Medium-term outcomes after magnetic sphincter augmentation vs. fundoplication for reflux disease due to hiatal hernia: a propensity-score matched comparison in 282 patients.

Abstract

An increasing number of reflux patients opt for magnetic sphincter augmentation (MSA) instead of fundoplication. However, few studies comparethe medium-term efficacy and safety of the procedures. We conducted a retrospective single-center analysis of consecutive MSA and Nissen fundoplication cases between 01/2015 and 06/2020. Patients underwent surgery, including hiatoplasty, for medical treatment-resistant reflux due to hiatal hernia. Surgical revision and proton pump inhibitor (PPI) reuptake rates were the primary outcomes. We also compared adverse event rates. Patients with severe preoperative dysphagia/motility disorders were assigned different treatment pathways and excluded from the analysis. We used propensity-score matching to reduce confounding between treatments. Out of 411 eligible patients, 141 patients who underwent MSA and 141 with fundoplication had similar propensity scores and were analyzed. On average, patients were 55 ± 12years old and overweight (BMI: 28 ± 5). At 3.9years of mean follow-up, MSA was associated with lower surgical revision risk as compared to fundoplication (1.2% vs 3.0% per year, respectively; HR: 0.38; 95% CI 0.15-0.96; p = 0.04), and similar PPI-reuptake risk (2.6% vs 4.2% per year; HR: 0.59; 95% CI 0.30-1.16; p = 0.12). Adverse event rates during primary stay were similar (MSA vs. fundoplication: 1% vs. 3%, p = 0.68). Fewer patients experienced adverse events in the MSA group after discharge (24% vs. 33%, p = 0.11), driven by higher rates of self-limiting dysphagia (1% vs. 9%, p < 0.01) and gas/bloating (10% vs. 18%, p = 0.06) after fundoplication. Differences between MSA and fundoplication in dysphagia requiring diagnostic endoscopy (11% vs. 8%, p = 0.54) or surgical revision (2% vs. 1%, p = 1.0) were non-significant. The device explantation rate was 4% (5/141). MSA reduces the re-operation risk compared to fundoplication and may decrease adverse event rates after discharge. Randomized head-to-head studies between available surgical options are needed.