TY - JOUR
T1 - Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
AU - Apovian, Caroline M.
AU - Shah, Sajani N.
AU - Wolfe, Bruce M.
AU - Ikramuddin, Sayeed
AU - Miller, Christopher J.
AU - Tweden, Katherine S.
AU - Billington, Charles J.
AU - Shikora, Scott A.
N1 - Publisher Copyright:
© 2016, The Author(s).
PY - 2017/1/1
Y1 - 2017/1/1
N2 - Background: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. Methods: Participants with body mass index (BMI) 40 to 45 kg/m2, or 35 to 40 kg/m2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. Results: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. Conclusions: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. Trial Registration: https://clinicaltrials.gov/ct2/show/NCT01327976
AB - Background: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. Methods: Participants with body mass index (BMI) 40 to 45 kg/m2, or 35 to 40 kg/m2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. Results: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. Conclusions: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. Trial Registration: https://clinicaltrials.gov/ct2/show/NCT01327976
KW - Obesity
KW - Quality of life
KW - Vagal nerve blocking
KW - Weight loss surgery
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U2 - 10.1007/s11695-016-2325-7
DO - 10.1007/s11695-016-2325-7
M3 - Article
C2 - 27506803
AN - SCOPUS:84981240471
SN - 0960-8923
VL - 27
SP - 169
EP - 176
JO - Obesity Surgery
JF - Obesity Surgery
IS - 1
ER -
