Kate Johnson

June 22, 2012

June 22, 2012 (San Diego, California) — With a final decision expected within days from the Centers for Medicare and Medicaid Services, there is now ample evidence supporting the agency's full coverage of laparoscopic sleeve gastrectomy (LSG), researchers asserted here at the American Society for Metabolic and Bariatric Surgery (ASMBS) 29th Annual Meeting.

Reporting the largest series to date, John Morton, MD, from Stanford University in California, said "laparoscopic sleeve gastrectomy is positioned between the band and the bypass for both safety and efficacy."

In a separate, unrelated study, Abraham Fridman, DO, from the Cleveland Clinic Florida in Weston, reported that sleeve gastrectomy showed the lowest morbidity of the 3 procedures.

In March, the Centers for Medicare and Medicaid Services revised its blanket policy of no coverage for LSG by allowing limited coverage of the procedure in randomized controlled trials.

In its so-called "coverage-with-evidence-development proposal," the agency is considering comparative evidence for LSG against other obesity surgeries, with its final decision due on June 27.

"There's considerable amount of evidence now for coverage of the sleeve. It's actually overwhelming, the amount of evidence," said Dr. Morton, who presented a national comparison of LSG vs laparoscopic Roux-en-Y gastric bypass (LRNYGB) and laparoscopic gastric banding (LGB) from the Bariatric Outcomes Longitudinal Database (BOLD) from 2007 to 2010.

The analysis included data on 271,726 patients from 540 hospitals and 1200 surgeons.

Comparing mortality, morbidity, and efficacy outcomes for 117,365 LGBs, 138,222 LRNYGBs, and 16,139 LSGs, the data clearly show that LSG is safe and effective, concluded Dr. Morton.

At 1-year postsurgery, the absolute body mass index [BMI] reduction was 16.6 kg/m2 for bypass patients, 13.4 kg/m2 for sleeve patients, and 7.6 kg/m2 for band patients.

Length of hospital stay was a mean of 2.3 days after bypass, 1.9 days after sleeve, and 0.7 after banding.

Improvement of baseline comorbidities of hypertension, type 2 diabetes, and dyslipidemia was seen after all surgeries, but was most significant in the bypass group, said Dr. Morton.

The bypass group also had the highest 30-day mortality and serious complication rate (0.14% and 1.25%), followed by sleeve gastrectomy (0.08% and 0.96%), and then gastric banding (0.03% and 0.25%).

The readmission and reoperation rates were also highest for bypass patients (4.62% and 2.73%), followed by sleeve patients (3.61% and 1.7%), and then banding patients (1.38% and 0.65%).

Although 30-day follow-up data were "great," Dr. Morton noted that the limitations of the study included poor follow-up beyond this time and lack of information about patients who might have been admitted to other hospitals.

However, he said, the data are convincing for the safety and efficacy of sleeve gastrectomy.

The second study, which included 2433 bariatric procedures, was performed at the Cleveland Clinic Florida between 2005 and 2011, with a mean follow-up of 17 months.

Similar to the BOLD study, this study also showed that BMI loss after the sleeve procedure (11.2 kg/m2) fell between that of bypass (14.8 kg/m2) and banding (5.6 kg/m2).

A total of 1327 bypass, 619 sleeve, and 233 band procedures were included in the analysis, reported Dr. Fridman.

However, looking at readmission and reoperation rates, this study showed that sleeve gastrectomy was superior to both bypass and banding.

Specifically, the average number of readmissions in the sleeve gastrectomy group was the lowest (1.49), followed by the band (1.54), and then the bypass (1.96). Similarly, the rate of reoperations for complications was lowest in the sleeve group (1.8%), followed by bypass (6.6%), and then banding (14.6%).

Asked to comment on the evidence for sleeve gastrectomy, Michel Gagner, MD, told Medscape Medical News, "I think it should be covered [by insurers]."

Dr. Gagner, a Canadian bariatric surgeon, practiced in the United States for 15 years at 3 different centers before returning to his native Montreal at the Hôpital du Sacré-Coeur.

He said he now performs sleeve gastrectomy in 90% of his patients, and "I think the evolution I went through we will see in a lot of practices in the United States," he said.

"Outside the US, sleeve gastrectomy is growing very fast, and there are several countries where it is number one," he said. "In Chile and Japan, it is very popular; in India, it's the number one procedure; and there are many countries in Europe where the number of sleeve gastrectomies has surpassed the number of bandings. This is seen in France and in Belgium, for example."

The BOLD data place sleeve gastrectomy between gastric banding and bypass in terms of morbidity and mortality, he noted. "When surgeons are looking at abandonment of banding, they are looking for a procedure with similar risk ratio, and actually I think that the weight loss and comorbidity resolution with sleeve was better than banding, while the mortality and morbidity rate was slightly higher. So I think it's still an excellent risk–benefit ratio."

In fact, Dr. Gagner said, the BOLD data for sleeve gastrectomy is likely to improve, as the current figures still include a steep learning curve for the new procedure.

"We know it's in the first 100 cases that we get the highest rate of leaks, highest rate of bleeding, and strictures and mortality. Once they go beyond, we're going to see a drop by 2-fold in the leak and major complication rate. So what we're going to see in the database in the future of sleeve gastrectomy is that it's going to be very close to banding, so it's going to be very convincing for surgeons who've been using banding that they could adopt a procedure that has almost the same morbidity and mortality as banding, but yet an increased benefit."

Dr. Morton noted that he is a consultant for Vibrynt and Ethicon. Dr. Fridman has disclosed no relevant financial relationships. Dr. Gagner is a speaker for Covidien, Ethicon and Gore.

American Society for Metabolic and Bariatric Surgery (ASMBS) 29th Annual Meeting: Abstracts PL104, presented June 20, 2012 and PL133, presented June 21, 2012.

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