The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective

Abstract

Background: Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0.

Methods: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated.

Results: Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001).

Conclusion: In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

Keywords: EsophyX; atypical GERD symptoms; heartburn; proton pump inhibitor (PPI); regurgitation; transoral incisionless fundoplication (TIF).

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KST, MR, and GS have received speaking honoraria from EndoGastric Solutions. WEB, ABS, PGM, JAH, and MAF have no conflicts of interest or financial ties to disclose. ERP and JAS have no conflicts of interest or financial ties to disclose.

Figures

Figure 1.

Study flowchart of treated and analyzed patients. Of the 85 patients not meeting eligibility criteria, 45% (38/85) had normal pH test, 36% (31/85) had hiatal hernia >2 cm in axial length or greatest transverse dimension, 13% had Hill grade >II, 2% had reflux esophagitis grade C or D (Los Angeles classification), 2% had body mass index >35 kg/m2, and 1% (1/85) had Barrett’s esophagus >2 cm. Additionally, 32 patients declined to participate, and 16 were excluded for other reasons. Abbreviation: LNF, laparoscopic Nissen fundoplication.

Figure 2.

Elimination of troublesome regurgitation, as assessed by the Reflux Disease Questionnaire at the 1-, 3-, and 5-year follow-ups.

Figure 3.

Regurgitation score, as assessed by the Reflux Disease Questionnaire, at screening and the 1-, 3-, and 5-year follow-ups. Abbreviation: PPI, proton pump inhibitor.

Figure 4.

Reflux Index Score at screening and 1-, 3-, and 5-year follow-up assessments. Abbreviation: PPI, proton pump inhibitor.

Figure 5.

Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire, at screening and 1-, 3-, and 5-year follow-up assessments.

Figure 6.

Percentage of patients on daily proton-pump inhibitor (PPI) therapy at screening and 1-, 3-, and 5-year follow-up assessments.

Figure 7.

The Optum database average utilization of health care resources (number of claims) for laparoscopic Nissen fundoplication (LNF) and transoral incisionless fundoplication (TIF) over 2 years.