PMID- 23054572
OWN - NLM
STAT- MEDLINE
DCOM- 20130820
LR  - 20231106
IS  - 1708-0428 (Electronic)
IS  - 0960-8923 (Print)
IS  - 0960-8923 (Linking)
VI  - 23
IP  - 2
DP  - 2013 Feb
TI  - 3-year real-world outcomes with the Swedish adjustable gastric band in France.
PG  - 184-96
LID - 10.1007/s11695-012-0765-2 [doi]
AB  - 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.
FAU - Ribaric, G
AU  - Ribaric G
AD  - Ethicon Endo-Surgery (Europe), European Surgical Institute, Hamburg, Germany. 
      GRibaric@its.jnj.com
FAU - Buchwald, J N
AU  - Buchwald JN
FAU - d'Orsay, G
AU  - d'Orsay G
FAU - Daoud, F
AU  - Daoud F
CN  - French Health Technology Assessment Body (Haute Autorite de Sante [HAS]) Swedish 
      Adjustable Gastric Band (SAGB) Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Obes Surg
JT  - Obesity surgery
JID - 9106714
SB  - IM
MH  - Adult
MH  - Body Mass Index
MH  - Comorbidity
MH  - Device Removal/statistics & numerical data
MH  - Female
MH  - Follow-Up Studies
MH  - France/epidemiology
MH  - Gastroplasty/adverse effects/*methods
MH  - Humans
MH  - *Laparoscopy/methods
MH  - Male
MH  - Obesity, Morbid/epidemiology/*surgery
MH  - Prospective Studies
MH  - Quality of Life
MH  - Time Factors
MH  - Treatment Outcome
MH  - Weight Loss
PMC - PMC3560940
FIR - Arnalsteen, L
IR  - Arnalsteen L
FIR - Arnoux, R
IR  - Arnoux R
FIR - Attal, E
IR  - Attal E
FIR - Barei, R
IR  - Barei R
FIR - Bergevin, P
IR  - Bergevin P
FIR - Campan, P
IR  - Campan P
FIR - Dehaye, B
IR  - Dehaye B
FIR - Deseguin, C
IR  - Deseguin C
FIR - Flaisler, J
IR  - Flaisler J
FIR - Fromont, G
IR  - Fromont G
FIR - Johanet, H
IR  - Johanet H
FIR - Juglard, G
IR  - Juglard G
FIR - Labbe, F
IR  - Labbe F
FIR - Legris, A
IR  - Legris A
FIR - Lointier, P
IR  - Lointier P
FIR - Meaux, F
IR  - Meaux F
FIR - Nini, E
IR  - Nini E
FIR - Noel, P
IR  - Noel P
FIR - Pattou, F
IR  - Pattou F
FIR - Pugnet, G
IR  - Pugnet G
FIR - Quinaux, D
IR  - Quinaux D
FIR - Rique, J L
IR  - Rique JL
FIR - Rossi, S
IR  - Rossi S
FIR - Sodji, M
IR  - Sodji M
FIR - Tussiot, J
IR  - Tussiot J
FIR - Vaudois, C
IR  - Vaudois C
FIR - Ain, J-F
IR  - Ain JF
FIR - Cady, J
IR  - Cady J
FIR - Catheline, J-M
IR  - Catheline JM
FIR - Chevallier, J-M
IR  - Chevallier JM
FIR - Dargent, J
IR  - Dargent J
EDAT- 2012/10/12 06:00
MHDA- 2013/08/21 06:00
PMCR- 2012/09/30
CRDT- 2012/10/12 06:00
PHST- 2012/10/12 06:00 [entrez]
PHST- 2012/10/12 06:00 [pubmed]
PHST- 2013/08/21 06:00 [medline]
PHST- 2012/09/30 00:00 [pmc-release]
AID - 765 [pii]
AID - 10.1007/s11695-012-0765-2 [doi]
PST - ppublish
SO  - Obes Surg. 2013 Feb;23(2):184-96. doi: 10.1007/s11695-012-0765-2.