5-year study confirms long-term safety, efficacy of LINX procedure for GERD
Magnetic sphincter augmentation with the LINX Reflux Management System was shown to provide safe and sustained control of GERD symptoms at 5 years in a recent study.
The LINX (magnetic sphincter augmentation, Torax) procedure is an alternative to fundoplication that entails a minimally invasive laparoscopic implantation of a small device made of interlinked titanium beads with magnetic cores, which prevents reflux by augmenting the esophageal sphincter’s barrier function, according to a press release.
“This study demonstrates the LINX procedure provides significant and durable improvement in heartburn, regurgitation, [proton pump inhibitor] independence and quality of life,” Robert Ganz, MD, FASGE, chief of gastroenterology, Abbott Northwestern Hospital, and associate professor of medicine, University of Minnesota, said in the press release. “Patients can now have a relatively simple procedure to restore their sphincter function and avoid the invasiveness required in fundoplication procedures. In my view, LINX represents the next generation of anti-reflux treatment.”
The FDA approved LINX for GERD in 2012 based on 2-year results from this prospective, multicenter, single-arm study in which patients served as their own controls. Ganz and colleagues have now reported the final results through 5 years of follow up.
One hundred adult GERD patients (52% men; median age, 53 years [range, 18-75 years]) with at least a 6-month history of GERD, partial response to daily proton pump inhibitor (PPI) therapy and confirmed pathologic esophageal acid exposure, underwent the LINX procedure at 14 centers in the U.S. and The Netherlands. Eighty-five patients were re-evaluated at 5 years for quality of life, reflux control, PPI use and side effects.
Based on predefined criteria, long-term efficacy was maintained; at year 5, 83% (95% CI, 73%-91%) of patients had a 50% reduction in GERD Health Related Quality of Life (HRQL) scores, and 89.4% (95% CI, 81%-95%) had at least a 50% reduction in average daily PPI dose.
All patients used PPIs daily at baseline, while 15.3% did at year 5.
At baseline, 89% of patients had moderate or severe heartburn, which decreased to 11.9% at 5 years; likewise, moderate or severe regurgitation decreased from 57% to 1.2% without PPI use, and patient dissatisfaction decreased from 95% before treatment to 7.1% at 5 years (all P < .001).
Median GERD-HRQL scores at baseline were 27 without PPIs and 11 with PPIs, which decreased to 4 at 5 years (P < .001).
All patients reported being able to belch and vomit if needed, while bothersome dysphagia increased from 5% at baseline to 6% at 5 years, and bothersome gas-bloat decreased from 52% to 8.3% (P < .001).
No device erosions, migrations, or malfunctions occurred, and no new safety concerns emerged since the last report at 3 years of follow-up. The device was removed in seven patients.
“In conclusion, this study showed that patients with chronic GERD and failed long-term PPI therapy benefited from surgical intervention with magnetic sphincter augmentation,” the researchers wrote. “Long-term safety and efficacy have bene validated for this procedure. It should be considered a first-line therapy for patients and physicians seeking a fundic-sparing antireflux procedure.” – by Adam Leitenberger
Disclosures: This study was funded by Torax Medical. Ganz reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.