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Surg Innov. 2018 Apr;25(2):149-157. doi: 10.1177/1553350618755214. Epub 2018 Feb 6.

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

Author information

1
1 The George Washington University School of Medicine and Health Science, Washington, DC, USA.
2
2 The George Washington University Medical Faculty Associates, Washington, DC, USA.
3
3 Livingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA.
4
4 Advanced Gastroenterology, Inc, Thousand Oaks, CA, USA.
5
5 Saint Mary Medical Center, Hobart, IN, USA.
6
6 Internal Medicine Associates, Merrillville, IN, USA.
7
7 Indiana Medical Research, Elkhart, IN, USA.
8
8 Unity Surgical Hospital, Mishawaka, IN, USA.
9
9 Hancock Regional Hospital, Greenfield, IN, USA.
10
10 Crossville Medical Group, Crossville, TN, USA.
11
11 Cumberland Medical Center, Crossville, TN, USA.

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)

PMID:
29405886
PMCID:
PMC5946656
DOI:
10.1177/1553350618755214
[Indexed for MEDLINE]
Free PMC Article

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