Robert A Ganz1, Steven A Edmundowicz2, Paul A Taiganides3, John C Lipham4, C Daniel Smith5, Kenneth R DeVault6, Santiago Horgan7, Garth Jacobsen7, James D Luketich8, Christopher C Smith9, Steven C Schlack-Haerer10, Shanu N Kothari11, Christy M Dunst12, Thomas J Watson13, Jeffrey Peters14, Brant K Oelschlager15, Kyle A Perry16, Scott Melvin16, Willem A Bemelman17, André J P M Smout18, Dan Dunn19. 1. Minnesota Gastroenterology PA, Plymouth, Minnesota. Electronic address: rganz@mngastro.com. 2. Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri. 3. Knox Regional Heartburn Treatment Center, Mount Vernon, Ohio. 4. Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California. 5. Department of Surgery, Mayo Clinic, Jacksonville, Florida. 6. Department of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida. 7. Department of Surgery, University of California at San Diego, San Diego, California. 8. Division of Thoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania. 9. Southern Reflux Center at Albany Surgical Center, Albany, Georgia. 10. Department of Gastroenterology, Gundersen Health System, LaCrosse, Wisconsin. 11. Department of Surgery, Gundersen Health System, LaCrosse, Wisconsin. 12. Gastrointestinal and Minimally Invasive Surgery Division, The Oregon Clinic, Portland, Oregon. 13. Department of Surgery, University of Rochester School of Medicine and Dentistry, Rochester, New York. 14. University Hospitals, Cleveland, Ohio. 15. Department of Surgery, University of Washington, Seattle, Washington. 16. Department of Surgery, The Ohio State University, Columbus, Ohio. 17. Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 18. Division of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 19. Division of Surgery, Abbott-Northwestern Hospital, Minneapolis, Minnesota.
Abstract
BACKGROUND & AIMS: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. METHODS: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. RESULTS: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. CONCLUSIONS: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.
BACKGROUND & AIMS: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. METHODS: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. RESULTS: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. CONCLUSIONS: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.
Authors: James M Tatum; Evan Alicuben; Nikolai Bildzukewicz; Kamran Samakar; Caitlin C Houghton; John C Lipham Journal: Surg Endosc Date: 2018-07-13 Impact factor: 4.584
Authors: Heather F Warren; Lisa M Brown; Matias Mihura; Alexander S Farivar; Ralph W Aye; Brian E Louie Journal: Surg Endosc Date: 2017-06-29 Impact factor: 4.584