Assessment of the safety, efficacy and single operator learning curve for performing transoral incisionless fundoplication 2.0

Aims Gastro-oesophageal reflux disease (GORD) occurs from disruption of the gastro-oesophageal flap valve. Transoral incisionless fundoplication 2.0 (TIF) using the EsophyX device is an endoscopic treatment for GORD that recreates this valve through a partial 270º wrap in patients with a hiatal hernia of 2cm or less. Due to the limited European experience, we conducted a UK-based, retrospective cohort study to determine the safety, efficacy, and procedural learning curve for performing TIF to help guide future training and implementation.

Methods Consecutive patients undergoing TIF were analysed between 2019-2024. Patient demographics, baseline reflux assessments, and procedural details were recorded. Primary outcomes were technical success and clinical success as determined by reduction in anti-acid therapy and/or GERD-HRQL score after a minimum of six months follow-up. A procedural learning curve was established through non-linear regression model and CUSUM analysis.

Results 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. Serious adverse events were reported using the AGREE classification and occurred in 6.1% (n=5; AGREE IIIa). Clinical success was 70.7% (n=41) and 54.4% (n=31) were able to come anti-acid therapy over a mean follow-up of 18.8 months (SD 9.9). There was a significant reduction in both acid exposure time (9.1% vs 5.1%; p=0.003) and GERD-HRQL (34.2 vs 9.7; p=0.0002), among those who underwent paired pre- and post-testing. Eight patients (9.9%) underwent a revisional procedure with TIF or Nissen fundoplication during follow-up due to recurrent hiatus hernia.

Conclusions TIF is an effective endoscopic procedure for the management of GORD in selected patients with a moderate safety profile. The importance of patient selection with thorough pre-operative hiatal hernia assessment cannot be understated. We have demonstrated, through a single operator learning curve, the requirement for procedural efficiency and mastery.

 

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Conflicts of Interest

BN, NA, AP, AT, MD, AS, AM, GJ, RSL, BM, and MM have no relevant conflicts of interest to declare. RH declares educational grants to support research infrastructure and educational courses from EndoGastric Solutions (now Merit Medical).

Publication History

Article published online:
27 March 2025