Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.
Document Type
Article
Publication Date
8-1-2019
Publication Title
Annals of surgery
Keywords
Adult; Aged; Deglutition; Esophageal Sphincter, Lower; Esophageal pH Monitoring; Female; Follow-Up Studies; Gastroesophageal Reflux; Humans; Magnets; Male; Middle Aged; Prospective Studies; Prosthesis Design; Surveys and Questionnaires; Time Factors; Treatment Outcome; Young Adult
Abstract
OBJECTIVE: To report 1-year results from a 5-year mandated study.
SUMMARY BACKGROUND DATA: In 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.
METHODS: Multicenter, 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.
RESULTS: A 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.
CONCLUSIONS: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.
Clinical Institute
Digestive Health
Department
Swedish Thoracic Surgery
Department
Surgery
Recommended Citation
Louie, Brian; Smith, C Daniel; Smith, Christopher C; Bell, Reginald C W; Gillian, George Kevin; Mandel, Jeffrey S; Perry, Kyle A; Birkenhagen, Walter Kurt; Taiganides, Paul A; Dunst, Christy M; McCollister, Howard M; Lipham, John C; Khaitan, Leena K; Tsuda, Shawn T; Jobe, Blair A; Kothari, Shanu N; and Gould, Jon C, "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study." (2019). Articles, Abstracts, and Reports. 2728.
https://digitalcommons.providence.org/publications/2728
