ULTRASOUND-GUIDED TRANSORAL FUNDOPLICATION FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE: RESULTS UP TO 24 MONTHS FROM A SINGLE-CENTER PROSPECTIVE STUDY

Background and Aim: Transoral incisionless fundoplication (TIF) with the MUSE sys tem is a new ultrasound-guided intervention for the treatment of gastroesophageal reflux disease (GERD). Aim of this study was to assess the safety of TIF with MUSE and its effects on clinical, pathophysiological and endoscopic results. Methods: TAF with MUSE was performed in a series of consecutive patients (pts) with symptomatic GERD, in a single-center study. All pts underwent GERD-Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires, upper gastrointes tinal endoscopy, 24h esophageal pH-impedance recording and high-resolution esophageal manometry (HRM) before TIF, 6 months and 12 months after TAF (HRM only before TIF and after 6 months). Symptomatic questionnaires and proton pump inhibitors (PPIs) consumption were also investigated at 24 months. Data were compared to baseline using Fisher’s exact test for frequencies and Wilcoxon signed rank test for nonparametric data. Results: Thirty-seven pts underwent TIF (21 males). In two cases it was not possible to perform esophageal intubation with the endostapler. TIF was successful in all other cases. Eleven pts had grade A esopha gitis, while 26 pts had NERD (pathological pH-impedance recording). Esophageal perforation occurred in two cases (overall complication rate: 5.1%). Clinical follow up was completed in 29, 23 and 16 pts at 6, 12 and 24 months, respectively. One pts requested surgery six months after TIF for inefficacy of the procedure on symptoms. Compared to baseline, median GERD-HRQL and RSI scores and PPIs consumption were significantly improved at 6, 12 and 24 months after TIF, respectively. Endoscopic follow-up was completed in 28 and 22 pts at 6 and 12 months, with 5 and 4 pts who had esophagitis, respectively. Pathophysiological follow-up was completed in 19 and 15 pts at 6 and 12 months, respectively. Compared to baseline, 6 months after TIF there were a significantly lower number of acid, proximal and total refluxes, detected by esophageal impedance and a significantly increase of lower esophageal sphincter length, esophagogastric junction contractile integral (EGJ-CI) and of peristaltic waves rate, detected by HRM. Conclusion: Our data showed TIF by MUSE safe and effective, allowing a significant improvement of symptom scores and a significant reduction of PPIs consumption and refluxes number, detected by esophageal impedance.