Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation
| Autor: | Jeffrey S Mandel, Reginald Bell, Walter Kurt Birkenhagen, Leena Khaitan, George Kevin Gillian, Paul A. Taiganides, Jon C. Gould, Shanu N. Kothari, C. Daniel Smith, Christy M. Dunst, Blair A. Jobe, C. Christopher Smith, Howard M. McCollister, Shawn Tsuda, Brian E. Louie, Kyle A. Perry, John C. Lipham |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Esophageal pH Monitoring Time Factors Prosthesis Design Esophageal Sphincter Lower Young Adult 03 medical and health sciences 0302 clinical medicine Quality of life Swallowing Surveys and Questionnaires Internal medicine medicine Humans Prospective Studies Adverse effect Prospective cohort study Aged medicine.diagnostic_test business.industry Reflux Middle Aged medicine.disease Deglutition Treatment Outcome medicine.anatomical_structure 030220 oncology & carcinogenesis Gastroesophageal Reflux Magnets GERD Sphincter Female 030211 gastroenterology & hepatology Surgery Esophageal pH monitoring business Follow-Up Studies |
| Zdroj: | Annals of Surgery. 270:302-308 |
| ISSN: | 1528-1140 0003-4932 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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