Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes

Abstract

Background Transoral incisionless fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE) is a new intervention for the treatment of the gastroesophageal reflux disease (GERD). The aim of this study was to assess the 12-month clinical, functional, and endoscopic effects of TIF by MUSE. Methods Patients undergoing MUSE completed the GERD-Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires, and underwent endoscopy, esophageal 24-hour pH-impedance recording, and high resolution manometry (HRM) before the TIF procedure and 12 months later, or after 6 months for HRM. Results Among the 37 patients treated, esophageal intubation was not possible in one and esophageal perforation occurred in another. Clinical and endoscopic follow-up at 12 months was completed in 20 patients, with significant improvements in GERD-HRQL, RSI, heartburn, regurgitation scores, and proton pump inhibitor (PPI) consumption observed. One patient required surgery for persisting symptoms. Functional follow-up was possible in 13 patients and showed no significant improvements in the analyzed parameters. Conclusions TIF with MUSE significantly improved symptoms at 1-year follow-up, allowing the consumption of PPIs to be stopped or halved in 90 % of patients.

Endoscopic anti-reflux therapy for gastroesophageal reflux disease

“…TIF 1.0 has been discontinued because TIF 2.0 achieves much better results[ 36 ]. The improved procedure has been evaluated in nine noncomparative studies[ 38 - 46 ] and in five RCTs[ 47 - 51 ] comprising 886 patients with moderate GERD without a large HH, Los Angeles grade C or D esophagitis, or Barrett´s esophagus (Table 3 ). Clinical success rates ranged from a modest 50% at 12 mo to as high as 92% at 10 years.…”

Chinese expert consensus on gastroesophageal reflux disease in 2020

“…One study followed up 37 patients with GERD for 1 year after TIF 116 . The results showed that the scores for QoL, heartburn and regurgitation, and the reflux symptom index decreased; 65% of patients discontinued PPI completely and 25% reduced their dose of PPI by 50%.…”

Gastroesophageal reflux disease: recent innovations in endoscopic assessment and treatment

“…Additionally, whether a combination of two kinds of invasive therapies can result in a double-overlapping effect and compensate for individual shortcomings remains unclear. A recent trial investigated the effect of a combination of MUSE TM and TIF, and satisfactory results showed that TIF with MUSE TM obviously improved the GERD-related symptoms; >90% of patients reduced or discontinued PPIs use [ 67 ].…”