Brian E Louie1, C Daniel Smith2, Christopher C Smith3, Reginald C W Bell4, George Kevin Gillian5, Jeffrey S Mandel6, Kyle A Perry7, Walter Kurt Birkenhagen8, Paul A Taiganides9, Christy M Dunst10, Howard M McCollister11, John C Lipham12, Leena K Khaitan13, Shawn T Tsuda14, Blair A Jobe15, Shanu N Kothari16, Jon C Gould17. 1. Division of Thoracic Surgery, Swedish Medical Center, Seattle, WA. 2. Esophageal Institute of Atlanta, Atlanta, GA. 3. Albany Surgical, Albany, GA. 4. SOFI Center for Esophageal Wellness, Englewood, CO. 5. Virginia Heartburn and Hernia Institute, Lorton, VA. 6. South Coast Health-Surgery, Savannah, GA. 7. Department of Surgery, Ohio State University, Columbus, OH. 8. General Surgery, Bingham Memorial Hospital, Pocatello, ID. 9. Knox Regional Heartburn Treatment Center, Mount Vernon, OH. 10. Division of Gastrointestinal and Minimally Invasive Surgery, Oregon Clinic, Portland, OR. 11. Minnesota Institute for Minimally Invasive Surgery, Cuyuna Regional Medical Center, Crosby, MN. 12. Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA. 13. Department of Surgery, University Hospitals Case Medical Center, Cleveland, OH. 14. Department of Surgery, University of Nevada School of Medicine, Las Vegas, NV. 15. Esophageal and Lung Institute, Allegheny Health Network, Pittsburgh, PA. 16. Department of Surgery, Gundersen Health System, La Crosse, WI. 17. Department of Surgery, Medical College of Wisconsin, Milwaukee, WI.
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.
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.
Authors: Matías Mihura Irribarra; Sandra Blitz; Candice L Wilshire; Anee Sophia Jackson; Alexander S Farivar; Ralph W Aye; Christy M Dunst; Brian E Louie Journal: J Gastrointest Surg Date: 2019-03-15 Impact factor: 3.452
Authors: Saurabh Chandan; Babu P Mohan; Shahab R Khan; Lokesh K Jha; Amaninder J Dhaliwal; Mohammad Bilal; Muhammad Aziz; Andrew Canakis; Sumant Arora; Sarah Malik; Lena L Kassab; Suresh Ponnada; Ishfaq Bhat; Alexander T Hewlett; Neil Sharma; Stephanie McDonough; Douglas G Adler Journal: Endosc Int Open Date: 2021-04-13