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GERD treatment

Five-year TEMPO outcomes show GERD improvements with TIF 2.0

Cost comparison analysis indicates significantly lower healthcare utilisation by TIF procedure patients

EndoGastric Solutions has published five-year follow-up data focused on control of gastroesophageal reflux disease (GERD) symptoms and healthcare economics after a Transoral Incisionless Fundoplication (TIF) 2.0 procedure from the TIF EsophyX vs Medical PPI Open Label (TEMPO) study. At five years post-procedure, all primary endpoints of the TEMPO study were met, with 86 percent of patients reporting the elimination of regurgitation and 80 percent of patients reporting elimination of all atypical symptoms.

In addition, the data released indicates that treatment with the TIF 2.0 procedure improved health-related quality of life scores (p<0.001) and patient satisfaction (two versus 70 percent) for patients with GERD. The paper, ‘The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective’, was published in the journal Surgical Innovation: Advances in Minimally Invasive Surgical Science, Technology, and Training.

“This report offers conclusive evidence that the early benefits and safety reported with the TIF 2.0 procedure in previous shorter-term prospective multi-centre randomised reports and prospective multi-centre observational studies are sustained at five years follow-up - a milestone that has never been achieved by previous endoluminal GERD therapies,” said Dr Karim Trad, Clinical Professor of Surgery at George Washington University School of Medicine and Health Sciences and principal investigator. “The elimination of troublesome symptoms was maintained without significant deterioration over time, with a low re-operation rate of 5% after five years. Going forward, the endoscopic TIF 2.0 procedure should be considered as a first-line therapy in carefully selected patients resistant or intolerant to PPIs.”

In the TEMPO study, sixty-three patients who suffered from chronic GERD symptoms were randomly assigned to either undergo TIF 2.0 procedure (n=40) using the EsophyX device or to receive proton pump inhibitor (PPI) therapy (n=23). 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.

Six months after the start of the study, all patients receiving PPI treatment (n=21) elected to crossover and receive the TIF 2.0 procedure. At five-year follow-up, data from 44 patients were available for analysis.

Of 63 patients, 60 were available at one year, 52 at years and 44 at five years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at one year, 90% at three years and 86% at five years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at one year, 88% at three years and 80% at five years. No serious adverse events occurred.

There were three reoperations by the end of the five-year follow-up. At the five-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 (Figure 1) improved by decreasing from 22.2 to 6.8 at 5 years (p<0.001).

 

Figure 1: TEMPO: Quality of life measurements (Reference: Trad, et al; The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective. SurgInnov. 2018 Feb 6)

“Five years after undergoing TIF 2.0, the great majority of TEMPO trial patients experienced durable elimination of all types of troublesome GERD manifestations, including regurgitation and atypical symptoms,” the study authors conclude in the paper. “There were no SAEs or any safety concerns associated with the TIF 2.0 procedure. It also appears that in the appropriate patient population, the TIF 2.0 procedure could be a cost-effective alternative to laparoscopic Nissen fundoplication.”

This report also included an economic analysis using the Optum healthcare database to determine overall healthcare utilization, which incorporated costs for hospitalizations, outpatient visits and PPI therapy. At two years post-TIF procedure, healthcare utilization and total healthcare costs were significantly less when compared to those associated with laparoscopic Nissen fundoplication (US$66,000 for TIF procedures verses US$124,000 for laparoscopic Nissen fundoplication patients).

“EndoGastric Solutions has consistently invested in the highest-grade research to validate the long-term effectiveness and healthcare economics of the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We are very encouraged that these investments continue to confirm that the TIF 2.0 procedure is a safe, efficacious, and viable endoscopic alternative to PPIs and more invasive anti-reflux surgery options.”

To access this paper, please click here

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