Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique

Abstract

Background

Vagal nerve blockade with the vBloc device (ReShape Lifesciences, St. Paul, MN) has been shown to provide durable 2-year weight loss in patients with moderate obesity. These devices may require removal. We present a series of patients and report our technique for laparoscopic removal of this device.

Methods

From December 2009 to December 2016, the medical records of patients who underwent laparoscopic explantation of a vagal blocking device at our institution were retrospectively reviewed. All patients initially underwent device placement as part of a multi-center, randomized, controlled trial. The device leads were removed with the application of firm traction in order to safely dissect them away from the stomach and esophagus as the body tended to form a fibrotic capsule surrounding the leads. Operative details, length of stay, 30-day post-operative complications, demographics and reasons for device removal were reported.

Results

Thirty patients were identified. Median age was 54 (37–65) years. Average operative time was 227.63 (± 100.21) min. Median time from implantation to removal was 41 (11–96) months. Removal reasons included device malfunction (7 patients, 23.3%), pain at the neuroregulator site (5 patients, 16.7%), retrosternal or epigastric pain (11 patients, 36.7%), weight regain or dissatisfaction with weight loss (15 patients, 50%), and severe nausea (2 patients, 6.7%). Two patients (6.7%) had Clavien–Dindo grade II complications following explantation. Thirteen patients (43.3%) had dense adhesions noted at the time of operation. Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%).

Conclusion

The vagal nerve blocking device can be safely removed laparoscopically with a low 30-day complication rate. Surgeons should be familiar with the details of the device appearance, the typical lead location, and should anticipate dense adhesions surrounding the leads. In addition, experience operating in the region of the gastroesophageal junction is imperative.

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Funding

Clinical care funded by ReShape Lifesciences.

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Correspondence to Erin W. Gilbert.

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Disclosures

Dr. Bruce Wolfe was a site investigator for the EMPOWER and ReCharge trials for ReShape Lifesciences. He received no financial remuneration for his role in the studies. Dr. Erin Gilbert was a co-investigator for the ReCharge trial for ReShape Lifesciences and received no financial remuneration for her role in the study. Drs. Worrest and Mattar have no conflicts of interest or financial ties to disclose.

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Worrest, T.C., Wolfe, B.M., Mattar, S.G. et al. Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique. Surg Endosc 33, 3600–3604 (2019). https://doi.org/10.1007/s00464-018-06643-4

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Keywords

  • Vagal blocking device
  • Bariatric surgery
  • vBloc