Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.
Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.
Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.
In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.
MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.
No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.
The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.
“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.
Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.
SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.