Perioperative safety in the longitudinal assessment of bariatric surgery

Abstract

Background: To improve decision making in the treatment of extreme obesity, the risks of bariatric surgical procedures require further characterization.

Methods: We performed a prospective, multicenter, observational study of 30-day outcomes in consecutive patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007. A composite end point of 30-day major adverse outcomes (including death; venous thromboembolism; percutaneous, endoscopic, or operative reintervention; and failure to be discharged from the hospital) was evaluated among patients undergoing first-time bariatric surgery.

Results: There were 4776 patients who had a first-time bariatric procedure (mean age, 44.5 years; 21.1% men; 10.9% nonwhite; median body-mass index [the weight in kilograms divided by the square of the height in meters], 46.5). More than half had at least two coexisting conditions. A Roux-en-Y gastric bypass was performed in 3412 patients (with 87.2% of the procedures performed laparoscopically), and laparoscopic adjustable gastric banding was performed in 1198 patients; 166 patients underwent other procedures and were not included in the analysis. The 30-day rate of death among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding was 0.3%; a total of 4.3% of patients had at least one major adverse outcome. A history of deep-vein thrombosis or pulmonary embolus, a diagnosis of obstructive sleep apnea, and impaired functional status were each independently associated with an increased risk of the composite end point. Extreme values of body-mass index were significantly associated with an increased risk of the composite end point, whereas age, sex, race, ethnic group, and other coexisting conditions were not.

Conclusions: The overall risk of death and other adverse outcomes after bariatric surgery was low and varied considerably according to patient characteristics. In helping patients make appropriate choices, short-term safety should be considered in conjunction with both the long-term effects of bariatric surgery and the risks associated with being extremely obese. (ClinicalTrials.gov number, NCT00433810.)

Conflict of interest statement

Disclosure: Dr. Chapman reports receiving grant support from Covidien and has served as an expert witness on legal cases involving MIS and bariatric surgery. Dr. Courcoulas reports receiving grant support from Allergan, Covidien, and Pfizer. Dr. Flum reports receiving grant support from Sanofi-Aventis and Covidien and has served as an expert witness on cases involving adverse events after bariatric surgery. Dr. McCloskey reports receiving grant support from Stryker. Dr. Mitchell reports receiving grant support from GlaxoSmithKline, Lilly Research and Pfizer. Dr. Patterson reports receiving consulting fees from Allergan Health; lecture fees from Allergan Health and Legacy Health; grant support from Allergan Health and Legacy Health; Dr. Patterson also served as an expert witness in a case involving adverse events after bariatric surgery. Dr. Pomp reports receiving consulting fees from Covidien, W.L. Gore & Associates and Ethicon EndoSurgery; lecture fees from Covidien and W.L. Gore & Associates; grant support from Covidien and Ethicon EndoSurgery; he has also served as an expert witness for legal cases involving bariatric and other laparoscopic procedures. Dr. Pories reports receiving consulting fees and grant support from Johnson & Johnson, and lecture fees from Tyco. Dr. Wolfe reports receiving grant support from EnteroMedics and consulting fees from Johnson & Johnson. Dr. Yanovski reports that her spouse has received grant support from Obecure. No other potential conflicts of interest relevant to this article were reported.

2009 Massachusetts Medical Society

Figures

Figure 1. Enrollment, Treatment, and Follow-up of the Patients

Figure 2. Predicted Probabilities of Adverse Outcomes, According to a History of Deep-Vein Thrombosis or Venous Thromboembolism (DVT) or Obstructive Sleep Apnea (OSA)

Probabilities of outcomes are shown as a function of the body-mass index (the weight in kilograms divided by the square of the height in meters) and have been adjusted according to functional status (ability or lack of ability to walk 61 m [approximately 200 ft]) and surgical procedures on the basis of the multivariable model (for details, see Table 2 in the Supplementary Appendix).