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Don’t neglect urinary tract in gynecologic procedures
LAS VEGAS – – but when the time is appropriate, John B. Gebhart, MD, MS, urged.
You don’t need to stop a procedure to fix a bladder injury. Rather, mark the spot with a suture, finish what you are doing, then come back and fix the bladder injury, he advised.
“We need to be thinking [of the]urinary tract all the time in the procedures that we’re doing,” Dr. Gebhart, a urogynecologist and reconstructive pelvic surgeon from the Mayo Clinic, Rochester, Minn, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
“Can you look at the bladder and see that it’s intact, that ureters are functioning like they should? You don’t need to have the skill set to place stents, but you should be able to look in and know you’re okay leaving the operating room,” he said.
According to Dr. Gebhart, urethral injuries can occur in these procedures: anterior repair, cystoscopy, midurethral sling, and treatment of diverticulitis or Skene’s duct abscess.
He offered these tips about urethral injuries:
- Use catheters, dyes, and urethroscopy to reveal injuries. “Putting in a catheter is great because it helps you identify injury because you can visually see it,” he said. “We can squirt some dye in the urethra and see if it’s leaking out. We can put in a zero-degree scope and do urethroscopy.”
- Consider linking multiple holes in the urethra. “Don’t make individual repairs,” he said. “Connect the holes, making them into one hole that you can fix in one setting.”
- Check your repairs for leakage. “I might take a little indigo carmine or methylene blue in a little [angiocatheter], squirt it down the urethra, and see if I’ve got anything leaking out from my repair site,” he said. “If I do, then I want to go back and repair that so that I’ve got a watertight closure.”
- Consider a catheter after repair. “If you do a repair, you want to place a catheter at the end of the splint in the urethra for 7 to 10 to 14 days to help prevent stricture afterwards.”
Dr. Gebhart also discussed bladder injuries, which he said can occur in anterior repair, cystoscopy, hysterectomy, midurethral slings, sacrocolpopexy, and other procedures.
He offered these tips:
- Use bladder backfilling to detect injury. “We can backfill the bladder with the little methylene blue stain–normal saline to help identify whether you’ve got a leak or an injury,” he said. “[Cystogram] can also be very helpful as well.”
- Don’t stop a hysterectomy to fix a bladder injury. “Mark the hole with a suture, finish the hysterectomy and get it out of the way, then come back and fix the hole in the bladder,” Dr. Gebhart said.
- After repair, drain the bladder with a catheter for 10-14 days. “You’re always better draining through a catheter a little longer than pulling the catheter too soon, putting a stretch on the bladder, and maybe compromising your repair,” he said.
He recommended performing a quick cystogram before pulling the catheter to make sure there’s no leak.
Dr. Gebhart disclosed consultant (Hologic) and advisory board (UroCure) relationships and royalties (UpToDate, Elsevier).
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 – – but when the time is appropriate, John B. Gebhart, MD, MS, urged.
You don’t need to stop a procedure to fix a bladder injury. Rather, mark the spot with a suture, finish what you are doing, then come back and fix the bladder injury, he advised.
“We need to be thinking [of the]urinary tract all the time in the procedures that we’re doing,” Dr. Gebhart, a urogynecologist and reconstructive pelvic surgeon from the Mayo Clinic, Rochester, Minn, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
“Can you look at the bladder and see that it’s intact, that ureters are functioning like they should? You don’t need to have the skill set to place stents, but you should be able to look in and know you’re okay leaving the operating room,” he said.
According to Dr. Gebhart, urethral injuries can occur in these procedures: anterior repair, cystoscopy, midurethral sling, and treatment of diverticulitis or Skene’s duct abscess.
He offered these tips about urethral injuries:
- Use catheters, dyes, and urethroscopy to reveal injuries. “Putting in a catheter is great because it helps you identify injury because you can visually see it,” he said. “We can squirt some dye in the urethra and see if it’s leaking out. We can put in a zero-degree scope and do urethroscopy.”
- Consider linking multiple holes in the urethra. “Don’t make individual repairs,” he said. “Connect the holes, making them into one hole that you can fix in one setting.”
- Check your repairs for leakage. “I might take a little indigo carmine or methylene blue in a little [angiocatheter], squirt it down the urethra, and see if I’ve got anything leaking out from my repair site,” he said. “If I do, then I want to go back and repair that so that I’ve got a watertight closure.”
- Consider a catheter after repair. “If you do a repair, you want to place a catheter at the end of the splint in the urethra for 7 to 10 to 14 days to help prevent stricture afterwards.”
Dr. Gebhart also discussed bladder injuries, which he said can occur in anterior repair, cystoscopy, hysterectomy, midurethral slings, sacrocolpopexy, and other procedures.
He offered these tips:
- Use bladder backfilling to detect injury. “We can backfill the bladder with the little methylene blue stain–normal saline to help identify whether you’ve got a leak or an injury,” he said. “[Cystogram] can also be very helpful as well.”
- Don’t stop a hysterectomy to fix a bladder injury. “Mark the hole with a suture, finish the hysterectomy and get it out of the way, then come back and fix the hole in the bladder,” Dr. Gebhart said.
- After repair, drain the bladder with a catheter for 10-14 days. “You’re always better draining through a catheter a little longer than pulling the catheter too soon, putting a stretch on the bladder, and maybe compromising your repair,” he said.
He recommended performing a quick cystogram before pulling the catheter to make sure there’s no leak.
Dr. Gebhart disclosed consultant (Hologic) and advisory board (UroCure) relationships and royalties (UpToDate, Elsevier).
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 – – but when the time is appropriate, John B. Gebhart, MD, MS, urged.
You don’t need to stop a procedure to fix a bladder injury. Rather, mark the spot with a suture, finish what you are doing, then come back and fix the bladder injury, he advised.
“We need to be thinking [of the]urinary tract all the time in the procedures that we’re doing,” Dr. Gebhart, a urogynecologist and reconstructive pelvic surgeon from the Mayo Clinic, Rochester, Minn, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
“Can you look at the bladder and see that it’s intact, that ureters are functioning like they should? You don’t need to have the skill set to place stents, but you should be able to look in and know you’re okay leaving the operating room,” he said.
According to Dr. Gebhart, urethral injuries can occur in these procedures: anterior repair, cystoscopy, midurethral sling, and treatment of diverticulitis or Skene’s duct abscess.
He offered these tips about urethral injuries:
- Use catheters, dyes, and urethroscopy to reveal injuries. “Putting in a catheter is great because it helps you identify injury because you can visually see it,” he said. “We can squirt some dye in the urethra and see if it’s leaking out. We can put in a zero-degree scope and do urethroscopy.”
- Consider linking multiple holes in the urethra. “Don’t make individual repairs,” he said. “Connect the holes, making them into one hole that you can fix in one setting.”
- Check your repairs for leakage. “I might take a little indigo carmine or methylene blue in a little [angiocatheter], squirt it down the urethra, and see if I’ve got anything leaking out from my repair site,” he said. “If I do, then I want to go back and repair that so that I’ve got a watertight closure.”
- Consider a catheter after repair. “If you do a repair, you want to place a catheter at the end of the splint in the urethra for 7 to 10 to 14 days to help prevent stricture afterwards.”
Dr. Gebhart also discussed bladder injuries, which he said can occur in anterior repair, cystoscopy, hysterectomy, midurethral slings, sacrocolpopexy, and other procedures.
He offered these tips:
- Use bladder backfilling to detect injury. “We can backfill the bladder with the little methylene blue stain–normal saline to help identify whether you’ve got a leak or an injury,” he said. “[Cystogram] can also be very helpful as well.”
- Don’t stop a hysterectomy to fix a bladder injury. “Mark the hole with a suture, finish the hysterectomy and get it out of the way, then come back and fix the hole in the bladder,” Dr. Gebhart said.
- After repair, drain the bladder with a catheter for 10-14 days. “You’re always better draining through a catheter a little longer than pulling the catheter too soon, putting a stretch on the bladder, and maybe compromising your repair,” he said.
He recommended performing a quick cystogram before pulling the catheter to make sure there’s no leak.
Dr. Gebhart disclosed consultant (Hologic) and advisory board (UroCure) relationships and royalties (UpToDate, Elsevier).
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.
EXPERT ANALYSIS FROM PAGS 2019
Beware the dangers of nerve injury in vaginal surgery
LAS VEGAS – a pelvic surgeon urged colleagues.
“It’s a very high medical and legal risk. You have to think about the various nerves that can be influenced,” urogynecologist Mickey M. Karram, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Dr. Karram, director of urogynecology and reconstructive surgery at the Christ Hospital in Cincinnati and clinical professor of obstetrics and gynecology at the University of Cincinnati, offered these pearls:
- Understand the anatomy of nerves at risk. These include the ilioinguinal nerve, obturator neurovascular bundle, and pudendal nerve.
- Position the patient correctly. The buttocks should be at edge of table, Dr. Karram said, and there should be slight extension and lateral rotation of the thigh. Beware of compression of the lateral knee.
- Avoid compression from stirrups. If you still use candy-cane stirrups, he said, you can get compression along the lateral aspect of the knee. “You can [get] common perineal nerve injuries. You can also get femoral nerve injuries that are stretch injuries and over-extension injuries as well. Just be careful about this.” Dr. Karram said he prefers fin-type stirrups such as the Allen Yellofin brand. Also, he said, avoid compression injuries that result when there are too many people between the patient’s legs and someone leans on the thighs, he said.
- Free the retractor in abdominal procedures. “If you’re operating abdominally and use retractors, free the retractor at times,” he said. Otherwise, “you can get injuries to the genitofemoral nerve and the femoral nerve itself.”
- Beware buttock pain after sacrospinous fixation. “About 15%-20% of the time, you’ll get extreme buttock pain,” Dr. Karram said. “Assuming the buttock pain doesn’t radiate anywhere and doesn’t go down the leg, it’s definitely not a problem. If it goes down the leg, then you have to think about things like deligating pretty quickly.”
Dr. Karram disclosed consulting (Coloplast and Cynosure/Hologic) and speaker (Allergan, Astellas, Coloplast, and Cynosure/Hologic) relationships. He has royalties from Fidelis Medical and LumeNXT.
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 – a pelvic surgeon urged colleagues.
“It’s a very high medical and legal risk. You have to think about the various nerves that can be influenced,” urogynecologist Mickey M. Karram, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Dr. Karram, director of urogynecology and reconstructive surgery at the Christ Hospital in Cincinnati and clinical professor of obstetrics and gynecology at the University of Cincinnati, offered these pearls:
- Understand the anatomy of nerves at risk. These include the ilioinguinal nerve, obturator neurovascular bundle, and pudendal nerve.
- Position the patient correctly. The buttocks should be at edge of table, Dr. Karram said, and there should be slight extension and lateral rotation of the thigh. Beware of compression of the lateral knee.
- Avoid compression from stirrups. If you still use candy-cane stirrups, he said, you can get compression along the lateral aspect of the knee. “You can [get] common perineal nerve injuries. You can also get femoral nerve injuries that are stretch injuries and over-extension injuries as well. Just be careful about this.” Dr. Karram said he prefers fin-type stirrups such as the Allen Yellofin brand. Also, he said, avoid compression injuries that result when there are too many people between the patient’s legs and someone leans on the thighs, he said.
- Free the retractor in abdominal procedures. “If you’re operating abdominally and use retractors, free the retractor at times,” he said. Otherwise, “you can get injuries to the genitofemoral nerve and the femoral nerve itself.”
- Beware buttock pain after sacrospinous fixation. “About 15%-20% of the time, you’ll get extreme buttock pain,” Dr. Karram said. “Assuming the buttock pain doesn’t radiate anywhere and doesn’t go down the leg, it’s definitely not a problem. If it goes down the leg, then you have to think about things like deligating pretty quickly.”
Dr. Karram disclosed consulting (Coloplast and Cynosure/Hologic) and speaker (Allergan, Astellas, Coloplast, and Cynosure/Hologic) relationships. He has royalties from Fidelis Medical and LumeNXT.
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 – a pelvic surgeon urged colleagues.
“It’s a very high medical and legal risk. You have to think about the various nerves that can be influenced,” urogynecologist Mickey M. Karram, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.
Dr. Karram, director of urogynecology and reconstructive surgery at the Christ Hospital in Cincinnati and clinical professor of obstetrics and gynecology at the University of Cincinnati, offered these pearls:
- Understand the anatomy of nerves at risk. These include the ilioinguinal nerve, obturator neurovascular bundle, and pudendal nerve.
- Position the patient correctly. The buttocks should be at edge of table, Dr. Karram said, and there should be slight extension and lateral rotation of the thigh. Beware of compression of the lateral knee.
- Avoid compression from stirrups. If you still use candy-cane stirrups, he said, you can get compression along the lateral aspect of the knee. “You can [get] common perineal nerve injuries. You can also get femoral nerve injuries that are stretch injuries and over-extension injuries as well. Just be careful about this.” Dr. Karram said he prefers fin-type stirrups such as the Allen Yellofin brand. Also, he said, avoid compression injuries that result when there are too many people between the patient’s legs and someone leans on the thighs, he said.
- Free the retractor in abdominal procedures. “If you’re operating abdominally and use retractors, free the retractor at times,” he said. Otherwise, “you can get injuries to the genitofemoral nerve and the femoral nerve itself.”
- Beware buttock pain after sacrospinous fixation. “About 15%-20% of the time, you’ll get extreme buttock pain,” Dr. Karram said. “Assuming the buttock pain doesn’t radiate anywhere and doesn’t go down the leg, it’s definitely not a problem. If it goes down the leg, then you have to think about things like deligating pretty quickly.”
Dr. Karram disclosed consulting (Coloplast and Cynosure/Hologic) and speaker (Allergan, Astellas, Coloplast, and Cynosure/Hologic) relationships. He has royalties from Fidelis Medical and LumeNXT.
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.
EXPERT ANALYSIS FROM PAGS 2019
Laparoscopic techniques for Essure device removal
Cultivating patient activation through technology
Tech alone is not enough
Patient activation refers to an individual’s knowledge, skill, and confidence in managing their health and health care, according to a recent BMJ editorial. It’s recognized as a critical aspect of high-quality, patient-centered health care – patient activation has the potential to improve patient outcomes while reducing costs.
Total knee replacement offers a great opportunity to study patient activation, said editorial lead author Jesse I. Wolfstadt, MD, MS, FRCSC, of the University of Toronto. “It may help address the one in five patients who are unsatisfied with their knee replacement despite an otherwise technically sound procedure.”
The authors considered some patient activation studies that have shown positive results for cultivating activation through technology. In one, patients engaging with a bedside multimedia intervention on a tablet after undergoing knee replacement reported better pain scores, length of stay, knee function, and satisfaction with care. Another study showed patients who received automated text messages after joint replacement improved time spent on home exercises, decreased their use of narcotics, and had fewer calls to the surgeon’s office.
But “negative mobile app studies seem to suggest that when technologies are used as a passive educational intervention, patient activation may suffer,” according to the editorial. “One possible key ingredient to successful patient activation is the engagement of the health care team that is facilitated through mobile technology. ... Mobile apps and other technological interventions also must have clear goals if they are to be used successfully; and these goals are likely to differ for different patient populations and disease processes.”
Technology alone is not enough to affect patient activation, Dr. Wolfstadt said. “The key to success will likely involve tailoring interventions to individual patients and facilitating increased engagement with the health care team. You can’t just give a patient an app or other form of technology and expect it to replace the function of patient-clinician communication/interaction.”
Reference
1. Wolfstadt JI et ak. Improving patient outcomes following total joint arthroplasty: Is there an app for that? BMJ Qual Saf. 2019 May 2019. doi: 10.1136/bmjqs-2019-009571.
Tech alone is not enough
Tech alone is not enough
Patient activation refers to an individual’s knowledge, skill, and confidence in managing their health and health care, according to a recent BMJ editorial. It’s recognized as a critical aspect of high-quality, patient-centered health care – patient activation has the potential to improve patient outcomes while reducing costs.
Total knee replacement offers a great opportunity to study patient activation, said editorial lead author Jesse I. Wolfstadt, MD, MS, FRCSC, of the University of Toronto. “It may help address the one in five patients who are unsatisfied with their knee replacement despite an otherwise technically sound procedure.”
The authors considered some patient activation studies that have shown positive results for cultivating activation through technology. In one, patients engaging with a bedside multimedia intervention on a tablet after undergoing knee replacement reported better pain scores, length of stay, knee function, and satisfaction with care. Another study showed patients who received automated text messages after joint replacement improved time spent on home exercises, decreased their use of narcotics, and had fewer calls to the surgeon’s office.
But “negative mobile app studies seem to suggest that when technologies are used as a passive educational intervention, patient activation may suffer,” according to the editorial. “One possible key ingredient to successful patient activation is the engagement of the health care team that is facilitated through mobile technology. ... Mobile apps and other technological interventions also must have clear goals if they are to be used successfully; and these goals are likely to differ for different patient populations and disease processes.”
Technology alone is not enough to affect patient activation, Dr. Wolfstadt said. “The key to success will likely involve tailoring interventions to individual patients and facilitating increased engagement with the health care team. You can’t just give a patient an app or other form of technology and expect it to replace the function of patient-clinician communication/interaction.”
Reference
1. Wolfstadt JI et ak. Improving patient outcomes following total joint arthroplasty: Is there an app for that? BMJ Qual Saf. 2019 May 2019. doi: 10.1136/bmjqs-2019-009571.
Patient activation refers to an individual’s knowledge, skill, and confidence in managing their health and health care, according to a recent BMJ editorial. It’s recognized as a critical aspect of high-quality, patient-centered health care – patient activation has the potential to improve patient outcomes while reducing costs.
Total knee replacement offers a great opportunity to study patient activation, said editorial lead author Jesse I. Wolfstadt, MD, MS, FRCSC, of the University of Toronto. “It may help address the one in five patients who are unsatisfied with their knee replacement despite an otherwise technically sound procedure.”
The authors considered some patient activation studies that have shown positive results for cultivating activation through technology. In one, patients engaging with a bedside multimedia intervention on a tablet after undergoing knee replacement reported better pain scores, length of stay, knee function, and satisfaction with care. Another study showed patients who received automated text messages after joint replacement improved time spent on home exercises, decreased their use of narcotics, and had fewer calls to the surgeon’s office.
But “negative mobile app studies seem to suggest that when technologies are used as a passive educational intervention, patient activation may suffer,” according to the editorial. “One possible key ingredient to successful patient activation is the engagement of the health care team that is facilitated through mobile technology. ... Mobile apps and other technological interventions also must have clear goals if they are to be used successfully; and these goals are likely to differ for different patient populations and disease processes.”
Technology alone is not enough to affect patient activation, Dr. Wolfstadt said. “The key to success will likely involve tailoring interventions to individual patients and facilitating increased engagement with the health care team. You can’t just give a patient an app or other form of technology and expect it to replace the function of patient-clinician communication/interaction.”
Reference
1. Wolfstadt JI et ak. Improving patient outcomes following total joint arthroplasty: Is there an app for that? BMJ Qual Saf. 2019 May 2019. doi: 10.1136/bmjqs-2019-009571.
Pelvic organ prolapse surgery isn’t as ‘simple’ as you think
LAS VEGAS – Surgical repair of pelvic organ prolapse often may seem like an uncomplicated procedure. But many factors play roles into decisions, and surgeons around the world vary widely in how they handle the operations, Mark D. Walters, MD, told colleagues at the Pelvic Anatomy and Gynecologic Surgery Symposium.
“These prolapse repairs seem relatively simple at first, but they’re not simple at all,” he said.
Questions to ask prior to surgery
It’s important to first answer a number of questions, said Dr. Walters, professor and vice-chair of gynecology at the Cleveland Clinic. “When you see a patient like this, you may not realize how many decisions you’re making.”
These questions include:
- Is the patient sexually active or planning to be?
- Has she had a hysterectomy, and or is one necessary? If so, how should it be done? What does the patient think about a hysterectomy?
- Should the prolapse procedure be performed vaginally, open, laparoscopically, or robotically?
- Is adding a graft advisable? What kind?
- Should there be a sling to prevent stress urinary incontinence?”
Worldwide differences in surgical technique choice
Dr. Walters talked to colleagues from several nations and learned about these variations in surgical techniques.
Chinese surgeons use a variety of techniques with transvaginal mesh (TVM). Their use is more common in more populated cities because of the effect of medical education; native tissue procedures are more common in less-populated regions that are considered “backward.”
TVM with hysteropexy (“apical sling”) also is common in Latin America, while Middle Eastern surgeons have little training in female pelvic medicine and reconstructive surgery.
In Europe, France embraces mesh surgery and laparoscopy, while the United Kingdom has “completely abandoned” mesh surgery, and the Netherlands rarely uses it in favor of vaginal procedures.
In the United States, he said, TVM is “discouraged” while a variety of other procedures are used.
What procedures should surgeons embrace? There are many topics of debate, Dr. Walters said, including type of transvaginal repair (native tissue or mesh-augmented or sacrocolpopexy?), repair of “defects” in the vagina (even if they’re nonsymptomatic?) and the removal of the uterus (yes or no?).
Dr. Walters pointed to several explanations for this variation, including lack of high-quality research, confirmation bias, economic conflicts – surgeons are in the business of surgery, after all – and lack of insight into what women prefer.
Consider patient choice
In a survey, Dr. Walters polled women in their 50s with this question: “How much do you value your uterus?” Three women, he said, had widely varied opinions on a scale of 1-10, with one at 10 and another at 0.
“A doctor doesn’t know this and doesn’t have a way to ask, and the doctor has [his/her] own opinion about the value of the uterus,” he said. “Shouldn’t we know what patients think?”
How to measure success
He offered these tips about measuring success:
- Focus on symptomatic cure more than clinical cure.
- Remember that perfect anatomic support isn’t linked to health-related quality of life, and some loss of anatomic support is normal.
- Understand that commonly used definitions of anatomic success often aren’t clinically relevant.
Dr. Walters’ disclosures: royalties (Elsevier, UpToDate), website/lecturer (International Academy of Pelvic Surgery), and website editor (Foundation for Female Health Awareness).
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 – Surgical repair of pelvic organ prolapse often may seem like an uncomplicated procedure. But many factors play roles into decisions, and surgeons around the world vary widely in how they handle the operations, Mark D. Walters, MD, told colleagues at the Pelvic Anatomy and Gynecologic Surgery Symposium.
“These prolapse repairs seem relatively simple at first, but they’re not simple at all,” he said.
Questions to ask prior to surgery
It’s important to first answer a number of questions, said Dr. Walters, professor and vice-chair of gynecology at the Cleveland Clinic. “When you see a patient like this, you may not realize how many decisions you’re making.”
These questions include:
- Is the patient sexually active or planning to be?
- Has she had a hysterectomy, and or is one necessary? If so, how should it be done? What does the patient think about a hysterectomy?
- Should the prolapse procedure be performed vaginally, open, laparoscopically, or robotically?
- Is adding a graft advisable? What kind?
- Should there be a sling to prevent stress urinary incontinence?”
Worldwide differences in surgical technique choice
Dr. Walters talked to colleagues from several nations and learned about these variations in surgical techniques.
Chinese surgeons use a variety of techniques with transvaginal mesh (TVM). Their use is more common in more populated cities because of the effect of medical education; native tissue procedures are more common in less-populated regions that are considered “backward.”
TVM with hysteropexy (“apical sling”) also is common in Latin America, while Middle Eastern surgeons have little training in female pelvic medicine and reconstructive surgery.
In Europe, France embraces mesh surgery and laparoscopy, while the United Kingdom has “completely abandoned” mesh surgery, and the Netherlands rarely uses it in favor of vaginal procedures.
In the United States, he said, TVM is “discouraged” while a variety of other procedures are used.
What procedures should surgeons embrace? There are many topics of debate, Dr. Walters said, including type of transvaginal repair (native tissue or mesh-augmented or sacrocolpopexy?), repair of “defects” in the vagina (even if they’re nonsymptomatic?) and the removal of the uterus (yes or no?).
Dr. Walters pointed to several explanations for this variation, including lack of high-quality research, confirmation bias, economic conflicts – surgeons are in the business of surgery, after all – and lack of insight into what women prefer.
Consider patient choice
In a survey, Dr. Walters polled women in their 50s with this question: “How much do you value your uterus?” Three women, he said, had widely varied opinions on a scale of 1-10, with one at 10 and another at 0.
“A doctor doesn’t know this and doesn’t have a way to ask, and the doctor has [his/her] own opinion about the value of the uterus,” he said. “Shouldn’t we know what patients think?”
How to measure success
He offered these tips about measuring success:
- Focus on symptomatic cure more than clinical cure.
- Remember that perfect anatomic support isn’t linked to health-related quality of life, and some loss of anatomic support is normal.
- Understand that commonly used definitions of anatomic success often aren’t clinically relevant.
Dr. Walters’ disclosures: royalties (Elsevier, UpToDate), website/lecturer (International Academy of Pelvic Surgery), and website editor (Foundation for Female Health Awareness).
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 – Surgical repair of pelvic organ prolapse often may seem like an uncomplicated procedure. But many factors play roles into decisions, and surgeons around the world vary widely in how they handle the operations, Mark D. Walters, MD, told colleagues at the Pelvic Anatomy and Gynecologic Surgery Symposium.
“These prolapse repairs seem relatively simple at first, but they’re not simple at all,” he said.
Questions to ask prior to surgery
It’s important to first answer a number of questions, said Dr. Walters, professor and vice-chair of gynecology at the Cleveland Clinic. “When you see a patient like this, you may not realize how many decisions you’re making.”
These questions include:
- Is the patient sexually active or planning to be?
- Has she had a hysterectomy, and or is one necessary? If so, how should it be done? What does the patient think about a hysterectomy?
- Should the prolapse procedure be performed vaginally, open, laparoscopically, or robotically?
- Is adding a graft advisable? What kind?
- Should there be a sling to prevent stress urinary incontinence?”
Worldwide differences in surgical technique choice
Dr. Walters talked to colleagues from several nations and learned about these variations in surgical techniques.
Chinese surgeons use a variety of techniques with transvaginal mesh (TVM). Their use is more common in more populated cities because of the effect of medical education; native tissue procedures are more common in less-populated regions that are considered “backward.”
TVM with hysteropexy (“apical sling”) also is common in Latin America, while Middle Eastern surgeons have little training in female pelvic medicine and reconstructive surgery.
In Europe, France embraces mesh surgery and laparoscopy, while the United Kingdom has “completely abandoned” mesh surgery, and the Netherlands rarely uses it in favor of vaginal procedures.
In the United States, he said, TVM is “discouraged” while a variety of other procedures are used.
What procedures should surgeons embrace? There are many topics of debate, Dr. Walters said, including type of transvaginal repair (native tissue or mesh-augmented or sacrocolpopexy?), repair of “defects” in the vagina (even if they’re nonsymptomatic?) and the removal of the uterus (yes or no?).
Dr. Walters pointed to several explanations for this variation, including lack of high-quality research, confirmation bias, economic conflicts – surgeons are in the business of surgery, after all – and lack of insight into what women prefer.
Consider patient choice
In a survey, Dr. Walters polled women in their 50s with this question: “How much do you value your uterus?” Three women, he said, had widely varied opinions on a scale of 1-10, with one at 10 and another at 0.
“A doctor doesn’t know this and doesn’t have a way to ask, and the doctor has [his/her] own opinion about the value of the uterus,” he said. “Shouldn’t we know what patients think?”
How to measure success
He offered these tips about measuring success:
- Focus on symptomatic cure more than clinical cure.
- Remember that perfect anatomic support isn’t linked to health-related quality of life, and some loss of anatomic support is normal.
- Understand that commonly used definitions of anatomic success often aren’t clinically relevant.
Dr. Walters’ disclosures: royalties (Elsevier, UpToDate), website/lecturer (International Academy of Pelvic Surgery), and website editor (Foundation for Female Health Awareness).
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.
EXPERT ANALYSIS FROM PAGS 2019
Mechanical circulatory support in PCI needs clearer guidance
PHILADELPHIA – Use of the Impella ventricular-assist device in patients with cardiogenic shock having percutaneous coronary interventions (PCI) has increased rapidly since its approval in 2008, but two studies comparing it with intra-aortic balloon pumps in PCI patients have raised questions about the safety, effectiveness, and cost of the ventricular-assist device, according to results of two studies presented at the American Heart Association scientific sessions.
The results of an observational analysis of 48,306 patients and a national real-world study of 28,304 patients may not be telling the complete story of the utility of ventricular assist in patients requiring mechanical circulatory support (MCS), one interventional cardiologist said in an interview. “It’s concerning; it’s sobering,” said Ranya N. Sweis, MD, of Northwestern University, Chicago. However, the data didn’t parse out patients who would have been routed to palliative care and otherwise wouldn’t have been candidates for PCI without MCS.
“What I take from it is that we need to get more randomized data,” she said. “Who are the patients that were doing worse? Who are the patients who really needed the Impella support for the PCI after cardiogenic shock?”
In the observational study, Amit P. Amin, MD, of Washington University, St. Louis, said that the use of MCS devices increased steadily to 32% of all PCI patients receiving MCS from 2008 to 2016 while use of intra-aortic balloon pump (IABP) declined, but that Impella was less likely to be used in critically ill patients. The study analyzed patients in the Premier Healthcare Database who had PCI with MCS at 432 hospitals from 2004 to 2016.
Outcomes in what Dr. Amin called “the Impella era,” showed significantly higher risks for death, acute kidney injury, and stroke, with odds ratios of 1.17, 1.91 and 3.34, respectively (P less than .001 for all). In the patient-level comparison of Impella versus IABP, Impella had a 24% higher risk of death (P less than .0001), 10% for bleeding (P = .0445), 8% for acute kidney injury (P = .0521) and 34% for stroke (P less than .0001). The findings were published simultaneously with the presentation (Circulation. 2019 Nov 17. doi: 10.1161/CIRCULATIONAHA.119.044007)
“The total length of stay, as well as the ICU length of stay, were actually lower with Impella use, by approximately a half day to 1 day,” Dr. Amin said. “Despite that, the total costs were approximately $15,000.”
Yet, the study found wide variation in the use of Impella among hospitals, some doing no cases with the device and others all of them, Dr. Amin said. The risk analysis also found wide variations in outcomes across hospitals using Impella. “We saw a 2.5-fold variation in bleeding across hospitals and a 1.5-fold variation in acute kidney injury, stroke and death,” he noted. The study found less variation in hospital stays and total cost of Impella, “perhaps related to the uniformly high device acquisition costs.”
“These data underscore the need for defining the appropriate use of mechanical circulatory support in patients undergoing PCI,” Dr. Amin said.
Dr. Sweis wasn’t surprised by the cost findings. “New technology is going to cost more,” she said in an interview. “I’m actually surprised that the cost wasn’t more significantly different just knowing the cost of some of these devices.
Patients who require MCS represent a small portion of PCI cases: 2%, according to Dr. Sweis. “It’s not like all PCI has increased because of MCS, and there’s a potential improvement in the length of stay so there are going to be cost savings that way.”
The national real-world study that Sanket S. Dhruva, MD, MHS, of the University of California San Francisco, reported on focused on Impella and IABP in PCI patients with acute MI complicated by cardiogenic shock (CS). The study used outcomes of patients with AMI-CS who had PCI from October 2015 to December 2017 in the National Cardiovascular Data Registry’s CathPCI and Chest Pain–MI registries. An estimated 4%-12% of AMIs present with CS.
Most patients in the study population had medical therapy only, but this study focused on the 1,768 who had Impella only and the 8,471 who had IABP only. The rates of in-hospital death and bleeding were 34.1% 16% in the IABP group, and 45% and 31.3% in the Impella group, Dr. Dhruva said. In this study population, the rate of Impella use increased from 3.5% in 2015 to 8.7% by the end of 2017 (P less than .001).
Dr. Dhruva acknowledged a number of limitations to the study findings, including residual confounding. However, the “robust propensity match” of 95% of the Impella-only patients and the results were consistent across multiple sensitivity analyses. “There may have been questions about the clinical severity of AMI-CS patients in the NCDR Registry,” he said. “However, the registry definition is similar to that used in the trials.”
The trial also failed to distinguish between the different types of Impella devices, but the results mostly pertain to the Impella 2.5 and CP because the 5.0 device requires a surgical cutdown, and the study excluded patients who received multiple devices.
“Better evidence and guidance are needed regarding the optimal management of patients with AMI-CS as well as the role of mechanical circulatory support devices in general and Impella in particular,” he said, adding that Impella has been on the U.S. market since 2008, but with limited randomized clinical trial evidence in cardiogenic shock.
The study population of patient’s with CS is “only a piece of the puzzle,” Dr. Sweis said. “We know that there are sick hearts that aren’t in shock right now, but you’re going to do triple-vessel intervention and use atherectomy. Those patients would not do very well during the procedure itself and it may not even be offered to them if there weren’t support.”
Impella is not going away, Dr. Sweis said. “It provides an option that a patient wouldn’t otherwise have. This is really stressing to me that we need to get rid of that variability in the safety related to these devices.”
Dr. Amin disclosed financial relationships with Terumo and GE Healthcare. Dr. Dhruva had no financial relationships to disclose. The study was supported in part by a Center of Excellence in Regulatory Science and Innovation grant from the Food and Drug Administration and the American College of Cardiology’s National Cardiovascular Data Registry.
PHILADELPHIA – Use of the Impella ventricular-assist device in patients with cardiogenic shock having percutaneous coronary interventions (PCI) has increased rapidly since its approval in 2008, but two studies comparing it with intra-aortic balloon pumps in PCI patients have raised questions about the safety, effectiveness, and cost of the ventricular-assist device, according to results of two studies presented at the American Heart Association scientific sessions.
The results of an observational analysis of 48,306 patients and a national real-world study of 28,304 patients may not be telling the complete story of the utility of ventricular assist in patients requiring mechanical circulatory support (MCS), one interventional cardiologist said in an interview. “It’s concerning; it’s sobering,” said Ranya N. Sweis, MD, of Northwestern University, Chicago. However, the data didn’t parse out patients who would have been routed to palliative care and otherwise wouldn’t have been candidates for PCI without MCS.
“What I take from it is that we need to get more randomized data,” she said. “Who are the patients that were doing worse? Who are the patients who really needed the Impella support for the PCI after cardiogenic shock?”
In the observational study, Amit P. Amin, MD, of Washington University, St. Louis, said that the use of MCS devices increased steadily to 32% of all PCI patients receiving MCS from 2008 to 2016 while use of intra-aortic balloon pump (IABP) declined, but that Impella was less likely to be used in critically ill patients. The study analyzed patients in the Premier Healthcare Database who had PCI with MCS at 432 hospitals from 2004 to 2016.
Outcomes in what Dr. Amin called “the Impella era,” showed significantly higher risks for death, acute kidney injury, and stroke, with odds ratios of 1.17, 1.91 and 3.34, respectively (P less than .001 for all). In the patient-level comparison of Impella versus IABP, Impella had a 24% higher risk of death (P less than .0001), 10% for bleeding (P = .0445), 8% for acute kidney injury (P = .0521) and 34% for stroke (P less than .0001). The findings were published simultaneously with the presentation (Circulation. 2019 Nov 17. doi: 10.1161/CIRCULATIONAHA.119.044007)
“The total length of stay, as well as the ICU length of stay, were actually lower with Impella use, by approximately a half day to 1 day,” Dr. Amin said. “Despite that, the total costs were approximately $15,000.”
Yet, the study found wide variation in the use of Impella among hospitals, some doing no cases with the device and others all of them, Dr. Amin said. The risk analysis also found wide variations in outcomes across hospitals using Impella. “We saw a 2.5-fold variation in bleeding across hospitals and a 1.5-fold variation in acute kidney injury, stroke and death,” he noted. The study found less variation in hospital stays and total cost of Impella, “perhaps related to the uniformly high device acquisition costs.”
“These data underscore the need for defining the appropriate use of mechanical circulatory support in patients undergoing PCI,” Dr. Amin said.
Dr. Sweis wasn’t surprised by the cost findings. “New technology is going to cost more,” she said in an interview. “I’m actually surprised that the cost wasn’t more significantly different just knowing the cost of some of these devices.
Patients who require MCS represent a small portion of PCI cases: 2%, according to Dr. Sweis. “It’s not like all PCI has increased because of MCS, and there’s a potential improvement in the length of stay so there are going to be cost savings that way.”
The national real-world study that Sanket S. Dhruva, MD, MHS, of the University of California San Francisco, reported on focused on Impella and IABP in PCI patients with acute MI complicated by cardiogenic shock (CS). The study used outcomes of patients with AMI-CS who had PCI from October 2015 to December 2017 in the National Cardiovascular Data Registry’s CathPCI and Chest Pain–MI registries. An estimated 4%-12% of AMIs present with CS.
Most patients in the study population had medical therapy only, but this study focused on the 1,768 who had Impella only and the 8,471 who had IABP only. The rates of in-hospital death and bleeding were 34.1% 16% in the IABP group, and 45% and 31.3% in the Impella group, Dr. Dhruva said. In this study population, the rate of Impella use increased from 3.5% in 2015 to 8.7% by the end of 2017 (P less than .001).
Dr. Dhruva acknowledged a number of limitations to the study findings, including residual confounding. However, the “robust propensity match” of 95% of the Impella-only patients and the results were consistent across multiple sensitivity analyses. “There may have been questions about the clinical severity of AMI-CS patients in the NCDR Registry,” he said. “However, the registry definition is similar to that used in the trials.”
The trial also failed to distinguish between the different types of Impella devices, but the results mostly pertain to the Impella 2.5 and CP because the 5.0 device requires a surgical cutdown, and the study excluded patients who received multiple devices.
“Better evidence and guidance are needed regarding the optimal management of patients with AMI-CS as well as the role of mechanical circulatory support devices in general and Impella in particular,” he said, adding that Impella has been on the U.S. market since 2008, but with limited randomized clinical trial evidence in cardiogenic shock.
The study population of patient’s with CS is “only a piece of the puzzle,” Dr. Sweis said. “We know that there are sick hearts that aren’t in shock right now, but you’re going to do triple-vessel intervention and use atherectomy. Those patients would not do very well during the procedure itself and it may not even be offered to them if there weren’t support.”
Impella is not going away, Dr. Sweis said. “It provides an option that a patient wouldn’t otherwise have. This is really stressing to me that we need to get rid of that variability in the safety related to these devices.”
Dr. Amin disclosed financial relationships with Terumo and GE Healthcare. Dr. Dhruva had no financial relationships to disclose. The study was supported in part by a Center of Excellence in Regulatory Science and Innovation grant from the Food and Drug Administration and the American College of Cardiology’s National Cardiovascular Data Registry.
PHILADELPHIA – Use of the Impella ventricular-assist device in patients with cardiogenic shock having percutaneous coronary interventions (PCI) has increased rapidly since its approval in 2008, but two studies comparing it with intra-aortic balloon pumps in PCI patients have raised questions about the safety, effectiveness, and cost of the ventricular-assist device, according to results of two studies presented at the American Heart Association scientific sessions.
The results of an observational analysis of 48,306 patients and a national real-world study of 28,304 patients may not be telling the complete story of the utility of ventricular assist in patients requiring mechanical circulatory support (MCS), one interventional cardiologist said in an interview. “It’s concerning; it’s sobering,” said Ranya N. Sweis, MD, of Northwestern University, Chicago. However, the data didn’t parse out patients who would have been routed to palliative care and otherwise wouldn’t have been candidates for PCI without MCS.
“What I take from it is that we need to get more randomized data,” she said. “Who are the patients that were doing worse? Who are the patients who really needed the Impella support for the PCI after cardiogenic shock?”
In the observational study, Amit P. Amin, MD, of Washington University, St. Louis, said that the use of MCS devices increased steadily to 32% of all PCI patients receiving MCS from 2008 to 2016 while use of intra-aortic balloon pump (IABP) declined, but that Impella was less likely to be used in critically ill patients. The study analyzed patients in the Premier Healthcare Database who had PCI with MCS at 432 hospitals from 2004 to 2016.
Outcomes in what Dr. Amin called “the Impella era,” showed significantly higher risks for death, acute kidney injury, and stroke, with odds ratios of 1.17, 1.91 and 3.34, respectively (P less than .001 for all). In the patient-level comparison of Impella versus IABP, Impella had a 24% higher risk of death (P less than .0001), 10% for bleeding (P = .0445), 8% for acute kidney injury (P = .0521) and 34% for stroke (P less than .0001). The findings were published simultaneously with the presentation (Circulation. 2019 Nov 17. doi: 10.1161/CIRCULATIONAHA.119.044007)
“The total length of stay, as well as the ICU length of stay, were actually lower with Impella use, by approximately a half day to 1 day,” Dr. Amin said. “Despite that, the total costs were approximately $15,000.”
Yet, the study found wide variation in the use of Impella among hospitals, some doing no cases with the device and others all of them, Dr. Amin said. The risk analysis also found wide variations in outcomes across hospitals using Impella. “We saw a 2.5-fold variation in bleeding across hospitals and a 1.5-fold variation in acute kidney injury, stroke and death,” he noted. The study found less variation in hospital stays and total cost of Impella, “perhaps related to the uniformly high device acquisition costs.”
“These data underscore the need for defining the appropriate use of mechanical circulatory support in patients undergoing PCI,” Dr. Amin said.
Dr. Sweis wasn’t surprised by the cost findings. “New technology is going to cost more,” she said in an interview. “I’m actually surprised that the cost wasn’t more significantly different just knowing the cost of some of these devices.
Patients who require MCS represent a small portion of PCI cases: 2%, according to Dr. Sweis. “It’s not like all PCI has increased because of MCS, and there’s a potential improvement in the length of stay so there are going to be cost savings that way.”
The national real-world study that Sanket S. Dhruva, MD, MHS, of the University of California San Francisco, reported on focused on Impella and IABP in PCI patients with acute MI complicated by cardiogenic shock (CS). The study used outcomes of patients with AMI-CS who had PCI from October 2015 to December 2017 in the National Cardiovascular Data Registry’s CathPCI and Chest Pain–MI registries. An estimated 4%-12% of AMIs present with CS.
Most patients in the study population had medical therapy only, but this study focused on the 1,768 who had Impella only and the 8,471 who had IABP only. The rates of in-hospital death and bleeding were 34.1% 16% in the IABP group, and 45% and 31.3% in the Impella group, Dr. Dhruva said. In this study population, the rate of Impella use increased from 3.5% in 2015 to 8.7% by the end of 2017 (P less than .001).
Dr. Dhruva acknowledged a number of limitations to the study findings, including residual confounding. However, the “robust propensity match” of 95% of the Impella-only patients and the results were consistent across multiple sensitivity analyses. “There may have been questions about the clinical severity of AMI-CS patients in the NCDR Registry,” he said. “However, the registry definition is similar to that used in the trials.”
The trial also failed to distinguish between the different types of Impella devices, but the results mostly pertain to the Impella 2.5 and CP because the 5.0 device requires a surgical cutdown, and the study excluded patients who received multiple devices.
“Better evidence and guidance are needed regarding the optimal management of patients with AMI-CS as well as the role of mechanical circulatory support devices in general and Impella in particular,” he said, adding that Impella has been on the U.S. market since 2008, but with limited randomized clinical trial evidence in cardiogenic shock.
The study population of patient’s with CS is “only a piece of the puzzle,” Dr. Sweis said. “We know that there are sick hearts that aren’t in shock right now, but you’re going to do triple-vessel intervention and use atherectomy. Those patients would not do very well during the procedure itself and it may not even be offered to them if there weren’t support.”
Impella is not going away, Dr. Sweis said. “It provides an option that a patient wouldn’t otherwise have. This is really stressing to me that we need to get rid of that variability in the safety related to these devices.”
Dr. Amin disclosed financial relationships with Terumo and GE Healthcare. Dr. Dhruva had no financial relationships to disclose. The study was supported in part by a Center of Excellence in Regulatory Science and Innovation grant from the Food and Drug Administration and the American College of Cardiology’s National Cardiovascular Data Registry.
REPORTING FROM AHA 2019
ASH releases guidelines on managing cardiopulmonary and kidney disease in SCD
ORLANDO – It is good practice to consult with a pulmonary hypertension (PH) expert before referring a patient with sickle cell disease (SCD) for right-heart catheterization or PH evaluation, according to new American Society of Hematology guidelines for the screening and management of cardiopulmonary and kidney disease in patients with SCD.
That “Good Practice” recommendation is one of several included in the evidence-based guidelines published Dec. 10 in Blood Advances and highlighted during a Special Education Session at the annual ASH meeting.
The guidelines provide 10 main recommendations intended to “support patients, clinicians, and other health care professionals in their decisions about screening, diagnosis, and management of cardiopulmonary and renal complications of SCD,” wrote Robert I. Liem, MD, of Ann & Robert H. Lurie Children’s Hospital of Chicago and colleagues.
The recommendations, agreed upon by a multidisciplinary guideline panel, relate to screening, diagnosis, and management of PH, pulmonary arterial hypertension (PAH), hypertension, proteinuria and chronic kidney disease, and venous thromboembolism (VTE). Most are “conditional,” as opposed to “strong,” because of a paucity of direct, high-quality outcomes data, and they are accompanied by the Good Practice Statements, descriptive remarks and caveats based on the available data, as well as suggestions for future research.
At the special ASH session, Ankit A. Desai, MD, highlighted some of the recommendations and discussed considerations for their practical application.
The Good Practice Statement on consulting a specialist before referring a patient for PH relates specifically to Recommendations 2a and 2b on the management of abnormal echocardiography, explained Dr. Desai of Indiana University, Indianapolis.
For asymptomatic children and adults with SCD and an isolated peak tricuspid regurgitant jet velocity (TRJV) of at least 2.5-2.9 m/s on echocardiography, the panel recommends against right-heart catheterization (Recommendation 2a, conditional), he said.
For children and adults with SCD and a peak TRJV of at least 2.5 m/s who also have a reduced 6-minute walk distance (6MWD) and/or elevated N-terminal proB-type natriuretic peptide (NT-proBNP), the panel supports right-heart catheterization (Recommendation 2b, conditional).
Dr. Desai noted that the 2.5 m/s threshold was found to be suboptimal when used as the sole criteria for right-heart catheterization. Using that threshold alone is associated with “moderate to large” harms, such as starting inappropriate PH-specific therapies and/or performing unnecessary right-heart catheterization. However, when used in combination with 6MWD, the predictive capacity improved significantly, and the risk for potential harm was low, he explained.
Another Good Practice Statement included in the guidelines, and relevant to these recommendations on managing abnormal echocardiography, addresses the importance of basing decisions about the need for right-heart catheterization on echocardiograms obtained at steady state rather than during acute illness, such as during hospitalization for pain or acute chest syndrome.
This is in part because of technical factors, Dr. Desai said.
“We know that repeating [echocardiography] is something that should be considered in patients because ... results vary – sometimes quite a bit – from study to study,” he said.
As for the cutoff values for 6MWD and NT-proBNP, “a decent amount of literature” suggests that less than 333 m and less than 160 pg/ml, respectively, are good thresholds, he said.
“Importantly, this should all be taken in the context of good clinical judgment ... along with discussion with a PH expert,” he added.
The full guidelines are available, along with additional ASH guidelines on immune thrombocytopenia and prevention of venous thromboembolism in surgical hospitalized patients, at the ASH publications website.
Of note, the SCD guidelines on cardiopulmonary disease and kidney disease are one of five sets of SCD guidelines that have been in development; these are the first of those to be published. The remaining four sets of guidelines will address pain, cerebrovascular complications, transfusion, and hematopoietic stem cell transplant. All will be published in Blood Advances, and according to Dr. Liem, the transfusion medicine guidelines have been accepted and should be published in January 2020, followed by those for cerebrovascular complications. Publication of the pain and transplant guidelines are anticipated later in 2020.
Dr. Liem and Dr. Desai reported having no conflicts of interest.
ORLANDO – It is good practice to consult with a pulmonary hypertension (PH) expert before referring a patient with sickle cell disease (SCD) for right-heart catheterization or PH evaluation, according to new American Society of Hematology guidelines for the screening and management of cardiopulmonary and kidney disease in patients with SCD.
That “Good Practice” recommendation is one of several included in the evidence-based guidelines published Dec. 10 in Blood Advances and highlighted during a Special Education Session at the annual ASH meeting.
The guidelines provide 10 main recommendations intended to “support patients, clinicians, and other health care professionals in their decisions about screening, diagnosis, and management of cardiopulmonary and renal complications of SCD,” wrote Robert I. Liem, MD, of Ann & Robert H. Lurie Children’s Hospital of Chicago and colleagues.
The recommendations, agreed upon by a multidisciplinary guideline panel, relate to screening, diagnosis, and management of PH, pulmonary arterial hypertension (PAH), hypertension, proteinuria and chronic kidney disease, and venous thromboembolism (VTE). Most are “conditional,” as opposed to “strong,” because of a paucity of direct, high-quality outcomes data, and they are accompanied by the Good Practice Statements, descriptive remarks and caveats based on the available data, as well as suggestions for future research.
At the special ASH session, Ankit A. Desai, MD, highlighted some of the recommendations and discussed considerations for their practical application.
The Good Practice Statement on consulting a specialist before referring a patient for PH relates specifically to Recommendations 2a and 2b on the management of abnormal echocardiography, explained Dr. Desai of Indiana University, Indianapolis.
For asymptomatic children and adults with SCD and an isolated peak tricuspid regurgitant jet velocity (TRJV) of at least 2.5-2.9 m/s on echocardiography, the panel recommends against right-heart catheterization (Recommendation 2a, conditional), he said.
For children and adults with SCD and a peak TRJV of at least 2.5 m/s who also have a reduced 6-minute walk distance (6MWD) and/or elevated N-terminal proB-type natriuretic peptide (NT-proBNP), the panel supports right-heart catheterization (Recommendation 2b, conditional).
Dr. Desai noted that the 2.5 m/s threshold was found to be suboptimal when used as the sole criteria for right-heart catheterization. Using that threshold alone is associated with “moderate to large” harms, such as starting inappropriate PH-specific therapies and/or performing unnecessary right-heart catheterization. However, when used in combination with 6MWD, the predictive capacity improved significantly, and the risk for potential harm was low, he explained.
Another Good Practice Statement included in the guidelines, and relevant to these recommendations on managing abnormal echocardiography, addresses the importance of basing decisions about the need for right-heart catheterization on echocardiograms obtained at steady state rather than during acute illness, such as during hospitalization for pain or acute chest syndrome.
This is in part because of technical factors, Dr. Desai said.
“We know that repeating [echocardiography] is something that should be considered in patients because ... results vary – sometimes quite a bit – from study to study,” he said.
As for the cutoff values for 6MWD and NT-proBNP, “a decent amount of literature” suggests that less than 333 m and less than 160 pg/ml, respectively, are good thresholds, he said.
“Importantly, this should all be taken in the context of good clinical judgment ... along with discussion with a PH expert,” he added.
The full guidelines are available, along with additional ASH guidelines on immune thrombocytopenia and prevention of venous thromboembolism in surgical hospitalized patients, at the ASH publications website.
Of note, the SCD guidelines on cardiopulmonary disease and kidney disease are one of five sets of SCD guidelines that have been in development; these are the first of those to be published. The remaining four sets of guidelines will address pain, cerebrovascular complications, transfusion, and hematopoietic stem cell transplant. All will be published in Blood Advances, and according to Dr. Liem, the transfusion medicine guidelines have been accepted and should be published in January 2020, followed by those for cerebrovascular complications. Publication of the pain and transplant guidelines are anticipated later in 2020.
Dr. Liem and Dr. Desai reported having no conflicts of interest.
ORLANDO – It is good practice to consult with a pulmonary hypertension (PH) expert before referring a patient with sickle cell disease (SCD) for right-heart catheterization or PH evaluation, according to new American Society of Hematology guidelines for the screening and management of cardiopulmonary and kidney disease in patients with SCD.
That “Good Practice” recommendation is one of several included in the evidence-based guidelines published Dec. 10 in Blood Advances and highlighted during a Special Education Session at the annual ASH meeting.
The guidelines provide 10 main recommendations intended to “support patients, clinicians, and other health care professionals in their decisions about screening, diagnosis, and management of cardiopulmonary and renal complications of SCD,” wrote Robert I. Liem, MD, of Ann & Robert H. Lurie Children’s Hospital of Chicago and colleagues.
The recommendations, agreed upon by a multidisciplinary guideline panel, relate to screening, diagnosis, and management of PH, pulmonary arterial hypertension (PAH), hypertension, proteinuria and chronic kidney disease, and venous thromboembolism (VTE). Most are “conditional,” as opposed to “strong,” because of a paucity of direct, high-quality outcomes data, and they are accompanied by the Good Practice Statements, descriptive remarks and caveats based on the available data, as well as suggestions for future research.
At the special ASH session, Ankit A. Desai, MD, highlighted some of the recommendations and discussed considerations for their practical application.
The Good Practice Statement on consulting a specialist before referring a patient for PH relates specifically to Recommendations 2a and 2b on the management of abnormal echocardiography, explained Dr. Desai of Indiana University, Indianapolis.
For asymptomatic children and adults with SCD and an isolated peak tricuspid regurgitant jet velocity (TRJV) of at least 2.5-2.9 m/s on echocardiography, the panel recommends against right-heart catheterization (Recommendation 2a, conditional), he said.
For children and adults with SCD and a peak TRJV of at least 2.5 m/s who also have a reduced 6-minute walk distance (6MWD) and/or elevated N-terminal proB-type natriuretic peptide (NT-proBNP), the panel supports right-heart catheterization (Recommendation 2b, conditional).
Dr. Desai noted that the 2.5 m/s threshold was found to be suboptimal when used as the sole criteria for right-heart catheterization. Using that threshold alone is associated with “moderate to large” harms, such as starting inappropriate PH-specific therapies and/or performing unnecessary right-heart catheterization. However, when used in combination with 6MWD, the predictive capacity improved significantly, and the risk for potential harm was low, he explained.
Another Good Practice Statement included in the guidelines, and relevant to these recommendations on managing abnormal echocardiography, addresses the importance of basing decisions about the need for right-heart catheterization on echocardiograms obtained at steady state rather than during acute illness, such as during hospitalization for pain or acute chest syndrome.
This is in part because of technical factors, Dr. Desai said.
“We know that repeating [echocardiography] is something that should be considered in patients because ... results vary – sometimes quite a bit – from study to study,” he said.
As for the cutoff values for 6MWD and NT-proBNP, “a decent amount of literature” suggests that less than 333 m and less than 160 pg/ml, respectively, are good thresholds, he said.
“Importantly, this should all be taken in the context of good clinical judgment ... along with discussion with a PH expert,” he added.
The full guidelines are available, along with additional ASH guidelines on immune thrombocytopenia and prevention of venous thromboembolism in surgical hospitalized patients, at the ASH publications website.
Of note, the SCD guidelines on cardiopulmonary disease and kidney disease are one of five sets of SCD guidelines that have been in development; these are the first of those to be published. The remaining four sets of guidelines will address pain, cerebrovascular complications, transfusion, and hematopoietic stem cell transplant. All will be published in Blood Advances, and according to Dr. Liem, the transfusion medicine guidelines have been accepted and should be published in January 2020, followed by those for cerebrovascular complications. Publication of the pain and transplant guidelines are anticipated later in 2020.
Dr. Liem and Dr. Desai reported having no conflicts of interest.
EXPERT ANALYSIS FROM ASH 2019
Employment is associated with high likelihood of declining epilepsy surgery
BALTIMORE – , according to an analysis presented at the annual meeting of the American Epilepsy Society. “Future work should confirm this finding prospectively, determine if it holds in other patient populations, and explore the decision to proceed with or decline epilepsy surgery from a patient-centered perspective,” said Vishal Mandge, MD, MPH, a clinical neurophysiology fellow at Duke University in Durham, N.C., and colleagues. “Identifying the role that factors such as the fear of losing employment due to complications from surgery and inability to take medical leave for an extended period of time play in the patient’s decision to proceed with epilepsy surgery may identify needs and suggest strategies to reduce barriers to this underutilized treatment.”
Although epilepsy surgery is known to be safe and effective, many surgical candidates with drug-resistant epilepsy decline to undergo the procedure. Prior investigations of the barriers to epilepsy surgery have focused on access to epilepsy centers that offer epilepsy surgery and patients’ reluctance to undergo presurgical evaluation. Dr. Mandge and colleagues instead set out to evaluate the association between various demographic, disease-specific, and epilepsy-evaluation variables and patients’ decision to decline surgery after they have been identified as candidates.
A retrospective case-control study
The investigators conducted a retrospective case-control study of patients who were discussed at the epilepsy surgery conference of a tertiary care hospital serving an urban New York community between Jan. 1, 2009, and June 30, 2017. They identified patients who were considered candidates for resective epilepsy surgery. Dr. Mandge and colleagues used the chi-squared test for nominal variables and analysis of variance for scale variables to evaluate these variables’ associations with a patient’s decision to decline epilepsy surgery. They also performed multivariate binary logistic regression to identify variables that predict a patient’s decision to decline surgery.
Dr. Mandge and colleagues identified 159 patients who were discussed during the study period. Of this group, 87 patients were eligible for resective epilepsy surgery after a thorough evaluation. Thirty-four (40%) of the eligible patients declined to undergo surgery. Approximately 20% of eligible patients were employed, and 70% of patients had a high school diploma or higher education.
Univariate analysis indicated that employment (odds ratio, 4.2), temporal lesion on MRI (OR, 0.35), temporal EEG localization (OR, 0.21), and temporal seizure onset zone (OR, 0.19) were independently and significantly associated with a patient’s decision to decline surgery. Multivariate logistic regression analysis indicated that current employment (OR, 7.5), the number of current antiepileptic drugs (AEDs; OR, 3.5), and concordance between seizure semiology, seizure onset on EEG, and imaging (OR, 0.08) were significantly associated with a patient’s decision to decline surgery.
Fear of unemployment may explain results
“With each additional AED, the patients were 3.5 times more likely to decline surgery, even after adjusting for other variables,” said Alexis D. Boro, MD, a neurologist at Montefiore Medical Center in New York and one of the investigators. “My suspicion is that some of this reflects the burden of taking a lot of seizure medication. While the medications are much, much safer than seizures, and looking for and dealing with side effects is a lot of what we do, people often don’t feel great when they are taking multiple seizure medications. We counsel our patients that they should generally expect to stay on some seizure medications after surgery. The reason for surgery is to stop the seizures, not to stop the medications. We are often able to reduce medications after a period of time after surgery, and for many patients, this is one of the benefits.”
The association between employment and increased likelihood of declining surgery was unexpected and may not hold everywhere, said Dr. Boro. “We had expected the opposite result because we assumed that employed patients would be concerned that a seizure at work might result in loss of work. But it may be that many of our patients who are employed are concerned about losing their jobs if they miss work for a medical procedure. Some of our patients may be concerned about sharing medical information with their employers. For some of our patients, being employed may imply limited insurance coverage.”
The study was not supported by external funding, and the investigators did not report any disclosures.
SOURCE: Mandge VA et al. AES 2019, Abstract 1.362.
BALTIMORE – , according to an analysis presented at the annual meeting of the American Epilepsy Society. “Future work should confirm this finding prospectively, determine if it holds in other patient populations, and explore the decision to proceed with or decline epilepsy surgery from a patient-centered perspective,” said Vishal Mandge, MD, MPH, a clinical neurophysiology fellow at Duke University in Durham, N.C., and colleagues. “Identifying the role that factors such as the fear of losing employment due to complications from surgery and inability to take medical leave for an extended period of time play in the patient’s decision to proceed with epilepsy surgery may identify needs and suggest strategies to reduce barriers to this underutilized treatment.”
Although epilepsy surgery is known to be safe and effective, many surgical candidates with drug-resistant epilepsy decline to undergo the procedure. Prior investigations of the barriers to epilepsy surgery have focused on access to epilepsy centers that offer epilepsy surgery and patients’ reluctance to undergo presurgical evaluation. Dr. Mandge and colleagues instead set out to evaluate the association between various demographic, disease-specific, and epilepsy-evaluation variables and patients’ decision to decline surgery after they have been identified as candidates.
A retrospective case-control study
The investigators conducted a retrospective case-control study of patients who were discussed at the epilepsy surgery conference of a tertiary care hospital serving an urban New York community between Jan. 1, 2009, and June 30, 2017. They identified patients who were considered candidates for resective epilepsy surgery. Dr. Mandge and colleagues used the chi-squared test for nominal variables and analysis of variance for scale variables to evaluate these variables’ associations with a patient’s decision to decline epilepsy surgery. They also performed multivariate binary logistic regression to identify variables that predict a patient’s decision to decline surgery.
Dr. Mandge and colleagues identified 159 patients who were discussed during the study period. Of this group, 87 patients were eligible for resective epilepsy surgery after a thorough evaluation. Thirty-four (40%) of the eligible patients declined to undergo surgery. Approximately 20% of eligible patients were employed, and 70% of patients had a high school diploma or higher education.
Univariate analysis indicated that employment (odds ratio, 4.2), temporal lesion on MRI (OR, 0.35), temporal EEG localization (OR, 0.21), and temporal seizure onset zone (OR, 0.19) were independently and significantly associated with a patient’s decision to decline surgery. Multivariate logistic regression analysis indicated that current employment (OR, 7.5), the number of current antiepileptic drugs (AEDs; OR, 3.5), and concordance between seizure semiology, seizure onset on EEG, and imaging (OR, 0.08) were significantly associated with a patient’s decision to decline surgery.
Fear of unemployment may explain results
“With each additional AED, the patients were 3.5 times more likely to decline surgery, even after adjusting for other variables,” said Alexis D. Boro, MD, a neurologist at Montefiore Medical Center in New York and one of the investigators. “My suspicion is that some of this reflects the burden of taking a lot of seizure medication. While the medications are much, much safer than seizures, and looking for and dealing with side effects is a lot of what we do, people often don’t feel great when they are taking multiple seizure medications. We counsel our patients that they should generally expect to stay on some seizure medications after surgery. The reason for surgery is to stop the seizures, not to stop the medications. We are often able to reduce medications after a period of time after surgery, and for many patients, this is one of the benefits.”
The association between employment and increased likelihood of declining surgery was unexpected and may not hold everywhere, said Dr. Boro. “We had expected the opposite result because we assumed that employed patients would be concerned that a seizure at work might result in loss of work. But it may be that many of our patients who are employed are concerned about losing their jobs if they miss work for a medical procedure. Some of our patients may be concerned about sharing medical information with their employers. For some of our patients, being employed may imply limited insurance coverage.”
The study was not supported by external funding, and the investigators did not report any disclosures.
SOURCE: Mandge VA et al. AES 2019, Abstract 1.362.
BALTIMORE – , according to an analysis presented at the annual meeting of the American Epilepsy Society. “Future work should confirm this finding prospectively, determine if it holds in other patient populations, and explore the decision to proceed with or decline epilepsy surgery from a patient-centered perspective,” said Vishal Mandge, MD, MPH, a clinical neurophysiology fellow at Duke University in Durham, N.C., and colleagues. “Identifying the role that factors such as the fear of losing employment due to complications from surgery and inability to take medical leave for an extended period of time play in the patient’s decision to proceed with epilepsy surgery may identify needs and suggest strategies to reduce barriers to this underutilized treatment.”
Although epilepsy surgery is known to be safe and effective, many surgical candidates with drug-resistant epilepsy decline to undergo the procedure. Prior investigations of the barriers to epilepsy surgery have focused on access to epilepsy centers that offer epilepsy surgery and patients’ reluctance to undergo presurgical evaluation. Dr. Mandge and colleagues instead set out to evaluate the association between various demographic, disease-specific, and epilepsy-evaluation variables and patients’ decision to decline surgery after they have been identified as candidates.
A retrospective case-control study
The investigators conducted a retrospective case-control study of patients who were discussed at the epilepsy surgery conference of a tertiary care hospital serving an urban New York community between Jan. 1, 2009, and June 30, 2017. They identified patients who were considered candidates for resective epilepsy surgery. Dr. Mandge and colleagues used the chi-squared test for nominal variables and analysis of variance for scale variables to evaluate these variables’ associations with a patient’s decision to decline epilepsy surgery. They also performed multivariate binary logistic regression to identify variables that predict a patient’s decision to decline surgery.
Dr. Mandge and colleagues identified 159 patients who were discussed during the study period. Of this group, 87 patients were eligible for resective epilepsy surgery after a thorough evaluation. Thirty-four (40%) of the eligible patients declined to undergo surgery. Approximately 20% of eligible patients were employed, and 70% of patients had a high school diploma or higher education.
Univariate analysis indicated that employment (odds ratio, 4.2), temporal lesion on MRI (OR, 0.35), temporal EEG localization (OR, 0.21), and temporal seizure onset zone (OR, 0.19) were independently and significantly associated with a patient’s decision to decline surgery. Multivariate logistic regression analysis indicated that current employment (OR, 7.5), the number of current antiepileptic drugs (AEDs; OR, 3.5), and concordance between seizure semiology, seizure onset on EEG, and imaging (OR, 0.08) were significantly associated with a patient’s decision to decline surgery.
Fear of unemployment may explain results
“With each additional AED, the patients were 3.5 times more likely to decline surgery, even after adjusting for other variables,” said Alexis D. Boro, MD, a neurologist at Montefiore Medical Center in New York and one of the investigators. “My suspicion is that some of this reflects the burden of taking a lot of seizure medication. While the medications are much, much safer than seizures, and looking for and dealing with side effects is a lot of what we do, people often don’t feel great when they are taking multiple seizure medications. We counsel our patients that they should generally expect to stay on some seizure medications after surgery. The reason for surgery is to stop the seizures, not to stop the medications. We are often able to reduce medications after a period of time after surgery, and for many patients, this is one of the benefits.”
The association between employment and increased likelihood of declining surgery was unexpected and may not hold everywhere, said Dr. Boro. “We had expected the opposite result because we assumed that employed patients would be concerned that a seizure at work might result in loss of work. But it may be that many of our patients who are employed are concerned about losing their jobs if they miss work for a medical procedure. Some of our patients may be concerned about sharing medical information with their employers. For some of our patients, being employed may imply limited insurance coverage.”
The study was not supported by external funding, and the investigators did not report any disclosures.
SOURCE: Mandge VA et al. AES 2019, Abstract 1.362.
REPORTING FROM AES 2019
New ASH guideline: VTE prophylaxis after major surgery
ORLANDO – The latest American Society of Hematology guideline on venous thromboembolism (VTE) tackles 30 key questions regarding prophylaxis in hospitalized patients undergoing surgery, according to the chair of the guideline panel, who highlighted 9 of those questions during a special session at the society’s annual meeting.
The clinical practice guideline, published just about a week before the annual meeting of the American Society of Hematology, focuses mainly on pharmacologic prophylaxis in specific surgical settings, said David R. Anderson, MD, dean of the faculty of medicine of Dalhousie University, Halifax, N.S.
“Our guidelines focused upon clinically important symptomatic outcomes, with less emphasis being placed on asymptomatic deep vein thrombosis detected by screening tests,” Dr. Anderson said.
At the special education session, Dr. Anderson highlighted several specific recommendations on prophylaxis in surgical patients.
Pharmacologic prophylaxis is not recommended for patients experiencing major trauma deemed to be at high risk of bleeding. Its use does reduce risk of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) by about 10 events per 1,000 patients treated; however, Dr. Anderson said, the panel’s opinion was that this benefit was outweighed by increased risk of major bleeding, at 24 events per 1,000 patients treated.
“We do recommend, however that this risk of bleeding must be reevaluated over the course of recovery of patients, and this may change the decision around this intervention over time,” Dr. Anderson told attendees at the special session.
That’s because pharmacologic prophylaxis is recommended in surgical patients at low to moderate risk of bleeding. In this scenario, the incremental risk of major bleeding (14 events per 1,000 patients treated) is outweighed by the benefit of the reduction of symptomatic VTE events, according to Dr. Anderson.
When pharmacologic prophylaxis is used, the panel recommends combined prophylaxis – mechanical prophylaxis in addition to pharmacologic prophylaxis – especially in those patients at high or very high risk of VTE. Evidence shows that the combination approach significantly reduces risk of PE, and strongly suggests it may also reduce risk of symptomatic proximal DVT, Dr. Anderson said.
In surgical patients not receiving pharmacologic prophylaxis, mechanical prophylaxis is recommended over no mechanical prophylaxis, he added. Moreover, in those patients receiving mechanical prophylaxis, the ASH panel recommends use of intermittent compression devices over graduated compression stockings.
The panel comes out against prophylactic inferior vena cava (IVC) filter insertion in the guidelines. Dr. Anderson said that the “small reduction” in PE risk seen in observational studies is outweighed by increased risk of DVT, and a resulting trend for increased mortality, associated with insertion of the devices.
“We did not consider other risks of IVC filters such as filter embolization or perforation, which again would be complications that would support our recommendation against routine use of these devices in patients undergoing major surgery,” he said.
In terms of the type of pharmacologic prophylaxis to use, the panel said low-molecular-weight heparin or unfractionated heparin would be reasonable choices in this setting. Available data do not demonstrate any significant differences between these choices for major clinical outcomes, Dr. Anderson added.
The guideline also addresses duration of pharmacologic prophylaxis, stating that extended prophylaxis – of at least 3 weeks – is favored over short-term prophylaxis, or up to 2 weeks of treatment. The extended approach significantly reduces risk of symptomatic PE and proximal DVT, though most of the supporting data come from studies of major joint arthroplasty and major general surgical procedures for patients with cancer. “We need more studies in other clinical areas to examine this particular question,” Dr. Anderson said.
The guideline on prophylaxis in surgical patients was published in Blood Advances (2019 Dec 3;3[23]:3898-944). Six other ASH VTE guidelines, all published in 2018, covered prophylaxis in medical patients, diagnosis, VTE in pregnancy, optimal anticoagulation, heparin-induced thrombocytopenia, and pediatric considerations. The guidelines are available on the ASH website.
Dr. Anderson reported having no relevant conflicts of interest.
ORLANDO – The latest American Society of Hematology guideline on venous thromboembolism (VTE) tackles 30 key questions regarding prophylaxis in hospitalized patients undergoing surgery, according to the chair of the guideline panel, who highlighted 9 of those questions during a special session at the society’s annual meeting.
The clinical practice guideline, published just about a week before the annual meeting of the American Society of Hematology, focuses mainly on pharmacologic prophylaxis in specific surgical settings, said David R. Anderson, MD, dean of the faculty of medicine of Dalhousie University, Halifax, N.S.
“Our guidelines focused upon clinically important symptomatic outcomes, with less emphasis being placed on asymptomatic deep vein thrombosis detected by screening tests,” Dr. Anderson said.
At the special education session, Dr. Anderson highlighted several specific recommendations on prophylaxis in surgical patients.
Pharmacologic prophylaxis is not recommended for patients experiencing major trauma deemed to be at high risk of bleeding. Its use does reduce risk of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) by about 10 events per 1,000 patients treated; however, Dr. Anderson said, the panel’s opinion was that this benefit was outweighed by increased risk of major bleeding, at 24 events per 1,000 patients treated.
“We do recommend, however that this risk of bleeding must be reevaluated over the course of recovery of patients, and this may change the decision around this intervention over time,” Dr. Anderson told attendees at the special session.
That’s because pharmacologic prophylaxis is recommended in surgical patients at low to moderate risk of bleeding. In this scenario, the incremental risk of major bleeding (14 events per 1,000 patients treated) is outweighed by the benefit of the reduction of symptomatic VTE events, according to Dr. Anderson.
When pharmacologic prophylaxis is used, the panel recommends combined prophylaxis – mechanical prophylaxis in addition to pharmacologic prophylaxis – especially in those patients at high or very high risk of VTE. Evidence shows that the combination approach significantly reduces risk of PE, and strongly suggests it may also reduce risk of symptomatic proximal DVT, Dr. Anderson said.
In surgical patients not receiving pharmacologic prophylaxis, mechanical prophylaxis is recommended over no mechanical prophylaxis, he added. Moreover, in those patients receiving mechanical prophylaxis, the ASH panel recommends use of intermittent compression devices over graduated compression stockings.
The panel comes out against prophylactic inferior vena cava (IVC) filter insertion in the guidelines. Dr. Anderson said that the “small reduction” in PE risk seen in observational studies is outweighed by increased risk of DVT, and a resulting trend for increased mortality, associated with insertion of the devices.
“We did not consider other risks of IVC filters such as filter embolization or perforation, which again would be complications that would support our recommendation against routine use of these devices in patients undergoing major surgery,” he said.
In terms of the type of pharmacologic prophylaxis to use, the panel said low-molecular-weight heparin or unfractionated heparin would be reasonable choices in this setting. Available data do not demonstrate any significant differences between these choices for major clinical outcomes, Dr. Anderson added.
The guideline also addresses duration of pharmacologic prophylaxis, stating that extended prophylaxis – of at least 3 weeks – is favored over short-term prophylaxis, or up to 2 weeks of treatment. The extended approach significantly reduces risk of symptomatic PE and proximal DVT, though most of the supporting data come from studies of major joint arthroplasty and major general surgical procedures for patients with cancer. “We need more studies in other clinical areas to examine this particular question,” Dr. Anderson said.
The guideline on prophylaxis in surgical patients was published in Blood Advances (2019 Dec 3;3[23]:3898-944). Six other ASH VTE guidelines, all published in 2018, covered prophylaxis in medical patients, diagnosis, VTE in pregnancy, optimal anticoagulation, heparin-induced thrombocytopenia, and pediatric considerations. The guidelines are available on the ASH website.
Dr. Anderson reported having no relevant conflicts of interest.
ORLANDO – The latest American Society of Hematology guideline on venous thromboembolism (VTE) tackles 30 key questions regarding prophylaxis in hospitalized patients undergoing surgery, according to the chair of the guideline panel, who highlighted 9 of those questions during a special session at the society’s annual meeting.
The clinical practice guideline, published just about a week before the annual meeting of the American Society of Hematology, focuses mainly on pharmacologic prophylaxis in specific surgical settings, said David R. Anderson, MD, dean of the faculty of medicine of Dalhousie University, Halifax, N.S.
“Our guidelines focused upon clinically important symptomatic outcomes, with less emphasis being placed on asymptomatic deep vein thrombosis detected by screening tests,” Dr. Anderson said.
At the special education session, Dr. Anderson highlighted several specific recommendations on prophylaxis in surgical patients.
Pharmacologic prophylaxis is not recommended for patients experiencing major trauma deemed to be at high risk of bleeding. Its use does reduce risk of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) by about 10 events per 1,000 patients treated; however, Dr. Anderson said, the panel’s opinion was that this benefit was outweighed by increased risk of major bleeding, at 24 events per 1,000 patients treated.
“We do recommend, however that this risk of bleeding must be reevaluated over the course of recovery of patients, and this may change the decision around this intervention over time,” Dr. Anderson told attendees at the special session.
That’s because pharmacologic prophylaxis is recommended in surgical patients at low to moderate risk of bleeding. In this scenario, the incremental risk of major bleeding (14 events per 1,000 patients treated) is outweighed by the benefit of the reduction of symptomatic VTE events, according to Dr. Anderson.
When pharmacologic prophylaxis is used, the panel recommends combined prophylaxis – mechanical prophylaxis in addition to pharmacologic prophylaxis – especially in those patients at high or very high risk of VTE. Evidence shows that the combination approach significantly reduces risk of PE, and strongly suggests it may also reduce risk of symptomatic proximal DVT, Dr. Anderson said.
In surgical patients not receiving pharmacologic prophylaxis, mechanical prophylaxis is recommended over no mechanical prophylaxis, he added. Moreover, in those patients receiving mechanical prophylaxis, the ASH panel recommends use of intermittent compression devices over graduated compression stockings.
The panel comes out against prophylactic inferior vena cava (IVC) filter insertion in the guidelines. Dr. Anderson said that the “small reduction” in PE risk seen in observational studies is outweighed by increased risk of DVT, and a resulting trend for increased mortality, associated with insertion of the devices.
“We did not consider other risks of IVC filters such as filter embolization or perforation, which again would be complications that would support our recommendation against routine use of these devices in patients undergoing major surgery,” he said.
In terms of the type of pharmacologic prophylaxis to use, the panel said low-molecular-weight heparin or unfractionated heparin would be reasonable choices in this setting. Available data do not demonstrate any significant differences between these choices for major clinical outcomes, Dr. Anderson added.
The guideline also addresses duration of pharmacologic prophylaxis, stating that extended prophylaxis – of at least 3 weeks – is favored over short-term prophylaxis, or up to 2 weeks of treatment. The extended approach significantly reduces risk of symptomatic PE and proximal DVT, though most of the supporting data come from studies of major joint arthroplasty and major general surgical procedures for patients with cancer. “We need more studies in other clinical areas to examine this particular question,” Dr. Anderson said.
The guideline on prophylaxis in surgical patients was published in Blood Advances (2019 Dec 3;3[23]:3898-944). Six other ASH VTE guidelines, all published in 2018, covered prophylaxis in medical patients, diagnosis, VTE in pregnancy, optimal anticoagulation, heparin-induced thrombocytopenia, and pediatric considerations. The guidelines are available on the ASH website.
Dr. Anderson reported having no relevant conflicts of interest.
EXPERT ANALYSIS FROM ASH 2019
Bariatric surgery tied to fewer cerebrovascular events
PHILADELPHIA – Obese people living in the United Kingdom who underwent bariatric surgery had a two-thirds lower rate of major cerebrovascular events than that of a matched group of obese residents who did not undergo bariatric surgery, in a retrospective study of 8,424 people followed for a mean of just over 11 years.
Although the cut in cerebrovascular events that linked with bariatric surgery shown by the analysis was mostly driven by a reduced rate of transient ischemic attacks, a potentially unreliable diagnosis, the results showed consistent reductions in the rates of acute ischemic strokes as well as in acute, nontraumatic intracranial hemorrhages, two other components of the combined primary endpoint, Maddalena Ardissino, MBBS, said at the American Heart Association scientific sessions.
This finding of an apparent benefit from bariatric surgery in obese patients in a large U.K. database confirms other findings from a “fast-growing” evidence base showing benefits from bariatric surgery for reducing other types of cardiovascular disease events, said Dr. Ardissino, a researcher at Imperial College, London. However, the impact of bariatric surgery specifically on cerebrovascular events had not received much attention in published studies, she noted.
Her study used data collected by the Clinical Practice Research Datalink, which has primary and secondary care health records for about 42 million U.K. residents. The researchers focused on more than 251,000 obese U.K. adults (body mass index of 30 kg/m2 or greater) without a history of a cerebrovascular event who had at least 1 year of follow-up, a data file that included 4,212 adults who had undergone bariatric surgery. Their analysis matched these surgical patients with an equal number of obese adults who did not have surgery, pairing the cases and controls based on age, sex, and BMI. The resulting matched cohorts each averaged 50 years old, with a mean BMI of 40.5 kg/m2.
During just over 11 years of average follow-up, the incidence of acute ischemic stroke, acute intracranial hemorrhage, subarachnoid hemorrhage, or transient ischemic attack was about 1.3% in those without bariatric surgery and about 0.4% in those who had surgery, an absolute risk reduction of 0.9 linked with surgery and a relative risk reduction of 65% that was statistically significant, Dr. Ardissino reported. All-cause mortality was about 70% lower in the group that underwent bariatric surgery compared with those who did not have surgery, a finding that confirmed prior reports. She cautioned that the analysis was limited by a relatively low number of total events, and by the small number of criteria used for cohort matching that might have left unadjusted certain potential confounders such as the level of engagement people had with their medical care.
SOURCE: Ardissino M. AHA 2019, Abstract 335.
PHILADELPHIA – Obese people living in the United Kingdom who underwent bariatric surgery had a two-thirds lower rate of major cerebrovascular events than that of a matched group of obese residents who did not undergo bariatric surgery, in a retrospective study of 8,424 people followed for a mean of just over 11 years.
Although the cut in cerebrovascular events that linked with bariatric surgery shown by the analysis was mostly driven by a reduced rate of transient ischemic attacks, a potentially unreliable diagnosis, the results showed consistent reductions in the rates of acute ischemic strokes as well as in acute, nontraumatic intracranial hemorrhages, two other components of the combined primary endpoint, Maddalena Ardissino, MBBS, said at the American Heart Association scientific sessions.
This finding of an apparent benefit from bariatric surgery in obese patients in a large U.K. database confirms other findings from a “fast-growing” evidence base showing benefits from bariatric surgery for reducing other types of cardiovascular disease events, said Dr. Ardissino, a researcher at Imperial College, London. However, the impact of bariatric surgery specifically on cerebrovascular events had not received much attention in published studies, she noted.
Her study used data collected by the Clinical Practice Research Datalink, which has primary and secondary care health records for about 42 million U.K. residents. The researchers focused on more than 251,000 obese U.K. adults (body mass index of 30 kg/m2 or greater) without a history of a cerebrovascular event who had at least 1 year of follow-up, a data file that included 4,212 adults who had undergone bariatric surgery. Their analysis matched these surgical patients with an equal number of obese adults who did not have surgery, pairing the cases and controls based on age, sex, and BMI. The resulting matched cohorts each averaged 50 years old, with a mean BMI of 40.5 kg/m2.
During just over 11 years of average follow-up, the incidence of acute ischemic stroke, acute intracranial hemorrhage, subarachnoid hemorrhage, or transient ischemic attack was about 1.3% in those without bariatric surgery and about 0.4% in those who had surgery, an absolute risk reduction of 0.9 linked with surgery and a relative risk reduction of 65% that was statistically significant, Dr. Ardissino reported. All-cause mortality was about 70% lower in the group that underwent bariatric surgery compared with those who did not have surgery, a finding that confirmed prior reports. She cautioned that the analysis was limited by a relatively low number of total events, and by the small number of criteria used for cohort matching that might have left unadjusted certain potential confounders such as the level of engagement people had with their medical care.
SOURCE: Ardissino M. AHA 2019, Abstract 335.
PHILADELPHIA – Obese people living in the United Kingdom who underwent bariatric surgery had a two-thirds lower rate of major cerebrovascular events than that of a matched group of obese residents who did not undergo bariatric surgery, in a retrospective study of 8,424 people followed for a mean of just over 11 years.
Although the cut in cerebrovascular events that linked with bariatric surgery shown by the analysis was mostly driven by a reduced rate of transient ischemic attacks, a potentially unreliable diagnosis, the results showed consistent reductions in the rates of acute ischemic strokes as well as in acute, nontraumatic intracranial hemorrhages, two other components of the combined primary endpoint, Maddalena Ardissino, MBBS, said at the American Heart Association scientific sessions.
This finding of an apparent benefit from bariatric surgery in obese patients in a large U.K. database confirms other findings from a “fast-growing” evidence base showing benefits from bariatric surgery for reducing other types of cardiovascular disease events, said Dr. Ardissino, a researcher at Imperial College, London. However, the impact of bariatric surgery specifically on cerebrovascular events had not received much attention in published studies, she noted.
Her study used data collected by the Clinical Practice Research Datalink, which has primary and secondary care health records for about 42 million U.K. residents. The researchers focused on more than 251,000 obese U.K. adults (body mass index of 30 kg/m2 or greater) without a history of a cerebrovascular event who had at least 1 year of follow-up, a data file that included 4,212 adults who had undergone bariatric surgery. Their analysis matched these surgical patients with an equal number of obese adults who did not have surgery, pairing the cases and controls based on age, sex, and BMI. The resulting matched cohorts each averaged 50 years old, with a mean BMI of 40.5 kg/m2.
During just over 11 years of average follow-up, the incidence of acute ischemic stroke, acute intracranial hemorrhage, subarachnoid hemorrhage, or transient ischemic attack was about 1.3% in those without bariatric surgery and about 0.4% in those who had surgery, an absolute risk reduction of 0.9 linked with surgery and a relative risk reduction of 65% that was statistically significant, Dr. Ardissino reported. All-cause mortality was about 70% lower in the group that underwent bariatric surgery compared with those who did not have surgery, a finding that confirmed prior reports. She cautioned that the analysis was limited by a relatively low number of total events, and by the small number of criteria used for cohort matching that might have left unadjusted certain potential confounders such as the level of engagement people had with their medical care.
SOURCE: Ardissino M. AHA 2019, Abstract 335.
REPORTING FROM AHA 2019