Patients who have weight-loss operations at nonaccredited bariatric surgical facilities in the United States are up to 1.4 times likelier to experience serious complications and more than twice as likely to die after the operation compared with patients who undergo these procedures at accredited bariatric surgical centers, researchers conclude. These results from a systematic review of published medical studies that included more than 1 million patients appear online as an "article in press" on the Journal of the American College of Surgeons website in advance of print publication.
These findings have potential implications for the increasing number of people who choose surgical treatment for obesity--widely considered the most effective long-term weight-loss therapy. An estimated 179,000 people underwent gastric bypass, gastric banding, and other bariatric operations in 2013 versus 158,000 two years earlier, according to the American Society for Metabolic and Bariatric Surgery (ASMBS).
The researchers called their new analysis the first comprehensive review of the best available evidence comparing bariatric surgical results in accredited versus nonaccredited U.S. centers.
"A preponderance of scientific evidence demonstrates that bariatric surgery becomes safer with accreditation of the surgical center," said principal investigator John Morton, MD, MPH, FACS, FASMBS, chief of bariatric and minimally invasive surgery, Stanford (Calif.) University School of Medicine. "Accreditation makes a big difference."
Despite the published evidence, the Centers for Medicare & Medicaid Services (CMS) no longer requires Medicare patients to undergo covered bariatric surgical procedures at an accredited bariatric center. The agency's decision in 2013 reversed a 2006 CMS policy to limit coverage for bariatric operations to only those performed at accredited bariatric surgical facilities.
Facility accreditation has been available in the bariatric surgery field for more than a decade. The American College of Surgeons (ACS) and the ASMBS merged their similar accreditation programs in 2012 to create the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). Currently more than 700 centers in the country now hold this accreditation, according to the MBSAQIP. This credential designates that a surgical facility has met rigorous standards for high-quality surgical care.
According to the ASMBS, most bariatric surgical procedures performed in recent years were minimally invasive laparoscopic procedures.
Dr. Morton, MBSAQIP Co-Chair and immediate past president of the ASMBS, said his prior research found that laparoscopic bariatric operations have fewer postoperative complications than do traditional "open" surgical procedures.
"Even though we use little incisions, it's still a big operation," he said. "Accreditation indicates that a bariatric surgical center has the resources and experience in place to take care of any complications that may potentially occur."
In their review article, Dr. Morton and first author Dan Azagury, MD, also from Stanford, included 13 studies published between 2009 and 2014 and totaling more than 1.5 million patients. Dr. Morton acknowledged that a number of patients might be duplicates because some studies used the same national database, and therefore he could estimate a total in excess of 1 million patients.
Eight of 11 studies that evaluated postoperative complications found that undergoing a bariatric operation in an accredited facility reduced the odds of having a serious complication by 9 to 39 percent (odds ratios of 1.09 to 1.39), the researchers reported.
The difference was reportedly even more pronounced for the risk of death occurring in the hospital or up to 90 days postoperatively. Six of eight studies that reported mortality showed that the odds of dying after a bariatric procedure, while low at an accredited center, was 2.26 to 3.57 times higher at a nonaccredited facility.
Nearly all the studies used risk adjustment, which compensates for different levels of patient risk and which experts believe makes results more accurate.
Only three studies (23 percent) failed to show a significant benefit of accreditation, and those studies had limitations, according to Dr. Morton. For instance, in one study most patients underwent their operations in a bariatric surgical collaborative, whose standards at even nonaccredited centers were very similar to those of accredited centers, he said.
When analyzing studies that reported average hospital charges, Drs. Morton and Azagury found lower costs at accredited centers.
"Accredited bariatric surgical centers provide not only safer care but also less expensive care," Dr. Morton said.
Patients often choose a bariatric surgical facility by its distance from home, he noted, but added, "It's worth it for patients to drive a few minutes longer to an accredited center, although the drive typically is short, with more than 700 accredited centers nationwide."
A systematic review was the best way to study this issue, according to Dr. Morton. He said most insurers today will not cover surgical care at nonaccredited bariatric centers, thus making it difficult to perform a randomized controlled clinical trial, which is considered the gold standard in medical research. Many private insurers, he explained, began to require accreditation after CMS initially required it for reimbursement 10 years ago, before later reversing the policy.
"These results provide important information that can be used to guide future policy decisions. Perhaps CMS should revisit this policy again," Dr. Morton suggested.