Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication

Luigi Bonavina, Thomas Horbach, Sebastian F Schoppmann, Janet DeMarchi, Luigi Bonavina, Thomas Horbach, Sebastian F Schoppmann, Janet DeMarchi

Abstract

Background: Magnetic sphincter augmentation (MSA) is a surgical intervention for gastroesophageal reflux disease (GERD) which has been evaluated in numerous studies and has shown beneficial effects. Long-term effectiveness data for MSA as well as laparoscopic fundoplication (LF) in patients with GERD are needed.

Objective: The objective of this study was to evaluate the 3-year outcomes for MSA and LF in patients with GERD.

Methods: This prospective, multi-center, observational registry study evaluated MSA and LF in clinical practice over 3 years (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, medication use, satisfaction and complications. Post-surgical evaluations were collected at yearly intervals.

Results: Between December 2009 and December 2014, 631 patients (465 MSA and 166 LF) were enrolled in the registry. Both MSA and LF resulted in improvements in total GERD-HRQL score (mean reduction in GERD-HRQL from baseline to 3 years post-surgery: MSA 22.0 to 4.6 and LF 23.6 to 4.9) and in satisfaction (GERD-HRQL satisfaction increase from baseline to 3 years: MSA 4.6% to 78.2% and LF 3.7% to 76.5%). Most patients were able to belch as needed with both therapies (MSA 97.6% and LF 91.7% at 3 years). MSA allowed a higher percentage of patients the ability to vomit as needed (MSA 91.2% and LF 68.0% at 3 years). PPI usage declined from baseline to 3 years for both groups after surgery (MSA 97.8% to 24.2% and LF 95.8% to 19.5%). The mean procedure time was shorter for MSA than for LF. Intraoperative and procedure-related complication rates (≤ 2%) were low for both therapies.

Conclusions: This 3-year prospective observational registry study contributes to the mounting evidence for the effectiveness of MSA and LF. Despite the more severe nature of GERD in the LF group, the clinical outcomes for MSA and LF were favorable from an effectiveness and safety standpoint.

Keywords: Anti-reflux surgery; Fundoplication; GERD; LINX; Proton pump inhibitors; Regurgitation.

Conflict of interest statement

Drs. Luigi Bonavina and Thomas Horbach have received consulting fees from Torax Medical Inc. in the past. Dr. Sebastian Schoppmann has received a research grant from Torax Medical Inc. Ms. DeMarchi is an employee of Ethicon. Drs. Luigi Bonavina, Sebastian Schoppmann and Thomas Horbach declare no current conflict of interest. This work was sponsored and partially funded by Torax Medical, Inc. (ClinicalTrials.gov identifier: NCT01624506).

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