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

Background: An increasing number of reflux patients opt for magnetic sphincter augmentation (MSA) instead of fundoplication. However, few studies compare the medium-term efficacy and safety of the procedures.

Methods: 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.

Results: 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 ± 12 years old and overweight (BMI: 28 ± 5). At 3.9 years 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).

Conclusion: 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.