Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial - 19/12/18

Doi : 10.1016/j.gie.2018.07.007

Reginald Bell, MD ^1,^⁎, John Lipham, MD ², Brian Louie, MD ³, Valerie Williams, MD ⁴, James Luketich, MD ⁵, Michael Hill, MD ⁶, William Richards, MD ⁷, Christy Dunst, MD ⁸, Dan Lister, MD ⁹, Lauren McDowell-Jacobs, MD ¹⁰, Patrick Reardon, MD ¹¹, Karen Woods, MD ¹¹, Jon Gould, MD ¹², F. Paul Buckley, MD ¹³, Shanu Kothari, MD ¹⁴, Leena Khaitan, MD ¹⁵, C. Daniel Smith, MD ¹⁶, Adrian Park, MD ¹⁷, Christopher Smith, MD ¹⁸, Garth Jacobsen, MD ¹⁹, Ghulam Abbas, MD ²⁰, Philip Katz, MD ²¹
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

^∗Reprint requests: Reginald C.W. Bell, MD, Institute of Esophageal and Reflux Surgery, 499 E Hampden Ave, Suite 290, Englewood, CO 80113.Institute of Esophageal and Reflux Surgery499 E Hampden Ave, Suite 290EnglewoodCO80113

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.)

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Graphical abstract

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Abbreviations : BID, FSQ, GERD-HRQL, ITT, LES, MSA, PPI, RDQ

Plan

Efficacy endpoints and outcomes

	DISCLOSURE: All authors are grant recipients from Torax Medical; A. Park, research grant support from Stryker Endoscopy.
	See CME section; p. 188.

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Vol 89 - N° 1

P. 14 - janvier 2019 Retour au numéro

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Refractory regurgitation responds to magnetic sphincter augmentation but not to increased proton pump inhibitor dose
Kenneth R. DeVault

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Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial - 19/12/18

Abstract

Background and Aims

Methods

Results

Conclusion

Graphical abstract

Plan

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