Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy

Abstract

Transoral incisionless fundoplication (TIF) using the EsophyX device has been shown to be effective and safe in patients with Gastroesophageal reflux disease (GERD); however, the subset of patients that would mostly benefit from this technique remains unknown. The aim of this study was to evaluate the long-term efficacy and safety of the TIF procedure in patients with a history of esophagitis or proven chronic GERD who have achieved symptom control with the administration of proton pump inhibitors (PPIs) but did not wish to continue receiving medications for life. Forty-five patients with typical GERD symptoms (heartburn, regurgitation, chest pain) and a history of esophagitis grade A and B or proven GERD by esophageal pH monitoring underwent TIF using Esophyx. Patients with eosphagitis C and D or those with large hiatal hernias (>2 cm in length) were excluded. The primary clinical effectiveness measure was GERD symptom elimination at follow up based on normalization of the GERD health related quality of life (GERD-HRQL) questionnaire. After a median follow up period of 59 months (36-75) the median GERD-HRQL scores improved significantly from 27 (2-45) at baseline to 4 (0-26) (P < 0.001) in the 44 patients completing the study. Heartburn was eliminated in 12 out of the 21 patients included (57.1%), regurgitation was eliminated in 15 out of the 17 patients included (88.2%) and finally chest pain was eliminated in 5 patients out of the six patients included (83.3%). Overall, 32 patients out of the 44 patients (72.7%) that completed the study follow up reported elimination of their main symptom, without the need for PPI administration (none PPI usage). Furthermore, six more patients (13.6%), five with heartburn, and one with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), while six more patients (four with heartburn, one with regurgitation, and one with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). Creation of an esophagogastric fundoplication using the EsophyX device abolished reflux symptoms in 72.7% of PPI-responsive GERD patients at a median 59 month follow-up.

Long-term reported outcomes of transoral incisionless fundoplication: an 8-year cohort study

“…This suggests that patients experienced durable improvement in disease-specific quality of life following TIF, although most patients did require daily PPI therapy to maintain these improvements in the long-term. Studies have shown that TIF is a promising endoscopic procedure with low adverse events, nearly non-existent chronic side effects, and encouraging short- and intermediate-term efficacy [9, 10, 14]. Although we did not directly study chronic side effects in this cohort, side effects of dysphagia, odynophagia, and gas-bloat were rare as assessed by the GERD-HRQL questionnaire.…”

pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication

“…Durability of the TIF 2.0 procedure has been demonstrated in multiple studies. 3–5,7,9,30–33 However, most reflux patients do present with a hiatal defect > 2 cm. The transoral incisionless fundoplication has advantages over laparoscopic fundoplication due to the avoidance of the bloat syndrome and its reproducibility.…”

Evolution and Outcome of Eight Patients Undergoing Treatment of Gastroesophageal Disease by Esophyx

“…After one year follow-up, patients were reported to be off PPIs in 25% of cases. EsophyX offers advantages over surgery [14][15][16][17], in particular the absence of incision and thus a faster remission, as well as fewer complications in the short and long term compared to the undesirable side effects associated with laparoscopic anti-reflux procedure compromising the results in some patients. Currently published literature suggests that incidence of persistent side effects after TIF is low [4][5][6].…”