Single operator learning curve and insights into the adoption of transoral incisionless fundoplication 2.0 in the UK

Transoral incisionless fundoplication (TIF) 2.0 using the EsophyX device is an increasingly recognized endoscopic treatment for symptomatic gastro-esophageal reflux disease (GORD). However, to date, there is no evidence on the learning curve for procedural efficiency and adoption into routine practice. In this UK-based, retrospective cohort study, we describe our single-operator learning curve and experience on procedural implementation following the introduction of TIF. Consecutive patients undergoing TIF were analyzed between 2019 and 2024. Patient demographics, baseline reflux assessments, and procedural details were recorded. The primary outcome was procedural efficiency and mastery based on a single operator learning curve using non-linear regression and CUSUM analysis. Secondary descriptive outcomes were technical success, change in clinical status, and adverse events. In total, 82 patients underwent TIF with a median age of 51 (IQR 37-64) and 28.1% were female. Technical success was 97.6% with an average procedure time of 48.9 minutes (SD 19.1). Procedural efficiency was achieved after 14 cases and mastery 35 cases. Among patients with ≥6-months follow-up (n = 58), 70.7% achieved a reduction in anti-acid therapy and/or quality of life score over 18.8 months (SD 9.9). Stratifying by our learning curve led to a non-significant improvement in symptoms at both procedural efficiency (n = 14; 64.3% vs 72.7%; P = 0.19) and mastery (n = 35; 62.9% vs 82.6%; P = 0.11). Adverse events were reported in 12.2% (6.1% AGREE grade IIIa). This study demonstrates the procedural learning curve required for efficiency and mastery of TIF2.0 and underscores the importance of collaboration between surgeons and endoscopists for successful service implementation.