3-year real-world outcomes with the Swedish adjustable gastric band™ in France.
The study objective was to ascertain outcomes with the Swedish adjustable gastric band (SAGB) on an intention-to-treat basis in multiple centers across the French social health insurance system. SAGB results at 3-year follow-up are reported. The noncomparative, observational, prospective, consecutive cohort study design sought a 500-patient minimum recruitment geographically representative of continental France. Safety (adverse events [AEs], device-related morbidity, and mortality) and effectiveness (change in body mass index [BMI, kilograms per square meter], percentage excess weight loss, comorbidities, quality of life [QoL]) were assessed. Adjustable gastric band survival was calculated. Thirty-one surgeons in 28 multidisciplinary teams/sites enrolled patients between September 2, 2007 and April 30, 2008. SAGB was successfully implanted in 517 patients: 88.0 % female; mean age, 37.5 years; obesity duration, 15.3 years (baseline: mean BMI, 41.0; comorbidities, 773 in 74.3 % of patients; Bariatric Analysis and Reporting Outcome System (BAROS), 1.4; EuroQoL 5-Dimensions (EQ-5D), 0.61; EuroQoL-visual analog scale (EQ-VAS), 52.3). At 3 years: BMI, 32.2 (mean change, -9.0; p < 0.0001); excess weight loss, 47.4 %; comorbidities, 161 in 27.2 %; BAROS, 3.6 (+2.2, p < 0.0001); EQ-5D, 0.84 (+0.22, p < 0.0001); EQ-VAS, 73.4 (+21.4, p < 0.0001). SAGB-induced weight loss was associated with substantially improved QoL. One death occurred and was unrelated to the treatment. No AE was reported in 68.3 % of patients, and no confirmed device-related AE in 77.0 %. Overall AE rate was 0.19 per patient year. Device retention was 87.0 %. Analysis of patients lost to follow-up showed a nonsignificant effect on overall study results. In a prospective, consecutive cohort, "real-world", nationwide study, the Swedish Adjustable Gastric Band was found safe and effective at 3-year follow-up.
Ethicon Endo-Surgery (Europe), European Surgical Institute, Hamburg, Germany. GRibaric@its.jnj.com
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Buchwald
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d'Orsay
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Daoud
D000328:Adult; D015992:Body Mass Index; D015897:Comorbidity; D020878:Device Removal / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D015391:Gastroplasty / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000379:methods; D008297:Male; D009767:Obesity, Morbid / Q000453:epidemiology / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss