Reginald Bell1, John Lipham2, Brian E Louie3, Valerie Williams4, James Luketich5, Michael Hill6, William Richards7, Christy Dunst8, Dan Lister9, Lauren McDowell-Jacobs10, Patrick Reardon11, Karen Woods12, Jon Gould13, F Paul Buckley14, Shanu Kothari15, Leena Khaitan16, C Daniel Smith17, Adrian Park18, Christopher Smith19, Garth Jacobsen20, Ghulam Abbas21, Philip Katz22. 1. Institute of Esophageal and Reflux Surgery, Englewood, Colorado. Electronic address: reg@iersurgery.com. 2. Department of Surgery, University of Southern California, Los Angeles, California. 3. Division of Thoracic Surgery, Swedish Medical Center, Seattle, Washington. 4. Thoracic Surgery Department, St. Elizabeth's Healthcare, Edgewood, Kentucky. 5. Division of Thoracic Surgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania. 6. Department of Surgery, Adirondack Medical Center and Adirondack Surgical Group, Saranac Lake, New York. 7. Department of Surgery, University of South Alabama, Mobile, Alabama. 8. Department of Surgery, Oregon Clinic, Portland, Oregon. 9. Arkansas Heartburn Treatment Center, Baptist Health Medical Center, Heber Springs, Arkansas. 10. Department of Surgery, Knox Community Hospital, Mount Vernon, Ohio. 11. Department of Surgery, Houston Methodist Hospital, Houston, Texas. 12. Department of Medicine, Houston Methodist Hospital, Houston, Texas. 13. Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin. 14. Department of Surgery and Perioperative Care, University of Texas at Austin, Austin, Texas. 15. Department of Surgery, Prisma Health, Greenville, South Carolina. 16. Department of Surgery, Digestive Health Institute, University Hospitals, Cleveland Medical Center, Cleveland, Cleveland, Ohio. 17. Esophageal Institute of Atlanta, Atlanta, Georgia. 18. Department of Surgery, Anne Arundel Health System and Johns Hopkins Medicine, Annapolis, Maryland. 19. Albany Surgical PC, Albany, Georgia. 20. Department of Surgery, University of California, San Diego, San Diego, California. 21. Division of Thoracic Surgery, West Virginia University School of Medicine, Morgantown, West Virginia. 22. Department of Gastroenterology, Weill Cornell Medicine, New York, New York.
Abstract
BACKGROUND & AIMS: Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS:Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS: Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS: In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.
RCT Entities:
BACKGROUND & AIMS:Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS:Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS:Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS: In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.
Authors: Philip O Katz; Kerry B Dunbar; Felice H Schnoll-Sussman; Katarina B Greer; Rena Yadlapati; Stuart Jon Spechler Journal: Am J Gastroenterol Date: 2022-01-01 Impact factor: 10.864
Authors: Shahin Ayazi; Andrew D Grubic; Ping Zheng; Ali H Zaidi; Katrin Schwameis; Adam C Alleyne; Brittney M Myers; Ashten N Omstead; Blair A Jobe Journal: Surg Endosc Date: 2020-10-13 Impact factor: 4.584