title: Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.
abstract: 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.
  
  
  
  Participants with body mass index (BMI) 40 to 45 kg/m2, or 35 to 40 kg/m2with 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.
  
  
  
  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 %.
  
  
  
  vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years.
  
  
  
  https://clinicaltrials.gov/ct2/show/NCT01327976.
authors: Boston University School of Medicine, 88 East Newton Street, Boston, MA, 02118, USA.
authors: Caroline M
authors: CM
authors: Apovian
authors: Tufts Medical Center, Boston, 800 Washington St, Boston, MA, 02111, USA.
authors: Sajani N
authors: SN
authors: Shah
authors: Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.
authors: Bruce M
authors: BM
authors: Wolfe
authors: University of Minnesota, 420 Delaware St, Minneapolis, MN, 55455, USA.
authors: Sayeed
authors: S
authors: Ikramuddin
authors: 3D Communications, LLC, 8386 Six Forks Rd, Raleigh, NC, 27615, USA.
authors: Christopher J
authors: CJ
authors: Miller
authors: EnteroMedics Inc., 2800 Patton Road, St. Paul, MN, 55113, USA. ktweden@enteromedics.com.
authors: Katherine S
authors: KS
authors: Tweden
authors: University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans Drive, Minneapolis, MN, 55417, USA.
authors: Charles J
authors: CJ
authors: Billington
authors: Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA.
authors: Scott A
authors: SA
authors: Shikora
mesh_terms: D000328:Adult; D001340:Autonomic Nerve Block / Q000009:adverse effects / Q000295:instrumentation*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004567:Electrodes, Implanted; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000378:metabolism / Q000628:therapy*; D011788:Quality of Life; D012307:Risk Factors; D016896:Treatment Outcome; D014630:Vagus Nerve / Q000473:pathology / Q000601:surgery*; D055536:Vagus Nerve Stimulation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D015431:Weight Loss / Q000502:physiology
keywords: Obesity; Quality of life; Vagal nerve blocking; Weight loss surgery