LAPAROSCOPIC adjustable gastric banding (LAGB) should remain as a key bariatric surgical option, say Australian experts, after US researchers found a high reoperation rate with the procedure and questioned its continued funding under the US Medicare program.
The US retrospective review of more than 25 000 Medicare patients who underwent gastric band placement between 2006 and 2013 found that 18.5% of patients (4636) underwent 17 539 reoperations, an average of 3.8 procedures per patient.
The review, published in JAMA Surgery, also found wide variation in the reoperation rate across the country, with a 13.3% reoperation rate in the lowest quartile, and a 39.1% in the highest quartile.
The authors said that of the $470 million paid by Medicare for LAGB over the study period, $224 million were for reoperations, and suggested that payers should reconsider funding the gastric band device.
However, an accompanying editorial warned that it was important not to “throw the baby out with the bathwater”.
Dr Jon Gould of the Medical College of Wisconsin said that the device still had a role to play, although limited, in the modern bariatric surgical program.
“Many patients do well for a long time,” he wrote, pointing to an Australian study of 3227 patients which showed that 47% of excess weight loss had been maintained after 15 years, regardless of whether reoperation had been required. “A committed surgeon and program and the ideal patient with a similar level of commitment are needed to achieve these best outcomes.”
Professor Paul O’Brien, emeritus director of the Centre for Obesity Research and Evaluation and lead author on the cited Australian research, said that he was compiling 20-year follow-up data and the findings would be available in August 2017.
“This is likely to show the same result of loss of around 50% of excess weight at 20 years, and that has changed the lives of these patients,” he said, adding that only 5.6% of the devices had been removed in the original study period and this too was unlikely to change in the 20-year data.
The original Australian study also found that revisional procedures were performed for proximal enlargement (26%), erosion (3.4%) and port and tubing problems (21%), but the need for revision decreased over time, with a 40% revision rate for proximal gastric enlargements in the first 10 years, reducing to 6.4% in the following 5 years.
Professor John Dixon, head of Clinical Obesity Research at the Baker IDI Heart and Diabetes Institute, said that reoperation rates for LAGB were undoubtedly high, but that all three commonly used bariatric procedures – sleeve gastrectomy, gastric bypass surgery and LAGB – had significant rates of reoperation.
“The reality is that people who have bariatric surgery have a high likelihood of having gastrointestinal symptoms and requiring some revision procedures over time,” Professor Dixon said.
He added, however, that all three procedures had been shown to be cost effective, even when reoperation rates were taken into account.
“We have no questions about their efficacy, they are extraordinarily safe operations, and they produce a major improvement in quality of life; therefore, their cost per quality adjusted life year is well within the effective range,” he said, adding that for people with diabetes, bariatric surgery had been found to be a cost-saving intervention.
Professor O’Brien said that the rate of reoperation for LAGB should not necessarily be viewed as a failing of the procedure.
“The ability to do a reoperation can be seen as a positive,” he said. “If something goes wrong with the band, we can fix it, but if I do a bypass and something goes wrong, I generally can’t fix it. If you get reflux oesophagitis after a sleeve, it’s very difficult to manage.”
Professor O’Brien said that there was a strong selection bias in the US data, which covered only surgery provided to Medicare beneficiaries and represented less than 10% of LAGB procedures performed in the US.
“Medicare funding is low [in the US], so for surgeons to treat Medicare patients, they barely make a profit on it,” Professor O’Brien said, adding that follow-up care, which is critical to the success of LAGB procedures, may suffer as a result.
He said that the high variability of the reoperation rate indicated that there may be a problem with the commitment and competence of the health professionals involved in providing the procedure to US Medicare patients.
“The band is a unique surgical procedure,” he said. “Placing the band just sets the scene for us to adjust the band and control appetite, but unless that after-care occurs – and it occurs accurately and competently – they won’t get a good result.”
The Fourth report of the Bariatric Surgery Registry, published in June 2016, found that there had been a decline in the proportion of LAGB procedures being performed in Australia, with LAGB accounting for 15% of procedures in the 6 months to June 2016, compared with 32% in the 12 months to June 2015.
Professor Dixon said that while the registry was not yet able to capture all bariatric procedures undertaken across Australia, there had been a “dramatic drop-off” in the number of band procedures performed.
He said that changes to the Medicare Benefits Schedule item descriptors in 2013 meant that GPs were no longer fully funded to adjust bands as well as provide a consultation.
“Properly trained and interested GPs were doing many band adjustments and that number has dropped because the funding to follow-up was [reduced],” Professor Dixon said, adding that GPs were now funded to either adjust the band or provide a consultation, but not in the same visit. “Many [bariatric surgery] practices in Australia are now going to the sleeve and bypass, because they are concerned about the follow-up with the band.”
Professor Dixon said that the reversible LAGB should have a continued role, particularly for patients under 30 years, as well as for the elderly and those patients with significant comorbidities, leading to a high operative risk.
“I don’t think any large, irreversible procedure such as a sleeve gastrectomy or bypass, with a lot of nutritional concerns over time, should be done on adolescents or children,” Professor Dixon said. “The reversibility of the band has the advantage of allowing a young person to switch to more effective drugs or procedures, if required, as they become available in the years to come.”
Professor Dixon said that the UK was in the process of conducting a randomised controlled trial of the three, major bariatric surgical options. Funded by the UK’s National Health Service, the By-Sleeve-Band is the largest randomised controlled trial of these interventions ever conducted, said Professor Dixon, who is on the steering committee for the trial.
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