Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States

Background: The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the Realize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band. Methods: A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted Realize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up. Results: Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 ± 9.4 years (range 18-61), and the preoperative body mass index was 44.5 ± 4.7 kg/m². The mean hospital stay was 1.2 ± 1.3 days. At 3 years, the average excess weight loss was 41.1% ± 25.1% or a decrease in the body mass index of 8.2 kg/m² (18.6%) (P < .001). In diabetic patients with a baseline elevated hemoglobin A₁c level, the level decreased by 1% (P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively (P < .001), and the high-density lipoprotein cholesterol increased by 25% (P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants. Conclusion: The results of our study have shown that the Realize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.