FROM JAMA SURGERY

About one in five laparoscopic gastric band surgeries result in device-related reoperations and reoperations account for almost half of all Medicare expenditures for gastric band surgery, a large retrospective study has found.

The laparoscopic adjustable gastric band for treatment of morbid obesity, approved in 2001 by the Food and Drug Administration, was once a common choice for bariatric patients. Although its use has declined from in recent years, the American Society for Metabolic and Bariatric Surgery estimated that 11,000 bands were placed in 2015 and many others remain in place (ASMBS, Estimate of bariatric surgery numbers, 2011-2015, https://goo.gl/f8iByl ). Many of these gastric bands will need to be removed, replaced, or revised in a series of procedures over the coming years.

Andrew M. Ibrahim, MD, Robert Wood Johnson Clinical Scholar at the Institute for Healthcare Policy & Innovation at the University of Michigan, Ann Arbor, and his colleagues conducted a retrospective review of medical records of 25,042 Medicare beneficiaries who had gastric band placement from 2006 to 2013. These data captured years of postprocedural follow-up and outcomes from the later generation of bands. The study, published in JAMA Surgery ( doi: 10.1001/jamasurg.2017.1093 ), focused on characteristics of patients who underwent reoperations on their gastric bands, rates of reoperation, the geographical distribution of reoperations, and finally, the costs of the reoperations.

Of the 24,042 gastric band patients in this study group, 4,636 (18.5%) underwent reoperation, defined as band removal, band replacement, or revision to a different bariatric procedure, but not including band size adjustment. Patients who had reoperations were more likely to be women, to be white, and to have slightly lower rates of hypertension and diabetes. But they were also more likely to have received a psychiatric, anemia, or electrolyte disorder diagnosis at the time of their index operations.

Among the 4,636 patients who had reoperations, 17,539 such procedures were performed, an average of 3.8 procedures per patient, in addition to the index operation, over an average follow-up of 4.5 years. The most common reoperation was for band removal (41.8%). Other reasons included conversion to laparoscopic Roux-en-Y gastric bypass (13.1%) or laparoscopic sleeve gastrectomy (5.3%).

Medicare paid $470 million for band placement and associated procedures, of which $224 million (47.6%) was for reoperations. Payment averaged $12,345 for the index operation and $19,657 for each subsequent reoperation. From 2006 to 2013, the annual share of Medicare spending for reoperations increased from 16.4% to 77.3% of total spending on laparoscopic gastric band–associated procedures. Not surprisingly, hospital costs, physician services, readmissions, and postoperative care were all higher for the reoperation than for the index operation.

The study also looked at the regional differences, reflecting the comparative success of some programs in managing laparoscopic gastric band placement. Reoperation rates across the referral hospitals ranged from 5% to 95.5%, The study found a nearly a threefold variation in reoperation rates across geographic regions. The bottom quartile of hospital referral regions had an average reoperation rate of 13.3% (0.3 standard deviation) and the top quartile had an average reoperation rate of 39.1% (0.21 SD). Top-quartile regions were concentrated in the West, but were otherwise distributed throughout the country.

Most reoperations were elective admissions (79.9%), while 10% were classified as urgent and another 10.1% as emergency. So although previous studies have documented complications such band slippage and gastric erosion, the preponderance of elective admissions suggests patient and clinician preferences, or weight loss failure, rather than emergency situations, may be the driving force in the reoperation trend.

The investigators concluded that patients should be fully informed about the likelihood of reoperation with the gastric band. In addition, the wide range of reoperation rates across regions and institutions suggests that more training or better patient selection may be needed to improve outcomes. However, they suggested that “taken together, these findings indicate that the gastric band is associated with high reoperation rates and considerable costs to the payers, which raises concerns about its safety, effectiveness, and value.” They added that “payers should reconsider their coverage of the gastric band device.”

Coauthor Justin B. Dimick, MD, disclosed a financial interest in ArborMetrix. The other coauthors reported having no financial disclosures. The Robert Wood Johnson Foundation, U.S. Department of Veterans Affairs, National Institute on Aging, and National Institute of Diabetes and Digestive and Kidney Diseases provided funding.

imnews@frontlinemedcom.com

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