User login
Bariatric surgery is most effective early in the diabetes trajectory
LOS ANGELES – In the clinical experience of Kurt GMM Alberti, DPhil, FRCP, FRCPath, The problem is, far fewer people with diabetes are being referred for the surgery than would benefit from it.
At the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease, Dr. Alberti said that only about 1% of eligible patients in the United States undergo bariatric surgery, compared with just 0.22% of eligible patients in the United Kingdom.
“Obesity is an increasing problem,” said Dr. Alberti, a senior research investigator in the section of diabetes, endocrinology, and metabolism at Imperial College, London. “The United States is leading the field [in obesity], and it doesn’t seem to be going away. This is in parallel with diabetes. According to the 2019 International Diabetes Federation’s Diabetes Atlas, the diabetes prevalence worldwide is now 463 million. It’s projected to reach 578 million by 2030 and 700 million by 2045. We have a major problem.”
Lifestyle modification with diet and exercise have been the cornerstone of diabetes therapy for more than 100 years, with only modest success. “A range of oral agents have been added [and they] certainly improve glycemic control, but few achieve lasting success, and few achieve remission,” Dr. Alberti said. Findings from DiRECT (Lancet. 2018;391:541-51) and the Look AHEAD (Action for Health in Diabetes) study (N Engl J Med. 2013;369:145-54) have shown dramatic improvements in glycemia, but only in the minority of patients who achieved weight loss of 10 kg or more. “In this group, 80% achieved remission after 2 years in DiRECT,” he said. “It is uncertain whether this can be sustained long term in real life, and how many people will respond. Major community prevention programs are under way in the U.S. and [United Kingdom], but many target individuals with prediabetes. Currently, it is unknown how successful these programs will be.”
The 2018 American Diabetes Association/European Association for the Study of Diabetes clinical guidelines state that bariatric surgery is a recommended treatment option for adults with type 2 diabetes and a body mass index of either 40.0 kg/m2 or higher (or 37.5 kg/m2 or higher in people of Asian ancestry) or 35.0-39.9 kg/m2 (32.5-37.4 kg/m2 in people of Asian ancestry) and who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. According to Dr. Alberti, surgery should be an accepted option in people who have type 2 diabetes and a body mass index of 30 kg/m2 or higher, and priority should be given to adolescents, young adults, and those with a shorter duration of diabetes.
The main suggestive evidence in favor of bariatric surgery having an impact on diabetes comes from the Swedish Obese Subjects Study, which had a median follow-up of 10 years (J Intern Med. 2013;273[3]:219-34). In patients with diabetes at baseline, 30% were still in remission at 15 years after surgery. After 18 years, cumulative microvascular disease had fallen from 42 to 21 per 1,000 person-years, and macrovascular complications had fallen by 25%. “This was not a randomized, controlled trial, however,” Dr. Alberti said. Several of these studies have now been performed, including the STAMPEDE trial (N Engl J Med. 2017;376:641-51) and recent studies led by Geltrude Mingrone, MD, PhD, which show major glycemic benefit (Lancet. 2015;386[9997]:P964-73) with bariatric surgery.
According to Dr. Alberti, laparoscopic adjustable gastric lap band is the easiest bariatric surgery to perform but it has fallen out of favor because of lower diabetes remission rates, compared with the other procedures. Roux-en-Y gastric bypass, sleeve gastrectomy, and biliary pancreatic diversion are all in use. Slightly higher remission rates have been shown with biliary pancreatic diversion. “There have also been consistent improvements in quality of life and cardiovascular risk factors,” he said. “Long-term follow-up is still [needed], but, in general, it seems that diabetic complications are lower than in medically treated control groups, and mortality may also be lower. The real question is, what is the impact on complications? There we have a problem, because we do not have any good randomized, controlled trials covering a 10- to 20-year period, which would give us clear evidence. There is reasonable evidence from cohort studies, though.”
Added benefits of bariatric surgery include improved quality of life, decreased blood pressure, less sleep apnea, improved cardiovascular risk factors, and better musculoskeletal function. For now, though, an unmet need persists. “The problem is that far fewer people are referred for bariatric surgery than would benefit,” Dr. Alberti said. “There are several barriers to greater use of bariatric surgery in those with diabetes. These include physician attitudes, inadequate referrals, patient perceptions, lack of awareness among patients, inadequate insurance coverage, and particularly health system capacity. There is also a lack of sympathy for overweight people in some places.”
Dr. Alberti reported having no financial disclosures.
LOS ANGELES – In the clinical experience of Kurt GMM Alberti, DPhil, FRCP, FRCPath, The problem is, far fewer people with diabetes are being referred for the surgery than would benefit from it.
At the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease, Dr. Alberti said that only about 1% of eligible patients in the United States undergo bariatric surgery, compared with just 0.22% of eligible patients in the United Kingdom.
“Obesity is an increasing problem,” said Dr. Alberti, a senior research investigator in the section of diabetes, endocrinology, and metabolism at Imperial College, London. “The United States is leading the field [in obesity], and it doesn’t seem to be going away. This is in parallel with diabetes. According to the 2019 International Diabetes Federation’s Diabetes Atlas, the diabetes prevalence worldwide is now 463 million. It’s projected to reach 578 million by 2030 and 700 million by 2045. We have a major problem.”
Lifestyle modification with diet and exercise have been the cornerstone of diabetes therapy for more than 100 years, with only modest success. “A range of oral agents have been added [and they] certainly improve glycemic control, but few achieve lasting success, and few achieve remission,” Dr. Alberti said. Findings from DiRECT (Lancet. 2018;391:541-51) and the Look AHEAD (Action for Health in Diabetes) study (N Engl J Med. 2013;369:145-54) have shown dramatic improvements in glycemia, but only in the minority of patients who achieved weight loss of 10 kg or more. “In this group, 80% achieved remission after 2 years in DiRECT,” he said. “It is uncertain whether this can be sustained long term in real life, and how many people will respond. Major community prevention programs are under way in the U.S. and [United Kingdom], but many target individuals with prediabetes. Currently, it is unknown how successful these programs will be.”
The 2018 American Diabetes Association/European Association for the Study of Diabetes clinical guidelines state that bariatric surgery is a recommended treatment option for adults with type 2 diabetes and a body mass index of either 40.0 kg/m2 or higher (or 37.5 kg/m2 or higher in people of Asian ancestry) or 35.0-39.9 kg/m2 (32.5-37.4 kg/m2 in people of Asian ancestry) and who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. According to Dr. Alberti, surgery should be an accepted option in people who have type 2 diabetes and a body mass index of 30 kg/m2 or higher, and priority should be given to adolescents, young adults, and those with a shorter duration of diabetes.
The main suggestive evidence in favor of bariatric surgery having an impact on diabetes comes from the Swedish Obese Subjects Study, which had a median follow-up of 10 years (J Intern Med. 2013;273[3]:219-34). In patients with diabetes at baseline, 30% were still in remission at 15 years after surgery. After 18 years, cumulative microvascular disease had fallen from 42 to 21 per 1,000 person-years, and macrovascular complications had fallen by 25%. “This was not a randomized, controlled trial, however,” Dr. Alberti said. Several of these studies have now been performed, including the STAMPEDE trial (N Engl J Med. 2017;376:641-51) and recent studies led by Geltrude Mingrone, MD, PhD, which show major glycemic benefit (Lancet. 2015;386[9997]:P964-73) with bariatric surgery.
According to Dr. Alberti, laparoscopic adjustable gastric lap band is the easiest bariatric surgery to perform but it has fallen out of favor because of lower diabetes remission rates, compared with the other procedures. Roux-en-Y gastric bypass, sleeve gastrectomy, and biliary pancreatic diversion are all in use. Slightly higher remission rates have been shown with biliary pancreatic diversion. “There have also been consistent improvements in quality of life and cardiovascular risk factors,” he said. “Long-term follow-up is still [needed], but, in general, it seems that diabetic complications are lower than in medically treated control groups, and mortality may also be lower. The real question is, what is the impact on complications? There we have a problem, because we do not have any good randomized, controlled trials covering a 10- to 20-year period, which would give us clear evidence. There is reasonable evidence from cohort studies, though.”
Added benefits of bariatric surgery include improved quality of life, decreased blood pressure, less sleep apnea, improved cardiovascular risk factors, and better musculoskeletal function. For now, though, an unmet need persists. “The problem is that far fewer people are referred for bariatric surgery than would benefit,” Dr. Alberti said. “There are several barriers to greater use of bariatric surgery in those with diabetes. These include physician attitudes, inadequate referrals, patient perceptions, lack of awareness among patients, inadequate insurance coverage, and particularly health system capacity. There is also a lack of sympathy for overweight people in some places.”
Dr. Alberti reported having no financial disclosures.
LOS ANGELES – In the clinical experience of Kurt GMM Alberti, DPhil, FRCP, FRCPath, The problem is, far fewer people with diabetes are being referred for the surgery than would benefit from it.
At the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease, Dr. Alberti said that only about 1% of eligible patients in the United States undergo bariatric surgery, compared with just 0.22% of eligible patients in the United Kingdom.
“Obesity is an increasing problem,” said Dr. Alberti, a senior research investigator in the section of diabetes, endocrinology, and metabolism at Imperial College, London. “The United States is leading the field [in obesity], and it doesn’t seem to be going away. This is in parallel with diabetes. According to the 2019 International Diabetes Federation’s Diabetes Atlas, the diabetes prevalence worldwide is now 463 million. It’s projected to reach 578 million by 2030 and 700 million by 2045. We have a major problem.”
Lifestyle modification with diet and exercise have been the cornerstone of diabetes therapy for more than 100 years, with only modest success. “A range of oral agents have been added [and they] certainly improve glycemic control, but few achieve lasting success, and few achieve remission,” Dr. Alberti said. Findings from DiRECT (Lancet. 2018;391:541-51) and the Look AHEAD (Action for Health in Diabetes) study (N Engl J Med. 2013;369:145-54) have shown dramatic improvements in glycemia, but only in the minority of patients who achieved weight loss of 10 kg or more. “In this group, 80% achieved remission after 2 years in DiRECT,” he said. “It is uncertain whether this can be sustained long term in real life, and how many people will respond. Major community prevention programs are under way in the U.S. and [United Kingdom], but many target individuals with prediabetes. Currently, it is unknown how successful these programs will be.”
The 2018 American Diabetes Association/European Association for the Study of Diabetes clinical guidelines state that bariatric surgery is a recommended treatment option for adults with type 2 diabetes and a body mass index of either 40.0 kg/m2 or higher (or 37.5 kg/m2 or higher in people of Asian ancestry) or 35.0-39.9 kg/m2 (32.5-37.4 kg/m2 in people of Asian ancestry) and who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. According to Dr. Alberti, surgery should be an accepted option in people who have type 2 diabetes and a body mass index of 30 kg/m2 or higher, and priority should be given to adolescents, young adults, and those with a shorter duration of diabetes.
The main suggestive evidence in favor of bariatric surgery having an impact on diabetes comes from the Swedish Obese Subjects Study, which had a median follow-up of 10 years (J Intern Med. 2013;273[3]:219-34). In patients with diabetes at baseline, 30% were still in remission at 15 years after surgery. After 18 years, cumulative microvascular disease had fallen from 42 to 21 per 1,000 person-years, and macrovascular complications had fallen by 25%. “This was not a randomized, controlled trial, however,” Dr. Alberti said. Several of these studies have now been performed, including the STAMPEDE trial (N Engl J Med. 2017;376:641-51) and recent studies led by Geltrude Mingrone, MD, PhD, which show major glycemic benefit (Lancet. 2015;386[9997]:P964-73) with bariatric surgery.
According to Dr. Alberti, laparoscopic adjustable gastric lap band is the easiest bariatric surgery to perform but it has fallen out of favor because of lower diabetes remission rates, compared with the other procedures. Roux-en-Y gastric bypass, sleeve gastrectomy, and biliary pancreatic diversion are all in use. Slightly higher remission rates have been shown with biliary pancreatic diversion. “There have also been consistent improvements in quality of life and cardiovascular risk factors,” he said. “Long-term follow-up is still [needed], but, in general, it seems that diabetic complications are lower than in medically treated control groups, and mortality may also be lower. The real question is, what is the impact on complications? There we have a problem, because we do not have any good randomized, controlled trials covering a 10- to 20-year period, which would give us clear evidence. There is reasonable evidence from cohort studies, though.”
Added benefits of bariatric surgery include improved quality of life, decreased blood pressure, less sleep apnea, improved cardiovascular risk factors, and better musculoskeletal function. For now, though, an unmet need persists. “The problem is that far fewer people are referred for bariatric surgery than would benefit,” Dr. Alberti said. “There are several barriers to greater use of bariatric surgery in those with diabetes. These include physician attitudes, inadequate referrals, patient perceptions, lack of awareness among patients, inadequate insurance coverage, and particularly health system capacity. There is also a lack of sympathy for overweight people in some places.”
Dr. Alberti reported having no financial disclosures.
EXPERT ANALYSIS FROM WCIRDC 2019
Diabetes boosts bariatric surgery complications
LAS VEGAS – compared with patients without diabetes, in an analysis of more than 550,000 patients who underwent this surgery.
The analysis also showed that among patients with diabetes undergoing bariatric surgery, those with insulin-dependent diabetes had significantly higher rates of these and other complications, compared with patients with diabetes but no insulin dependence, Andrew A. Wheeler, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The specific factors driving these observations remain unknown, but may relate at least in part to the efficacy of glycemic control in patients during the months and weeks before surgery, said Dr. Wheeler, chief of metabolic and bariatric surgery at the University of Missouri in Columbia.
“Perioperative blood glucose control reflected in hemoglobin A1c may help us understand if certain patients with diabetes are at increased risk of surgical complications,” Dr. Wheeler said during his talk. “We need to see whether preoperative hemoglobin A1c tracks with the rate of complications,” he added in an interview. “Some surgeons will defer surgery until the level goes down, but right now, everyone uses a different level.”
The study by Dr. Wheeler and associates used data collected from essentially all the bariatric surgeries done at the roughly 840 U.S. centers accredited to do the surgery during 2015-2017 – a total of 555,239 patients – in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program run by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The cohort included 413,239 patients without diabetes and 136,010 with diabetes, with the remainder having an unknown status. Nearly all patients underwent either sleeve gastrectomy or gastric bypass, with significantly more patients, 74%, having sleeve gastrectomy in the group without diabetes, and 62% of those with diabetes undergoing sleeve gastrectomy.
Patients with diabetes uniformly had significantly higher rates of complications as measured by several parameters, and among those with diabetes, the complication rates were highest in those with insulin dependence. The researchers ran a multivariate analysis that controlled for many demographic and clinical variables, and found that despite these corrections, patients with diabetes, and especially those with insulin dependence, had higher relative rates of many complications that were statistically significant. In addition to the increased rates of deep surgical-site infections and 30-day ICU admissions, patients with diabetes had a 54% relatively increased rate of wound disruption, and a 29% increased relative rate of superficial surgical-site infections, compared with those without diabetes. And among patients with diabetes, those with insulin dependence had a 40% increased rate of surgical-site infections, a 74% increase in progressive renal failure, and a 39% increased rate of hospital readmission relative to patients with diabetes that was not insulin dependent, Dr. Wheeler reported.
The absolute complication rates were, in general, low. For example, the total rate of superficial plus deep surgical-site infections was less than 1% both in patients with diabetes and those without, although the rate rose above 1% in patients with insulin-dependent diabetes. The most common complication reported by Dr. Wheeler was 30-day hospital readmission, which was 4.0% in patients without diabetes, 4.8% in those with diabetes, and 6.4% in patients with insulin-dependent diabetes. The data also showed that gastric bypass led to more complications than did sleeve gastrectomy, but complications with both types of surgeries increased in patients with diabetes, compared with those without diabetes.
Dr. Wheeler had no disclosures.
SOURCE: Wheeler AA et al. Obesity Week 2019, Abstract A133.
Most bariatric surgeons believe that patients with diabetes who undergo this surgery will have more complications than will patients without diabetes, based on their anecdotal experience and findings from previous, smaller studies. But in Dr. Wheeler’s report, we see this demonstrated in an incredibly large number of patients. This is one of the first studies to use 3 years of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, which included more than half a million patients.
A randomized study involving more than 18,000 cases showed that putting bariatric surgery patients on an “enhanced recovery program” before surgery and including measures that minimized insulin resistance and catabolism perioperatively led to a substantial reduction in extended length of stay (Surg Obes Relat Dis. 2019 Nov;15[11]:1977-89). In routine care, bariatric surgeons are now often routinely using “prehabilitation” to prepare patients for surgery.
Corrigan McBride, MD , is professor of surgery and director of bariatric surgery at the University of Nebraska Medical Center in Omaha. She had no disclosures. She made these comments in an interview.
Most bariatric surgeons believe that patients with diabetes who undergo this surgery will have more complications than will patients without diabetes, based on their anecdotal experience and findings from previous, smaller studies. But in Dr. Wheeler’s report, we see this demonstrated in an incredibly large number of patients. This is one of the first studies to use 3 years of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, which included more than half a million patients.
A randomized study involving more than 18,000 cases showed that putting bariatric surgery patients on an “enhanced recovery program” before surgery and including measures that minimized insulin resistance and catabolism perioperatively led to a substantial reduction in extended length of stay (Surg Obes Relat Dis. 2019 Nov;15[11]:1977-89). In routine care, bariatric surgeons are now often routinely using “prehabilitation” to prepare patients for surgery.
Corrigan McBride, MD , is professor of surgery and director of bariatric surgery at the University of Nebraska Medical Center in Omaha. She had no disclosures. She made these comments in an interview.
Most bariatric surgeons believe that patients with diabetes who undergo this surgery will have more complications than will patients without diabetes, based on their anecdotal experience and findings from previous, smaller studies. But in Dr. Wheeler’s report, we see this demonstrated in an incredibly large number of patients. This is one of the first studies to use 3 years of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, which included more than half a million patients.
A randomized study involving more than 18,000 cases showed that putting bariatric surgery patients on an “enhanced recovery program” before surgery and including measures that minimized insulin resistance and catabolism perioperatively led to a substantial reduction in extended length of stay (Surg Obes Relat Dis. 2019 Nov;15[11]:1977-89). In routine care, bariatric surgeons are now often routinely using “prehabilitation” to prepare patients for surgery.
Corrigan McBride, MD , is professor of surgery and director of bariatric surgery at the University of Nebraska Medical Center in Omaha. She had no disclosures. She made these comments in an interview.
LAS VEGAS – compared with patients without diabetes, in an analysis of more than 550,000 patients who underwent this surgery.
The analysis also showed that among patients with diabetes undergoing bariatric surgery, those with insulin-dependent diabetes had significantly higher rates of these and other complications, compared with patients with diabetes but no insulin dependence, Andrew A. Wheeler, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The specific factors driving these observations remain unknown, but may relate at least in part to the efficacy of glycemic control in patients during the months and weeks before surgery, said Dr. Wheeler, chief of metabolic and bariatric surgery at the University of Missouri in Columbia.
“Perioperative blood glucose control reflected in hemoglobin A1c may help us understand if certain patients with diabetes are at increased risk of surgical complications,” Dr. Wheeler said during his talk. “We need to see whether preoperative hemoglobin A1c tracks with the rate of complications,” he added in an interview. “Some surgeons will defer surgery until the level goes down, but right now, everyone uses a different level.”
The study by Dr. Wheeler and associates used data collected from essentially all the bariatric surgeries done at the roughly 840 U.S. centers accredited to do the surgery during 2015-2017 – a total of 555,239 patients – in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program run by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The cohort included 413,239 patients without diabetes and 136,010 with diabetes, with the remainder having an unknown status. Nearly all patients underwent either sleeve gastrectomy or gastric bypass, with significantly more patients, 74%, having sleeve gastrectomy in the group without diabetes, and 62% of those with diabetes undergoing sleeve gastrectomy.
Patients with diabetes uniformly had significantly higher rates of complications as measured by several parameters, and among those with diabetes, the complication rates were highest in those with insulin dependence. The researchers ran a multivariate analysis that controlled for many demographic and clinical variables, and found that despite these corrections, patients with diabetes, and especially those with insulin dependence, had higher relative rates of many complications that were statistically significant. In addition to the increased rates of deep surgical-site infections and 30-day ICU admissions, patients with diabetes had a 54% relatively increased rate of wound disruption, and a 29% increased relative rate of superficial surgical-site infections, compared with those without diabetes. And among patients with diabetes, those with insulin dependence had a 40% increased rate of surgical-site infections, a 74% increase in progressive renal failure, and a 39% increased rate of hospital readmission relative to patients with diabetes that was not insulin dependent, Dr. Wheeler reported.
The absolute complication rates were, in general, low. For example, the total rate of superficial plus deep surgical-site infections was less than 1% both in patients with diabetes and those without, although the rate rose above 1% in patients with insulin-dependent diabetes. The most common complication reported by Dr. Wheeler was 30-day hospital readmission, which was 4.0% in patients without diabetes, 4.8% in those with diabetes, and 6.4% in patients with insulin-dependent diabetes. The data also showed that gastric bypass led to more complications than did sleeve gastrectomy, but complications with both types of surgeries increased in patients with diabetes, compared with those without diabetes.
Dr. Wheeler had no disclosures.
SOURCE: Wheeler AA et al. Obesity Week 2019, Abstract A133.
LAS VEGAS – compared with patients without diabetes, in an analysis of more than 550,000 patients who underwent this surgery.
The analysis also showed that among patients with diabetes undergoing bariatric surgery, those with insulin-dependent diabetes had significantly higher rates of these and other complications, compared with patients with diabetes but no insulin dependence, Andrew A. Wheeler, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The specific factors driving these observations remain unknown, but may relate at least in part to the efficacy of glycemic control in patients during the months and weeks before surgery, said Dr. Wheeler, chief of metabolic and bariatric surgery at the University of Missouri in Columbia.
“Perioperative blood glucose control reflected in hemoglobin A1c may help us understand if certain patients with diabetes are at increased risk of surgical complications,” Dr. Wheeler said during his talk. “We need to see whether preoperative hemoglobin A1c tracks with the rate of complications,” he added in an interview. “Some surgeons will defer surgery until the level goes down, but right now, everyone uses a different level.”
The study by Dr. Wheeler and associates used data collected from essentially all the bariatric surgeries done at the roughly 840 U.S. centers accredited to do the surgery during 2015-2017 – a total of 555,239 patients – in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program run by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The cohort included 413,239 patients without diabetes and 136,010 with diabetes, with the remainder having an unknown status. Nearly all patients underwent either sleeve gastrectomy or gastric bypass, with significantly more patients, 74%, having sleeve gastrectomy in the group without diabetes, and 62% of those with diabetes undergoing sleeve gastrectomy.
Patients with diabetes uniformly had significantly higher rates of complications as measured by several parameters, and among those with diabetes, the complication rates were highest in those with insulin dependence. The researchers ran a multivariate analysis that controlled for many demographic and clinical variables, and found that despite these corrections, patients with diabetes, and especially those with insulin dependence, had higher relative rates of many complications that were statistically significant. In addition to the increased rates of deep surgical-site infections and 30-day ICU admissions, patients with diabetes had a 54% relatively increased rate of wound disruption, and a 29% increased relative rate of superficial surgical-site infections, compared with those without diabetes. And among patients with diabetes, those with insulin dependence had a 40% increased rate of surgical-site infections, a 74% increase in progressive renal failure, and a 39% increased rate of hospital readmission relative to patients with diabetes that was not insulin dependent, Dr. Wheeler reported.
The absolute complication rates were, in general, low. For example, the total rate of superficial plus deep surgical-site infections was less than 1% both in patients with diabetes and those without, although the rate rose above 1% in patients with insulin-dependent diabetes. The most common complication reported by Dr. Wheeler was 30-day hospital readmission, which was 4.0% in patients without diabetes, 4.8% in those with diabetes, and 6.4% in patients with insulin-dependent diabetes. The data also showed that gastric bypass led to more complications than did sleeve gastrectomy, but complications with both types of surgeries increased in patients with diabetes, compared with those without diabetes.
Dr. Wheeler had no disclosures.
SOURCE: Wheeler AA et al. Obesity Week 2019, Abstract A133.
REPORTING FROM OBESITY WEEK 2019
Evidence builds for bariatric surgery’s role in cancer prevention
LAS VEGAS – The ability of bariatric surgery and substantial subsequent weight loss to cut the incidence of a variety of obesity-related cancers and other malignancies received further confirmation in results from two studies reported at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
In one study, 2,107 adults enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study showed a statistically significant halving of the cancer incidence during 7 years of follow-up in patients who underwent bariatric surgery and had a reduction of at least 20% in their presurgical body mass index (BMI), compared with patients in the study who underwent bariatric surgery but lost less weight, reported Andrea M. Stroud, MD, a bariatric surgeon at the Oregon Health & Science University, Portland.
In the second study, analysis of about 1.7 million hospitalized U.S. patients in the National Inpatient Sample showed that the incidence of an obesity-related cancer was 21% higher in more than 1.4 million obese individuals (BMI, 35 kg/m2 or greater) with no history of bariatric surgery, compared with nearly 247,000 people in the same database with a history of both obesity and bariatric surgery, said Juliana Henrique, MD, a bariatric surgeon at the Cleveland Clinic Florida in Weston.
The study reported by Dr. Henrique focused specifically on the 13 cancer types identified by the Centers for Disease Control and Prevention as having an incidence that links with overweight and obesity (Morb Mortal Wkly Rep. 2017;66[39]:1052-8), whereas the study presented by Dr. Stroud included all incident cancers during follow-up, but which were predominantly obesity related, with breast cancer – an obesity-related malignancy – having the highest incidence. Overall, 40% of all U.S. cancers in 2014 were obesity related, according to the CDC’s report.
“A number of studies have shown decreases in cancer rates after bariatric surgery, especially female cancers like breast and ovarian,” commented John Scott, MD, director of metabolic and bariatric surgery for Prism Health–Upstate in Greenville, S.C. “These two reports build on that.”
The evidence for weight loss after bariatric surgery as a means to cut the risk of a first or recurrent cancer has become strong enough for some patients to see cancer prophylaxis as a prime reason to undergo the procedure, said surgeons at the meeting.
Bariatric surgery and subsequent weight loss “is a substantial preventive factor for cancer, especially in patients who have obesity and diabetes,” commented Theresa LaMasters, MD, a bariatric surgeon in West Des Moines, Iowa. “It might not just be weight loss. It’s likely a multifactorial effect, including reduced inflammation after bariatric surgery, but weight loss is a component” of the effect, Dr. LaMasters said in an interview. It is now common for her to see patients seeking bariatric surgery because of a family or personal history of cancer. “Patients are trying to reduce their future risk” for cancer with bariatric surgery, she added.
The LABS-2 study enrolled 2,458 patients who were part of the first LABS cohort, LABS-1, but followed them longer term. The data Dr. Stroud reported came from 2,107 of the LABS-2 patients without a history of cancer, no cancer diagnosed in the first year after bariatric surgery, and longer-term follow-up of 7 years. About three-quarters of the patients underwent gastric bypass, with the rest undergoing laparoscopic gastric band placement. Nearly half of those included had diabetes. Their average BMI was 45-50 kg/m2.
Dr. Stroud and associates ran an analysis that divided the populations into tertiles based on percentage of baseline body mass lost at 12 months after surgery and cancer-free survival during the 7 years after the 12-month follow-up. The incidence of cancer was 51% lower in patients who lost 20%-34% of their BMI, compared with those who lost less than 20%, a statistically significant difference, and patients who lost 35% or more of their BMI had a 31% reduced cancer rate, compared with those who lost less than 20%, a difference that was not statistically significant, Dr. Stroud reported. The patients who lost less weight after surgery mostly underwent gastric banding, whereas those who lost more mostly underwent gastric bypass.
The analysis reported by Dr. Henrique used data collected in the U.S. National Inpatient Sample during 2010-2014, which totaled more than 7 million patients hospitalized for cancer, including 1,423,367 with a history of obesity and 246,668 with obesity who had undergone bariatric surgery. Those without bariatric surgery had a 21% higher rate of developing obesity-related cancers after adjustment for many baseline demographic and clinical features, Dr. Henrique said. The cancer protection after bariatric surgery was especially notable in the subset of patients in the sample with a genetic predisposition to developing cancer.
LABS-1 and LABS-2 were funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Stroud and Dr. Henrique had no disclosures.
SOURCES: Stroud AM et al. Obesity Week, Abstract A107; Henrique J et al. Obesity Week, Abstract A108.
LAS VEGAS – The ability of bariatric surgery and substantial subsequent weight loss to cut the incidence of a variety of obesity-related cancers and other malignancies received further confirmation in results from two studies reported at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
In one study, 2,107 adults enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study showed a statistically significant halving of the cancer incidence during 7 years of follow-up in patients who underwent bariatric surgery and had a reduction of at least 20% in their presurgical body mass index (BMI), compared with patients in the study who underwent bariatric surgery but lost less weight, reported Andrea M. Stroud, MD, a bariatric surgeon at the Oregon Health & Science University, Portland.
In the second study, analysis of about 1.7 million hospitalized U.S. patients in the National Inpatient Sample showed that the incidence of an obesity-related cancer was 21% higher in more than 1.4 million obese individuals (BMI, 35 kg/m2 or greater) with no history of bariatric surgery, compared with nearly 247,000 people in the same database with a history of both obesity and bariatric surgery, said Juliana Henrique, MD, a bariatric surgeon at the Cleveland Clinic Florida in Weston.
The study reported by Dr. Henrique focused specifically on the 13 cancer types identified by the Centers for Disease Control and Prevention as having an incidence that links with overweight and obesity (Morb Mortal Wkly Rep. 2017;66[39]:1052-8), whereas the study presented by Dr. Stroud included all incident cancers during follow-up, but which were predominantly obesity related, with breast cancer – an obesity-related malignancy – having the highest incidence. Overall, 40% of all U.S. cancers in 2014 were obesity related, according to the CDC’s report.
“A number of studies have shown decreases in cancer rates after bariatric surgery, especially female cancers like breast and ovarian,” commented John Scott, MD, director of metabolic and bariatric surgery for Prism Health–Upstate in Greenville, S.C. “These two reports build on that.”
The evidence for weight loss after bariatric surgery as a means to cut the risk of a first or recurrent cancer has become strong enough for some patients to see cancer prophylaxis as a prime reason to undergo the procedure, said surgeons at the meeting.
Bariatric surgery and subsequent weight loss “is a substantial preventive factor for cancer, especially in patients who have obesity and diabetes,” commented Theresa LaMasters, MD, a bariatric surgeon in West Des Moines, Iowa. “It might not just be weight loss. It’s likely a multifactorial effect, including reduced inflammation after bariatric surgery, but weight loss is a component” of the effect, Dr. LaMasters said in an interview. It is now common for her to see patients seeking bariatric surgery because of a family or personal history of cancer. “Patients are trying to reduce their future risk” for cancer with bariatric surgery, she added.
The LABS-2 study enrolled 2,458 patients who were part of the first LABS cohort, LABS-1, but followed them longer term. The data Dr. Stroud reported came from 2,107 of the LABS-2 patients without a history of cancer, no cancer diagnosed in the first year after bariatric surgery, and longer-term follow-up of 7 years. About three-quarters of the patients underwent gastric bypass, with the rest undergoing laparoscopic gastric band placement. Nearly half of those included had diabetes. Their average BMI was 45-50 kg/m2.
Dr. Stroud and associates ran an analysis that divided the populations into tertiles based on percentage of baseline body mass lost at 12 months after surgery and cancer-free survival during the 7 years after the 12-month follow-up. The incidence of cancer was 51% lower in patients who lost 20%-34% of their BMI, compared with those who lost less than 20%, a statistically significant difference, and patients who lost 35% or more of their BMI had a 31% reduced cancer rate, compared with those who lost less than 20%, a difference that was not statistically significant, Dr. Stroud reported. The patients who lost less weight after surgery mostly underwent gastric banding, whereas those who lost more mostly underwent gastric bypass.
The analysis reported by Dr. Henrique used data collected in the U.S. National Inpatient Sample during 2010-2014, which totaled more than 7 million patients hospitalized for cancer, including 1,423,367 with a history of obesity and 246,668 with obesity who had undergone bariatric surgery. Those without bariatric surgery had a 21% higher rate of developing obesity-related cancers after adjustment for many baseline demographic and clinical features, Dr. Henrique said. The cancer protection after bariatric surgery was especially notable in the subset of patients in the sample with a genetic predisposition to developing cancer.
LABS-1 and LABS-2 were funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Stroud and Dr. Henrique had no disclosures.
SOURCES: Stroud AM et al. Obesity Week, Abstract A107; Henrique J et al. Obesity Week, Abstract A108.
LAS VEGAS – The ability of bariatric surgery and substantial subsequent weight loss to cut the incidence of a variety of obesity-related cancers and other malignancies received further confirmation in results from two studies reported at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
In one study, 2,107 adults enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study showed a statistically significant halving of the cancer incidence during 7 years of follow-up in patients who underwent bariatric surgery and had a reduction of at least 20% in their presurgical body mass index (BMI), compared with patients in the study who underwent bariatric surgery but lost less weight, reported Andrea M. Stroud, MD, a bariatric surgeon at the Oregon Health & Science University, Portland.
In the second study, analysis of about 1.7 million hospitalized U.S. patients in the National Inpatient Sample showed that the incidence of an obesity-related cancer was 21% higher in more than 1.4 million obese individuals (BMI, 35 kg/m2 or greater) with no history of bariatric surgery, compared with nearly 247,000 people in the same database with a history of both obesity and bariatric surgery, said Juliana Henrique, MD, a bariatric surgeon at the Cleveland Clinic Florida in Weston.
The study reported by Dr. Henrique focused specifically on the 13 cancer types identified by the Centers for Disease Control and Prevention as having an incidence that links with overweight and obesity (Morb Mortal Wkly Rep. 2017;66[39]:1052-8), whereas the study presented by Dr. Stroud included all incident cancers during follow-up, but which were predominantly obesity related, with breast cancer – an obesity-related malignancy – having the highest incidence. Overall, 40% of all U.S. cancers in 2014 were obesity related, according to the CDC’s report.
“A number of studies have shown decreases in cancer rates after bariatric surgery, especially female cancers like breast and ovarian,” commented John Scott, MD, director of metabolic and bariatric surgery for Prism Health–Upstate in Greenville, S.C. “These two reports build on that.”
The evidence for weight loss after bariatric surgery as a means to cut the risk of a first or recurrent cancer has become strong enough for some patients to see cancer prophylaxis as a prime reason to undergo the procedure, said surgeons at the meeting.
Bariatric surgery and subsequent weight loss “is a substantial preventive factor for cancer, especially in patients who have obesity and diabetes,” commented Theresa LaMasters, MD, a bariatric surgeon in West Des Moines, Iowa. “It might not just be weight loss. It’s likely a multifactorial effect, including reduced inflammation after bariatric surgery, but weight loss is a component” of the effect, Dr. LaMasters said in an interview. It is now common for her to see patients seeking bariatric surgery because of a family or personal history of cancer. “Patients are trying to reduce their future risk” for cancer with bariatric surgery, she added.
The LABS-2 study enrolled 2,458 patients who were part of the first LABS cohort, LABS-1, but followed them longer term. The data Dr. Stroud reported came from 2,107 of the LABS-2 patients without a history of cancer, no cancer diagnosed in the first year after bariatric surgery, and longer-term follow-up of 7 years. About three-quarters of the patients underwent gastric bypass, with the rest undergoing laparoscopic gastric band placement. Nearly half of those included had diabetes. Their average BMI was 45-50 kg/m2.
Dr. Stroud and associates ran an analysis that divided the populations into tertiles based on percentage of baseline body mass lost at 12 months after surgery and cancer-free survival during the 7 years after the 12-month follow-up. The incidence of cancer was 51% lower in patients who lost 20%-34% of their BMI, compared with those who lost less than 20%, a statistically significant difference, and patients who lost 35% or more of their BMI had a 31% reduced cancer rate, compared with those who lost less than 20%, a difference that was not statistically significant, Dr. Stroud reported. The patients who lost less weight after surgery mostly underwent gastric banding, whereas those who lost more mostly underwent gastric bypass.
The analysis reported by Dr. Henrique used data collected in the U.S. National Inpatient Sample during 2010-2014, which totaled more than 7 million patients hospitalized for cancer, including 1,423,367 with a history of obesity and 246,668 with obesity who had undergone bariatric surgery. Those without bariatric surgery had a 21% higher rate of developing obesity-related cancers after adjustment for many baseline demographic and clinical features, Dr. Henrique said. The cancer protection after bariatric surgery was especially notable in the subset of patients in the sample with a genetic predisposition to developing cancer.
LABS-1 and LABS-2 were funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Stroud and Dr. Henrique had no disclosures.
SOURCES: Stroud AM et al. Obesity Week, Abstract A107; Henrique J et al. Obesity Week, Abstract A108.
REPORTING FROM OBESITY WEEK 2019
Bariatric surgery candidates show high prevalence of thrombophilia
LAS VEGAS – More than half the patients seeking laparoscopic sleeve gastrectomy at a pair of large U.S. programs tested positive for thrombophilia, and for most of these patients, their thrombophilia stemmed from an abnormally elevated level of clotting factor VIII. This thrombophilia seemed to link with a small, but potentially meaningful, excess of portomesenteric venous thrombosis that could warrant treating patients with an anticoagulation regimen for an extended, 30-day period post surgery, Manish S. Parikh, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Although measurement of factor VIII excess can be done with a test that costs about $25, Dr. Parikh suggested that giving extended, 30-day anticoagulant prophylaxis to all patients undergoing laparoscopic sleeve gastrectomy (LSG) is a reasonable alternative to screening all patients first. “You could use our data to support 30-day prophylaxis for all LSG patients,” said Dr. Parikh, a metabolic and bariatric surgeon at NYU Langone Health in New York. He acknowledged that some logistic barriers can hamper the efficacy of extended prophylaxis.
The factor VIII elevations seen in many of these obese patients seeking metabolic surgery seems to be inherent and independent of their current weight. Although Dr. Parikh and his associates do not have long-term follow-up for all their LSG patients, “we’ve followed some patients, and their factor VIII is still elevated years later, after they’ve lost weight. We encourage lifelong anticoagulation [for these patients] because of their high risk for recurrent clot. This reflects their factor VIII and is independent of weight,” he said.
For their study, the researchers considered a factor VIII level above 150% of the normal level as abnormally elevated and prothrombotic.
The increased rate of portomesenteric venous thrombosis (PMVT) seen in the thrombophilic patients after LSG “is strongly related to the sleeve specifically,” added Dr. Parikh. He suggested that “something related to redirection of blood flow by taking the branches of the gastroepiploic arcade may lead to this.”
The interest of Dr. Parikh and his associates in thrombophilia and factor VIII excess began with a review they ran of more than 25,000 patients who underwent bariatric surgery at six U.S. centers during 2006-2016 that identified 40 patients who developed PMVT, all from the subgroup of nearly 10,000 patients who had LSG for their bariatric procedure. The prevalence of thrombophilia among those 40 patients with PMVT was 92%, with 76% having excess factor VIII (Surg Obes Relat Dis. 2017;13[11]:1835-9).
Based on those findings, the researchers began a practice of prospectively testing for thrombophilia in all patients who were assessed for LSG at two New York centers during August 2018–March 2019, a total of 1,075 patients, of whom 745 subsequently underwent the procedure. They tested the patients for factor VIII and four additional proteins in the clotting cascade that flag thrombophilia, a test panel that cost $103 per patient. That identified 563 surgery candidates (52%) with any thrombophilia, of whom 92% had excess factor VIII (48% of the total cohort of 1,075). Those patients received an extended, 30-day anticoagulant regimen.
To estimate the impact of this approach, the researchers compared the incidence of PMVT among the recent 745 patients who underwent LSG with a historic control group of 4,228 patients who underwent LSG at the two centers during the 4.5 years before routine thrombophilia screening. None of those 4,228 controls received extended anticoagulation.
During 30-day follow-up, 1 patient in the recent group of 745 patients (0.1%) developed PMVT, whereas 18 of the controls (0.4%) had PMVT. The incidence of bleeding was 0.6% in the recent patients and 0.4% in the controls. The researchers did not report a statistical analysis of these data, because the number of PMVT episodes was too small to allow reliable calculations, Dr. Parikh said. He also cautioned that the generalizability of the finding of thrombophilia prevalence is uncertain because the study population of 1,075 patients considering LSG was 84% Hispanic and 15% non-Hispanic African American.
Dr. Parikh had no disclosures.
SOURCE: Parikh MS et al. Obesity Week 2019, Abstract A109.
Vivek N. Prachand, MD , is professor of surgery and director of minimally invasive surgery at the University of Chicago. He had no disclosures. He made these comments as designated discussant for the report.
Vivek N. Prachand, MD , is professor of surgery and director of minimally invasive surgery at the University of Chicago. He had no disclosures. He made these comments as designated discussant for the report.
Vivek N. Prachand, MD , is professor of surgery and director of minimally invasive surgery at the University of Chicago. He had no disclosures. He made these comments as designated discussant for the report.
LAS VEGAS – More than half the patients seeking laparoscopic sleeve gastrectomy at a pair of large U.S. programs tested positive for thrombophilia, and for most of these patients, their thrombophilia stemmed from an abnormally elevated level of clotting factor VIII. This thrombophilia seemed to link with a small, but potentially meaningful, excess of portomesenteric venous thrombosis that could warrant treating patients with an anticoagulation regimen for an extended, 30-day period post surgery, Manish S. Parikh, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Although measurement of factor VIII excess can be done with a test that costs about $25, Dr. Parikh suggested that giving extended, 30-day anticoagulant prophylaxis to all patients undergoing laparoscopic sleeve gastrectomy (LSG) is a reasonable alternative to screening all patients first. “You could use our data to support 30-day prophylaxis for all LSG patients,” said Dr. Parikh, a metabolic and bariatric surgeon at NYU Langone Health in New York. He acknowledged that some logistic barriers can hamper the efficacy of extended prophylaxis.
The factor VIII elevations seen in many of these obese patients seeking metabolic surgery seems to be inherent and independent of their current weight. Although Dr. Parikh and his associates do not have long-term follow-up for all their LSG patients, “we’ve followed some patients, and their factor VIII is still elevated years later, after they’ve lost weight. We encourage lifelong anticoagulation [for these patients] because of their high risk for recurrent clot. This reflects their factor VIII and is independent of weight,” he said.
For their study, the researchers considered a factor VIII level above 150% of the normal level as abnormally elevated and prothrombotic.
The increased rate of portomesenteric venous thrombosis (PMVT) seen in the thrombophilic patients after LSG “is strongly related to the sleeve specifically,” added Dr. Parikh. He suggested that “something related to redirection of blood flow by taking the branches of the gastroepiploic arcade may lead to this.”
The interest of Dr. Parikh and his associates in thrombophilia and factor VIII excess began with a review they ran of more than 25,000 patients who underwent bariatric surgery at six U.S. centers during 2006-2016 that identified 40 patients who developed PMVT, all from the subgroup of nearly 10,000 patients who had LSG for their bariatric procedure. The prevalence of thrombophilia among those 40 patients with PMVT was 92%, with 76% having excess factor VIII (Surg Obes Relat Dis. 2017;13[11]:1835-9).
Based on those findings, the researchers began a practice of prospectively testing for thrombophilia in all patients who were assessed for LSG at two New York centers during August 2018–March 2019, a total of 1,075 patients, of whom 745 subsequently underwent the procedure. They tested the patients for factor VIII and four additional proteins in the clotting cascade that flag thrombophilia, a test panel that cost $103 per patient. That identified 563 surgery candidates (52%) with any thrombophilia, of whom 92% had excess factor VIII (48% of the total cohort of 1,075). Those patients received an extended, 30-day anticoagulant regimen.
To estimate the impact of this approach, the researchers compared the incidence of PMVT among the recent 745 patients who underwent LSG with a historic control group of 4,228 patients who underwent LSG at the two centers during the 4.5 years before routine thrombophilia screening. None of those 4,228 controls received extended anticoagulation.
During 30-day follow-up, 1 patient in the recent group of 745 patients (0.1%) developed PMVT, whereas 18 of the controls (0.4%) had PMVT. The incidence of bleeding was 0.6% in the recent patients and 0.4% in the controls. The researchers did not report a statistical analysis of these data, because the number of PMVT episodes was too small to allow reliable calculations, Dr. Parikh said. He also cautioned that the generalizability of the finding of thrombophilia prevalence is uncertain because the study population of 1,075 patients considering LSG was 84% Hispanic and 15% non-Hispanic African American.
Dr. Parikh had no disclosures.
SOURCE: Parikh MS et al. Obesity Week 2019, Abstract A109.
LAS VEGAS – More than half the patients seeking laparoscopic sleeve gastrectomy at a pair of large U.S. programs tested positive for thrombophilia, and for most of these patients, their thrombophilia stemmed from an abnormally elevated level of clotting factor VIII. This thrombophilia seemed to link with a small, but potentially meaningful, excess of portomesenteric venous thrombosis that could warrant treating patients with an anticoagulation regimen for an extended, 30-day period post surgery, Manish S. Parikh, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Although measurement of factor VIII excess can be done with a test that costs about $25, Dr. Parikh suggested that giving extended, 30-day anticoagulant prophylaxis to all patients undergoing laparoscopic sleeve gastrectomy (LSG) is a reasonable alternative to screening all patients first. “You could use our data to support 30-day prophylaxis for all LSG patients,” said Dr. Parikh, a metabolic and bariatric surgeon at NYU Langone Health in New York. He acknowledged that some logistic barriers can hamper the efficacy of extended prophylaxis.
The factor VIII elevations seen in many of these obese patients seeking metabolic surgery seems to be inherent and independent of their current weight. Although Dr. Parikh and his associates do not have long-term follow-up for all their LSG patients, “we’ve followed some patients, and their factor VIII is still elevated years later, after they’ve lost weight. We encourage lifelong anticoagulation [for these patients] because of their high risk for recurrent clot. This reflects their factor VIII and is independent of weight,” he said.
For their study, the researchers considered a factor VIII level above 150% of the normal level as abnormally elevated and prothrombotic.
The increased rate of portomesenteric venous thrombosis (PMVT) seen in the thrombophilic patients after LSG “is strongly related to the sleeve specifically,” added Dr. Parikh. He suggested that “something related to redirection of blood flow by taking the branches of the gastroepiploic arcade may lead to this.”
The interest of Dr. Parikh and his associates in thrombophilia and factor VIII excess began with a review they ran of more than 25,000 patients who underwent bariatric surgery at six U.S. centers during 2006-2016 that identified 40 patients who developed PMVT, all from the subgroup of nearly 10,000 patients who had LSG for their bariatric procedure. The prevalence of thrombophilia among those 40 patients with PMVT was 92%, with 76% having excess factor VIII (Surg Obes Relat Dis. 2017;13[11]:1835-9).
Based on those findings, the researchers began a practice of prospectively testing for thrombophilia in all patients who were assessed for LSG at two New York centers during August 2018–March 2019, a total of 1,075 patients, of whom 745 subsequently underwent the procedure. They tested the patients for factor VIII and four additional proteins in the clotting cascade that flag thrombophilia, a test panel that cost $103 per patient. That identified 563 surgery candidates (52%) with any thrombophilia, of whom 92% had excess factor VIII (48% of the total cohort of 1,075). Those patients received an extended, 30-day anticoagulant regimen.
To estimate the impact of this approach, the researchers compared the incidence of PMVT among the recent 745 patients who underwent LSG with a historic control group of 4,228 patients who underwent LSG at the two centers during the 4.5 years before routine thrombophilia screening. None of those 4,228 controls received extended anticoagulation.
During 30-day follow-up, 1 patient in the recent group of 745 patients (0.1%) developed PMVT, whereas 18 of the controls (0.4%) had PMVT. The incidence of bleeding was 0.6% in the recent patients and 0.4% in the controls. The researchers did not report a statistical analysis of these data, because the number of PMVT episodes was too small to allow reliable calculations, Dr. Parikh said. He also cautioned that the generalizability of the finding of thrombophilia prevalence is uncertain because the study population of 1,075 patients considering LSG was 84% Hispanic and 15% non-Hispanic African American.
Dr. Parikh had no disclosures.
SOURCE: Parikh MS et al. Obesity Week 2019, Abstract A109.
REPORTING FROM OBESITY WEEK 2019
Score predicts bariatric surgery’s benefits for obesity, type 2 diabetes
LAS VEGAS –
The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.
The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.
“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.
The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m2 or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m2), and the prevalence of various comorbidities at baseline.
Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).
The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.
The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.
The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.
The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.
SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.
LAS VEGAS –
The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.
The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.
“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.
The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m2 or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m2), and the prevalence of various comorbidities at baseline.
Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).
The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.
The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.
The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.
The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.
SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.
LAS VEGAS –
The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.
The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.
“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.
The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m2 or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m2), and the prevalence of various comorbidities at baseline.
Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).
The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.
The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.
The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.
The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.
SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.
REPORTING FROM OBESITY WEEK 2019
Bariatric surgery tied to fewer cerebrovascular events
PHILADELPHIA – Obese people living in the United Kingdom who underwent bariatric surgery had a two-thirds lower rate of major cerebrovascular events than that of a matched group of obese residents who did not undergo bariatric surgery, in a retrospective study of 8,424 people followed for a mean of just over 11 years.
Although the cut in cerebrovascular events that linked with bariatric surgery shown by the analysis was mostly driven by a reduced rate of transient ischemic attacks, a potentially unreliable diagnosis, the results showed consistent reductions in the rates of acute ischemic strokes as well as in acute, nontraumatic intracranial hemorrhages, two other components of the combined primary endpoint, Maddalena Ardissino, MBBS, said at the American Heart Association scientific sessions.
This finding of an apparent benefit from bariatric surgery in obese patients in a large U.K. database confirms other findings from a “fast-growing” evidence base showing benefits from bariatric surgery for reducing other types of cardiovascular disease events, said Dr. Ardissino, a researcher at Imperial College, London. However, the impact of bariatric surgery specifically on cerebrovascular events had not received much attention in published studies, she noted.
Her study used data collected by the Clinical Practice Research Datalink, which has primary and secondary care health records for about 42 million U.K. residents. The researchers focused on more than 251,000 obese U.K. adults (body mass index of 30 kg/m2 or greater) without a history of a cerebrovascular event who had at least 1 year of follow-up, a data file that included 4,212 adults who had undergone bariatric surgery. Their analysis matched these surgical patients with an equal number of obese adults who did not have surgery, pairing the cases and controls based on age, sex, and BMI. The resulting matched cohorts each averaged 50 years old, with a mean BMI of 40.5 kg/m2.
During just over 11 years of average follow-up, the incidence of acute ischemic stroke, acute intracranial hemorrhage, subarachnoid hemorrhage, or transient ischemic attack was about 1.3% in those without bariatric surgery and about 0.4% in those who had surgery, an absolute risk reduction of 0.9 linked with surgery and a relative risk reduction of 65% that was statistically significant, Dr. Ardissino reported. All-cause mortality was about 70% lower in the group that underwent bariatric surgery compared with those who did not have surgery, a finding that confirmed prior reports. She cautioned that the analysis was limited by a relatively low number of total events, and by the small number of criteria used for cohort matching that might have left unadjusted certain potential confounders such as the level of engagement people had with their medical care.
SOURCE: Ardissino M. AHA 2019, Abstract 335.
PHILADELPHIA – Obese people living in the United Kingdom who underwent bariatric surgery had a two-thirds lower rate of major cerebrovascular events than that of a matched group of obese residents who did not undergo bariatric surgery, in a retrospective study of 8,424 people followed for a mean of just over 11 years.
Although the cut in cerebrovascular events that linked with bariatric surgery shown by the analysis was mostly driven by a reduced rate of transient ischemic attacks, a potentially unreliable diagnosis, the results showed consistent reductions in the rates of acute ischemic strokes as well as in acute, nontraumatic intracranial hemorrhages, two other components of the combined primary endpoint, Maddalena Ardissino, MBBS, said at the American Heart Association scientific sessions.
This finding of an apparent benefit from bariatric surgery in obese patients in a large U.K. database confirms other findings from a “fast-growing” evidence base showing benefits from bariatric surgery for reducing other types of cardiovascular disease events, said Dr. Ardissino, a researcher at Imperial College, London. However, the impact of bariatric surgery specifically on cerebrovascular events had not received much attention in published studies, she noted.
Her study used data collected by the Clinical Practice Research Datalink, which has primary and secondary care health records for about 42 million U.K. residents. The researchers focused on more than 251,000 obese U.K. adults (body mass index of 30 kg/m2 or greater) without a history of a cerebrovascular event who had at least 1 year of follow-up, a data file that included 4,212 adults who had undergone bariatric surgery. Their analysis matched these surgical patients with an equal number of obese adults who did not have surgery, pairing the cases and controls based on age, sex, and BMI. The resulting matched cohorts each averaged 50 years old, with a mean BMI of 40.5 kg/m2.
During just over 11 years of average follow-up, the incidence of acute ischemic stroke, acute intracranial hemorrhage, subarachnoid hemorrhage, or transient ischemic attack was about 1.3% in those without bariatric surgery and about 0.4% in those who had surgery, an absolute risk reduction of 0.9 linked with surgery and a relative risk reduction of 65% that was statistically significant, Dr. Ardissino reported. All-cause mortality was about 70% lower in the group that underwent bariatric surgery compared with those who did not have surgery, a finding that confirmed prior reports. She cautioned that the analysis was limited by a relatively low number of total events, and by the small number of criteria used for cohort matching that might have left unadjusted certain potential confounders such as the level of engagement people had with their medical care.
SOURCE: Ardissino M. AHA 2019, Abstract 335.
PHILADELPHIA – Obese people living in the United Kingdom who underwent bariatric surgery had a two-thirds lower rate of major cerebrovascular events than that of a matched group of obese residents who did not undergo bariatric surgery, in a retrospective study of 8,424 people followed for a mean of just over 11 years.
Although the cut in cerebrovascular events that linked with bariatric surgery shown by the analysis was mostly driven by a reduced rate of transient ischemic attacks, a potentially unreliable diagnosis, the results showed consistent reductions in the rates of acute ischemic strokes as well as in acute, nontraumatic intracranial hemorrhages, two other components of the combined primary endpoint, Maddalena Ardissino, MBBS, said at the American Heart Association scientific sessions.
This finding of an apparent benefit from bariatric surgery in obese patients in a large U.K. database confirms other findings from a “fast-growing” evidence base showing benefits from bariatric surgery for reducing other types of cardiovascular disease events, said Dr. Ardissino, a researcher at Imperial College, London. However, the impact of bariatric surgery specifically on cerebrovascular events had not received much attention in published studies, she noted.
Her study used data collected by the Clinical Practice Research Datalink, which has primary and secondary care health records for about 42 million U.K. residents. The researchers focused on more than 251,000 obese U.K. adults (body mass index of 30 kg/m2 or greater) without a history of a cerebrovascular event who had at least 1 year of follow-up, a data file that included 4,212 adults who had undergone bariatric surgery. Their analysis matched these surgical patients with an equal number of obese adults who did not have surgery, pairing the cases and controls based on age, sex, and BMI. The resulting matched cohorts each averaged 50 years old, with a mean BMI of 40.5 kg/m2.
During just over 11 years of average follow-up, the incidence of acute ischemic stroke, acute intracranial hemorrhage, subarachnoid hemorrhage, or transient ischemic attack was about 1.3% in those without bariatric surgery and about 0.4% in those who had surgery, an absolute risk reduction of 0.9 linked with surgery and a relative risk reduction of 65% that was statistically significant, Dr. Ardissino reported. All-cause mortality was about 70% lower in the group that underwent bariatric surgery compared with those who did not have surgery, a finding that confirmed prior reports. She cautioned that the analysis was limited by a relatively low number of total events, and by the small number of criteria used for cohort matching that might have left unadjusted certain potential confounders such as the level of engagement people had with their medical care.
SOURCE: Ardissino M. AHA 2019, Abstract 335.
REPORTING FROM AHA 2019
Bariatric surgery shows metabolic benefits in lower-BMI patients
LAS VEGAS – It’s time to take bariatric out of bariatric surgery.
“The way forward is to not call it bariatric surgery or weight-loss surgery but surgery to treat diabetes, hypertension, hyperlipidemia, and other metabolic diseases,” said Oliver A. Varban, MD, at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “We need to reframe the conversation with patients about what success [with bariatric surgery] looks like. Weight loss can be a side effect of the operation if patients have surgery to resolve their diabetes. It’s not about BMI; it’s about treating metabolic disease.”
Dr. Varban, a bariatric surgeon at the University of Michigan in Ann Arbor, reported data showing that bariatric surgery with sleeve gastrectomy in patients with baseline body mass index (BMI) levels below 35 kg/m2 was as effective at normalizing a range of metabolically associated disorders as it was in more obese patients in an observational study of more than 45,000 patients who underwent surgery in Michigan.
The findings add to an already extensive pool of evidence for loosening current guidelines that restrict bariatric surgery to patients with a BMI of 35 kg/m2 or greater, Dr. Varban said. But an influential bariatric surgery consensus statement from the National Institutes of Health that dates from 1991 and remains in place, recommends this surgery only for people with a BMI of at least 35 kg/m2, and this guidance often limits access to the surgery for patients at lower BMI, he noted.
A more inclusive assessment of patients as potential candidates for bariatric surgery should include a range of considerations in addition to weight and height, he explained in an interview. “Even if people have a BMI of less than 30 kg/m2 but have, or are at high risk for developing, metabolic disease, they should also be offered the operation.”
The guidance from the NIH results in a U.S. bariatric surgery population that effectively centers mainly on women with a BMI of 40 kg/m2 or greater and makes procedures like sleeve gastrectomy unavailable to many other types of patients who could benefit from it, Dr. Varban said. In 2018, the American Society for Metabolic and Bariatric Surgery released a position statement that summarized the evidence for the safety and efficacy of bariatric surgery in people with a BMI of 30-34 kg/m2, and cited the lingering and restrictive impact of the 1991 NIH consensus statement.
The study run by Dr. Varban and his associates used data collected by 43 programs in the Michigan Bariatric Surgery Collaborative during 2006-2018 that included 1,073 patients who had a BMI of less than 35 kg/m2 on the day they underwent sleeve gastrectomy, and 44,511 patients who had the same procedure and had a BMI of at least 35 kg/m2. The operations were performed by any one of 81 surgeons who worked at the centers during this time.
The patients with lower BMIs were older, with an average age of 51 years, compared with 45 years in the higher-BMI group, and they had higher prevalences of certain metabolic disorders. Diabetes affected 37% of those in the lower-BMI group and 31% of those with higher BMIs; hyperlipidemia affected 57% and 45%, respectively; and gastroesophageal reflux disease affected 56% and 49%, respectively. Obstructive sleep apnea was more common in the group with higher BMIs, at 47%, compared with 41% of those with lower BMIs.
The average BMI in the lower group was 33.7 kg/m2; in the higher group it was 46.7 kg/m2. Dr. Varban did not have data on whether any patients in the lower-BMI group had a BMI below 30 kg/m2. Roughly a third of the patients in the lower-BMI group had a BMI of less than 35 kg/m2 at the time of their initial examination, whereas the other two-thirds had a BMI that low only on the day of their surgery.At follow-up 1 year after their surgery, patients who started with lower BMIs had, in general, a very similar pattern of responses as those who started with higher BMIs, with rates of discontinuation of treatments for diabetes, hypertension, hyperlipidemia, obstructive sleep apnea, and gastroesophageal reflux of about 50%-80% and similar in both treatment arms. For example, discontinuation of oral diabetes drugs occurred in 79% and 78% of those with low and high BMIs, respectively, and discontinuation of hypertension medications occurred in 60% and 54%, respectively. Although the average absolute weight loss in the patients with lower BMIs was nearly half that of patients with higher starting BMIs, a much greater percentage of patients in the lower-BMI group achieved a BMI of less than 25 kg/m2, compared with the higher-BMI group (36% vs. 6%, respectively).
Patients from the lower-BMI group also showed high levels of satisfaction with their surgery and its results after 1 year. Questionnaire results from roughly half the patients in each treatment group showed that 90% were very satisfied in the lower-BMI group, compared with 84% of those who began with higher BMIs, with a dissatisfaction rate of 1% and 2%, respectively. The average body-image score at 1 year follow-up was significantly higher in those who started with lower BMIs. The rate of complications was low and similar in the two groups, with a 6% rate in the lower-BMI group and 5% in those with higher BMIs.
The study received no commercial funding. Dr. Varban receives salary support from Blue Cross Blue Shield of Michigan.
SOURCE: Varban et al. Obesity Week 2019, Abstract A105.
This article was updated 11/8/2020.
This is a very important topic and study, and its findings are very positive and reinforcing for more liberal use of bariatric surgery. Results from several prior studies had documented the safety and efficacy of bariatric surgery in patients with lower body mass index, and its fantastic to now have additional data that show the same outcomes. A major challenge is making patients and more physicians aware of the range of comorbidities that can be effectively managed with bariatric surgery, even in patients with lower body mass index.
Mona Misra, MD, is associate director of the Bariatric Program at Cedars-Sinai Marina Del Rey Hospital in Los Angeles. She had no relevant disclosures. She made these comments as designated discussant for the study.
This is a very important topic and study, and its findings are very positive and reinforcing for more liberal use of bariatric surgery. Results from several prior studies had documented the safety and efficacy of bariatric surgery in patients with lower body mass index, and its fantastic to now have additional data that show the same outcomes. A major challenge is making patients and more physicians aware of the range of comorbidities that can be effectively managed with bariatric surgery, even in patients with lower body mass index.
Mona Misra, MD, is associate director of the Bariatric Program at Cedars-Sinai Marina Del Rey Hospital in Los Angeles. She had no relevant disclosures. She made these comments as designated discussant for the study.
This is a very important topic and study, and its findings are very positive and reinforcing for more liberal use of bariatric surgery. Results from several prior studies had documented the safety and efficacy of bariatric surgery in patients with lower body mass index, and its fantastic to now have additional data that show the same outcomes. A major challenge is making patients and more physicians aware of the range of comorbidities that can be effectively managed with bariatric surgery, even in patients with lower body mass index.
Mona Misra, MD, is associate director of the Bariatric Program at Cedars-Sinai Marina Del Rey Hospital in Los Angeles. She had no relevant disclosures. She made these comments as designated discussant for the study.
LAS VEGAS – It’s time to take bariatric out of bariatric surgery.
“The way forward is to not call it bariatric surgery or weight-loss surgery but surgery to treat diabetes, hypertension, hyperlipidemia, and other metabolic diseases,” said Oliver A. Varban, MD, at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “We need to reframe the conversation with patients about what success [with bariatric surgery] looks like. Weight loss can be a side effect of the operation if patients have surgery to resolve their diabetes. It’s not about BMI; it’s about treating metabolic disease.”
Dr. Varban, a bariatric surgeon at the University of Michigan in Ann Arbor, reported data showing that bariatric surgery with sleeve gastrectomy in patients with baseline body mass index (BMI) levels below 35 kg/m2 was as effective at normalizing a range of metabolically associated disorders as it was in more obese patients in an observational study of more than 45,000 patients who underwent surgery in Michigan.
The findings add to an already extensive pool of evidence for loosening current guidelines that restrict bariatric surgery to patients with a BMI of 35 kg/m2 or greater, Dr. Varban said. But an influential bariatric surgery consensus statement from the National Institutes of Health that dates from 1991 and remains in place, recommends this surgery only for people with a BMI of at least 35 kg/m2, and this guidance often limits access to the surgery for patients at lower BMI, he noted.
A more inclusive assessment of patients as potential candidates for bariatric surgery should include a range of considerations in addition to weight and height, he explained in an interview. “Even if people have a BMI of less than 30 kg/m2 but have, or are at high risk for developing, metabolic disease, they should also be offered the operation.”
The guidance from the NIH results in a U.S. bariatric surgery population that effectively centers mainly on women with a BMI of 40 kg/m2 or greater and makes procedures like sleeve gastrectomy unavailable to many other types of patients who could benefit from it, Dr. Varban said. In 2018, the American Society for Metabolic and Bariatric Surgery released a position statement that summarized the evidence for the safety and efficacy of bariatric surgery in people with a BMI of 30-34 kg/m2, and cited the lingering and restrictive impact of the 1991 NIH consensus statement.
The study run by Dr. Varban and his associates used data collected by 43 programs in the Michigan Bariatric Surgery Collaborative during 2006-2018 that included 1,073 patients who had a BMI of less than 35 kg/m2 on the day they underwent sleeve gastrectomy, and 44,511 patients who had the same procedure and had a BMI of at least 35 kg/m2. The operations were performed by any one of 81 surgeons who worked at the centers during this time.
The patients with lower BMIs were older, with an average age of 51 years, compared with 45 years in the higher-BMI group, and they had higher prevalences of certain metabolic disorders. Diabetes affected 37% of those in the lower-BMI group and 31% of those with higher BMIs; hyperlipidemia affected 57% and 45%, respectively; and gastroesophageal reflux disease affected 56% and 49%, respectively. Obstructive sleep apnea was more common in the group with higher BMIs, at 47%, compared with 41% of those with lower BMIs.
The average BMI in the lower group was 33.7 kg/m2; in the higher group it was 46.7 kg/m2. Dr. Varban did not have data on whether any patients in the lower-BMI group had a BMI below 30 kg/m2. Roughly a third of the patients in the lower-BMI group had a BMI of less than 35 kg/m2 at the time of their initial examination, whereas the other two-thirds had a BMI that low only on the day of their surgery.At follow-up 1 year after their surgery, patients who started with lower BMIs had, in general, a very similar pattern of responses as those who started with higher BMIs, with rates of discontinuation of treatments for diabetes, hypertension, hyperlipidemia, obstructive sleep apnea, and gastroesophageal reflux of about 50%-80% and similar in both treatment arms. For example, discontinuation of oral diabetes drugs occurred in 79% and 78% of those with low and high BMIs, respectively, and discontinuation of hypertension medications occurred in 60% and 54%, respectively. Although the average absolute weight loss in the patients with lower BMIs was nearly half that of patients with higher starting BMIs, a much greater percentage of patients in the lower-BMI group achieved a BMI of less than 25 kg/m2, compared with the higher-BMI group (36% vs. 6%, respectively).
Patients from the lower-BMI group also showed high levels of satisfaction with their surgery and its results after 1 year. Questionnaire results from roughly half the patients in each treatment group showed that 90% were very satisfied in the lower-BMI group, compared with 84% of those who began with higher BMIs, with a dissatisfaction rate of 1% and 2%, respectively. The average body-image score at 1 year follow-up was significantly higher in those who started with lower BMIs. The rate of complications was low and similar in the two groups, with a 6% rate in the lower-BMI group and 5% in those with higher BMIs.
The study received no commercial funding. Dr. Varban receives salary support from Blue Cross Blue Shield of Michigan.
SOURCE: Varban et al. Obesity Week 2019, Abstract A105.
This article was updated 11/8/2020.
LAS VEGAS – It’s time to take bariatric out of bariatric surgery.
“The way forward is to not call it bariatric surgery or weight-loss surgery but surgery to treat diabetes, hypertension, hyperlipidemia, and other metabolic diseases,” said Oliver A. Varban, MD, at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “We need to reframe the conversation with patients about what success [with bariatric surgery] looks like. Weight loss can be a side effect of the operation if patients have surgery to resolve their diabetes. It’s not about BMI; it’s about treating metabolic disease.”
Dr. Varban, a bariatric surgeon at the University of Michigan in Ann Arbor, reported data showing that bariatric surgery with sleeve gastrectomy in patients with baseline body mass index (BMI) levels below 35 kg/m2 was as effective at normalizing a range of metabolically associated disorders as it was in more obese patients in an observational study of more than 45,000 patients who underwent surgery in Michigan.
The findings add to an already extensive pool of evidence for loosening current guidelines that restrict bariatric surgery to patients with a BMI of 35 kg/m2 or greater, Dr. Varban said. But an influential bariatric surgery consensus statement from the National Institutes of Health that dates from 1991 and remains in place, recommends this surgery only for people with a BMI of at least 35 kg/m2, and this guidance often limits access to the surgery for patients at lower BMI, he noted.
A more inclusive assessment of patients as potential candidates for bariatric surgery should include a range of considerations in addition to weight and height, he explained in an interview. “Even if people have a BMI of less than 30 kg/m2 but have, or are at high risk for developing, metabolic disease, they should also be offered the operation.”
The guidance from the NIH results in a U.S. bariatric surgery population that effectively centers mainly on women with a BMI of 40 kg/m2 or greater and makes procedures like sleeve gastrectomy unavailable to many other types of patients who could benefit from it, Dr. Varban said. In 2018, the American Society for Metabolic and Bariatric Surgery released a position statement that summarized the evidence for the safety and efficacy of bariatric surgery in people with a BMI of 30-34 kg/m2, and cited the lingering and restrictive impact of the 1991 NIH consensus statement.
The study run by Dr. Varban and his associates used data collected by 43 programs in the Michigan Bariatric Surgery Collaborative during 2006-2018 that included 1,073 patients who had a BMI of less than 35 kg/m2 on the day they underwent sleeve gastrectomy, and 44,511 patients who had the same procedure and had a BMI of at least 35 kg/m2. The operations were performed by any one of 81 surgeons who worked at the centers during this time.
The patients with lower BMIs were older, with an average age of 51 years, compared with 45 years in the higher-BMI group, and they had higher prevalences of certain metabolic disorders. Diabetes affected 37% of those in the lower-BMI group and 31% of those with higher BMIs; hyperlipidemia affected 57% and 45%, respectively; and gastroesophageal reflux disease affected 56% and 49%, respectively. Obstructive sleep apnea was more common in the group with higher BMIs, at 47%, compared with 41% of those with lower BMIs.
The average BMI in the lower group was 33.7 kg/m2; in the higher group it was 46.7 kg/m2. Dr. Varban did not have data on whether any patients in the lower-BMI group had a BMI below 30 kg/m2. Roughly a third of the patients in the lower-BMI group had a BMI of less than 35 kg/m2 at the time of their initial examination, whereas the other two-thirds had a BMI that low only on the day of their surgery.At follow-up 1 year after their surgery, patients who started with lower BMIs had, in general, a very similar pattern of responses as those who started with higher BMIs, with rates of discontinuation of treatments for diabetes, hypertension, hyperlipidemia, obstructive sleep apnea, and gastroesophageal reflux of about 50%-80% and similar in both treatment arms. For example, discontinuation of oral diabetes drugs occurred in 79% and 78% of those with low and high BMIs, respectively, and discontinuation of hypertension medications occurred in 60% and 54%, respectively. Although the average absolute weight loss in the patients with lower BMIs was nearly half that of patients with higher starting BMIs, a much greater percentage of patients in the lower-BMI group achieved a BMI of less than 25 kg/m2, compared with the higher-BMI group (36% vs. 6%, respectively).
Patients from the lower-BMI group also showed high levels of satisfaction with their surgery and its results after 1 year. Questionnaire results from roughly half the patients in each treatment group showed that 90% were very satisfied in the lower-BMI group, compared with 84% of those who began with higher BMIs, with a dissatisfaction rate of 1% and 2%, respectively. The average body-image score at 1 year follow-up was significantly higher in those who started with lower BMIs. The rate of complications was low and similar in the two groups, with a 6% rate in the lower-BMI group and 5% in those with higher BMIs.
The study received no commercial funding. Dr. Varban receives salary support from Blue Cross Blue Shield of Michigan.
SOURCE: Varban et al. Obesity Week 2019, Abstract A105.
This article was updated 11/8/2020.
REPORTING FROM OBESITY WEEK 2019
Key clinical point:
Major finding: Discontinuation of hypertension drugs occurred in 60% of patients with lower BMIs at baseline and 54% of those with higher BMIs.
Study details: Review of prospectively collected data from 45,584 patients who underwent sleeve gastrectomy in Michigan during 2006-2018.
Disclosures: The study received no commercial funding. Dr. Varban receives salary support from Blue Cross Blue Shield of Michigan. Dr. Misra had no relevant disclosures.
Source: Varban OA et al. Obesity Week 2019, Abstract A105.
Greater weight loss with sleeve gastroplasty than with diet therapy
Endoscopic sleeve gastroplasty achieves significantly greater weight loss than that of a high-intensity diet and lifestyle therapy program, according to a study published in Gastrointestinal Endoscopy.
In the retrospective case-matched study, 105 patients who underwent endoscopic sleeve gastroplasty, in combination with a low-intensity diet and lifestyle therapy, were compared with 281 patients who participated in a high-intensity diet and lifestyle therapy program.
“As ESG [endoscopic sleeve gastroplasty] continues to gain traction worldwide, a comprehensive understanding of its outcomes and relative place among the battery of weight loss treatments is important,” wrote Lawrence J. Cheskin, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and coauthors, noting that only two studies have compared endoscopic sleeve gastroscopy with another weight loss therapy.
The high-intensity program involved patients being prescribed a low-calorie, high-protein diet of 800-1,200 calories a day, and taking part in behavioral, nutritional, and exercise counseling as well as optional support from psychotherapy, support groups, and meal replacements.
The study found that patients who underwent the gastroplasty lost significantly greater mean percentage of body weight compared with those who participated in the therapy program.
At 1 month, mean percentage body weight loss was 9.3% in the gastroplasty group compared with 7% in the therapy group. At 3 months it was 14% compared with 11.3%, at 6 months it was 17.7% compared with 14.7%, and at 12 months it was 20.6% compared with 14.3%. Significantly more patients in the gastroplasty group reached 5%, 10%, and 20% weight loss compared with the therapy group.
The authors noted that high-intensity diet and lifestyle therapy programs had “notoriously” high rates of noncompliance and withdrawal from treatment; adherence rates of 63.1% and 59.6% had been seen in previous observational studies.
“Therefore, ESG may be a valuable alternative for patients who have had trouble adhering to HIDLT [high-intensity diet and lifestyle therapy],” they wrote. “Given the diversity of the obese population, ESG may begin to fill some gaps in the obesity treatment arsenal.”
A subgroup analysis looked at patients with a baseline body mass index below or above 40 kg/m2, and found even after adjustment for age and sex, both groups showed significantly more weight loss at 1 and 3 months for patients who underwent gastroplasty. However, at 6 and 12 months, the study saw no significant difference between gastroplasty and the therapy program for patients with a baseline BMI above 40 kg/m2.
While the cause of this difference in effect in higher BMI patients was unknown, it may be that sleeve gastroplasty is less effective because it is counteracted by neurohormonal effects that are altered with bariatric surgery, the authors wrote.
“This is worth exploring in future randomized control trials because it will give us insight into which patients are superior candidates for endoscopic bariatric therapy,” they wrote.
There were five moderate to severe adverse events in the gastroplasty cohort and none in the therapy group. There were three cases of upper gastrointestinal bleeding caused by gastric ulceration. In one case, the patient underwent diagnostic endoscopy, admission, and 48-hour monitoring. Another patient developed perigastric fluid collection, and one was admitted for intravenous hydration after experiencing dehydration. Despite this, the authors suggested the adverse event rate associated with the procedure may be acceptable to patients because of the superior weight loss effect compared with therapy programs.
No funding was declared. Three authors declared consultancies, advisory board positions, and personal fees from medical device companies including those in the endoscopy space. No other conflicts of interest were declared.
SOURCE: Cheskin L et al. Gastrointest Endosc. 2019 Sep 27. doi: 10.1016/j.gie.2019.09.029.
Endoscopic sleeve gastroplasty achieves significantly greater weight loss than that of a high-intensity diet and lifestyle therapy program, according to a study published in Gastrointestinal Endoscopy.
In the retrospective case-matched study, 105 patients who underwent endoscopic sleeve gastroplasty, in combination with a low-intensity diet and lifestyle therapy, were compared with 281 patients who participated in a high-intensity diet and lifestyle therapy program.
“As ESG [endoscopic sleeve gastroplasty] continues to gain traction worldwide, a comprehensive understanding of its outcomes and relative place among the battery of weight loss treatments is important,” wrote Lawrence J. Cheskin, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and coauthors, noting that only two studies have compared endoscopic sleeve gastroscopy with another weight loss therapy.
The high-intensity program involved patients being prescribed a low-calorie, high-protein diet of 800-1,200 calories a day, and taking part in behavioral, nutritional, and exercise counseling as well as optional support from psychotherapy, support groups, and meal replacements.
The study found that patients who underwent the gastroplasty lost significantly greater mean percentage of body weight compared with those who participated in the therapy program.
At 1 month, mean percentage body weight loss was 9.3% in the gastroplasty group compared with 7% in the therapy group. At 3 months it was 14% compared with 11.3%, at 6 months it was 17.7% compared with 14.7%, and at 12 months it was 20.6% compared with 14.3%. Significantly more patients in the gastroplasty group reached 5%, 10%, and 20% weight loss compared with the therapy group.
The authors noted that high-intensity diet and lifestyle therapy programs had “notoriously” high rates of noncompliance and withdrawal from treatment; adherence rates of 63.1% and 59.6% had been seen in previous observational studies.
“Therefore, ESG may be a valuable alternative for patients who have had trouble adhering to HIDLT [high-intensity diet and lifestyle therapy],” they wrote. “Given the diversity of the obese population, ESG may begin to fill some gaps in the obesity treatment arsenal.”
A subgroup analysis looked at patients with a baseline body mass index below or above 40 kg/m2, and found even after adjustment for age and sex, both groups showed significantly more weight loss at 1 and 3 months for patients who underwent gastroplasty. However, at 6 and 12 months, the study saw no significant difference between gastroplasty and the therapy program for patients with a baseline BMI above 40 kg/m2.
While the cause of this difference in effect in higher BMI patients was unknown, it may be that sleeve gastroplasty is less effective because it is counteracted by neurohormonal effects that are altered with bariatric surgery, the authors wrote.
“This is worth exploring in future randomized control trials because it will give us insight into which patients are superior candidates for endoscopic bariatric therapy,” they wrote.
There were five moderate to severe adverse events in the gastroplasty cohort and none in the therapy group. There were three cases of upper gastrointestinal bleeding caused by gastric ulceration. In one case, the patient underwent diagnostic endoscopy, admission, and 48-hour monitoring. Another patient developed perigastric fluid collection, and one was admitted for intravenous hydration after experiencing dehydration. Despite this, the authors suggested the adverse event rate associated with the procedure may be acceptable to patients because of the superior weight loss effect compared with therapy programs.
No funding was declared. Three authors declared consultancies, advisory board positions, and personal fees from medical device companies including those in the endoscopy space. No other conflicts of interest were declared.
SOURCE: Cheskin L et al. Gastrointest Endosc. 2019 Sep 27. doi: 10.1016/j.gie.2019.09.029.
Endoscopic sleeve gastroplasty achieves significantly greater weight loss than that of a high-intensity diet and lifestyle therapy program, according to a study published in Gastrointestinal Endoscopy.
In the retrospective case-matched study, 105 patients who underwent endoscopic sleeve gastroplasty, in combination with a low-intensity diet and lifestyle therapy, were compared with 281 patients who participated in a high-intensity diet and lifestyle therapy program.
“As ESG [endoscopic sleeve gastroplasty] continues to gain traction worldwide, a comprehensive understanding of its outcomes and relative place among the battery of weight loss treatments is important,” wrote Lawrence J. Cheskin, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and coauthors, noting that only two studies have compared endoscopic sleeve gastroscopy with another weight loss therapy.
The high-intensity program involved patients being prescribed a low-calorie, high-protein diet of 800-1,200 calories a day, and taking part in behavioral, nutritional, and exercise counseling as well as optional support from psychotherapy, support groups, and meal replacements.
The study found that patients who underwent the gastroplasty lost significantly greater mean percentage of body weight compared with those who participated in the therapy program.
At 1 month, mean percentage body weight loss was 9.3% in the gastroplasty group compared with 7% in the therapy group. At 3 months it was 14% compared with 11.3%, at 6 months it was 17.7% compared with 14.7%, and at 12 months it was 20.6% compared with 14.3%. Significantly more patients in the gastroplasty group reached 5%, 10%, and 20% weight loss compared with the therapy group.
The authors noted that high-intensity diet and lifestyle therapy programs had “notoriously” high rates of noncompliance and withdrawal from treatment; adherence rates of 63.1% and 59.6% had been seen in previous observational studies.
“Therefore, ESG may be a valuable alternative for patients who have had trouble adhering to HIDLT [high-intensity diet and lifestyle therapy],” they wrote. “Given the diversity of the obese population, ESG may begin to fill some gaps in the obesity treatment arsenal.”
A subgroup analysis looked at patients with a baseline body mass index below or above 40 kg/m2, and found even after adjustment for age and sex, both groups showed significantly more weight loss at 1 and 3 months for patients who underwent gastroplasty. However, at 6 and 12 months, the study saw no significant difference between gastroplasty and the therapy program for patients with a baseline BMI above 40 kg/m2.
While the cause of this difference in effect in higher BMI patients was unknown, it may be that sleeve gastroplasty is less effective because it is counteracted by neurohormonal effects that are altered with bariatric surgery, the authors wrote.
“This is worth exploring in future randomized control trials because it will give us insight into which patients are superior candidates for endoscopic bariatric therapy,” they wrote.
There were five moderate to severe adverse events in the gastroplasty cohort and none in the therapy group. There were three cases of upper gastrointestinal bleeding caused by gastric ulceration. In one case, the patient underwent diagnostic endoscopy, admission, and 48-hour monitoring. Another patient developed perigastric fluid collection, and one was admitted for intravenous hydration after experiencing dehydration. Despite this, the authors suggested the adverse event rate associated with the procedure may be acceptable to patients because of the superior weight loss effect compared with therapy programs.
No funding was declared. Three authors declared consultancies, advisory board positions, and personal fees from medical device companies including those in the endoscopy space. No other conflicts of interest were declared.
SOURCE: Cheskin L et al. Gastrointest Endosc. 2019 Sep 27. doi: 10.1016/j.gie.2019.09.029.
FROM GASTROINTESTINAL ENDOSCOPY
Prior maternal gastric bypass surgery tied to fewer birth defects
according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.
“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.
In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.
Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.
The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.
Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.
Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.
“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.
In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.
Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.
The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.
Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.
Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.
“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.
In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.
Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.
The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.
Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.
Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
FROM JAMA
Key clinical point: Infants whose mothers previously underwent gastric bypass surgery had a lower risk of birth defects than did the infants of matched controls.
Major finding: Major birth defects occurred in 3% of infants whose mothers had gastric bypass surgery, compared with 5% of infants born to control women.
Study details: The data come from a cohort study of 2,921 women with history of gastric bypass surgery and 30,573 matched controls.
Disclosures: Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
Source: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.
Weight loss surgery linked to lower CV event risk in diabetes
, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.
The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.
At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).
The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.
Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).
In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.
In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m2 or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.
The surgery was also associated with significantly greater reductions in HbA1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.
The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.
In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.
“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.
“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.
The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.
“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.
The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.
SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.
Despite a focus on reducing macrovascular events in individuals with type 2 diabetes, none of the major randomized controlled trials of glucose-lowering interventions that support current treatment guidelines have achieved this outcome. This study of bariatric surgery in obese patients with diabetes, however, does show reductions in major adverse cardiovascular events, although these outcomes should be interpreted with caution because of their observational nature and imprecise matching of the study groups.
Despite this, the many known benefits associated with bariatric surgery–induced weight loss suggest that for carefully selected, motivated patients with obesity and type 2 diabetes – who have been unable to lose weight by other means – this could be the preferred treatment option.
Dr. Edward H. Livingston is the deputy editor of JAMA and with the department of surgery at the University of California, Los Angeles. These comments are adapted from an accompanying editorial (JAMA 2019, Sept 2. DOI:10.1001/jama.2019.14577). No conflicts of interest were declared.
Despite a focus on reducing macrovascular events in individuals with type 2 diabetes, none of the major randomized controlled trials of glucose-lowering interventions that support current treatment guidelines have achieved this outcome. This study of bariatric surgery in obese patients with diabetes, however, does show reductions in major adverse cardiovascular events, although these outcomes should be interpreted with caution because of their observational nature and imprecise matching of the study groups.
Despite this, the many known benefits associated with bariatric surgery–induced weight loss suggest that for carefully selected, motivated patients with obesity and type 2 diabetes – who have been unable to lose weight by other means – this could be the preferred treatment option.
Dr. Edward H. Livingston is the deputy editor of JAMA and with the department of surgery at the University of California, Los Angeles. These comments are adapted from an accompanying editorial (JAMA 2019, Sept 2. DOI:10.1001/jama.2019.14577). No conflicts of interest were declared.
Despite a focus on reducing macrovascular events in individuals with type 2 diabetes, none of the major randomized controlled trials of glucose-lowering interventions that support current treatment guidelines have achieved this outcome. This study of bariatric surgery in obese patients with diabetes, however, does show reductions in major adverse cardiovascular events, although these outcomes should be interpreted with caution because of their observational nature and imprecise matching of the study groups.
Despite this, the many known benefits associated with bariatric surgery–induced weight loss suggest that for carefully selected, motivated patients with obesity and type 2 diabetes – who have been unable to lose weight by other means – this could be the preferred treatment option.
Dr. Edward H. Livingston is the deputy editor of JAMA and with the department of surgery at the University of California, Los Angeles. These comments are adapted from an accompanying editorial (JAMA 2019, Sept 2. DOI:10.1001/jama.2019.14577). No conflicts of interest were declared.
, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.
The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.
At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).
The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.
Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).
In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.
In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m2 or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.
The surgery was also associated with significantly greater reductions in HbA1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.
The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.
In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.
“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.
“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.
The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.
“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.
The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.
SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.
, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.
The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.
At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).
The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.
Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).
In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.
In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m2 or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.
The surgery was also associated with significantly greater reductions in HbA1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.
The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.
In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.
“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.
“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.
The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.
“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.
The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.
SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.
AT THE ESC CONGRESS 2019
Key clinical point: Bariatric surgery may reduce the risk of cardiovascular events in people with type 2 diabetes.
Major finding: Bariatric surgery is associated with a 39% reduction in risk of major cardiovascular events.
Study details: Retrospective cohort study in 13,722 individuals with type 2 diabetes and obesity.
Disclosures: The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.
Source: Aminian A et al. JAMA 2019, September 2. DOI: 10.1001/jama.2019.14231.