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Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients.

Ribaric G, Buchwald J - Croat. Med. J. (2014)

Bottom Line: Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated.There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years.In a retrospective analysis of a subgroup of BMI<35 kg/m2 patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.

View Article: PubMed Central - PubMed

Affiliation: Goran Ribaric, Director, Regional Safety Officer EMEA, Medical Devices and Diagnostics, Johnson and Johnson, Ethicon Endo Surgery (Europe) GmbH, Hummelsbütteler Steindamm 71, 22851 Norderstedt, Germany, gribaric@its.jnj.com.

ABSTRACT

Aim: To analyze the 3-year outcomes of lower body mass index (BMI) (<35 kg/m2) adjustable gastric band (AGB) recipients across multiple sites in the French health insurance system.

Methods: From prospectively collected data on a cohort of 517 morbidly obese Swedish Adjustable Gastric Band® (SAGB) patients (Clinical Trials Web database, #NCT01183975), a retrospective analysis of a subgroup of 29 low-BMI patients was conducted. Patients had a severe obesity-related comorbidity, had undergone a prior bariatric procedure requiring reintervention, or had a maximum adult BMI≥40. Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated.

Results: Multiple surgical teams/sites enrolled patients and performed SAGB procedures between September 2, 2007 and April 30, 2008. Of 29 low-BMI patients (mean age, 41.3±10.3 years), 89.7% were female, and obesity duration was 13.6±7.3 years. Mean BMI was 31.5±3.7; there were 37 comorbidities in 15/29 patients. At 3-year follow-up, BMI was 29.4±4.9 (mean change, -2.3±6.2; P=0.069); total cohort EWL, 7.3±74.8%; TBWL, 6.2±18.8%; BMI≥30 to <35 EWL, 38.8±48.0%; there were 7 comorbidities in 15/29 patients (P<0.031). There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years.

Conclusions: In a retrospective analysis of a subgroup of BMI<35 kg/m2 patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.

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Related in: MedlinePlus

Scatter plot and regression line illustrating direct relationship between preoperative body mass index (BMI, kg/m2) and percentage total body weight loss (%TBWL) for BMI<35 patients following Swedish Adjustable Gastric Band (SAGB) procedure at 3 years. Intersecting reference lines represent the point on the BMI axis (BMI = 30) above which a positive %TBWL is predicted to occur at 3-year SAGB follow-up.
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Figure 3: Scatter plot and regression line illustrating direct relationship between preoperative body mass index (BMI, kg/m2) and percentage total body weight loss (%TBWL) for BMI<35 patients following Swedish Adjustable Gastric Band (SAGB) procedure at 3 years. Intersecting reference lines represent the point on the BMI axis (BMI = 30) above which a positive %TBWL is predicted to occur at 3-year SAGB follow-up.

Mentions: In the development of a multivariate regression model exploring preoperative clinical variables significantly related to %TBWL (ie, presence of comorbidity [r = 0.493, P = 0.012], QoL [EQ-VAS] [r = -0.482, P = 0.027], type of SAGB operation (prior bariatric procedure or index SAGB procedure) [r = 0.591, P = 0.002], and BMI [r = 0.631, P = 0.001]), only baseline BMI was found to be an independent predictor of 3-year %TBWL in the BMI<35 SAGB cohort. Results of simple linear regression of %TBWL on baseline BMI in the form of a scatterplot and regression line are presented in Figure 3. Baseline BMI and 3-year %TBWL correlated at r = 0.631 (P = 0.001). A logistic regression model using BMI as the lone predictor was shown to correctly classify 83.3% of patients into their respective “weight-loss” vs “weight-gain” groups. Logistic results are presented in the form of a probability curve in Figure 4 (BMI odds ratio = 1.53 [95% CI: 1.1, 2.2]; beta coefficient = 0.428, P = 0.048; model constant = -13.2, P = 0.008).


Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients.

Ribaric G, Buchwald J - Croat. Med. J. (2014)

Scatter plot and regression line illustrating direct relationship between preoperative body mass index (BMI, kg/m2) and percentage total body weight loss (%TBWL) for BMI<35 patients following Swedish Adjustable Gastric Band (SAGB) procedure at 3 years. Intersecting reference lines represent the point on the BMI axis (BMI = 30) above which a positive %TBWL is predicted to occur at 3-year SAGB follow-up.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4157389&req=5

Figure 3: Scatter plot and regression line illustrating direct relationship between preoperative body mass index (BMI, kg/m2) and percentage total body weight loss (%TBWL) for BMI<35 patients following Swedish Adjustable Gastric Band (SAGB) procedure at 3 years. Intersecting reference lines represent the point on the BMI axis (BMI = 30) above which a positive %TBWL is predicted to occur at 3-year SAGB follow-up.
Mentions: In the development of a multivariate regression model exploring preoperative clinical variables significantly related to %TBWL (ie, presence of comorbidity [r = 0.493, P = 0.012], QoL [EQ-VAS] [r = -0.482, P = 0.027], type of SAGB operation (prior bariatric procedure or index SAGB procedure) [r = 0.591, P = 0.002], and BMI [r = 0.631, P = 0.001]), only baseline BMI was found to be an independent predictor of 3-year %TBWL in the BMI<35 SAGB cohort. Results of simple linear regression of %TBWL on baseline BMI in the form of a scatterplot and regression line are presented in Figure 3. Baseline BMI and 3-year %TBWL correlated at r = 0.631 (P = 0.001). A logistic regression model using BMI as the lone predictor was shown to correctly classify 83.3% of patients into their respective “weight-loss” vs “weight-gain” groups. Logistic results are presented in the form of a probability curve in Figure 4 (BMI odds ratio = 1.53 [95% CI: 1.1, 2.2]; beta coefficient = 0.428, P = 0.048; model constant = -13.2, P = 0.008).

Bottom Line: Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated.There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years.In a retrospective analysis of a subgroup of BMI<35 kg/m2 patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.

View Article: PubMed Central - PubMed

Affiliation: Goran Ribaric, Director, Regional Safety Officer EMEA, Medical Devices and Diagnostics, Johnson and Johnson, Ethicon Endo Surgery (Europe) GmbH, Hummelsbütteler Steindamm 71, 22851 Norderstedt, Germany, gribaric@its.jnj.com.

ABSTRACT

Aim: To analyze the 3-year outcomes of lower body mass index (BMI) (<35 kg/m2) adjustable gastric band (AGB) recipients across multiple sites in the French health insurance system.

Methods: From prospectively collected data on a cohort of 517 morbidly obese Swedish Adjustable Gastric Band® (SAGB) patients (Clinical Trials Web database, #NCT01183975), a retrospective analysis of a subgroup of 29 low-BMI patients was conducted. Patients had a severe obesity-related comorbidity, had undergone a prior bariatric procedure requiring reintervention, or had a maximum adult BMI≥40. Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated.

Results: Multiple surgical teams/sites enrolled patients and performed SAGB procedures between September 2, 2007 and April 30, 2008. Of 29 low-BMI patients (mean age, 41.3±10.3 years), 89.7% were female, and obesity duration was 13.6±7.3 years. Mean BMI was 31.5±3.7; there were 37 comorbidities in 15/29 patients. At 3-year follow-up, BMI was 29.4±4.9 (mean change, -2.3±6.2; P=0.069); total cohort EWL, 7.3±74.8%; TBWL, 6.2±18.8%; BMI≥30 to <35 EWL, 38.8±48.0%; there were 7 comorbidities in 15/29 patients (P<0.031). There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years.

Conclusions: In a retrospective analysis of a subgroup of BMI<35 kg/m2 patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.

Show MeSH
Related in: MedlinePlus