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EsophyX-2 achieves short-term improvement of antireflux barrier, no long-term reflux control
Transoral incisionless fundoplication with the Esophyx-2 device improved antireflux barrier in the short-term for patients with chronic GERD, but failed to provide long-term objective reflux control, according to new study data.
Aiming to compare the efficacy of transoral incisionless fundoplication (TIF) with the Esophyx-2 device (TIF2; EndoGastric Solutions) vs. proton pump inhibitors in patients with chronic GERD who were well controlled on daily PPI therapy, Bart P. L. Witteman, MD, PhD, from Maastricht University Medical Centre and Rijnstate Hospital in the Netherlands, and colleagues performed a randomized controlled trial involving 60 such patients (62% men) in 2011. Patients were randomly assigned to undergo TIF (n = 40) or continue on PPIs (n = 20), and crossover to TIF for the PPI group was allowed at 6 months.
This trial “tested the hypothesis that TIF would be as effective as PPI treatment in controlling GERD symptoms, esophageal acid exposure and esophagitis, but would be more effective in controlling reflux and thereby improve the quality of life,” Witteman told Healio Gastroenterology.
At 6 months 55% of patients in the TIF group had at least 50% improvement in symptom-related quality of life compared with 5% of the PPI group (P < .001). Greater improvement of esophageal acid exposure was achieved in the PPI group, but there was no significant difference between groups, and improvement was comparable to baseline. Normalization of pH was 50% for the TIF group compared with 63% for PPI. TIF2 increased lower esophageal sphincter resting pressure compared with PPI (P = .004), but improvement in number of reflux episodes at impedance measurements was not significant.
At 6 months, all patients in the PPI group selected to crossover to TIF. Quality of life remained improved after TIF2 at 1 year compared with baseline (P < .05); however, esophageal acid exposure was not significantly improved. Furthermore, pH normalization was achieved in only 29% at 1 year and 61% resumed PPI therapy.
“Although a short-term improvement of the anti-reflux barrier was found, which supports the validity of the concept of TIF2, no long-term reflux control was achieved and therefore, the study was terminated after interim analysis,” Witteman said. “The endoscopically created anti-reflux barrier deteriorated with increased follow-up duration and therefore, in this form, TIF2 is no equivalent alternative for PPIs in GERD treatment, even in this highly selected population. A next generation endoscopic fundoplication technique may improve outcomes, if equipped with a more solid suturing or stapling mechanism to better withstand intra-abdominal traction forces and warrant durability.” – by Adam Leitenberger
Disclosure: The researchers report no relevant financial disclosures.
Editor’s Note: This article was updated on April 7 to reflect additional information.