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Multicenter Study
. 2013 Feb;23(2):184-96.
doi: 10.1007/s11695-012-0765-2.

3-year real-world outcomes with the Swedish adjustable gastric band™ in France

G Ribaric  1 , J N Buchwald, G d'Orsay, F Daoud; French Health Technology Assessment Body (Haute Autorité de Santé [HAS]) Swedish Adjustable Gastric Band (SAGB™) Study Group
Collaborators, Affiliations
Multicenter Study

3-year real-world outcomes with the Swedish adjustable gastric band™ in France

G Ribaric et al. Obes Surg. 2013 Feb.

Abstract

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.

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Figures

Fig. 1
Fig. 1
Time distribution of adverse events or re-interventions
Fig. 2
Fig. 2
Kaplan–Meier band survival curve
Fig. 3
Fig. 3
SAGB cohort body mass index evolution
Fig. 4
Fig. 4
Evolution of SAGB cohort quality of life scores as measured by the Bariatric Analysis and Reporting Outcome System (BAROS®)
Fig. 5
Fig. 5
Relationship between body mass index reduction and quality of life changes as measured by EuroQoL 5-dimensions (EQ-5D). v1 = baseline; v8 = 3-year follow-up
See this image and copyright information in PMC

References

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    1. Avis de la CEPP du 1er septembre 2004 modifié le 20 octobre 2004 SAGB (anneau gastrique ajustable suédois), implant annulaire ajustable pour gastroplastie. Modèles 2100-X et 2200-X. http://www.santedev.org/biblio/pdf2/has/cepp/2004/10/20/pp020367.pdf. Accessed: March 12, 2012
    1. Avis de la CEPP 8 mars 2006 SAGB (anneau gastrique ajustable suédois) Quick-Close fourni avec le site VELOCITY et son applicateur, implant annulaire ajustable pour gastroplastie. Modèle BD2XV.
    1. Association Française d’Etudes et de Recherches sur l’Obésité, Association de Langue Française pour l’Etude du Diabète et des Maladies Métaboliques, Société de Nutrition et de Diététique de Langue Française Recommandations pour le diagnostic, la prévention et le traitement des obésités en France. Cah Nutr Diet. 1998;33:10–42.

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