Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial

Obes Surg. 2017 Jan;27(1):169-176. doi: 10.1007/s11695-016-2325-7.

Abstract

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.

Keywords: Obesity; Quality of life; Vagal nerve blocking; Weight loss surgery.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Autonomic Nerve Block / adverse effects
  • Autonomic Nerve Block / instrumentation*
  • Cross-Over Studies
  • Double-Blind Method
  • Electric Stimulation Therapy* / adverse effects
  • Electric Stimulation Therapy* / instrumentation
  • Electric Stimulation Therapy* / methods
  • Electrodes, Implanted*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Obesity, Morbid / metabolism
  • Obesity, Morbid / therapy*
  • Quality of Life
  • Risk Factors
  • Treatment Outcome
  • Vagus Nerve / pathology
  • Vagus Nerve / surgery*
  • Vagus Nerve Stimulation / adverse effects
  • Vagus Nerve Stimulation / instrumentation
  • Vagus Nerve Stimulation / methods*
  • Weight Loss / physiology

Associated data

  • ClinicalTrials.gov/NCT01327976