Introduction
Gastro-oesophageal reflux disease (GORD) is a common disorder with a prevalence of 10-20%. It occurs from disruption of the gastro-oesophageal flap valve (GFV) and/or a diaphragmatic abnormality causing a hiatus hernia (HH). Transoral incisionless fundoplication (TIF2.0) using the EsophyX device (Endogastric solutions) is an endoscopic treatment for GORD, which recreates the GFV through a partial 270º wrap. Prospective trials show the procedure is safe and effective and is recommended in North American guidelines, yet the experience of TIF is limited in Europe.
Aims & Methods
We conducted a UK-based, retrospective, cohort study to determine the safety and efficacy of TIF2.0. Patients undergoing TIF2.0 by a single operator were identified and analysed between 2019-2023. Patient demographics, reflux assessments (GERD-HRQL, endoscopy, pH testing), and procedural details were recorded. Primary outcomes were technical success and clinical response defined as complete (off regular anti-acid therapy) or partial (reduction from baseline in anti-acid therapy, GERD-HRQL score, and/or physiological parameters) without the need for revision. Secondary outcomes were adverse events and changes in reflux parameters measured by Wilcoxon signed-rank test. A p-value <0.05 was significant.
Results
In total, 81 patients underwent TIF2.0 with 92.0% on oral anti-acid therapy. Median age was 51 (IQR 37-64), 23 (28.4%) were female, and the median ASA grade was 1 (IQR 1-2). A HH was present in 84.6% with an average size of 1.9cm (SD 0.5). The average acid exposure time (AET) was 8.9% (SD 4.1; n=61). The clinical outcomes are summarised in table 1. Technical success was 97.5% (n=79) with an average procedural time of 38.0 minutes (SD 10.3), and 1-day (IQR 1) inpatient stay. The device could not pass the cricopharynx in two patients despite routine balloon dilatation. Over 15.5 months of median follow-up (IQR 7-24), 55% had a complete response, and 71.7% partial response. On logistic regression analysis, no variables were predictive of response. Among those with paired pre-/post-testing, the average GERD-HRQL score reduced significantly (33.9 ±18.6 to 9.1 ±9.2; P<0.001) as well as the average AET (8.9 ±4.1 to 5.1 ±4.0; P=0.005) post-procedure. Procedure or device-related adverse events occurred in 12.2% (n=10), which were all managed conservatively. The single perforation was delayed and managed with intravenous antibiotics and endoscopic vacuum therapy. Seven patients underwent a revisional procedure, including two surgical fundoplications, with 83.3% due to recurrent HH.
IQR – interquartile range; ; SD – standard deviation
* Off all regular anti-acid therapy (respondents during follow-up: n=60)
† Reduction from baseline in anti-acid therapy, symptomatology based on HRQL-GERD questionnaire, and/or physiological parameters (respondents during follow-up: n=60)
‡ Mucosal injury (n=1), chest infection (n=3), perforation (n=1), leak/collection (n=1), bleeding (n=1), dysphagia (n=2), admission for nausea and vomiting (n=1).
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| Table 1 - Clinical outcomes among patients undergoing Transoral Incisionless Fundoplication 2.0 |
| Procedure time in minutes (SD) | 38.0 (7.2) |
| Technical success (%) | 79 (97.5) |
| Inpatient stay (IQR) | 1 (1) |
| Complete response* | 33 (55.0) |
| Partial response† | 43 (71.7)
|
| Follow-up in months (IQR) | 15.5 (7-24) |
| Repeat procedure (%) | 7 (8.6) |
| Adverse events (%)‡ | 10 (12.2) |
Conclusion
TIF2.0 is associated with technical success in 97.5%, clinical response in 71.7%, and significant improvements in GERD-HRQL and AET. Recurrent HH is a frequent cause of failure showing the importance of patient selection and/or need for concomitant HH repair.
Disclosure
RH declares educational grants to support research infrastructure from Cook medical, Odin Vision, Pentax medical, Endogastric Solutions, Apollo Endosurgery, Medtronic, and Aqua Medical
