Endoscopy, Pancreas, & Biliary Tract

SAN DIEGO – Laparoscopic sleeve gastrectomy is safe and effective in obese candidates for organ transplantation, results from a novel pilot study demonstrated.

Nationwide, 15%-20% of patients on the transplant waiting list are morbidly obese, with a body mass index of greater than 35 kg/m², "but many cannot be transplanted unless they lose weight," said Dr. Matthew Y. Lin of the surgery department at the University of California, San Francisco (UCSF). "Morbid obesity can contribute to end-stage kidney or liver failure. For example, obesity-related nonalcoholic steatohepatitis is now the third most common indication for liver transplant in the United States and will likely become first in the future."

In what Dr. Lin said is the only reported case series of bariatric surgery in obese transplant candidates, he and his associates conducted a pilot study of 26 morbidly obese patients with liver or kidney failure who underwent laparoscopic sleeve gastrectomy at UCSF from 2006 to 2012. They chose sleeve gastrectomy over gastric banding "to avoid foreign body implantation, in anticipation of post-transplant immunosuppression," Dr. Lin explained at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We chose sleeve gastrectomy over gastric bypass to maintain endoscopic access to the biliary system, to reduce surgical complexity, and to avoid unpredictable immunosuppression absorption," he said.

Morbid obesity is a relative contraindication for solid organ transplantation at most centers because of poor post-transplant outcomes, according to Dr. Lin. "At UCSF, the selection criteria are a BMI of less than 40 for liver transplant, less than 38 for kidney transplant, and less than 34 for kidney transplant in patients with diabetes." The researchers hypothesized that laparoscopic sleeve gastrectomy could be safely performed in high-risk patients with liver or kidney failure and achieve enough weight loss to allow for transplantation.

The 26 patients had a mean age of 57 years, 17 were women, 20 were white, and their average preoperative BMI was 48. Twenty patients had liver insufficiency with a mean Model for End-Stage Liver Disease (MELD) score of 11, and 6 had kidney insufficiency with a mean glomerular filtration rate of 10 mL/min. Five of these patients were on hemodialysis.

All 26 patients had laparoscopic sleeve gastrectomy performed by the same surgeon. The mean operative time was 151 minutes, and the mean length of stay was 4.2 days. Complications that occurred within 30 days were two cases of superficial wound infection and one case each of worsened hepatic encephalopathy, acute renal insufficiency, need for blood transfusion, and staple line leak. There was no mortality within 30 days, but after that period two patients died awaiting transplant and one patient died from complications of the staple line leak and progressive liver failure 4 years after surgery.

After 2 years, the average BMI of study participants dropped from a mean of 48 to a mean of 29. "Between the 6- and 12-month marks, most patients were able to achieve a BMI that would make them acceptable for transplant," Dr. Lin said.

At 1, 3, 12, and 24 months, the percent of excess body weight lost was 17%, 26%, 50%, and 66%, respectively. "The weight-loss profile is similar to [those of] the general bariatric sleeve gastrectomy population," he noted.

Of the 13 patients who had diabetes preoperatively, 7 had complete resolution after the procedure and 1 had partial resolution. Mean postoperative albumin levels for all 26 patients after sleeve gastrectomy were 3.1 g/dL at 6 months and 3.3 g/dL at 12 months.

Eight patients went on to receive their organ transplant, Dr. Lin said. Their mean age was 56 years, and six were women. They waited a mean of 17 months for their procedures, which included six liver transplants, one liver and kidney transplant, and one kidney transplant. Their mean BMI before sleeve gastrectomy was 46, and their mean BMI prior to transplantation was 31. Immediately before transplant, their mean albumin level was 3.2 g/dL, and the most current measurement remained the same. "No increased acute rejection or difficulty maintaining immunosuppression was observed," he said.

Dr. Lin acknowledged certain limitations of the study, including its single-center design, lack of a control population, and the fact that "there is very little statistical power to estimate the true complication rate in this high-risk surgical group. Furthermore, we only have short-term follow-up."

Dr. Lin said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Laparoscopic sleeve gastrectomy is safe and effective in obese candidates for organ transplantation, results from a novel pilot study demonstrated.

Nationwide, 15%-20% of patients on the transplant waiting list are morbidly obese, with a body mass index of greater than 35 kg/m², "but many cannot be transplanted unless they lose weight," said Dr. Matthew Y. Lin of the surgery department at the University of California, San Francisco (UCSF). "Morbid obesity can contribute to end-stage kidney or liver failure. For example, obesity-related nonalcoholic steatohepatitis is now the third most common indication for liver transplant in the United States and will likely become first in the future."

In what Dr. Lin said is the only reported case series of bariatric surgery in obese transplant candidates, he and his associates conducted a pilot study of 26 morbidly obese patients with liver or kidney failure who underwent laparoscopic sleeve gastrectomy at UCSF from 2006 to 2012. They chose sleeve gastrectomy over gastric banding "to avoid foreign body implantation, in anticipation of post-transplant immunosuppression," Dr. Lin explained at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We chose sleeve gastrectomy over gastric bypass to maintain endoscopic access to the biliary system, to reduce surgical complexity, and to avoid unpredictable immunosuppression absorption," he said.

Morbid obesity is a relative contraindication for solid organ transplantation at most centers because of poor post-transplant outcomes, according to Dr. Lin. "At UCSF, the selection criteria are a BMI of less than 40 for liver transplant, less than 38 for kidney transplant, and less than 34 for kidney transplant in patients with diabetes." The researchers hypothesized that laparoscopic sleeve gastrectomy could be safely performed in high-risk patients with liver or kidney failure and achieve enough weight loss to allow for transplantation.

The 26 patients had a mean age of 57 years, 17 were women, 20 were white, and their average preoperative BMI was 48. Twenty patients had liver insufficiency with a mean Model for End-Stage Liver Disease (MELD) score of 11, and 6 had kidney insufficiency with a mean glomerular filtration rate of 10 mL/min. Five of these patients were on hemodialysis.

All 26 patients had laparoscopic sleeve gastrectomy performed by the same surgeon. The mean operative time was 151 minutes, and the mean length of stay was 4.2 days. Complications that occurred within 30 days were two cases of superficial wound infection and one case each of worsened hepatic encephalopathy, acute renal insufficiency, need for blood transfusion, and staple line leak. There was no mortality within 30 days, but after that period two patients died awaiting transplant and one patient died from complications of the staple line leak and progressive liver failure 4 years after surgery.

After 2 years, the average BMI of study participants dropped from a mean of 48 to a mean of 29. "Between the 6- and 12-month marks, most patients were able to achieve a BMI that would make them acceptable for transplant," Dr. Lin said.

At 1, 3, 12, and 24 months, the percent of excess body weight lost was 17%, 26%, 50%, and 66%, respectively. "The weight-loss profile is similar to [those of] the general bariatric sleeve gastrectomy population," he noted.

Of the 13 patients who had diabetes preoperatively, 7 had complete resolution after the procedure and 1 had partial resolution. Mean postoperative albumin levels for all 26 patients after sleeve gastrectomy were 3.1 g/dL at 6 months and 3.3 g/dL at 12 months.

Eight patients went on to receive their organ transplant, Dr. Lin said. Their mean age was 56 years, and six were women. They waited a mean of 17 months for their procedures, which included six liver transplants, one liver and kidney transplant, and one kidney transplant. Their mean BMI before sleeve gastrectomy was 46, and their mean BMI prior to transplantation was 31. Immediately before transplant, their mean albumin level was 3.2 g/dL, and the most current measurement remained the same. "No increased acute rejection or difficulty maintaining immunosuppression was observed," he said.

Dr. Lin acknowledged certain limitations of the study, including its single-center design, lack of a control population, and the fact that "there is very little statistical power to estimate the true complication rate in this high-risk surgical group. Furthermore, we only have short-term follow-up."

Dr. Lin said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Laparoscopic sleeve gastrectomy is safe and effective in obese candidates for organ transplantation, results from a novel pilot study demonstrated.

Nationwide, 15%-20% of patients on the transplant waiting list are morbidly obese, with a body mass index of greater than 35 kg/m², "but many cannot be transplanted unless they lose weight," said Dr. Matthew Y. Lin of the surgery department at the University of California, San Francisco (UCSF). "Morbid obesity can contribute to end-stage kidney or liver failure. For example, obesity-related nonalcoholic steatohepatitis is now the third most common indication for liver transplant in the United States and will likely become first in the future."

In what Dr. Lin said is the only reported case series of bariatric surgery in obese transplant candidates, he and his associates conducted a pilot study of 26 morbidly obese patients with liver or kidney failure who underwent laparoscopic sleeve gastrectomy at UCSF from 2006 to 2012. They chose sleeve gastrectomy over gastric banding "to avoid foreign body implantation, in anticipation of post-transplant immunosuppression," Dr. Lin explained at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

"We chose sleeve gastrectomy over gastric bypass to maintain endoscopic access to the biliary system, to reduce surgical complexity, and to avoid unpredictable immunosuppression absorption," he said.

Morbid obesity is a relative contraindication for solid organ transplantation at most centers because of poor post-transplant outcomes, according to Dr. Lin. "At UCSF, the selection criteria are a BMI of less than 40 for liver transplant, less than 38 for kidney transplant, and less than 34 for kidney transplant in patients with diabetes." The researchers hypothesized that laparoscopic sleeve gastrectomy could be safely performed in high-risk patients with liver or kidney failure and achieve enough weight loss to allow for transplantation.

The 26 patients had a mean age of 57 years, 17 were women, 20 were white, and their average preoperative BMI was 48. Twenty patients had liver insufficiency with a mean Model for End-Stage Liver Disease (MELD) score of 11, and 6 had kidney insufficiency with a mean glomerular filtration rate of 10 mL/min. Five of these patients were on hemodialysis.

All 26 patients had laparoscopic sleeve gastrectomy performed by the same surgeon. The mean operative time was 151 minutes, and the mean length of stay was 4.2 days. Complications that occurred within 30 days were two cases of superficial wound infection and one case each of worsened hepatic encephalopathy, acute renal insufficiency, need for blood transfusion, and staple line leak. There was no mortality within 30 days, but after that period two patients died awaiting transplant and one patient died from complications of the staple line leak and progressive liver failure 4 years after surgery.

After 2 years, the average BMI of study participants dropped from a mean of 48 to a mean of 29. "Between the 6- and 12-month marks, most patients were able to achieve a BMI that would make them acceptable for transplant," Dr. Lin said.

At 1, 3, 12, and 24 months, the percent of excess body weight lost was 17%, 26%, 50%, and 66%, respectively. "The weight-loss profile is similar to [those of] the general bariatric sleeve gastrectomy population," he noted.

Of the 13 patients who had diabetes preoperatively, 7 had complete resolution after the procedure and 1 had partial resolution. Mean postoperative albumin levels for all 26 patients after sleeve gastrectomy were 3.1 g/dL at 6 months and 3.3 g/dL at 12 months.

Eight patients went on to receive their organ transplant, Dr. Lin said. Their mean age was 56 years, and six were women. They waited a mean of 17 months for their procedures, which included six liver transplants, one liver and kidney transplant, and one kidney transplant. Their mean BMI before sleeve gastrectomy was 46, and their mean BMI prior to transplantation was 31. Immediately before transplant, their mean albumin level was 3.2 g/dL, and the most current measurement remained the same. "No increased acute rejection or difficulty maintaining immunosuppression was observed," he said.

Dr. Lin acknowledged certain limitations of the study, including its single-center design, lack of a control population, and the fact that "there is very little statistical power to estimate the true complication rate in this high-risk surgical group. Furthermore, we only have short-term follow-up."

Dr. Lin said that he had no relevant financial conflicts to disclose.

SAN DIEGO – The most experienced bariatric surgeons are those who are most likely to be sued, judging by responses to a survey from more than 300 members of the American Society for Metabolic and Bariatric Surgery.

"There are no resources, national registries, or easily accessible databases to analyze bariatric-specific medical malpractice claims in the United States," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice litigation and develop patient safety improvements. Nor do there exist easily accessible measures of trends in bariatric surgery litigation."

In an effort to obtain a snapshot of the liability landscape in bariatric surgery, Dr. Dallal and other members of the ASMBS Patient Safety Committee e-mailed a survey to 1,672 surgeon members of the ASMBS in July 2011. A total of 330 surgeons in 46 states responded, for a response rate of 20%. Their mean number of years in practice was 15, which represented 5,042 years of bariatric surgery–specific liability exposure. Most respondents (38%) practiced in a hospital or academic group, 26% in a single specialty group, 20% in solo practice, 13% in a multispecialty group, and 3% in other settings.

Nine respondents chose not to have malpractice insurance. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200.

Nearly half of respondents (48%) reported having no malpractice insurance cases since their careers began, but the average number of lifetime cases reported by their counterparts was 1.5.

Of the 464 lawsuits reported by 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, and 19% went to trial or arbitration.

Of those cases that went to trial, 72% were found in favor of the surgeon-defendant. The mean lifetime amount paid in lawsuits was $250,000, including one settlement for $7,000,000. The total amount paid by the respondents was $70,871,998.

Using multivariate logistic regression analysis, the researchers determined that the probability of reporting at least one lawsuit independently increased with the number of years in practice (odds ratio, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01). "In essence, our most experienced surgeons are the ones being sued the most," said Dr. Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network, Philadelphia.

The odds of having lost a malpractice case that resulted in monetary compensation independently increased with the number of years in practice (OR, 1.09; P less than .0005), and the number of lawsuits experienced (OR, 1.42; P = .02). "The type of practice and the lack of a bariatric surgeon expert witness did not independently predict a payout," Dr. Dallal said.

Nearly 7% of survey respondents reported that the primary expert witness in determining the standard of bariatric surgery care was not a bariatric surgeon. In such cases, the surgeon-defendant had an 11-fold increased risk of having a lawsuit (P = .018). However, the use of an expert witness who was not a bariatric surgeon was not associated with the chance of settlement or the case’s going to trial.

Dr. Dallal noted that many lawsuits are filed about 2 years after the alleged injury, and another 1-2 years may pass before resolution of that lawsuit occurs. "So, there is a built-in bias against surgeons who have been in practice longer," he said.

He noted that successful lawsuits that are based on patient harm "do occur and are devastating to all involved. Improving the patient safety culture is the mainstay of reducing liability risk."

Dr. Dallal said that he had no relevant financial conflicts to disclose.

SAN DIEGO – The most experienced bariatric surgeons are those who are most likely to be sued, judging by responses to a survey from more than 300 members of the American Society for Metabolic and Bariatric Surgery.

"There are no resources, national registries, or easily accessible databases to analyze bariatric-specific medical malpractice claims in the United States," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice litigation and develop patient safety improvements. Nor do there exist easily accessible measures of trends in bariatric surgery litigation."

In an effort to obtain a snapshot of the liability landscape in bariatric surgery, Dr. Dallal and other members of the ASMBS Patient Safety Committee e-mailed a survey to 1,672 surgeon members of the ASMBS in July 2011. A total of 330 surgeons in 46 states responded, for a response rate of 20%. Their mean number of years in practice was 15, which represented 5,042 years of bariatric surgery–specific liability exposure. Most respondents (38%) practiced in a hospital or academic group, 26% in a single specialty group, 20% in solo practice, 13% in a multispecialty group, and 3% in other settings.

Nine respondents chose not to have malpractice insurance. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200.

Nearly half of respondents (48%) reported having no malpractice insurance cases since their careers began, but the average number of lifetime cases reported by their counterparts was 1.5.

Of the 464 lawsuits reported by 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, and 19% went to trial or arbitration.

Of those cases that went to trial, 72% were found in favor of the surgeon-defendant. The mean lifetime amount paid in lawsuits was $250,000, including one settlement for $7,000,000. The total amount paid by the respondents was $70,871,998.

Using multivariate logistic regression analysis, the researchers determined that the probability of reporting at least one lawsuit independently increased with the number of years in practice (odds ratio, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01). "In essence, our most experienced surgeons are the ones being sued the most," said Dr. Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network, Philadelphia.

The odds of having lost a malpractice case that resulted in monetary compensation independently increased with the number of years in practice (OR, 1.09; P less than .0005), and the number of lawsuits experienced (OR, 1.42; P = .02). "The type of practice and the lack of a bariatric surgeon expert witness did not independently predict a payout," Dr. Dallal said.

Nearly 7% of survey respondents reported that the primary expert witness in determining the standard of bariatric surgery care was not a bariatric surgeon. In such cases, the surgeon-defendant had an 11-fold increased risk of having a lawsuit (P = .018). However, the use of an expert witness who was not a bariatric surgeon was not associated with the chance of settlement or the case’s going to trial.

Dr. Dallal noted that many lawsuits are filed about 2 years after the alleged injury, and another 1-2 years may pass before resolution of that lawsuit occurs. "So, there is a built-in bias against surgeons who have been in practice longer," he said.

He noted that successful lawsuits that are based on patient harm "do occur and are devastating to all involved. Improving the patient safety culture is the mainstay of reducing liability risk."

Dr. Dallal said that he had no relevant financial conflicts to disclose.

SAN DIEGO – The most experienced bariatric surgeons are those who are most likely to be sued, judging by responses to a survey from more than 300 members of the American Society for Metabolic and Bariatric Surgery.

"There are no resources, national registries, or easily accessible databases to analyze bariatric-specific medical malpractice claims in the United States," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice litigation and develop patient safety improvements. Nor do there exist easily accessible measures of trends in bariatric surgery litigation."

In an effort to obtain a snapshot of the liability landscape in bariatric surgery, Dr. Dallal and other members of the ASMBS Patient Safety Committee e-mailed a survey to 1,672 surgeon members of the ASMBS in July 2011. A total of 330 surgeons in 46 states responded, for a response rate of 20%. Their mean number of years in practice was 15, which represented 5,042 years of bariatric surgery–specific liability exposure. Most respondents (38%) practiced in a hospital or academic group, 26% in a single specialty group, 20% in solo practice, 13% in a multispecialty group, and 3% in other settings.

Nine respondents chose not to have malpractice insurance. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200.

Nearly half of respondents (48%) reported having no malpractice insurance cases since their careers began, but the average number of lifetime cases reported by their counterparts was 1.5.

Of the 464 lawsuits reported by 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, and 19% went to trial or arbitration.

Of those cases that went to trial, 72% were found in favor of the surgeon-defendant. The mean lifetime amount paid in lawsuits was $250,000, including one settlement for $7,000,000. The total amount paid by the respondents was $70,871,998.

Using multivariate logistic regression analysis, the researchers determined that the probability of reporting at least one lawsuit independently increased with the number of years in practice (odds ratio, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01). "In essence, our most experienced surgeons are the ones being sued the most," said Dr. Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network, Philadelphia.

The odds of having lost a malpractice case that resulted in monetary compensation independently increased with the number of years in practice (OR, 1.09; P less than .0005), and the number of lawsuits experienced (OR, 1.42; P = .02). "The type of practice and the lack of a bariatric surgeon expert witness did not independently predict a payout," Dr. Dallal said.

Nearly 7% of survey respondents reported that the primary expert witness in determining the standard of bariatric surgery care was not a bariatric surgeon. In such cases, the surgeon-defendant had an 11-fold increased risk of having a lawsuit (P = .018). However, the use of an expert witness who was not a bariatric surgeon was not associated with the chance of settlement or the case’s going to trial.

Dr. Dallal noted that many lawsuits are filed about 2 years after the alleged injury, and another 1-2 years may pass before resolution of that lawsuit occurs. "So, there is a built-in bias against surgeons who have been in practice longer," he said.

He noted that successful lawsuits that are based on patient harm "do occur and are devastating to all involved. Improving the patient safety culture is the mainstay of reducing liability risk."

Dr. Dallal said that he had no relevant financial conflicts to disclose.

SAN DIEGO – At 30 days, the mortality rate from robotic-assisted gastric bypass surgery was zero and the rate of leak or abscess was just 0.3%, a multicenter study showed.

"Complications are few and may be less than with conventional laparoscopic techniques, even in different centers," Dr. Erik B. Wilson said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

In what he said is the largest reported series of its kind, Dr. Wilson and his associates reviewed 1,695 robotic-assisted Roux-en-Y gastric bypass procedures performed with the da Vinci Surgical System (Intuitive Surgical) between February 2003 and September 2011. The operations were performed at three centers: the University of Texas Health Science Center at Houston (578 procedures), Eastern Maine Medical Center, Bangor (708 procedures), and Florida Hospital Celebration Health (409). The mean body mass index of patients was 48.9 kg/m², and the researchers evaluated complications and outcomes that occurred within the first 30 days of surgery.

Dr. Wilson, associate professor of surgery at the University of Texas Health Science Center at Houston, reported that the average length of stay was 2.2 days. Within the first 30 days of surgery there were 81 readmissions (4.8%), "which is not too different from what you’d expect in most populations," he said. Of these, 49 (2.9%) were for dehydration, 27 (1.6%) were for nausea/vomiting, and 5 (0.3%) were for stricture requiring dilation.

There were 46 reoperations (2.7%) within the first 30 days of surgery. Of these, 18 (1.06%) were for bowel obstruction/hernia, 17 (1%) were for bleeding/hematoma, 6 (0.35%) were for negative exploration of patients the surgeons were concerned about, and 5 (0.29%) were for abscess/leak.

There were 26 early major complications (1.5%). Of these, 14 (0.83%) were bleeding requiring transfusion, 5 (0.29%) were stricture requiring dilation, 3 (0.18%) were abscesses, 2 (0.12%) were anastomotic leaks, and 2 (0.12%) were cases of pulmonary embolism/infarct. There was no mortality, "which we think is very favorable," Dr. Wilson said.

Average operating times varied by center: 156 minutes in Houston, 128 minutes in Florida, and 104 minutes in Maine. "As time has gone on, and as we engage each other on how we do things, these operative times have continued to decrease, with current times approaching 90 minutes," Dr. Wilson said. "So long operative times are not necessary when you do robotic surgery."

He concluded by describing robotic-assisted bypass surgery as "an enabling technology that allows for excellent reproducible outcomes, because we have multiple centers doing it well. Future studies should focus on revisional and more complex procedures such as biliopancreatic conversion."

Dr. Wilson disclosed that he is a consultant for Intuitive Surgical, Ethicon Endo-Surgery, Apollo Endosurgery, and EndoGastric Solutions. He is also a proctor for Intuitive Surgical, and has received an educational grant from Gore.

SAN DIEGO – At 30 days, the mortality rate from robotic-assisted gastric bypass surgery was zero and the rate of leak or abscess was just 0.3%, a multicenter study showed.

"Complications are few and may be less than with conventional laparoscopic techniques, even in different centers," Dr. Erik B. Wilson said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

In what he said is the largest reported series of its kind, Dr. Wilson and his associates reviewed 1,695 robotic-assisted Roux-en-Y gastric bypass procedures performed with the da Vinci Surgical System (Intuitive Surgical) between February 2003 and September 2011. The operations were performed at three centers: the University of Texas Health Science Center at Houston (578 procedures), Eastern Maine Medical Center, Bangor (708 procedures), and Florida Hospital Celebration Health (409). The mean body mass index of patients was 48.9 kg/m², and the researchers evaluated complications and outcomes that occurred within the first 30 days of surgery.

Dr. Wilson, associate professor of surgery at the University of Texas Health Science Center at Houston, reported that the average length of stay was 2.2 days. Within the first 30 days of surgery there were 81 readmissions (4.8%), "which is not too different from what you’d expect in most populations," he said. Of these, 49 (2.9%) were for dehydration, 27 (1.6%) were for nausea/vomiting, and 5 (0.3%) were for stricture requiring dilation.

There were 46 reoperations (2.7%) within the first 30 days of surgery. Of these, 18 (1.06%) were for bowel obstruction/hernia, 17 (1%) were for bleeding/hematoma, 6 (0.35%) were for negative exploration of patients the surgeons were concerned about, and 5 (0.29%) were for abscess/leak.

There were 26 early major complications (1.5%). Of these, 14 (0.83%) were bleeding requiring transfusion, 5 (0.29%) were stricture requiring dilation, 3 (0.18%) were abscesses, 2 (0.12%) were anastomotic leaks, and 2 (0.12%) were cases of pulmonary embolism/infarct. There was no mortality, "which we think is very favorable," Dr. Wilson said.

Average operating times varied by center: 156 minutes in Houston, 128 minutes in Florida, and 104 minutes in Maine. "As time has gone on, and as we engage each other on how we do things, these operative times have continued to decrease, with current times approaching 90 minutes," Dr. Wilson said. "So long operative times are not necessary when you do robotic surgery."

He concluded by describing robotic-assisted bypass surgery as "an enabling technology that allows for excellent reproducible outcomes, because we have multiple centers doing it well. Future studies should focus on revisional and more complex procedures such as biliopancreatic conversion."

Dr. Wilson disclosed that he is a consultant for Intuitive Surgical, Ethicon Endo-Surgery, Apollo Endosurgery, and EndoGastric Solutions. He is also a proctor for Intuitive Surgical, and has received an educational grant from Gore.

SAN DIEGO – At 30 days, the mortality rate from robotic-assisted gastric bypass surgery was zero and the rate of leak or abscess was just 0.3%, a multicenter study showed.

"Complications are few and may be less than with conventional laparoscopic techniques, even in different centers," Dr. Erik B. Wilson said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

In what he said is the largest reported series of its kind, Dr. Wilson and his associates reviewed 1,695 robotic-assisted Roux-en-Y gastric bypass procedures performed with the da Vinci Surgical System (Intuitive Surgical) between February 2003 and September 2011. The operations were performed at three centers: the University of Texas Health Science Center at Houston (578 procedures), Eastern Maine Medical Center, Bangor (708 procedures), and Florida Hospital Celebration Health (409). The mean body mass index of patients was 48.9 kg/m², and the researchers evaluated complications and outcomes that occurred within the first 30 days of surgery.

Dr. Wilson, associate professor of surgery at the University of Texas Health Science Center at Houston, reported that the average length of stay was 2.2 days. Within the first 30 days of surgery there were 81 readmissions (4.8%), "which is not too different from what you’d expect in most populations," he said. Of these, 49 (2.9%) were for dehydration, 27 (1.6%) were for nausea/vomiting, and 5 (0.3%) were for stricture requiring dilation.

There were 46 reoperations (2.7%) within the first 30 days of surgery. Of these, 18 (1.06%) were for bowel obstruction/hernia, 17 (1%) were for bleeding/hematoma, 6 (0.35%) were for negative exploration of patients the surgeons were concerned about, and 5 (0.29%) were for abscess/leak.

There were 26 early major complications (1.5%). Of these, 14 (0.83%) were bleeding requiring transfusion, 5 (0.29%) were stricture requiring dilation, 3 (0.18%) were abscesses, 2 (0.12%) were anastomotic leaks, and 2 (0.12%) were cases of pulmonary embolism/infarct. There was no mortality, "which we think is very favorable," Dr. Wilson said.

Average operating times varied by center: 156 minutes in Houston, 128 minutes in Florida, and 104 minutes in Maine. "As time has gone on, and as we engage each other on how we do things, these operative times have continued to decrease, with current times approaching 90 minutes," Dr. Wilson said. "So long operative times are not necessary when you do robotic surgery."

He concluded by describing robotic-assisted bypass surgery as "an enabling technology that allows for excellent reproducible outcomes, because we have multiple centers doing it well. Future studies should focus on revisional and more complex procedures such as biliopancreatic conversion."

Dr. Wilson disclosed that he is a consultant for Intuitive Surgical, Ethicon Endo-Surgery, Apollo Endosurgery, and EndoGastric Solutions. He is also a proctor for Intuitive Surgical, and has received an educational grant from Gore.

SAN DIEGO – Bariatric surgery induced a significant and durable improvement in diabetic nephropathy after 5 years of follow-up, results from a single-center study showed.

"In addition to significant weight loss, [bariatric surgery] achieves profound metabolic effects, including improvements in glycemic control and insulin sensitivity, as well as a decrease in cardiovascular disease risk and mortality," lead author Dr. Helen M. Heneghan said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "We hypothesized that improving diabetic control with bariatric surgery may have positive effects on the end-organ complications of this disease, such as diabetic nephropathy. We also wanted to address one of the prevailing questions in this field: whether or not the effects of bariatric surgery on diabetes and its complications are durable."

Dr. Heneghan, a bariatric surgery fellow at the Cleveland Clinic Bariatric and Metabolic Institute, and her associates identified 52 patients who underwent bariatric surgery at the institute and had completed the 5-year follow-up. At baseline, the mean age of patients was 51 years, and 75% were women. Their preoperative mean body mass index was 49 kg/m2, 84% had hypertension, and 71% had hyperlipidemia. Preoperatively, the mean duration of diabetes was 8.6 years, and 29% were already taking insulin. Their mean hemoglobin A_1c level was 7.7%, and 38% had diabetic nephropathy as indicated by microalbuminuria (30-299 mg of albumin per g of creatinine) or macroalbuminura (greater than 300 mg/g), and 22% of patients were prescribed an ACE inhibitor or angiotensin receptor blocker.

The majority of patients (69%) underwent gastric bypass; 25% had laparoscopic gastric banding and 6% had sleeve gastrectomy. Dr. Heneghan reported that 5 years after their surgery, 44% of patients had sustained remission of their type 2 diabetes, 33% had a significant improvement, and 23% had no change or worsening of their disease. This latter cohort "had the least amount of weight loss and were those who had the longest standing duration of diabetes preoperatively."

The rates of patients with remission, improvement, or change in hypertension were 16%, 50%, and 34%, respectively, whereas the rates for patients with dyslipidemia were 39%, 20%, and 41%.

Only 25% of patients who did not have diabetic nephropathy at the time of surgery went on to develop the condition. Among patients with preoperative microalbuminuria, 42% remained stable whereas 58% regressed and had no albuminuria 5 years after surgery. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years.*

There were no preoperative differences in the mean urinary albumin to creatinine ratio (ACR) between patients who were and patients who were not prescribed a renoprotective agent. However, postoperatively, patients who were not on a renoprotective agent had a significantly lower urinary ACR, compared with those who remained on a renoprotective agent (P = .039). "This probably reflects the fact that patients who had improvement of their diabetes and regression or nonprogression of their nephropathy status also had a significant improvement in – or remission of – hypertension, and were no longer prescribed an antihypertensive medication," Dr. Heneghan explained.

She characterized the study’s overall findings as "remarkable, considering that diabetes is a chronic, progressive disease, and certainly warrant further investigation in the form of a prospective and larger study."

Dr. Heneghan said that she had no relevant financial conflicts to disclose.

*CORRECTION 8/28/12: The original sentence contained an error in describing the patients. The sentence should read" "Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years."

SAN DIEGO – Bariatric surgery induced a significant and durable improvement in diabetic nephropathy after 5 years of follow-up, results from a single-center study showed.

"In addition to significant weight loss, [bariatric surgery] achieves profound metabolic effects, including improvements in glycemic control and insulin sensitivity, as well as a decrease in cardiovascular disease risk and mortality," lead author Dr. Helen M. Heneghan said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "We hypothesized that improving diabetic control with bariatric surgery may have positive effects on the end-organ complications of this disease, such as diabetic nephropathy. We also wanted to address one of the prevailing questions in this field: whether or not the effects of bariatric surgery on diabetes and its complications are durable."

Dr. Heneghan, a bariatric surgery fellow at the Cleveland Clinic Bariatric and Metabolic Institute, and her associates identified 52 patients who underwent bariatric surgery at the institute and had completed the 5-year follow-up. At baseline, the mean age of patients was 51 years, and 75% were women. Their preoperative mean body mass index was 49 kg/m2, 84% had hypertension, and 71% had hyperlipidemia. Preoperatively, the mean duration of diabetes was 8.6 years, and 29% were already taking insulin. Their mean hemoglobin A_1c level was 7.7%, and 38% had diabetic nephropathy as indicated by microalbuminuria (30-299 mg of albumin per g of creatinine) or macroalbuminura (greater than 300 mg/g), and 22% of patients were prescribed an ACE inhibitor or angiotensin receptor blocker.

The majority of patients (69%) underwent gastric bypass; 25% had laparoscopic gastric banding and 6% had sleeve gastrectomy. Dr. Heneghan reported that 5 years after their surgery, 44% of patients had sustained remission of their type 2 diabetes, 33% had a significant improvement, and 23% had no change or worsening of their disease. This latter cohort "had the least amount of weight loss and were those who had the longest standing duration of diabetes preoperatively."

The rates of patients with remission, improvement, or change in hypertension were 16%, 50%, and 34%, respectively, whereas the rates for patients with dyslipidemia were 39%, 20%, and 41%.

Only 25% of patients who did not have diabetic nephropathy at the time of surgery went on to develop the condition. Among patients with preoperative microalbuminuria, 42% remained stable whereas 58% regressed and had no albuminuria 5 years after surgery. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years.*

There were no preoperative differences in the mean urinary albumin to creatinine ratio (ACR) between patients who were and patients who were not prescribed a renoprotective agent. However, postoperatively, patients who were not on a renoprotective agent had a significantly lower urinary ACR, compared with those who remained on a renoprotective agent (P = .039). "This probably reflects the fact that patients who had improvement of their diabetes and regression or nonprogression of their nephropathy status also had a significant improvement in – or remission of – hypertension, and were no longer prescribed an antihypertensive medication," Dr. Heneghan explained.

She characterized the study’s overall findings as "remarkable, considering that diabetes is a chronic, progressive disease, and certainly warrant further investigation in the form of a prospective and larger study."

Dr. Heneghan said that she had no relevant financial conflicts to disclose.

*CORRECTION 8/28/12: The original sentence contained an error in describing the patients. The sentence should read" "Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years."

SAN DIEGO – Bariatric surgery induced a significant and durable improvement in diabetic nephropathy after 5 years of follow-up, results from a single-center study showed.

"In addition to significant weight loss, [bariatric surgery] achieves profound metabolic effects, including improvements in glycemic control and insulin sensitivity, as well as a decrease in cardiovascular disease risk and mortality," lead author Dr. Helen M. Heneghan said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "We hypothesized that improving diabetic control with bariatric surgery may have positive effects on the end-organ complications of this disease, such as diabetic nephropathy. We also wanted to address one of the prevailing questions in this field: whether or not the effects of bariatric surgery on diabetes and its complications are durable."

Dr. Heneghan, a bariatric surgery fellow at the Cleveland Clinic Bariatric and Metabolic Institute, and her associates identified 52 patients who underwent bariatric surgery at the institute and had completed the 5-year follow-up. At baseline, the mean age of patients was 51 years, and 75% were women. Their preoperative mean body mass index was 49 kg/m2, 84% had hypertension, and 71% had hyperlipidemia. Preoperatively, the mean duration of diabetes was 8.6 years, and 29% were already taking insulin. Their mean hemoglobin A_1c level was 7.7%, and 38% had diabetic nephropathy as indicated by microalbuminuria (30-299 mg of albumin per g of creatinine) or macroalbuminura (greater than 300 mg/g), and 22% of patients were prescribed an ACE inhibitor or angiotensin receptor blocker.

The majority of patients (69%) underwent gastric bypass; 25% had laparoscopic gastric banding and 6% had sleeve gastrectomy. Dr. Heneghan reported that 5 years after their surgery, 44% of patients had sustained remission of their type 2 diabetes, 33% had a significant improvement, and 23% had no change or worsening of their disease. This latter cohort "had the least amount of weight loss and were those who had the longest standing duration of diabetes preoperatively."

The rates of patients with remission, improvement, or change in hypertension were 16%, 50%, and 34%, respectively, whereas the rates for patients with dyslipidemia were 39%, 20%, and 41%.

Only 25% of patients who did not have diabetic nephropathy at the time of surgery went on to develop the condition. Among patients with preoperative microalbuminuria, 42% remained stable whereas 58% regressed and had no albuminuria 5 years after surgery. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years.*

There were no preoperative differences in the mean urinary albumin to creatinine ratio (ACR) between patients who were and patients who were not prescribed a renoprotective agent. However, postoperatively, patients who were not on a renoprotective agent had a significantly lower urinary ACR, compared with those who remained on a renoprotective agent (P = .039). "This probably reflects the fact that patients who had improvement of their diabetes and regression or nonprogression of their nephropathy status also had a significant improvement in – or remission of – hypertension, and were no longer prescribed an antihypertensive medication," Dr. Heneghan explained.

She characterized the study’s overall findings as "remarkable, considering that diabetes is a chronic, progressive disease, and certainly warrant further investigation in the form of a prospective and larger study."

Dr. Heneghan said that she had no relevant financial conflicts to disclose.

*CORRECTION 8/28/12: The original sentence contained an error in describing the patients. The sentence should read" "Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years."

SAN DIEGO – Laparoscopic sleeve gastrectomy is positioned between gastric banding and the laparoscopic gastric bypass for both safety and efficacy, results from the largest comparative study of its kind demonstrated.

The finding comes at a time when the Centers for Medicare and Medicaid Services is reviewing evidence to consider including sleeve gastrectomy as a covered benefit. Currently, gastric bypass, vertical banded gastroplasty, duodenal switch, and gastric banding are the only CMS-sanctioned bariatric procedures.

The study, which involved nearly 300,000 patients, "shows that across the board, regardless of the procedure, bariatric surgery is safe and effective," Dr. John M. Morton said in an interview at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "The emerging new procedure, the sleeve gastrectomy, is shown to be right between the bypass and the band. As a result, we have seen more interest from payers to cover it. In fact there are about 100 million lives that are covered. Our only outlier is CMS in deciding to cover. We hope that these data will help influence CMS in granting coverage for the sleeve gastrectomy."

Dr. Morton, associate professor of surgery and director of bariatric surgery at Stanford Hospitals and Clinics at Stanford (Calif.) University, and his associates examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRNYGB), gastric banding (LAGB), and sleeve gastrectomy (LSG) from June 2007 to December 2010. BOLD, the largest bariatric-specific database, is maintained by the ASMBS Bariatric Surgery Center of Excellence program, and includes more than 1,200 surgeons at 540 hospitals. Dr. Morton described the data as a "clinically rich" variable set that includes age, gender, race, insurance status, body mass index, excess body weight, and comorbidities.

"There is a definite need for more data around comparison of different procedures," Dr. Morton said at the meeting. "Our study hypothesis is very straightforward: Do demographics and outcomes for bariatric surgery vary by procedure?"

The primary outcomes were 30-day mortality, serious complications, and readmissions. The definitions of serious complications included death, anastomotic leakage, cardiac arrest, deep venous thrombosis, evisceration, heart failure and/or pulmonary edema, liver failure, and bleeding requiring transfusion.

Dr. Morton reported outcomes from 117,365 patients in the LAGB group, 138,222 in the LRNYGB group, and 16,139 in the LSG group. Patients in each group were generally the same age (a mean of 45, 46, and 45 years, respectively), mostly female (78%, 79%, and 74%), and mostly white (72%, 73%, and 72%). "The one area where there was a sizable difference was around self-pay," Dr. Morton said. About 21% of patients in the LSG group paid out-of-pocket, compared with 6% of those in the LAGB group and 2% of those in the LRNYGB group.

The proportion of preoperative comorbidities was similar among the three groups, with two exceptions. The prevalence of diabetes was highest in the LRNYGB group (37%, compared with 30% in the LSG group and 28% in the LAGB group; P less than .0001). A similar association was seen in the proportion of patients with five or more preoperative comorbidities (62%, 55%, and 52%, respectively; P less than .0001).

The mean length of stay was 0.7 days for the LAGB group, 1.9 days for the LSG group, and 2.3 days for the LRNYGB group. The percent change in BMI at 12 months was 7.6%, 13.4%, and 16.4%, respectively; the rate of 30-day serious complications was 0.25%, 0.96%, and 1.25%; and the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%. All differences between the groups were significant (P less than .0001).

"If you look at the remainder of the safety outcomes – everything from 30-day readmission to 30-day reoperation – it’s pretty much the same order, with the band group having the lowest [percentage], and the bypass having the highest, and the sleeve being right in between," Dr. Morton said. "When we looked at age greater than 65 in isolation, we found that the order of safety remains, with the banding having the least amount of mortality and the sleeve being right between the band procedure and the bypass."

Logistic regression analysis revealed several significant factors that predicted serious adverse events at 30 days: male gender (odds ratio, 1.67), having nonprivate insurance (OR, 1.15), stepwise progression with increasing age (for example, an OR of 1.27 for those aged 26-35 years and an OR of 4.42 for those above age 65), and stepwise progression with increasing BMI (for example, an OR of 1.37 for those with a BMI of 46-55 kg/m² and an OR of 3.03 for those with a BMI greater than 65).

The invited discussant, Dr. Matthew M. Hutter, of Massachusetts General Hospital, Boston, described the size of the overall study cohort as remarkable. "What I find most interesting about this study is that it shows that sleeve gastrectomy – a brand-new, very complex procedure – can be introduced safely and effectively when performed under the standards of a bariatric accreditation program," Dr. Hutter said. "Other surgical procedures such as laparoscopic cholecystectomy or laparoscopic colectomy had very high morbidity and conversion rates when they were first implemented. However, this new complex procedure has been safe and effective from the get-go, and that is really quite impressive. The other remarkable finding is how consistent this is with all of the other major [bariatric surgery] data collection programs."

Dr. Morton acknowledged certain limitations of the study, including the fact that 1-year follow-up was available in only 60% of patients, while 30-day follow-up was available in 98% of the cohort. "Potentially, patients could have been admitted to other hospitals," he added. "These are research-consented patients, so about 70% consented. Some of this is surgeon-directed reporting."

Dr. Morton said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Laparoscopic sleeve gastrectomy is positioned between gastric banding and the laparoscopic gastric bypass for both safety and efficacy, results from the largest comparative study of its kind demonstrated.

The finding comes at a time when the Centers for Medicare and Medicaid Services is reviewing evidence to consider including sleeve gastrectomy as a covered benefit. Currently, gastric bypass, vertical banded gastroplasty, duodenal switch, and gastric banding are the only CMS-sanctioned bariatric procedures.

The study, which involved nearly 300,000 patients, "shows that across the board, regardless of the procedure, bariatric surgery is safe and effective," Dr. John M. Morton said in an interview at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "The emerging new procedure, the sleeve gastrectomy, is shown to be right between the bypass and the band. As a result, we have seen more interest from payers to cover it. In fact there are about 100 million lives that are covered. Our only outlier is CMS in deciding to cover. We hope that these data will help influence CMS in granting coverage for the sleeve gastrectomy."

Dr. Morton, associate professor of surgery and director of bariatric surgery at Stanford Hospitals and Clinics at Stanford (Calif.) University, and his associates examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRNYGB), gastric banding (LAGB), and sleeve gastrectomy (LSG) from June 2007 to December 2010. BOLD, the largest bariatric-specific database, is maintained by the ASMBS Bariatric Surgery Center of Excellence program, and includes more than 1,200 surgeons at 540 hospitals. Dr. Morton described the data as a "clinically rich" variable set that includes age, gender, race, insurance status, body mass index, excess body weight, and comorbidities.

"There is a definite need for more data around comparison of different procedures," Dr. Morton said at the meeting. "Our study hypothesis is very straightforward: Do demographics and outcomes for bariatric surgery vary by procedure?"

The primary outcomes were 30-day mortality, serious complications, and readmissions. The definitions of serious complications included death, anastomotic leakage, cardiac arrest, deep venous thrombosis, evisceration, heart failure and/or pulmonary edema, liver failure, and bleeding requiring transfusion.

Dr. Morton reported outcomes from 117,365 patients in the LAGB group, 138,222 in the LRNYGB group, and 16,139 in the LSG group. Patients in each group were generally the same age (a mean of 45, 46, and 45 years, respectively), mostly female (78%, 79%, and 74%), and mostly white (72%, 73%, and 72%). "The one area where there was a sizable difference was around self-pay," Dr. Morton said. About 21% of patients in the LSG group paid out-of-pocket, compared with 6% of those in the LAGB group and 2% of those in the LRNYGB group.

The proportion of preoperative comorbidities was similar among the three groups, with two exceptions. The prevalence of diabetes was highest in the LRNYGB group (37%, compared with 30% in the LSG group and 28% in the LAGB group; P less than .0001). A similar association was seen in the proportion of patients with five or more preoperative comorbidities (62%, 55%, and 52%, respectively; P less than .0001).

The mean length of stay was 0.7 days for the LAGB group, 1.9 days for the LSG group, and 2.3 days for the LRNYGB group. The percent change in BMI at 12 months was 7.6%, 13.4%, and 16.4%, respectively; the rate of 30-day serious complications was 0.25%, 0.96%, and 1.25%; and the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%. All differences between the groups were significant (P less than .0001).

"If you look at the remainder of the safety outcomes – everything from 30-day readmission to 30-day reoperation – it’s pretty much the same order, with the band group having the lowest [percentage], and the bypass having the highest, and the sleeve being right in between," Dr. Morton said. "When we looked at age greater than 65 in isolation, we found that the order of safety remains, with the banding having the least amount of mortality and the sleeve being right between the band procedure and the bypass."

Logistic regression analysis revealed several significant factors that predicted serious adverse events at 30 days: male gender (odds ratio, 1.67), having nonprivate insurance (OR, 1.15), stepwise progression with increasing age (for example, an OR of 1.27 for those aged 26-35 years and an OR of 4.42 for those above age 65), and stepwise progression with increasing BMI (for example, an OR of 1.37 for those with a BMI of 46-55 kg/m² and an OR of 3.03 for those with a BMI greater than 65).

The invited discussant, Dr. Matthew M. Hutter, of Massachusetts General Hospital, Boston, described the size of the overall study cohort as remarkable. "What I find most interesting about this study is that it shows that sleeve gastrectomy – a brand-new, very complex procedure – can be introduced safely and effectively when performed under the standards of a bariatric accreditation program," Dr. Hutter said. "Other surgical procedures such as laparoscopic cholecystectomy or laparoscopic colectomy had very high morbidity and conversion rates when they were first implemented. However, this new complex procedure has been safe and effective from the get-go, and that is really quite impressive. The other remarkable finding is how consistent this is with all of the other major [bariatric surgery] data collection programs."

Dr. Morton acknowledged certain limitations of the study, including the fact that 1-year follow-up was available in only 60% of patients, while 30-day follow-up was available in 98% of the cohort. "Potentially, patients could have been admitted to other hospitals," he added. "These are research-consented patients, so about 70% consented. Some of this is surgeon-directed reporting."

Dr. Morton said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Laparoscopic sleeve gastrectomy is positioned between gastric banding and the laparoscopic gastric bypass for both safety and efficacy, results from the largest comparative study of its kind demonstrated.

The finding comes at a time when the Centers for Medicare and Medicaid Services is reviewing evidence to consider including sleeve gastrectomy as a covered benefit. Currently, gastric bypass, vertical banded gastroplasty, duodenal switch, and gastric banding are the only CMS-sanctioned bariatric procedures.

The study, which involved nearly 300,000 patients, "shows that across the board, regardless of the procedure, bariatric surgery is safe and effective," Dr. John M. Morton said in an interview at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "The emerging new procedure, the sleeve gastrectomy, is shown to be right between the bypass and the band. As a result, we have seen more interest from payers to cover it. In fact there are about 100 million lives that are covered. Our only outlier is CMS in deciding to cover. We hope that these data will help influence CMS in granting coverage for the sleeve gastrectomy."

Dr. Morton, associate professor of surgery and director of bariatric surgery at Stanford Hospitals and Clinics at Stanford (Calif.) University, and his associates examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRNYGB), gastric banding (LAGB), and sleeve gastrectomy (LSG) from June 2007 to December 2010. BOLD, the largest bariatric-specific database, is maintained by the ASMBS Bariatric Surgery Center of Excellence program, and includes more than 1,200 surgeons at 540 hospitals. Dr. Morton described the data as a "clinically rich" variable set that includes age, gender, race, insurance status, body mass index, excess body weight, and comorbidities.

"There is a definite need for more data around comparison of different procedures," Dr. Morton said at the meeting. "Our study hypothesis is very straightforward: Do demographics and outcomes for bariatric surgery vary by procedure?"

The primary outcomes were 30-day mortality, serious complications, and readmissions. The definitions of serious complications included death, anastomotic leakage, cardiac arrest, deep venous thrombosis, evisceration, heart failure and/or pulmonary edema, liver failure, and bleeding requiring transfusion.

Dr. Morton reported outcomes from 117,365 patients in the LAGB group, 138,222 in the LRNYGB group, and 16,139 in the LSG group. Patients in each group were generally the same age (a mean of 45, 46, and 45 years, respectively), mostly female (78%, 79%, and 74%), and mostly white (72%, 73%, and 72%). "The one area where there was a sizable difference was around self-pay," Dr. Morton said. About 21% of patients in the LSG group paid out-of-pocket, compared with 6% of those in the LAGB group and 2% of those in the LRNYGB group.

The proportion of preoperative comorbidities was similar among the three groups, with two exceptions. The prevalence of diabetes was highest in the LRNYGB group (37%, compared with 30% in the LSG group and 28% in the LAGB group; P less than .0001). A similar association was seen in the proportion of patients with five or more preoperative comorbidities (62%, 55%, and 52%, respectively; P less than .0001).

The mean length of stay was 0.7 days for the LAGB group, 1.9 days for the LSG group, and 2.3 days for the LRNYGB group. The percent change in BMI at 12 months was 7.6%, 13.4%, and 16.4%, respectively; the rate of 30-day serious complications was 0.25%, 0.96%, and 1.25%; and the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%. All differences between the groups were significant (P less than .0001).

"If you look at the remainder of the safety outcomes – everything from 30-day readmission to 30-day reoperation – it’s pretty much the same order, with the band group having the lowest [percentage], and the bypass having the highest, and the sleeve being right in between," Dr. Morton said. "When we looked at age greater than 65 in isolation, we found that the order of safety remains, with the banding having the least amount of mortality and the sleeve being right between the band procedure and the bypass."

Logistic regression analysis revealed several significant factors that predicted serious adverse events at 30 days: male gender (odds ratio, 1.67), having nonprivate insurance (OR, 1.15), stepwise progression with increasing age (for example, an OR of 1.27 for those aged 26-35 years and an OR of 4.42 for those above age 65), and stepwise progression with increasing BMI (for example, an OR of 1.37 for those with a BMI of 46-55 kg/m² and an OR of 3.03 for those with a BMI greater than 65).

The invited discussant, Dr. Matthew M. Hutter, of Massachusetts General Hospital, Boston, described the size of the overall study cohort as remarkable. "What I find most interesting about this study is that it shows that sleeve gastrectomy – a brand-new, very complex procedure – can be introduced safely and effectively when performed under the standards of a bariatric accreditation program," Dr. Hutter said. "Other surgical procedures such as laparoscopic cholecystectomy or laparoscopic colectomy had very high morbidity and conversion rates when they were first implemented. However, this new complex procedure has been safe and effective from the get-go, and that is really quite impressive. The other remarkable finding is how consistent this is with all of the other major [bariatric surgery] data collection programs."

Dr. Morton acknowledged certain limitations of the study, including the fact that 1-year follow-up was available in only 60% of patients, while 30-day follow-up was available in 98% of the cohort. "Potentially, patients could have been admitted to other hospitals," he added. "These are research-consented patients, so about 70% consented. Some of this is surgeon-directed reporting."

Dr. Morton said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Being black, male, or older significantly raised the risk for weight-loss failure after gastric bypass in a single-center study of more than 1,200 patients.

"Long-term treatments of obesity are hampered by the fixed behaviors that induce obesity, the possibility of weight set points, and the ever-present exposure to high-calorie foods. The treatments of obesity all have great variability in outcome," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

To determine predictors of weight-loss failure after gastric bypass surgery, Dr. Dallal and his associate at the department of surgery at Einstein Healthcare Network, Philadelphia, reviewed the medical records of 1,256 gastric bypass patients who had a least 1 year of follow-up. They separated patients into two groups: those who were above the 75th percentile in weight loss (success) and those who were below the 25th percentile in weight loss (failure). Multivariate logistic regression was performed to examine the impact of sex, race, age, initial weight, initial glycosylated hemoglobin (HbA_1c) level, and insurance type (Medicare/Medicaid vs. private insurance).

The mean preoperative body mass index of the 1,256 patients was 48.3 kg/m², their mean age was 42 years, and 82% were women. More than one-quarter of patients (27%) had diabetes, and the mean HbA_1c level was 6.6% in blacks and 6.3% in whites. The majority of patients (75%) had private insurance, 19% were on Medicare, and 6% were on Medicaid.

Dr. Dallal reported that after a mean follow-up period of 665 days, the mean excess weight loss among all patients was 70%, and was significantly different between whites and blacks (72% vs. 63%, respectively), between those aged 65 years and older and those younger than age 40 (61% vs. 71%), and between men and women (62% vs. 71%). The calculated threshold estimated weight loss for the upper 75th and lower 25th percentiles was 82% vs. 57%, respectively.

Multivariate logistic regression analysis revealed the following independent predictors of weight-loss failure: being black (odds ratio, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having a higher initial body weight (OR, 0.86; P less than .0005). Initial HbA_1c and insurance type were not independent predictors of weight-loss failure.

Dr. Dallal acknowledged certain limitations of the study, including the fact that the ideal body weight calculations used "may not necessarily be valid for all ethnicities. Also, we did not distinguish between primary weight-loss failures (those who never reached adequate weight loss) and those [who had] a secondary weight-loss failure (regain of lost weight)."

Dr. Dallal said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Being black, male, or older significantly raised the risk for weight-loss failure after gastric bypass in a single-center study of more than 1,200 patients.

"Long-term treatments of obesity are hampered by the fixed behaviors that induce obesity, the possibility of weight set points, and the ever-present exposure to high-calorie foods. The treatments of obesity all have great variability in outcome," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

To determine predictors of weight-loss failure after gastric bypass surgery, Dr. Dallal and his associate at the department of surgery at Einstein Healthcare Network, Philadelphia, reviewed the medical records of 1,256 gastric bypass patients who had a least 1 year of follow-up. They separated patients into two groups: those who were above the 75th percentile in weight loss (success) and those who were below the 25th percentile in weight loss (failure). Multivariate logistic regression was performed to examine the impact of sex, race, age, initial weight, initial glycosylated hemoglobin (HbA_1c) level, and insurance type (Medicare/Medicaid vs. private insurance).

The mean preoperative body mass index of the 1,256 patients was 48.3 kg/m², their mean age was 42 years, and 82% were women. More than one-quarter of patients (27%) had diabetes, and the mean HbA_1c level was 6.6% in blacks and 6.3% in whites. The majority of patients (75%) had private insurance, 19% were on Medicare, and 6% were on Medicaid.

Dr. Dallal reported that after a mean follow-up period of 665 days, the mean excess weight loss among all patients was 70%, and was significantly different between whites and blacks (72% vs. 63%, respectively), between those aged 65 years and older and those younger than age 40 (61% vs. 71%), and between men and women (62% vs. 71%). The calculated threshold estimated weight loss for the upper 75th and lower 25th percentiles was 82% vs. 57%, respectively.

Multivariate logistic regression analysis revealed the following independent predictors of weight-loss failure: being black (odds ratio, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having a higher initial body weight (OR, 0.86; P less than .0005). Initial HbA_1c and insurance type were not independent predictors of weight-loss failure.

Dr. Dallal acknowledged certain limitations of the study, including the fact that the ideal body weight calculations used "may not necessarily be valid for all ethnicities. Also, we did not distinguish between primary weight-loss failures (those who never reached adequate weight loss) and those [who had] a secondary weight-loss failure (regain of lost weight)."

Dr. Dallal said that he had no relevant financial conflicts to disclose.

SAN DIEGO – Being black, male, or older significantly raised the risk for weight-loss failure after gastric bypass in a single-center study of more than 1,200 patients.

"Long-term treatments of obesity are hampered by the fixed behaviors that induce obesity, the possibility of weight set points, and the ever-present exposure to high-calorie foods. The treatments of obesity all have great variability in outcome," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

To determine predictors of weight-loss failure after gastric bypass surgery, Dr. Dallal and his associate at the department of surgery at Einstein Healthcare Network, Philadelphia, reviewed the medical records of 1,256 gastric bypass patients who had a least 1 year of follow-up. They separated patients into two groups: those who were above the 75th percentile in weight loss (success) and those who were below the 25th percentile in weight loss (failure). Multivariate logistic regression was performed to examine the impact of sex, race, age, initial weight, initial glycosylated hemoglobin (HbA_1c) level, and insurance type (Medicare/Medicaid vs. private insurance).

The mean preoperative body mass index of the 1,256 patients was 48.3 kg/m², their mean age was 42 years, and 82% were women. More than one-quarter of patients (27%) had diabetes, and the mean HbA_1c level was 6.6% in blacks and 6.3% in whites. The majority of patients (75%) had private insurance, 19% were on Medicare, and 6% were on Medicaid.

Dr. Dallal reported that after a mean follow-up period of 665 days, the mean excess weight loss among all patients was 70%, and was significantly different between whites and blacks (72% vs. 63%, respectively), between those aged 65 years and older and those younger than age 40 (61% vs. 71%), and between men and women (62% vs. 71%). The calculated threshold estimated weight loss for the upper 75th and lower 25th percentiles was 82% vs. 57%, respectively.

Multivariate logistic regression analysis revealed the following independent predictors of weight-loss failure: being black (odds ratio, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having a higher initial body weight (OR, 0.86; P less than .0005). Initial HbA_1c and insurance type were not independent predictors of weight-loss failure.

Dr. Dallal acknowledged certain limitations of the study, including the fact that the ideal body weight calculations used "may not necessarily be valid for all ethnicities. Also, we did not distinguish between primary weight-loss failures (those who never reached adequate weight loss) and those [who had] a secondary weight-loss failure (regain of lost weight)."

Dr. Dallal said that he had no relevant financial conflicts to disclose.

HOUSTON – One in five patients whose type 2 diabetes went into remission following gastric bypass surgery experienced disease re-emergence within 5 years postoperatively.

The likelihood of diabetes recurrence in this retrospective single-center study wasn’t affected by preoperative body mass index or the amount of weight regained postsurgically.

Indeed, the only significant risk factor for diabetes reemergence was a longer duration of type 2 diabetes preoperatively. Patients with a greater than 5-year preoperative history of the disease were 3.8-fold more likely to experience disease recurrence, according to Dr. Yessica Ramos of the Mayo Clinic Arizona, Scottsdale.

The clinical implication: "Early surgical intervention in the type 2 diabetic obese population may improve the durability of remission of type 2 diabetes," she said.

Dr. Ramos reported on 72 obese patients with type 2 diabetes who underwent Roux-en-Y gastric bypass at the Mayo Clinic Arizona during 2000-2007 for whom 5-year follow-up data were available. The patients’ mean preoperative body mass index was 45 kg/m², with an average age of 49.5 years.

Sixty-six of the 72 patients (92%) experienced remission of their diabetes as defined by a hemoglobin A_1c below 6.5% while off all antidiabetic medications. The other six patients had persistent type 2 diabetes throughout follow-up.

A total of 14 of 66 patients, or 21%, whose type 2 diabetes went into remission subsequently saw their disease return as defined by an HbA_1c of 6.5% or more, a fasting blood glucose greater than 7 mmol/L, or use of antidiabetic drugs.

Diabetes returned as early as 2 years post surgery in five patients.

The explanation for the high rate of diabetes reemergence remains unclear. Retrospective studies of bariatric surgery patients are notoriously difficult because the surgery is often life changing and patients are frequently lost to follow-up.

Dr. Ramos’s working hypothesis is that patients with longer duration of type 2 diabetes are at a higher risk of recurrence because they have more compromised beta cell function. But definitive answers must await further reports from prospective randomized trials of surgery vs. medication as a treatment for type 2 diabetes in obese patients, such as the one reported from the Cleveland Clinic (N. Engl. J. Med. 2012;366:1567-76), or analysis of data from the large multicenter bariatric surgery registries.

Dr. Ramos reported having no financial conflicts.

HOUSTON – One in five patients whose type 2 diabetes went into remission following gastric bypass surgery experienced disease re-emergence within 5 years postoperatively.

The likelihood of diabetes recurrence in this retrospective single-center study wasn’t affected by preoperative body mass index or the amount of weight regained postsurgically.

Indeed, the only significant risk factor for diabetes reemergence was a longer duration of type 2 diabetes preoperatively. Patients with a greater than 5-year preoperative history of the disease were 3.8-fold more likely to experience disease recurrence, according to Dr. Yessica Ramos of the Mayo Clinic Arizona, Scottsdale.

The clinical implication: "Early surgical intervention in the type 2 diabetic obese population may improve the durability of remission of type 2 diabetes," she said.

Dr. Ramos reported on 72 obese patients with type 2 diabetes who underwent Roux-en-Y gastric bypass at the Mayo Clinic Arizona during 2000-2007 for whom 5-year follow-up data were available. The patients’ mean preoperative body mass index was 45 kg/m², with an average age of 49.5 years.

Sixty-six of the 72 patients (92%) experienced remission of their diabetes as defined by a hemoglobin A_1c below 6.5% while off all antidiabetic medications. The other six patients had persistent type 2 diabetes throughout follow-up.

A total of 14 of 66 patients, or 21%, whose type 2 diabetes went into remission subsequently saw their disease return as defined by an HbA_1c of 6.5% or more, a fasting blood glucose greater than 7 mmol/L, or use of antidiabetic drugs.

Diabetes returned as early as 2 years post surgery in five patients.

The explanation for the high rate of diabetes reemergence remains unclear. Retrospective studies of bariatric surgery patients are notoriously difficult because the surgery is often life changing and patients are frequently lost to follow-up.

Dr. Ramos’s working hypothesis is that patients with longer duration of type 2 diabetes are at a higher risk of recurrence because they have more compromised beta cell function. But definitive answers must await further reports from prospective randomized trials of surgery vs. medication as a treatment for type 2 diabetes in obese patients, such as the one reported from the Cleveland Clinic (N. Engl. J. Med. 2012;366:1567-76), or analysis of data from the large multicenter bariatric surgery registries.

Dr. Ramos reported having no financial conflicts.

HOUSTON – One in five patients whose type 2 diabetes went into remission following gastric bypass surgery experienced disease re-emergence within 5 years postoperatively.

The likelihood of diabetes recurrence in this retrospective single-center study wasn’t affected by preoperative body mass index or the amount of weight regained postsurgically.

Indeed, the only significant risk factor for diabetes reemergence was a longer duration of type 2 diabetes preoperatively. Patients with a greater than 5-year preoperative history of the disease were 3.8-fold more likely to experience disease recurrence, according to Dr. Yessica Ramos of the Mayo Clinic Arizona, Scottsdale.

The clinical implication: "Early surgical intervention in the type 2 diabetic obese population may improve the durability of remission of type 2 diabetes," she said.

Dr. Ramos reported on 72 obese patients with type 2 diabetes who underwent Roux-en-Y gastric bypass at the Mayo Clinic Arizona during 2000-2007 for whom 5-year follow-up data were available. The patients’ mean preoperative body mass index was 45 kg/m², with an average age of 49.5 years.

Sixty-six of the 72 patients (92%) experienced remission of their diabetes as defined by a hemoglobin A_1c below 6.5% while off all antidiabetic medications. The other six patients had persistent type 2 diabetes throughout follow-up.

A total of 14 of 66 patients, or 21%, whose type 2 diabetes went into remission subsequently saw their disease return as defined by an HbA_1c of 6.5% or more, a fasting blood glucose greater than 7 mmol/L, or use of antidiabetic drugs.

Diabetes returned as early as 2 years post surgery in five patients.

The explanation for the high rate of diabetes reemergence remains unclear. Retrospective studies of bariatric surgery patients are notoriously difficult because the surgery is often life changing and patients are frequently lost to follow-up.

Dr. Ramos’s working hypothesis is that patients with longer duration of type 2 diabetes are at a higher risk of recurrence because they have more compromised beta cell function. But definitive answers must await further reports from prospective randomized trials of surgery vs. medication as a treatment for type 2 diabetes in obese patients, such as the one reported from the Cleveland Clinic (N. Engl. J. Med. 2012;366:1567-76), or analysis of data from the large multicenter bariatric surgery registries.

Dr. Ramos reported having no financial conflicts.

Early results from a small clinical trial suggest the new oral skin cancer drug vismodegib may be therapeutic in patients receiving chemotherapy for metastatic pancreatic cancer.

Half of 20 patients treated with vismodegib (Erivedge, GDC-0449) and gemcitabine (Gemzar) were progression free at 3 months, investigators reported during a pancreatic cancer conference sponsored by the American Association for Cancer Research. Five patients had partial responses, and five had stable disease.

The study found pretreatment sonic hedgehog expression level was the biological correlate most predictive of therapeutic benefit. Vismodegib, a small molecule drug from Genentech, blocks the Smoothened (SMO) protein in the hedgehog signaling pathway

If validated in additional studies, the combination of vismodegib and gemcitabine "has the potential to change the way we treat pancreatic cancer" lead author Dr. Edward Kim of the University of Michigan Comprehensive Cancer Center in Ann Arbor, said in a press briefing at the meeting in Lake Tahoe, Nev.

In previous research, the investigators determined that specific pancreatic cancer stem cells express significantly elevated levels of sonic hedgehog (Cancer Res. 2007;67:1030-7), which led to successful phase I studies, Dr. Kim said in an interview. Building on that foundation, for the current clinical trial, the researchers incorporated pair core tumor biopsies to prospectively compare the inhibition of the hedgehog pathway in pancreatic cancer before and after vismodegib treatment.

To date, 21 of the study’s planned 25 patients with advanced pancreatic cancer have been enrolled. Data from 20 of the patients with paired biopsies who had completed three treatment cycles were reported at the meeting.

All of the patients had previously untreated metastatic pancreatic cancer, for which the protocol initiated daily monotherapy with vismodegib for 4 weeks, followed by combination treatment with vismodegib and gemcitabine on days 1, 8, and 15 of each month in a 3-month cycle, Dr. Kim reported. Each patient underwent two sets of three core biopsies – one set prior to treatment and another set 3 weeks after treatment initiation.

To evaluate the effects of the experimental drug on pancreatic cancer stem cells, the investigators used immunohistochemistry to evaluate expression of sonic hedgehog and Ki-67, a static marker of tumor proliferation.

"After three cycles of therapy, five patients showed evidence of partial disease response [defined as a minimum 30% decrease in the sum of the longest-diameter target lesions relative to baseline, based on RECIST criteria] and five patients had stable disease, yielding 3-month progression-free survival rate of 50%," Dr. Kim stated. Additionally, half of the evaluable patients demonstrated an average 60% reduction in pancreatic cancer stem cells and a 54% decrease in the proliferation index.

Importantly, Dr. Kim noted, "sonic hedgehog expression was more highly expressed in patients who had a partial response or stable disease compared with patients whose disease progressed." Specifically, the mean pretreatment hedgehog expression H-score (intensity times the percentage of positive cells) was 285 in patients with partial response or stable disease compared with 168 in those with progression.

"We are currently conducting further correlative studies to determine the best predictors of which patients stand to benefit from this treatment regimen," he said. The researchers also are continuing to investigate the effect that vismodegib has on hedgehog pathway target genes.

The response rate observed in this study exceeded expectations, according to session moderator Dr. Daniel Von Hoff, chief scientific officer for the Scottsdale Healthcare Research Institute and physician-in-chief at TGen (Translational Genomics Research Institute) in Phoenix. "We usually see about a 5%-9% change of response to gemcitabine by itself, but here it was 25%. The good news is that this drug doesn’t add any toxicities."

The Food and Drug Administration approved vismodegib Jan. 30 for locally advanced or metastatic basal cell carcinoma that cannot be treated with surgery or radiation. It has not been considered for an indication in pancreatic cancer.

Dr. Kim and Dr. Von Hoff disclosed having no relevant financial conflicts of interest.

Early results from a small clinical trial suggest the new oral skin cancer drug vismodegib may be therapeutic in patients receiving chemotherapy for metastatic pancreatic cancer.

Half of 20 patients treated with vismodegib (Erivedge, GDC-0449) and gemcitabine (Gemzar) were progression free at 3 months, investigators reported during a pancreatic cancer conference sponsored by the American Association for Cancer Research. Five patients had partial responses, and five had stable disease.

The study found pretreatment sonic hedgehog expression level was the biological correlate most predictive of therapeutic benefit. Vismodegib, a small molecule drug from Genentech, blocks the Smoothened (SMO) protein in the hedgehog signaling pathway

If validated in additional studies, the combination of vismodegib and gemcitabine "has the potential to change the way we treat pancreatic cancer" lead author Dr. Edward Kim of the University of Michigan Comprehensive Cancer Center in Ann Arbor, said in a press briefing at the meeting in Lake Tahoe, Nev.

In previous research, the investigators determined that specific pancreatic cancer stem cells express significantly elevated levels of sonic hedgehog (Cancer Res. 2007;67:1030-7), which led to successful phase I studies, Dr. Kim said in an interview. Building on that foundation, for the current clinical trial, the researchers incorporated pair core tumor biopsies to prospectively compare the inhibition of the hedgehog pathway in pancreatic cancer before and after vismodegib treatment.

To date, 21 of the study’s planned 25 patients with advanced pancreatic cancer have been enrolled. Data from 20 of the patients with paired biopsies who had completed three treatment cycles were reported at the meeting.

All of the patients had previously untreated metastatic pancreatic cancer, for which the protocol initiated daily monotherapy with vismodegib for 4 weeks, followed by combination treatment with vismodegib and gemcitabine on days 1, 8, and 15 of each month in a 3-month cycle, Dr. Kim reported. Each patient underwent two sets of three core biopsies – one set prior to treatment and another set 3 weeks after treatment initiation.

To evaluate the effects of the experimental drug on pancreatic cancer stem cells, the investigators used immunohistochemistry to evaluate expression of sonic hedgehog and Ki-67, a static marker of tumor proliferation.

"After three cycles of therapy, five patients showed evidence of partial disease response [defined as a minimum 30% decrease in the sum of the longest-diameter target lesions relative to baseline, based on RECIST criteria] and five patients had stable disease, yielding 3-month progression-free survival rate of 50%," Dr. Kim stated. Additionally, half of the evaluable patients demonstrated an average 60% reduction in pancreatic cancer stem cells and a 54% decrease in the proliferation index.

Importantly, Dr. Kim noted, "sonic hedgehog expression was more highly expressed in patients who had a partial response or stable disease compared with patients whose disease progressed." Specifically, the mean pretreatment hedgehog expression H-score (intensity times the percentage of positive cells) was 285 in patients with partial response or stable disease compared with 168 in those with progression.

"We are currently conducting further correlative studies to determine the best predictors of which patients stand to benefit from this treatment regimen," he said. The researchers also are continuing to investigate the effect that vismodegib has on hedgehog pathway target genes.

The response rate observed in this study exceeded expectations, according to session moderator Dr. Daniel Von Hoff, chief scientific officer for the Scottsdale Healthcare Research Institute and physician-in-chief at TGen (Translational Genomics Research Institute) in Phoenix. "We usually see about a 5%-9% change of response to gemcitabine by itself, but here it was 25%. The good news is that this drug doesn’t add any toxicities."

The Food and Drug Administration approved vismodegib Jan. 30 for locally advanced or metastatic basal cell carcinoma that cannot be treated with surgery or radiation. It has not been considered for an indication in pancreatic cancer.

Dr. Kim and Dr. Von Hoff disclosed having no relevant financial conflicts of interest.

Early results from a small clinical trial suggest the new oral skin cancer drug vismodegib may be therapeutic in patients receiving chemotherapy for metastatic pancreatic cancer.

Half of 20 patients treated with vismodegib (Erivedge, GDC-0449) and gemcitabine (Gemzar) were progression free at 3 months, investigators reported during a pancreatic cancer conference sponsored by the American Association for Cancer Research. Five patients had partial responses, and five had stable disease.

The study found pretreatment sonic hedgehog expression level was the biological correlate most predictive of therapeutic benefit. Vismodegib, a small molecule drug from Genentech, blocks the Smoothened (SMO) protein in the hedgehog signaling pathway

If validated in additional studies, the combination of vismodegib and gemcitabine "has the potential to change the way we treat pancreatic cancer" lead author Dr. Edward Kim of the University of Michigan Comprehensive Cancer Center in Ann Arbor, said in a press briefing at the meeting in Lake Tahoe, Nev.

In previous research, the investigators determined that specific pancreatic cancer stem cells express significantly elevated levels of sonic hedgehog (Cancer Res. 2007;67:1030-7), which led to successful phase I studies, Dr. Kim said in an interview. Building on that foundation, for the current clinical trial, the researchers incorporated pair core tumor biopsies to prospectively compare the inhibition of the hedgehog pathway in pancreatic cancer before and after vismodegib treatment.

To date, 21 of the study’s planned 25 patients with advanced pancreatic cancer have been enrolled. Data from 20 of the patients with paired biopsies who had completed three treatment cycles were reported at the meeting.

All of the patients had previously untreated metastatic pancreatic cancer, for which the protocol initiated daily monotherapy with vismodegib for 4 weeks, followed by combination treatment with vismodegib and gemcitabine on days 1, 8, and 15 of each month in a 3-month cycle, Dr. Kim reported. Each patient underwent two sets of three core biopsies – one set prior to treatment and another set 3 weeks after treatment initiation.

To evaluate the effects of the experimental drug on pancreatic cancer stem cells, the investigators used immunohistochemistry to evaluate expression of sonic hedgehog and Ki-67, a static marker of tumor proliferation.

"After three cycles of therapy, five patients showed evidence of partial disease response [defined as a minimum 30% decrease in the sum of the longest-diameter target lesions relative to baseline, based on RECIST criteria] and five patients had stable disease, yielding 3-month progression-free survival rate of 50%," Dr. Kim stated. Additionally, half of the evaluable patients demonstrated an average 60% reduction in pancreatic cancer stem cells and a 54% decrease in the proliferation index.

Importantly, Dr. Kim noted, "sonic hedgehog expression was more highly expressed in patients who had a partial response or stable disease compared with patients whose disease progressed." Specifically, the mean pretreatment hedgehog expression H-score (intensity times the percentage of positive cells) was 285 in patients with partial response or stable disease compared with 168 in those with progression.

"We are currently conducting further correlative studies to determine the best predictors of which patients stand to benefit from this treatment regimen," he said. The researchers also are continuing to investigate the effect that vismodegib has on hedgehog pathway target genes.

The response rate observed in this study exceeded expectations, according to session moderator Dr. Daniel Von Hoff, chief scientific officer for the Scottsdale Healthcare Research Institute and physician-in-chief at TGen (Translational Genomics Research Institute) in Phoenix. "We usually see about a 5%-9% change of response to gemcitabine by itself, but here it was 25%. The good news is that this drug doesn’t add any toxicities."

The Food and Drug Administration approved vismodegib Jan. 30 for locally advanced or metastatic basal cell carcinoma that cannot be treated with surgery or radiation. It has not been considered for an indication in pancreatic cancer.

Dr. Kim and Dr. Von Hoff disclosed having no relevant financial conflicts of interest.

SAN DIEGO – A proposed quality measure for pancreatic surgery has the potential to assess performance more thoroughly than current volume and mortality measures, judging by surgeons’ responses to a recent survey.

The 12-item "Quality Scorecard," developed by Dr. Brian T. Kalish of Beth Israel Deaconess Medical Center, Boston, and a team of pancreatic surgeons from multiple academic medical centers, consists of actionable and meaningful measures. The scorecard is aligned with the Institute of Medicine’s health care quality domains: safety, timeliness, effectiveness, patient centeredness, efficiency, and equitability.

"Traditional quality metrics in high-acuity surgery on their own cannot measure or satisfy the [IOM] domains," Dr. Kalish explained in a plenary presentation at the annual Digestive Disease Week. "Our goal was to evaluate the need for broader quality metrics and whether such broader metrics would align to contemporary IOM domains."

"We expect the scorecard to reveal quality to an extent that volume and mortality alone cannot."

Toward this end, the development team worked with a professional market research firm to create a web-based survey and distribute it to expert pancreatic surgeons identified through specialty societies and verified by survey demographics, Dr. Kalish explained. "The survey asked respondents to rank [62] proposed quality metrics on level of importance, from essential to not important, and to align the metric to one or more of the [IOM] quality domains." Points were awarded for level of importance and multidomain alignment, and the two scores for a given quality metric were averaged to render a total quality score that was then normalized to a 100-point scale, he said.

The 21% survey response rate represented 106 surgeons primarily from academic medical centers in North America who perform an average of 43 pancreatic operations per year, said Dr. Kalish. The need for improved quality metrics was indicated by 90% of the respondents, while 81% believed that a "quality scorecard" in pancreatic surgery would probably or definitely be of value, he reported. More than one-third of the proposed metrics aligned to more than one IOM domain, and at least half of the respondents rated these as essential or very important, he said.

Of the 62 metrics, 12 emerged with the highest total quality score. In rank order, they are: multidisciplinary services for pancreatic diseases, major complication rate, perioperative mortality, overall complication rate, incidence of postoperative hemorrhage, venous thromboembolism prophylaxis, patients with malignancy who undergo adjuvant therapy, readmission rates (30 day, 90 day, total), incidence of postoperative pancreatic fistula, timely and appropriate perioperative antibiotics, survival rates (1 year and 5 year), and timing from diagnosis to surgical consultation.

"The metrics related to mortality, the rate and severity of complications, and access to multidisciplinary services for pancreatic disease had the highest total quality scores; technical and perioperative metrics had intermediate scores; and metrics related to patient satisfaction with care, costs of care, and patient demographics had the lowest total quality scores," Dr. Kalish observed. With respect to the IOM domains, "the least represented domains were equitability, efficiency, and patient-centeredness," he said.

Although the actual performance thresholds for each of the metrics require further definition and validation, "we expect the scorecard to reveal quality to an extent that volume and mortality alone cannot," Dr. Kalish stated, noting that the development process is ongoing.

Future efforts include the organization of patient focus groups and a formal survey of patients and family members to attain insight into which quality metrics are important to those receiving care, as well as a multicenter prospective validation.

Dr. Kalish reported having no relevant financial conflicts of interest.

SAN DIEGO – A proposed quality measure for pancreatic surgery has the potential to assess performance more thoroughly than current volume and mortality measures, judging by surgeons’ responses to a recent survey.

The 12-item "Quality Scorecard," developed by Dr. Brian T. Kalish of Beth Israel Deaconess Medical Center, Boston, and a team of pancreatic surgeons from multiple academic medical centers, consists of actionable and meaningful measures. The scorecard is aligned with the Institute of Medicine’s health care quality domains: safety, timeliness, effectiveness, patient centeredness, efficiency, and equitability.

"Traditional quality metrics in high-acuity surgery on their own cannot measure or satisfy the [IOM] domains," Dr. Kalish explained in a plenary presentation at the annual Digestive Disease Week. "Our goal was to evaluate the need for broader quality metrics and whether such broader metrics would align to contemporary IOM domains."

"We expect the scorecard to reveal quality to an extent that volume and mortality alone cannot."

Toward this end, the development team worked with a professional market research firm to create a web-based survey and distribute it to expert pancreatic surgeons identified through specialty societies and verified by survey demographics, Dr. Kalish explained. "The survey asked respondents to rank [62] proposed quality metrics on level of importance, from essential to not important, and to align the metric to one or more of the [IOM] quality domains." Points were awarded for level of importance and multidomain alignment, and the two scores for a given quality metric were averaged to render a total quality score that was then normalized to a 100-point scale, he said.

The 21% survey response rate represented 106 surgeons primarily from academic medical centers in North America who perform an average of 43 pancreatic operations per year, said Dr. Kalish. The need for improved quality metrics was indicated by 90% of the respondents, while 81% believed that a "quality scorecard" in pancreatic surgery would probably or definitely be of value, he reported. More than one-third of the proposed metrics aligned to more than one IOM domain, and at least half of the respondents rated these as essential or very important, he said.

Of the 62 metrics, 12 emerged with the highest total quality score. In rank order, they are: multidisciplinary services for pancreatic diseases, major complication rate, perioperative mortality, overall complication rate, incidence of postoperative hemorrhage, venous thromboembolism prophylaxis, patients with malignancy who undergo adjuvant therapy, readmission rates (30 day, 90 day, total), incidence of postoperative pancreatic fistula, timely and appropriate perioperative antibiotics, survival rates (1 year and 5 year), and timing from diagnosis to surgical consultation.

"The metrics related to mortality, the rate and severity of complications, and access to multidisciplinary services for pancreatic disease had the highest total quality scores; technical and perioperative metrics had intermediate scores; and metrics related to patient satisfaction with care, costs of care, and patient demographics had the lowest total quality scores," Dr. Kalish observed. With respect to the IOM domains, "the least represented domains were equitability, efficiency, and patient-centeredness," he said.

Although the actual performance thresholds for each of the metrics require further definition and validation, "we expect the scorecard to reveal quality to an extent that volume and mortality alone cannot," Dr. Kalish stated, noting that the development process is ongoing.

Future efforts include the organization of patient focus groups and a formal survey of patients and family members to attain insight into which quality metrics are important to those receiving care, as well as a multicenter prospective validation.

Dr. Kalish reported having no relevant financial conflicts of interest.

SAN DIEGO – A proposed quality measure for pancreatic surgery has the potential to assess performance more thoroughly than current volume and mortality measures, judging by surgeons’ responses to a recent survey.

The 12-item "Quality Scorecard," developed by Dr. Brian T. Kalish of Beth Israel Deaconess Medical Center, Boston, and a team of pancreatic surgeons from multiple academic medical centers, consists of actionable and meaningful measures. The scorecard is aligned with the Institute of Medicine’s health care quality domains: safety, timeliness, effectiveness, patient centeredness, efficiency, and equitability.

"Traditional quality metrics in high-acuity surgery on their own cannot measure or satisfy the [IOM] domains," Dr. Kalish explained in a plenary presentation at the annual Digestive Disease Week. "Our goal was to evaluate the need for broader quality metrics and whether such broader metrics would align to contemporary IOM domains."

"We expect the scorecard to reveal quality to an extent that volume and mortality alone cannot."

Toward this end, the development team worked with a professional market research firm to create a web-based survey and distribute it to expert pancreatic surgeons identified through specialty societies and verified by survey demographics, Dr. Kalish explained. "The survey asked respondents to rank [62] proposed quality metrics on level of importance, from essential to not important, and to align the metric to one or more of the [IOM] quality domains." Points were awarded for level of importance and multidomain alignment, and the two scores for a given quality metric were averaged to render a total quality score that was then normalized to a 100-point scale, he said.

The 21% survey response rate represented 106 surgeons primarily from academic medical centers in North America who perform an average of 43 pancreatic operations per year, said Dr. Kalish. The need for improved quality metrics was indicated by 90% of the respondents, while 81% believed that a "quality scorecard" in pancreatic surgery would probably or definitely be of value, he reported. More than one-third of the proposed metrics aligned to more than one IOM domain, and at least half of the respondents rated these as essential or very important, he said.

Of the 62 metrics, 12 emerged with the highest total quality score. In rank order, they are: multidisciplinary services for pancreatic diseases, major complication rate, perioperative mortality, overall complication rate, incidence of postoperative hemorrhage, venous thromboembolism prophylaxis, patients with malignancy who undergo adjuvant therapy, readmission rates (30 day, 90 day, total), incidence of postoperative pancreatic fistula, timely and appropriate perioperative antibiotics, survival rates (1 year and 5 year), and timing from diagnosis to surgical consultation.

"The metrics related to mortality, the rate and severity of complications, and access to multidisciplinary services for pancreatic disease had the highest total quality scores; technical and perioperative metrics had intermediate scores; and metrics related to patient satisfaction with care, costs of care, and patient demographics had the lowest total quality scores," Dr. Kalish observed. With respect to the IOM domains, "the least represented domains were equitability, efficiency, and patient-centeredness," he said.

Although the actual performance thresholds for each of the metrics require further definition and validation, "we expect the scorecard to reveal quality to an extent that volume and mortality alone cannot," Dr. Kalish stated, noting that the development process is ongoing.

Future efforts include the organization of patient focus groups and a formal survey of patients and family members to attain insight into which quality metrics are important to those receiving care, as well as a multicenter prospective validation.

Dr. Kalish reported having no relevant financial conflicts of interest.

Patients with severe diabetes but only mild obesity see a dramatic benefit after gastric bypass surgery, a new study has found, with 88% experiencing durable disease remission within 6 months, along with major reductions in 10-year cardiovascular risk.

No mortality, major surgical complications, excessive weight loss, or malnutrition was seen among the 66 patients in the study, all of whom underwent laparoscopic Roux-en-Y gastric bypass (RYGB) surgery, according to the findings published in the July issue of Diabetes Care (2012;35:1420-8) and presented at the annual scientific sessions of the American Diabetes Association in Philadelphia.

Bariatric surgery is currently recommended by the National Institutes of Health only for people with a body mass index (BMI) of 40 kg/m² or higher, or above 35 for people with comorbidities such as severe diabetes. Very obese patients with diabetes have seen dramatic reductions in disease activity after RYGB surgery, with an estimated 80%-85% experiencing durable remission. There is increasing evidence that the procedure triggers hormonal and metabolic antidiabetes responses independent of weight loss (Annu. Rev. Med. 2010;61:393-411; Int. J. Obes. 2009;33:S33-S40; Endocrinology 2009;150:2518-25).

People with mild obesity and diabetes constitute a larger group than the very obese, yet they do not currently qualify for bariatric surgery.

Dr. Ricardo V. Cohen of Oswaldo Cruz Hospital and Marcia Maria Braido Hospital, both in São Paulo, Brazil, and his colleagues sought to investigate whether people with a lower BMI and poorly controlled diabetes also would see significant benefit. More than one-fourth of people in the United States with diabetes have class I obesity, or a BMI of 30-35 (Int. J. Clin. Pract. 2007;61:737-47).

For their research, Dr. Cohen and his colleagues recruited 40 men and 26 women. All were white and ranged in age from 31 to 63 years, and had a BMI of 30.0-34.9 and diabetes lasting 7 years or more at the time of surgery. The mean HbA_1c level was 9.7% at the time of surgery, despite the use of insulin and/or oral diabetes medications (n = 7 on insulin). Follow-up on the cohort was 100%, for a median 5 years.

Within 26 weeks after surgery, 88% of patients were able to discontinue their diabetes medications and maintain an HbA_1c level of less than 6.5% without resuming diabetes medications in the follow-up period.

Improvement without remission was seen in 11% of patients, who were able to withdraw insulin and/or reduce dosages of oral medications between 3 and 14 weeks after surgery. One patient showed no improvement in glycemic control, but was able to withdraw insulin and achieve diabetes control with oral medications 7 months post surgery.

Mean HbA_1c for the entire cohort fell progressively throughout the study, from 9.7% to 5.9% (P less than .001). Fasting plasma glucose (FPG) fell from 156 mg/dL to 97 mg/dL (P less than .001). Most of these changes occurred within the first 6 months.

All patients saw progressive reductions in waist circumference and total body weight, although the magnitude of weight loss was not seen as corresponding with decreases in either FPG or HbA_1c until after 5 years post surgery, when the investigators saw significant correlations between weight loss and decrease in FPG. No correlations were seen between weight loss and decrease in HbA_1c. Also, while the ratio of change in C-peptide to change in glucose increased significantly in the postoperative period, there was no correlation seen between the magnitude of the increase and weight lost. All these findings suggest that the surgery induces mechanisms of antidiabetes action independent of weight loss.

The predicted 10-year risk of cardiovascular disease fell after surgery in the cohort, with a 71% decrease in coronary heart disease (CHD, P = .001), 84% decrease in fatal CHD (P = .001), 50% decrease in stroke (P = .01), and 57% decrease in fatal stroke (P = .009). Hypertension and dyslipidemia were also seen to have improved, with hypertension resolving in 15 of the 26 (58%) patients who had it at baseline, hypercholesterolemia resolving in 21 of 33 (64%) patients, and hypertriglyceridemia resolving in 18 of 31 (58%), in the follow-up period.

Importantly, none of the subjects lost excessive weight or showed evidence of malnutrition. The lowest BMI observed in the follow-up period was 23.6.

The findings, Dr. Cohen and his colleagues wrote in their analysis, have broad implications for health policy, as they "indicate that RYGB is a safe, effective procedure to ameliorate type 2 diabetes and associated comorbidities, thereby reducing predicted cardiovascular disease risk, in patients with a BMI of 30–35 kg/m²."

While randomized controlled trial data are required to confirm that the procedure can be recommended in these patients, the investigators wrote, "our favorable findings from a relatively large, long-term study help justify such trials to clarify whether standard indications for RYGB should be broadened and whether this operation might be viewed primarily as ‘metabolic,’ rather than ‘bariatric,’ surgery."

Dr. Cohen and colleagues’ study was funded by the Municipal Health Authority and Marcia Maria Braido Hospital in São Paulo, Brazil. Dr. Cohen disclosed that he received previous study funding from Covidien, and one of his coauthors, Dr. David E. Cummings of the University of Washington, Seattle, disclosed receiving past funding from Ethicon Endo-Surgery. The other authors said they had no relevant financial disclosures.

Patients with severe diabetes but only mild obesity see a dramatic benefit after gastric bypass surgery, a new study has found, with 88% experiencing durable disease remission within 6 months, along with major reductions in 10-year cardiovascular risk.

No mortality, major surgical complications, excessive weight loss, or malnutrition was seen among the 66 patients in the study, all of whom underwent laparoscopic Roux-en-Y gastric bypass (RYGB) surgery, according to the findings published in the July issue of Diabetes Care (2012;35:1420-8) and presented at the annual scientific sessions of the American Diabetes Association in Philadelphia.

Bariatric surgery is currently recommended by the National Institutes of Health only for people with a body mass index (BMI) of 40 kg/m² or higher, or above 35 for people with comorbidities such as severe diabetes. Very obese patients with diabetes have seen dramatic reductions in disease activity after RYGB surgery, with an estimated 80%-85% experiencing durable remission. There is increasing evidence that the procedure triggers hormonal and metabolic antidiabetes responses independent of weight loss (Annu. Rev. Med. 2010;61:393-411; Int. J. Obes. 2009;33:S33-S40; Endocrinology 2009;150:2518-25).

People with mild obesity and diabetes constitute a larger group than the very obese, yet they do not currently qualify for bariatric surgery.

Dr. Ricardo V. Cohen of Oswaldo Cruz Hospital and Marcia Maria Braido Hospital, both in São Paulo, Brazil, and his colleagues sought to investigate whether people with a lower BMI and poorly controlled diabetes also would see significant benefit. More than one-fourth of people in the United States with diabetes have class I obesity, or a BMI of 30-35 (Int. J. Clin. Pract. 2007;61:737-47).

For their research, Dr. Cohen and his colleagues recruited 40 men and 26 women. All were white and ranged in age from 31 to 63 years, and had a BMI of 30.0-34.9 and diabetes lasting 7 years or more at the time of surgery. The mean HbA_1c level was 9.7% at the time of surgery, despite the use of insulin and/or oral diabetes medications (n = 7 on insulin). Follow-up on the cohort was 100%, for a median 5 years.

Within 26 weeks after surgery, 88% of patients were able to discontinue their diabetes medications and maintain an HbA_1c level of less than 6.5% without resuming diabetes medications in the follow-up period.

Improvement without remission was seen in 11% of patients, who were able to withdraw insulin and/or reduce dosages of oral medications between 3 and 14 weeks after surgery. One patient showed no improvement in glycemic control, but was able to withdraw insulin and achieve diabetes control with oral medications 7 months post surgery.

Mean HbA_1c for the entire cohort fell progressively throughout the study, from 9.7% to 5.9% (P less than .001). Fasting plasma glucose (FPG) fell from 156 mg/dL to 97 mg/dL (P less than .001). Most of these changes occurred within the first 6 months.

All patients saw progressive reductions in waist circumference and total body weight, although the magnitude of weight loss was not seen as corresponding with decreases in either FPG or HbA_1c until after 5 years post surgery, when the investigators saw significant correlations between weight loss and decrease in FPG. No correlations were seen between weight loss and decrease in HbA_1c. Also, while the ratio of change in C-peptide to change in glucose increased significantly in the postoperative period, there was no correlation seen between the magnitude of the increase and weight lost. All these findings suggest that the surgery induces mechanisms of antidiabetes action independent of weight loss.

The predicted 10-year risk of cardiovascular disease fell after surgery in the cohort, with a 71% decrease in coronary heart disease (CHD, P = .001), 84% decrease in fatal CHD (P = .001), 50% decrease in stroke (P = .01), and 57% decrease in fatal stroke (P = .009). Hypertension and dyslipidemia were also seen to have improved, with hypertension resolving in 15 of the 26 (58%) patients who had it at baseline, hypercholesterolemia resolving in 21 of 33 (64%) patients, and hypertriglyceridemia resolving in 18 of 31 (58%), in the follow-up period.

Importantly, none of the subjects lost excessive weight or showed evidence of malnutrition. The lowest BMI observed in the follow-up period was 23.6.

The findings, Dr. Cohen and his colleagues wrote in their analysis, have broad implications for health policy, as they "indicate that RYGB is a safe, effective procedure to ameliorate type 2 diabetes and associated comorbidities, thereby reducing predicted cardiovascular disease risk, in patients with a BMI of 30–35 kg/m²."

While randomized controlled trial data are required to confirm that the procedure can be recommended in these patients, the investigators wrote, "our favorable findings from a relatively large, long-term study help justify such trials to clarify whether standard indications for RYGB should be broadened and whether this operation might be viewed primarily as ‘metabolic,’ rather than ‘bariatric,’ surgery."

Dr. Cohen and colleagues’ study was funded by the Municipal Health Authority and Marcia Maria Braido Hospital in São Paulo, Brazil. Dr. Cohen disclosed that he received previous study funding from Covidien, and one of his coauthors, Dr. David E. Cummings of the University of Washington, Seattle, disclosed receiving past funding from Ethicon Endo-Surgery. The other authors said they had no relevant financial disclosures.

Patients with severe diabetes but only mild obesity see a dramatic benefit after gastric bypass surgery, a new study has found, with 88% experiencing durable disease remission within 6 months, along with major reductions in 10-year cardiovascular risk.

No mortality, major surgical complications, excessive weight loss, or malnutrition was seen among the 66 patients in the study, all of whom underwent laparoscopic Roux-en-Y gastric bypass (RYGB) surgery, according to the findings published in the July issue of Diabetes Care (2012;35:1420-8) and presented at the annual scientific sessions of the American Diabetes Association in Philadelphia.

Bariatric surgery is currently recommended by the National Institutes of Health only for people with a body mass index (BMI) of 40 kg/m² or higher, or above 35 for people with comorbidities such as severe diabetes. Very obese patients with diabetes have seen dramatic reductions in disease activity after RYGB surgery, with an estimated 80%-85% experiencing durable remission. There is increasing evidence that the procedure triggers hormonal and metabolic antidiabetes responses independent of weight loss (Annu. Rev. Med. 2010;61:393-411; Int. J. Obes. 2009;33:S33-S40; Endocrinology 2009;150:2518-25).

People with mild obesity and diabetes constitute a larger group than the very obese, yet they do not currently qualify for bariatric surgery.

Dr. Ricardo V. Cohen of Oswaldo Cruz Hospital and Marcia Maria Braido Hospital, both in São Paulo, Brazil, and his colleagues sought to investigate whether people with a lower BMI and poorly controlled diabetes also would see significant benefit. More than one-fourth of people in the United States with diabetes have class I obesity, or a BMI of 30-35 (Int. J. Clin. Pract. 2007;61:737-47).

For their research, Dr. Cohen and his colleagues recruited 40 men and 26 women. All were white and ranged in age from 31 to 63 years, and had a BMI of 30.0-34.9 and diabetes lasting 7 years or more at the time of surgery. The mean HbA_1c level was 9.7% at the time of surgery, despite the use of insulin and/or oral diabetes medications (n = 7 on insulin). Follow-up on the cohort was 100%, for a median 5 years.

Within 26 weeks after surgery, 88% of patients were able to discontinue their diabetes medications and maintain an HbA_1c level of less than 6.5% without resuming diabetes medications in the follow-up period.

Improvement without remission was seen in 11% of patients, who were able to withdraw insulin and/or reduce dosages of oral medications between 3 and 14 weeks after surgery. One patient showed no improvement in glycemic control, but was able to withdraw insulin and achieve diabetes control with oral medications 7 months post surgery.

Mean HbA_1c for the entire cohort fell progressively throughout the study, from 9.7% to 5.9% (P less than .001). Fasting plasma glucose (FPG) fell from 156 mg/dL to 97 mg/dL (P less than .001). Most of these changes occurred within the first 6 months.

All patients saw progressive reductions in waist circumference and total body weight, although the magnitude of weight loss was not seen as corresponding with decreases in either FPG or HbA_1c until after 5 years post surgery, when the investigators saw significant correlations between weight loss and decrease in FPG. No correlations were seen between weight loss and decrease in HbA_1c. Also, while the ratio of change in C-peptide to change in glucose increased significantly in the postoperative period, there was no correlation seen between the magnitude of the increase and weight lost. All these findings suggest that the surgery induces mechanisms of antidiabetes action independent of weight loss.

The predicted 10-year risk of cardiovascular disease fell after surgery in the cohort, with a 71% decrease in coronary heart disease (CHD, P = .001), 84% decrease in fatal CHD (P = .001), 50% decrease in stroke (P = .01), and 57% decrease in fatal stroke (P = .009). Hypertension and dyslipidemia were also seen to have improved, with hypertension resolving in 15 of the 26 (58%) patients who had it at baseline, hypercholesterolemia resolving in 21 of 33 (64%) patients, and hypertriglyceridemia resolving in 18 of 31 (58%), in the follow-up period.

Importantly, none of the subjects lost excessive weight or showed evidence of malnutrition. The lowest BMI observed in the follow-up period was 23.6.

The findings, Dr. Cohen and his colleagues wrote in their analysis, have broad implications for health policy, as they "indicate that RYGB is a safe, effective procedure to ameliorate type 2 diabetes and associated comorbidities, thereby reducing predicted cardiovascular disease risk, in patients with a BMI of 30–35 kg/m²."

While randomized controlled trial data are required to confirm that the procedure can be recommended in these patients, the investigators wrote, "our favorable findings from a relatively large, long-term study help justify such trials to clarify whether standard indications for RYGB should be broadened and whether this operation might be viewed primarily as ‘metabolic,’ rather than ‘bariatric,’ surgery."

Dr. Cohen and colleagues’ study was funded by the Municipal Health Authority and Marcia Maria Braido Hospital in São Paulo, Brazil. Dr. Cohen disclosed that he received previous study funding from Covidien, and one of his coauthors, Dr. David E. Cummings of the University of Washington, Seattle, disclosed receiving past funding from Ethicon Endo-Surgery. The other authors said they had no relevant financial disclosures.