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Résultats à 3 ans du Swedish Adjustable Gastric BandTM (anneau gastrique ajustable suédois) dans la population générale en France

3-Year Real-World Outcomes with the Swedish Adjustable Gastric Band in France

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Obésité

Résumé

L’objectif de l’étude consistait à contrôler les résultats du Swedish adjustable gastric band (SAGB, anneau gastrique ajustable suédois) sur la base de l’intention de traiter dans plusieurs centres au sein du système français de sécurité sociale. Les résultats de suivi à 3 ans avec le SAGB sont présentés. Le plan de cette étude de cohorte non comparative, observationnelle, prospective et consécutive a visé le recrutement d’un minimum de 500 patients géographiquement représentatifs du territoire français métropolitain. L’innocuité (événements indésirables [EI], morbidité liée au dispositif, et mortalité) et l’efficacité (variation de l’indice de masse corporelle [IMC, kilogrammes par mètre carré], perte de poids en excès en pourcentage, comorbidités, qualité de vie [QoL]) ont été évaluées. La survie avec anneau gastrique ajustable a été calculée. Trente-et-un chirurgiens de 28 équipes / sites multidisciplinaires ont recruté des patients entre le 2 septembre 2007 et le 30 avril 2008. Un SAGB a été implanté avec succès chez 517 patients : 88,0 % de femmes ; âge moyen, 37,5 ans ; durée d’obésité, 15,3 ans (valeurs à l’inclusion : IMC moyen, 41,0 ; comorbidités, 773 chez 74,3 % des patients ; système d’analyse bariatrique et de notification des résultats (Bariatric Analysis and Reporting Outcome System, BAROS), 1,4 ; EuroQoL 5-Dimensions (EQ-5D), 0,61 ; échelle visuelle analogique EuroQoL (EQ-EVA), 52,3). À 3 ans : IMC, 32,2 (variation moyenne, −9,0 ; p < 0,0001) ; perte de poids en excès, 47,4 %; comorbidités, 161 chez 27,2 % ; BAROS, 3,6 (+2,2, p < 0,0001) ; EQ-5D, 0,84 (+0,22, p < 0,0001) ; EQ-EVA, 73,4 (+21,4, p < 0,0001). La perte de poids induite par le SAGB était associée à une amélioration substantielle de la QoL. Un décès est survenu, sans rapport avec le traitement. 68,3 % des patients n’ont rapporté aucun EI, et 77,0 % aucun EI confirmé et lié au dispositif. Le taux global d’EI était de 0,19 par patients-année. La conservation du dispositif était de 87,0 %. L’analyse des patients perdus de vue a montré un effet non significatif sur les résultats globaux de l’étude. Le Swedish Adjustable Gastric Band est apparu sûr et efficace dans le suivi à 3 ans d’une étude nationale de cohorte consécutive, prospective et dans la population générale.

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], devicerelated 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 devicerelated 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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Authors and Affiliations

  1. Ethicon Endo-Surgery (Europe), European Surgical Institute, Hamburg, Germany

    G. Ribaric

  2. Division of Scientific Writing, Medwrite Medical Communications, Maiden Rock, WI, USA

    J. -N. Buchwald

  3. Johnson & Johnson Medical, Ethicon SAS, Paris, France

    G. d’Orsay

  4. Data Management & Biometrics, Medextens SARL, Paris, France

    F. Daoud

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Ribaric, G., Buchwald, J.N., d’Orsay, G. et al. Résultats à 3 ans du Swedish Adjustable Gastric BandTM (anneau gastrique ajustable suédois) dans la population générale en France. Obes 8, 8–21 (2013). https://doi.org/10.1007/s11690-013-0356-y

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