Compared with proton pump inhibitor (PPI) therapy, magnetic sphincter augmentation (MSA) was far superior for reducing regurgitation in regurgitative gastroesophageal reflux disease (GERD), and relief is sustained over 12 months, according to a study published in Clinical Gastroenterology and Hepatology.
Regurgitative GERD refractive to medical treatment is typical and cause by mechanical failure of the anti-reflux barrier. In this prospective, double-arm, controlled, randomized, crossover study which enrolled 152 participants from 21 clinical sites in the United States between July 2015 and February 2017, the researchers compared the effects of MSA with those of PPIs in patients with regurgitation and GERD. All participants had moderate-to-severe regurgitation symptoms, had been taking PPIs once daily for at least 8 weeks, and had a body mass index <35, normal esophageal motility, abnormal pH testing results, and absence of Los Angeles Classification Grade C/D esophagitis or Barrett’s esophagus. At 6- and 12-month follow-up, participants were administered the Reflux Disease Questionnaire 31, the GERD–Health-Related Quality of Life 32, standardized quality of life surveys, clinical tests, and specific questions regarding flatulence, diarrhea, bloating, and baseline medication use.
Participants were randomly assigned 2:1 to twice-daily PPI therapy (PPI cohort) with omeprazole 20 mg (n=102) or laparoscopic MSA (MSA cohort; n=50), and then efficacy was measured at 6 months. For the second half of the study, PPI participants with persistent regurgitation were offered laparoscopic MSA (MSA crossover cohort), and the rest had their omeprazole dosage reduced to 20 mg once daily (Step-Down cohort). At 12 months, participants repeated quality of life assessments and were evaluated for adverse events, regurgitation, esophageal acid exposure, and foregut scores.
Only 19% (8 of 43) patients in the PPI cohort achieved regurgitation control at 12 months (P <.001). Of the 79 participants who completed this phase of treatment, 31 moved into the MSA crossover cohort. Similar outcomes were seen for both the MSA cohort participants and the participants in the MSA crossover cohort (n=75). MSA resulted in regurgitation control in 96% of these participants (72 of 75), and this control was independent of preoperative PPI response. Sixty-eight percent (51 of 75) of participants reported complete elimination of regurgitation, compared with 2% of the Step-Down cohort, with the remainder reporting mild regurgitation (P <.001).
Among the 75 participants given MSA, 81% (n=61) showed improvements in baseline GERD–Health-Related Quality of Life (>50%) at 6 months post-implantation compared with 96% (42 of 44) at 12 months post-implantation (P <.001). Ninety-one percent (68 of 75) of participants receiving MSA discontinued daily PPIs at study completion. The proportion of participants with dysphagia decreased from 15% at baseline to 11% (8 of 75) at 6 months post-MSA implantation and 7% (3 of 44) at 12 months post-implantation (P =.0184). The proportion of participants with bloating while taking PPIs decreased from 55% at baseline to 15% (11 of 75) at 6 months post-MSA implantation and 27% (12 of 44) at 12 months post-implantation (P =.0416). MSA was not associated with any erosions, migrations, device explants, or peri-operative events, and 70% (48 of 69) achieved pH normalization at study completion.
Study investigators conclude, “The final results of this RCT found that MSA was superior to bid PPI therapy in patients with moderate-to-severe regurgitation despite daily PPI therapy … Regurgitation and associated heartburn symptoms responded to MSA even when completely non-responsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms. Dysphagia improved by QOL measures; bloating and gas were not significant after MSA. MSA is an effective surgical treatment option for patients with medically-refractory regurgitative GERD.”
Disclosure: This clinical trial was supported by Ethicon, Inc. Please see the original reference for a full list of authors’ disclosures.
Bell R, Lipham J, Louie BE, et al. Magnetic sphincter augmentation superior to proton pump inhibitors for regurgitation in a 1-year randomized trial [published online September 10, 2019]. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2019.08.056