Trends in Use of Bariatric Surgery, 2003−2008
ABSTRACT During the past decade, the field of bariatric surgery has changed dramatically. This study was intended to determine trends in the use of bariatric surgery in the United States. Data used were from the Nationwide Inpatient Sample from 2003 through 2008.
We used ICD-9 diagnosis and procedural codes to identify all hospitalizations during which a bariatric procedure was performed for the treatment of morbid obesity between 2003 and 2008. Data were reviewed for patient characteristics, annual number of bariatric procedures, and proportion of laparoscopic cases. US Census data were used to calculate the population-based annual rate of bariatric surgery per 100,000 adults. The number of surgeons performing bariatric surgery was estimated by the number of members in the American Society for Metabolic and Bariatric Surgery.
For the period between 2003 and 2008, the number of bariatric operations peaked in 2004 at 135,985 cases and plateaued at 124,838 cases in 2008. The annual rate of bariatric operations peaked at 63.9 procedures per 100,000 adults in 2004 and decreased to 54.2 procedures in 2008. The proportion of laparoscopic bariatric operations increased from 20.1% in 2003 to 90.2% in 2008. The number of bariatric surgeons with membership in the American Society for Metabolic and Bariatric Surgery increased from 931 to 1,819 during the 6 years studied. The in-hospital mortality rate decreased from 0.21% in 2003 to 0.10% in 2008.
In the United States, the number of bariatric operations peaked in 2004 and plateaued thereafter. Use of the laparoscopic approach to bariatric surgery has increased to >90% of bariatric operations. In-hospital mortality continually decreased throughout the 6-year period.
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ABSTRACT: Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health. Five-hundred and forty United States adults with body mass index (BMI) ≥30 kg/m(2) evaluated tradeoffs among effectiveness, safety, and other attributes of weight-loss devices in a scientific survey. Discrete-choice experiments were used to quantify the importance of safety, effectiveness, and other attributes of weight-loss devices to obese respondents. A tool based on these measures is being used to inform benefit-risk assessments for premarket approval of medical devices. Respondent choices yielded preference scores indicating their relative value for attributes of weight-loss devices in this study. We developed a tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss. For example, to accept a device with 0.01 % mortality risk, a risk tolerant patient will require about 10 % total body weight loss lasting 5 years. Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.Surgical Endoscopy 01/2015; DOI:10.1007/s00464-014-4044-2 · 3.31 Impact Factor
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ABSTRACT: Obesity is a major public health concern. Given its lasting efficacy for improving obesity and obesity-related diseases, bariatric surgery is an increasingly common treatment option. As the implementation of the Affordable Care Act progresses, the impending physician shortage will become more severe. Thus there will be an even greater need for doctors specialized in the management and treatment of obese patients. The development of integrated bariatric surgery residency programs could be considered and is discussed herein.Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 01/2014; 7:543-544. DOI:10.2147/DMSO.S52215
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ABSTRACT: Beloranib is an investigational weight loss therapy with a novel mechanism of action. This study assessed the efficacy, safety, and tolerability of beloranib treatment for obesity. This Phase 2, double-blind, randomized study investigated the effects of beloranib suspension (0.6, 1.2, and 2.4 mg) or placebo, administered subcutaneously, for 12 weeks in 147 participants (primarily White females) with obesity. No diet or exercise advice was administered. At Week 12, beloranib resulted in dose-dependent progressive weight loss of -5.5 ± 0.5, -6.9 ± 0.6, and -10.9 ± 1.1 kg for the 0.6, 1.2, and 2.4 mg beloranib doses, compared to -0.4 ± 0.4 kg with placebo (all p < 0.0001 vs. placebo). Weight loss with beloranib was associated with corresponding reductions in waist circumference and body fat mass, as well as improvements in lipids, hsCRP, and blood pressure. Sleep disturbance and gastrointestinal adverse events were more common with beloranib than placebo; these were generally mild to moderate, transient, and dose-related, and led to more early study withdrawals in participants in the group with the highest dose of beloranib. In this 12-week Phase 2 study, beloranib produced clinically and statistically significant weight loss and corresponding improvements in cardiometabolic risk factors. Beloranib appeared safe and the 0.6 and 1.2 mg doses were generally well tolerated; the 2.4 mg dose was associated with increased sleep latency and mild to moderate gastrointestinal adverse events over the first month of treatment. These findings represent a novel mechanism for producing clinically meaningful weight loss. Trial Registration: clinicaltrials.gov Identifier NCT01666691. This article is protected by copyright. All rights reserved.