3-YEAR REAL-WORLD OUTCOMES WITH THE SWEDISH ADJUSTABLE GASTRIC BANDTM IN FRANCE
Author(s)
Ribaric GJohnson & Johnson, Norderstedt, Germany
OBJECTIVES: To prospectively ascertain outcomes typical of the French national experience with the Swedish Adjustable Gastric BandTM (SAGBTM) in a consecutive-series, patient sample. METHODS: A common protocol for prospective data collection was provided to both urban and rural centres across regions of continental France. The protocol stipulated collection of data for body mass index (BMI, kg/m2), excess weight (kg), comorbidities, quality of life (QoL), and adverse events. RESULTS: Thirty-one surgeons in 28 teams implanted SAGBs.The cohort of 517 patients included 88.0% female; mean age of 37.5 years; mean disease duration, 15.3 years; mean preoperative BMI, 41.2. Measures of obesity were significantly reduced at 3 years, with a within-patient mean BMI reduction of 9.0 (95% CI: 8.5, 9.5; p<0.0001), excess body weight reduction of 24.5 kg (23.1, 25.9; p<0.0001), and corresponding 47.4% EWL (44.3, 51.0). Arthropathy, hypertension, dyslipidemia, and gastro-oesophageal reflux disease were the 4 most frequently cited comorbidities. Comorbidity prevalence fell significantly from a baseline of 74.3% (773 reported comorbidities in 381/513) to 27.2% (161 comorbidities in 116/424); thus, at 3-year follow-up, 72.8% reported no comorbidity. The majority of SAGB patients (68.3%) experienced no adverse events. Confirmed adverse events associated with the SAGB procedure totaled 290, occurring in 31.7% of patients. An overall adverse event rate of 0.19 events per patient-year.There was 1 unrelated death.Obesity-specific BAROSTM and non-disease specific Euro-QoLTMpresented improvement in QoL over 3 years post-SAGB implantation. Global QoL improvement was significantly associated with magnitude of BMI reduction (p<0.001) CONCLUSIONS: SAGB was effective at 3 yrs; BMI was reduced by 9.0 kg/m2, from 41.0 to 32.2 kg/m2. Average number of comorbidities per patient decreased over time. The 3-year implant-survival rate was 87.0%. SAGB-induced weight loss was associated with substantially improved QoL.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PSU1
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Diabetes/Endocrine/Metabolic Disorders