Patients with medically refractory GERD reported that magnetic sphincter augmentation sustained regurgitation control over 12 months, according to study results.
Reginald C.W. Bell, MD, of the Institute of Esophageal and Reflux Surgery, and colleagues wrote that regurgitation persists in about 13% of patients with GERD despite treatment with proton pump inhibitors.
“PPIs do nothing to restore a weak [lower esophageal sphincter] and are frequently ineffective in alleviating regurgitation despite the common misperception that medications are sufficient therapy,” they wrote. “Anti-reflux surgery is the most effective therapy to control medically refractory regurgitative symptoms.”
The study was a 12-month follow-up to the CALIBER trial, which found the superiority of magnetic sphincter augmentation (MSA) over PPIs during a 6-month period.
Researchers randomly assigned patients with moderate to severe regurgitation despite once-daily PPI therapy (assessed by Foregut Symptom Questionnaire; n = 152) to undergo MSA (n = 50) or receive twice-daily PPIs (n = 102). Patients also responded to the foregut-specific reflux disease questionnaire and a GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence and medication use at baseline, and at 6 and 12 months.
After 6 months of PPI therapy, investigators also offered MSA to patients with persistent moderate to severe regurgitation and excess reflux episodes. Patients in the initial MSA group and patients who crossed over experienced similar outcomes.
Bell and colleagues found that MSA helped provide regurgitation control in 72 of 75 patients who underwent the procedure independent of their preoperative response to PPIs, whereas only eight of 43 patients who underwent PPI therapy reported control of their regurgitation.
Additionally, 81% of patients who underwent MSA also experienced a greater than 50% improvement to GERD health-related quality of life scores, and 91% discontinued daily PPI use.
From the beginning of the study to 1 year after MSA, the proportion of patients with dysphagia (15% to 7%), bloating (55% to 25%) and esophageal acid exposure (10.7% to 1.3%) all decreased (combined P < .001). The procedure was also not associated with any perioperative events, device explants, erosions or migrations.
“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,” Bell and colleagues wrote. “MSA is an effective surgical treatment option for patients with medically refractory regurgitative GERD.” – by Alex Young
Disclosures: Bell reports he received honoraria from Ethicon for teaching services. Please see the study for all other authors’ relevant financial disclosures.