Abstract
BACKGROUND: Magnetic sphincter augmentation (MSA) through placement of the LINX device is an alternative to fundoplication in the management of gastro-esophageal reflux disease (GERD). This systematic review and meta-analysis aimed to assess efficacy, quality of life, and safety in patients that underwent MSA, with a comparison to fundoplication. METHODS: A literature search of MEDLINE, Embase, Emcare, Scopus, Web of Science, and Cochrane library databases was performed for studies that reported data on outcomes of MSA, with or without a comparison group undergoing fundoplication, for GERD from January 2000 to January 2023. Meta-analysis was performed using random-effect models and between-study heterogeneity was assessed. RESULTS: Thirty-nine studies with 8075 patients were included: 6983 patients underwent MSA and 1092 patients had laparoscopic fundoplication procedure. Ten of these studies (seven retrospective and three prospective) directly compared MSA with fundoplication. A higher proportion of individuals successfully discontinued proton-pump inhibitors ( P <0.001; WMD 0.83; 95% CI: 0.72-0.93; I2 =96.8%) and had higher patient satisfaction ( P <0.001; WMD 0.85; 95% CI: 0.78-0.93; I2 =85.2%) following MSA when compared to fundoplication. Functional outcomes were better after MSA than after fundoplication including ability to belch ( P <0.001; WMD 0.96; 95% CI: 0.93-0.98; I2 =67.8) and emesis ( P <0.001; WMD 0.92; 95% CI: 0.89-0.95; I2 =42.8%), and bloating ( P =0.003; WMD 0.20; 95% CI: 0.07-0.33; I2 =97.0%). MSA had higher rates of dysphagia ( P =0.001; WMD 0.41; 95% CI: 0.17-0.65; I2 =97.3%) when compared to fundoplication. The overall erosion and removal rate following MSA was 0.24% and 3.9%, respectively, with no difference in surgical reintervention rates between MSA and fundoplication ( P =0.446; WMD 0.001; 95% CI: -0.001-0.002; I2 =78.5%). CONCLUSIONS: MSA is a safe and effective procedure at reducing symptom burden of GERD and can potentially improve patient satisfaction and functional outcomes. However, randomized controlled trials directly comparing MSA with fundoplication are necessary to determine where MSA precisely fits in the management pathway of GERD.