Affiliation:
1. Division of Gastroenterology and Gastrointestinal Endoscopy IRCCS Ospedale San Raffaele Milan Italy
2. UniSR‐Social.Lab, Faculty of Psychology Vita‐Salute San Raffaele University Milan Italy
3. Department of Social and Developmental Psychology “La Sapienza” University Rome Italy
Abstract
ObjectivesWe compared the efficacy and safety of transoral incisionless fundoplication (TIF) with the EsophyX2.0 and MUSE systems for treatment of gastroesophageal reflux disease (GERD).MethodsTIF outcomes from prospective protocols (Esophy2.0X: 2007–2012; MUSE: 2015–2019) were retrospectively compared regarding technical success, moderate/severe adverse events, morpho‐functional findings up to 1 year, and clinical outcomes up to 3 years. Inclusion criteria were: (i) at least 6‐month symptomatic GERD, full/partial response to proton pump inhibitors (PPI), esophagitis, and nonerosive reflux disease/hypersensitive esophagus (both protocols); (ii) hiatal hernia <3 cm (Esophy2.0X) and ≤2.5 cm (MUSE); and (iii) Barrett's esophagus <3 cm (MUSE).ResultsIn the 50 EsophyX2.0 and 46 MUSE procedures, technical success and adverse event rates were similar, but MUSE‐related adverse events (4.4%) were life‐threatening. At 12 months, hiatal hernia recurred more frequently after EsophyX2.0 (P = 0.008). At 6 months, significantly fewer total and acid refluxes were reported after both TIF, but not more significantly at 1 year. Symptoms improved after both TIF up to 1 year (P < 0.0001), but to a greater extent in MUSE patients up to 3 years (P < 0.0001 vs. P < 0.01 for EsophyX2.0). The rates of 3‐year off‐PPI therapy patients were 73.5% in the MUSE and 53.3% in the EsophyX2.0 series (P = 0.069).ConclusionAlthough no conclusion could be drawn from this limited study, the MUSE technique seemed more effective in the long term in patients with hiatal hernia; however, there were more severe adverse events than with EsophyX2.0.