Surgery

ATLANTA – One of the goals in soon-to-be-published Takayasu’s arteritis guidelines from the American College of Rheumatology is to wean patients off high-dose steroids once they are in remission.

M. Alexander Otto

This recommendation is in opposition to another option – namely, switching these patients to low-dose glucocorticoids. The idea is to prevent long-term side effects, particularly in children. The guidelines also recommend against escalating immunotherapy for asymptomatic increases in inflammatory markers and generally recommend against surgery – stenting in most cases – unless there is threat to life, limb, or organ and also if limb pain is so severe it cramps quality of life and dose escalation doesn’t get the job done. If surgery is planned, patients should be on perioperative steroids if there’s active disease.

It’s draft guidance for now, but it’s probably what the final document will say when it’s published in 2020, according to a presentation at the annual meeting of the American College of Rheumatology by one of the authors, Anisha Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. She gave a sneak preview at the meeting.

In general, severe, active Takayasu’s calls for high-dose oral steroids in conjunction with a nonsteroid immunosuppressive, such as methotrexate, azathioprine, leflunomide, or mycophenolate mofetil. There’s evidence that dual therapy gives a more durable remission and also reduces the need for steroids.

When that approach doesn’t do the trick, the next step is a tumor necrosis factor (TNF) inhibitor. There’s evidence for infliximab, adalimumab, certolizumab, and etanercept. Dr. Dua noted, “We still can consider” tocilizumab, but it failed to meet its primary endpoint in a randomized trial, and evidence for other biologics is sparse or nonexistent. “TNF inhibitors are the first line” for refractory disease, Dr. Dua said.

The steroid taper comes after 6-12 months of remission. Given their toxicity, “our goal for steroids is zero,” especially in pediatric populations. Even in remission, patients should have a clinical assessment, including inflammatory markers, every 3-12 months.

A rise in C-reactive protein or erythrocyte sedimentation rate, with no new symptoms, might be a reason for more frequent monitoring, but it’s not a reason to escalate immunosuppression. That should be kept in reserve for new vascular lesions, rapid progression on an old one, or worsening of organ or limb ischemia.

“We recommend [escalation] over surgical intervention” because patients often develop collateral circulation that solves the problem; it also gives the disease time to quiet down should the patient eventually go into surgery. Immediate surgery is reserved for organ or life-threatening disease, Dr. Dua said.

“Takayasu’s is different from other vasculitides in the sense that patients often present with certain nonspecific constitutional symptoms,” and there’s not a lot of pathology or histology to work with, “so we do tend to rely on imaging a lot,” Dr. Dua said.

Angiography has fallen out of favor because it’s invasive and exposes patients to radiation, among other problems. The field has moved to noninvasive imaging such as color Doppler ultrasound, CT angiography, magnetic resonance angiography, and PET CT.

“We do recommend regularly scheduled, noninvasive imaging every 6-12 months, in addition to the routine clinical assessment,” except in children with inactive disease; the risk of sedation outweighs the imaging benefit, Dr. Dua said.

In patients with single-vessel cranial or cervical stenosis, without symptoms, “we recommend medical over surgical management because of the risk of surgery. Surgery can be considered for multivessel involvement,” she said.

She and her colleagues also recommend medical management for renal artery stenosis, including antihypertensives and immunotherapy escalation for active disease. Surgery is considered for refractory hypertension or worsening kidney function

Dr. Dua is a primary investigator and adviser for Chemocentryx and an adviser for Novartis and AbbVie.

[email protected]

ATLANTA – One of the goals in soon-to-be-published Takayasu’s arteritis guidelines from the American College of Rheumatology is to wean patients off high-dose steroids once they are in remission.

M. Alexander Otto

This recommendation is in opposition to another option – namely, switching these patients to low-dose glucocorticoids. The idea is to prevent long-term side effects, particularly in children. The guidelines also recommend against escalating immunotherapy for asymptomatic increases in inflammatory markers and generally recommend against surgery – stenting in most cases – unless there is threat to life, limb, or organ and also if limb pain is so severe it cramps quality of life and dose escalation doesn’t get the job done. If surgery is planned, patients should be on perioperative steroids if there’s active disease.

It’s draft guidance for now, but it’s probably what the final document will say when it’s published in 2020, according to a presentation at the annual meeting of the American College of Rheumatology by one of the authors, Anisha Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. She gave a sneak preview at the meeting.

In general, severe, active Takayasu’s calls for high-dose oral steroids in conjunction with a nonsteroid immunosuppressive, such as methotrexate, azathioprine, leflunomide, or mycophenolate mofetil. There’s evidence that dual therapy gives a more durable remission and also reduces the need for steroids.

When that approach doesn’t do the trick, the next step is a tumor necrosis factor (TNF) inhibitor. There’s evidence for infliximab, adalimumab, certolizumab, and etanercept. Dr. Dua noted, “We still can consider” tocilizumab, but it failed to meet its primary endpoint in a randomized trial, and evidence for other biologics is sparse or nonexistent. “TNF inhibitors are the first line” for refractory disease, Dr. Dua said.

The steroid taper comes after 6-12 months of remission. Given their toxicity, “our goal for steroids is zero,” especially in pediatric populations. Even in remission, patients should have a clinical assessment, including inflammatory markers, every 3-12 months.

A rise in C-reactive protein or erythrocyte sedimentation rate, with no new symptoms, might be a reason for more frequent monitoring, but it’s not a reason to escalate immunosuppression. That should be kept in reserve for new vascular lesions, rapid progression on an old one, or worsening of organ or limb ischemia.

“We recommend [escalation] over surgical intervention” because patients often develop collateral circulation that solves the problem; it also gives the disease time to quiet down should the patient eventually go into surgery. Immediate surgery is reserved for organ or life-threatening disease, Dr. Dua said.

“Takayasu’s is different from other vasculitides in the sense that patients often present with certain nonspecific constitutional symptoms,” and there’s not a lot of pathology or histology to work with, “so we do tend to rely on imaging a lot,” Dr. Dua said.

Angiography has fallen out of favor because it’s invasive and exposes patients to radiation, among other problems. The field has moved to noninvasive imaging such as color Doppler ultrasound, CT angiography, magnetic resonance angiography, and PET CT.

“We do recommend regularly scheduled, noninvasive imaging every 6-12 months, in addition to the routine clinical assessment,” except in children with inactive disease; the risk of sedation outweighs the imaging benefit, Dr. Dua said.

In patients with single-vessel cranial or cervical stenosis, without symptoms, “we recommend medical over surgical management because of the risk of surgery. Surgery can be considered for multivessel involvement,” she said.

She and her colleagues also recommend medical management for renal artery stenosis, including antihypertensives and immunotherapy escalation for active disease. Surgery is considered for refractory hypertension or worsening kidney function

Dr. Dua is a primary investigator and adviser for Chemocentryx and an adviser for Novartis and AbbVie.

[email protected]

ATLANTA – One of the goals in soon-to-be-published Takayasu’s arteritis guidelines from the American College of Rheumatology is to wean patients off high-dose steroids once they are in remission.

M. Alexander Otto

This recommendation is in opposition to another option – namely, switching these patients to low-dose glucocorticoids. The idea is to prevent long-term side effects, particularly in children. The guidelines also recommend against escalating immunotherapy for asymptomatic increases in inflammatory markers and generally recommend against surgery – stenting in most cases – unless there is threat to life, limb, or organ and also if limb pain is so severe it cramps quality of life and dose escalation doesn’t get the job done. If surgery is planned, patients should be on perioperative steroids if there’s active disease.

It’s draft guidance for now, but it’s probably what the final document will say when it’s published in 2020, according to a presentation at the annual meeting of the American College of Rheumatology by one of the authors, Anisha Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. She gave a sneak preview at the meeting.

In general, severe, active Takayasu’s calls for high-dose oral steroids in conjunction with a nonsteroid immunosuppressive, such as methotrexate, azathioprine, leflunomide, or mycophenolate mofetil. There’s evidence that dual therapy gives a more durable remission and also reduces the need for steroids.

When that approach doesn’t do the trick, the next step is a tumor necrosis factor (TNF) inhibitor. There’s evidence for infliximab, adalimumab, certolizumab, and etanercept. Dr. Dua noted, “We still can consider” tocilizumab, but it failed to meet its primary endpoint in a randomized trial, and evidence for other biologics is sparse or nonexistent. “TNF inhibitors are the first line” for refractory disease, Dr. Dua said.

The steroid taper comes after 6-12 months of remission. Given their toxicity, “our goal for steroids is zero,” especially in pediatric populations. Even in remission, patients should have a clinical assessment, including inflammatory markers, every 3-12 months.

A rise in C-reactive protein or erythrocyte sedimentation rate, with no new symptoms, might be a reason for more frequent monitoring, but it’s not a reason to escalate immunosuppression. That should be kept in reserve for new vascular lesions, rapid progression on an old one, or worsening of organ or limb ischemia.

“We recommend [escalation] over surgical intervention” because patients often develop collateral circulation that solves the problem; it also gives the disease time to quiet down should the patient eventually go into surgery. Immediate surgery is reserved for organ or life-threatening disease, Dr. Dua said.

“Takayasu’s is different from other vasculitides in the sense that patients often present with certain nonspecific constitutional symptoms,” and there’s not a lot of pathology or histology to work with, “so we do tend to rely on imaging a lot,” Dr. Dua said.

Angiography has fallen out of favor because it’s invasive and exposes patients to radiation, among other problems. The field has moved to noninvasive imaging such as color Doppler ultrasound, CT angiography, magnetic resonance angiography, and PET CT.

“We do recommend regularly scheduled, noninvasive imaging every 6-12 months, in addition to the routine clinical assessment,” except in children with inactive disease; the risk of sedation outweighs the imaging benefit, Dr. Dua said.

In patients with single-vessel cranial or cervical stenosis, without symptoms, “we recommend medical over surgical management because of the risk of surgery. Surgery can be considered for multivessel involvement,” she said.

She and her colleagues also recommend medical management for renal artery stenosis, including antihypertensives and immunotherapy escalation for active disease. Surgery is considered for refractory hypertension or worsening kidney function

Dr. Dua is a primary investigator and adviser for Chemocentryx and an adviser for Novartis and AbbVie.

[email protected]

LAS VEGAS – Inappropriate patient positioning can cause nerve injuries in gynecologic laparoscopic surgery, and it’s not just nerves below the waist that are vulnerable.

But the risk can be lowered through careful positioning that avoids pressure and over-stretching, the two main causes of nerve injuries in these surgeries, Cleveland Clinic obstetrician-gynecologist and surgeon Tommaso Falcone, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Falcone offered tips about avoiding injuries to these nerves:

Brachial plexus. To avoid injury to this nerve, arms should be tucked and pronated or kept at less than a 90-degree angle from the body. Hyperextension injuries can occur when the arm is outstretched too much, said Dr. Falcone, who recommends putting a cushion under the elbow and wrist.

How can you know if an injury has occurred? The patient will typically wake up with a dropped wrist and numbness in the arm, he said, signs suggesting a stretch injury to the brachial plexus.

Ulnar nerve: Improper tucking of the arms can injure the ulnar nerve and cause numbness and weakness in the fourth and fifth fingers. Dr. Falcone recommends keeping the arms pronated if they’re tucked and supinated if they’re on arm boards. Again, he emphasized placing a cushion under the elbow and wrist.

Femoral nerve: Hyperflexion or hyperextension can compress the femoral nerve under the inguinal ligament and cause it to become ischemic, Dr. Falcone said.

Femoral nerve injury can lead to numbness (in the anterior and medial thigh), decreased patellar reflex, weakness of the quadriceps, and loss of knee extension flexibility. Patients may need to use a wheelchair for a time and undergo physical therapy, he said.

Obdurator nerve: Excessive lateral thigh abduction – outward movement – can stretch this nerve, Dr. Falcone said. Avoid excessive abduction by keeping the thigh-to-thigh angle under 90 degrees, he recommended. (This rule also helps to prevent femoral nerve injury.)

Signs of injury can include numbness on the medial aspect of the thigh and weakness in the adductor muscles. Physical therapy can be helpful, he said.

Sciatic nerve: Beware of hyperflexion of the hips followed by sudden straightening of the knees, he said. According to him, this can occur when candy-cane stirrups are used. Signs of injury can include foot drop and numbness (calf, dorsum, sole, and lateral side of the foot).

Peroneal nerve: Prolonged pressure against the knee can injure this nerve and cause foot drop and numbness (over the lower anterior leg and dorsum of the foot).

Dr. Falcone reports honoraria (Journal of Minimally Invasive Gynecology and Up-To-Date) and federal research funds. This meeting was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

LAS VEGAS – Inappropriate patient positioning can cause nerve injuries in gynecologic laparoscopic surgery, and it’s not just nerves below the waist that are vulnerable.

But the risk can be lowered through careful positioning that avoids pressure and over-stretching, the two main causes of nerve injuries in these surgeries, Cleveland Clinic obstetrician-gynecologist and surgeon Tommaso Falcone, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Falcone offered tips about avoiding injuries to these nerves:

Brachial plexus. To avoid injury to this nerve, arms should be tucked and pronated or kept at less than a 90-degree angle from the body. Hyperextension injuries can occur when the arm is outstretched too much, said Dr. Falcone, who recommends putting a cushion under the elbow and wrist.

How can you know if an injury has occurred? The patient will typically wake up with a dropped wrist and numbness in the arm, he said, signs suggesting a stretch injury to the brachial plexus.

Ulnar nerve: Improper tucking of the arms can injure the ulnar nerve and cause numbness and weakness in the fourth and fifth fingers. Dr. Falcone recommends keeping the arms pronated if they’re tucked and supinated if they’re on arm boards. Again, he emphasized placing a cushion under the elbow and wrist.

Femoral nerve: Hyperflexion or hyperextension can compress the femoral nerve under the inguinal ligament and cause it to become ischemic, Dr. Falcone said.

Femoral nerve injury can lead to numbness (in the anterior and medial thigh), decreased patellar reflex, weakness of the quadriceps, and loss of knee extension flexibility. Patients may need to use a wheelchair for a time and undergo physical therapy, he said.

Obdurator nerve: Excessive lateral thigh abduction – outward movement – can stretch this nerve, Dr. Falcone said. Avoid excessive abduction by keeping the thigh-to-thigh angle under 90 degrees, he recommended. (This rule also helps to prevent femoral nerve injury.)

Signs of injury can include numbness on the medial aspect of the thigh and weakness in the adductor muscles. Physical therapy can be helpful, he said.

Sciatic nerve: Beware of hyperflexion of the hips followed by sudden straightening of the knees, he said. According to him, this can occur when candy-cane stirrups are used. Signs of injury can include foot drop and numbness (calf, dorsum, sole, and lateral side of the foot).

Peroneal nerve: Prolonged pressure against the knee can injure this nerve and cause foot drop and numbness (over the lower anterior leg and dorsum of the foot).

Dr. Falcone reports honoraria (Journal of Minimally Invasive Gynecology and Up-To-Date) and federal research funds. This meeting was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

LAS VEGAS – Inappropriate patient positioning can cause nerve injuries in gynecologic laparoscopic surgery, and it’s not just nerves below the waist that are vulnerable.

But the risk can be lowered through careful positioning that avoids pressure and over-stretching, the two main causes of nerve injuries in these surgeries, Cleveland Clinic obstetrician-gynecologist and surgeon Tommaso Falcone, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Falcone offered tips about avoiding injuries to these nerves:

Brachial plexus. To avoid injury to this nerve, arms should be tucked and pronated or kept at less than a 90-degree angle from the body. Hyperextension injuries can occur when the arm is outstretched too much, said Dr. Falcone, who recommends putting a cushion under the elbow and wrist.

How can you know if an injury has occurred? The patient will typically wake up with a dropped wrist and numbness in the arm, he said, signs suggesting a stretch injury to the brachial plexus.

Ulnar nerve: Improper tucking of the arms can injure the ulnar nerve and cause numbness and weakness in the fourth and fifth fingers. Dr. Falcone recommends keeping the arms pronated if they’re tucked and supinated if they’re on arm boards. Again, he emphasized placing a cushion under the elbow and wrist.

Femoral nerve: Hyperflexion or hyperextension can compress the femoral nerve under the inguinal ligament and cause it to become ischemic, Dr. Falcone said.

Femoral nerve injury can lead to numbness (in the anterior and medial thigh), decreased patellar reflex, weakness of the quadriceps, and loss of knee extension flexibility. Patients may need to use a wheelchair for a time and undergo physical therapy, he said.

Obdurator nerve: Excessive lateral thigh abduction – outward movement – can stretch this nerve, Dr. Falcone said. Avoid excessive abduction by keeping the thigh-to-thigh angle under 90 degrees, he recommended. (This rule also helps to prevent femoral nerve injury.)

Signs of injury can include numbness on the medial aspect of the thigh and weakness in the adductor muscles. Physical therapy can be helpful, he said.

Sciatic nerve: Beware of hyperflexion of the hips followed by sudden straightening of the knees, he said. According to him, this can occur when candy-cane stirrups are used. Signs of injury can include foot drop and numbness (calf, dorsum, sole, and lateral side of the foot).

Peroneal nerve: Prolonged pressure against the knee can injure this nerve and cause foot drop and numbness (over the lower anterior leg and dorsum of the foot).

Dr. Falcone reports honoraria (Journal of Minimally Invasive Gynecology and Up-To-Date) and federal research funds. This meeting was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

A new study summarizing and reanalyzing the international evidence base for uterine balloon tamponade for postpartum hemorrhage found it an overall safe and efficacious procedure.

Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.

In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.

Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.

“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.

One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.

UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.

Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.

The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.

To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.

The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.

Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.

Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.

Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”

“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”

Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”

The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.

SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.

A new study summarizing and reanalyzing the international evidence base for uterine balloon tamponade for postpartum hemorrhage found it an overall safe and efficacious procedure.

Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.

In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.

Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.

“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.

One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.

UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.

Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.

The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.

To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.

The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.

Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.

Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.

Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”

“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”

Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”

The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.

SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.

A new study summarizing and reanalyzing the international evidence base for uterine balloon tamponade for postpartum hemorrhage found it an overall safe and efficacious procedure.

Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.

In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.

Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.

“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.

One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.

UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.

Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.

The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.

To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.

The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.

Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.

Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.

Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”

“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”

Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”

The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.

SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.

NEW SACRAL NEUROMODULATION DEVICE

FOR MORE INFORMATION, VISIT: https://www.axonics.com/

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

FOR MORE INFORMATION, VISIT: https://cystosure.com/

NEXT FRONTIER IN VACCINE IMMUNIZATION

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

FOR MORE INFORMATION, VISIT: https://www.pfizer.com/

NEW SACRAL NEUROMODULATION DEVICE

FOR MORE INFORMATION, VISIT: https://www.axonics.com/

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

FOR MORE INFORMATION, VISIT: https://cystosure.com/

NEXT FRONTIER IN VACCINE IMMUNIZATION

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

FOR MORE INFORMATION, VISIT: https://www.pfizer.com/

NEW SACRAL NEUROMODULATION DEVICE

FOR MORE INFORMATION, VISIT: https://www.axonics.com/

CERVICAL SEAL FOR HYSTEROSCOPIC DEVICES

For more information, visit: https://gynsurgicalsolutions.com/product/omni-lok/

UNIVERSAL CYSTOSCOPY SIMPLIFIED

FOR MORE INFORMATION, VISIT: https://cystosure.com/

NEXT FRONTIER IN VACCINE IMMUNIZATION

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.

FOR MORE INFORMATION, VISIT: https://www.pfizer.com/

LAS VEGAS – The ability of bariatric surgery and substantial subsequent weight loss to cut the incidence of a variety of obesity-related cancers and other malignancies received further confirmation in results from two studies reported at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Mitchel L. Zoler/MDedge News

In one study, 2,107 adults enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study showed a statistically significant halving of the cancer incidence during 7 years of follow-up in patients who underwent bariatric surgery and had a reduction of at least 20% in their presurgical body mass index (BMI), compared with patients in the study who underwent bariatric surgery but lost less weight, reported Andrea M. Stroud, MD, a bariatric surgeon at the Oregon Health & Science University, Portland.

In the second study, analysis of about 1.7 million hospitalized U.S. patients in the National Inpatient Sample showed that the incidence of an obesity-related cancer was 21% higher in more than 1.4 million obese individuals (BMI, 35 kg/m² or greater) with no history of bariatric surgery, compared with nearly 247,000 people in the same database with a history of both obesity and bariatric surgery, said Juliana Henrique, MD, a bariatric surgeon at the Cleveland Clinic Florida in Weston.

The study reported by Dr. Henrique focused specifically on the 13 cancer types identified by the Centers for Disease Control and Prevention as having an incidence that links with overweight and obesity (Morb Mortal Wkly Rep. 2017;66[39]:1052-8), whereas the study presented by Dr. Stroud included all incident cancers during follow-up, but which were predominantly obesity related, with breast cancer – an obesity-related malignancy – having the highest incidence. Overall, 40% of all U.S. cancers in 2014 were obesity related, according to the CDC’s report.

Mitchel L. Zoler/MDedge News

“A number of studies have shown decreases in cancer rates after bariatric surgery, especially female cancers like breast and ovarian,” commented John Scott, MD, director of metabolic and bariatric surgery for Prism Health–Upstate in Greenville, S.C. “These two reports build on that.”

The evidence for weight loss after bariatric surgery as a means to cut the risk of a first or recurrent cancer has become strong enough for some patients to see cancer prophylaxis as a prime reason to undergo the procedure, said surgeons at the meeting.

Bariatric surgery and subsequent weight loss “is a substantial preventive factor for cancer, especially in patients who have obesity and diabetes,” commented Theresa LaMasters, MD, a bariatric surgeon in West Des Moines, Iowa. “It might not just be weight loss. It’s likely a multifactorial effect, including reduced inflammation after bariatric surgery, but weight loss is a component” of the effect, Dr. LaMasters said in an interview. It is now common for her to see patients seeking bariatric surgery because of a family or personal history of cancer. “Patients are trying to reduce their future risk” for cancer with bariatric surgery, she added.

The LABS-2 study enrolled 2,458 patients who were part of the first LABS cohort, LABS-1, but followed them longer term. The data Dr. Stroud reported came from 2,107 of the LABS-2 patients without a history of cancer, no cancer diagnosed in the first year after bariatric surgery, and longer-term follow-up of 7 years. About three-quarters of the patients underwent gastric bypass, with the rest undergoing laparoscopic gastric band placement. Nearly half of those included had diabetes. Their average BMI was 45-50 kg/m².

Dr. Stroud and associates ran an analysis that divided the populations into tertiles based on percentage of baseline body mass lost at 12 months after surgery and cancer-free survival during the 7 years after the 12-month follow-up. The incidence of cancer was 51% lower in patients who lost 20%-34% of their BMI, compared with those who lost less than 20%, a statistically significant difference, and patients who lost 35% or more of their BMI had a 31% reduced cancer rate, compared with those who lost less than 20%, a difference that was not statistically significant, Dr. Stroud reported. The patients who lost less weight after surgery mostly underwent gastric banding, whereas those who lost more mostly underwent gastric bypass.

Mitchel L. Zoler/MDedge News

The analysis reported by Dr. Henrique used data collected in the U.S. National Inpatient Sample during 2010-2014, which totaled more than 7 million patients hospitalized for cancer, including 1,423,367 with a history of obesity and 246,668 with obesity who had undergone bariatric surgery. Those without bariatric surgery had a 21% higher rate of developing obesity-related cancers after adjustment for many baseline demographic and clinical features, Dr. Henrique said. The cancer protection after bariatric surgery was especially notable in the subset of patients in the sample with a genetic predisposition to developing cancer.

LABS-1 and LABS-2 were funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Stroud and Dr. Henrique had no disclosures.

[email protected]

SOURCES: Stroud AM et al. Obesity Week, Abstract A107; Henrique J et al. Obesity Week, Abstract A108.

LAS VEGAS – The ability of bariatric surgery and substantial subsequent weight loss to cut the incidence of a variety of obesity-related cancers and other malignancies received further confirmation in results from two studies reported at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Mitchel L. Zoler/MDedge News

In one study, 2,107 adults enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study showed a statistically significant halving of the cancer incidence during 7 years of follow-up in patients who underwent bariatric surgery and had a reduction of at least 20% in their presurgical body mass index (BMI), compared with patients in the study who underwent bariatric surgery but lost less weight, reported Andrea M. Stroud, MD, a bariatric surgeon at the Oregon Health & Science University, Portland.

In the second study, analysis of about 1.7 million hospitalized U.S. patients in the National Inpatient Sample showed that the incidence of an obesity-related cancer was 21% higher in more than 1.4 million obese individuals (BMI, 35 kg/m² or greater) with no history of bariatric surgery, compared with nearly 247,000 people in the same database with a history of both obesity and bariatric surgery, said Juliana Henrique, MD, a bariatric surgeon at the Cleveland Clinic Florida in Weston.

The study reported by Dr. Henrique focused specifically on the 13 cancer types identified by the Centers for Disease Control and Prevention as having an incidence that links with overweight and obesity (Morb Mortal Wkly Rep. 2017;66[39]:1052-8), whereas the study presented by Dr. Stroud included all incident cancers during follow-up, but which were predominantly obesity related, with breast cancer – an obesity-related malignancy – having the highest incidence. Overall, 40% of all U.S. cancers in 2014 were obesity related, according to the CDC’s report.

Mitchel L. Zoler/MDedge News

“A number of studies have shown decreases in cancer rates after bariatric surgery, especially female cancers like breast and ovarian,” commented John Scott, MD, director of metabolic and bariatric surgery for Prism Health–Upstate in Greenville, S.C. “These two reports build on that.”

The evidence for weight loss after bariatric surgery as a means to cut the risk of a first or recurrent cancer has become strong enough for some patients to see cancer prophylaxis as a prime reason to undergo the procedure, said surgeons at the meeting.

Bariatric surgery and subsequent weight loss “is a substantial preventive factor for cancer, especially in patients who have obesity and diabetes,” commented Theresa LaMasters, MD, a bariatric surgeon in West Des Moines, Iowa. “It might not just be weight loss. It’s likely a multifactorial effect, including reduced inflammation after bariatric surgery, but weight loss is a component” of the effect, Dr. LaMasters said in an interview. It is now common for her to see patients seeking bariatric surgery because of a family or personal history of cancer. “Patients are trying to reduce their future risk” for cancer with bariatric surgery, she added.

The LABS-2 study enrolled 2,458 patients who were part of the first LABS cohort, LABS-1, but followed them longer term. The data Dr. Stroud reported came from 2,107 of the LABS-2 patients without a history of cancer, no cancer diagnosed in the first year after bariatric surgery, and longer-term follow-up of 7 years. About three-quarters of the patients underwent gastric bypass, with the rest undergoing laparoscopic gastric band placement. Nearly half of those included had diabetes. Their average BMI was 45-50 kg/m².

Dr. Stroud and associates ran an analysis that divided the populations into tertiles based on percentage of baseline body mass lost at 12 months after surgery and cancer-free survival during the 7 years after the 12-month follow-up. The incidence of cancer was 51% lower in patients who lost 20%-34% of their BMI, compared with those who lost less than 20%, a statistically significant difference, and patients who lost 35% or more of their BMI had a 31% reduced cancer rate, compared with those who lost less than 20%, a difference that was not statistically significant, Dr. Stroud reported. The patients who lost less weight after surgery mostly underwent gastric banding, whereas those who lost more mostly underwent gastric bypass.

Mitchel L. Zoler/MDedge News

The analysis reported by Dr. Henrique used data collected in the U.S. National Inpatient Sample during 2010-2014, which totaled more than 7 million patients hospitalized for cancer, including 1,423,367 with a history of obesity and 246,668 with obesity who had undergone bariatric surgery. Those without bariatric surgery had a 21% higher rate of developing obesity-related cancers after adjustment for many baseline demographic and clinical features, Dr. Henrique said. The cancer protection after bariatric surgery was especially notable in the subset of patients in the sample with a genetic predisposition to developing cancer.

LABS-1 and LABS-2 were funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Stroud and Dr. Henrique had no disclosures.

[email protected]

SOURCES: Stroud AM et al. Obesity Week, Abstract A107; Henrique J et al. Obesity Week, Abstract A108.

LAS VEGAS – The ability of bariatric surgery and substantial subsequent weight loss to cut the incidence of a variety of obesity-related cancers and other malignancies received further confirmation in results from two studies reported at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Mitchel L. Zoler/MDedge News

In one study, 2,107 adults enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study showed a statistically significant halving of the cancer incidence during 7 years of follow-up in patients who underwent bariatric surgery and had a reduction of at least 20% in their presurgical body mass index (BMI), compared with patients in the study who underwent bariatric surgery but lost less weight, reported Andrea M. Stroud, MD, a bariatric surgeon at the Oregon Health & Science University, Portland.

In the second study, analysis of about 1.7 million hospitalized U.S. patients in the National Inpatient Sample showed that the incidence of an obesity-related cancer was 21% higher in more than 1.4 million obese individuals (BMI, 35 kg/m² or greater) with no history of bariatric surgery, compared with nearly 247,000 people in the same database with a history of both obesity and bariatric surgery, said Juliana Henrique, MD, a bariatric surgeon at the Cleveland Clinic Florida in Weston.

The study reported by Dr. Henrique focused specifically on the 13 cancer types identified by the Centers for Disease Control and Prevention as having an incidence that links with overweight and obesity (Morb Mortal Wkly Rep. 2017;66[39]:1052-8), whereas the study presented by Dr. Stroud included all incident cancers during follow-up, but which were predominantly obesity related, with breast cancer – an obesity-related malignancy – having the highest incidence. Overall, 40% of all U.S. cancers in 2014 were obesity related, according to the CDC’s report.

Mitchel L. Zoler/MDedge News

“A number of studies have shown decreases in cancer rates after bariatric surgery, especially female cancers like breast and ovarian,” commented John Scott, MD, director of metabolic and bariatric surgery for Prism Health–Upstate in Greenville, S.C. “These two reports build on that.”

The evidence for weight loss after bariatric surgery as a means to cut the risk of a first or recurrent cancer has become strong enough for some patients to see cancer prophylaxis as a prime reason to undergo the procedure, said surgeons at the meeting.

Bariatric surgery and subsequent weight loss “is a substantial preventive factor for cancer, especially in patients who have obesity and diabetes,” commented Theresa LaMasters, MD, a bariatric surgeon in West Des Moines, Iowa. “It might not just be weight loss. It’s likely a multifactorial effect, including reduced inflammation after bariatric surgery, but weight loss is a component” of the effect, Dr. LaMasters said in an interview. It is now common for her to see patients seeking bariatric surgery because of a family or personal history of cancer. “Patients are trying to reduce their future risk” for cancer with bariatric surgery, she added.

The LABS-2 study enrolled 2,458 patients who were part of the first LABS cohort, LABS-1, but followed them longer term. The data Dr. Stroud reported came from 2,107 of the LABS-2 patients without a history of cancer, no cancer diagnosed in the first year after bariatric surgery, and longer-term follow-up of 7 years. About three-quarters of the patients underwent gastric bypass, with the rest undergoing laparoscopic gastric band placement. Nearly half of those included had diabetes. Their average BMI was 45-50 kg/m².

Dr. Stroud and associates ran an analysis that divided the populations into tertiles based on percentage of baseline body mass lost at 12 months after surgery and cancer-free survival during the 7 years after the 12-month follow-up. The incidence of cancer was 51% lower in patients who lost 20%-34% of their BMI, compared with those who lost less than 20%, a statistically significant difference, and patients who lost 35% or more of their BMI had a 31% reduced cancer rate, compared with those who lost less than 20%, a difference that was not statistically significant, Dr. Stroud reported. The patients who lost less weight after surgery mostly underwent gastric banding, whereas those who lost more mostly underwent gastric bypass.

Mitchel L. Zoler/MDedge News

The analysis reported by Dr. Henrique used data collected in the U.S. National Inpatient Sample during 2010-2014, which totaled more than 7 million patients hospitalized for cancer, including 1,423,367 with a history of obesity and 246,668 with obesity who had undergone bariatric surgery. Those without bariatric surgery had a 21% higher rate of developing obesity-related cancers after adjustment for many baseline demographic and clinical features, Dr. Henrique said. The cancer protection after bariatric surgery was especially notable in the subset of patients in the sample with a genetic predisposition to developing cancer.

LABS-1 and LABS-2 were funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Stroud and Dr. Henrique had no disclosures.

[email protected]

SOURCES: Stroud AM et al. Obesity Week, Abstract A107; Henrique J et al. Obesity Week, Abstract A108.

Coleman RL, Spirtos NM, Enserro D, et al. Secondary surgical cytoreduction for recurrent ovarian cancer. N Engl J Med. 2019;381:1929-1939.

EXPERT COMMENTARY

Ovarian cancer represents the most lethal gynecologic cancer, with an estimated 14,000 deaths in 2019.¹ While the incidence of this disease is low in comparison to uterine cancer, the advanced stage at diagnosis portends poor prognosis. While stage is an independent risk factor for death, it is also a risk for recurrence, with more than 80% of women developing recurrent disease.^2-4 Secondary cytoreduction remains an option for patients in which disease recurs; up until now this management option was driven by retrospective data.⁵

Details of the study

Coleman and colleagues conducted the Gynecologic Oncology Group (GOG) 0213 trial—a phase 3, multicenter, randomized clinical trial that included 485 women with recurrent ovarian cancer. The surgical objective of the trial was to determine whether secondary cytoreduction in operable, platinum-sensitive (PS) patients improved overall survival (OS).

Patients were eligible to participate in the surgical portion of the trial if they had PS measurable disease and had the intention to achieve complete gross resection. Women with ascites, evidence of extraabdominal disease, and “diffuse carcinomatosis” were excluded. The primary and secondary end points were OS and progression-free survival (PFS), respectively.

Results. There were no statistical differences between the surgery and no surgery groups with regard to median OS (50.6 months vs 64.7 months, respectively; hazard ratio [HR], 1.29; 95% confidence interval [CI], 0.97–1.72) or median PFS (18.9 months vs 16.2 months; HR, 0.82; 95% CI, 0.66 to 1.01). When comparing patients in which complete gross resection was achieved (150 patients vs 245 who did not receive surgery), there was only a statistical difference in PFS in favor of the surgical group (22.4 months vs 16.2 months; HR, 0.62; 95% CI, 0.48–0.80).

Of note, 67% of the patients who received surgery (63% intention-to-treat) were debulked to complete gross resection. There were 33% more patients with extraabdominal disease (10% vs 7% of total patients in each group) and 15% more patients with upper abdominal disease (40% vs 33% of total patients in each group) included in the surgical group. Finally, the median time to chemotherapy was 40 days in the surgery group versus 7 days in the no surgery group.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

The authors deserve to be commended for this well-designed and laborious trial, which is the first of its kind. The strength of the study is its randomized design producing level I data.

Study weaknesses include lack of reporting of BRCA status and the impact of receiving targeted therapies after the trial was over. It is well established that BRCA-mutated patients have an independent survival advantage, even when taking into account platinum sensitivity.^6-8BRCA status of the study population is not specifically addressed in this paper. The authors noted in the first GOG 0213 trial publication, which assessed bevacizumab in the recurrent setting, that BRCA status has an impact on patient outcomes. Subsequently, they state that they do not report BRCA status because “…its independent effect on response to an anti-angiogenesis agent was unknown,” but it clearly would affect survival analysis if unbalanced between groups.⁹

Similarly, in the introduction to their study, Coleman and colleagues list availability of maintenance therapy, for instance poly ADP (adenosine diphosphate–ribose) polymerase (PARP) inhibitors, as rationale for conducting their trial. They subsequently cite this as a possible reason that the median overall survival was 3 times longer than expected. However, they provide no data on which patients received maintenance therapy, which again could have drastically affected survival outcomes.¹⁰ They do report in the supplementary information that, when stratifying those receiving bevacizumab adjuvantly during the trial, the median OS was comparable between the surgical and nonsurgical groups (58.5 months vs 61.7 months).

The authors discuss the presence of patient selection bias as a weakness in the study. Selection bias is evident in this trial (as in many surgical trials) because patients with a limited volume of disease were selected to participate over those with large-volume disease. It is reasonable to conclude that this study is likely selecting patients with less aggressive tumor biology, not only evident by low-volume disease at recurrence but also by the 20.4-month median platinum-free interval in the surgical group, which certainly affects the trial’s validity. Despite being considered PS, the disease biology in a patient with a platinum-free interval of 20.4 months is surely different from the disease biology in a patient with a 6.4-month platinum-free interval; therefore, it is difficult to generalize these data to all PS recurrent ovarian cancer patients. Similarly, other research has suggested strict selection criteria, which was not apparent in this study’s methodology.¹¹ While the number of metastatic sites were relatively equal between the surgery and no surgery groups, there were more patients in the surgical group with extraabdominal disease, which the authors used as an exclusion criterion.

Lastly, the time to treatment commencement in each arm, which was 40 days for the surgical arm and 7 days in the nonsurgical arm, could represent a flaw in this trial. While we expect a difference in duration to account for recovery time, many centers start chemotherapy as soon as 21 days after surgery, which is almost half of the median interval in the surgical group in this trial. While the authors address this by stating that they completed a landmark analysis, no data or information about what time points they used for the analysis are provided. They simply report an interquartile range of 28 to 51 days. It is hard to know what effect this may have had on the outcome.

Coleman RL, Spirtos NM, Enserro D, et al. Secondary surgical cytoreduction for recurrent ovarian cancer. N Engl J Med. 2019;381:1929-1939.

EXPERT COMMENTARY

Ovarian cancer represents the most lethal gynecologic cancer, with an estimated 14,000 deaths in 2019.¹ While the incidence of this disease is low in comparison to uterine cancer, the advanced stage at diagnosis portends poor prognosis. While stage is an independent risk factor for death, it is also a risk for recurrence, with more than 80% of women developing recurrent disease.^2-4 Secondary cytoreduction remains an option for patients in which disease recurs; up until now this management option was driven by retrospective data.⁵

Details of the study

Coleman and colleagues conducted the Gynecologic Oncology Group (GOG) 0213 trial—a phase 3, multicenter, randomized clinical trial that included 485 women with recurrent ovarian cancer. The surgical objective of the trial was to determine whether secondary cytoreduction in operable, platinum-sensitive (PS) patients improved overall survival (OS).

Patients were eligible to participate in the surgical portion of the trial if they had PS measurable disease and had the intention to achieve complete gross resection. Women with ascites, evidence of extraabdominal disease, and “diffuse carcinomatosis” were excluded. The primary and secondary end points were OS and progression-free survival (PFS), respectively.

Results. There were no statistical differences between the surgery and no surgery groups with regard to median OS (50.6 months vs 64.7 months, respectively; hazard ratio [HR], 1.29; 95% confidence interval [CI], 0.97–1.72) or median PFS (18.9 months vs 16.2 months; HR, 0.82; 95% CI, 0.66 to 1.01). When comparing patients in which complete gross resection was achieved (150 patients vs 245 who did not receive surgery), there was only a statistical difference in PFS in favor of the surgical group (22.4 months vs 16.2 months; HR, 0.62; 95% CI, 0.48–0.80).

Of note, 67% of the patients who received surgery (63% intention-to-treat) were debulked to complete gross resection. There were 33% more patients with extraabdominal disease (10% vs 7% of total patients in each group) and 15% more patients with upper abdominal disease (40% vs 33% of total patients in each group) included in the surgical group. Finally, the median time to chemotherapy was 40 days in the surgery group versus 7 days in the no surgery group.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

The authors deserve to be commended for this well-designed and laborious trial, which is the first of its kind. The strength of the study is its randomized design producing level I data.

Study weaknesses include lack of reporting of BRCA status and the impact of receiving targeted therapies after the trial was over. It is well established that BRCA-mutated patients have an independent survival advantage, even when taking into account platinum sensitivity.^6-8BRCA status of the study population is not specifically addressed in this paper. The authors noted in the first GOG 0213 trial publication, which assessed bevacizumab in the recurrent setting, that BRCA status has an impact on patient outcomes. Subsequently, they state that they do not report BRCA status because “…its independent effect on response to an anti-angiogenesis agent was unknown,” but it clearly would affect survival analysis if unbalanced between groups.⁹

Similarly, in the introduction to their study, Coleman and colleagues list availability of maintenance therapy, for instance poly ADP (adenosine diphosphate–ribose) polymerase (PARP) inhibitors, as rationale for conducting their trial. They subsequently cite this as a possible reason that the median overall survival was 3 times longer than expected. However, they provide no data on which patients received maintenance therapy, which again could have drastically affected survival outcomes.¹⁰ They do report in the supplementary information that, when stratifying those receiving bevacizumab adjuvantly during the trial, the median OS was comparable between the surgical and nonsurgical groups (58.5 months vs 61.7 months).

The authors discuss the presence of patient selection bias as a weakness in the study. Selection bias is evident in this trial (as in many surgical trials) because patients with a limited volume of disease were selected to participate over those with large-volume disease. It is reasonable to conclude that this study is likely selecting patients with less aggressive tumor biology, not only evident by low-volume disease at recurrence but also by the 20.4-month median platinum-free interval in the surgical group, which certainly affects the trial’s validity. Despite being considered PS, the disease biology in a patient with a platinum-free interval of 20.4 months is surely different from the disease biology in a patient with a 6.4-month platinum-free interval; therefore, it is difficult to generalize these data to all PS recurrent ovarian cancer patients. Similarly, other research has suggested strict selection criteria, which was not apparent in this study’s methodology.¹¹ While the number of metastatic sites were relatively equal between the surgery and no surgery groups, there were more patients in the surgical group with extraabdominal disease, which the authors used as an exclusion criterion.

Lastly, the time to treatment commencement in each arm, which was 40 days for the surgical arm and 7 days in the nonsurgical arm, could represent a flaw in this trial. While we expect a difference in duration to account for recovery time, many centers start chemotherapy as soon as 21 days after surgery, which is almost half of the median interval in the surgical group in this trial. While the authors address this by stating that they completed a landmark analysis, no data or information about what time points they used for the analysis are provided. They simply report an interquartile range of 28 to 51 days. It is hard to know what effect this may have had on the outcome.

Coleman RL, Spirtos NM, Enserro D, et al. Secondary surgical cytoreduction for recurrent ovarian cancer. N Engl J Med. 2019;381:1929-1939.

EXPERT COMMENTARY

Ovarian cancer represents the most lethal gynecologic cancer, with an estimated 14,000 deaths in 2019.¹ While the incidence of this disease is low in comparison to uterine cancer, the advanced stage at diagnosis portends poor prognosis. While stage is an independent risk factor for death, it is also a risk for recurrence, with more than 80% of women developing recurrent disease.^2-4 Secondary cytoreduction remains an option for patients in which disease recurs; up until now this management option was driven by retrospective data.⁵

Details of the study

Coleman and colleagues conducted the Gynecologic Oncology Group (GOG) 0213 trial—a phase 3, multicenter, randomized clinical trial that included 485 women with recurrent ovarian cancer. The surgical objective of the trial was to determine whether secondary cytoreduction in operable, platinum-sensitive (PS) patients improved overall survival (OS).

Patients were eligible to participate in the surgical portion of the trial if they had PS measurable disease and had the intention to achieve complete gross resection. Women with ascites, evidence of extraabdominal disease, and “diffuse carcinomatosis” were excluded. The primary and secondary end points were OS and progression-free survival (PFS), respectively.

Results. There were no statistical differences between the surgery and no surgery groups with regard to median OS (50.6 months vs 64.7 months, respectively; hazard ratio [HR], 1.29; 95% confidence interval [CI], 0.97–1.72) or median PFS (18.9 months vs 16.2 months; HR, 0.82; 95% CI, 0.66 to 1.01). When comparing patients in which complete gross resection was achieved (150 patients vs 245 who did not receive surgery), there was only a statistical difference in PFS in favor of the surgical group (22.4 months vs 16.2 months; HR, 0.62; 95% CI, 0.48–0.80).

Of note, 67% of the patients who received surgery (63% intention-to-treat) were debulked to complete gross resection. There were 33% more patients with extraabdominal disease (10% vs 7% of total patients in each group) and 15% more patients with upper abdominal disease (40% vs 33% of total patients in each group) included in the surgical group. Finally, the median time to chemotherapy was 40 days in the surgery group versus 7 days in the no surgery group.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

The authors deserve to be commended for this well-designed and laborious trial, which is the first of its kind. The strength of the study is its randomized design producing level I data.

Study weaknesses include lack of reporting of BRCA status and the impact of receiving targeted therapies after the trial was over. It is well established that BRCA-mutated patients have an independent survival advantage, even when taking into account platinum sensitivity.^6-8BRCA status of the study population is not specifically addressed in this paper. The authors noted in the first GOG 0213 trial publication, which assessed bevacizumab in the recurrent setting, that BRCA status has an impact on patient outcomes. Subsequently, they state that they do not report BRCA status because “…its independent effect on response to an anti-angiogenesis agent was unknown,” but it clearly would affect survival analysis if unbalanced between groups.⁹

Similarly, in the introduction to their study, Coleman and colleagues list availability of maintenance therapy, for instance poly ADP (adenosine diphosphate–ribose) polymerase (PARP) inhibitors, as rationale for conducting their trial. They subsequently cite this as a possible reason that the median overall survival was 3 times longer than expected. However, they provide no data on which patients received maintenance therapy, which again could have drastically affected survival outcomes.¹⁰ They do report in the supplementary information that, when stratifying those receiving bevacizumab adjuvantly during the trial, the median OS was comparable between the surgical and nonsurgical groups (58.5 months vs 61.7 months).

The authors discuss the presence of patient selection bias as a weakness in the study. Selection bias is evident in this trial (as in many surgical trials) because patients with a limited volume of disease were selected to participate over those with large-volume disease. It is reasonable to conclude that this study is likely selecting patients with less aggressive tumor biology, not only evident by low-volume disease at recurrence but also by the 20.4-month median platinum-free interval in the surgical group, which certainly affects the trial’s validity. Despite being considered PS, the disease biology in a patient with a platinum-free interval of 20.4 months is surely different from the disease biology in a patient with a 6.4-month platinum-free interval; therefore, it is difficult to generalize these data to all PS recurrent ovarian cancer patients. Similarly, other research has suggested strict selection criteria, which was not apparent in this study’s methodology.¹¹ While the number of metastatic sites were relatively equal between the surgery and no surgery groups, there were more patients in the surgical group with extraabdominal disease, which the authors used as an exclusion criterion.

Lastly, the time to treatment commencement in each arm, which was 40 days for the surgical arm and 7 days in the nonsurgical arm, could represent a flaw in this trial. While we expect a difference in duration to account for recovery time, many centers start chemotherapy as soon as 21 days after surgery, which is almost half of the median interval in the surgical group in this trial. While the authors address this by stating that they completed a landmark analysis, no data or information about what time points they used for the analysis are provided. They simply report an interquartile range of 28 to 51 days. It is hard to know what effect this may have had on the outcome.

LAS VEGAS – Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m² or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m²), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).

The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

[email protected]

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

LAS VEGAS – Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m² or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m²), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).

The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

[email protected]

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

LAS VEGAS – Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m² or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m²), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).

The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

[email protected]

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

Whether or not women experience symptoms from uterine fibroid(s) can be dependent on a fibroid’s size and location. Heavy menstrual bleeding (HMB) is the most common symptom resulting from fibroids, and it occurs in up to one-third of women with fibroids. For fibroids that are large (>10 cm), “bulk” symptoms may occur, including pelvic pressure, urinary urgency or frequency, incontinence, constipation, abdominal protrusion, etc.¹

Elagolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, was US Food and Drug Administration–approved in 2018 to treat moderate to severe pain caused by endometriosis. ² Elagolix is being evaluated in 2 phase 3 randomized, double-blind trials for the additional treatment of HMB associated with uterine fibroids. The results of these studies were presented at the 2019 AAGL meeting on November 12, in Vancouver, Canada.
 

Phase 3 study details

Premenopausal women aged 18 to 51 years were included in the Elaris UF-1 and UF-2 studies if they had HMB (defined using the alkaline hematin methodology as menstrual blood loss [MBL] >80 mL/cycle) and uterine fibroids as confirmed through ultrasound. Because elagolix suppresses estrogen and progesterone, treatment results in dose- and duration-dependent decreases in bone mineral density (BMD),² and add-back therapy can lessen these adverse effects. Subsequently, participants were randomly assigned 1:1:2 to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily with add-back therapy (1 mg estradiol/0.5 mg norethidrone acetate [E2/NETA]) once daily. Uterine volume and size and location of uterine fibroid(s) were assessed by ultrasound. Subgroups were defined by baseline FIGO categories, grouped FIGO 0-3, FIGO 4, or FIGO 5-8.³

Over the 6-month studies, 72.2% (95% confidence interval [CI], 67.65–76.73) of the 395 women who received elagolix plus E2/NETA achieved < 80 mL MBL during the final month and ≥ 50% MBL reduction from baseline to the final month. When stratified by FIGO classification, the results were similar for all subgroups: FIGO 0-3, 77.7% (95% CI, 67.21–80.85). Similar results were seen in women with a primary fibroid volume of either greater or less than 36.2 cm³ (median).³



The most frequently reported adverse events among women taking elagolix plus E2/NETA were hot flushes, night sweats, nausea, and headache. Changes in BMD among these women were not significant compared with women taking placebo.³

The Elaris UF-1 and UF-2 studies are funded by AbbVie Inc.

Whether or not women experience symptoms from uterine fibroid(s) can be dependent on a fibroid’s size and location. Heavy menstrual bleeding (HMB) is the most common symptom resulting from fibroids, and it occurs in up to one-third of women with fibroids. For fibroids that are large (>10 cm), “bulk” symptoms may occur, including pelvic pressure, urinary urgency or frequency, incontinence, constipation, abdominal protrusion, etc.¹

Elagolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, was US Food and Drug Administration–approved in 2018 to treat moderate to severe pain caused by endometriosis. ² Elagolix is being evaluated in 2 phase 3 randomized, double-blind trials for the additional treatment of HMB associated with uterine fibroids. The results of these studies were presented at the 2019 AAGL meeting on November 12, in Vancouver, Canada.
 

Phase 3 study details

Premenopausal women aged 18 to 51 years were included in the Elaris UF-1 and UF-2 studies if they had HMB (defined using the alkaline hematin methodology as menstrual blood loss [MBL] >80 mL/cycle) and uterine fibroids as confirmed through ultrasound. Because elagolix suppresses estrogen and progesterone, treatment results in dose- and duration-dependent decreases in bone mineral density (BMD),² and add-back therapy can lessen these adverse effects. Subsequently, participants were randomly assigned 1:1:2 to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily with add-back therapy (1 mg estradiol/0.5 mg norethidrone acetate [E2/NETA]) once daily. Uterine volume and size and location of uterine fibroid(s) were assessed by ultrasound. Subgroups were defined by baseline FIGO categories, grouped FIGO 0-3, FIGO 4, or FIGO 5-8.³

Over the 6-month studies, 72.2% (95% confidence interval [CI], 67.65–76.73) of the 395 women who received elagolix plus E2/NETA achieved < 80 mL MBL during the final month and ≥ 50% MBL reduction from baseline to the final month. When stratified by FIGO classification, the results were similar for all subgroups: FIGO 0-3, 77.7% (95% CI, 67.21–80.85). Similar results were seen in women with a primary fibroid volume of either greater or less than 36.2 cm³ (median).³



The most frequently reported adverse events among women taking elagolix plus E2/NETA were hot flushes, night sweats, nausea, and headache. Changes in BMD among these women were not significant compared with women taking placebo.³

The Elaris UF-1 and UF-2 studies are funded by AbbVie Inc.

Whether or not women experience symptoms from uterine fibroid(s) can be dependent on a fibroid’s size and location. Heavy menstrual bleeding (HMB) is the most common symptom resulting from fibroids, and it occurs in up to one-third of women with fibroids. For fibroids that are large (>10 cm), “bulk” symptoms may occur, including pelvic pressure, urinary urgency or frequency, incontinence, constipation, abdominal protrusion, etc.¹

Elagolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, was US Food and Drug Administration–approved in 2018 to treat moderate to severe pain caused by endometriosis. ² Elagolix is being evaluated in 2 phase 3 randomized, double-blind trials for the additional treatment of HMB associated with uterine fibroids. The results of these studies were presented at the 2019 AAGL meeting on November 12, in Vancouver, Canada.
 

Phase 3 study details

Premenopausal women aged 18 to 51 years were included in the Elaris UF-1 and UF-2 studies if they had HMB (defined using the alkaline hematin methodology as menstrual blood loss [MBL] >80 mL/cycle) and uterine fibroids as confirmed through ultrasound. Because elagolix suppresses estrogen and progesterone, treatment results in dose- and duration-dependent decreases in bone mineral density (BMD),² and add-back therapy can lessen these adverse effects. Subsequently, participants were randomly assigned 1:1:2 to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily with add-back therapy (1 mg estradiol/0.5 mg norethidrone acetate [E2/NETA]) once daily. Uterine volume and size and location of uterine fibroid(s) were assessed by ultrasound. Subgroups were defined by baseline FIGO categories, grouped FIGO 0-3, FIGO 4, or FIGO 5-8.³

Over the 6-month studies, 72.2% (95% confidence interval [CI], 67.65–76.73) of the 395 women who received elagolix plus E2/NETA achieved < 80 mL MBL during the final month and ≥ 50% MBL reduction from baseline to the final month. When stratified by FIGO classification, the results were similar for all subgroups: FIGO 0-3, 77.7% (95% CI, 67.21–80.85). Similar results were seen in women with a primary fibroid volume of either greater or less than 36.2 cm³ (median).³



The most frequently reported adverse events among women taking elagolix plus E2/NETA were hot flushes, night sweats, nausea, and headache. Changes in BMD among these women were not significant compared with women taking placebo.³

The Elaris UF-1 and UF-2 studies are funded by AbbVie Inc.

Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2019 Dec 5. Doi: 10.1097/AOG.0000000000003580.

EXPERT COMMENTARY

Vaginal pessaries are a common and effective approach for managing pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). Vaginal mucosal erosions, however, may complicate pessary use. The risk for erosions may be associated with the frequency of pessary change, which involves removing the pessary, washing it, and replacing it in the vagina. Existing data do not address the frequency of pessary change. Recently, however, investigators conducted a randomized noninferiority trial to evaluate the effect of pessary visit intervals on the development of vaginal epithelial abnormalities.

Details of the study

At a single US hospital, Propst and colleagues randomly assigned women who used pessaries for POP, SUI, or both to routine pessary care (offices visits every 12 weeks) or to extended interval pessary care (office visits every 24 weeks). The women used ring, incontinence dish, or Gelhorn pessaries, did not change their pessaries on their own, and had no vaginal mucosal abnormalities.

A total of 130 women were randomly assigned, 64 to the routine care group and 66 to the extended interval care group. The mean age was 79 years and 90% were white, 4.6% were black, and 4% were Hispanic. Approximately 74% of the women used vaginal estrogen.

The primary outcome was the rate of vaginal epithelial abnormalities, including epithelial breaks or erosions. The predetermined noninferiority margin was set at 7.5%.

Results. At the 48-week follow-up, the rate of epithelial erosion was 7.4% in the routine care group and 1.7% in the extended interval care group, thus meeting the prespecified criteria for noninferiority of extended interval pessary care.

Women in each care group reported a similar amount of bothersome vaginal discharge. This was reported on a 5-point scale, with higher numbers indicating greater degree of bother. The mean scores were 1.39 in the routine care group and 1.34 in the extended interval care group. No other pessary-related adverse events occurred in either care group.

Study strengths and limitations

This trial provides good evidence that the timing of office pessary care can be extended to 24 weeks without compromising outcomes. However, since nearly three-quarters of the study participants used vaginal estrogen, the results may not be applicable to pessary users who do not use vaginal estrogen.

Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2019 Dec 5. Doi: 10.1097/AOG.0000000000003580.

EXPERT COMMENTARY

Vaginal pessaries are a common and effective approach for managing pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). Vaginal mucosal erosions, however, may complicate pessary use. The risk for erosions may be associated with the frequency of pessary change, which involves removing the pessary, washing it, and replacing it in the vagina. Existing data do not address the frequency of pessary change. Recently, however, investigators conducted a randomized noninferiority trial to evaluate the effect of pessary visit intervals on the development of vaginal epithelial abnormalities.

Details of the study

At a single US hospital, Propst and colleagues randomly assigned women who used pessaries for POP, SUI, or both to routine pessary care (offices visits every 12 weeks) or to extended interval pessary care (office visits every 24 weeks). The women used ring, incontinence dish, or Gelhorn pessaries, did not change their pessaries on their own, and had no vaginal mucosal abnormalities.

A total of 130 women were randomly assigned, 64 to the routine care group and 66 to the extended interval care group. The mean age was 79 years and 90% were white, 4.6% were black, and 4% were Hispanic. Approximately 74% of the women used vaginal estrogen.

The primary outcome was the rate of vaginal epithelial abnormalities, including epithelial breaks or erosions. The predetermined noninferiority margin was set at 7.5%.

Results. At the 48-week follow-up, the rate of epithelial erosion was 7.4% in the routine care group and 1.7% in the extended interval care group, thus meeting the prespecified criteria for noninferiority of extended interval pessary care.

Women in each care group reported a similar amount of bothersome vaginal discharge. This was reported on a 5-point scale, with higher numbers indicating greater degree of bother. The mean scores were 1.39 in the routine care group and 1.34 in the extended interval care group. No other pessary-related adverse events occurred in either care group.

Study strengths and limitations

This trial provides good evidence that the timing of office pessary care can be extended to 24 weeks without compromising outcomes. However, since nearly three-quarters of the study participants used vaginal estrogen, the results may not be applicable to pessary users who do not use vaginal estrogen.

Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2019 Dec 5. Doi: 10.1097/AOG.0000000000003580.

EXPERT COMMENTARY

Vaginal pessaries are a common and effective approach for managing pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). Vaginal mucosal erosions, however, may complicate pessary use. The risk for erosions may be associated with the frequency of pessary change, which involves removing the pessary, washing it, and replacing it in the vagina. Existing data do not address the frequency of pessary change. Recently, however, investigators conducted a randomized noninferiority trial to evaluate the effect of pessary visit intervals on the development of vaginal epithelial abnormalities.

Details of the study

At a single US hospital, Propst and colleagues randomly assigned women who used pessaries for POP, SUI, or both to routine pessary care (offices visits every 12 weeks) or to extended interval pessary care (office visits every 24 weeks). The women used ring, incontinence dish, or Gelhorn pessaries, did not change their pessaries on their own, and had no vaginal mucosal abnormalities.

A total of 130 women were randomly assigned, 64 to the routine care group and 66 to the extended interval care group. The mean age was 79 years and 90% were white, 4.6% were black, and 4% were Hispanic. Approximately 74% of the women used vaginal estrogen.

The primary outcome was the rate of vaginal epithelial abnormalities, including epithelial breaks or erosions. The predetermined noninferiority margin was set at 7.5%.

Results. At the 48-week follow-up, the rate of epithelial erosion was 7.4% in the routine care group and 1.7% in the extended interval care group, thus meeting the prespecified criteria for noninferiority of extended interval pessary care.

Women in each care group reported a similar amount of bothersome vaginal discharge. This was reported on a 5-point scale, with higher numbers indicating greater degree of bother. The mean scores were 1.39 in the routine care group and 1.34 in the extended interval care group. No other pessary-related adverse events occurred in either care group.

Study strengths and limitations

This trial provides good evidence that the timing of office pessary care can be extended to 24 weeks without compromising outcomes. However, since nearly three-quarters of the study participants used vaginal estrogen, the results may not be applicable to pessary users who do not use vaginal estrogen.