Bariatric surgeons might be willing to accept less weight loss and more risk in revisional than in primary endoluminal procedures, according to a survey distributed here at the American Society for Metabolic & Bariatric Surgery (ASMBS) 25th Annual Meeting. The results indicate the levels of weight loss and risk considered acceptable for currently developing bariatric endoluminal procedures.
The questionnaire was developed by the ASMBS Emerging Technologies Committee and was distributed to society members; 16% were completed and returned (n = 214). Risk was assessed for 5 common procedures: diagnostic endoscopy (considered low risk), endoscopic polypectomy, endoscopic retrograde cholangiopancreatography, laparoscopic adjustable gastric banding, and laparoscopic Roux-en-Y gastric bypass (considered high risk).
"In general, I think concern about the risk of these [endoluminal] procedures is pretty low," said presenter Stacy A. Brethauer, MD, from the section of advanced laparoscopic and bariatric surgery in the department of general surgery at the Cleveland Clinic, in Ohio, who spoke with Medscape General Surgery. "So we did assess risk, but mainly to compare what people would tolerate in terms of the risk–benefit ratio for the primary and revisional procedures."
Survey questions about risk included:
What level of risk would you be willing to accept for a revisional endoluminal procedure that achieves 10% to 20% excess weight loss (EWL) at 1 year? What about 30% to 40% EWL at 1 year?
What level of risk would you be willing to accept for a primary endoluminal bariatric procedure that achieves 10% to 20% EWL at 1 year? What about 30% to 40% EWL at 1 year?
Benefit questions assessed the percent excess weight loss (%EWL) that would be acceptable:
What %EWL would you accept as a good outcome 1 year after an endoscopic anastomotic-reduction procedure for weight regain after gastric bypass?
What %EWL would you accept as a good outcome 1 year after a primary endoscopic bariatric procedure?
When patient benefit was relatively low (10%–20% EWL), the majority of respondents selected a risk tolerance similar to that for a therapeutic endoscopic procedure (i.e., the 3 lowest risk categories) for primary (82%) and revisional (77%) procedures.
When patient benefits were higher (30%–40% EWL), 47% of respondents were willing to accept a risk equivalent to laparoscopic adjustable gastric banding for primary procedures, and 35% of were willing to accept this degree of risk for revisional procedures (P = .04). Risk equivalent to Roux-en-Y gastric bypass was acceptable to only 7% of respondents for primary procedures but to 22% of respondents for revisional procedures (P = .0002).
"Revisional procedures are performed on patients who have already had a gastric bypass and have weight regain…. Right now, the only alternative for weight regain is another surgery, a revisional surgery, which carries a very high risk," explained Dr. Brethauer. "I think people were willing to accept a higher degree of risk for the revisional endoscopic procedures because the alternative is not good."
Acceptable %EWL outcomes differed significantly for primary and revisional procedures: 62% of respondents considered 10% to 30% EWL a good outcome for revisional procedures, but only 34% found this a good outcome for primary procedures (P < .0001 for %EWL >30%). "We know that people are willing to accept lower weight loss for the revisional procedures; in our experience, it's hard to induce further weight loss when somebody's had weight regain without being fairly invasive," said Dr. Brethauer.
The survey also determined that primary endoluminal bariatric procedures should be performed only on patients who meet current National Institutes of Health (NIH) criteria (23%), those with a body mass index (BMI) >30 kg/m2 (27%), or those at high risk (22%). Only 18% of respondents favored the procedures for patients with a BMI of 30 kg/m2 to 35 kg/m2 (the remaining 10% checked "other"). The greatest concerns of respondents were the unproven efficacy and durability of endoluminal bariatric procedures; 68% agreed that "the effectiveness of a new procedure needs to be proven before…using it on patients."
Medscape General Surgery discussed the survey with session moderator Marina S. Kurian, MD, FACS, assistant professor of surgery, and medical director of the program for surgical weight loss at New York University School of Medicine, in New York. "With this particular procedure and particular area being so interesting to so many different people…, the Bariatric Society is truly trying to measure who is doing it, what people are expecting, and what people are finding," said Dr. Kurian.
"Is this something that's going to become a bigger procedure for all bariatric surgeons to do, or for gastroenterologists to do?" Dr. Kurian asked. "I think the next step is to find out what the actual success rate is among the different surgeons to clearly validate the procedure."
She feels that the endoluminal procedure should stay in the realm of bariatric surgeons "because we have a follow-up. We provide dietary and nutritional counseling for the patients, and that's how we can really control what the outcomes are for our patients. The follow-up is incredibly important…. We need to be accountable for our procedures, we obviously have to…check what our outcomes are. But the patients themselves need to be accountable to us," Dr. Kurian said.
Dr. Brethauer has received grant or research support from Ethicon Endo-Surgery, Bard Davol, and Tyco US Surgical corporations. Dr. Kurian has received honoraria, grant, teaching, and research support from Inamed/Allergan.
American Society for Metabolic & Bariatric Surgery 25th Annual Meeting: Abstract PL-44. Presented June 20, 2008.
Reviewed by Ramaz Mitaishvili, MD
