Transoral incisionless fundoplication demonstrates durability at up to 9 years

Abstract

Goals: To assess the long-term results of transoral incisionless fundoplication (TIF 2). Background: TIF with the EsophyX2 is an accepted procedure to treat gastroesophageal reflux disease (GERD). Long-term data have been limited. We report clinical outcomes of 151 patients followed up to 9 years. Study: A single institution prospective registry of patients undergoing TIF 2 between 11/2008 and 7/2015. Outcomes were assessed by complications, re-interventions, and a mixed effect model of clinical response over time. Results: A total of 151 patients (87 women), mean age 62 years (30–91), mean body mass index (BMI) 26.6 (20–36.1), 93% on daily proton pump inhibitor (PPI), underwent TIF 2 without hiatal hernia repair; 131 of the 151 patients (86%) were available for follow-up at a median of 4.92 years (0.7–9.7 years). Of 120 patients ⩾5 years post-TIF, 62 (51%) were followed for a median 6.8 years. Median GERD-health-related quality of life (HRQL) scores decreased from 21 (interquartile range (IQR) 9.5–30) off PPI and 14 (4–24) on PPI at baseline to 4 (2–8) at 4.92 years and remained at 5 (2–9) in the 62 patients 5–9 years post-TIF. Sixty-four per cent had successful (>50%) reductions in GERD-HRQL scores at 4.92 years and 68% of patients followed ⩾5 years. Median regurgitation decreased from 15 (8–20) off PPI and 11 (5–20) on PPI at baseline to 0 (0–4) at 4.92 years, remaining at 1 (0–3) in 62 patients 5–9 years post-TIF. Mixed model analyses confirmed significant and stable improvements in GERD-HRQL and regurgitation scores at all annual follow-up time points after TIF. Daily PPI use decreased from 93% to 32% at 4.92, and 22% at ⩾5 years post-TIF. Revision to laparoscopic fundoplication in 33(22%) showed comparable outcomes. Two patients recovered uneventfully after laparoscopic surgery for localized perforation. Conclusions: TIF 2 provides durable relief of GERD symptoms at up to 9 years with 69–80% of patients having a successful outcome by symptom response and PPI use.