Abstract
Background: Magnetic sphincter augmentation (MSA) is an alternative treatment option to laparoscopic fundoplication (LF) for patients with gastroesophageal reflux disease. To date, over 40,000 devices have been implanted worldwide since first approval in Europe in 2010 and the USA in 2012. Despite this clinical reality, the long-term safety and effectiveness of the procedure continues to be questioned. This study aims to systematically summarize and appraise the currently available evidence for MSA relative to effectiveness, safety, and healthcare resource use. Methods: A systematic literature search was carried out to identify all clinical studies published in English, as of February 15, 2023. Required endpoints were safety, effectiveness, and cost effectiveness. Results: The systematic search identified 212 publications and 14 entries in study registries. After screening and full text analysis, 82 publications were included in qualitative synthesis. One RCT established superiority of MSA compared to twice daily proton-pump inhibitors with respect to the elimination of moderate to severe regurgitation (89% vs 10%, RR 0.11, 95% CI 0.06-0.20, P < 0.001). Eleven cohort studies comparing MSA to LF showed no statistical difference in safety profile and effectiveness measured by post-operative GERD-HRQL score. In addition, patients undergoing MSA significantly retained the ability to belch and vomit when compared to LF. These results were consistent in follow-up out to 7 years. Conclusions: LINX has been shown to provide long lasting relief to patients suffering from persistent GERD while maintaining an acceptable safety profile. As an outpatient day-procedure, MSA is cost effective with short recovery.
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