Linx more effective than PPIs for treating regurgitation in GERD

CHICAGO — Magnetic sphincter augmentation using the Linx device was more effective than proton pump inhibitor therapy for treating regurgitation in patients with GERD, according to interim data from the Caliber trial presented at Digestive Disease Week.

“Regurgitation is a common symptom in GERD. It occurs in up to 80% of patients [and] it doesn’t respond as well to medication as does heartburn, so it’s often frustrating to deal with [using] medication,” Reginald Bell, MD, of the SurgOne Foregut Institute in Englewood, Colorado, said during his presentation.

Reginald Bell

Thus, Bell and colleagues sought to evaluate the effect of magnetic sphincter augmentation using the Linx device (Torax Medical), “a laparoscopic outpatient procedure wherein a bracelet of magnetic beads is placed ... around the lower esophageal sphincter,” he said.

Investigators compared double-dose PPI therapy and magnetic sphincter augmentation for the treatment of GERD patients from 22 centers who reported moderate-to-severe regurgitation despite treatment with once daily 20 mg omeprazole.

They randomly assigned 50 patients to undergo magnetic sphincter augmentation and 100 patients to receive double-dose PPIs at 20 mg twice per day for 6 months, and invited patients in the PPI group to crossover to the magnetic sphincter augmentation group if their symptoms persisted.

While the investigators will continue follow-up through 1 year, Bell reported interim 6-month data that was available for 25 patients who underwent magnetic sphincter augmentation and 55 patients who received double-dose PPIs.

Among patients treated with magnetic sphincter augmentation, 92.6% experienced resolution of their moderate or severe regurgitation compared with 8.6% of patients treated with double-dose PPIs.

Further, 88.9% of patients treated with magnetic sphincter augmentation achieved more than a 50% reduction in their GERD health-related quality of life scores at 6 months, compared with 6.8% of the patients treated with double-dose PPIs. Bell noted that the average GERD HR-QOL symptom score improved significantly from baseline to 6 months after magnetic sphincter augmentation, but not after double-dose PPIs.

Additionally, 92.3% of the patients treated with magnetic sphincter augmentation had a normal number of reflux episodes — defined as fewer than 57 — compared with 36% of the patients treated with double-dose PPIs.

One patient treated with magnetic sphincter augmentation was rehospitalized for an esophageal spasm that was successfully treated with medication. No serious adverse events occurred in the PPI group.

“This study at least in preliminary analysis has demonstrated superiority of the magnetic sphincter augmentation procedure using the Linx device compared with twice daily PPI therapy in control of regurgitation, control of heartburn and control of gastroesophageal reflux measured objectively,” Bell concluded. – by Adam Leitenberger

Reference:

Bell R, et al. Abstract #874i. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosures: Bell reports consulting for Torax Medical, which supported the study.