Surgery

Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.

Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.

Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.

This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
 

Question: Could you summarize the clinical problem with chronic kidney disease?

Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce. Our goal has been to develop a mass-produced, universal donor kidney to render the issue of scarcity – scarcity of time, scarcity of resources, scarcity of money, scarcity of donor organs – irrelevant.

Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?

Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.

Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.

How did you two come up with this idea? How did you get started working together?

Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.

How does the artificial kidney differ from dialysis?

Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.

The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
 

How does the artificial kidney work?

Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.

Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.

We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells –  not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
 

Would patients need immunosuppressive or anticoagulation medication?

Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.

What is the state of the technology now?

Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.

So it’s more a matter of money than time until the first clinical trials?

Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.

A version of this article first appeared on Medscape.com.

Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.

Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.

Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.

This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
 

Question: Could you summarize the clinical problem with chronic kidney disease?

Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce. Our goal has been to develop a mass-produced, universal donor kidney to render the issue of scarcity – scarcity of time, scarcity of resources, scarcity of money, scarcity of donor organs – irrelevant.

Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?

Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.

Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.

How did you two come up with this idea? How did you get started working together?

Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.

How does the artificial kidney differ from dialysis?

Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.

The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
 

How does the artificial kidney work?

Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.

Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.

We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells –  not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
 

Would patients need immunosuppressive or anticoagulation medication?

Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.

What is the state of the technology now?

Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.

So it’s more a matter of money than time until the first clinical trials?

Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.

A version of this article first appeared on Medscape.com.

Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.

Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.

Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.

This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
 

Question: Could you summarize the clinical problem with chronic kidney disease?

Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce. Our goal has been to develop a mass-produced, universal donor kidney to render the issue of scarcity – scarcity of time, scarcity of resources, scarcity of money, scarcity of donor organs – irrelevant.

Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?

Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.

Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.

How did you two come up with this idea? How did you get started working together?

Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.

How does the artificial kidney differ from dialysis?

Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.

The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
 

How does the artificial kidney work?

Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.

Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.

We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells –  not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
 

Would patients need immunosuppressive or anticoagulation medication?

Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.

What is the state of the technology now?

Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.

So it’s more a matter of money than time until the first clinical trials?

Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.

A version of this article first appeared on Medscape.com.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

Rahn_David_TEX_web.jpg

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

Enklaar_Rosa_NETH_web.PNG

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

Nager_Charles_CALIF_web.jpg

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

Rahn_David_TEX_web.jpg

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

Enklaar_Rosa_NETH_web.PNG

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

Nager_Charles_CALIF_web.jpg

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

Rahn_David_TEX_web.jpg

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

Enklaar_Rosa_NETH_web.PNG

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

Nager_Charles_CALIF_web.jpg

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

A version of this article first appeared on Medscape.com.

Use of dural-puncture epidural (DPE) shortened the onset time to surgical anesthesia by approximately 3 minutes, compared with standard epidural in patients undergoing cesarean delivery, based on data from 140 individuals.

DPE, while not new, has become more popular as an option for initiating labor analgesia, but data comparing DPE with standard epidural in conversion to surgical anesthesia for cesarean deliveries are limited, Nadir Sharawi, MD, of the University of Arkansas for Medical Sciences, Little Rock, and colleagues wrote.

Sharawi_Nadir_ARK_web.jpg

DPE involves no injection of intrathecal drugs, and the potential advantages include easier translocation of epidural medications into the intrathecal space for improved analgesia, but the effects of DPE on the onset and reliability of surgical anesthesia remain unknown, they said.

In a study published in JAMA Network Open, the researchers randomized 70 women scheduled for cesarean delivery of singleton pregnancies to DPE and 70 to a standard epidural. The participants were aged 18 years and older, with a mean age of the 30.1 years; the study was conducted between April 2019 and October 2022 at a single center.

The primary outcome was the time to the loss of sharp sensation at T6, defined as “the start of epidural extension anesthesia (time zero on the stopwatch) to when the patient could no longer feel sharp sensation at T6 (assessed bilaterally at the midclavicular line),” the researchers wrote.

The onset time to surgical anesthesia was faster in the DPE group, compared with the standard group, with a median of 422 seconds versus 655 seconds.

A key secondary outcome was a composite measure of the quality of epidural anesthesia that included failure to achieve a T10 bilateral block preoperatively in the delivery room, failure to achieve a surgical block at T6 within 15 minutes of chloroprocaine administration, requirement for intraoperative analgesia, repeat neuraxial procedure, and conversion to general anesthesia. The composite rates of lower quality anesthesia were significantly less in the DPE group, compared with the standard group (15.7% vs. 36.3%; P = .007).

Additional secondary outcomes included maternal satisfaction and pain score during surgery, adverse events, opioid use in the first 24 hours, maternal vasopressor requirements, epidural block assessments, and neonatal outcomes. No significant differences in these outcomes were noted between the groups, and no instances of local anesthetic systemic toxicity or neurological complications were reported.

The findings were limited by several factors including the study population of women scheduled for cesarean delivery and not in labor, and the inability to detect less frequent complications such as post–dural-puncture headache and accidental dural puncture, the researchers noted.

In addition, the results may vary with the use of other combinations of local anesthetics and opioids. “Chloroprocaine was chosen in this study because of its ease of administration without the need for opioids and other additives along with the low risk of systemic toxic effects, which favors rapid administration for emergent cesarean delivery,” they wrote.

However, the results show an association between DPE within an hour of epidural extension for elective cesarean delivery and a faster onset of anesthesia, improved block quality, and a more favorable ratio of risks versus benefits, compared with the use of standard epidural, the researchers concluded.
 

No need for general anesthesia?

“There is controversy over whether the dural puncture epidural technique improves labor analgesia when compared to a standard epidural,” Dr. Shawari said in an interview. “However, there are limited data on whether the dural puncture epidural technique decreases the onset time to surgical anesthesia when compared to a standard epidural for cesarean delivery. This is important as a pre-existing epidural is commonly used to convert labor analgesia to surgical anesthesia in the setting of urgent cesarean delivery. A faster onset of epidural anesthesia could potentially avoid the need for general anesthesia in an emergency.”

The researchers were not surprised by the findings given their experience with performing dural puncture epidurals for labor analgesia, Dr. Shawari said. In those cases, DPE provided a faster onset when converting cesarean anesthesia, compared with a standard epidural.

The takeaway from the current study is that DPE also provided “a faster onset and improved quality of anesthesia when compared to standard epidural for elective cesarean delivery,” Dr. Shawari said. However, additional research is needed to confirm the findings for intrapartum cesarean delivery.
 

Progress in improving pain control

“Adequate pain control during cesarean delivery is incredibly important,” Catherine Albright, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, said in an interview. “Inadequate pain control leads to the need to provide additional intravenous medications or the need to be put under general anesthesia, which changes the birth experience and is more dangerous for the birthing person and the neonate.

Albright_Catherine_WASH_web.jpg

“In my clinical experience, there are many times when patients do not have adequate pain control during a cesarean delivery,” said Dr. Albright, who was not involved in the current study. “I am pleased to see that there is research underway about how to best manage pain on labor and delivery, especially in the setting of conversion from labor anesthesia to cesarean anesthesia.”

The findings may have implications for clinical practice, said Dr. Albright. If the dural puncture epidural can improve cesarean anesthesia following an epidural during labor, rather than anesthesia provided for an elective cesarean), “then I believe it would reduce the number of patients who require additional pain medication, have a poor cesarean experience, and/or need to be put under general anesthesia.”

However, “as noted by the authors, additional research is needed to further determine possible risks and side effects from this technique, and also to ensure that it also works in the setting of labor, rather than for an elective cesarean,” Dr. Albright added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Use of dural-puncture epidural (DPE) shortened the onset time to surgical anesthesia by approximately 3 minutes, compared with standard epidural in patients undergoing cesarean delivery, based on data from 140 individuals.

DPE, while not new, has become more popular as an option for initiating labor analgesia, but data comparing DPE with standard epidural in conversion to surgical anesthesia for cesarean deliveries are limited, Nadir Sharawi, MD, of the University of Arkansas for Medical Sciences, Little Rock, and colleagues wrote.

Sharawi_Nadir_ARK_web.jpg

DPE involves no injection of intrathecal drugs, and the potential advantages include easier translocation of epidural medications into the intrathecal space for improved analgesia, but the effects of DPE on the onset and reliability of surgical anesthesia remain unknown, they said.

In a study published in JAMA Network Open, the researchers randomized 70 women scheduled for cesarean delivery of singleton pregnancies to DPE and 70 to a standard epidural. The participants were aged 18 years and older, with a mean age of the 30.1 years; the study was conducted between April 2019 and October 2022 at a single center.

The primary outcome was the time to the loss of sharp sensation at T6, defined as “the start of epidural extension anesthesia (time zero on the stopwatch) to when the patient could no longer feel sharp sensation at T6 (assessed bilaterally at the midclavicular line),” the researchers wrote.

The onset time to surgical anesthesia was faster in the DPE group, compared with the standard group, with a median of 422 seconds versus 655 seconds.

A key secondary outcome was a composite measure of the quality of epidural anesthesia that included failure to achieve a T10 bilateral block preoperatively in the delivery room, failure to achieve a surgical block at T6 within 15 minutes of chloroprocaine administration, requirement for intraoperative analgesia, repeat neuraxial procedure, and conversion to general anesthesia. The composite rates of lower quality anesthesia were significantly less in the DPE group, compared with the standard group (15.7% vs. 36.3%; P = .007).

Additional secondary outcomes included maternal satisfaction and pain score during surgery, adverse events, opioid use in the first 24 hours, maternal vasopressor requirements, epidural block assessments, and neonatal outcomes. No significant differences in these outcomes were noted between the groups, and no instances of local anesthetic systemic toxicity or neurological complications were reported.

The findings were limited by several factors including the study population of women scheduled for cesarean delivery and not in labor, and the inability to detect less frequent complications such as post–dural-puncture headache and accidental dural puncture, the researchers noted.

In addition, the results may vary with the use of other combinations of local anesthetics and opioids. “Chloroprocaine was chosen in this study because of its ease of administration without the need for opioids and other additives along with the low risk of systemic toxic effects, which favors rapid administration for emergent cesarean delivery,” they wrote.

However, the results show an association between DPE within an hour of epidural extension for elective cesarean delivery and a faster onset of anesthesia, improved block quality, and a more favorable ratio of risks versus benefits, compared with the use of standard epidural, the researchers concluded.
 

No need for general anesthesia?

“There is controversy over whether the dural puncture epidural technique improves labor analgesia when compared to a standard epidural,” Dr. Shawari said in an interview. “However, there are limited data on whether the dural puncture epidural technique decreases the onset time to surgical anesthesia when compared to a standard epidural for cesarean delivery. This is important as a pre-existing epidural is commonly used to convert labor analgesia to surgical anesthesia in the setting of urgent cesarean delivery. A faster onset of epidural anesthesia could potentially avoid the need for general anesthesia in an emergency.”

The researchers were not surprised by the findings given their experience with performing dural puncture epidurals for labor analgesia, Dr. Shawari said. In those cases, DPE provided a faster onset when converting cesarean anesthesia, compared with a standard epidural.

The takeaway from the current study is that DPE also provided “a faster onset and improved quality of anesthesia when compared to standard epidural for elective cesarean delivery,” Dr. Shawari said. However, additional research is needed to confirm the findings for intrapartum cesarean delivery.
 

Progress in improving pain control

“Adequate pain control during cesarean delivery is incredibly important,” Catherine Albright, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, said in an interview. “Inadequate pain control leads to the need to provide additional intravenous medications or the need to be put under general anesthesia, which changes the birth experience and is more dangerous for the birthing person and the neonate.

Albright_Catherine_WASH_web.jpg

“In my clinical experience, there are many times when patients do not have adequate pain control during a cesarean delivery,” said Dr. Albright, who was not involved in the current study. “I am pleased to see that there is research underway about how to best manage pain on labor and delivery, especially in the setting of conversion from labor anesthesia to cesarean anesthesia.”

The findings may have implications for clinical practice, said Dr. Albright. If the dural puncture epidural can improve cesarean anesthesia following an epidural during labor, rather than anesthesia provided for an elective cesarean), “then I believe it would reduce the number of patients who require additional pain medication, have a poor cesarean experience, and/or need to be put under general anesthesia.”

However, “as noted by the authors, additional research is needed to further determine possible risks and side effects from this technique, and also to ensure that it also works in the setting of labor, rather than for an elective cesarean,” Dr. Albright added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Use of dural-puncture epidural (DPE) shortened the onset time to surgical anesthesia by approximately 3 minutes, compared with standard epidural in patients undergoing cesarean delivery, based on data from 140 individuals.

DPE, while not new, has become more popular as an option for initiating labor analgesia, but data comparing DPE with standard epidural in conversion to surgical anesthesia for cesarean deliveries are limited, Nadir Sharawi, MD, of the University of Arkansas for Medical Sciences, Little Rock, and colleagues wrote.

Sharawi_Nadir_ARK_web.jpg

DPE involves no injection of intrathecal drugs, and the potential advantages include easier translocation of epidural medications into the intrathecal space for improved analgesia, but the effects of DPE on the onset and reliability of surgical anesthesia remain unknown, they said.

In a study published in JAMA Network Open, the researchers randomized 70 women scheduled for cesarean delivery of singleton pregnancies to DPE and 70 to a standard epidural. The participants were aged 18 years and older, with a mean age of the 30.1 years; the study was conducted between April 2019 and October 2022 at a single center.

The primary outcome was the time to the loss of sharp sensation at T6, defined as “the start of epidural extension anesthesia (time zero on the stopwatch) to when the patient could no longer feel sharp sensation at T6 (assessed bilaterally at the midclavicular line),” the researchers wrote.

The onset time to surgical anesthesia was faster in the DPE group, compared with the standard group, with a median of 422 seconds versus 655 seconds.

A key secondary outcome was a composite measure of the quality of epidural anesthesia that included failure to achieve a T10 bilateral block preoperatively in the delivery room, failure to achieve a surgical block at T6 within 15 minutes of chloroprocaine administration, requirement for intraoperative analgesia, repeat neuraxial procedure, and conversion to general anesthesia. The composite rates of lower quality anesthesia were significantly less in the DPE group, compared with the standard group (15.7% vs. 36.3%; P = .007).

Additional secondary outcomes included maternal satisfaction and pain score during surgery, adverse events, opioid use in the first 24 hours, maternal vasopressor requirements, epidural block assessments, and neonatal outcomes. No significant differences in these outcomes were noted between the groups, and no instances of local anesthetic systemic toxicity or neurological complications were reported.

The findings were limited by several factors including the study population of women scheduled for cesarean delivery and not in labor, and the inability to detect less frequent complications such as post–dural-puncture headache and accidental dural puncture, the researchers noted.

In addition, the results may vary with the use of other combinations of local anesthetics and opioids. “Chloroprocaine was chosen in this study because of its ease of administration without the need for opioids and other additives along with the low risk of systemic toxic effects, which favors rapid administration for emergent cesarean delivery,” they wrote.

However, the results show an association between DPE within an hour of epidural extension for elective cesarean delivery and a faster onset of anesthesia, improved block quality, and a more favorable ratio of risks versus benefits, compared with the use of standard epidural, the researchers concluded.
 

No need for general anesthesia?

“There is controversy over whether the dural puncture epidural technique improves labor analgesia when compared to a standard epidural,” Dr. Shawari said in an interview. “However, there are limited data on whether the dural puncture epidural technique decreases the onset time to surgical anesthesia when compared to a standard epidural for cesarean delivery. This is important as a pre-existing epidural is commonly used to convert labor analgesia to surgical anesthesia in the setting of urgent cesarean delivery. A faster onset of epidural anesthesia could potentially avoid the need for general anesthesia in an emergency.”

The researchers were not surprised by the findings given their experience with performing dural puncture epidurals for labor analgesia, Dr. Shawari said. In those cases, DPE provided a faster onset when converting cesarean anesthesia, compared with a standard epidural.

The takeaway from the current study is that DPE also provided “a faster onset and improved quality of anesthesia when compared to standard epidural for elective cesarean delivery,” Dr. Shawari said. However, additional research is needed to confirm the findings for intrapartum cesarean delivery.
 

Progress in improving pain control

“Adequate pain control during cesarean delivery is incredibly important,” Catherine Albright, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, said in an interview. “Inadequate pain control leads to the need to provide additional intravenous medications or the need to be put under general anesthesia, which changes the birth experience and is more dangerous for the birthing person and the neonate.

Albright_Catherine_WASH_web.jpg

“In my clinical experience, there are many times when patients do not have adequate pain control during a cesarean delivery,” said Dr. Albright, who was not involved in the current study. “I am pleased to see that there is research underway about how to best manage pain on labor and delivery, especially in the setting of conversion from labor anesthesia to cesarean anesthesia.”

The findings may have implications for clinical practice, said Dr. Albright. If the dural puncture epidural can improve cesarean anesthesia following an epidural during labor, rather than anesthesia provided for an elective cesarean), “then I believe it would reduce the number of patients who require additional pain medication, have a poor cesarean experience, and/or need to be put under general anesthesia.”

However, “as noted by the authors, additional research is needed to further determine possible risks and side effects from this technique, and also to ensure that it also works in the setting of labor, rather than for an elective cesarean,” Dr. Albright added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

Continuous glucose monitors (CGMs) may help curb the severity of hypoglycemia after weight loss operations and even other gastrointestinal procedures, according to recent findings from a small study published in Diabetes, Obesity, and Metabolism.

Hypoglycemia is a chronic and persistent complication common in patients following bariatric surgery, affecting as many as 30% of people who undergo a sleeve gastrectomy or Roux-en-Y gastric bypass.

The symptoms of hypoglycemia, including lightheadedness, heart palpitations, difficulty concentrating, and confusion, can mimic anxiety disorders, arrhythmia, and dumping syndrome.

If a postoperative patient experiences these symptoms within a few hours following a meal or exercising, “primary care doctors should consider the possibility that hypoglycemia may be a contributor,” said Mary-Elizabeth Patti, MD, director of the Hypoglycemia Clinic at the Joslin Diabetes Center in Boston and senior author of the new study. 

“In fact, hypoglycemia is a possible diagnosis even among those who underwent [operations other than bariatric, including] fundoplication or other upper gastrointestinal or esophageal surgeries,” she said. 

To understand how CGM could benefit patients, Dr. Patti and colleagues recruited 22 participants who had undergone bariatric surgery more than 8 years prior and had postbariatric hypoglycemia. Their mean age was 51 years, 90% were women, 82% were diagnosed with level 3 hypoglycemia, and none had type 1 or 2 diabetes. 

All participants experienced neuronal dysfunction with symptoms like fatigue, concentration difficulties, and confusion. More than 90% had received medical nutrition therapy for postbariatric hypoglycemia in the past.

CGM data were collected in the 22 individuals in two sequential phases: masked (no access to sensor glucose or alarms) and unmasked (access to sensor glucose and alarms for low or rapidly declining sensor glucose). Twelve participants wore a CGM (Dexcom G4 device) for a total of 28 days, whereas 10 wore a CGM (the Dexcom G6 device) for a total of 20 days.

The team observed that the percentage of time when the participants’ blood glucose was below 70 mg/dL – the definition of hypoglycemia – was significantly lower during the unmasked phase. 

Though CGM devices are not sensitive enough to serve as a diagnostic tool for hypoglycemia, “the alarms on CGM devices can provide some much-needed awareness,” Dr. Patti said. “After a detailed diagnosis, CGM devices can be a helpful tool to assess dietary patterns and make modifications that could reduce the severity of postbariatric hypoglycemia.”

If a patient frequently experiences hypoglycemia, they may not sense when their glucose levels drop, also known as hypoglycemia unawareness, according to Dr. Patti. Studies have found that postbariatric hypoglycemia remains underdiagnosed because most patients are asymptomatic. 

“The use of CGM devices may improve safety in postbariatric hypoglycemia, particularly for patients with hypoglycemia unawareness,” the researchers conclude.
 

Next steps 

Patients are more vulnerable to hypoglycemia after a sleeve gastrectomy or gastric bypass surgery because these procedures involve removing the pylorus. This valve plays a crucial role in only allowing small portions of food to enter the intestine and prevents sudden spikes in blood glucose.

Without the pylorus, large amounts of food directly enter the intestine and soon result in large amounts of glucose getting absorbed, according to Sriram Machineni, MD, an associate professor of medicine at Albert Einstein College of Medicine, New York, who was not affiliated with the study.

“The pancreas then goes into overdrive and produces a lot of insulin, which continues reducing sugar levels,” Dr. Machineni said. “That is what causes hypoglycemia.”

Dr. Patti and associates are next working on research using CGM-derived data to investigate how different types of meals, physical activities, and other factors could influence glucose metabolism patterns in patients with hypoglycemia.

The study was funded by Dexcom, a manufacturer of continuous glucose monitoring systems. Dr. Patti reported receiving grant funding from the Diabetes Research Center.

A version of this article appeared on Medscape.com.

Continuous glucose monitors (CGMs) may help curb the severity of hypoglycemia after weight loss operations and even other gastrointestinal procedures, according to recent findings from a small study published in Diabetes, Obesity, and Metabolism.

Hypoglycemia is a chronic and persistent complication common in patients following bariatric surgery, affecting as many as 30% of people who undergo a sleeve gastrectomy or Roux-en-Y gastric bypass.

The symptoms of hypoglycemia, including lightheadedness, heart palpitations, difficulty concentrating, and confusion, can mimic anxiety disorders, arrhythmia, and dumping syndrome.

If a postoperative patient experiences these symptoms within a few hours following a meal or exercising, “primary care doctors should consider the possibility that hypoglycemia may be a contributor,” said Mary-Elizabeth Patti, MD, director of the Hypoglycemia Clinic at the Joslin Diabetes Center in Boston and senior author of the new study. 

“In fact, hypoglycemia is a possible diagnosis even among those who underwent [operations other than bariatric, including] fundoplication or other upper gastrointestinal or esophageal surgeries,” she said. 

To understand how CGM could benefit patients, Dr. Patti and colleagues recruited 22 participants who had undergone bariatric surgery more than 8 years prior and had postbariatric hypoglycemia. Their mean age was 51 years, 90% were women, 82% were diagnosed with level 3 hypoglycemia, and none had type 1 or 2 diabetes. 

All participants experienced neuronal dysfunction with symptoms like fatigue, concentration difficulties, and confusion. More than 90% had received medical nutrition therapy for postbariatric hypoglycemia in the past.

CGM data were collected in the 22 individuals in two sequential phases: masked (no access to sensor glucose or alarms) and unmasked (access to sensor glucose and alarms for low or rapidly declining sensor glucose). Twelve participants wore a CGM (Dexcom G4 device) for a total of 28 days, whereas 10 wore a CGM (the Dexcom G6 device) for a total of 20 days.

The team observed that the percentage of time when the participants’ blood glucose was below 70 mg/dL – the definition of hypoglycemia – was significantly lower during the unmasked phase. 

Though CGM devices are not sensitive enough to serve as a diagnostic tool for hypoglycemia, “the alarms on CGM devices can provide some much-needed awareness,” Dr. Patti said. “After a detailed diagnosis, CGM devices can be a helpful tool to assess dietary patterns and make modifications that could reduce the severity of postbariatric hypoglycemia.”

If a patient frequently experiences hypoglycemia, they may not sense when their glucose levels drop, also known as hypoglycemia unawareness, according to Dr. Patti. Studies have found that postbariatric hypoglycemia remains underdiagnosed because most patients are asymptomatic. 

“The use of CGM devices may improve safety in postbariatric hypoglycemia, particularly for patients with hypoglycemia unawareness,” the researchers conclude.
 

Next steps 

Patients are more vulnerable to hypoglycemia after a sleeve gastrectomy or gastric bypass surgery because these procedures involve removing the pylorus. This valve plays a crucial role in only allowing small portions of food to enter the intestine and prevents sudden spikes in blood glucose.

Without the pylorus, large amounts of food directly enter the intestine and soon result in large amounts of glucose getting absorbed, according to Sriram Machineni, MD, an associate professor of medicine at Albert Einstein College of Medicine, New York, who was not affiliated with the study.

“The pancreas then goes into overdrive and produces a lot of insulin, which continues reducing sugar levels,” Dr. Machineni said. “That is what causes hypoglycemia.”

Dr. Patti and associates are next working on research using CGM-derived data to investigate how different types of meals, physical activities, and other factors could influence glucose metabolism patterns in patients with hypoglycemia.

The study was funded by Dexcom, a manufacturer of continuous glucose monitoring systems. Dr. Patti reported receiving grant funding from the Diabetes Research Center.

A version of this article appeared on Medscape.com.

Continuous glucose monitors (CGMs) may help curb the severity of hypoglycemia after weight loss operations and even other gastrointestinal procedures, according to recent findings from a small study published in Diabetes, Obesity, and Metabolism.

Hypoglycemia is a chronic and persistent complication common in patients following bariatric surgery, affecting as many as 30% of people who undergo a sleeve gastrectomy or Roux-en-Y gastric bypass.

The symptoms of hypoglycemia, including lightheadedness, heart palpitations, difficulty concentrating, and confusion, can mimic anxiety disorders, arrhythmia, and dumping syndrome.

If a postoperative patient experiences these symptoms within a few hours following a meal or exercising, “primary care doctors should consider the possibility that hypoglycemia may be a contributor,” said Mary-Elizabeth Patti, MD, director of the Hypoglycemia Clinic at the Joslin Diabetes Center in Boston and senior author of the new study. 

“In fact, hypoglycemia is a possible diagnosis even among those who underwent [operations other than bariatric, including] fundoplication or other upper gastrointestinal or esophageal surgeries,” she said. 

To understand how CGM could benefit patients, Dr. Patti and colleagues recruited 22 participants who had undergone bariatric surgery more than 8 years prior and had postbariatric hypoglycemia. Their mean age was 51 years, 90% were women, 82% were diagnosed with level 3 hypoglycemia, and none had type 1 or 2 diabetes. 

All participants experienced neuronal dysfunction with symptoms like fatigue, concentration difficulties, and confusion. More than 90% had received medical nutrition therapy for postbariatric hypoglycemia in the past.

CGM data were collected in the 22 individuals in two sequential phases: masked (no access to sensor glucose or alarms) and unmasked (access to sensor glucose and alarms for low or rapidly declining sensor glucose). Twelve participants wore a CGM (Dexcom G4 device) for a total of 28 days, whereas 10 wore a CGM (the Dexcom G6 device) for a total of 20 days.

The team observed that the percentage of time when the participants’ blood glucose was below 70 mg/dL – the definition of hypoglycemia – was significantly lower during the unmasked phase. 

Though CGM devices are not sensitive enough to serve as a diagnostic tool for hypoglycemia, “the alarms on CGM devices can provide some much-needed awareness,” Dr. Patti said. “After a detailed diagnosis, CGM devices can be a helpful tool to assess dietary patterns and make modifications that could reduce the severity of postbariatric hypoglycemia.”

If a patient frequently experiences hypoglycemia, they may not sense when their glucose levels drop, also known as hypoglycemia unawareness, according to Dr. Patti. Studies have found that postbariatric hypoglycemia remains underdiagnosed because most patients are asymptomatic. 

“The use of CGM devices may improve safety in postbariatric hypoglycemia, particularly for patients with hypoglycemia unawareness,” the researchers conclude.
 

Next steps 

Patients are more vulnerable to hypoglycemia after a sleeve gastrectomy or gastric bypass surgery because these procedures involve removing the pylorus. This valve plays a crucial role in only allowing small portions of food to enter the intestine and prevents sudden spikes in blood glucose.

Without the pylorus, large amounts of food directly enter the intestine and soon result in large amounts of glucose getting absorbed, according to Sriram Machineni, MD, an associate professor of medicine at Albert Einstein College of Medicine, New York, who was not affiliated with the study.

“The pancreas then goes into overdrive and produces a lot of insulin, which continues reducing sugar levels,” Dr. Machineni said. “That is what causes hypoglycemia.”

Dr. Patti and associates are next working on research using CGM-derived data to investigate how different types of meals, physical activities, and other factors could influence glucose metabolism patterns in patients with hypoglycemia.

The study was funded by Dexcom, a manufacturer of continuous glucose monitoring systems. Dr. Patti reported receiving grant funding from the Diabetes Research Center.

A version of this article appeared on Medscape.com.

A woman who was born without a uterus has given birth to a boy in Alabama.

It’s the first time that a baby has been born to a woman with a transplanted uterus outside of a clinical trial. Officials from University of Alabama–Birmingham Hospital, where the 2-year process took place, said in a statement on July 24 that the birth sets its uterus transplant program on track to perhaps become covered under insurance plans.

The process of uterus transplant, in vitro fertilization, and pregnancy involves 50 medical providers and is open to women who have uterine factor infertility (UFI). The condition may affect up to 5% of reproductive-age women worldwide. Women with UFI cannot carry a pregnancy to term because they were either born without a uterus, had it removed via hysterectomy, or have a uterus that does not function properly.

The woman, whom the hospital identified as Mallory, moved with her family to the Birmingham area to enter the transplant program, which is one of four programs operating in the United States. Mallory learned when she was 17 years old that she was born without a uterus because of Mayer-Rokitansky-Küster-Hauser syndrome. Her first child, a daughter, was born after her sister carried the pregnancy as a surrogate.

Mallory received her uterus from a deceased donor. Her son was born in May.

“As with other types of organ transplants, the woman must take immunosuppressive medications to prevent the body from rejecting the transplanted uterus,” the transplant program’s website states. “After the baby is born and if the woman does not want more children, the transplanted uterus is removed with a hysterectomy procedure, and the woman no longer needs to take antirejection medications.”

“There are all different ways to grow your family if you have uterine factor infertility, but this [uterus transplantation] is what I feel like I knew that I was supposed to do,” Mallory said in a statement. “I mean, just hearing the cry at first was just, you know, mind blowing.”

A version of this article first appeared on WebMD.com.

A woman who was born without a uterus has given birth to a boy in Alabama.

It’s the first time that a baby has been born to a woman with a transplanted uterus outside of a clinical trial. Officials from University of Alabama–Birmingham Hospital, where the 2-year process took place, said in a statement on July 24 that the birth sets its uterus transplant program on track to perhaps become covered under insurance plans.

The process of uterus transplant, in vitro fertilization, and pregnancy involves 50 medical providers and is open to women who have uterine factor infertility (UFI). The condition may affect up to 5% of reproductive-age women worldwide. Women with UFI cannot carry a pregnancy to term because they were either born without a uterus, had it removed via hysterectomy, or have a uterus that does not function properly.

The woman, whom the hospital identified as Mallory, moved with her family to the Birmingham area to enter the transplant program, which is one of four programs operating in the United States. Mallory learned when she was 17 years old that she was born without a uterus because of Mayer-Rokitansky-Küster-Hauser syndrome. Her first child, a daughter, was born after her sister carried the pregnancy as a surrogate.

Mallory received her uterus from a deceased donor. Her son was born in May.

“As with other types of organ transplants, the woman must take immunosuppressive medications to prevent the body from rejecting the transplanted uterus,” the transplant program’s website states. “After the baby is born and if the woman does not want more children, the transplanted uterus is removed with a hysterectomy procedure, and the woman no longer needs to take antirejection medications.”

“There are all different ways to grow your family if you have uterine factor infertility, but this [uterus transplantation] is what I feel like I knew that I was supposed to do,” Mallory said in a statement. “I mean, just hearing the cry at first was just, you know, mind blowing.”

A version of this article first appeared on WebMD.com.

A woman who was born without a uterus has given birth to a boy in Alabama.

It’s the first time that a baby has been born to a woman with a transplanted uterus outside of a clinical trial. Officials from University of Alabama–Birmingham Hospital, where the 2-year process took place, said in a statement on July 24 that the birth sets its uterus transplant program on track to perhaps become covered under insurance plans.

The process of uterus transplant, in vitro fertilization, and pregnancy involves 50 medical providers and is open to women who have uterine factor infertility (UFI). The condition may affect up to 5% of reproductive-age women worldwide. Women with UFI cannot carry a pregnancy to term because they were either born without a uterus, had it removed via hysterectomy, or have a uterus that does not function properly.

The woman, whom the hospital identified as Mallory, moved with her family to the Birmingham area to enter the transplant program, which is one of four programs operating in the United States. Mallory learned when she was 17 years old that she was born without a uterus because of Mayer-Rokitansky-Küster-Hauser syndrome. Her first child, a daughter, was born after her sister carried the pregnancy as a surrogate.

Mallory received her uterus from a deceased donor. Her son was born in May.

“As with other types of organ transplants, the woman must take immunosuppressive medications to prevent the body from rejecting the transplanted uterus,” the transplant program’s website states. “After the baby is born and if the woman does not want more children, the transplanted uterus is removed with a hysterectomy procedure, and the woman no longer needs to take antirejection medications.”

“There are all different ways to grow your family if you have uterine factor infertility, but this [uterus transplantation] is what I feel like I knew that I was supposed to do,” Mallory said in a statement. “I mean, just hearing the cry at first was just, you know, mind blowing.”

A version of this article first appeared on WebMD.com.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

[embed:render:related:node:228422]

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

A version of this article first appeared on Medscape.com.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

[embed:render:related:node:228422]

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

A version of this article first appeared on Medscape.com.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

[embed:render:related:node:228422]

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

A version of this article first appeared on Medscape.com.

obgm03507_ss2_ridgeyway_570x300.jpg

“If you don’t have a seat at the table, you are probably on the menu.” I first heard this quote in 2013, and it launched my interest in health care leadership and influenced me countless times over the last 10 years.

As Chief of Staff at Cleveland Clinic, I oversee nearly 5,000 physicians and scientists across the globe. I am involved in the physician life cycle: recruiting, hiring, privileging and credentialing, talent development, promotion, professionalism, and career transitions. I also sit at the intersection of medical care and the business of medicine. This means leading 18 clinical service lines responsible for 5.6 million visits, 161,000 surgeries, and billions of dollars in operating revenue per year. How I spend most of my time is a far cry from what I spent 11 years’ training to do—gynecologic surgery. This shift in my career was not because I changed my mind about caring for patients or that I tired of being a full-time surgeon. Nothing could be further from the truth. Women’s health remains my “why,” and my leadership journey has taught me that it is critical to have a seat at the table for the sake of ObGyns and women everywhere.

Women’s health on the menu

I will start with a concrete example of when we, as women and ObGyns, were on the menu. In late 2019, the Ohio state House of Representatives introduced a bill that subjected doctors to potential murder charges if they did not try everything to save the life of a mother and fetus, “including attempting to reimplant an ectopic pregnancy into the woman’s uterus.”¹ This bill was based on 2 case reports—one from 1915 and one from 1980—which were both low quality, and the latter case was deemed to be fraudulent.² How did this happen?

An Ohio state representative developed the bill with help from a lobbyist and without input from physicians or content experts. When asked, the representative shared that “he never researched whether re-implanting an ectopic pregnancy into a woman’s uterus was a viable medical procedure before including it in the bill.”³ He added, “I heard about it over the years. I never questioned it or gave it a lot of thought.”³

This example resonates deeply with many of us; it inspires us to speak up and act. As ObGyns, we clearly understand the consequences of legal and regulatory change in women’s health and how it directly impacts our patients and each of us as physicians. Let’s shift to something that you may feel less passion about, but I believe is equally important. This is where obstetrician-gynecologists sit in the intersection of medical care and business. This is the space where I spend most of my time, and from this vantage point, I worry about our field.

The business of medicine

Starting at the macroeconomic level, let’s think about how we as physicians are reimbursed and who makes these decisions. Looking at the national health care expenditure data, Medicare and Medicaid spending makes up nearly 40% of the total spend, and it is growing.⁴ Additionally, private health insurance tends to follow Centers for Medicare and Medicaid Services (CMS) decision making, further compounding its influence.⁴ In simple terms, CMS decides what is covered and how much we are paid. Whether you are in a solo private practice, an employer health care organization, or an academic medical center, physician reimbursement is declining.

In fact, Congress passed its year-end omnibus legislation in the final days of 2022, including a 2% Medicare physician payment cut for 2023,⁵ at a time when expenses to practice medicine, including nonphysician staff and supplies, are at an all-time high and we are living in a 6% inflationary state. This translates into being asked to serve more patients and cut costs. Our day-to-day feels much tighter, and this is why: Medicare physician pay increased just 11% over the past 20 years⁶ (2001–2021) in comparison to the cost of running a medical practice, which increased nearly 40% during that time. In other words, adjusting for inflation in practice costs, Medicare physician payment has fallen 22% over the last 20 years.⁷

Depending on your employment model, you may feel insulated from these changes as increases in reimbursement have occurred in other areas, such as hospitals and ambulatory surgery centers.⁸ In the short term, these increases help, as organizations will see additional funds. But there are 2 main issues: First, it is not nearly enough when you consider the soaring costs of running a hospital. And second, looking at our national population, we rely tremendously on self-employed doctors to serve our patients.

More than 80% of US counties lack adequate health care infrastructure.⁹ More than a third of the US population has less-than-adequate access to pharmacies, primary care physicians, hospitals, trauma centers, and low-cost health centers.⁹ To put things into perspective, more than 20% of counties in the United States are hospital deserts, where most people must drive more than 30 minutes to reach the closest hospital.⁹

There is good reason for this. Operating a hospital is a challenging endeavor. Even before the COVID-19 pandemic and the most recent health care financial challenges, most health care systems and large hospitals operated with very low operating margins (2%–3%). Businesses with similar margins include grocery stores and car dealerships. These low-margin businesses, including health care, rely on high volume for sustainability. High patient volumes distribute expensive hospital costs over many encounters. If physicians cannot sustain practices across the country, it is challenging to have sufficient admission and surgical volumes to justify the cost base of hospitals.

To tie this together, we have very little influence on what we are paid for our services. Reimbursement is declining, which makes it hard to have financially sustainable practices. As hospitals struggle, there is more pressure to prioritize highly profitable service lines, like orthopedics and urology, which are associated with favorable technical revenue. As hospitals are threatened, health care deserts widen, which leaves our entire health care system in jeopardy. Not surprisingly, this most likely affects those who face additional barriers to access, such as those with lower income, limited internet access, and lack of insurance. Together, these barriers further widen disparities in health care outcomes, including outcomes for women. Additionally, this death by a thousand cuts has eroded morale and increased physician burnout.

Transforming how we practice medicine is the only viable solution. I have good news: You are the leaders you have been waiting for.

Continue to: Physicians make good managers...

Physicians make good managers

To successfully transform how we practice medicine, it is critical that those leading the transformation deeply understand how medicine is practiced. The level of understanding required can be achieved only through years of medical practice, as a doctor. We understand how medical teams interact and that different sectors of our health care system are interdependent. Also, because physicians drive patient activity and ultimately reimbursement, having a seat at the table is crucial.

Some health care systems are run by businesspeople—people with finance backgrounds—and others are led by physicians. In 2017, Becker’s Hospital Review listed the chief executive officers (CEOs) of 183 nonprofit hospital and health systems.¹⁰ Of these, only 25% were led by individuals with an MD. Looking at the 115 largest hospitals in the United States, 30% are physician led.¹⁰ Considering the top 10 hospitals ranked by U.S. News & World Report for 2022, 8 of 10 have a physician at the helm.

Beyond raters and rankers, physician-led hospitals do better. Goodall compared CEOs in the top 100 best hospitals in U.S. News & World Report in 3 key medical specialties: cancer, digestive disorders, and cardiac care.¹¹ The study explored the question: “Are hospitals’ quality ranked more highly when they are led by a medically trained doctor or non-MD professional managers?”¹¹ Analysis revealed that hospital quality scores are about 25% higher in physician-run hospitals than in manager-run hospitals.¹¹ Additional research shows that good management practices correlate with hospital performance, and that “the proportion of managers with a clinical degree has the largest positive effect.”¹²

Several theories exist as to why doctors make good managers in the health care setting.^13,14 Doctors may create a more sympathetic and productive work environment for other clinicians because they are one of them. They have peer-to-peer credibility—because they have walked the walk, they have insight and perspective into how medicine is practiced.

Physicians serve as effective change agents for their organizations in several ways:

• First, physicians take a clinical approach in their leadership roles¹³ and focus on patient care at the center of their decisions. We see the people behind the numbers. Simply put, we humanize the operational side of health care.
• As physicians, we understand the interconnectivity in the practice of medicine. While closing certain service lines may be financially beneficial, these services are often closely linked to profitable service lines.
• Beyond physicians taking a clinical approach to leadership, we emphasize quality.¹³ Because we all have experienced complications and lived through bad outcomes alongside our patients, we understand deeply how important patient safety and quality is, and we are not willing to sacrifice that for financial gain. For us, this is personal. We don’t see our solution to health care challenges as an “or” situation, instead we view it as an “and” situation.
• Physician leaders often can improve medical staff engagement.¹³ A 2018 national survey of physicians found that those who are satisfied with their leadership are more engaged at work, have greater job satisfaction, and are less likely to experience signs of burnout.¹⁵ Physician administrators add value here.

Continue to: Surgeons as leaders...

Surgeons as leaders

What do we know about surgeons as physician leaders? Looking at the previously mentioned lists of physician leaders, surgeons are relatively absent. In the Becker’s Hospital Review study of nonprofit hospitals, only 9% of CEOs were surgeons.¹⁰ In addition, when reviewing data that associated physician leaders and hospital performance, only 3 of the CEOs were surgeons.¹¹ Given that surgeons make up approximately 19% of US physicians, we are underrepresented.

The omission of surgeons as leaders seems inappropriate given that most hospitals are financially reliant on revenue related to surgical care and optimizing this space is an enormous opportunity. Berger and colleagues offered 3 theories as to why there are fewer surgeon leaders¹⁶:

• The relative pay of surgeons exceeds that of most other specialties, and there may be less incentive to accept the challenges presented by leadership roles. (I will add that surgeon leadership is more costly to a system.)
• The craftsmanship nature of surgery discourages the development of other career interests beginning at the trainee level.
• Surgeons have been perceived stereotypically to exhibit arrogance, a characteristic that others may not warm to.

This last observation stings. Successful leadership takes social skill and teamwork.¹⁴ Although medical care is one of the few disciplines in which lack of teamwork might cost lives, physicians are not trained to be team players. We recognize how our training has led us to be lone wolves or gunners, situations where we as individuals had to beat others to secure our spot. We have been trained in command-and-control environments, in stepping up as a leader in highly stressful situations. This part of surgical culture may handicap surgeons in their quest to be health care leaders.

Other traits, however, make us particularly great leaders in health care. Our desire to succeed, willingness to push ourselves to extremes, ability to laser focus on a task, acceptance of delayed gratification, and aptitude for making timely decisions on limited data help us succeed in leadership roles. Seven years of surgical training helped me develop the grit I use every day in the C-suite.

We need more physician and surgeon leadership to thrive in the challenging health care landscape. Berger and colleagues proposed 3 potential solutions to increase the number of surgeons in hospital leadership positions¹⁶:

Nurture future surgical leaders through exposure to management training. Given the contribution to both expense in support services and resources and revenue related to surgical care, each organization needs a content expert to guide these decisions.

Recognize the important contributions that surgeons already make regarding quality, safety, and operational efficiency. An excellent example of this is the American College of Surgeons National Surgical Quality Improvement Program. Because surgeons are content experts in this area, we are primed to lead.

Hospitals, medical schools, and academic departments of surgery should recognize administrative efforts as an important part of the overall academic mission. As the adage states, “No margin, no mission.” We need bright minds to preserve and grow our margins so that we can further invest in our missions.

This is not easy. Given the barriers, this will not happen organically. Charan and colleagues provided an outline for a leadership pathway adapted for physicians (FIGURE).^17,18 It starts with the individual practitioner who is a practicing physician and spends most of their time focused on patient care. As a physician becomes more interested in leadership, they develop new skills and take on more and more responsibility. As they increase in leadership responsibility, they tend to reduce clinical time and increase time spent on strategic and business management. This framework creates a pipeline so that physicians and surgeons can be developed strategically and given increasing responsibility as they develop their capabilities and expand their skill sets.

obgm03507_ss2_ridgeyway_fig.jpg

The leadership challenge

To thrive, we must transform health care by changing how we practice medicine. As ObGyns, we are the leaders we have been waiting for. As you ponder your future, think of your current career and the opportunities you might have. Do you have a seat at the table? What table is that? How are you using your knowledge, expertise, and privilege to advance health care and medicine? I challenge you to critically evaluate this—and lead. ●

obgm03507_ss2_ridgeyway_570x300.jpg

“If you don’t have a seat at the table, you are probably on the menu.” I first heard this quote in 2013, and it launched my interest in health care leadership and influenced me countless times over the last 10 years.

As Chief of Staff at Cleveland Clinic, I oversee nearly 5,000 physicians and scientists across the globe. I am involved in the physician life cycle: recruiting, hiring, privileging and credentialing, talent development, promotion, professionalism, and career transitions. I also sit at the intersection of medical care and the business of medicine. This means leading 18 clinical service lines responsible for 5.6 million visits, 161,000 surgeries, and billions of dollars in operating revenue per year. How I spend most of my time is a far cry from what I spent 11 years’ training to do—gynecologic surgery. This shift in my career was not because I changed my mind about caring for patients or that I tired of being a full-time surgeon. Nothing could be further from the truth. Women’s health remains my “why,” and my leadership journey has taught me that it is critical to have a seat at the table for the sake of ObGyns and women everywhere.

Women’s health on the menu

I will start with a concrete example of when we, as women and ObGyns, were on the menu. In late 2019, the Ohio state House of Representatives introduced a bill that subjected doctors to potential murder charges if they did not try everything to save the life of a mother and fetus, “including attempting to reimplant an ectopic pregnancy into the woman’s uterus.”¹ This bill was based on 2 case reports—one from 1915 and one from 1980—which were both low quality, and the latter case was deemed to be fraudulent.² How did this happen?

An Ohio state representative developed the bill with help from a lobbyist and without input from physicians or content experts. When asked, the representative shared that “he never researched whether re-implanting an ectopic pregnancy into a woman’s uterus was a viable medical procedure before including it in the bill.”³ He added, “I heard about it over the years. I never questioned it or gave it a lot of thought.”³

This example resonates deeply with many of us; it inspires us to speak up and act. As ObGyns, we clearly understand the consequences of legal and regulatory change in women’s health and how it directly impacts our patients and each of us as physicians. Let’s shift to something that you may feel less passion about, but I believe is equally important. This is where obstetrician-gynecologists sit in the intersection of medical care and business. This is the space where I spend most of my time, and from this vantage point, I worry about our field.

The business of medicine

Starting at the macroeconomic level, let’s think about how we as physicians are reimbursed and who makes these decisions. Looking at the national health care expenditure data, Medicare and Medicaid spending makes up nearly 40% of the total spend, and it is growing.⁴ Additionally, private health insurance tends to follow Centers for Medicare and Medicaid Services (CMS) decision making, further compounding its influence.⁴ In simple terms, CMS decides what is covered and how much we are paid. Whether you are in a solo private practice, an employer health care organization, or an academic medical center, physician reimbursement is declining.

In fact, Congress passed its year-end omnibus legislation in the final days of 2022, including a 2% Medicare physician payment cut for 2023,⁵ at a time when expenses to practice medicine, including nonphysician staff and supplies, are at an all-time high and we are living in a 6% inflationary state. This translates into being asked to serve more patients and cut costs. Our day-to-day feels much tighter, and this is why: Medicare physician pay increased just 11% over the past 20 years⁶ (2001–2021) in comparison to the cost of running a medical practice, which increased nearly 40% during that time. In other words, adjusting for inflation in practice costs, Medicare physician payment has fallen 22% over the last 20 years.⁷

Depending on your employment model, you may feel insulated from these changes as increases in reimbursement have occurred in other areas, such as hospitals and ambulatory surgery centers.⁸ In the short term, these increases help, as organizations will see additional funds. But there are 2 main issues: First, it is not nearly enough when you consider the soaring costs of running a hospital. And second, looking at our national population, we rely tremendously on self-employed doctors to serve our patients.

More than 80% of US counties lack adequate health care infrastructure.⁹ More than a third of the US population has less-than-adequate access to pharmacies, primary care physicians, hospitals, trauma centers, and low-cost health centers.⁹ To put things into perspective, more than 20% of counties in the United States are hospital deserts, where most people must drive more than 30 minutes to reach the closest hospital.⁹

There is good reason for this. Operating a hospital is a challenging endeavor. Even before the COVID-19 pandemic and the most recent health care financial challenges, most health care systems and large hospitals operated with very low operating margins (2%–3%). Businesses with similar margins include grocery stores and car dealerships. These low-margin businesses, including health care, rely on high volume for sustainability. High patient volumes distribute expensive hospital costs over many encounters. If physicians cannot sustain practices across the country, it is challenging to have sufficient admission and surgical volumes to justify the cost base of hospitals.

To tie this together, we have very little influence on what we are paid for our services. Reimbursement is declining, which makes it hard to have financially sustainable practices. As hospitals struggle, there is more pressure to prioritize highly profitable service lines, like orthopedics and urology, which are associated with favorable technical revenue. As hospitals are threatened, health care deserts widen, which leaves our entire health care system in jeopardy. Not surprisingly, this most likely affects those who face additional barriers to access, such as those with lower income, limited internet access, and lack of insurance. Together, these barriers further widen disparities in health care outcomes, including outcomes for women. Additionally, this death by a thousand cuts has eroded morale and increased physician burnout.

Transforming how we practice medicine is the only viable solution. I have good news: You are the leaders you have been waiting for.

Continue to: Physicians make good managers...

Physicians make good managers

To successfully transform how we practice medicine, it is critical that those leading the transformation deeply understand how medicine is practiced. The level of understanding required can be achieved only through years of medical practice, as a doctor. We understand how medical teams interact and that different sectors of our health care system are interdependent. Also, because physicians drive patient activity and ultimately reimbursement, having a seat at the table is crucial.

Some health care systems are run by businesspeople—people with finance backgrounds—and others are led by physicians. In 2017, Becker’s Hospital Review listed the chief executive officers (CEOs) of 183 nonprofit hospital and health systems.¹⁰ Of these, only 25% were led by individuals with an MD. Looking at the 115 largest hospitals in the United States, 30% are physician led.¹⁰ Considering the top 10 hospitals ranked by U.S. News & World Report for 2022, 8 of 10 have a physician at the helm.

Beyond raters and rankers, physician-led hospitals do better. Goodall compared CEOs in the top 100 best hospitals in U.S. News & World Report in 3 key medical specialties: cancer, digestive disorders, and cardiac care.¹¹ The study explored the question: “Are hospitals’ quality ranked more highly when they are led by a medically trained doctor or non-MD professional managers?”¹¹ Analysis revealed that hospital quality scores are about 25% higher in physician-run hospitals than in manager-run hospitals.¹¹ Additional research shows that good management practices correlate with hospital performance, and that “the proportion of managers with a clinical degree has the largest positive effect.”¹²

Several theories exist as to why doctors make good managers in the health care setting.^13,14 Doctors may create a more sympathetic and productive work environment for other clinicians because they are one of them. They have peer-to-peer credibility—because they have walked the walk, they have insight and perspective into how medicine is practiced.

Physicians serve as effective change agents for their organizations in several ways:

• First, physicians take a clinical approach in their leadership roles¹³ and focus on patient care at the center of their decisions. We see the people behind the numbers. Simply put, we humanize the operational side of health care.
• As physicians, we understand the interconnectivity in the practice of medicine. While closing certain service lines may be financially beneficial, these services are often closely linked to profitable service lines.
• Beyond physicians taking a clinical approach to leadership, we emphasize quality.¹³ Because we all have experienced complications and lived through bad outcomes alongside our patients, we understand deeply how important patient safety and quality is, and we are not willing to sacrifice that for financial gain. For us, this is personal. We don’t see our solution to health care challenges as an “or” situation, instead we view it as an “and” situation.
• Physician leaders often can improve medical staff engagement.¹³ A 2018 national survey of physicians found that those who are satisfied with their leadership are more engaged at work, have greater job satisfaction, and are less likely to experience signs of burnout.¹⁵ Physician administrators add value here.

Continue to: Surgeons as leaders...

Surgeons as leaders

What do we know about surgeons as physician leaders? Looking at the previously mentioned lists of physician leaders, surgeons are relatively absent. In the Becker’s Hospital Review study of nonprofit hospitals, only 9% of CEOs were surgeons.¹⁰ In addition, when reviewing data that associated physician leaders and hospital performance, only 3 of the CEOs were surgeons.¹¹ Given that surgeons make up approximately 19% of US physicians, we are underrepresented.

The omission of surgeons as leaders seems inappropriate given that most hospitals are financially reliant on revenue related to surgical care and optimizing this space is an enormous opportunity. Berger and colleagues offered 3 theories as to why there are fewer surgeon leaders¹⁶:

• The relative pay of surgeons exceeds that of most other specialties, and there may be less incentive to accept the challenges presented by leadership roles. (I will add that surgeon leadership is more costly to a system.)
• The craftsmanship nature of surgery discourages the development of other career interests beginning at the trainee level.
• Surgeons have been perceived stereotypically to exhibit arrogance, a characteristic that others may not warm to.

This last observation stings. Successful leadership takes social skill and teamwork.¹⁴ Although medical care is one of the few disciplines in which lack of teamwork might cost lives, physicians are not trained to be team players. We recognize how our training has led us to be lone wolves or gunners, situations where we as individuals had to beat others to secure our spot. We have been trained in command-and-control environments, in stepping up as a leader in highly stressful situations. This part of surgical culture may handicap surgeons in their quest to be health care leaders.

Other traits, however, make us particularly great leaders in health care. Our desire to succeed, willingness to push ourselves to extremes, ability to laser focus on a task, acceptance of delayed gratification, and aptitude for making timely decisions on limited data help us succeed in leadership roles. Seven years of surgical training helped me develop the grit I use every day in the C-suite.

We need more physician and surgeon leadership to thrive in the challenging health care landscape. Berger and colleagues proposed 3 potential solutions to increase the number of surgeons in hospital leadership positions¹⁶:

Nurture future surgical leaders through exposure to management training. Given the contribution to both expense in support services and resources and revenue related to surgical care, each organization needs a content expert to guide these decisions.

Recognize the important contributions that surgeons already make regarding quality, safety, and operational efficiency. An excellent example of this is the American College of Surgeons National Surgical Quality Improvement Program. Because surgeons are content experts in this area, we are primed to lead.

Hospitals, medical schools, and academic departments of surgery should recognize administrative efforts as an important part of the overall academic mission. As the adage states, “No margin, no mission.” We need bright minds to preserve and grow our margins so that we can further invest in our missions.

This is not easy. Given the barriers, this will not happen organically. Charan and colleagues provided an outline for a leadership pathway adapted for physicians (FIGURE).^17,18 It starts with the individual practitioner who is a practicing physician and spends most of their time focused on patient care. As a physician becomes more interested in leadership, they develop new skills and take on more and more responsibility. As they increase in leadership responsibility, they tend to reduce clinical time and increase time spent on strategic and business management. This framework creates a pipeline so that physicians and surgeons can be developed strategically and given increasing responsibility as they develop their capabilities and expand their skill sets.

obgm03507_ss2_ridgeyway_fig.jpg

The leadership challenge

To thrive, we must transform health care by changing how we practice medicine. As ObGyns, we are the leaders we have been waiting for. As you ponder your future, think of your current career and the opportunities you might have. Do you have a seat at the table? What table is that? How are you using your knowledge, expertise, and privilege to advance health care and medicine? I challenge you to critically evaluate this—and lead. ●

obgm03507_ss2_ridgeyway_570x300.jpg

“If you don’t have a seat at the table, you are probably on the menu.” I first heard this quote in 2013, and it launched my interest in health care leadership and influenced me countless times over the last 10 years.

As Chief of Staff at Cleveland Clinic, I oversee nearly 5,000 physicians and scientists across the globe. I am involved in the physician life cycle: recruiting, hiring, privileging and credentialing, talent development, promotion, professionalism, and career transitions. I also sit at the intersection of medical care and the business of medicine. This means leading 18 clinical service lines responsible for 5.6 million visits, 161,000 surgeries, and billions of dollars in operating revenue per year. How I spend most of my time is a far cry from what I spent 11 years’ training to do—gynecologic surgery. This shift in my career was not because I changed my mind about caring for patients or that I tired of being a full-time surgeon. Nothing could be further from the truth. Women’s health remains my “why,” and my leadership journey has taught me that it is critical to have a seat at the table for the sake of ObGyns and women everywhere.

Women’s health on the menu

I will start with a concrete example of when we, as women and ObGyns, were on the menu. In late 2019, the Ohio state House of Representatives introduced a bill that subjected doctors to potential murder charges if they did not try everything to save the life of a mother and fetus, “including attempting to reimplant an ectopic pregnancy into the woman’s uterus.”¹ This bill was based on 2 case reports—one from 1915 and one from 1980—which were both low quality, and the latter case was deemed to be fraudulent.² How did this happen?

An Ohio state representative developed the bill with help from a lobbyist and without input from physicians or content experts. When asked, the representative shared that “he never researched whether re-implanting an ectopic pregnancy into a woman’s uterus was a viable medical procedure before including it in the bill.”³ He added, “I heard about it over the years. I never questioned it or gave it a lot of thought.”³

This example resonates deeply with many of us; it inspires us to speak up and act. As ObGyns, we clearly understand the consequences of legal and regulatory change in women’s health and how it directly impacts our patients and each of us as physicians. Let’s shift to something that you may feel less passion about, but I believe is equally important. This is where obstetrician-gynecologists sit in the intersection of medical care and business. This is the space where I spend most of my time, and from this vantage point, I worry about our field.

The business of medicine

Starting at the macroeconomic level, let’s think about how we as physicians are reimbursed and who makes these decisions. Looking at the national health care expenditure data, Medicare and Medicaid spending makes up nearly 40% of the total spend, and it is growing.⁴ Additionally, private health insurance tends to follow Centers for Medicare and Medicaid Services (CMS) decision making, further compounding its influence.⁴ In simple terms, CMS decides what is covered and how much we are paid. Whether you are in a solo private practice, an employer health care organization, or an academic medical center, physician reimbursement is declining.

In fact, Congress passed its year-end omnibus legislation in the final days of 2022, including a 2% Medicare physician payment cut for 2023,⁵ at a time when expenses to practice medicine, including nonphysician staff and supplies, are at an all-time high and we are living in a 6% inflationary state. This translates into being asked to serve more patients and cut costs. Our day-to-day feels much tighter, and this is why: Medicare physician pay increased just 11% over the past 20 years⁶ (2001–2021) in comparison to the cost of running a medical practice, which increased nearly 40% during that time. In other words, adjusting for inflation in practice costs, Medicare physician payment has fallen 22% over the last 20 years.⁷

Depending on your employment model, you may feel insulated from these changes as increases in reimbursement have occurred in other areas, such as hospitals and ambulatory surgery centers.⁸ In the short term, these increases help, as organizations will see additional funds. But there are 2 main issues: First, it is not nearly enough when you consider the soaring costs of running a hospital. And second, looking at our national population, we rely tremendously on self-employed doctors to serve our patients.

More than 80% of US counties lack adequate health care infrastructure.⁹ More than a third of the US population has less-than-adequate access to pharmacies, primary care physicians, hospitals, trauma centers, and low-cost health centers.⁹ To put things into perspective, more than 20% of counties in the United States are hospital deserts, where most people must drive more than 30 minutes to reach the closest hospital.⁹

There is good reason for this. Operating a hospital is a challenging endeavor. Even before the COVID-19 pandemic and the most recent health care financial challenges, most health care systems and large hospitals operated with very low operating margins (2%–3%). Businesses with similar margins include grocery stores and car dealerships. These low-margin businesses, including health care, rely on high volume for sustainability. High patient volumes distribute expensive hospital costs over many encounters. If physicians cannot sustain practices across the country, it is challenging to have sufficient admission and surgical volumes to justify the cost base of hospitals.

To tie this together, we have very little influence on what we are paid for our services. Reimbursement is declining, which makes it hard to have financially sustainable practices. As hospitals struggle, there is more pressure to prioritize highly profitable service lines, like orthopedics and urology, which are associated with favorable technical revenue. As hospitals are threatened, health care deserts widen, which leaves our entire health care system in jeopardy. Not surprisingly, this most likely affects those who face additional barriers to access, such as those with lower income, limited internet access, and lack of insurance. Together, these barriers further widen disparities in health care outcomes, including outcomes for women. Additionally, this death by a thousand cuts has eroded morale and increased physician burnout.

Transforming how we practice medicine is the only viable solution. I have good news: You are the leaders you have been waiting for.

Continue to: Physicians make good managers...

Physicians make good managers

To successfully transform how we practice medicine, it is critical that those leading the transformation deeply understand how medicine is practiced. The level of understanding required can be achieved only through years of medical practice, as a doctor. We understand how medical teams interact and that different sectors of our health care system are interdependent. Also, because physicians drive patient activity and ultimately reimbursement, having a seat at the table is crucial.

Some health care systems are run by businesspeople—people with finance backgrounds—and others are led by physicians. In 2017, Becker’s Hospital Review listed the chief executive officers (CEOs) of 183 nonprofit hospital and health systems.¹⁰ Of these, only 25% were led by individuals with an MD. Looking at the 115 largest hospitals in the United States, 30% are physician led.¹⁰ Considering the top 10 hospitals ranked by U.S. News & World Report for 2022, 8 of 10 have a physician at the helm.

Beyond raters and rankers, physician-led hospitals do better. Goodall compared CEOs in the top 100 best hospitals in U.S. News & World Report in 3 key medical specialties: cancer, digestive disorders, and cardiac care.¹¹ The study explored the question: “Are hospitals’ quality ranked more highly when they are led by a medically trained doctor or non-MD professional managers?”¹¹ Analysis revealed that hospital quality scores are about 25% higher in physician-run hospitals than in manager-run hospitals.¹¹ Additional research shows that good management practices correlate with hospital performance, and that “the proportion of managers with a clinical degree has the largest positive effect.”¹²

Several theories exist as to why doctors make good managers in the health care setting.^13,14 Doctors may create a more sympathetic and productive work environment for other clinicians because they are one of them. They have peer-to-peer credibility—because they have walked the walk, they have insight and perspective into how medicine is practiced.

Physicians serve as effective change agents for their organizations in several ways:

• First, physicians take a clinical approach in their leadership roles¹³ and focus on patient care at the center of their decisions. We see the people behind the numbers. Simply put, we humanize the operational side of health care.
• As physicians, we understand the interconnectivity in the practice of medicine. While closing certain service lines may be financially beneficial, these services are often closely linked to profitable service lines.
• Beyond physicians taking a clinical approach to leadership, we emphasize quality.¹³ Because we all have experienced complications and lived through bad outcomes alongside our patients, we understand deeply how important patient safety and quality is, and we are not willing to sacrifice that for financial gain. For us, this is personal. We don’t see our solution to health care challenges as an “or” situation, instead we view it as an “and” situation.
• Physician leaders often can improve medical staff engagement.¹³ A 2018 national survey of physicians found that those who are satisfied with their leadership are more engaged at work, have greater job satisfaction, and are less likely to experience signs of burnout.¹⁵ Physician administrators add value here.

Continue to: Surgeons as leaders...

Surgeons as leaders

What do we know about surgeons as physician leaders? Looking at the previously mentioned lists of physician leaders, surgeons are relatively absent. In the Becker’s Hospital Review study of nonprofit hospitals, only 9% of CEOs were surgeons.¹⁰ In addition, when reviewing data that associated physician leaders and hospital performance, only 3 of the CEOs were surgeons.¹¹ Given that surgeons make up approximately 19% of US physicians, we are underrepresented.

The omission of surgeons as leaders seems inappropriate given that most hospitals are financially reliant on revenue related to surgical care and optimizing this space is an enormous opportunity. Berger and colleagues offered 3 theories as to why there are fewer surgeon leaders¹⁶:

• The relative pay of surgeons exceeds that of most other specialties, and there may be less incentive to accept the challenges presented by leadership roles. (I will add that surgeon leadership is more costly to a system.)
• The craftsmanship nature of surgery discourages the development of other career interests beginning at the trainee level.
• Surgeons have been perceived stereotypically to exhibit arrogance, a characteristic that others may not warm to.

This last observation stings. Successful leadership takes social skill and teamwork.¹⁴ Although medical care is one of the few disciplines in which lack of teamwork might cost lives, physicians are not trained to be team players. We recognize how our training has led us to be lone wolves or gunners, situations where we as individuals had to beat others to secure our spot. We have been trained in command-and-control environments, in stepping up as a leader in highly stressful situations. This part of surgical culture may handicap surgeons in their quest to be health care leaders.

Other traits, however, make us particularly great leaders in health care. Our desire to succeed, willingness to push ourselves to extremes, ability to laser focus on a task, acceptance of delayed gratification, and aptitude for making timely decisions on limited data help us succeed in leadership roles. Seven years of surgical training helped me develop the grit I use every day in the C-suite.

We need more physician and surgeon leadership to thrive in the challenging health care landscape. Berger and colleagues proposed 3 potential solutions to increase the number of surgeons in hospital leadership positions¹⁶:

Nurture future surgical leaders through exposure to management training. Given the contribution to both expense in support services and resources and revenue related to surgical care, each organization needs a content expert to guide these decisions.

Recognize the important contributions that surgeons already make regarding quality, safety, and operational efficiency. An excellent example of this is the American College of Surgeons National Surgical Quality Improvement Program. Because surgeons are content experts in this area, we are primed to lead.

Hospitals, medical schools, and academic departments of surgery should recognize administrative efforts as an important part of the overall academic mission. As the adage states, “No margin, no mission.” We need bright minds to preserve and grow our margins so that we can further invest in our missions.

This is not easy. Given the barriers, this will not happen organically. Charan and colleagues provided an outline for a leadership pathway adapted for physicians (FIGURE).^17,18 It starts with the individual practitioner who is a practicing physician and spends most of their time focused on patient care. As a physician becomes more interested in leadership, they develop new skills and take on more and more responsibility. As they increase in leadership responsibility, they tend to reduce clinical time and increase time spent on strategic and business management. This framework creates a pipeline so that physicians and surgeons can be developed strategically and given increasing responsibility as they develop their capabilities and expand their skill sets.

obgm03507_ss2_ridgeyway_fig.jpg

The leadership challenge

To thrive, we must transform health care by changing how we practice medicine. As ObGyns, we are the leaders we have been waiting for. As you ponder your future, think of your current career and the opportunities you might have. Do you have a seat at the table? What table is that? How are you using your knowledge, expertise, and privilege to advance health care and medicine? I challenge you to critically evaluate this—and lead. ●

Over the last 3 decades, abundant evidence has demonstrated the association between surgical volume and outcomes. Patients operated on by high-volume surgeons and at high-volume hospitals have superior outcomes.^1,2 This relationship has provided a framework for a number of public health policies to try to align patients with appropriate providers and centers to optimize perioperative outcomes. In this article, we examine the volume-outcomes paradigm for gynecologic surgery and explore how this relationship is influencing patterns of care and policy.

Surgical volume in gynecology

The association between both hospital and surgeon volume and outcomes has been explored across a number of gynecologic procedures.³ A meta-analysis that included 741,000 patients found that low-volume surgeons had an increased rate of complications overall, a higher rate of intraoperative complications, and a higher rate of postoperative complications compared with high-volume surgeons. While there was no association between volume and mortality overall, when limited to gynecologic oncology studies, low surgeon volume was associated with increased perioperative mortality.³

While these studies demonstrated a statistically significant association between surgeon volume and perioperative outcomes, the magnitude of the effect is modest compared with other higher-risk procedures associated with greater perioperative morbidity. For example, in a large study that examined oncologic and cardiovascular surgery, perioperative mortality in patients who underwent pancreatic resection was reduced from 15% for low-volume surgeons to 5% for high-volume surgeons.¹ By contrast, for gynecologic surgery, complications occurred in 97 per 1,000 patients operated on by high-volume surgeons compared with between 114 and 137 per 1,000 for low-volume surgeons. Thus, to avoid 1 in-hospital complication, 30 surgeries performed by low-volume surgeons would need to be moved to high-volume surgeons. For intraoperative complications, 38 patients would need to be moved from low- to high-volume surgeons to prevent 1 such complication.³ In addition to morbidity and mortality, higher surgeon volume is associated with greater use of minimally invasive surgery, a lower likelihood of conversion to laparotomy, and lower costs.³

obgm03507_ss7_wright_570x300.jpg

Continue to: Public health applications of gynecologic surgical volume...

Public health applications of gynecologic surgical volume

The large body of literature on volume and outcomes has led to a number of public health initiatives aimed at reducing perioperative morbidity and mortality. Broadly, these efforts focus on regionalization of care, targeted quality improvement, and the development of minimum volume standards. Each strategy holds promise but also the potential to lead to unwanted consequences.

Regionalization of care

Recognition of the volume-outcomes paradigm has led to efforts to regionalize care for complex procedures to high-volume surgeons and centers.¹⁰ A cohort study of surgical patterns of care for Medicare recipients who underwent cancer resections or abdominal aortic aneurysm repair from 1999 to 2008 demonstrated these shifting practice patterns. For example, in 1999–2000, pancreatectomy was performed in 1,308 hospitals, with a median case volume of 5 procedures per year. By 2007–2008, the number of hospitals in which pancreatectomy was performed declined to 978, and the median case volume rose to 16 procedures per year. Importantly, over this time period, risk-adjusted mortality for pancreatectomy declined by 19%, and increased hospital volume was responsible for more than two-thirds of the decline in mortality.¹⁰

There has similarly been a gradual concentration of some gynecologic procedures to higher-volume surgeons and centers.^11,12 Among patients undergoing hysterectomy for endometrial cancer in New York State, 845 surgeons with a mean case volume of 3 procedures per year treated patients in 2000. By 2014, the number of surgeons who performed these operations declined to 317 while mean annual case volume rose to 10 procedures per year. The number of hospitals in which women with endometrial cancer were treated declined from 182 to 98 over the same time period.¹¹ Similar trends were noted for patients undergoing ovarian cancer resection.¹² While patterns of gynecologic care for some surgical procedures have clearly changed, it has been more difficult to link these changes to improvements in outcomes.^11,12

Despite the intuitive appeal of regionalization of surgical care, such a strategy has a number of limitations and practical challenges. Not surprisingly, limiting the number of surgeons and hospitals that perform a given procedure necessitates that patients travel a greater distance to obtain necessary surgical care.^13,14 An analysis of endometrial cancer patients in New York State stratified patients based on their area of residence into 10 hospital referral regions (HRRs), which represent health care markets for tertiary medical care. From 2000 to 2014, the distance patients traveled to receive their surgical care increased in all of the HRRs studied. This was most pronounced in 1 of the HRRs in which the median travel distance rose by 47 miles over the 15-year period (FIGURE 1; FIGURE 2).¹⁴

Whether patients are willing to travel for care remains a matter of debate and depends on the disease, the surgical procedure, and the anticipated benefit associated with a longer travel distance.^15,16 In a discrete choice experiment, 100 participants were given a hypothetical scenario in which they had potentially resectable pancreatic cancer; they were queried on their willingness to travel for care based on varying differences in mortality between a local and regional hospital.¹⁵ When mortality at the local hospital was double that of the regional hospital (6% vs 3%), 45% of patients chose to remain at the local hospital. When the differential increased to a 4 times greater mortality at the local hospital (12% vs 3%), 23% of patients still chose to remain at the local hospital.¹⁵

obgm03507_ss7_wright_fig1.jpg

obgm03507_ss7_wright_fig2.jpg

Lastly, a number of studies have shown that regionalization of surgical care disproportionately affects Black and Hispanic patients and those with low socioeconomic status.^12,13,17 A simulation study on the effect of regionalizing care for pancreatectomy noted that using a hospital volume threshold of 20 procedures per year, a higher percentage of Black and Hispanic patients than White patients would be required to travel to a higher-volume center.¹³ Similarly, Medicaid recipients were more likely to be affected.¹³ Despite the inequities in who must travel for regionalized care, prior work has suggested that regionalization of cancer care to high-volume centers may reduce racial and socioeconomic disparities in survival for some cancers.¹⁸

Targeted quality improvement

Realizing the practical limitations of regionalization of care, an alternative strategy is to improve the quality of care at low-volume hospitals.^5,19 Quality of care and surgical volume often are correlated, and the delivery of high-quality care can mitigate some of the influence of surgical volume on outcomes.

These principles were demonstrated in a study of more than 100,000 patients with ovarian cancer that stratified treating hospitals into volume quintiles.⁵ As expected, survival (both 2- and 5-year) was highest in the highest-volume quintile hospitals (FIGURE 3).⁵ Similarly, quality of care, measured through adherence to various process measures, was also highest in the highest-volume quintile hospitals. Interestingly, in the second-fourth volume quintile hospitals, there was substantial variation in adherence to quality metrics. Among hospitals with higher quality care, an improved survival was noted compared with lower quality care hospitals within the same volume quintile. Survival at high-quality, intermediate-volume hospitals approached that of the high-volume quintile hospitals.⁵

obgm03507_ss7_wright_fig3.jpg

Continue to: Minimum volume standards...

While efforts to regionalize surgical care have gradually evolved, calls have been growing to formalize policies that limit the performance of some procedures to surgeons and centers that meet a minimum volume threshold or standard.²¹ One such effort, based on consensus from 3 academic hospital systems, was a campaign for hospitals to “Take the Volume Pledge.”²¹ The campaign’s goal is to encourage health care systems to restrict the performance of 10 procedures to surgeons and hospitals within their systems that meet a minimum volume standard for the given operations.²¹ In essence, procedures would be restricted for low-volume providers and centers and triaged to higher-volume surgeons and hospitals within a given health care system.²¹

Proponents of the Volume Pledge argue that it is a relatively straightforward way to align patients and providers to optimize outcomes. The Volume Pledge focuses on larger hospital systems and encourages referral within the given system, thus mitigating competitive and financial concerns about referring patients to outside providers. Those who have argued against the Volume Pledge point out that the volume cut points chosen are somewhat arbitrary, that these policies have the potential to negatively impact rural hospitals and those serving smaller communities, and that quality is a more appropriate metric than volume.²² The Volume Pledge does not include any gynecologic procedures, and to date it has met with only limited success.²³

Perhaps more directly applicable to gynecologic surgeons are ongoing national trends to base hospital credentialing on surgical volume. In essence, individual surgeons must demonstrate that they have performed a minimum number of procedures to obtain or retain privileges.^24,25 While there is strong evidence of the association between volume and outcomes for some complex surgical procedures, linking volume to credentialing has a number of potential pitfalls. Studies of surgical outcomes based on volume represent average performance, and many low-volume providers have better-than-expected outcomes. Volume measures typically represent recent performance; it is difficult to measure the overall experience of individual surgeons. Similarly, surgical outcomes depend on both the surgeon and the system in which the surgeon operates. It is difficult, if not impossible, to account for differences in the environment in which a surgeon works.²⁵

A study of gynecologic surgeons who performed hysterectomy in New York State demonstrates many of the complexities of volume-based credentialing.²⁶ In a cohort of more than55,000 patients who underwent abdominal hysterectomy, there was a strong association between low surgeon volume and a higher-than-expected rate of complications. If one were to consider limiting privileges to even the lowest-volume providers, there would be a significant impact on the surgical workforce. In this cohort, limiting credentialing to the lowest-volume providers, those who performed only 1 abdominal hysterectomy in the prior year would restrict the privileges of 17.5% of the surgeons in the cohort. Further, in this low-volume cohort that performed only 1 abdominal hysterectomy in the prior year, 69% of the surgeons actually had outcomes that were better than predicted.²⁶ These data highlight not only the difficulty of applying averages to individual surgeons but also the profound impact that policy changes could have on the practice of gynecologic surgery.

Volume-outcomes paradigm discussions continue

The association between higher surgeon and hospital procedural volume for gynecologic surgeries and improved outcomes now has been convincingly demonstrated. With this knowledge, over the last decade the patterns of care for patients undergoing gynecologic surgery have clearly shifted, and these operations are now more commonly being performed by a smaller number of physicians and at fewer hospitals.

While efforts to improve quality are clearly important, many policy interventions, such as regionalization of care, have untoward consequences that must be considered. As we move forward, it will be essential to ensure that there is a robust debate among patients, providers, and policymakers on the merits of public health policies based on the volume-outcomes paradigm. ●

Over the last 3 decades, abundant evidence has demonstrated the association between surgical volume and outcomes. Patients operated on by high-volume surgeons and at high-volume hospitals have superior outcomes.^1,2 This relationship has provided a framework for a number of public health policies to try to align patients with appropriate providers and centers to optimize perioperative outcomes. In this article, we examine the volume-outcomes paradigm for gynecologic surgery and explore how this relationship is influencing patterns of care and policy.

Surgical volume in gynecology

The association between both hospital and surgeon volume and outcomes has been explored across a number of gynecologic procedures.³ A meta-analysis that included 741,000 patients found that low-volume surgeons had an increased rate of complications overall, a higher rate of intraoperative complications, and a higher rate of postoperative complications compared with high-volume surgeons. While there was no association between volume and mortality overall, when limited to gynecologic oncology studies, low surgeon volume was associated with increased perioperative mortality.³

While these studies demonstrated a statistically significant association between surgeon volume and perioperative outcomes, the magnitude of the effect is modest compared with other higher-risk procedures associated with greater perioperative morbidity. For example, in a large study that examined oncologic and cardiovascular surgery, perioperative mortality in patients who underwent pancreatic resection was reduced from 15% for low-volume surgeons to 5% for high-volume surgeons.¹ By contrast, for gynecologic surgery, complications occurred in 97 per 1,000 patients operated on by high-volume surgeons compared with between 114 and 137 per 1,000 for low-volume surgeons. Thus, to avoid 1 in-hospital complication, 30 surgeries performed by low-volume surgeons would need to be moved to high-volume surgeons. For intraoperative complications, 38 patients would need to be moved from low- to high-volume surgeons to prevent 1 such complication.³ In addition to morbidity and mortality, higher surgeon volume is associated with greater use of minimally invasive surgery, a lower likelihood of conversion to laparotomy, and lower costs.³

obgm03507_ss7_wright_570x300.jpg

Continue to: Public health applications of gynecologic surgical volume...

Public health applications of gynecologic surgical volume

The large body of literature on volume and outcomes has led to a number of public health initiatives aimed at reducing perioperative morbidity and mortality. Broadly, these efforts focus on regionalization of care, targeted quality improvement, and the development of minimum volume standards. Each strategy holds promise but also the potential to lead to unwanted consequences.

Regionalization of care

Recognition of the volume-outcomes paradigm has led to efforts to regionalize care for complex procedures to high-volume surgeons and centers.¹⁰ A cohort study of surgical patterns of care for Medicare recipients who underwent cancer resections or abdominal aortic aneurysm repair from 1999 to 2008 demonstrated these shifting practice patterns. For example, in 1999–2000, pancreatectomy was performed in 1,308 hospitals, with a median case volume of 5 procedures per year. By 2007–2008, the number of hospitals in which pancreatectomy was performed declined to 978, and the median case volume rose to 16 procedures per year. Importantly, over this time period, risk-adjusted mortality for pancreatectomy declined by 19%, and increased hospital volume was responsible for more than two-thirds of the decline in mortality.¹⁰

There has similarly been a gradual concentration of some gynecologic procedures to higher-volume surgeons and centers.^11,12 Among patients undergoing hysterectomy for endometrial cancer in New York State, 845 surgeons with a mean case volume of 3 procedures per year treated patients in 2000. By 2014, the number of surgeons who performed these operations declined to 317 while mean annual case volume rose to 10 procedures per year. The number of hospitals in which women with endometrial cancer were treated declined from 182 to 98 over the same time period.¹¹ Similar trends were noted for patients undergoing ovarian cancer resection.¹² While patterns of gynecologic care for some surgical procedures have clearly changed, it has been more difficult to link these changes to improvements in outcomes.^11,12

Despite the intuitive appeal of regionalization of surgical care, such a strategy has a number of limitations and practical challenges. Not surprisingly, limiting the number of surgeons and hospitals that perform a given procedure necessitates that patients travel a greater distance to obtain necessary surgical care.^13,14 An analysis of endometrial cancer patients in New York State stratified patients based on their area of residence into 10 hospital referral regions (HRRs), which represent health care markets for tertiary medical care. From 2000 to 2014, the distance patients traveled to receive their surgical care increased in all of the HRRs studied. This was most pronounced in 1 of the HRRs in which the median travel distance rose by 47 miles over the 15-year period (FIGURE 1; FIGURE 2).¹⁴

Whether patients are willing to travel for care remains a matter of debate and depends on the disease, the surgical procedure, and the anticipated benefit associated with a longer travel distance.^15,16 In a discrete choice experiment, 100 participants were given a hypothetical scenario in which they had potentially resectable pancreatic cancer; they were queried on their willingness to travel for care based on varying differences in mortality between a local and regional hospital.¹⁵ When mortality at the local hospital was double that of the regional hospital (6% vs 3%), 45% of patients chose to remain at the local hospital. When the differential increased to a 4 times greater mortality at the local hospital (12% vs 3%), 23% of patients still chose to remain at the local hospital.¹⁵

obgm03507_ss7_wright_fig1.jpg

obgm03507_ss7_wright_fig2.jpg

Lastly, a number of studies have shown that regionalization of surgical care disproportionately affects Black and Hispanic patients and those with low socioeconomic status.^12,13,17 A simulation study on the effect of regionalizing care for pancreatectomy noted that using a hospital volume threshold of 20 procedures per year, a higher percentage of Black and Hispanic patients than White patients would be required to travel to a higher-volume center.¹³ Similarly, Medicaid recipients were more likely to be affected.¹³ Despite the inequities in who must travel for regionalized care, prior work has suggested that regionalization of cancer care to high-volume centers may reduce racial and socioeconomic disparities in survival for some cancers.¹⁸

Targeted quality improvement

Realizing the practical limitations of regionalization of care, an alternative strategy is to improve the quality of care at low-volume hospitals.^5,19 Quality of care and surgical volume often are correlated, and the delivery of high-quality care can mitigate some of the influence of surgical volume on outcomes.

These principles were demonstrated in a study of more than 100,000 patients with ovarian cancer that stratified treating hospitals into volume quintiles.⁵ As expected, survival (both 2- and 5-year) was highest in the highest-volume quintile hospitals (FIGURE 3).⁵ Similarly, quality of care, measured through adherence to various process measures, was also highest in the highest-volume quintile hospitals. Interestingly, in the second-fourth volume quintile hospitals, there was substantial variation in adherence to quality metrics. Among hospitals with higher quality care, an improved survival was noted compared with lower quality care hospitals within the same volume quintile. Survival at high-quality, intermediate-volume hospitals approached that of the high-volume quintile hospitals.⁵

obgm03507_ss7_wright_fig3.jpg

Continue to: Minimum volume standards...

While efforts to regionalize surgical care have gradually evolved, calls have been growing to formalize policies that limit the performance of some procedures to surgeons and centers that meet a minimum volume threshold or standard.²¹ One such effort, based on consensus from 3 academic hospital systems, was a campaign for hospitals to “Take the Volume Pledge.”²¹ The campaign’s goal is to encourage health care systems to restrict the performance of 10 procedures to surgeons and hospitals within their systems that meet a minimum volume standard for the given operations.²¹ In essence, procedures would be restricted for low-volume providers and centers and triaged to higher-volume surgeons and hospitals within a given health care system.²¹

Proponents of the Volume Pledge argue that it is a relatively straightforward way to align patients and providers to optimize outcomes. The Volume Pledge focuses on larger hospital systems and encourages referral within the given system, thus mitigating competitive and financial concerns about referring patients to outside providers. Those who have argued against the Volume Pledge point out that the volume cut points chosen are somewhat arbitrary, that these policies have the potential to negatively impact rural hospitals and those serving smaller communities, and that quality is a more appropriate metric than volume.²² The Volume Pledge does not include any gynecologic procedures, and to date it has met with only limited success.²³

Perhaps more directly applicable to gynecologic surgeons are ongoing national trends to base hospital credentialing on surgical volume. In essence, individual surgeons must demonstrate that they have performed a minimum number of procedures to obtain or retain privileges.^24,25 While there is strong evidence of the association between volume and outcomes for some complex surgical procedures, linking volume to credentialing has a number of potential pitfalls. Studies of surgical outcomes based on volume represent average performance, and many low-volume providers have better-than-expected outcomes. Volume measures typically represent recent performance; it is difficult to measure the overall experience of individual surgeons. Similarly, surgical outcomes depend on both the surgeon and the system in which the surgeon operates. It is difficult, if not impossible, to account for differences in the environment in which a surgeon works.²⁵

A study of gynecologic surgeons who performed hysterectomy in New York State demonstrates many of the complexities of volume-based credentialing.²⁶ In a cohort of more than55,000 patients who underwent abdominal hysterectomy, there was a strong association between low surgeon volume and a higher-than-expected rate of complications. If one were to consider limiting privileges to even the lowest-volume providers, there would be a significant impact on the surgical workforce. In this cohort, limiting credentialing to the lowest-volume providers, those who performed only 1 abdominal hysterectomy in the prior year would restrict the privileges of 17.5% of the surgeons in the cohort. Further, in this low-volume cohort that performed only 1 abdominal hysterectomy in the prior year, 69% of the surgeons actually had outcomes that were better than predicted.²⁶ These data highlight not only the difficulty of applying averages to individual surgeons but also the profound impact that policy changes could have on the practice of gynecologic surgery.

Volume-outcomes paradigm discussions continue

The association between higher surgeon and hospital procedural volume for gynecologic surgeries and improved outcomes now has been convincingly demonstrated. With this knowledge, over the last decade the patterns of care for patients undergoing gynecologic surgery have clearly shifted, and these operations are now more commonly being performed by a smaller number of physicians and at fewer hospitals.

While efforts to improve quality are clearly important, many policy interventions, such as regionalization of care, have untoward consequences that must be considered. As we move forward, it will be essential to ensure that there is a robust debate among patients, providers, and policymakers on the merits of public health policies based on the volume-outcomes paradigm. ●

Over the last 3 decades, abundant evidence has demonstrated the association between surgical volume and outcomes. Patients operated on by high-volume surgeons and at high-volume hospitals have superior outcomes.^1,2 This relationship has provided a framework for a number of public health policies to try to align patients with appropriate providers and centers to optimize perioperative outcomes. In this article, we examine the volume-outcomes paradigm for gynecologic surgery and explore how this relationship is influencing patterns of care and policy.

Surgical volume in gynecology

The association between both hospital and surgeon volume and outcomes has been explored across a number of gynecologic procedures.³ A meta-analysis that included 741,000 patients found that low-volume surgeons had an increased rate of complications overall, a higher rate of intraoperative complications, and a higher rate of postoperative complications compared with high-volume surgeons. While there was no association between volume and mortality overall, when limited to gynecologic oncology studies, low surgeon volume was associated with increased perioperative mortality.³

While these studies demonstrated a statistically significant association between surgeon volume and perioperative outcomes, the magnitude of the effect is modest compared with other higher-risk procedures associated with greater perioperative morbidity. For example, in a large study that examined oncologic and cardiovascular surgery, perioperative mortality in patients who underwent pancreatic resection was reduced from 15% for low-volume surgeons to 5% for high-volume surgeons.¹ By contrast, for gynecologic surgery, complications occurred in 97 per 1,000 patients operated on by high-volume surgeons compared with between 114 and 137 per 1,000 for low-volume surgeons. Thus, to avoid 1 in-hospital complication, 30 surgeries performed by low-volume surgeons would need to be moved to high-volume surgeons. For intraoperative complications, 38 patients would need to be moved from low- to high-volume surgeons to prevent 1 such complication.³ In addition to morbidity and mortality, higher surgeon volume is associated with greater use of minimally invasive surgery, a lower likelihood of conversion to laparotomy, and lower costs.³

obgm03507_ss7_wright_570x300.jpg

Continue to: Public health applications of gynecologic surgical volume...

Public health applications of gynecologic surgical volume

The large body of literature on volume and outcomes has led to a number of public health initiatives aimed at reducing perioperative morbidity and mortality. Broadly, these efforts focus on regionalization of care, targeted quality improvement, and the development of minimum volume standards. Each strategy holds promise but also the potential to lead to unwanted consequences.

Regionalization of care

Recognition of the volume-outcomes paradigm has led to efforts to regionalize care for complex procedures to high-volume surgeons and centers.¹⁰ A cohort study of surgical patterns of care for Medicare recipients who underwent cancer resections or abdominal aortic aneurysm repair from 1999 to 2008 demonstrated these shifting practice patterns. For example, in 1999–2000, pancreatectomy was performed in 1,308 hospitals, with a median case volume of 5 procedures per year. By 2007–2008, the number of hospitals in which pancreatectomy was performed declined to 978, and the median case volume rose to 16 procedures per year. Importantly, over this time period, risk-adjusted mortality for pancreatectomy declined by 19%, and increased hospital volume was responsible for more than two-thirds of the decline in mortality.¹⁰

There has similarly been a gradual concentration of some gynecologic procedures to higher-volume surgeons and centers.^11,12 Among patients undergoing hysterectomy for endometrial cancer in New York State, 845 surgeons with a mean case volume of 3 procedures per year treated patients in 2000. By 2014, the number of surgeons who performed these operations declined to 317 while mean annual case volume rose to 10 procedures per year. The number of hospitals in which women with endometrial cancer were treated declined from 182 to 98 over the same time period.¹¹ Similar trends were noted for patients undergoing ovarian cancer resection.¹² While patterns of gynecologic care for some surgical procedures have clearly changed, it has been more difficult to link these changes to improvements in outcomes.^11,12

Despite the intuitive appeal of regionalization of surgical care, such a strategy has a number of limitations and practical challenges. Not surprisingly, limiting the number of surgeons and hospitals that perform a given procedure necessitates that patients travel a greater distance to obtain necessary surgical care.^13,14 An analysis of endometrial cancer patients in New York State stratified patients based on their area of residence into 10 hospital referral regions (HRRs), which represent health care markets for tertiary medical care. From 2000 to 2014, the distance patients traveled to receive their surgical care increased in all of the HRRs studied. This was most pronounced in 1 of the HRRs in which the median travel distance rose by 47 miles over the 15-year period (FIGURE 1; FIGURE 2).¹⁴

Whether patients are willing to travel for care remains a matter of debate and depends on the disease, the surgical procedure, and the anticipated benefit associated with a longer travel distance.^15,16 In a discrete choice experiment, 100 participants were given a hypothetical scenario in which they had potentially resectable pancreatic cancer; they were queried on their willingness to travel for care based on varying differences in mortality between a local and regional hospital.¹⁵ When mortality at the local hospital was double that of the regional hospital (6% vs 3%), 45% of patients chose to remain at the local hospital. When the differential increased to a 4 times greater mortality at the local hospital (12% vs 3%), 23% of patients still chose to remain at the local hospital.¹⁵

obgm03507_ss7_wright_fig1.jpg

obgm03507_ss7_wright_fig2.jpg

Lastly, a number of studies have shown that regionalization of surgical care disproportionately affects Black and Hispanic patients and those with low socioeconomic status.^12,13,17 A simulation study on the effect of regionalizing care for pancreatectomy noted that using a hospital volume threshold of 20 procedures per year, a higher percentage of Black and Hispanic patients than White patients would be required to travel to a higher-volume center.¹³ Similarly, Medicaid recipients were more likely to be affected.¹³ Despite the inequities in who must travel for regionalized care, prior work has suggested that regionalization of cancer care to high-volume centers may reduce racial and socioeconomic disparities in survival for some cancers.¹⁸

Targeted quality improvement

Realizing the practical limitations of regionalization of care, an alternative strategy is to improve the quality of care at low-volume hospitals.^5,19 Quality of care and surgical volume often are correlated, and the delivery of high-quality care can mitigate some of the influence of surgical volume on outcomes.

These principles were demonstrated in a study of more than 100,000 patients with ovarian cancer that stratified treating hospitals into volume quintiles.⁵ As expected, survival (both 2- and 5-year) was highest in the highest-volume quintile hospitals (FIGURE 3).⁵ Similarly, quality of care, measured through adherence to various process measures, was also highest in the highest-volume quintile hospitals. Interestingly, in the second-fourth volume quintile hospitals, there was substantial variation in adherence to quality metrics. Among hospitals with higher quality care, an improved survival was noted compared with lower quality care hospitals within the same volume quintile. Survival at high-quality, intermediate-volume hospitals approached that of the high-volume quintile hospitals.⁵

obgm03507_ss7_wright_fig3.jpg

Continue to: Minimum volume standards...

While efforts to regionalize surgical care have gradually evolved, calls have been growing to formalize policies that limit the performance of some procedures to surgeons and centers that meet a minimum volume threshold or standard.²¹ One such effort, based on consensus from 3 academic hospital systems, was a campaign for hospitals to “Take the Volume Pledge.”²¹ The campaign’s goal is to encourage health care systems to restrict the performance of 10 procedures to surgeons and hospitals within their systems that meet a minimum volume standard for the given operations.²¹ In essence, procedures would be restricted for low-volume providers and centers and triaged to higher-volume surgeons and hospitals within a given health care system.²¹

Proponents of the Volume Pledge argue that it is a relatively straightforward way to align patients and providers to optimize outcomes. The Volume Pledge focuses on larger hospital systems and encourages referral within the given system, thus mitigating competitive and financial concerns about referring patients to outside providers. Those who have argued against the Volume Pledge point out that the volume cut points chosen are somewhat arbitrary, that these policies have the potential to negatively impact rural hospitals and those serving smaller communities, and that quality is a more appropriate metric than volume.²² The Volume Pledge does not include any gynecologic procedures, and to date it has met with only limited success.²³

Perhaps more directly applicable to gynecologic surgeons are ongoing national trends to base hospital credentialing on surgical volume. In essence, individual surgeons must demonstrate that they have performed a minimum number of procedures to obtain or retain privileges.^24,25 While there is strong evidence of the association between volume and outcomes for some complex surgical procedures, linking volume to credentialing has a number of potential pitfalls. Studies of surgical outcomes based on volume represent average performance, and many low-volume providers have better-than-expected outcomes. Volume measures typically represent recent performance; it is difficult to measure the overall experience of individual surgeons. Similarly, surgical outcomes depend on both the surgeon and the system in which the surgeon operates. It is difficult, if not impossible, to account for differences in the environment in which a surgeon works.²⁵

A study of gynecologic surgeons who performed hysterectomy in New York State demonstrates many of the complexities of volume-based credentialing.²⁶ In a cohort of more than55,000 patients who underwent abdominal hysterectomy, there was a strong association between low surgeon volume and a higher-than-expected rate of complications. If one were to consider limiting privileges to even the lowest-volume providers, there would be a significant impact on the surgical workforce. In this cohort, limiting credentialing to the lowest-volume providers, those who performed only 1 abdominal hysterectomy in the prior year would restrict the privileges of 17.5% of the surgeons in the cohort. Further, in this low-volume cohort that performed only 1 abdominal hysterectomy in the prior year, 69% of the surgeons actually had outcomes that were better than predicted.²⁶ These data highlight not only the difficulty of applying averages to individual surgeons but also the profound impact that policy changes could have on the practice of gynecologic surgery.

Volume-outcomes paradigm discussions continue

The association between higher surgeon and hospital procedural volume for gynecologic surgeries and improved outcomes now has been convincingly demonstrated. With this knowledge, over the last decade the patterns of care for patients undergoing gynecologic surgery have clearly shifted, and these operations are now more commonly being performed by a smaller number of physicians and at fewer hospitals.

While efforts to improve quality are clearly important, many policy interventions, such as regionalization of care, have untoward consequences that must be considered. As we move forward, it will be essential to ensure that there is a robust debate among patients, providers, and policymakers on the merits of public health policies based on the volume-outcomes paradigm. ●