Karim S. Trad
Transoral incisionless fundoplication with the EsophyX device was successful in reducing GERD symptoms through 5 years of follow-up, according to a new study published in Surgical Innovation.
Karim S. Trad, MD, clinical professor of surgery at George Washington University School of Medicine and Health Services, and colleagues conducted the study to address any remaining questions about the therapeutic durability of transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions).
“This report offers conclusive evidence that the early benefits and safety reported with the TIF 2.0 procedure in previous shorter-term prospective multi-center randomized reports and prospective multi-center observational studies are sustained at 5 years follow-up — a milestone that has never been achieved by previous endoluminal GERD therapies,” Trad said in a press release. “The elimination of troublesome symptoms was maintained without significant deterioration over time, with a low re-operation rate of 5% after 5 years. Going forward, the endoscopic TIF 2.0 procedure should be considered as a first-line therapy in carefully selected patients resistant or intolerant to PPIs.”
TIF using the EsophyX device reconstructs the gastroesophageal valve to restore barrier function and prevent reflux.
For the trial, Trad and colleagues randomly assigned 63 patients with chronic GERD symptoms to undergo either TIF (n = 40) or PPI therapy (n = 23), and after 6 months, all the remaining 21 PPI patients opted to undergo TIF.
After a 4-year follow-up, 89% of patients reported that they no longer experienced regurgitation, while 87% reported atypical symptom elimination, as previously reported by Healio Gastroenterology and Liver Disease.
The new data showed that after 5 years, 86% of patients reported the elimination of troublesome regurgitation, and 80% reported elimination of troublesome atypical symptoms.
“EndoGastric Solutions has consistently invested in the highest-grade research to validate the long-term effectiveness and health care economics of the TIF 2.0 procedure,” Skip Baldino, president and CEO of EndoGastric Solutions said in the press release. “We are very encouraged that these investments continue to confirm that the TIF 2.0 procedure is a safe, efficacious and viable endoscopic alternative to PPIs and more invasive anti-reflux surgery options.” – by Alex Young
Disclosures: Trad reports he received honoraria from EndoGastric Solutions. Baldino is employed by EndoGastric Solutions.