• Brian E Louie, C Daniel Smith, Christopher C Smith, BellReginald C WRCWSOFI Center for Esophageal Wellness, Englewood, CO., George Kevin Gillian, Jeffrey S Mandel, Kyle A Perry, Walter Kurt Birkenhagen, Paul A Taiganides, Christy M Dunst, Howard M McCollister, John C Lipham, Leena K Khaitan, Shawn T Tsuda, Blair A Jobe, Shanu N Kothari, and Jon C Gould.
• Division of Thoracic Surgery, Swedish Medical Center, Seattle, WA.
• Ann. Surg. 2019 Aug 1; 270 (2): 302-308.

ObjectiveTo report 1-year results from a 5-year mandated study.Summary Background DataIn 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study.MethodsMulticenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors.ResultsA total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported.ConclusionsSafety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

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