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

Caroline M. Apovian, Sajani N. Shah, Bruce Wolfe, Sayeed Ikramuddin, Christopher J. Miller, Katherine S. Tweden, Charles J. Billington, Scott A. Shikora

Research output: Contribution to journalArticle

38 Citations (Scopus)

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

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalObesity Surgery
DOIs
StateAccepted/In press - Aug 10 2016

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Weight Loss
Obesity
Therapeutics
Quality of Life
Blood Pressure
Heartburn
Morbid Obesity
Dyspepsia
HDL Cholesterol
Triglycerides
Body Mass Index
Safety
Pain
Equipment and Supplies

Keywords

  • Obesity
  • Quality of life
  • Vagal nerve blocking
  • Weight loss surgery

ASJC Scopus subject areas

  • Surgery
  • Endocrinology, Diabetes and Metabolism
  • Medicine(all)
  • Nutrition and Dietetics

Cite this

Apovian, C. M., Shah, S. N., Wolfe, B., Ikramuddin, S., Miller, C. J., Tweden, K. S., ... Shikora, S. A. (Accepted/In press). Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial. Obesity Surgery, 1-8. https://doi.org/10.1007/s11695-016-2325-7

Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial. / Apovian, Caroline M.; Shah, Sajani N.; Wolfe, Bruce; Ikramuddin, Sayeed; Miller, Christopher J.; Tweden, Katherine S.; Billington, Charles J.; Shikora, Scott A.

In: Obesity Surgery, 10.08.2016, p. 1-8.

Research output: Contribution to journalArticle

Apovian, CM, Shah, SN, Wolfe, B, Ikramuddin, S, Miller, CJ, Tweden, KS, Billington, CJ & Shikora, SA 2016, 'Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial', Obesity Surgery, pp. 1-8. https://doi.org/10.1007/s11695-016-2325-7
Apovian, Caroline M. ; Shah, Sajani N. ; Wolfe, Bruce ; Ikramuddin, Sayeed ; Miller, Christopher J. ; Tweden, Katherine S. ; Billington, Charles J. ; Shikora, Scott A. / Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial. In: Obesity Surgery. 2016 ; pp. 1-8.
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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",
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AU - Ikramuddin, Sayeed

AU - Miller, Christopher J.

AU - Tweden, Katherine S.

AU - Billington, Charles J.

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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

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