Comorbidity outcomes of the REALIZE adjustable gastric band at 3 years

Kulmeet K Sandhu, MD, Adrienne Youdim, MD, Scott A Cunneen, MD, Sayeed Ikramuddin, MD, Natan Zundel, MD, Robert T Marema, MD, Edward H Phillips, MD

Cedars-Sinai Medical Center (Los Angeles, CA); University of Minnesota Medical Center (Minneapolis, MN); Cleveland Clinic Florida (Weston, FL); U.S. Bariatric (Ft. St. Augustine, FL); Ethicon Endo-Surgery, Inc (Cincinnati, Ohio)

Introduction:

Metabolic syndrome (MetS), a cluster of cardiovascular disease (CVD) risk factors, is strongly associated with obesity. Bariatric surgery is the most effective treatment for obesity and its comorbidities.

Methods and Procedures:

Twelve academic and/or private practice bariatric centers in the United Sates participated in a prospective, non-randomized, multicenter study with centralized laboratory testing. Changes in parameters associated with dyslipidemia, type 2 diabetes mellitus, hypertension, and MetS at 3 years post-Realize Band implantation were evaluated.

Results:

276 laparoscopic adjustable gastric band (LAGB) subjects were enrolled, of which181 (66%) had MetS. Of the MetS cases, 53.6% resolved and 91.3% of the subjects without preoperative MetS remained without it at 3 years. In subjects without MetS at study end, mean percent excess weight loss (%EWL) and mean % decrease in waist circumference were 46.0 ± 26.5% and 16.5 ± 10.7%, respectively; compared to 31.3 ± 18.4% and 10.3 ± 8.0%, respectively in subjects with MetS at study end (p<.0001 for each within group change). Percent EWL was 39.6 ± 19.8%, 41.4 ± 24.1%, and 40.1% ± 26.0% in subjects with diabetes, hypertension, and dyslipidemia, respectively. Mean glycosylated hemoglobin (HbA1c) and systolic blood pressure (SBP) decreased from 7.4 ± 1.5% and 133 ± 15 to 6.4 ± 1.0% and 128 ± 16 mmHg (p<.0001), respectively. Mean high-density lipoprotein (HDL) increased from 46 ± 13 to 55 ± 15 mg/dL (p <.005). Of the subjects taking anti-diabetic, antihypertensive, and lipid-lowering drugs preoperatively, 86%, 77%, and 41% respectively, decreased or stopped their use.

Conclusion:

LAGB significantly improves metabolic syndrome and cardiovascular co-morbidity risk in subjects with morbid obesity. The presence of MetS preoperatively does not impact overall weight loss, but the extent of weight loss and central obesity postoperatively appear to impact cardio-metabolic disease in patients with morbid obesity.

Session: Poster Presentation

Program Number: P437