Lasting Safety, Efficacy for Magnetic Device in GERD
Lasting improvements in health-related QoL with magnetic sphincter augmentation device
TUESDAY, May 3, 2016 (HealthDay News) -- For patients with gastroesophageal reflux disease (GERD), a magnetic device is safe and effective for augmenting lower esophageal sphincter function over a five-year follow-up period, according to a study published in the May issue of Clinical Gastroenterology and Hepatology.
Robert A. Ganz, M.D., from Minnesota Gastroenterology PA in Plymouth, and colleagues conducted a prospective study of the safety and efficacy of a magnetic sphincter augmentation device in patients with GERD. Participants, from 14 centers in the United States and the Netherlands, were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure. Eighty-five patients were followed for up to five years.
The researchers observed no device erosions, migrations, or malfunctions during the follow-up period. The median GERD-health-related quality of life scores were 27 and 11 in patients not taking and on PPIs, respectively, at baseline; this score decreased to 4 at five years after device placement. At baseline, all patients used PPIs, compared with 15.3 percent at five years. Moderate or severe regurgitation occurred in 57 and 1.2 percent of subjects at baseline and at five years. All patients were able to belch and vomit if necessary. Bothersome gas-bloat decreased from 52 percent at baseline to 8.3 percent at five years.
"These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD," the authors write.
Several authors disclosed financial ties to Torax Medical, which manufactures the magnetic sphincter augmentation device and funded the study.