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New England Journal of Medicine– Significant Study on the Safety of Bariatric Surgery
July 30, 2009

One of the most significant studies every conducted on the safety of bariatric surgery has been published in today’s New England Journal of Medicine. The findings of this research very strongly reaffirm the safety of bariatric surgery and should help to inspire greater confidence from the general public and policymakers, thus making it more difficult to deny or delay coverage of these life-saving and life-extending procedures. The safety and effectiveness of bariatric surgery on morbid obesity and expensive obesity-related conditions is emerging as an even more powerful force in this new era of healthcare reform.

We encourage you to review the study and discuss these new findings in your community.

“Perioperative Safety in the Longitudinal Assessment of Bariatric Surgery” by the Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; N Engl J Med 2009;361:445-54.

Key findings include:
• National Institutes of Health (NIH) study found the risks of bariatric surgery have dropped dramatically and now are no greater than gallbladder or hip replacement surgery
• Risks are lower than the longer-term risk of dying from heart disease, diabetes and other consequences of carrying more weight than a person’s organs can tolerate
• At 30 days post-surgery, researchers found the mortality rate among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding to be 0.3 percent, and a total of 4.3 percent of patients had at least one major adverse outcome
• This data should support a higher level of confidence in bariatric surgery among primary care doctors
• An accompanying editorial stated: “Surgery is safe, effective and affordable” because it can lower the number of doctor visits, medication use and other medical expenses
Study parameters:
• First large-scale study conducted by LABS (Longitudinal Assessment of Bariatric Surgery) – followed 4,776 first-time bariatric surgery patients for 30 days at 10 U.S. hospitals between 2005 and 2007 (3.412 gastric bypass patients and 1,198 gastric band patients, 166 patients had other procedures that were not included in the final analysis)
• Complication rates were greater in people with a history of clot problems, sleep apnea and certain other medical issues
The study received national media coverage, and commentary from experts (including ASMBS members) were part of the coverage:
• “Many other studies have compared the odds, and all show a higher risk of dying if you do not have surgical treatment than if you do.”
• “Prior to LABS, the risks and benefits for bariatric surgery had not been thoroughly assessed using multicenter, rigorous methodology.”
• “The surgery is safe. It should give more patients and their primary care providers confidence to look at surgery.”
• “Coronary bypass surgery carries a risk of death 10 times greater than the risk this study found for bariatric surgery.”
• “There’s data that weight loss clearly benefits the health of severely overweight people, and surgery is the most effective way to weight loss.”
• “The very low mortality of bariatric procedures found in this study are consistent with several recent publications which confirm that risk of complications and mortality of bariatric surgery has decreased significantly.”

June 24, 2009 919.792.1717
Bariatric Surgery Centers of Excellence Demonstrate Exceptional Safety SRC Releases First Analysis from Largest National Bariatric Surgery Database

RALEIGH, NC — Surgical Review Corporation (SRC), an independent, non-profit organization that advances the safety, efficacy and efficiency of bariatric and metabolic surgery, today announced results from the first analysis of data in its Bariatric Outcomes Longitudinal Database™ (BOLD™), the world’s largest dedicated repository of clinical bariatric surgery patient information. The study validates the safety of bariatric surgery performed by participants in the Bariatric Surgery Centers of Excellence®
(BSCOE®) program and represents the first step toward identifying benchmarks for quality and establishing guidelines for best clinical practices.

“Our results confirm the extraordinarily low risk associated with bariatric surgery,” said Eric J. DeMaria, M.D., lead study author, Chairman of SRC’s Research Advisory Committee and Vice Chair of the Department of Surgery at Duke University Medical Center. “When compared to national statistics, procedures performed by BSCOEs are significantly safer than common operations like hip replacement and gallbladder removal.
BOLD provides the type and volume of data necessary to effectively support these claims, which in turn underscores the value of the BSCOE program.”

Dr. DeMaria presented the study at the American Society for Metabolic and Bariatric Surgery (ASMBS) 26th Annual Meeting in Grapevine, Texas. Results were based on clinical data from 57,918 research-consented patients, representing the largest bariatric surgery patient population ever analyzed:

Procedure: The most common bariatric procedure was gastric bypass (54.8%), followed by gastric banding (39.8%), sleeve gastrectomy (2.3%) and biliopancreatic diversion (0.9%).
Complications: Overall, 10.77% of patients experienced one or more adverse events following surgery. Most complications were considered relatively minor; nausea/vomiting was the most frequently reported adverse event post-discharge.
Mortality: The total mortality rate across all procedures was 0.135%, approximately one death per 1,000 patients. Rates for 90- and 30-day all-cause mortality were 0.112% and 0.089%, respectively.
Age: A majority of patients were between ages 19-65 (94.08%), while a minority were younger than 19 (0.14%) or older than 65 (5.67%).
Gender: Females comprised a significant majority of the study population (78.76%).
Race: 78.12% of patients were identified as Caucasian, 10.52% African-American, 6.02% Hispanic, 0.2% Asian and 0.46% Native American.
“Our centers of excellence are truly living up to their designation,” said Deborah A. Winegar, Ph.D., Director of Research at SRC and a study co-author. “Through BOLD, the safety of bariatric surgical procedures performed by BSCOEs can now be substantiated with a meaningful, high quality data source.”

BOLD currently contains information on more than 130,000 bariatric surgery patients. For this study, SRC analyzed prospective data entered into BOLD between its launch in June 2007 and May 2009 by participants in the ASMBS BSCOE program. Participants are required to enter information into BOLD for all phases of bariatric surgical care, including procedures, medications, demographic characteristics, weight loss and maintenance, complications, and comorbidities. To ensure data quality, SRC continuously verifies information entered into BOLD through automated data checks and chart reviews conducted during site inspections.

Unlike other research databases, information is entered into BOLD in real-time, providing immediate analytical capabilities and a platform for clinical studies. Users have immediate data access to guide clinical decisions, and they can compare their own results against national aggregate benchmark data to continuously strengthen care delivery.