFI is traditionally described as mass effect on the QFM by the ischium/hamstring tendons origin and the lesser trochanter, we propose expansion of this criteria to include narrowing resulting from the greater trochanter in external rotation as a potential source of impingement. By use of FROM MRI, we adapted measurements previously described for IFI to evaluate for compression of the QFM by adjacent osseous and tendinous structures throughout the full range of internal/external hip rotation. In this case, FROM imaging provided evidence of possible anatomical narrowing caused by the greater trochanter, in addition to that caused by the lesser trochanter. Given that impingement may be caused by either the greater or lesser trochanters, it is prudent to perform FROM MRI in evaluating patients with suspected IFI. If FROM imaging is not feasible, static imaging in both maximal internal and external rotation may allow for better assessment. There have been no large studies conducted to assess the normal interval between the ischial tuberosity/hamstring origins and the greater trochanter.

The purpose of this report is to call attention to a source of impingement that may be undetected with static MRI, possibly leading to a missed diagnosis. While we believe this to be the first reported example of impingement involving the greater trochanter, larger studies should be conducted to explore this possible source of impingement. Information about the incidence of greater trochanteric impingement could lead to changes in our understanding of this syndrome and its management.

Preventable medical errors rank as the third most common cause of death in the United States after heart disease and cancer.¹ They are responsible for 400,000 deaths each year (over 1095 per day) and another 10,000 serious complications resulting from medical errors each day.¹ That is the equivalent of two 747 airliner midair crashes per day. The economic cost to our nation is $1 trillion per year.¹

On July 17, 2014, the US Senate Subcommittee on Primary Health and Aging met to address this crisis. Participants included senators and John James, PhD, Founder, Patient Safety America, Houston, Texas; Ashish Jha, MD, MPH, Professor of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts; Tejal Gandhi, MD, MPH, President, National Patient Safety Foundation, and Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts; Peter Pronovost, MD, PhD, Senior Vice President for Patient Safety and Quality, and Director of the Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, Maryland; Joanne Disch, PhD, RN, Professor ad Honorem, University of Minnesota School of Nursing, Minneapolis, Minnesota; and Lisa McGiffert, Director, Safe Patient Project, Consumers Union, Austin, Texas. While each speaker suggested various strategies for improving patient safety, they all agreed that information technology is not living up to our expectations for meeting this need. They also agreed that health care has become increasingly “high tech and low touch,” and, as a result, the medical community is leveraging neither technology nor the knowledge accrued from individual patient/physician interactions to improve patient safety and outcomes.¹

Last year my mother had a spinal fusion. The surgery was a success by all measures. Two days after she was discharged home, she became weak and was unable to walk. She went to the emergency room, where it was noted that she was severely hyponatremic, weak, and experiencing severe back pain. For the next 36 hours she was not seen by a physician or physician assistant (PA), as the PA who admitted her to the hospital had not notified the “team” that she was admitted. My father, who is a vascular surgeon, notified her spine surgeon, who came to see her. Her hyponatremia was markedly worse, and she was transferred to the intensive care unit (ICU). She continued to decline and was started on hypertonic intravenous (IV) saline. Over the next several days her hyponatremia improved, and she was transferred out of the ICU but continued to have pain. The spine surgeon examined her several times, and imaging showed no evidence of epidural bleeding, infection, or misplaced hardware.

Over the next several days, I was informed by family members that the nurses were “keeping the pain in check” with IV narcotics and that my mom was heavily sedated most of the time. My dad later informed me that she had a foot drop on the left, and the next day another family member told me the foot drop was on the right. My dad and stepbrother each assured me that they were right. When my mom could talk, she told me how weak she was and that sometimes it was her right leg and other times her left. She was seen by a neurologist on 6 out of the next 10 days and underwent 3 computed tomography scans and magnetic resonance imaging, and the neurologist assured us that she had not had a stroke. On a Friday evening, I called my mom, who was progressively short of breath, and she told me that she felt weaker and weaker each day. The “foot drop,” which was now bilateral according to the neurologist, was from “not using it while she was in the ICU.”

My mom, who is an artist, commented that she was having trouble using her hands now and unable to hold a cup. I called the physician on call, who assured me that she was taking care of my mom’s blood pressure (which was labile for the first time ever; she had no history of hypertension) and her pain score was a 5. I explained that I knew that she was not “looking to play mystery diagnosis with an orthopedic surgeon 500 miles away, but I think my mom has Guillain-Barré syndrome.” Fortunately, the doctor said, “Oh my god, I think you’re right.” Monday morning, her diagnosis was confirmed and she has made a remarkable recovery. So how is it that she could be seen by a neurologist and a team of nurses, doctors, therapists, and resident staff and no one made a diagnosis? Certainly contributing factors include a system of multiple medical teams with frequent turnovers and a desire to consult others but no real “quarterback” who was looking at the overall care in a responsible and critical way. A thorough history and physical examination, rather than a multitude of expensive and unnecessary imaging studies, could certainly have led to a quicker diagnosis and avoidance of a protracted hospital stay and rehabilitation.

To be sure, there are many factors that lead to delays in diagnosis. The reliance on advanced imaging, the lack of a simple physical examination, and the lack of critical thinking played prominently in the failure to make a diagnosis in my mom’s case. Some would argue that we need information technology (IT) systems that will allow us to better diagnose and treat patients. They believe that with electronic medical records (EMRs) data points will be entered and a diagnosis will be made. Major corporations like IBM and GE are working to make this a reality. Although Watson (the artificially intelligent computer system created by IBM) may be able to win on Jeopardy and may move the needle forward to improving patient care, 2 things are certain: (1) Appropriate data will need to be input by people, and (2) without critical thinking, the appropriate data can’t be entered or interpreted correctly. 

The fact remains that EMR has fallen short of expectations. We have more data at our fingertips but this has not translated into a significant improvement in patient safety. The human factor remains critical. Even though industry and health care workers strive to innovate and merge technological advances with improved patient outcomes, technology will continue to fall short of expectations without the input of critical thinking. There are things that computers and technological advances can do that people can’t, and there are things that people can do that computers can’t.

We cannot become a profession reliant on technology to substitute for critical thinking, and we cannot become a profession that doesn’t recognize what technology can bring to us and our patients. Like a railroad track that needs 2 parallel tracks to move trains, we must continue to build on 2 tracks: innovation and critical thinking. ◾

Preventable medical errors rank as the third most common cause of death in the United States after heart disease and cancer.¹ They are responsible for 400,000 deaths each year (over 1095 per day) and another 10,000 serious complications resulting from medical errors each day.¹ That is the equivalent of two 747 airliner midair crashes per day. The economic cost to our nation is $1 trillion per year.¹

On July 17, 2014, the US Senate Subcommittee on Primary Health and Aging met to address this crisis. Participants included senators and John James, PhD, Founder, Patient Safety America, Houston, Texas; Ashish Jha, MD, MPH, Professor of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts; Tejal Gandhi, MD, MPH, President, National Patient Safety Foundation, and Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts; Peter Pronovost, MD, PhD, Senior Vice President for Patient Safety and Quality, and Director of the Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, Maryland; Joanne Disch, PhD, RN, Professor ad Honorem, University of Minnesota School of Nursing, Minneapolis, Minnesota; and Lisa McGiffert, Director, Safe Patient Project, Consumers Union, Austin, Texas. While each speaker suggested various strategies for improving patient safety, they all agreed that information technology is not living up to our expectations for meeting this need. They also agreed that health care has become increasingly “high tech and low touch,” and, as a result, the medical community is leveraging neither technology nor the knowledge accrued from individual patient/physician interactions to improve patient safety and outcomes.¹

Last year my mother had a spinal fusion. The surgery was a success by all measures. Two days after she was discharged home, she became weak and was unable to walk. She went to the emergency room, where it was noted that she was severely hyponatremic, weak, and experiencing severe back pain. For the next 36 hours she was not seen by a physician or physician assistant (PA), as the PA who admitted her to the hospital had not notified the “team” that she was admitted. My father, who is a vascular surgeon, notified her spine surgeon, who came to see her. Her hyponatremia was markedly worse, and she was transferred to the intensive care unit (ICU). She continued to decline and was started on hypertonic intravenous (IV) saline. Over the next several days her hyponatremia improved, and she was transferred out of the ICU but continued to have pain. The spine surgeon examined her several times, and imaging showed no evidence of epidural bleeding, infection, or misplaced hardware.

Over the next several days, I was informed by family members that the nurses were “keeping the pain in check” with IV narcotics and that my mom was heavily sedated most of the time. My dad later informed me that she had a foot drop on the left, and the next day another family member told me the foot drop was on the right. My dad and stepbrother each assured me that they were right. When my mom could talk, she told me how weak she was and that sometimes it was her right leg and other times her left. She was seen by a neurologist on 6 out of the next 10 days and underwent 3 computed tomography scans and magnetic resonance imaging, and the neurologist assured us that she had not had a stroke. On a Friday evening, I called my mom, who was progressively short of breath, and she told me that she felt weaker and weaker each day. The “foot drop,” which was now bilateral according to the neurologist, was from “not using it while she was in the ICU.”

My mom, who is an artist, commented that she was having trouble using her hands now and unable to hold a cup. I called the physician on call, who assured me that she was taking care of my mom’s blood pressure (which was labile for the first time ever; she had no history of hypertension) and her pain score was a 5. I explained that I knew that she was not “looking to play mystery diagnosis with an orthopedic surgeon 500 miles away, but I think my mom has Guillain-Barré syndrome.” Fortunately, the doctor said, “Oh my god, I think you’re right.” Monday morning, her diagnosis was confirmed and she has made a remarkable recovery. So how is it that she could be seen by a neurologist and a team of nurses, doctors, therapists, and resident staff and no one made a diagnosis? Certainly contributing factors include a system of multiple medical teams with frequent turnovers and a desire to consult others but no real “quarterback” who was looking at the overall care in a responsible and critical way. A thorough history and physical examination, rather than a multitude of expensive and unnecessary imaging studies, could certainly have led to a quicker diagnosis and avoidance of a protracted hospital stay and rehabilitation.

To be sure, there are many factors that lead to delays in diagnosis. The reliance on advanced imaging, the lack of a simple physical examination, and the lack of critical thinking played prominently in the failure to make a diagnosis in my mom’s case. Some would argue that we need information technology (IT) systems that will allow us to better diagnose and treat patients. They believe that with electronic medical records (EMRs) data points will be entered and a diagnosis will be made. Major corporations like IBM and GE are working to make this a reality. Although Watson (the artificially intelligent computer system created by IBM) may be able to win on Jeopardy and may move the needle forward to improving patient care, 2 things are certain: (1) Appropriate data will need to be input by people, and (2) without critical thinking, the appropriate data can’t be entered or interpreted correctly. 

The fact remains that EMR has fallen short of expectations. We have more data at our fingertips but this has not translated into a significant improvement in patient safety. The human factor remains critical. Even though industry and health care workers strive to innovate and merge technological advances with improved patient outcomes, technology will continue to fall short of expectations without the input of critical thinking. There are things that computers and technological advances can do that people can’t, and there are things that people can do that computers can’t.

We cannot become a profession reliant on technology to substitute for critical thinking, and we cannot become a profession that doesn’t recognize what technology can bring to us and our patients. Like a railroad track that needs 2 parallel tracks to move trains, we must continue to build on 2 tracks: innovation and critical thinking. ◾

Preventable medical errors rank as the third most common cause of death in the United States after heart disease and cancer.¹ They are responsible for 400,000 deaths each year (over 1095 per day) and another 10,000 serious complications resulting from medical errors each day.¹ That is the equivalent of two 747 airliner midair crashes per day. The economic cost to our nation is $1 trillion per year.¹

On July 17, 2014, the US Senate Subcommittee on Primary Health and Aging met to address this crisis. Participants included senators and John James, PhD, Founder, Patient Safety America, Houston, Texas; Ashish Jha, MD, MPH, Professor of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts; Tejal Gandhi, MD, MPH, President, National Patient Safety Foundation, and Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts; Peter Pronovost, MD, PhD, Senior Vice President for Patient Safety and Quality, and Director of the Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, Maryland; Joanne Disch, PhD, RN, Professor ad Honorem, University of Minnesota School of Nursing, Minneapolis, Minnesota; and Lisa McGiffert, Director, Safe Patient Project, Consumers Union, Austin, Texas. While each speaker suggested various strategies for improving patient safety, they all agreed that information technology is not living up to our expectations for meeting this need. They also agreed that health care has become increasingly “high tech and low touch,” and, as a result, the medical community is leveraging neither technology nor the knowledge accrued from individual patient/physician interactions to improve patient safety and outcomes.¹

Last year my mother had a spinal fusion. The surgery was a success by all measures. Two days after she was discharged home, she became weak and was unable to walk. She went to the emergency room, where it was noted that she was severely hyponatremic, weak, and experiencing severe back pain. For the next 36 hours she was not seen by a physician or physician assistant (PA), as the PA who admitted her to the hospital had not notified the “team” that she was admitted. My father, who is a vascular surgeon, notified her spine surgeon, who came to see her. Her hyponatremia was markedly worse, and she was transferred to the intensive care unit (ICU). She continued to decline and was started on hypertonic intravenous (IV) saline. Over the next several days her hyponatremia improved, and she was transferred out of the ICU but continued to have pain. The spine surgeon examined her several times, and imaging showed no evidence of epidural bleeding, infection, or misplaced hardware.

Over the next several days, I was informed by family members that the nurses were “keeping the pain in check” with IV narcotics and that my mom was heavily sedated most of the time. My dad later informed me that she had a foot drop on the left, and the next day another family member told me the foot drop was on the right. My dad and stepbrother each assured me that they were right. When my mom could talk, she told me how weak she was and that sometimes it was her right leg and other times her left. She was seen by a neurologist on 6 out of the next 10 days and underwent 3 computed tomography scans and magnetic resonance imaging, and the neurologist assured us that she had not had a stroke. On a Friday evening, I called my mom, who was progressively short of breath, and she told me that she felt weaker and weaker each day. The “foot drop,” which was now bilateral according to the neurologist, was from “not using it while she was in the ICU.”

My mom, who is an artist, commented that she was having trouble using her hands now and unable to hold a cup. I called the physician on call, who assured me that she was taking care of my mom’s blood pressure (which was labile for the first time ever; she had no history of hypertension) and her pain score was a 5. I explained that I knew that she was not “looking to play mystery diagnosis with an orthopedic surgeon 500 miles away, but I think my mom has Guillain-Barré syndrome.” Fortunately, the doctor said, “Oh my god, I think you’re right.” Monday morning, her diagnosis was confirmed and she has made a remarkable recovery. So how is it that she could be seen by a neurologist and a team of nurses, doctors, therapists, and resident staff and no one made a diagnosis? Certainly contributing factors include a system of multiple medical teams with frequent turnovers and a desire to consult others but no real “quarterback” who was looking at the overall care in a responsible and critical way. A thorough history and physical examination, rather than a multitude of expensive and unnecessary imaging studies, could certainly have led to a quicker diagnosis and avoidance of a protracted hospital stay and rehabilitation.

To be sure, there are many factors that lead to delays in diagnosis. The reliance on advanced imaging, the lack of a simple physical examination, and the lack of critical thinking played prominently in the failure to make a diagnosis in my mom’s case. Some would argue that we need information technology (IT) systems that will allow us to better diagnose and treat patients. They believe that with electronic medical records (EMRs) data points will be entered and a diagnosis will be made. Major corporations like IBM and GE are working to make this a reality. Although Watson (the artificially intelligent computer system created by IBM) may be able to win on Jeopardy and may move the needle forward to improving patient care, 2 things are certain: (1) Appropriate data will need to be input by people, and (2) without critical thinking, the appropriate data can’t be entered or interpreted correctly. 

The fact remains that EMR has fallen short of expectations. We have more data at our fingertips but this has not translated into a significant improvement in patient safety. The human factor remains critical. Even though industry and health care workers strive to innovate and merge technological advances with improved patient outcomes, technology will continue to fall short of expectations without the input of critical thinking. There are things that computers and technological advances can do that people can’t, and there are things that people can do that computers can’t.

We cannot become a profession reliant on technology to substitute for critical thinking, and we cannot become a profession that doesn’t recognize what technology can bring to us and our patients. Like a railroad track that needs 2 parallel tracks to move trains, we must continue to build on 2 tracks: innovation and critical thinking. ◾

Glomus tumors are neoplasms that originate from normal glomus bodies in the skin and are most commonly found in the subungual areas of the digits.¹ Glomus bodies are neuromyoarterial structures in the reticular dermis that serve as specialized arteriovenous anastomoses. These bodies contain afferent arterioles and efferent veins with multiple connections, and glomus cells have contractile properties because of their similarity to smooth muscle cells.^1,2 Glomus bodies help regulate blood flow and temperature of the skin and are found in their largest concentration in the fingertips, palms of the hands, and soles of the feet.^3,4

Glomus tumors represent hyperplastic glomus bodies and make up 1% to 4.5% of upper extremity neoplasms, with approximately 75% in the hand and 50% in the subungual area.^1,5,6 These tumors can also present in multiple locations at once and can occur in atypical and ectopic locations.³ Although generally benign, glomus tumors can also exhibit malignant and metastatic potential in rare cases.^7,8 They can also be locally aggressive with bony destruction of the distal phalynx.^2,9,10 Tumors typically present as painful solitary soft-tissue lesions that are exquisitely tender to palpation, dark red-purple or bluish, and hypersensitive to cold.^5,10 Van Geertruyden and colleagues¹⁰ reported that the diagnosis of glomus tumor can be made clinically in 90% of cases. However, glomus tumors can easily be mistaken for other lesions, such as hemangiomas, angiomas, neuromas, neurofibromas, lipomas, and ganglion cysts. An inaccurate or incomplete workup can result in persistent pain and symptoms along with intraoperative complications.³ Magnetic resonance imaging (MRI), the most sensitive imaging modality for detecting glomus tumors of the hand, can assist in the workup.^3,11,12

Extradigital glomus tumors are difficult to diagnose because of their rarity and unspecific symptoms and presentation.¹³ Misdiagnosis and delayed diagnosis can result in significant chronic pain, disuse syndromes, and disability.^1,10 Correct diagnosis and surgical resection are generally curative with complete resolution of symptoms.

In this article, we report a case of a large atypical glomus tumor that occurred on the wrist and involved the radial artery. This tumor was successfully treated with surgical excision. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 63-year-old man presented to clinic with an extremely tender soft-tissue mass on his nondominant, left wrist. The mass had been increasing in size for a year. It was painless at rest but very painful to light palpation, with referred pain proximally up to the shoulder.

The patient did not recall any traumatic or inciting event, had not undergone any prior workup or treatment for symptoms, and had no history of masses elsewhere on the body. Past medical history was significant for type 2 diabetes and colon and prostate cancer, which had been treated with chemotherapy and was now in remission.

Physical examination revealed a 2×2.5-cm well-circumscribed soft-tissue mass on the volar-radial aspect of the left wrist proximal to the thenar eminence and radial to the flexor carpi radialis tendon (Figure 1). The mass was soft, mobile, and nonfluctuant and did not transilluminate. The overlying skin was normal in color and appearance—no discoloration, erythema, wounds, or drainage. The radial artery was palpable, and the mass did not pulsate or have a bruit. The patient had normal wrist range of motion limited by pain on compression of the mass with motor and sensation intact throughout the hand. Plain radiographs of the wrist showed no bony pathology or involvement from the mass. A soft-tissue shadow was visible around the wrist without calcifications. A wrist MRI was performed to better evaluate the mass, and the T2-weighted images showed a heterogeneous subcutaneous mass adjacent to the radial artery with increased signal intensity from surrounding feeding vessels (Figure 2).

Given the clinical and imaging findings, there was concern for a possible vascular tumor. Therefore, excisional biopsy was recommended over needle biopsy because of the bleeding risk. With the patient under general anesthesia, and a tourniquet used without exsanguination, a Brunner-type zigzag incision was made centered over the mass with elevated skin flaps. The 2.7×2.6×1.1-cm mass was superficial and involved the radial artery (Figure 3). After the radial artery was dissected proximally and distally, 2 perforating vessels were found entering the mass. These vessels were ligated, which allowed the mass to be peeled completely off the artery. Histology with hematoxylin-eosin staining showed solid sheets of uniform round cells with interspersed capillaries and centrally placed nuclei without evidence of malignancy (Figure 4).

The tourniquet was released before skin closure, and adequate hemostasis was obtained. The wound was closed, and the patient was placed in a volar wrist splint for immobilization. Pain relief after excision of the mass was immediate, and the postoperative course uneventful. After surgery, immunohistochemistry of the mass showed minimal mitotic activity, with a positive immunoperoxidase stain for smooth muscle actin confirming a diagnosis of glomus tumor (Figure 5). At 3-year follow-up, the patient had no pain, symptoms, or tumor recurrence.

Discussion

Glomus tumors are an established cause of pain in the subungual areas of the hand; numerous cases have been reported.^1,5,10,14 However, extradigital glomus tumors, particularly those involving the wrist, are rare, and only a few have been described. Given the lack of consistent findings and presentations, diagnosis is difficult. Case series have documented an overall 2:1 female-to-male predominance of glomus tumors,⁶ but extradigital tumors are more common in men (4.6:1 male-to-female ratio).³ Extradigital glomus tumors are commonly diagnosed between ages 40 and 80 years. Classic symptoms of subungual tumors include pain, localized tenderness, and cold hypersensitivity,^1,10 but symptoms are much more variable with extradigital locations. Previous trauma or injury to the lesion area is reported in 20% to 30% of cases before symptom onset.^3,15 Intravascular locations of glomus tumors are extremely rare; only 4 cases of tumors involving venous structures have been reported.^16-19 In the present case, the patient’s main complaints were pain and localized tenderness associated with a progressively increasing mass without any history of trauma. The large size of his mass (~2.5 cm in diameter) on examination was unique, as was involvement of the radial artery.

Misdiagnosis and delayed diagnosis of extradigital glomus tumors are common, and symptoms such as chronic pain typically persist for 7 to 11 years before the correct diagnosis is made.^1,10 On average, 2.5 physician consultants (including psychiatrists) evaluate the patient before glomus tumor is identified.¹⁰ There are other reports of atypical or ectopic glomus tumors taking 5 to 25 years to be diagnosed.^20-22 The differential diagnosis for glomus tumors includes hemangiomas, cellular or cavernous hemangiomas, vascular tumors, neuromas, neurofibromas, lipomas, paragangliomas, ganglion cysts, pigmented nevi, Pacinian corpuscle hyperplasia, and foreign bodies. A key element of clinical diagnosis is the disproportionate amount of pain and localized tenderness caused by the lesion relative to its size. The hypersensitivity of this tumor is thought to result from enlargement of the tumor and impingement on nearby Pacinian corpuscles, nerve endings in the skin that are responsible for sensitivity to vibration and pressure.^2,9

Plain radiographs can be useful in detecting glomus tumors of the hand but are less helpful with extradigital tumors, with identification rates of 24% in certain series.³ MRI is the most sensitive imaging modality for diagnosing glomus tumors of the hand; a detection rate of 80% to 100% has been reported in various case series.^3,11,12 Specificity of MRI for glomus tumors has been reported at 50%.^11,23 Placement of a radiographic marker directly over the area of most pain can assist in tumor localization.³ Glomus tumors typically have decreased signal intensity on T1-weighted images and increased intensity on T2-weighted images, but signal patterns are variable and particularly difficult to differentiate with small tumors. MRI is useful in the setting of recurrent glomus tumors, where incomplete excision is possible. In 24 cases of continued pain after glomus tumor excision, Theumann and colleagues²⁴ used MRI to identify a nodule consistent with recurrent glomus tumor in all patients. Three-dimensional contrast-enhanced magnetic resonance angiography (MRA) can also help diagnose glomus tumors while providing valuable information regarding size and location for surgical planning.^25,26 With MRA, it is crucial to evaluate the arterial or arteriovenous phase of imaging, as the glomus tumor is richly vascularized and shows contrast enhancement after intravenous injection of gadolinium.²⁷ Angiography, ultrasonography, thermography, and scintigraphy have all been used to diagnose glomus tumors but have shown limited utility and accuracy.¹¹

Treatment of glomus tumors is complete surgical excision because of their relatively small size and subcutaneous location. Resection success rates are consistently higher than 95%, with resolution of all symptoms.^1,10,14 Local recurrence of tumors after excision occurs in 1% to 33% of cases, depending on series, and may be immediate or delayed, with immediate recurrence commonly caused by inadequate excision.^1,10,15,28 Delayed recurrence is less common and presents several years after excision, typically with a new growth near the previous excision.¹⁰ Recurrence years after surgery may also represent multiple tumors unrecognized during initial workup and can be treated with repeat excision or radiotherapy.

Robert and colleagues²⁹ recently reported the case of a glomus tumor, on the dorsal aspect of the wrist, discovered incidentally in a 71-year-old patient and treated with surgical excision. Several years earlier, Chim and colleagues³⁰ described a similar case, of a large wrist glomus tumor worked up with MRI. In a retrospective review of all extradigital glomus tumors seen over a 20-year period, Schiefer and colleagues³ reported 4 glomus tumors of the wrist out of 56 tumors total. The most common sites were forearm (11 cases) and knee (10 cases), and the majority of patients presented with pain and localized tenderness. Mean tumor size was 0.66 cm (range, 0.1-0.3 cm), with 77% of tumors less than 1 cm. Our patient’s 2.7×2.6×1.1-cm tumor was large for a glomus tumor. Its involvement with the radial artery feeding vessels likely contributed to its large and progressively increasing size. It is worth noting that, in the series by Schiefer and colleagues,³ the only patient with symptoms persisting after excision had a large (3 cm in diameter) deep tumor of the foot; the entire tumor was removed, and there was no recurrence by 10-year follow-up. Folpe and colleagues⁷ suggested that deep tumors larger than 2 cm should be at higher suspicion for malignancy. Joseph and Posner²¹ reported 3 cases of glomus tumors, on the ulnar side of the wrist, diagnosed with help of a provocative test using ethyl chloride spray.

Conclusion

Overall, glomus tumors are rare and challenging to diagnosis and should be in the differential in any symptomatic patient with a painful soft-tissue mass of the wrist. Advanced imaging studies, such as MRI, can assist in localization, diagnosis, and preoperative planning. Histology and immunohistochemistry are essential to differentiate glomus tumor from other vascular tumors, and complete excision is necessary to prevent local recurrence.

Glomus tumors are neoplasms that originate from normal glomus bodies in the skin and are most commonly found in the subungual areas of the digits.¹ Glomus bodies are neuromyoarterial structures in the reticular dermis that serve as specialized arteriovenous anastomoses. These bodies contain afferent arterioles and efferent veins with multiple connections, and glomus cells have contractile properties because of their similarity to smooth muscle cells.^1,2 Glomus bodies help regulate blood flow and temperature of the skin and are found in their largest concentration in the fingertips, palms of the hands, and soles of the feet.^3,4

Glomus tumors represent hyperplastic glomus bodies and make up 1% to 4.5% of upper extremity neoplasms, with approximately 75% in the hand and 50% in the subungual area.^1,5,6 These tumors can also present in multiple locations at once and can occur in atypical and ectopic locations.³ Although generally benign, glomus tumors can also exhibit malignant and metastatic potential in rare cases.^7,8 They can also be locally aggressive with bony destruction of the distal phalynx.^2,9,10 Tumors typically present as painful solitary soft-tissue lesions that are exquisitely tender to palpation, dark red-purple or bluish, and hypersensitive to cold.^5,10 Van Geertruyden and colleagues¹⁰ reported that the diagnosis of glomus tumor can be made clinically in 90% of cases. However, glomus tumors can easily be mistaken for other lesions, such as hemangiomas, angiomas, neuromas, neurofibromas, lipomas, and ganglion cysts. An inaccurate or incomplete workup can result in persistent pain and symptoms along with intraoperative complications.³ Magnetic resonance imaging (MRI), the most sensitive imaging modality for detecting glomus tumors of the hand, can assist in the workup.^3,11,12

Extradigital glomus tumors are difficult to diagnose because of their rarity and unspecific symptoms and presentation.¹³ Misdiagnosis and delayed diagnosis can result in significant chronic pain, disuse syndromes, and disability.^1,10 Correct diagnosis and surgical resection are generally curative with complete resolution of symptoms.

In this article, we report a case of a large atypical glomus tumor that occurred on the wrist and involved the radial artery. This tumor was successfully treated with surgical excision. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 63-year-old man presented to clinic with an extremely tender soft-tissue mass on his nondominant, left wrist. The mass had been increasing in size for a year. It was painless at rest but very painful to light palpation, with referred pain proximally up to the shoulder.

The patient did not recall any traumatic or inciting event, had not undergone any prior workup or treatment for symptoms, and had no history of masses elsewhere on the body. Past medical history was significant for type 2 diabetes and colon and prostate cancer, which had been treated with chemotherapy and was now in remission.

Physical examination revealed a 2×2.5-cm well-circumscribed soft-tissue mass on the volar-radial aspect of the left wrist proximal to the thenar eminence and radial to the flexor carpi radialis tendon (Figure 1). The mass was soft, mobile, and nonfluctuant and did not transilluminate. The overlying skin was normal in color and appearance—no discoloration, erythema, wounds, or drainage. The radial artery was palpable, and the mass did not pulsate or have a bruit. The patient had normal wrist range of motion limited by pain on compression of the mass with motor and sensation intact throughout the hand. Plain radiographs of the wrist showed no bony pathology or involvement from the mass. A soft-tissue shadow was visible around the wrist without calcifications. A wrist MRI was performed to better evaluate the mass, and the T2-weighted images showed a heterogeneous subcutaneous mass adjacent to the radial artery with increased signal intensity from surrounding feeding vessels (Figure 2).

Given the clinical and imaging findings, there was concern for a possible vascular tumor. Therefore, excisional biopsy was recommended over needle biopsy because of the bleeding risk. With the patient under general anesthesia, and a tourniquet used without exsanguination, a Brunner-type zigzag incision was made centered over the mass with elevated skin flaps. The 2.7×2.6×1.1-cm mass was superficial and involved the radial artery (Figure 3). After the radial artery was dissected proximally and distally, 2 perforating vessels were found entering the mass. These vessels were ligated, which allowed the mass to be peeled completely off the artery. Histology with hematoxylin-eosin staining showed solid sheets of uniform round cells with interspersed capillaries and centrally placed nuclei without evidence of malignancy (Figure 4).

The tourniquet was released before skin closure, and adequate hemostasis was obtained. The wound was closed, and the patient was placed in a volar wrist splint for immobilization. Pain relief after excision of the mass was immediate, and the postoperative course uneventful. After surgery, immunohistochemistry of the mass showed minimal mitotic activity, with a positive immunoperoxidase stain for smooth muscle actin confirming a diagnosis of glomus tumor (Figure 5). At 3-year follow-up, the patient had no pain, symptoms, or tumor recurrence.

Discussion

Glomus tumors are an established cause of pain in the subungual areas of the hand; numerous cases have been reported.^1,5,10,14 However, extradigital glomus tumors, particularly those involving the wrist, are rare, and only a few have been described. Given the lack of consistent findings and presentations, diagnosis is difficult. Case series have documented an overall 2:1 female-to-male predominance of glomus tumors,⁶ but extradigital tumors are more common in men (4.6:1 male-to-female ratio).³ Extradigital glomus tumors are commonly diagnosed between ages 40 and 80 years. Classic symptoms of subungual tumors include pain, localized tenderness, and cold hypersensitivity,^1,10 but symptoms are much more variable with extradigital locations. Previous trauma or injury to the lesion area is reported in 20% to 30% of cases before symptom onset.^3,15 Intravascular locations of glomus tumors are extremely rare; only 4 cases of tumors involving venous structures have been reported.^16-19 In the present case, the patient’s main complaints were pain and localized tenderness associated with a progressively increasing mass without any history of trauma. The large size of his mass (~2.5 cm in diameter) on examination was unique, as was involvement of the radial artery.

Misdiagnosis and delayed diagnosis of extradigital glomus tumors are common, and symptoms such as chronic pain typically persist for 7 to 11 years before the correct diagnosis is made.^1,10 On average, 2.5 physician consultants (including psychiatrists) evaluate the patient before glomus tumor is identified.¹⁰ There are other reports of atypical or ectopic glomus tumors taking 5 to 25 years to be diagnosed.^20-22 The differential diagnosis for glomus tumors includes hemangiomas, cellular or cavernous hemangiomas, vascular tumors, neuromas, neurofibromas, lipomas, paragangliomas, ganglion cysts, pigmented nevi, Pacinian corpuscle hyperplasia, and foreign bodies. A key element of clinical diagnosis is the disproportionate amount of pain and localized tenderness caused by the lesion relative to its size. The hypersensitivity of this tumor is thought to result from enlargement of the tumor and impingement on nearby Pacinian corpuscles, nerve endings in the skin that are responsible for sensitivity to vibration and pressure.^2,9

Plain radiographs can be useful in detecting glomus tumors of the hand but are less helpful with extradigital tumors, with identification rates of 24% in certain series.³ MRI is the most sensitive imaging modality for diagnosing glomus tumors of the hand; a detection rate of 80% to 100% has been reported in various case series.^3,11,12 Specificity of MRI for glomus tumors has been reported at 50%.^11,23 Placement of a radiographic marker directly over the area of most pain can assist in tumor localization.³ Glomus tumors typically have decreased signal intensity on T1-weighted images and increased intensity on T2-weighted images, but signal patterns are variable and particularly difficult to differentiate with small tumors. MRI is useful in the setting of recurrent glomus tumors, where incomplete excision is possible. In 24 cases of continued pain after glomus tumor excision, Theumann and colleagues²⁴ used MRI to identify a nodule consistent with recurrent glomus tumor in all patients. Three-dimensional contrast-enhanced magnetic resonance angiography (MRA) can also help diagnose glomus tumors while providing valuable information regarding size and location for surgical planning.^25,26 With MRA, it is crucial to evaluate the arterial or arteriovenous phase of imaging, as the glomus tumor is richly vascularized and shows contrast enhancement after intravenous injection of gadolinium.²⁷ Angiography, ultrasonography, thermography, and scintigraphy have all been used to diagnose glomus tumors but have shown limited utility and accuracy.¹¹

Treatment of glomus tumors is complete surgical excision because of their relatively small size and subcutaneous location. Resection success rates are consistently higher than 95%, with resolution of all symptoms.^1,10,14 Local recurrence of tumors after excision occurs in 1% to 33% of cases, depending on series, and may be immediate or delayed, with immediate recurrence commonly caused by inadequate excision.^1,10,15,28 Delayed recurrence is less common and presents several years after excision, typically with a new growth near the previous excision.¹⁰ Recurrence years after surgery may also represent multiple tumors unrecognized during initial workup and can be treated with repeat excision or radiotherapy.

Robert and colleagues²⁹ recently reported the case of a glomus tumor, on the dorsal aspect of the wrist, discovered incidentally in a 71-year-old patient and treated with surgical excision. Several years earlier, Chim and colleagues³⁰ described a similar case, of a large wrist glomus tumor worked up with MRI. In a retrospective review of all extradigital glomus tumors seen over a 20-year period, Schiefer and colleagues³ reported 4 glomus tumors of the wrist out of 56 tumors total. The most common sites were forearm (11 cases) and knee (10 cases), and the majority of patients presented with pain and localized tenderness. Mean tumor size was 0.66 cm (range, 0.1-0.3 cm), with 77% of tumors less than 1 cm. Our patient’s 2.7×2.6×1.1-cm tumor was large for a glomus tumor. Its involvement with the radial artery feeding vessels likely contributed to its large and progressively increasing size. It is worth noting that, in the series by Schiefer and colleagues,³ the only patient with symptoms persisting after excision had a large (3 cm in diameter) deep tumor of the foot; the entire tumor was removed, and there was no recurrence by 10-year follow-up. Folpe and colleagues⁷ suggested that deep tumors larger than 2 cm should be at higher suspicion for malignancy. Joseph and Posner²¹ reported 3 cases of glomus tumors, on the ulnar side of the wrist, diagnosed with help of a provocative test using ethyl chloride spray.

Conclusion

Overall, glomus tumors are rare and challenging to diagnosis and should be in the differential in any symptomatic patient with a painful soft-tissue mass of the wrist. Advanced imaging studies, such as MRI, can assist in localization, diagnosis, and preoperative planning. Histology and immunohistochemistry are essential to differentiate glomus tumor from other vascular tumors, and complete excision is necessary to prevent local recurrence.

Glomus tumors are neoplasms that originate from normal glomus bodies in the skin and are most commonly found in the subungual areas of the digits.¹ Glomus bodies are neuromyoarterial structures in the reticular dermis that serve as specialized arteriovenous anastomoses. These bodies contain afferent arterioles and efferent veins with multiple connections, and glomus cells have contractile properties because of their similarity to smooth muscle cells.^1,2 Glomus bodies help regulate blood flow and temperature of the skin and are found in their largest concentration in the fingertips, palms of the hands, and soles of the feet.^3,4

Glomus tumors represent hyperplastic glomus bodies and make up 1% to 4.5% of upper extremity neoplasms, with approximately 75% in the hand and 50% in the subungual area.^1,5,6 These tumors can also present in multiple locations at once and can occur in atypical and ectopic locations.³ Although generally benign, glomus tumors can also exhibit malignant and metastatic potential in rare cases.^7,8 They can also be locally aggressive with bony destruction of the distal phalynx.^2,9,10 Tumors typically present as painful solitary soft-tissue lesions that are exquisitely tender to palpation, dark red-purple or bluish, and hypersensitive to cold.^5,10 Van Geertruyden and colleagues¹⁰ reported that the diagnosis of glomus tumor can be made clinically in 90% of cases. However, glomus tumors can easily be mistaken for other lesions, such as hemangiomas, angiomas, neuromas, neurofibromas, lipomas, and ganglion cysts. An inaccurate or incomplete workup can result in persistent pain and symptoms along with intraoperative complications.³ Magnetic resonance imaging (MRI), the most sensitive imaging modality for detecting glomus tumors of the hand, can assist in the workup.^3,11,12

Extradigital glomus tumors are difficult to diagnose because of their rarity and unspecific symptoms and presentation.¹³ Misdiagnosis and delayed diagnosis can result in significant chronic pain, disuse syndromes, and disability.^1,10 Correct diagnosis and surgical resection are generally curative with complete resolution of symptoms.

In this article, we report a case of a large atypical glomus tumor that occurred on the wrist and involved the radial artery. This tumor was successfully treated with surgical excision. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 63-year-old man presented to clinic with an extremely tender soft-tissue mass on his nondominant, left wrist. The mass had been increasing in size for a year. It was painless at rest but very painful to light palpation, with referred pain proximally up to the shoulder.

The patient did not recall any traumatic or inciting event, had not undergone any prior workup or treatment for symptoms, and had no history of masses elsewhere on the body. Past medical history was significant for type 2 diabetes and colon and prostate cancer, which had been treated with chemotherapy and was now in remission.

Physical examination revealed a 2×2.5-cm well-circumscribed soft-tissue mass on the volar-radial aspect of the left wrist proximal to the thenar eminence and radial to the flexor carpi radialis tendon (Figure 1). The mass was soft, mobile, and nonfluctuant and did not transilluminate. The overlying skin was normal in color and appearance—no discoloration, erythema, wounds, or drainage. The radial artery was palpable, and the mass did not pulsate or have a bruit. The patient had normal wrist range of motion limited by pain on compression of the mass with motor and sensation intact throughout the hand. Plain radiographs of the wrist showed no bony pathology or involvement from the mass. A soft-tissue shadow was visible around the wrist without calcifications. A wrist MRI was performed to better evaluate the mass, and the T2-weighted images showed a heterogeneous subcutaneous mass adjacent to the radial artery with increased signal intensity from surrounding feeding vessels (Figure 2).

Given the clinical and imaging findings, there was concern for a possible vascular tumor. Therefore, excisional biopsy was recommended over needle biopsy because of the bleeding risk. With the patient under general anesthesia, and a tourniquet used without exsanguination, a Brunner-type zigzag incision was made centered over the mass with elevated skin flaps. The 2.7×2.6×1.1-cm mass was superficial and involved the radial artery (Figure 3). After the radial artery was dissected proximally and distally, 2 perforating vessels were found entering the mass. These vessels were ligated, which allowed the mass to be peeled completely off the artery. Histology with hematoxylin-eosin staining showed solid sheets of uniform round cells with interspersed capillaries and centrally placed nuclei without evidence of malignancy (Figure 4).

The tourniquet was released before skin closure, and adequate hemostasis was obtained. The wound was closed, and the patient was placed in a volar wrist splint for immobilization. Pain relief after excision of the mass was immediate, and the postoperative course uneventful. After surgery, immunohistochemistry of the mass showed minimal mitotic activity, with a positive immunoperoxidase stain for smooth muscle actin confirming a diagnosis of glomus tumor (Figure 5). At 3-year follow-up, the patient had no pain, symptoms, or tumor recurrence.

Discussion

Glomus tumors are an established cause of pain in the subungual areas of the hand; numerous cases have been reported.^1,5,10,14 However, extradigital glomus tumors, particularly those involving the wrist, are rare, and only a few have been described. Given the lack of consistent findings and presentations, diagnosis is difficult. Case series have documented an overall 2:1 female-to-male predominance of glomus tumors,⁶ but extradigital tumors are more common in men (4.6:1 male-to-female ratio).³ Extradigital glomus tumors are commonly diagnosed between ages 40 and 80 years. Classic symptoms of subungual tumors include pain, localized tenderness, and cold hypersensitivity,^1,10 but symptoms are much more variable with extradigital locations. Previous trauma or injury to the lesion area is reported in 20% to 30% of cases before symptom onset.^3,15 Intravascular locations of glomus tumors are extremely rare; only 4 cases of tumors involving venous structures have been reported.^16-19 In the present case, the patient’s main complaints were pain and localized tenderness associated with a progressively increasing mass without any history of trauma. The large size of his mass (~2.5 cm in diameter) on examination was unique, as was involvement of the radial artery.

Misdiagnosis and delayed diagnosis of extradigital glomus tumors are common, and symptoms such as chronic pain typically persist for 7 to 11 years before the correct diagnosis is made.^1,10 On average, 2.5 physician consultants (including psychiatrists) evaluate the patient before glomus tumor is identified.¹⁰ There are other reports of atypical or ectopic glomus tumors taking 5 to 25 years to be diagnosed.^20-22 The differential diagnosis for glomus tumors includes hemangiomas, cellular or cavernous hemangiomas, vascular tumors, neuromas, neurofibromas, lipomas, paragangliomas, ganglion cysts, pigmented nevi, Pacinian corpuscle hyperplasia, and foreign bodies. A key element of clinical diagnosis is the disproportionate amount of pain and localized tenderness caused by the lesion relative to its size. The hypersensitivity of this tumor is thought to result from enlargement of the tumor and impingement on nearby Pacinian corpuscles, nerve endings in the skin that are responsible for sensitivity to vibration and pressure.^2,9

Plain radiographs can be useful in detecting glomus tumors of the hand but are less helpful with extradigital tumors, with identification rates of 24% in certain series.³ MRI is the most sensitive imaging modality for diagnosing glomus tumors of the hand; a detection rate of 80% to 100% has been reported in various case series.^3,11,12 Specificity of MRI for glomus tumors has been reported at 50%.^11,23 Placement of a radiographic marker directly over the area of most pain can assist in tumor localization.³ Glomus tumors typically have decreased signal intensity on T1-weighted images and increased intensity on T2-weighted images, but signal patterns are variable and particularly difficult to differentiate with small tumors. MRI is useful in the setting of recurrent glomus tumors, where incomplete excision is possible. In 24 cases of continued pain after glomus tumor excision, Theumann and colleagues²⁴ used MRI to identify a nodule consistent with recurrent glomus tumor in all patients. Three-dimensional contrast-enhanced magnetic resonance angiography (MRA) can also help diagnose glomus tumors while providing valuable information regarding size and location for surgical planning.^25,26 With MRA, it is crucial to evaluate the arterial or arteriovenous phase of imaging, as the glomus tumor is richly vascularized and shows contrast enhancement after intravenous injection of gadolinium.²⁷ Angiography, ultrasonography, thermography, and scintigraphy have all been used to diagnose glomus tumors but have shown limited utility and accuracy.¹¹

Treatment of glomus tumors is complete surgical excision because of their relatively small size and subcutaneous location. Resection success rates are consistently higher than 95%, with resolution of all symptoms.^1,10,14 Local recurrence of tumors after excision occurs in 1% to 33% of cases, depending on series, and may be immediate or delayed, with immediate recurrence commonly caused by inadequate excision.^1,10,15,28 Delayed recurrence is less common and presents several years after excision, typically with a new growth near the previous excision.¹⁰ Recurrence years after surgery may also represent multiple tumors unrecognized during initial workup and can be treated with repeat excision or radiotherapy.

Robert and colleagues²⁹ recently reported the case of a glomus tumor, on the dorsal aspect of the wrist, discovered incidentally in a 71-year-old patient and treated with surgical excision. Several years earlier, Chim and colleagues³⁰ described a similar case, of a large wrist glomus tumor worked up with MRI. In a retrospective review of all extradigital glomus tumors seen over a 20-year period, Schiefer and colleagues³ reported 4 glomus tumors of the wrist out of 56 tumors total. The most common sites were forearm (11 cases) and knee (10 cases), and the majority of patients presented with pain and localized tenderness. Mean tumor size was 0.66 cm (range, 0.1-0.3 cm), with 77% of tumors less than 1 cm. Our patient’s 2.7×2.6×1.1-cm tumor was large for a glomus tumor. Its involvement with the radial artery feeding vessels likely contributed to its large and progressively increasing size. It is worth noting that, in the series by Schiefer and colleagues,³ the only patient with symptoms persisting after excision had a large (3 cm in diameter) deep tumor of the foot; the entire tumor was removed, and there was no recurrence by 10-year follow-up. Folpe and colleagues⁷ suggested that deep tumors larger than 2 cm should be at higher suspicion for malignancy. Joseph and Posner²¹ reported 3 cases of glomus tumors, on the ulnar side of the wrist, diagnosed with help of a provocative test using ethyl chloride spray.

Conclusion

Overall, glomus tumors are rare and challenging to diagnosis and should be in the differential in any symptomatic patient with a painful soft-tissue mass of the wrist. Advanced imaging studies, such as MRI, can assist in localization, diagnosis, and preoperative planning. Histology and immunohistochemistry are essential to differentiate glomus tumor from other vascular tumors, and complete excision is necessary to prevent local recurrence.

Because of the complex anatomy of the ankle joint and foot, the wide array of possible bone and soft-tissue injuries, and the uncommon occurrence of tumors at these sites, osteoid osteomas (OOs) are often not included in the differential diagnosis of foot and ankle pain.^1,2 Patients with OO usually complain of severe pain that is worse at night and is relieved with use of nonsteroidal anti-inflammatory drugs (NSAIDs).^1-4 This classic clinical presentation, combined with the characteristic imaging features, facilitates making an accurate diagnosis.

OOs were first described in 1935 by Jaffe,⁵ who characterized them as benign, solitary, osteoblastic tumors consisting of atypical bone and osteoid. On radiographs and thin-slice computed tomography (CT), these tumors are small osteolytic lesions surrounded by a larger region of cortical thickening, medullary sclerosis, and benign periosteal new bone formation.^4,6,7 They often contain a central focus of calcification—the nidus. OOs typically occur in children and young adults; the majority of patients are younger than 25 years. OOs show a predilection for the appendicular skeleton, with the majority of the lesions in the femur and tibia.^4,6,7 OOs infrequently occur in the bones of the hands and feet.^8-12 Previous studies of foot and ankle OOs have been predominantly limited to case reports; the largest study, conducted almost 20 years ago, included only 10 patients.¹

We conducted a study to evaluate the epidemiology and radiographic features of foot and ankle OOs, to evaluate surgical treatment options and outcomes in patients with foot and ankle OOs, and to evaluate the disease course of patients with foot and ankle OOs treated surgically or with radiofrequency ablation (RFA).

Materials and Methods

After obtaining approval from our institutional review board, we retrospectively reviewed all cases of patients who underwent a surgical or an interventional radiologic procedure and had a preoperative diagnosis of a lower extremity OO between 1990 and 2010. Only patients with a histologically confirmed diagnosis of OO were included in the review of foot and ankle cases.

The medical records of patients with a diagnosis of foot or ankle OO were reviewed for patient sex, age, OO site, clinical presentation, radiographic studies, pain characteristics, treatment modality, histologic diagnosis, and clinical outcome of the surgical or RFA procedure. Preoperative and postoperative clinical outcome scores were calculated using American Orthopedic Foot and Ankle Society (AOFAS) scores.

Whether to perform surgical excision or RFA was discussed between the treating surgeon and the radiologist before treatment. The goal was to treat each lesion while minimizing damage to normal, surrounding structures. If there was any question whether a lesion could be something other than OO based on radiographic features, the lesion was treated with surgical excision. Surgical excision consisted of curettage and bone grafting or en bloc removal. Surgical hardware was placed only when an osteotomy was needed to access the lesion. RFA was performed by consultant musculoskeletal radiologists. Before ablation, a CT-guided needle biopsy of the lesion was performed to obtain tissue for pathologic diagnosis. Recurrence was defined as return of preoperative symptoms after treatment, along with radiographic features of recurrence.

Statistical analysis was done with SPSS software (IBM, New York, New York) using unpaired Student t tests and Fisher exact tests. Statistical significance was set at P < .05.

Results

Of the 117 patients with a lower extremity OO, 13 (11%) had it in the bones of the foot or ankle (Table). Mean age at presentation was 20.1 years (range, 9-38 years). There was no statistically significant difference in age between patients with foot or ankle OO and patients with OO of the long bones of the lower extremity (P = .27). Of the 13 patients, 12 were male and 1 was female (Table). The foot and ankle OO sites were the talus (n = 5), the distal tibia/plafond (n = 3), the calcaneus (n = 2), the tarsal bones (n = 2), and the phalanx (n = 1). All 13 foot and ankle lesions were histologically confirmed as OO.

The 13 patients’ primary complaint was foot or ankle pain. Ten of the 13 were referred to our institution for clinical workup and management of foot or ankle pain and for assessment of radiographic features of OO (Figure 1). For all patients in the study, preoperative plain film radiographs of the affected extremity were obtained. Nine patients (69%) had a CT scan (Figure 2), 6 (46%) had a magnetic resonance imaging (MRI) scan, and 2 (15%) had a bone scan. Despite undergoing advanced imaging (1 CT, 1 MRI), 2 patients (15%) did not get a differential diagnosis of OO before being treated. The same 2 patients did not have radiographic images available for review to determine why a differential diagnosis of OO was not included based on imaging features prior to surgery. For the patients who did not have a diagnosis of OO before being evaluated at our institution, preliminary diagnoses included osteomyelitis and painful osteophytes. Twelve of the 13 patients complained of pain that was worse at night and was not relieved with use of NSAIDs. Mean time from symptom onset to presentation at our institution was 14.4 months (range, 3-42 months). All patients reported pain relief after the procedure. There was a significant (P = .0001) increase in AOFAS scores after surgery. Mean AOFAS score was 65.42 (range, 54-80) before surgery and 97.91 (range, 90-100) after surgery.

Before 1998, all foot and ankle OOs (n = 6) were treated with surgical excision. After RFA was introduced at our institution, 3 foot and ankle OOs (43%) were treated with RFA (Figures 3A, 3B), and 4 (57%) were treated with surgical curettage (Figure 4). The 4 surgical patients’ OOs were not amenable to RFA primarily because of anatomical considerations: In 2 patients, the OO was too near the articular surface; in another patient, the lesion was in intimate contact with a neurovascular bundle; in the fourth patient, the lesion was amenable to RFA, but the patient’s family selected surgical curettage instead.

Mean tumor nidus size was 7.5 mm (range, 3-12 mm). Bone graft was placed in 3 patients (30%), and surgical hardware was placed to repair a medial malleolar osteotomy in 1 (10%) of the patients treated surgically. The majority of the lesions (8) were in cancellous bone in a subcortical location. Three lesions were intracortical. Seven lesions were intra-articular, and 4 were extra-articular. Two patients did not have radiographic images available for review.

One patient had a recurrence of OO and underwent a repeat procedure 4 months after the initial one. At final follow-up, on average 1 year after the initial procedure (range, 2 weeks–3 years), there were no reported recurrences. One patient underwent a procedure to remove painful hardware that had been implanted, during the primary procedure, to repair the medial malleolar osteotomy used to access the lesion. Recurrence rates for RFA (n = 1) and surgical excision (n = 0) were similar.

Discussion

OOs are relatively common bone tumors that account for about 13% of all benign bone tumors.^4,13 OOs typically occur in children or young adults—the majority of patients are younger than 25 years—and are 3 times more common in males than females.^4,13 Our findings for all patients with a lower extremity OO are consistent with those previously reported: male predominance (75 males, 42 females) and mean age under 25 years (mean age, 18.7 years). In patients with foot or ankle OO, male predominance was substantially greater (12 males, 1 female), though mean age at presentation (20.1 years) was similar.

Local pain is the most common complaint in patients who present with OO.^4,13 Pain is thought to be generated by a combination of multiple nerve endings in the tumor¹⁴ and prostaglandin production by the tumor nidus (prostaglandins E2 and I2)³ causing an inflammatory reaction.⁶ In accord with previous studies,⁴ localized foot or ankle pain was the most common complaint at time of presentation in our study; 100% of our patients had it. All but 1 patient (92%) in our study described pain that was worse at night and relieved by aspirin or other nonsteroidal anti-inflammatory medications. Pain reduction after NSAID use was observed in 92% (12/13) of our patients as well; the 1 patient who did not report pain relief had not used NSAIDs before being evaluated at our institution. Our patient population reported night pain and pain relief with NSAID use more frequently than patients in other studies did.^15,16

The bone most commonly involved in our patients’ foot and ankle OOs was the talus (5/13, 38%). This is in accord with 1 study¹ but contradicts another, in which the most common foot and ankle site was the calcaneus.¹⁷ The site of the lesion in the bone can be subclassified as cortical, cancellous, or subperiosteal.^11,12 Cortical OOs were the most common in our study, but in previous reports the most common were subperiosteal and cancellous.^1,11 As all our OOs were cortical, we classified them (on the basis of the relationship of the nidus to the cortex) as intracortical, periosteal, or subcortical (endosteal) instead of subperiosteal or cancellous. Three of our patients’ lesions were intracortical, 8 were subcortical, and 2 patients did not have radiographs available for review at the time of the study.

Although the classic clinical presentation of OO is often sufficient to raise suspicion for the diagnosis, imaging studies play a crucial role in accurate diagnosis. An accurate diagnosis of OO in the long bones can be made if the lesion presents with characteristic imaging features, as a small round lytic lesion with associated cortical thickening, medullary sclerosis, and chronic benign periosteal new bone formation.¹⁵ In some cases, however, the nidus may be obscured by the extensive associated reactive changes on the radiographs, and therefore the differential diagnosis may also include stress fracture, Brodie abscess, or even osteosarcoma. High-resolution CT is the imaging modality of choice for accurate diagnosis of OO, and it often plays an instrumental role in making the diagnosis and excluding other diagnostic possibilities.^15-17

As foot OOs often occur near the joint (7 intra-articular lesions in our study), they often lack the exuberant periosteal reaction, cortical thickening, and reactive medullary sclerosis that characterize these lesions in the appendicular skeleton.¹⁷ In addition, the anatomical complexity of the small bones of the foot and ankle, particularly the hindfoot, where the bones are flat and irregular, makes identifying the lesions difficult.¹⁷ Conventional radiographs are the initial imaging modality of choice for evaluating patients with a clinical suspicion of OO, and they may identify the tumor. However, if radiographs are nondiagnostic, and the diagnosis of OO is suspected, high-resolution CT should be performed.

MRI is commonly used to assess for ligamentous, tendinous, and articular cartilage injuries in patients with ankle and hindfoot pain. However, as already discussed, and as reported in previous studies,¹⁷ accurate diagnosis of OO can be challenging with MRI (Figure 5A), and often the patients who had MRI scans then underwent CT (Table) for the definitive diagnosis (Figure 5B). In only 1 patient in our study was MRI used to make the preoperative diagnosis of OO (Table). In 2 patients (15%), even advanced imaging did not result in OO being included in the differential diagnosis. This is consistent with other reports, which found that a diagnosis was not made in 11% of patients.¹⁶ Although almost a quarter of patients did not have radiographic features diagnostic of OO, CT is the modality of choice for all patients who have clinical features suggestive of a diagnosis of OO.

Surgical treatment of OO is effective when the entire nidus is removed, with excision providing rapid pain relief.^4,6,7,11,12 Historically, the tumor was often treated with wide, en bloc resection, but this is a large operation involving removal of a substantial amount of surrounding normal bone, as the lesion is often difficult to identify intraoperatively without preoperative localization.^4,6,13 Curettage was performed on the lesion to reduce the amount of bone removed.⁴ Both techniques are reportedly very successful in treating OOs, with recurrence rates ranging from 0% to 15%.^18,19 In our study, none of the surgically treated lesions recurred, and their AOFAS score improved from 67.11 (range, 54-80) before surgery to 98.33 (range, 93-100) after surgery. However, all surgically treated patients required a mean of 3 weeks (0-2.5 months) of either partial weight-bearing or non-weight-bearing of the affected extremity. A variety of treatment techniques have been used as alternatives to surgical resection in an attempt to treat OOs effectively and minimize damage to the surrounding normal bone.^4,6,13 These techniques have included percutaneous CT-guided tumor excision with a trephine; percutaneous or surgical ablation using laser, cryotherapy, or ethanol; CT-guided localization followed by operative excision; and CT-guided percutaneous RFA.^4,6,13,20 Over the past 2 decades, CT-guided percutaneous RFA has evolved to become the treatment of choice for painful OOs of the appendicular skeleton.^15,21,22 The success of this procedure depends on accurate preprocedure diagnosis and precise anatomical localization with CT. Our results correlate with those in series reported in the literature, showing no significant difference in tumor recurrence rates between this technique and surgical excision.²²

In our study, 3 patients were treated with CT-guided RFA. Because of recurrent pain, 1 of these patients had a repeat RFA 4 months after the initial procedure. After the second procedure, the patient was asymptomatic. Pain recurrence rates have ranged from 2% to 11% in large series of treated nonspinal OOs.^21-23 Our RFA patients’ mean AOFAS score notably improved from 60.33 (range, 60-61) before surgery to 96.66 (range, 90-100) after surgery.

One of the distinct advantages of CT-guided RFA of OO is that it provides a minimally invasive technique for curative treatment with minimal damage to the adjacent normal bone by providing selective and controlled ablation of the tumor nidus.¹⁵ Additional advantages are that it can be performed as an outpatient procedure, and patients convalesce quickly with unrestricted weight-bearing and immediate return to activities of daily living.^21-23 In addition, when RFA and surgical excision were compared on their average costs of hospitalization and treatment for OO, RFA was found to be less expensive.²⁴

There were no RFA-related complications in our study population, but complications have been reported (albeit rarely) in other large studies of using RFA throughout the appendicular skeleton.^21,25 Reported complications include skin burns, nerve damage, reflex sympathetic dystrophy, cellulitis, and thrombophlebitis.^21,25 To reduce the risk for these complications, the investigators emphasized the importance of avoiding use of RFA for lesions near a neurovascular bundle (<1.5 cm away) or in a superficial location near the surface of the skin (<1.0 cm away).^21,25

We believe that surgical resection and RFA provide equally effective treatment outcomes for patients with foot and ankle OOs. The major contraindication to RFA is anatomical proximity (<1.5 cm) to a major neurovascular bundle. Theoretically, articular cartilage can be damaged during RFA.^21,25 To our knowledge, there have been no reported complications involving articular cartilage damage. However, surgeons should carefully measure the distance from lesion to articular cartilage and select the treatment option that will cause the least amount of damage to the cartilage.

Two limitations of this study are its retrospective nature and relatively small number of patients. As all the lesions in the study were treated surgically or with RFA, we are unable to comment on the natural history of untreated foot and ankle OOs. Although there were no recurrences, late recurrence is possible with longer follow-up. However, we think this study will not only increase familiarity with the imaging features of OOs involving the bones of the foot and ankle, but it will help clinicians formulate optimal treatment plans.

Overall, OOs are relatively common benign bone tumors, with limited reports of their occurrence in the foot and ankle. There should be a high index of suspicion for the diagnosis if a patient presents with the symptoms classically associated with the tumor, but in some cases the diagnosis can be challenging. Proper imaging is essential for prompt and accurate diagnosis.

Because of the complex anatomy of the ankle joint and foot, the wide array of possible bone and soft-tissue injuries, and the uncommon occurrence of tumors at these sites, osteoid osteomas (OOs) are often not included in the differential diagnosis of foot and ankle pain.^1,2 Patients with OO usually complain of severe pain that is worse at night and is relieved with use of nonsteroidal anti-inflammatory drugs (NSAIDs).^1-4 This classic clinical presentation, combined with the characteristic imaging features, facilitates making an accurate diagnosis.

OOs were first described in 1935 by Jaffe,⁵ who characterized them as benign, solitary, osteoblastic tumors consisting of atypical bone and osteoid. On radiographs and thin-slice computed tomography (CT), these tumors are small osteolytic lesions surrounded by a larger region of cortical thickening, medullary sclerosis, and benign periosteal new bone formation.^4,6,7 They often contain a central focus of calcification—the nidus. OOs typically occur in children and young adults; the majority of patients are younger than 25 years. OOs show a predilection for the appendicular skeleton, with the majority of the lesions in the femur and tibia.^4,6,7 OOs infrequently occur in the bones of the hands and feet.^8-12 Previous studies of foot and ankle OOs have been predominantly limited to case reports; the largest study, conducted almost 20 years ago, included only 10 patients.¹

We conducted a study to evaluate the epidemiology and radiographic features of foot and ankle OOs, to evaluate surgical treatment options and outcomes in patients with foot and ankle OOs, and to evaluate the disease course of patients with foot and ankle OOs treated surgically or with radiofrequency ablation (RFA).

Materials and Methods

After obtaining approval from our institutional review board, we retrospectively reviewed all cases of patients who underwent a surgical or an interventional radiologic procedure and had a preoperative diagnosis of a lower extremity OO between 1990 and 2010. Only patients with a histologically confirmed diagnosis of OO were included in the review of foot and ankle cases.

The medical records of patients with a diagnosis of foot or ankle OO were reviewed for patient sex, age, OO site, clinical presentation, radiographic studies, pain characteristics, treatment modality, histologic diagnosis, and clinical outcome of the surgical or RFA procedure. Preoperative and postoperative clinical outcome scores were calculated using American Orthopedic Foot and Ankle Society (AOFAS) scores.

Whether to perform surgical excision or RFA was discussed between the treating surgeon and the radiologist before treatment. The goal was to treat each lesion while minimizing damage to normal, surrounding structures. If there was any question whether a lesion could be something other than OO based on radiographic features, the lesion was treated with surgical excision. Surgical excision consisted of curettage and bone grafting or en bloc removal. Surgical hardware was placed only when an osteotomy was needed to access the lesion. RFA was performed by consultant musculoskeletal radiologists. Before ablation, a CT-guided needle biopsy of the lesion was performed to obtain tissue for pathologic diagnosis. Recurrence was defined as return of preoperative symptoms after treatment, along with radiographic features of recurrence.

Statistical analysis was done with SPSS software (IBM, New York, New York) using unpaired Student t tests and Fisher exact tests. Statistical significance was set at P < .05.

Results

Of the 117 patients with a lower extremity OO, 13 (11%) had it in the bones of the foot or ankle (Table). Mean age at presentation was 20.1 years (range, 9-38 years). There was no statistically significant difference in age between patients with foot or ankle OO and patients with OO of the long bones of the lower extremity (P = .27). Of the 13 patients, 12 were male and 1 was female (Table). The foot and ankle OO sites were the talus (n = 5), the distal tibia/plafond (n = 3), the calcaneus (n = 2), the tarsal bones (n = 2), and the phalanx (n = 1). All 13 foot and ankle lesions were histologically confirmed as OO.

The 13 patients’ primary complaint was foot or ankle pain. Ten of the 13 were referred to our institution for clinical workup and management of foot or ankle pain and for assessment of radiographic features of OO (Figure 1). For all patients in the study, preoperative plain film radiographs of the affected extremity were obtained. Nine patients (69%) had a CT scan (Figure 2), 6 (46%) had a magnetic resonance imaging (MRI) scan, and 2 (15%) had a bone scan. Despite undergoing advanced imaging (1 CT, 1 MRI), 2 patients (15%) did not get a differential diagnosis of OO before being treated. The same 2 patients did not have radiographic images available for review to determine why a differential diagnosis of OO was not included based on imaging features prior to surgery. For the patients who did not have a diagnosis of OO before being evaluated at our institution, preliminary diagnoses included osteomyelitis and painful osteophytes. Twelve of the 13 patients complained of pain that was worse at night and was not relieved with use of NSAIDs. Mean time from symptom onset to presentation at our institution was 14.4 months (range, 3-42 months). All patients reported pain relief after the procedure. There was a significant (P = .0001) increase in AOFAS scores after surgery. Mean AOFAS score was 65.42 (range, 54-80) before surgery and 97.91 (range, 90-100) after surgery.

Before 1998, all foot and ankle OOs (n = 6) were treated with surgical excision. After RFA was introduced at our institution, 3 foot and ankle OOs (43%) were treated with RFA (Figures 3A, 3B), and 4 (57%) were treated with surgical curettage (Figure 4). The 4 surgical patients’ OOs were not amenable to RFA primarily because of anatomical considerations: In 2 patients, the OO was too near the articular surface; in another patient, the lesion was in intimate contact with a neurovascular bundle; in the fourth patient, the lesion was amenable to RFA, but the patient’s family selected surgical curettage instead.

Mean tumor nidus size was 7.5 mm (range, 3-12 mm). Bone graft was placed in 3 patients (30%), and surgical hardware was placed to repair a medial malleolar osteotomy in 1 (10%) of the patients treated surgically. The majority of the lesions (8) were in cancellous bone in a subcortical location. Three lesions were intracortical. Seven lesions were intra-articular, and 4 were extra-articular. Two patients did not have radiographic images available for review.

One patient had a recurrence of OO and underwent a repeat procedure 4 months after the initial one. At final follow-up, on average 1 year after the initial procedure (range, 2 weeks–3 years), there were no reported recurrences. One patient underwent a procedure to remove painful hardware that had been implanted, during the primary procedure, to repair the medial malleolar osteotomy used to access the lesion. Recurrence rates for RFA (n = 1) and surgical excision (n = 0) were similar.

Discussion

OOs are relatively common bone tumors that account for about 13% of all benign bone tumors.^4,13 OOs typically occur in children or young adults—the majority of patients are younger than 25 years—and are 3 times more common in males than females.^4,13 Our findings for all patients with a lower extremity OO are consistent with those previously reported: male predominance (75 males, 42 females) and mean age under 25 years (mean age, 18.7 years). In patients with foot or ankle OO, male predominance was substantially greater (12 males, 1 female), though mean age at presentation (20.1 years) was similar.

Local pain is the most common complaint in patients who present with OO.^4,13 Pain is thought to be generated by a combination of multiple nerve endings in the tumor¹⁴ and prostaglandin production by the tumor nidus (prostaglandins E2 and I2)³ causing an inflammatory reaction.⁶ In accord with previous studies,⁴ localized foot or ankle pain was the most common complaint at time of presentation in our study; 100% of our patients had it. All but 1 patient (92%) in our study described pain that was worse at night and relieved by aspirin or other nonsteroidal anti-inflammatory medications. Pain reduction after NSAID use was observed in 92% (12/13) of our patients as well; the 1 patient who did not report pain relief had not used NSAIDs before being evaluated at our institution. Our patient population reported night pain and pain relief with NSAID use more frequently than patients in other studies did.^15,16

The bone most commonly involved in our patients’ foot and ankle OOs was the talus (5/13, 38%). This is in accord with 1 study¹ but contradicts another, in which the most common foot and ankle site was the calcaneus.¹⁷ The site of the lesion in the bone can be subclassified as cortical, cancellous, or subperiosteal.^11,12 Cortical OOs were the most common in our study, but in previous reports the most common were subperiosteal and cancellous.^1,11 As all our OOs were cortical, we classified them (on the basis of the relationship of the nidus to the cortex) as intracortical, periosteal, or subcortical (endosteal) instead of subperiosteal or cancellous. Three of our patients’ lesions were intracortical, 8 were subcortical, and 2 patients did not have radiographs available for review at the time of the study.

Although the classic clinical presentation of OO is often sufficient to raise suspicion for the diagnosis, imaging studies play a crucial role in accurate diagnosis. An accurate diagnosis of OO in the long bones can be made if the lesion presents with characteristic imaging features, as a small round lytic lesion with associated cortical thickening, medullary sclerosis, and chronic benign periosteal new bone formation.¹⁵ In some cases, however, the nidus may be obscured by the extensive associated reactive changes on the radiographs, and therefore the differential diagnosis may also include stress fracture, Brodie abscess, or even osteosarcoma. High-resolution CT is the imaging modality of choice for accurate diagnosis of OO, and it often plays an instrumental role in making the diagnosis and excluding other diagnostic possibilities.^15-17

As foot OOs often occur near the joint (7 intra-articular lesions in our study), they often lack the exuberant periosteal reaction, cortical thickening, and reactive medullary sclerosis that characterize these lesions in the appendicular skeleton.¹⁷ In addition, the anatomical complexity of the small bones of the foot and ankle, particularly the hindfoot, where the bones are flat and irregular, makes identifying the lesions difficult.¹⁷ Conventional radiographs are the initial imaging modality of choice for evaluating patients with a clinical suspicion of OO, and they may identify the tumor. However, if radiographs are nondiagnostic, and the diagnosis of OO is suspected, high-resolution CT should be performed.

MRI is commonly used to assess for ligamentous, tendinous, and articular cartilage injuries in patients with ankle and hindfoot pain. However, as already discussed, and as reported in previous studies,¹⁷ accurate diagnosis of OO can be challenging with MRI (Figure 5A), and often the patients who had MRI scans then underwent CT (Table) for the definitive diagnosis (Figure 5B). In only 1 patient in our study was MRI used to make the preoperative diagnosis of OO (Table). In 2 patients (15%), even advanced imaging did not result in OO being included in the differential diagnosis. This is consistent with other reports, which found that a diagnosis was not made in 11% of patients.¹⁶ Although almost a quarter of patients did not have radiographic features diagnostic of OO, CT is the modality of choice for all patients who have clinical features suggestive of a diagnosis of OO.

Surgical treatment of OO is effective when the entire nidus is removed, with excision providing rapid pain relief.^4,6,7,11,12 Historically, the tumor was often treated with wide, en bloc resection, but this is a large operation involving removal of a substantial amount of surrounding normal bone, as the lesion is often difficult to identify intraoperatively without preoperative localization.^4,6,13 Curettage was performed on the lesion to reduce the amount of bone removed.⁴ Both techniques are reportedly very successful in treating OOs, with recurrence rates ranging from 0% to 15%.^18,19 In our study, none of the surgically treated lesions recurred, and their AOFAS score improved from 67.11 (range, 54-80) before surgery to 98.33 (range, 93-100) after surgery. However, all surgically treated patients required a mean of 3 weeks (0-2.5 months) of either partial weight-bearing or non-weight-bearing of the affected extremity. A variety of treatment techniques have been used as alternatives to surgical resection in an attempt to treat OOs effectively and minimize damage to the surrounding normal bone.^4,6,13 These techniques have included percutaneous CT-guided tumor excision with a trephine; percutaneous or surgical ablation using laser, cryotherapy, or ethanol; CT-guided localization followed by operative excision; and CT-guided percutaneous RFA.^4,6,13,20 Over the past 2 decades, CT-guided percutaneous RFA has evolved to become the treatment of choice for painful OOs of the appendicular skeleton.^15,21,22 The success of this procedure depends on accurate preprocedure diagnosis and precise anatomical localization with CT. Our results correlate with those in series reported in the literature, showing no significant difference in tumor recurrence rates between this technique and surgical excision.²²

In our study, 3 patients were treated with CT-guided RFA. Because of recurrent pain, 1 of these patients had a repeat RFA 4 months after the initial procedure. After the second procedure, the patient was asymptomatic. Pain recurrence rates have ranged from 2% to 11% in large series of treated nonspinal OOs.^21-23 Our RFA patients’ mean AOFAS score notably improved from 60.33 (range, 60-61) before surgery to 96.66 (range, 90-100) after surgery.

One of the distinct advantages of CT-guided RFA of OO is that it provides a minimally invasive technique for curative treatment with minimal damage to the adjacent normal bone by providing selective and controlled ablation of the tumor nidus.¹⁵ Additional advantages are that it can be performed as an outpatient procedure, and patients convalesce quickly with unrestricted weight-bearing and immediate return to activities of daily living.^21-23 In addition, when RFA and surgical excision were compared on their average costs of hospitalization and treatment for OO, RFA was found to be less expensive.²⁴

There were no RFA-related complications in our study population, but complications have been reported (albeit rarely) in other large studies of using RFA throughout the appendicular skeleton.^21,25 Reported complications include skin burns, nerve damage, reflex sympathetic dystrophy, cellulitis, and thrombophlebitis.^21,25 To reduce the risk for these complications, the investigators emphasized the importance of avoiding use of RFA for lesions near a neurovascular bundle (<1.5 cm away) or in a superficial location near the surface of the skin (<1.0 cm away).^21,25

We believe that surgical resection and RFA provide equally effective treatment outcomes for patients with foot and ankle OOs. The major contraindication to RFA is anatomical proximity (<1.5 cm) to a major neurovascular bundle. Theoretically, articular cartilage can be damaged during RFA.^21,25 To our knowledge, there have been no reported complications involving articular cartilage damage. However, surgeons should carefully measure the distance from lesion to articular cartilage and select the treatment option that will cause the least amount of damage to the cartilage.

Two limitations of this study are its retrospective nature and relatively small number of patients. As all the lesions in the study were treated surgically or with RFA, we are unable to comment on the natural history of untreated foot and ankle OOs. Although there were no recurrences, late recurrence is possible with longer follow-up. However, we think this study will not only increase familiarity with the imaging features of OOs involving the bones of the foot and ankle, but it will help clinicians formulate optimal treatment plans.

Overall, OOs are relatively common benign bone tumors, with limited reports of their occurrence in the foot and ankle. There should be a high index of suspicion for the diagnosis if a patient presents with the symptoms classically associated with the tumor, but in some cases the diagnosis can be challenging. Proper imaging is essential for prompt and accurate diagnosis.

Because of the complex anatomy of the ankle joint and foot, the wide array of possible bone and soft-tissue injuries, and the uncommon occurrence of tumors at these sites, osteoid osteomas (OOs) are often not included in the differential diagnosis of foot and ankle pain.^1,2 Patients with OO usually complain of severe pain that is worse at night and is relieved with use of nonsteroidal anti-inflammatory drugs (NSAIDs).^1-4 This classic clinical presentation, combined with the characteristic imaging features, facilitates making an accurate diagnosis.

OOs were first described in 1935 by Jaffe,⁵ who characterized them as benign, solitary, osteoblastic tumors consisting of atypical bone and osteoid. On radiographs and thin-slice computed tomography (CT), these tumors are small osteolytic lesions surrounded by a larger region of cortical thickening, medullary sclerosis, and benign periosteal new bone formation.^4,6,7 They often contain a central focus of calcification—the nidus. OOs typically occur in children and young adults; the majority of patients are younger than 25 years. OOs show a predilection for the appendicular skeleton, with the majority of the lesions in the femur and tibia.^4,6,7 OOs infrequently occur in the bones of the hands and feet.^8-12 Previous studies of foot and ankle OOs have been predominantly limited to case reports; the largest study, conducted almost 20 years ago, included only 10 patients.¹

We conducted a study to evaluate the epidemiology and radiographic features of foot and ankle OOs, to evaluate surgical treatment options and outcomes in patients with foot and ankle OOs, and to evaluate the disease course of patients with foot and ankle OOs treated surgically or with radiofrequency ablation (RFA).

Materials and Methods

After obtaining approval from our institutional review board, we retrospectively reviewed all cases of patients who underwent a surgical or an interventional radiologic procedure and had a preoperative diagnosis of a lower extremity OO between 1990 and 2010. Only patients with a histologically confirmed diagnosis of OO were included in the review of foot and ankle cases.

The medical records of patients with a diagnosis of foot or ankle OO were reviewed for patient sex, age, OO site, clinical presentation, radiographic studies, pain characteristics, treatment modality, histologic diagnosis, and clinical outcome of the surgical or RFA procedure. Preoperative and postoperative clinical outcome scores were calculated using American Orthopedic Foot and Ankle Society (AOFAS) scores.

Whether to perform surgical excision or RFA was discussed between the treating surgeon and the radiologist before treatment. The goal was to treat each lesion while minimizing damage to normal, surrounding structures. If there was any question whether a lesion could be something other than OO based on radiographic features, the lesion was treated with surgical excision. Surgical excision consisted of curettage and bone grafting or en bloc removal. Surgical hardware was placed only when an osteotomy was needed to access the lesion. RFA was performed by consultant musculoskeletal radiologists. Before ablation, a CT-guided needle biopsy of the lesion was performed to obtain tissue for pathologic diagnosis. Recurrence was defined as return of preoperative symptoms after treatment, along with radiographic features of recurrence.

Statistical analysis was done with SPSS software (IBM, New York, New York) using unpaired Student t tests and Fisher exact tests. Statistical significance was set at P < .05.

Results

Of the 117 patients with a lower extremity OO, 13 (11%) had it in the bones of the foot or ankle (Table). Mean age at presentation was 20.1 years (range, 9-38 years). There was no statistically significant difference in age between patients with foot or ankle OO and patients with OO of the long bones of the lower extremity (P = .27). Of the 13 patients, 12 were male and 1 was female (Table). The foot and ankle OO sites were the talus (n = 5), the distal tibia/plafond (n = 3), the calcaneus (n = 2), the tarsal bones (n = 2), and the phalanx (n = 1). All 13 foot and ankle lesions were histologically confirmed as OO.

The 13 patients’ primary complaint was foot or ankle pain. Ten of the 13 were referred to our institution for clinical workup and management of foot or ankle pain and for assessment of radiographic features of OO (Figure 1). For all patients in the study, preoperative plain film radiographs of the affected extremity were obtained. Nine patients (69%) had a CT scan (Figure 2), 6 (46%) had a magnetic resonance imaging (MRI) scan, and 2 (15%) had a bone scan. Despite undergoing advanced imaging (1 CT, 1 MRI), 2 patients (15%) did not get a differential diagnosis of OO before being treated. The same 2 patients did not have radiographic images available for review to determine why a differential diagnosis of OO was not included based on imaging features prior to surgery. For the patients who did not have a diagnosis of OO before being evaluated at our institution, preliminary diagnoses included osteomyelitis and painful osteophytes. Twelve of the 13 patients complained of pain that was worse at night and was not relieved with use of NSAIDs. Mean time from symptom onset to presentation at our institution was 14.4 months (range, 3-42 months). All patients reported pain relief after the procedure. There was a significant (P = .0001) increase in AOFAS scores after surgery. Mean AOFAS score was 65.42 (range, 54-80) before surgery and 97.91 (range, 90-100) after surgery.

Before 1998, all foot and ankle OOs (n = 6) were treated with surgical excision. After RFA was introduced at our institution, 3 foot and ankle OOs (43%) were treated with RFA (Figures 3A, 3B), and 4 (57%) were treated with surgical curettage (Figure 4). The 4 surgical patients’ OOs were not amenable to RFA primarily because of anatomical considerations: In 2 patients, the OO was too near the articular surface; in another patient, the lesion was in intimate contact with a neurovascular bundle; in the fourth patient, the lesion was amenable to RFA, but the patient’s family selected surgical curettage instead.

Mean tumor nidus size was 7.5 mm (range, 3-12 mm). Bone graft was placed in 3 patients (30%), and surgical hardware was placed to repair a medial malleolar osteotomy in 1 (10%) of the patients treated surgically. The majority of the lesions (8) were in cancellous bone in a subcortical location. Three lesions were intracortical. Seven lesions were intra-articular, and 4 were extra-articular. Two patients did not have radiographic images available for review.

One patient had a recurrence of OO and underwent a repeat procedure 4 months after the initial one. At final follow-up, on average 1 year after the initial procedure (range, 2 weeks–3 years), there were no reported recurrences. One patient underwent a procedure to remove painful hardware that had been implanted, during the primary procedure, to repair the medial malleolar osteotomy used to access the lesion. Recurrence rates for RFA (n = 1) and surgical excision (n = 0) were similar.

Discussion

OOs are relatively common bone tumors that account for about 13% of all benign bone tumors.^4,13 OOs typically occur in children or young adults—the majority of patients are younger than 25 years—and are 3 times more common in males than females.^4,13 Our findings for all patients with a lower extremity OO are consistent with those previously reported: male predominance (75 males, 42 females) and mean age under 25 years (mean age, 18.7 years). In patients with foot or ankle OO, male predominance was substantially greater (12 males, 1 female), though mean age at presentation (20.1 years) was similar.

Local pain is the most common complaint in patients who present with OO.^4,13 Pain is thought to be generated by a combination of multiple nerve endings in the tumor¹⁴ and prostaglandin production by the tumor nidus (prostaglandins E2 and I2)³ causing an inflammatory reaction.⁶ In accord with previous studies,⁴ localized foot or ankle pain was the most common complaint at time of presentation in our study; 100% of our patients had it. All but 1 patient (92%) in our study described pain that was worse at night and relieved by aspirin or other nonsteroidal anti-inflammatory medications. Pain reduction after NSAID use was observed in 92% (12/13) of our patients as well; the 1 patient who did not report pain relief had not used NSAIDs before being evaluated at our institution. Our patient population reported night pain and pain relief with NSAID use more frequently than patients in other studies did.^15,16

The bone most commonly involved in our patients’ foot and ankle OOs was the talus (5/13, 38%). This is in accord with 1 study¹ but contradicts another, in which the most common foot and ankle site was the calcaneus.¹⁷ The site of the lesion in the bone can be subclassified as cortical, cancellous, or subperiosteal.^11,12 Cortical OOs were the most common in our study, but in previous reports the most common were subperiosteal and cancellous.^1,11 As all our OOs were cortical, we classified them (on the basis of the relationship of the nidus to the cortex) as intracortical, periosteal, or subcortical (endosteal) instead of subperiosteal or cancellous. Three of our patients’ lesions were intracortical, 8 were subcortical, and 2 patients did not have radiographs available for review at the time of the study.

Although the classic clinical presentation of OO is often sufficient to raise suspicion for the diagnosis, imaging studies play a crucial role in accurate diagnosis. An accurate diagnosis of OO in the long bones can be made if the lesion presents with characteristic imaging features, as a small round lytic lesion with associated cortical thickening, medullary sclerosis, and chronic benign periosteal new bone formation.¹⁵ In some cases, however, the nidus may be obscured by the extensive associated reactive changes on the radiographs, and therefore the differential diagnosis may also include stress fracture, Brodie abscess, or even osteosarcoma. High-resolution CT is the imaging modality of choice for accurate diagnosis of OO, and it often plays an instrumental role in making the diagnosis and excluding other diagnostic possibilities.^15-17

As foot OOs often occur near the joint (7 intra-articular lesions in our study), they often lack the exuberant periosteal reaction, cortical thickening, and reactive medullary sclerosis that characterize these lesions in the appendicular skeleton.¹⁷ In addition, the anatomical complexity of the small bones of the foot and ankle, particularly the hindfoot, where the bones are flat and irregular, makes identifying the lesions difficult.¹⁷ Conventional radiographs are the initial imaging modality of choice for evaluating patients with a clinical suspicion of OO, and they may identify the tumor. However, if radiographs are nondiagnostic, and the diagnosis of OO is suspected, high-resolution CT should be performed.

MRI is commonly used to assess for ligamentous, tendinous, and articular cartilage injuries in patients with ankle and hindfoot pain. However, as already discussed, and as reported in previous studies,¹⁷ accurate diagnosis of OO can be challenging with MRI (Figure 5A), and often the patients who had MRI scans then underwent CT (Table) for the definitive diagnosis (Figure 5B). In only 1 patient in our study was MRI used to make the preoperative diagnosis of OO (Table). In 2 patients (15%), even advanced imaging did not result in OO being included in the differential diagnosis. This is consistent with other reports, which found that a diagnosis was not made in 11% of patients.¹⁶ Although almost a quarter of patients did not have radiographic features diagnostic of OO, CT is the modality of choice for all patients who have clinical features suggestive of a diagnosis of OO.

Surgical treatment of OO is effective when the entire nidus is removed, with excision providing rapid pain relief.^4,6,7,11,12 Historically, the tumor was often treated with wide, en bloc resection, but this is a large operation involving removal of a substantial amount of surrounding normal bone, as the lesion is often difficult to identify intraoperatively without preoperative localization.^4,6,13 Curettage was performed on the lesion to reduce the amount of bone removed.⁴ Both techniques are reportedly very successful in treating OOs, with recurrence rates ranging from 0% to 15%.^18,19 In our study, none of the surgically treated lesions recurred, and their AOFAS score improved from 67.11 (range, 54-80) before surgery to 98.33 (range, 93-100) after surgery. However, all surgically treated patients required a mean of 3 weeks (0-2.5 months) of either partial weight-bearing or non-weight-bearing of the affected extremity. A variety of treatment techniques have been used as alternatives to surgical resection in an attempt to treat OOs effectively and minimize damage to the surrounding normal bone.^4,6,13 These techniques have included percutaneous CT-guided tumor excision with a trephine; percutaneous or surgical ablation using laser, cryotherapy, or ethanol; CT-guided localization followed by operative excision; and CT-guided percutaneous RFA.^4,6,13,20 Over the past 2 decades, CT-guided percutaneous RFA has evolved to become the treatment of choice for painful OOs of the appendicular skeleton.^15,21,22 The success of this procedure depends on accurate preprocedure diagnosis and precise anatomical localization with CT. Our results correlate with those in series reported in the literature, showing no significant difference in tumor recurrence rates between this technique and surgical excision.²²

In our study, 3 patients were treated with CT-guided RFA. Because of recurrent pain, 1 of these patients had a repeat RFA 4 months after the initial procedure. After the second procedure, the patient was asymptomatic. Pain recurrence rates have ranged from 2% to 11% in large series of treated nonspinal OOs.^21-23 Our RFA patients’ mean AOFAS score notably improved from 60.33 (range, 60-61) before surgery to 96.66 (range, 90-100) after surgery.

One of the distinct advantages of CT-guided RFA of OO is that it provides a minimally invasive technique for curative treatment with minimal damage to the adjacent normal bone by providing selective and controlled ablation of the tumor nidus.¹⁵ Additional advantages are that it can be performed as an outpatient procedure, and patients convalesce quickly with unrestricted weight-bearing and immediate return to activities of daily living.^21-23 In addition, when RFA and surgical excision were compared on their average costs of hospitalization and treatment for OO, RFA was found to be less expensive.²⁴

There were no RFA-related complications in our study population, but complications have been reported (albeit rarely) in other large studies of using RFA throughout the appendicular skeleton.^21,25 Reported complications include skin burns, nerve damage, reflex sympathetic dystrophy, cellulitis, and thrombophlebitis.^21,25 To reduce the risk for these complications, the investigators emphasized the importance of avoiding use of RFA for lesions near a neurovascular bundle (<1.5 cm away) or in a superficial location near the surface of the skin (<1.0 cm away).^21,25

We believe that surgical resection and RFA provide equally effective treatment outcomes for patients with foot and ankle OOs. The major contraindication to RFA is anatomical proximity (<1.5 cm) to a major neurovascular bundle. Theoretically, articular cartilage can be damaged during RFA.^21,25 To our knowledge, there have been no reported complications involving articular cartilage damage. However, surgeons should carefully measure the distance from lesion to articular cartilage and select the treatment option that will cause the least amount of damage to the cartilage.

Two limitations of this study are its retrospective nature and relatively small number of patients. As all the lesions in the study were treated surgically or with RFA, we are unable to comment on the natural history of untreated foot and ankle OOs. Although there were no recurrences, late recurrence is possible with longer follow-up. However, we think this study will not only increase familiarity with the imaging features of OOs involving the bones of the foot and ankle, but it will help clinicians formulate optimal treatment plans.

Overall, OOs are relatively common benign bone tumors, with limited reports of their occurrence in the foot and ankle. There should be a high index of suspicion for the diagnosis if a patient presents with the symptoms classically associated with the tumor, but in some cases the diagnosis can be challenging. Proper imaging is essential for prompt and accurate diagnosis.

CHICAGO – The first guidelines recommending antibiotic prophylaxis for invasive dental procedures were issued in 1955, and controversy has gone hand in hand with each revision that has called for shorter treatment duration and fewer eligible patients.

A study presented at the American Heart Association scientific sessions adds to that controversy – and has prompted the United Kingdom’s National Institute for Health and Care Excellence to immediately review its 2008 guidelines.

Those guidelines recommend that antibiotics should not be prescribed to prevent infective endocarditis (IE) for people undergoing dental procedures or procedures in the upper and lower gastrointestinal tract, genitourinary tract, and upper and lower respiratory tract.

Five years post NICE, the new study found that antibiotic prophylaxis prescribing fell almost 90% in the United Kingdom, from 10,900 prescriptions per month to 1,307 per month in the last 6 months of the study, reported Dr. Mark Dayer of Taunton and Somerset NHS Trust, Somerset, England. The study was simultaneously published in the Lancet (2014 Nov. 18[doi:10.1016/S0140-6736(14)62007-9]).

In a video interview, study coauthor Dr. Martin Thornhill of the University of Sheffield, England, and AHA President-Elect Dr. Mark Creager, director of the vascular center at Brigham and Women’s Hospital, Boston, talked about the findings, their potential limitations, and whether it’s time for clinicians to change their approach to antibiotic prophylaxis.

The study was funded by the National Institutes of Dental and Cranofacial Research, Heart Research–UK, and Simplyhealth. Dr. Thornhill and Dr. Creager reported no conflicting interests.

[email protected]

CHICAGO – The first guidelines recommending antibiotic prophylaxis for invasive dental procedures were issued in 1955, and controversy has gone hand in hand with each revision that has called for shorter treatment duration and fewer eligible patients.

A study presented at the American Heart Association scientific sessions adds to that controversy – and has prompted the United Kingdom’s National Institute for Health and Care Excellence to immediately review its 2008 guidelines.

Those guidelines recommend that antibiotics should not be prescribed to prevent infective endocarditis (IE) for people undergoing dental procedures or procedures in the upper and lower gastrointestinal tract, genitourinary tract, and upper and lower respiratory tract.

Five years post NICE, the new study found that antibiotic prophylaxis prescribing fell almost 90% in the United Kingdom, from 10,900 prescriptions per month to 1,307 per month in the last 6 months of the study, reported Dr. Mark Dayer of Taunton and Somerset NHS Trust, Somerset, England. The study was simultaneously published in the Lancet (2014 Nov. 18[doi:10.1016/S0140-6736(14)62007-9]).

In a video interview, study coauthor Dr. Martin Thornhill of the University of Sheffield, England, and AHA President-Elect Dr. Mark Creager, director of the vascular center at Brigham and Women’s Hospital, Boston, talked about the findings, their potential limitations, and whether it’s time for clinicians to change their approach to antibiotic prophylaxis.

The study was funded by the National Institutes of Dental and Cranofacial Research, Heart Research–UK, and Simplyhealth. Dr. Thornhill and Dr. Creager reported no conflicting interests.

[email protected]

CHICAGO – The first guidelines recommending antibiotic prophylaxis for invasive dental procedures were issued in 1955, and controversy has gone hand in hand with each revision that has called for shorter treatment duration and fewer eligible patients.

A study presented at the American Heart Association scientific sessions adds to that controversy – and has prompted the United Kingdom’s National Institute for Health and Care Excellence to immediately review its 2008 guidelines.

Those guidelines recommend that antibiotics should not be prescribed to prevent infective endocarditis (IE) for people undergoing dental procedures or procedures in the upper and lower gastrointestinal tract, genitourinary tract, and upper and lower respiratory tract.

Five years post NICE, the new study found that antibiotic prophylaxis prescribing fell almost 90% in the United Kingdom, from 10,900 prescriptions per month to 1,307 per month in the last 6 months of the study, reported Dr. Mark Dayer of Taunton and Somerset NHS Trust, Somerset, England. The study was simultaneously published in the Lancet (2014 Nov. 18[doi:10.1016/S0140-6736(14)62007-9]).

In a video interview, study coauthor Dr. Martin Thornhill of the University of Sheffield, England, and AHA President-Elect Dr. Mark Creager, director of the vascular center at Brigham and Women’s Hospital, Boston, talked about the findings, their potential limitations, and whether it’s time for clinicians to change their approach to antibiotic prophylaxis.

The study was funded by the National Institutes of Dental and Cranofacial Research, Heart Research–UK, and Simplyhealth. Dr. Thornhill and Dr. Creager reported no conflicting interests.

[email protected]

Minimally invasive synthetic midurethral slings may be considered the standard of care for the surgical treatment of stress urinary incontinence – and a first-line treatment for severe cases of the condition – based on the publication of numerous level 1 randomized trials, high-quality reviews, and recent position statements from professional societies.

The current evidence base shows that midurethral sling operations are as effective as bladder neck slings and colposuspension, with less morbidity. Operating times are shorter, and local anesthesia is possible. Compared with pubovaginal slings, which are fixed at the bladder neck, midurethral slings are associated with less postoperative voiding dysfunction and fewer de novo urgency symptoms.

Midurethral slings (MUS) also have been shown to be more successful – and more cost-effective – than pelvic floor physiotherapy for stress urinary incontinence (SUI) overall, with the possible exception of mild SUI.

Physiotherapy involving pelvic floor muscle therapy has long been advocated as a first-line treatment for SUI, with MUS surgery often recommended when physiotherapy is unsuccessful. In recent years, however, with high success rates for MUS, the role of physiotherapy as a first-line treatment has become more debatable.

A multicenter randomized trial in 660 women published last year in the New England Journal of Medicine substantiated what many of us have seen in our practices and in other published studies: significantly lower rates of improvement and cure with initial physiotherapy than with primary surgery.

Initial MUS surgery resulted in higher rates of subjective improvement, compared with initial physiotherapy (91% vs. 64%), subjective cure (85% v. 53%), and objective cure (77% v. 59%) at 1 year. Moreover, a significant number of women – 49% – chose to abandon conservative therapy and have MUS surgery for their SUI during the study period (N. Engl. J. Med. 2013;369:1124-33).

A joint position statement published in early 2014 by the American Urogynecologic Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) calls MUS the most extensively studied anti-incontinence procedure and “probably the most important advancement in the treatment of SUI in the last 50 years.” More than 2,000 publications in the literature have described the procedure for SUI, and multiple randomized controlled trials have compared various types of MUS procedures as well as MUS to other nonmesh SUI procedures, the statement says.

My colleague and I recently modeled the cost-effectiveness of pelvic floor muscle therapy and continence pessaries vs. surgical treatment with MUS for initial treatment of SUI. Initial treatment with MUS was the best strategy, with an incremental cost-effectiveness ratio of $32,132 per quality-adjusted life-year, compared with initial treatment with pelvic floor muscle therapy. Under our model, treatment with a continence pessary would never be the preferred choice due to low subjective cure rates (Am. J. Obstet. Gynecol. 2014;211:565.e1-6).

I now tell patients who present with a history of severe stress incontinence, and who leak on a cough stress test, that a trial of pelvic floor physiotherapy is an option but one with a lower likelihood of success. I recommend an MUS as primary treatment for these patients, and the question then often becomes which sling to use.

Sling selection

There are two broad approaches to MUS surgery – retropubic and transobturator – and within each approach, there are different routes for the delivery of the polypropylene mesh sling.

Retropubic slings. Retropubic slings are passed transvaginally at the midurethral level through the retropubic space. Tension-free vaginal tape (TVT) has been used in millions of women worldwide, with good long-term outcomes, since it was introduced by Dr. Ulf Ulmsten in 1995. The TVT procedure utilizes a bottom-up approach, with curved needles being passed from a small vaginal incision up through the retropubic space to exit through two suprapubic incisions.

A second type of retropubic sling – the suprapubic urethral support sling (SPARC, American Medical Systems) – utilizes a downward-pass, or top-down, approach in which a metal trocar is passed through suprapubic incisions and down through the retropubic space to exit a vaginal incision.

The theoretical advantages of this modification to the TVT procedure have included more control over the needle introducer near the rectus fascia, and a lower risk of bowel and vascular injury. However, comparisons during the last decade of the two retropubic approaches have suggested slightly better outcomes – relating both to cure rates and to complication rates – with TVT compared with SPARC.

A Cochrane Review published in 2009, titled “Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women,” provided higher-level evidence in favor of bottom-up slings. A sub-meta-analysis of five randomized controlled trials – part of a broader intervention review – showed that a retropubic bottom-up approach was more effective than a top-down route (risk ratio, 1.10), with higher subjective and objective SUI cure rates (Cochrane Database Syst. Rev. 2009(4): CD006375). There also was significantly less bladder perforation, less mesh erosion, and less voiding dysfunction.

TVT slings, therefore, appear to be somewhat superior, with statistically significant differences in each of the domains of efficacy and morbidity. Still, surgeon experience and skill remain factors in sling selection; the surgeon who feels comfortable and skilled with a top-down approach and has little experience with a bottom-up approach should continue with SPARC. For surgeons who are skilled with both approaches, it might well be preferable to favor TVT.

Transobturator slings. The transobturator approach was developed to minimize the potential for bladder and bowel injuries by avoiding the pelvic organs in the retropubic space. The sling is introduced either through an inside-out technique, with the needle passed from a vaginal incision and out through the obturator foramen, or through an outside-in technique, with the needle passed through the thigh and then out through the vaginal incision.

A meta-analysis of trials of transobturator sling procedures – including four direct-comparison, randomized controlled trials of the inside-out technique vs. the outside-in technique – showed no significant differences between the two approaches in subjective and objective SUI cure rates in the short term. Rates of postoperative voiding difficulties and de novo urgency symptoms were similar (BJU Int. 2010;106:68-76).

Making a choice. Each of the currently available midurethral slings appears to work well, overall, with few clinically significant differences in outcomes. On the other hand, midurethral slings are not all the same. It is important to appreciate the more subtle differences, to be aware of the evidence, and to be appropriately trained. Often, sling selection involves weighing the risks and benefits for the individual.

On a broad scale, the most recent high-level comparison of the retropubic and transobturator slings appears to be a meta-analysis in which retropubic midurethral slings showed better objective and subjective cure rates than transobturator midurethral slings. Women treated with retropubic slings had a 35% higher odds of objective cure and a 24% higher odds of subjective cure. (The weighted average objective cure rates were 87% for retropubic slings vs. 83% for transobturator slings with a weighted average follow-up of approximately 17 months. The weighted average subjective cure rates were 76% and 73%, respectively.)

Operating times were longer with retropubic slings, but lengths of stay were equivalent between the two types of procedures. This was based on 17 studies of about 3,000 women (J. Urology 2014 [doi: 10.1016/j.juro.2014.09.104]).

The types of complications seen with each approach differed. Bladder perforation was significantly more common with retropubic slings (3.2% vs. 0.2%), as was bleeding (3.2% v. 1.1%). Transobturator slings were associated with more cases of neurologic symptoms (9.4% v. 3.5%) and vaginal perforation (3.6% v. 0.9%).

This new review provides updated information to the 2009 Cochrane Review mentioned above, which reported that women were less likely to be continent after operations performed via the obturator route, but also less likely to have encountered complications. More specifically, objective cure rates were slightly higher with retropubic slings than with transobturator slings (88% vs. 84%) in the 2009 review. There was no difference in subjective cure rates. With the obturator route, there was less voiding dysfunction, blood loss, and bladder perforation (0.3% v. 5.5%).

Other pivotal trials since the 2009 Cochrane Review include a multicenter randomized equivalence trial published in the New England Journal of Medicine in 2010. The trial randomized 597 women to transobturator or retropubic sling surgery, and found no significant differences in subjective success (56% vs. 62%) or in objective success (78% vs. 81%) at 12 months (N. Engl. J. Med. 2010;362:2066-76).

There is some level 1 evidence suggesting that for severe incontinence involving intrinsic sphincter deficiency (ISD), a retropubic TVT sling is the more effective procedure. A randomized trial of 164 women with urodynamic SUI and ISD, for instance, found that 21% of those in the TVT group and 45% of those in the transobturator group had urodynamic SUI 6 months postoperatively.

The risk ratio of repeat surgery was 2.6 times higher in the transobturator group than in the retropubic TVT group (Obstet. Gynecol. 2008;112:1253-61). TVT was more effective both with and without concurrent pelvic organ prolapse repair.

I tell my patients with severe SUI or ISD, therefore, that retropubic sling procedures appear to be preferable. (Exceptions include the patient who has a history of retropubic surgeries, in whom passing the sling through this route may not be the safest approach, as well as the patient who has had mesh erosion into the bladder.)

In patients whose SUI is less severe, I counsel that a transobturator sling confers satisfaction rates similar to those of a retropubic sling and has a lower risk of complications, such as postoperative voiding dysfunction and bladder perforations, but with the possible trade-off of more thigh discomfort. I also might recommend a transobturator sling to patients with more pronounced initial complaints of urinary urgency and frequency, and to patients who have minor voiding dysfunction or a low level of incomplete bladder emptying.

While often short-lived, the small risk of thigh pain with a transobturator sling makes me less likely to recommend this type of sling for a woman who is a marathon runner or competitive athlete. In her case, an analysis of possible complications includes the consideration that bladder perforation can be addressed relatively quickly in the operating room, while persistent thigh discomfort, though relatively rare, could be a debilitating problem.

Single-incision slings

There appears to be emerging evidence suggesting that some of the fixed and adjustable single-incision slings currently available may have efficacy similar to that of the slings that are now widely used.

A Cochrane Review presented at the 2014 AUGS-IUGA scientific meeting and published this summer concludes that there is not enough evidence on single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons, and that additional, adequately powered, high-quality trials with longer-term follow-up are needed (Cochrane Database Sys. Rev. 2014;6:CD008709). However, research completed since the review offers additional data.

For instance, at the 2014 AUGS-IUGA scientific meeting this summer, an oral paper presentation highlighted findings of a randomized controlled trial that showed similar cure rates after surgery with the MiniArc, a fixed single-incision sling, and the Monarc transobturator sling (both by American Medical Systems) at 24 months. The study randomized 234 women to either sling and found no significant differences in subjective outcomes, objective outcomes, or results on various quality-of-life questionnaires.

As such studies are published and more evidence emerges, we will gain a clearer picture of how the newer single-incision slings compare to the well-tested retropubic and transobturator slings with respect to efficacy and safety.

Single-incision slings require only a small vaginal incision and no exit points. Without abdominal or thigh incisions, these new procedures – intended for less severe SUI (no ISD) – may offer improved perioperative and postoperative patient comfort and a potentially decreased risk of surgical injury to the adductor muscles, as well as a decreased risk of vascular and nerve injury. Candidates for these slings may include those who are very athletic, those who are obese, and those with a history of prior retropubic or pelvic surgery.

Research appears to be progressing, but at this time we do not yet have level 1 evidence to support their routine use.

Dr. Sokol reported that he owns stock in Pelvalon, and is a clinical adviser to that company. He also is a national principal investigator for American Medical Systems, and the recipient of research grants from Acell and several other companies.

Minimally invasive synthetic midurethral slings may be considered the standard of care for the surgical treatment of stress urinary incontinence – and a first-line treatment for severe cases of the condition – based on the publication of numerous level 1 randomized trials, high-quality reviews, and recent position statements from professional societies.

The current evidence base shows that midurethral sling operations are as effective as bladder neck slings and colposuspension, with less morbidity. Operating times are shorter, and local anesthesia is possible. Compared with pubovaginal slings, which are fixed at the bladder neck, midurethral slings are associated with less postoperative voiding dysfunction and fewer de novo urgency symptoms.

Midurethral slings (MUS) also have been shown to be more successful – and more cost-effective – than pelvic floor physiotherapy for stress urinary incontinence (SUI) overall, with the possible exception of mild SUI.

Physiotherapy involving pelvic floor muscle therapy has long been advocated as a first-line treatment for SUI, with MUS surgery often recommended when physiotherapy is unsuccessful. In recent years, however, with high success rates for MUS, the role of physiotherapy as a first-line treatment has become more debatable.

A multicenter randomized trial in 660 women published last year in the New England Journal of Medicine substantiated what many of us have seen in our practices and in other published studies: significantly lower rates of improvement and cure with initial physiotherapy than with primary surgery.

Initial MUS surgery resulted in higher rates of subjective improvement, compared with initial physiotherapy (91% vs. 64%), subjective cure (85% v. 53%), and objective cure (77% v. 59%) at 1 year. Moreover, a significant number of women – 49% – chose to abandon conservative therapy and have MUS surgery for their SUI during the study period (N. Engl. J. Med. 2013;369:1124-33).

A joint position statement published in early 2014 by the American Urogynecologic Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) calls MUS the most extensively studied anti-incontinence procedure and “probably the most important advancement in the treatment of SUI in the last 50 years.” More than 2,000 publications in the literature have described the procedure for SUI, and multiple randomized controlled trials have compared various types of MUS procedures as well as MUS to other nonmesh SUI procedures, the statement says.

My colleague and I recently modeled the cost-effectiveness of pelvic floor muscle therapy and continence pessaries vs. surgical treatment with MUS for initial treatment of SUI. Initial treatment with MUS was the best strategy, with an incremental cost-effectiveness ratio of $32,132 per quality-adjusted life-year, compared with initial treatment with pelvic floor muscle therapy. Under our model, treatment with a continence pessary would never be the preferred choice due to low subjective cure rates (Am. J. Obstet. Gynecol. 2014;211:565.e1-6).

I now tell patients who present with a history of severe stress incontinence, and who leak on a cough stress test, that a trial of pelvic floor physiotherapy is an option but one with a lower likelihood of success. I recommend an MUS as primary treatment for these patients, and the question then often becomes which sling to use.

Sling selection

There are two broad approaches to MUS surgery – retropubic and transobturator – and within each approach, there are different routes for the delivery of the polypropylene mesh sling.

Retropubic slings. Retropubic slings are passed transvaginally at the midurethral level through the retropubic space. Tension-free vaginal tape (TVT) has been used in millions of women worldwide, with good long-term outcomes, since it was introduced by Dr. Ulf Ulmsten in 1995. The TVT procedure utilizes a bottom-up approach, with curved needles being passed from a small vaginal incision up through the retropubic space to exit through two suprapubic incisions.

A second type of retropubic sling – the suprapubic urethral support sling (SPARC, American Medical Systems) – utilizes a downward-pass, or top-down, approach in which a metal trocar is passed through suprapubic incisions and down through the retropubic space to exit a vaginal incision.

The theoretical advantages of this modification to the TVT procedure have included more control over the needle introducer near the rectus fascia, and a lower risk of bowel and vascular injury. However, comparisons during the last decade of the two retropubic approaches have suggested slightly better outcomes – relating both to cure rates and to complication rates – with TVT compared with SPARC.

A Cochrane Review published in 2009, titled “Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women,” provided higher-level evidence in favor of bottom-up slings. A sub-meta-analysis of five randomized controlled trials – part of a broader intervention review – showed that a retropubic bottom-up approach was more effective than a top-down route (risk ratio, 1.10), with higher subjective and objective SUI cure rates (Cochrane Database Syst. Rev. 2009(4): CD006375). There also was significantly less bladder perforation, less mesh erosion, and less voiding dysfunction.

TVT slings, therefore, appear to be somewhat superior, with statistically significant differences in each of the domains of efficacy and morbidity. Still, surgeon experience and skill remain factors in sling selection; the surgeon who feels comfortable and skilled with a top-down approach and has little experience with a bottom-up approach should continue with SPARC. For surgeons who are skilled with both approaches, it might well be preferable to favor TVT.

Transobturator slings. The transobturator approach was developed to minimize the potential for bladder and bowel injuries by avoiding the pelvic organs in the retropubic space. The sling is introduced either through an inside-out technique, with the needle passed from a vaginal incision and out through the obturator foramen, or through an outside-in technique, with the needle passed through the thigh and then out through the vaginal incision.

A meta-analysis of trials of transobturator sling procedures – including four direct-comparison, randomized controlled trials of the inside-out technique vs. the outside-in technique – showed no significant differences between the two approaches in subjective and objective SUI cure rates in the short term. Rates of postoperative voiding difficulties and de novo urgency symptoms were similar (BJU Int. 2010;106:68-76).

Making a choice. Each of the currently available midurethral slings appears to work well, overall, with few clinically significant differences in outcomes. On the other hand, midurethral slings are not all the same. It is important to appreciate the more subtle differences, to be aware of the evidence, and to be appropriately trained. Often, sling selection involves weighing the risks and benefits for the individual.

On a broad scale, the most recent high-level comparison of the retropubic and transobturator slings appears to be a meta-analysis in which retropubic midurethral slings showed better objective and subjective cure rates than transobturator midurethral slings. Women treated with retropubic slings had a 35% higher odds of objective cure and a 24% higher odds of subjective cure. (The weighted average objective cure rates were 87% for retropubic slings vs. 83% for transobturator slings with a weighted average follow-up of approximately 17 months. The weighted average subjective cure rates were 76% and 73%, respectively.)

Operating times were longer with retropubic slings, but lengths of stay were equivalent between the two types of procedures. This was based on 17 studies of about 3,000 women (J. Urology 2014 [doi: 10.1016/j.juro.2014.09.104]).

The types of complications seen with each approach differed. Bladder perforation was significantly more common with retropubic slings (3.2% vs. 0.2%), as was bleeding (3.2% v. 1.1%). Transobturator slings were associated with more cases of neurologic symptoms (9.4% v. 3.5%) and vaginal perforation (3.6% v. 0.9%).

This new review provides updated information to the 2009 Cochrane Review mentioned above, which reported that women were less likely to be continent after operations performed via the obturator route, but also less likely to have encountered complications. More specifically, objective cure rates were slightly higher with retropubic slings than with transobturator slings (88% vs. 84%) in the 2009 review. There was no difference in subjective cure rates. With the obturator route, there was less voiding dysfunction, blood loss, and bladder perforation (0.3% v. 5.5%).

Other pivotal trials since the 2009 Cochrane Review include a multicenter randomized equivalence trial published in the New England Journal of Medicine in 2010. The trial randomized 597 women to transobturator or retropubic sling surgery, and found no significant differences in subjective success (56% vs. 62%) or in objective success (78% vs. 81%) at 12 months (N. Engl. J. Med. 2010;362:2066-76).

There is some level 1 evidence suggesting that for severe incontinence involving intrinsic sphincter deficiency (ISD), a retropubic TVT sling is the more effective procedure. A randomized trial of 164 women with urodynamic SUI and ISD, for instance, found that 21% of those in the TVT group and 45% of those in the transobturator group had urodynamic SUI 6 months postoperatively.

The risk ratio of repeat surgery was 2.6 times higher in the transobturator group than in the retropubic TVT group (Obstet. Gynecol. 2008;112:1253-61). TVT was more effective both with and without concurrent pelvic organ prolapse repair.

I tell my patients with severe SUI or ISD, therefore, that retropubic sling procedures appear to be preferable. (Exceptions include the patient who has a history of retropubic surgeries, in whom passing the sling through this route may not be the safest approach, as well as the patient who has had mesh erosion into the bladder.)

In patients whose SUI is less severe, I counsel that a transobturator sling confers satisfaction rates similar to those of a retropubic sling and has a lower risk of complications, such as postoperative voiding dysfunction and bladder perforations, but with the possible trade-off of more thigh discomfort. I also might recommend a transobturator sling to patients with more pronounced initial complaints of urinary urgency and frequency, and to patients who have minor voiding dysfunction or a low level of incomplete bladder emptying.

While often short-lived, the small risk of thigh pain with a transobturator sling makes me less likely to recommend this type of sling for a woman who is a marathon runner or competitive athlete. In her case, an analysis of possible complications includes the consideration that bladder perforation can be addressed relatively quickly in the operating room, while persistent thigh discomfort, though relatively rare, could be a debilitating problem.

Single-incision slings

There appears to be emerging evidence suggesting that some of the fixed and adjustable single-incision slings currently available may have efficacy similar to that of the slings that are now widely used.

A Cochrane Review presented at the 2014 AUGS-IUGA scientific meeting and published this summer concludes that there is not enough evidence on single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons, and that additional, adequately powered, high-quality trials with longer-term follow-up are needed (Cochrane Database Sys. Rev. 2014;6:CD008709). However, research completed since the review offers additional data.

For instance, at the 2014 AUGS-IUGA scientific meeting this summer, an oral paper presentation highlighted findings of a randomized controlled trial that showed similar cure rates after surgery with the MiniArc, a fixed single-incision sling, and the Monarc transobturator sling (both by American Medical Systems) at 24 months. The study randomized 234 women to either sling and found no significant differences in subjective outcomes, objective outcomes, or results on various quality-of-life questionnaires.

As such studies are published and more evidence emerges, we will gain a clearer picture of how the newer single-incision slings compare to the well-tested retropubic and transobturator slings with respect to efficacy and safety.

Single-incision slings require only a small vaginal incision and no exit points. Without abdominal or thigh incisions, these new procedures – intended for less severe SUI (no ISD) – may offer improved perioperative and postoperative patient comfort and a potentially decreased risk of surgical injury to the adductor muscles, as well as a decreased risk of vascular and nerve injury. Candidates for these slings may include those who are very athletic, those who are obese, and those with a history of prior retropubic or pelvic surgery.

Research appears to be progressing, but at this time we do not yet have level 1 evidence to support their routine use.

Dr. Sokol reported that he owns stock in Pelvalon, and is a clinical adviser to that company. He also is a national principal investigator for American Medical Systems, and the recipient of research grants from Acell and several other companies.

Minimally invasive synthetic midurethral slings may be considered the standard of care for the surgical treatment of stress urinary incontinence – and a first-line treatment for severe cases of the condition – based on the publication of numerous level 1 randomized trials, high-quality reviews, and recent position statements from professional societies.

The current evidence base shows that midurethral sling operations are as effective as bladder neck slings and colposuspension, with less morbidity. Operating times are shorter, and local anesthesia is possible. Compared with pubovaginal slings, which are fixed at the bladder neck, midurethral slings are associated with less postoperative voiding dysfunction and fewer de novo urgency symptoms.

Midurethral slings (MUS) also have been shown to be more successful – and more cost-effective – than pelvic floor physiotherapy for stress urinary incontinence (SUI) overall, with the possible exception of mild SUI.

Physiotherapy involving pelvic floor muscle therapy has long been advocated as a first-line treatment for SUI, with MUS surgery often recommended when physiotherapy is unsuccessful. In recent years, however, with high success rates for MUS, the role of physiotherapy as a first-line treatment has become more debatable.

A multicenter randomized trial in 660 women published last year in the New England Journal of Medicine substantiated what many of us have seen in our practices and in other published studies: significantly lower rates of improvement and cure with initial physiotherapy than with primary surgery.

Initial MUS surgery resulted in higher rates of subjective improvement, compared with initial physiotherapy (91% vs. 64%), subjective cure (85% v. 53%), and objective cure (77% v. 59%) at 1 year. Moreover, a significant number of women – 49% – chose to abandon conservative therapy and have MUS surgery for their SUI during the study period (N. Engl. J. Med. 2013;369:1124-33).

A joint position statement published in early 2014 by the American Urogynecologic Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) calls MUS the most extensively studied anti-incontinence procedure and “probably the most important advancement in the treatment of SUI in the last 50 years.” More than 2,000 publications in the literature have described the procedure for SUI, and multiple randomized controlled trials have compared various types of MUS procedures as well as MUS to other nonmesh SUI procedures, the statement says.

My colleague and I recently modeled the cost-effectiveness of pelvic floor muscle therapy and continence pessaries vs. surgical treatment with MUS for initial treatment of SUI. Initial treatment with MUS was the best strategy, with an incremental cost-effectiveness ratio of $32,132 per quality-adjusted life-year, compared with initial treatment with pelvic floor muscle therapy. Under our model, treatment with a continence pessary would never be the preferred choice due to low subjective cure rates (Am. J. Obstet. Gynecol. 2014;211:565.e1-6).

I now tell patients who present with a history of severe stress incontinence, and who leak on a cough stress test, that a trial of pelvic floor physiotherapy is an option but one with a lower likelihood of success. I recommend an MUS as primary treatment for these patients, and the question then often becomes which sling to use.

Sling selection

There are two broad approaches to MUS surgery – retropubic and transobturator – and within each approach, there are different routes for the delivery of the polypropylene mesh sling.

Retropubic slings. Retropubic slings are passed transvaginally at the midurethral level through the retropubic space. Tension-free vaginal tape (TVT) has been used in millions of women worldwide, with good long-term outcomes, since it was introduced by Dr. Ulf Ulmsten in 1995. The TVT procedure utilizes a bottom-up approach, with curved needles being passed from a small vaginal incision up through the retropubic space to exit through two suprapubic incisions.

A second type of retropubic sling – the suprapubic urethral support sling (SPARC, American Medical Systems) – utilizes a downward-pass, or top-down, approach in which a metal trocar is passed through suprapubic incisions and down through the retropubic space to exit a vaginal incision.

The theoretical advantages of this modification to the TVT procedure have included more control over the needle introducer near the rectus fascia, and a lower risk of bowel and vascular injury. However, comparisons during the last decade of the two retropubic approaches have suggested slightly better outcomes – relating both to cure rates and to complication rates – with TVT compared with SPARC.

A Cochrane Review published in 2009, titled “Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women,” provided higher-level evidence in favor of bottom-up slings. A sub-meta-analysis of five randomized controlled trials – part of a broader intervention review – showed that a retropubic bottom-up approach was more effective than a top-down route (risk ratio, 1.10), with higher subjective and objective SUI cure rates (Cochrane Database Syst. Rev. 2009(4): CD006375). There also was significantly less bladder perforation, less mesh erosion, and less voiding dysfunction.

TVT slings, therefore, appear to be somewhat superior, with statistically significant differences in each of the domains of efficacy and morbidity. Still, surgeon experience and skill remain factors in sling selection; the surgeon who feels comfortable and skilled with a top-down approach and has little experience with a bottom-up approach should continue with SPARC. For surgeons who are skilled with both approaches, it might well be preferable to favor TVT.

Transobturator slings. The transobturator approach was developed to minimize the potential for bladder and bowel injuries by avoiding the pelvic organs in the retropubic space. The sling is introduced either through an inside-out technique, with the needle passed from a vaginal incision and out through the obturator foramen, or through an outside-in technique, with the needle passed through the thigh and then out through the vaginal incision.

A meta-analysis of trials of transobturator sling procedures – including four direct-comparison, randomized controlled trials of the inside-out technique vs. the outside-in technique – showed no significant differences between the two approaches in subjective and objective SUI cure rates in the short term. Rates of postoperative voiding difficulties and de novo urgency symptoms were similar (BJU Int. 2010;106:68-76).

Making a choice. Each of the currently available midurethral slings appears to work well, overall, with few clinically significant differences in outcomes. On the other hand, midurethral slings are not all the same. It is important to appreciate the more subtle differences, to be aware of the evidence, and to be appropriately trained. Often, sling selection involves weighing the risks and benefits for the individual.

On a broad scale, the most recent high-level comparison of the retropubic and transobturator slings appears to be a meta-analysis in which retropubic midurethral slings showed better objective and subjective cure rates than transobturator midurethral slings. Women treated with retropubic slings had a 35% higher odds of objective cure and a 24% higher odds of subjective cure. (The weighted average objective cure rates were 87% for retropubic slings vs. 83% for transobturator slings with a weighted average follow-up of approximately 17 months. The weighted average subjective cure rates were 76% and 73%, respectively.)

Operating times were longer with retropubic slings, but lengths of stay were equivalent between the two types of procedures. This was based on 17 studies of about 3,000 women (J. Urology 2014 [doi: 10.1016/j.juro.2014.09.104]).

The types of complications seen with each approach differed. Bladder perforation was significantly more common with retropubic slings (3.2% vs. 0.2%), as was bleeding (3.2% v. 1.1%). Transobturator slings were associated with more cases of neurologic symptoms (9.4% v. 3.5%) and vaginal perforation (3.6% v. 0.9%).

This new review provides updated information to the 2009 Cochrane Review mentioned above, which reported that women were less likely to be continent after operations performed via the obturator route, but also less likely to have encountered complications. More specifically, objective cure rates were slightly higher with retropubic slings than with transobturator slings (88% vs. 84%) in the 2009 review. There was no difference in subjective cure rates. With the obturator route, there was less voiding dysfunction, blood loss, and bladder perforation (0.3% v. 5.5%).

Other pivotal trials since the 2009 Cochrane Review include a multicenter randomized equivalence trial published in the New England Journal of Medicine in 2010. The trial randomized 597 women to transobturator or retropubic sling surgery, and found no significant differences in subjective success (56% vs. 62%) or in objective success (78% vs. 81%) at 12 months (N. Engl. J. Med. 2010;362:2066-76).

There is some level 1 evidence suggesting that for severe incontinence involving intrinsic sphincter deficiency (ISD), a retropubic TVT sling is the more effective procedure. A randomized trial of 164 women with urodynamic SUI and ISD, for instance, found that 21% of those in the TVT group and 45% of those in the transobturator group had urodynamic SUI 6 months postoperatively.

The risk ratio of repeat surgery was 2.6 times higher in the transobturator group than in the retropubic TVT group (Obstet. Gynecol. 2008;112:1253-61). TVT was more effective both with and without concurrent pelvic organ prolapse repair.

I tell my patients with severe SUI or ISD, therefore, that retropubic sling procedures appear to be preferable. (Exceptions include the patient who has a history of retropubic surgeries, in whom passing the sling through this route may not be the safest approach, as well as the patient who has had mesh erosion into the bladder.)

In patients whose SUI is less severe, I counsel that a transobturator sling confers satisfaction rates similar to those of a retropubic sling and has a lower risk of complications, such as postoperative voiding dysfunction and bladder perforations, but with the possible trade-off of more thigh discomfort. I also might recommend a transobturator sling to patients with more pronounced initial complaints of urinary urgency and frequency, and to patients who have minor voiding dysfunction or a low level of incomplete bladder emptying.

While often short-lived, the small risk of thigh pain with a transobturator sling makes me less likely to recommend this type of sling for a woman who is a marathon runner or competitive athlete. In her case, an analysis of possible complications includes the consideration that bladder perforation can be addressed relatively quickly in the operating room, while persistent thigh discomfort, though relatively rare, could be a debilitating problem.

Single-incision slings

There appears to be emerging evidence suggesting that some of the fixed and adjustable single-incision slings currently available may have efficacy similar to that of the slings that are now widely used.

A Cochrane Review presented at the 2014 AUGS-IUGA scientific meeting and published this summer concludes that there is not enough evidence on single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons, and that additional, adequately powered, high-quality trials with longer-term follow-up are needed (Cochrane Database Sys. Rev. 2014;6:CD008709). However, research completed since the review offers additional data.

For instance, at the 2014 AUGS-IUGA scientific meeting this summer, an oral paper presentation highlighted findings of a randomized controlled trial that showed similar cure rates after surgery with the MiniArc, a fixed single-incision sling, and the Monarc transobturator sling (both by American Medical Systems) at 24 months. The study randomized 234 women to either sling and found no significant differences in subjective outcomes, objective outcomes, or results on various quality-of-life questionnaires.

As such studies are published and more evidence emerges, we will gain a clearer picture of how the newer single-incision slings compare to the well-tested retropubic and transobturator slings with respect to efficacy and safety.

Single-incision slings require only a small vaginal incision and no exit points. Without abdominal or thigh incisions, these new procedures – intended for less severe SUI (no ISD) – may offer improved perioperative and postoperative patient comfort and a potentially decreased risk of surgical injury to the adductor muscles, as well as a decreased risk of vascular and nerve injury. Candidates for these slings may include those who are very athletic, those who are obese, and those with a history of prior retropubic or pelvic surgery.

Research appears to be progressing, but at this time we do not yet have level 1 evidence to support their routine use.

Dr. Sokol reported that he owns stock in Pelvalon, and is a clinical adviser to that company. He also is a national principal investigator for American Medical Systems, and the recipient of research grants from Acell and several other companies.

CHICAGO – The next time the U.S. hypertension management guideline gets revised, possibly within another couple of years, it may abandon the current approach of focusing primarily on a person’s blood pressure numbers and center instead on assessing a patient’s overall cardiovascular risk and using that status to guide the need for antihypertensive treatment and how aggressively it is applied.

In short, what some preventive cardiologists see coming down the pike is a blood pressure management guideline that follows the same path carved by the cholesterol management guideline issued by the American College of Cardiology and American Heart Association in 2013 (Circulation 2014 [doi: 10.1161/01.cir.0000437738.63853.7a]) that linked use of lipid-lowering treatment with a statin mostly to a patient’s atherosclerotic cardiovascular disease (ASCVD) risk rather than to their level of LDL cholesterol.

Mitchel L. Zoler/Frontline Medical News

One example of the evidence driving this revisionist approach to thinking about hypertension definition came in a report at the American Heart Association Scientific Sessions that showed “a blood pressure treatment strategy focused just on blood pressure leaves substantial CVD risk unaddressed,” said Dr. Kunal N. Karmali, a cardiologist at Northwestern University, Chicago. “Multivariate risk estimation may help identify types of individuals who are likely to benefit from risk-reducing therapy across the spectrum of blood pressure.”

Dr. Karmali and his associates ran their analysis using data from two well-defined U.S. population data bases that included long-term follow-up, the Atherosclerosis Risk in Communities study and the Framingham Offspring Study, which together provided data for 18,898 people. The researchers categorized these people by their baseline systolic blood pressures into six groups, from below 120 mm Hg to 160 mm Hg and above, and calculated each person’s risk for an incident ASCVD event according to their baseline ASCVD risk score using the risk calculator that accompanied release of the 2013 cholesterol management guidelines. By subtracting the baseline risk–derived prediction of the CVD event rate from the actual number of events during follow-up, Dr. Karmali’s group came up with an estimate of the level of “excess” risk for people within each 10 mm Hg blood pressure stratum.

Ten-year follow-up of the two cohorts identified 739 ASCVD events, of which more than 500 were “excess;” the people in the two cohorts had substantially more ASCVD events than would have been predicted by their risk factors alone. These excess events occurred at all levels of blood pressure. The 6,656 people with baseline systolic blood pressures of 120-139 mm Hg, 35% of the people included in the study, had 45% of the excess events, Dr. Karmali reported.

While people with blood pressures of 120-139 mm Hg would generally not be candidates for antihypertensive treatment based on the existing U.S. guideline (JAMA 2014;311[5]:507-20), a sizable majority, 73%, had high baseline ASCVD risk levels, with predicted 10-year CVD rates of 7.5% or greater.

“An implication of this finding is to think beyond just blood pressure,” Dr. Karmali said. “You need to consider multiple risk factors and use overall risk assessment to inform your management decisions. Looking at just the single risk factor of blood pressure doesn’t capture the true benefits of treatment and weigh that against the risks from treatment,” he said in an interview.

He gave the example of an otherwise healthy woman aged 40 years with a systolic blood pressure of 142 mm Hg, who clearly has a different 10-year risk level than a man aged 70 years who has diabetes and smokes and also has a systolic pressure of 142 mm Hg.

“For cholesterol, we now direct our interventions at people who are at the highest risk, but for blood pressure we still focus on just the single number. Multivariate risk assessment would allow us to direct the interventions at the people who are more likely to benefit,” Dr. Kamali said.

Other recent analyses have also supported this approach, he noted. For example, a metaanalysis published in August used data from nearly 52,000 people collected in 11 studies to show that blood pressure–lowering treatment had a very similar impact on reducing future cardiovascular disease events regardless of a person’s baseline cardiovascular risk level (Lancet 2014;384:591-8).

For middle-aged adults and older people, “I think we would become much more efficient in our selection of people with modestly elevated blood pressure [who need drug treatment] by considering their global risk,” said Dr. Donald M. Lloyd-Jones, professor and chairman of preventive medicine at Northwestern University, and a collaborator on Dr. Karmali’s study.

Another advantage of a risk-based approach to blood pressure management over a number-based approach is that “putting blood pressure into the global context of risk makes me think about global risk management, and that is where clinicians need to move,” Dr. Lloyd-Jones said in an interview. “It’s not just, ‘get a number, treat it, and you’re done.’ You need to also think about statin treatment.”

He acknowledged the need for some caution in this approach, such as recognizing that blood pressure must be carefully reduced in, for example, people with a systolic pressure of 120-129 mm Hg so that blood pressure is not reduced to a dangerously low level (unlike cholesterol, which so far has not shown been shown to cause problems when reduced to very low levels). He also noted that a young adult with a fairly high systolic pressure of, say, 160 mm Hg should receive antihypertensive treatment even if the person has an otherwise low ASCVD risk. But in general a risk-based approach should provide better patient care, he said.

“If this is where new hypertension management guidelines go it would be a significant change,” Dr. Lloyd-Jones acknowledged, “but I think it would help patients. I think this approach merits real consideration” by the panel that will soon create the next revision to the U.S. hypertension management guideline.

[email protected]

On Twitter @mitchelzoler

CHICAGO – The next time the U.S. hypertension management guideline gets revised, possibly within another couple of years, it may abandon the current approach of focusing primarily on a person’s blood pressure numbers and center instead on assessing a patient’s overall cardiovascular risk and using that status to guide the need for antihypertensive treatment and how aggressively it is applied.

In short, what some preventive cardiologists see coming down the pike is a blood pressure management guideline that follows the same path carved by the cholesterol management guideline issued by the American College of Cardiology and American Heart Association in 2013 (Circulation 2014 [doi: 10.1161/01.cir.0000437738.63853.7a]) that linked use of lipid-lowering treatment with a statin mostly to a patient’s atherosclerotic cardiovascular disease (ASCVD) risk rather than to their level of LDL cholesterol.

Mitchel L. Zoler/Frontline Medical News

One example of the evidence driving this revisionist approach to thinking about hypertension definition came in a report at the American Heart Association Scientific Sessions that showed “a blood pressure treatment strategy focused just on blood pressure leaves substantial CVD risk unaddressed,” said Dr. Kunal N. Karmali, a cardiologist at Northwestern University, Chicago. “Multivariate risk estimation may help identify types of individuals who are likely to benefit from risk-reducing therapy across the spectrum of blood pressure.”

Dr. Karmali and his associates ran their analysis using data from two well-defined U.S. population data bases that included long-term follow-up, the Atherosclerosis Risk in Communities study and the Framingham Offspring Study, which together provided data for 18,898 people. The researchers categorized these people by their baseline systolic blood pressures into six groups, from below 120 mm Hg to 160 mm Hg and above, and calculated each person’s risk for an incident ASCVD event according to their baseline ASCVD risk score using the risk calculator that accompanied release of the 2013 cholesterol management guidelines. By subtracting the baseline risk–derived prediction of the CVD event rate from the actual number of events during follow-up, Dr. Karmali’s group came up with an estimate of the level of “excess” risk for people within each 10 mm Hg blood pressure stratum.

Ten-year follow-up of the two cohorts identified 739 ASCVD events, of which more than 500 were “excess;” the people in the two cohorts had substantially more ASCVD events than would have been predicted by their risk factors alone. These excess events occurred at all levels of blood pressure. The 6,656 people with baseline systolic blood pressures of 120-139 mm Hg, 35% of the people included in the study, had 45% of the excess events, Dr. Karmali reported.

While people with blood pressures of 120-139 mm Hg would generally not be candidates for antihypertensive treatment based on the existing U.S. guideline (JAMA 2014;311[5]:507-20), a sizable majority, 73%, had high baseline ASCVD risk levels, with predicted 10-year CVD rates of 7.5% or greater.

“An implication of this finding is to think beyond just blood pressure,” Dr. Karmali said. “You need to consider multiple risk factors and use overall risk assessment to inform your management decisions. Looking at just the single risk factor of blood pressure doesn’t capture the true benefits of treatment and weigh that against the risks from treatment,” he said in an interview.

He gave the example of an otherwise healthy woman aged 40 years with a systolic blood pressure of 142 mm Hg, who clearly has a different 10-year risk level than a man aged 70 years who has diabetes and smokes and also has a systolic pressure of 142 mm Hg.

“For cholesterol, we now direct our interventions at people who are at the highest risk, but for blood pressure we still focus on just the single number. Multivariate risk assessment would allow us to direct the interventions at the people who are more likely to benefit,” Dr. Kamali said.

Other recent analyses have also supported this approach, he noted. For example, a metaanalysis published in August used data from nearly 52,000 people collected in 11 studies to show that blood pressure–lowering treatment had a very similar impact on reducing future cardiovascular disease events regardless of a person’s baseline cardiovascular risk level (Lancet 2014;384:591-8).

For middle-aged adults and older people, “I think we would become much more efficient in our selection of people with modestly elevated blood pressure [who need drug treatment] by considering their global risk,” said Dr. Donald M. Lloyd-Jones, professor and chairman of preventive medicine at Northwestern University, and a collaborator on Dr. Karmali’s study.

Another advantage of a risk-based approach to blood pressure management over a number-based approach is that “putting blood pressure into the global context of risk makes me think about global risk management, and that is where clinicians need to move,” Dr. Lloyd-Jones said in an interview. “It’s not just, ‘get a number, treat it, and you’re done.’ You need to also think about statin treatment.”

He acknowledged the need for some caution in this approach, such as recognizing that blood pressure must be carefully reduced in, for example, people with a systolic pressure of 120-129 mm Hg so that blood pressure is not reduced to a dangerously low level (unlike cholesterol, which so far has not shown been shown to cause problems when reduced to very low levels). He also noted that a young adult with a fairly high systolic pressure of, say, 160 mm Hg should receive antihypertensive treatment even if the person has an otherwise low ASCVD risk. But in general a risk-based approach should provide better patient care, he said.

“If this is where new hypertension management guidelines go it would be a significant change,” Dr. Lloyd-Jones acknowledged, “but I think it would help patients. I think this approach merits real consideration” by the panel that will soon create the next revision to the U.S. hypertension management guideline.

[email protected]

On Twitter @mitchelzoler

CHICAGO – The next time the U.S. hypertension management guideline gets revised, possibly within another couple of years, it may abandon the current approach of focusing primarily on a person’s blood pressure numbers and center instead on assessing a patient’s overall cardiovascular risk and using that status to guide the need for antihypertensive treatment and how aggressively it is applied.

In short, what some preventive cardiologists see coming down the pike is a blood pressure management guideline that follows the same path carved by the cholesterol management guideline issued by the American College of Cardiology and American Heart Association in 2013 (Circulation 2014 [doi: 10.1161/01.cir.0000437738.63853.7a]) that linked use of lipid-lowering treatment with a statin mostly to a patient’s atherosclerotic cardiovascular disease (ASCVD) risk rather than to their level of LDL cholesterol.

Mitchel L. Zoler/Frontline Medical News

One example of the evidence driving this revisionist approach to thinking about hypertension definition came in a report at the American Heart Association Scientific Sessions that showed “a blood pressure treatment strategy focused just on blood pressure leaves substantial CVD risk unaddressed,” said Dr. Kunal N. Karmali, a cardiologist at Northwestern University, Chicago. “Multivariate risk estimation may help identify types of individuals who are likely to benefit from risk-reducing therapy across the spectrum of blood pressure.”

Dr. Karmali and his associates ran their analysis using data from two well-defined U.S. population data bases that included long-term follow-up, the Atherosclerosis Risk in Communities study and the Framingham Offspring Study, which together provided data for 18,898 people. The researchers categorized these people by their baseline systolic blood pressures into six groups, from below 120 mm Hg to 160 mm Hg and above, and calculated each person’s risk for an incident ASCVD event according to their baseline ASCVD risk score using the risk calculator that accompanied release of the 2013 cholesterol management guidelines. By subtracting the baseline risk–derived prediction of the CVD event rate from the actual number of events during follow-up, Dr. Karmali’s group came up with an estimate of the level of “excess” risk for people within each 10 mm Hg blood pressure stratum.

Ten-year follow-up of the two cohorts identified 739 ASCVD events, of which more than 500 were “excess;” the people in the two cohorts had substantially more ASCVD events than would have been predicted by their risk factors alone. These excess events occurred at all levels of blood pressure. The 6,656 people with baseline systolic blood pressures of 120-139 mm Hg, 35% of the people included in the study, had 45% of the excess events, Dr. Karmali reported.

While people with blood pressures of 120-139 mm Hg would generally not be candidates for antihypertensive treatment based on the existing U.S. guideline (JAMA 2014;311[5]:507-20), a sizable majority, 73%, had high baseline ASCVD risk levels, with predicted 10-year CVD rates of 7.5% or greater.

“An implication of this finding is to think beyond just blood pressure,” Dr. Karmali said. “You need to consider multiple risk factors and use overall risk assessment to inform your management decisions. Looking at just the single risk factor of blood pressure doesn’t capture the true benefits of treatment and weigh that against the risks from treatment,” he said in an interview.

He gave the example of an otherwise healthy woman aged 40 years with a systolic blood pressure of 142 mm Hg, who clearly has a different 10-year risk level than a man aged 70 years who has diabetes and smokes and also has a systolic pressure of 142 mm Hg.

“For cholesterol, we now direct our interventions at people who are at the highest risk, but for blood pressure we still focus on just the single number. Multivariate risk assessment would allow us to direct the interventions at the people who are more likely to benefit,” Dr. Kamali said.

Other recent analyses have also supported this approach, he noted. For example, a metaanalysis published in August used data from nearly 52,000 people collected in 11 studies to show that blood pressure–lowering treatment had a very similar impact on reducing future cardiovascular disease events regardless of a person’s baseline cardiovascular risk level (Lancet 2014;384:591-8).

For middle-aged adults and older people, “I think we would become much more efficient in our selection of people with modestly elevated blood pressure [who need drug treatment] by considering their global risk,” said Dr. Donald M. Lloyd-Jones, professor and chairman of preventive medicine at Northwestern University, and a collaborator on Dr. Karmali’s study.

Another advantage of a risk-based approach to blood pressure management over a number-based approach is that “putting blood pressure into the global context of risk makes me think about global risk management, and that is where clinicians need to move,” Dr. Lloyd-Jones said in an interview. “It’s not just, ‘get a number, treat it, and you’re done.’ You need to also think about statin treatment.”

He acknowledged the need for some caution in this approach, such as recognizing that blood pressure must be carefully reduced in, for example, people with a systolic pressure of 120-129 mm Hg so that blood pressure is not reduced to a dangerously low level (unlike cholesterol, which so far has not shown been shown to cause problems when reduced to very low levels). He also noted that a young adult with a fairly high systolic pressure of, say, 160 mm Hg should receive antihypertensive treatment even if the person has an otherwise low ASCVD risk. But in general a risk-based approach should provide better patient care, he said.

“If this is where new hypertension management guidelines go it would be a significant change,” Dr. Lloyd-Jones acknowledged, “but I think it would help patients. I think this approach merits real consideration” by the panel that will soon create the next revision to the U.S. hypertension management guideline.

[email protected]

On Twitter @mitchelzoler

According to a 2004 article by Dr. Eric S. Rovner and Dr. Alan J. Wein, 200 different surgical procedures have been described to treat stress urinary incontinence (Rev. Urol. 2004;6(Suppl 3):S29-47). Two goals exist in such surgical procedures:

1. Urethra repositioning or stabilization of the urethra and bladder neck through creation of retropubic support that is impervious to intraabdominal pressure changes.

2. Augmentation of the ureteral resistance provided by the intrinsic sphincter unit, with or without impacting urethra and bladder neck support (sling vs. periurethral injectables, or a combination of the two).

Sling procedures were initially introduced almost a century ago and have recently become increasingly popular – in part, secondary to a decrease in associated morbidity. Unlike transabdominal or transvaginal urethropexy, a sling not only provides support to the vesicourethral junction, but also may create some aspect of urethral coaptation or compression.

Midurethral slings were introduced nearly 20 years ago. These procedures can be performed with a local anesthetic or with minimal regional anesthesia – thus, in an outpatient setting. In addition, midurethral slings are associated with decreased pain and postoperative convalescence.

I have asked Dr. Eric Russell Sokol to lead this state-of-the-art discussion on midurethral slings. Dr. Sokol is an associate professor of obstetrics and gynecology, associate professor of urology (by courtesy), and cochief of the division of urogynecology and pelvic reconstructive surgery at Stanford (Calif.) University. He has published many articles regarding urogynecology and minimally invasive surgery. Dr. Sokol has been awarded numerous teaching awards, and he is a reviewer for multiple prestigious, peer-reviewed journals. It is a pleasure and an honor to welcome Dr. Sokol to this edition of Master Class in Gynecologic Surgery, the second installment on urinary incontinence.

Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and on the speaker’s bureau for Ethicon.

According to a 2004 article by Dr. Eric S. Rovner and Dr. Alan J. Wein, 200 different surgical procedures have been described to treat stress urinary incontinence (Rev. Urol. 2004;6(Suppl 3):S29-47). Two goals exist in such surgical procedures:

1. Urethra repositioning or stabilization of the urethra and bladder neck through creation of retropubic support that is impervious to intraabdominal pressure changes.

2. Augmentation of the ureteral resistance provided by the intrinsic sphincter unit, with or without impacting urethra and bladder neck support (sling vs. periurethral injectables, or a combination of the two).

Sling procedures were initially introduced almost a century ago and have recently become increasingly popular – in part, secondary to a decrease in associated morbidity. Unlike transabdominal or transvaginal urethropexy, a sling not only provides support to the vesicourethral junction, but also may create some aspect of urethral coaptation or compression.

Midurethral slings were introduced nearly 20 years ago. These procedures can be performed with a local anesthetic or with minimal regional anesthesia – thus, in an outpatient setting. In addition, midurethral slings are associated with decreased pain and postoperative convalescence.

I have asked Dr. Eric Russell Sokol to lead this state-of-the-art discussion on midurethral slings. Dr. Sokol is an associate professor of obstetrics and gynecology, associate professor of urology (by courtesy), and cochief of the division of urogynecology and pelvic reconstructive surgery at Stanford (Calif.) University. He has published many articles regarding urogynecology and minimally invasive surgery. Dr. Sokol has been awarded numerous teaching awards, and he is a reviewer for multiple prestigious, peer-reviewed journals. It is a pleasure and an honor to welcome Dr. Sokol to this edition of Master Class in Gynecologic Surgery, the second installment on urinary incontinence.

Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and on the speaker’s bureau for Ethicon.

According to a 2004 article by Dr. Eric S. Rovner and Dr. Alan J. Wein, 200 different surgical procedures have been described to treat stress urinary incontinence (Rev. Urol. 2004;6(Suppl 3):S29-47). Two goals exist in such surgical procedures:

1. Urethra repositioning or stabilization of the urethra and bladder neck through creation of retropubic support that is impervious to intraabdominal pressure changes.

2. Augmentation of the ureteral resistance provided by the intrinsic sphincter unit, with or without impacting urethra and bladder neck support (sling vs. periurethral injectables, or a combination of the two).

Sling procedures were initially introduced almost a century ago and have recently become increasingly popular – in part, secondary to a decrease in associated morbidity. Unlike transabdominal or transvaginal urethropexy, a sling not only provides support to the vesicourethral junction, but also may create some aspect of urethral coaptation or compression.

Midurethral slings were introduced nearly 20 years ago. These procedures can be performed with a local anesthetic or with minimal regional anesthesia – thus, in an outpatient setting. In addition, midurethral slings are associated with decreased pain and postoperative convalescence.

I have asked Dr. Eric Russell Sokol to lead this state-of-the-art discussion on midurethral slings. Dr. Sokol is an associate professor of obstetrics and gynecology, associate professor of urology (by courtesy), and cochief of the division of urogynecology and pelvic reconstructive surgery at Stanford (Calif.) University. He has published many articles regarding urogynecology and minimally invasive surgery. Dr. Sokol has been awarded numerous teaching awards, and he is a reviewer for multiple prestigious, peer-reviewed journals. It is a pleasure and an honor to welcome Dr. Sokol to this edition of Master Class in Gynecologic Surgery, the second installment on urinary incontinence.

Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and on the speaker’s bureau for Ethicon.

Preparing drugs for a trial

Credit: Esther Dyson

Combining the proteasome inhibitor ixazomib with lenalidomide and dexamethasone shows promise for treating patients with newly diagnosed multiple myeloma (MM), according to researchers.

In a phase 1/2 study, the all-oral combination produced a 92% overall response rate and a 27% complete response rate.

Drug-related adverse events occurred in 100% of patients, with events of grade 3 or higher occurring in 63% of patients.

These results appear in The Lancet Oncology. The study was funded by Millennium Pharmaceuticals, the company developing ixazomib.

“Ixazomib is an investigational, oral proteasome inhibitor with promising anti-myeloma effects and low rates of peripheral neuropathy,” said study author Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minnesota.

“While it is well known that a combination of bortezomib, lenalidomide, and dexamethasone is highly effective in treating newly diagnosed multiple myeloma, we wanted to study the safety, tolerability, and activity of ixazomib in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma.”

Dr Kumar and colleagues enrolled 65 patients—15 for phase 1 and 50 for phase 2 of the study—who were newly diagnosed with MM and 18 years of age or older. Patients had measurable disease, ECOG performance status of 0 to 2, and no grade 2 or higher peripheral neuropathy.

They received ixazomib (on days 1, 8, and 15) plus lenalidomide at 25 mg (on days 1 to 21) and dexamethasone at 40 mg (on days 1, 8, 15, and 22) for up to twelve 28-day cycles, followed by maintenance therapy with ixazomib alone.

In phase 1, patients received escalating doses of ixazomib, from 1.68 mg/m² to 3.95 mg/m², to establish the recommended dose for phase 2. The researchers established 2.97 mg/m² as the maximum-tolerated dose and recommended the phase 2 dose be 2.23 mg/m². This was converted to a 4.0 mg fixed dose based on population pharmacokinetic results.

Adverse events

The researchers said the combination was well tolerated, and most toxic effects were managed through dose modifications.

All patients reported at least one treatment-emergent adverse event, and 75% reported at least one treatment-emergent event that was grade 3 or higher.

Fifty-seven percent of patients had adverse events that led to dose reductions, including 53% of patients in the dose-escalation cohort and 58% of patients in the phase 2 cohort.

The most common adverse events resulting in dose reductions included skin and subcutaneous tissue disorders (20%), fatigue (14%), diarrhea (8%), peripheral neuropathy not elsewhere classified (8%), insomnia (6%), and increased body weight (6%). Five patients had adverse events leading to treatment discontinuation.

Two patients in the phase 2 cohort died while on study. One patient died of respiratory syncytial viral pneumonia that was thought to be treatment-related. The other patient died from cardiorespiratory arrest, which was considered not related to treatment.

Response and survival rates

Of the 64 response-evaluable patients, 92% responded to treatment. Fifty-eight percent had a partial response or better, and 27% had a complete response.

Responses deepened with an increasing number of treatment cycles. In the 25 patients continuing with maintenance therapy, 5 (20%) had an improvement in the depth of response during this phase.

The median duration of response has not been reached, but patients maintained responses for up to 2 years.

At last follow-up, 9 patients had progressed or died. The estimated 1-year progression-free survival was 88%, and 2-year progression-free survival was 67%.

The median overall survival has not been reached, but the estimated 1-year overall survival was 94%.

“The all-oral combination of weekly ixazomib plus lenalidomide and dexamethasone was generally well-tolerated and appeared active in patients with newly diagnosed multiple myeloma,” Dr Kumar said. “Our results support the development of a phase 3 trial studying this combination for multiple myeloma.”

Preparing drugs for a trial

Credit: Esther Dyson

Combining the proteasome inhibitor ixazomib with lenalidomide and dexamethasone shows promise for treating patients with newly diagnosed multiple myeloma (MM), according to researchers.

In a phase 1/2 study, the all-oral combination produced a 92% overall response rate and a 27% complete response rate.

Drug-related adverse events occurred in 100% of patients, with events of grade 3 or higher occurring in 63% of patients.

These results appear in The Lancet Oncology. The study was funded by Millennium Pharmaceuticals, the company developing ixazomib.

“Ixazomib is an investigational, oral proteasome inhibitor with promising anti-myeloma effects and low rates of peripheral neuropathy,” said study author Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minnesota.

“While it is well known that a combination of bortezomib, lenalidomide, and dexamethasone is highly effective in treating newly diagnosed multiple myeloma, we wanted to study the safety, tolerability, and activity of ixazomib in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma.”

Dr Kumar and colleagues enrolled 65 patients—15 for phase 1 and 50 for phase 2 of the study—who were newly diagnosed with MM and 18 years of age or older. Patients had measurable disease, ECOG performance status of 0 to 2, and no grade 2 or higher peripheral neuropathy.

They received ixazomib (on days 1, 8, and 15) plus lenalidomide at 25 mg (on days 1 to 21) and dexamethasone at 40 mg (on days 1, 8, 15, and 22) for up to twelve 28-day cycles, followed by maintenance therapy with ixazomib alone.

In phase 1, patients received escalating doses of ixazomib, from 1.68 mg/m² to 3.95 mg/m², to establish the recommended dose for phase 2. The researchers established 2.97 mg/m² as the maximum-tolerated dose and recommended the phase 2 dose be 2.23 mg/m². This was converted to a 4.0 mg fixed dose based on population pharmacokinetic results.

Adverse events

The researchers said the combination was well tolerated, and most toxic effects were managed through dose modifications.

All patients reported at least one treatment-emergent adverse event, and 75% reported at least one treatment-emergent event that was grade 3 or higher.

Fifty-seven percent of patients had adverse events that led to dose reductions, including 53% of patients in the dose-escalation cohort and 58% of patients in the phase 2 cohort.

The most common adverse events resulting in dose reductions included skin and subcutaneous tissue disorders (20%), fatigue (14%), diarrhea (8%), peripheral neuropathy not elsewhere classified (8%), insomnia (6%), and increased body weight (6%). Five patients had adverse events leading to treatment discontinuation.

Two patients in the phase 2 cohort died while on study. One patient died of respiratory syncytial viral pneumonia that was thought to be treatment-related. The other patient died from cardiorespiratory arrest, which was considered not related to treatment.

Response and survival rates

Of the 64 response-evaluable patients, 92% responded to treatment. Fifty-eight percent had a partial response or better, and 27% had a complete response.

Responses deepened with an increasing number of treatment cycles. In the 25 patients continuing with maintenance therapy, 5 (20%) had an improvement in the depth of response during this phase.

The median duration of response has not been reached, but patients maintained responses for up to 2 years.

At last follow-up, 9 patients had progressed or died. The estimated 1-year progression-free survival was 88%, and 2-year progression-free survival was 67%.

The median overall survival has not been reached, but the estimated 1-year overall survival was 94%.

“The all-oral combination of weekly ixazomib plus lenalidomide and dexamethasone was generally well-tolerated and appeared active in patients with newly diagnosed multiple myeloma,” Dr Kumar said. “Our results support the development of a phase 3 trial studying this combination for multiple myeloma.”

Preparing drugs for a trial

Credit: Esther Dyson

Combining the proteasome inhibitor ixazomib with lenalidomide and dexamethasone shows promise for treating patients with newly diagnosed multiple myeloma (MM), according to researchers.

In a phase 1/2 study, the all-oral combination produced a 92% overall response rate and a 27% complete response rate.

Drug-related adverse events occurred in 100% of patients, with events of grade 3 or higher occurring in 63% of patients.

These results appear in The Lancet Oncology. The study was funded by Millennium Pharmaceuticals, the company developing ixazomib.

“Ixazomib is an investigational, oral proteasome inhibitor with promising anti-myeloma effects and low rates of peripheral neuropathy,” said study author Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minnesota.

“While it is well known that a combination of bortezomib, lenalidomide, and dexamethasone is highly effective in treating newly diagnosed multiple myeloma, we wanted to study the safety, tolerability, and activity of ixazomib in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma.”

Dr Kumar and colleagues enrolled 65 patients—15 for phase 1 and 50 for phase 2 of the study—who were newly diagnosed with MM and 18 years of age or older. Patients had measurable disease, ECOG performance status of 0 to 2, and no grade 2 or higher peripheral neuropathy.

They received ixazomib (on days 1, 8, and 15) plus lenalidomide at 25 mg (on days 1 to 21) and dexamethasone at 40 mg (on days 1, 8, 15, and 22) for up to twelve 28-day cycles, followed by maintenance therapy with ixazomib alone.

In phase 1, patients received escalating doses of ixazomib, from 1.68 mg/m² to 3.95 mg/m², to establish the recommended dose for phase 2. The researchers established 2.97 mg/m² as the maximum-tolerated dose and recommended the phase 2 dose be 2.23 mg/m². This was converted to a 4.0 mg fixed dose based on population pharmacokinetic results.

Adverse events

The researchers said the combination was well tolerated, and most toxic effects were managed through dose modifications.

All patients reported at least one treatment-emergent adverse event, and 75% reported at least one treatment-emergent event that was grade 3 or higher.

Fifty-seven percent of patients had adverse events that led to dose reductions, including 53% of patients in the dose-escalation cohort and 58% of patients in the phase 2 cohort.

The most common adverse events resulting in dose reductions included skin and subcutaneous tissue disorders (20%), fatigue (14%), diarrhea (8%), peripheral neuropathy not elsewhere classified (8%), insomnia (6%), and increased body weight (6%). Five patients had adverse events leading to treatment discontinuation.

Two patients in the phase 2 cohort died while on study. One patient died of respiratory syncytial viral pneumonia that was thought to be treatment-related. The other patient died from cardiorespiratory arrest, which was considered not related to treatment.

Response and survival rates

Of the 64 response-evaluable patients, 92% responded to treatment. Fifty-eight percent had a partial response or better, and 27% had a complete response.

Responses deepened with an increasing number of treatment cycles. In the 25 patients continuing with maintenance therapy, 5 (20%) had an improvement in the depth of response during this phase.

The median duration of response has not been reached, but patients maintained responses for up to 2 years.

At last follow-up, 9 patients had progressed or died. The estimated 1-year progression-free survival was 88%, and 2-year progression-free survival was 67%.

The median overall survival has not been reached, but the estimated 1-year overall survival was 94%.

“The all-oral combination of weekly ixazomib plus lenalidomide and dexamethasone was generally well-tolerated and appeared active in patients with newly diagnosed multiple myeloma,” Dr Kumar said. “Our results support the development of a phase 3 trial studying this combination for multiple myeloma.”