Reginald Bell1, John Lipham2, Brian Louie3, Valerie Williams4, James Luketich5, Michael Hill6, William Richards7, Christy Dunst8, Dan Lister9, Lauren McDowell-Jacobs10, Patrick Reardon11, Karen Woods11, Jon Gould12, F Paul Buckley13, Shanu Kothari14, Leena Khaitan15, C Daniel Smith16, Adrian Park17, Christopher Smith18, Garth Jacobsen19, Ghulam Abbas20, Philip Katz21. 1. Institute of Esophageal and Reflux Surgery, Englewood, Colorado, USA. 2. Department of Surgery, University of Southern California, Los Angeles, California, USA. 3. Swedish Cancer Institute and Medical Center, Seattle, Washington, USA. 4. St. Elizabeth's Healthcare, Edgewood, Kentucky, USA. 5. University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA. 6. Adirondack Surgical Group, Saranac Lake, New York, USA. 7. University of South Alabama, Mobile, Alabama, USA. 8. The Oregon Clinic, Portland, Oregon, USA. 9. Arkansas Heartburn Treatment Center, Heber Springs, Arkansas, USA. 10. Knox Community Hospital, Mount Vernon, Ohio, USA. 11. Houston Methodist, Houston, Texas, USA. 12. Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 13. The University of Texas at Austin, Austin, Texas, USA. 14. Gundersen Health System, La Crosse, Wisconsin, USA. 15. University Hospitals, Cleveland, Cleveland, Ohio, USA. 16. Esophageal Institute of Atlanta, Atlanta, Georgia, USA. 17. Anne Arundel Health System, Annapolis, Maryland, USA. 18. Albany Surgical PC, Albany, Georgia, USA. 19. University of California, San Diego, San Diego, California, USA. 20. West Virginia University School of Medicine, Morgantown, West Virginia, USA. 21. Weill Cornell Medicine, New York, USA.
Abstract
BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS:One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION:Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).
RCT Entities:
BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS: One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSApatients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSApatients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION:Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).
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