Published Clinical Results for the TIF Procedure

Clinical results to date for the TIF procedure have been comparable to those of conventional anti-reflux surgery.

Clinical results data is generated from more than 70 published studies which chronicle successful outcomes on over 1100 unique patients from over 50 centers in the US and Europe. All published data consistently demonstrate [1,2]:

• Improved quality of life scores on a variety of questionnaires (validated instruments)
• Patients off regular daily PPI therapy (see charts below)
• Healing of esophagitis (see charts below)
• Improvements in acid exposure (pH parameters)
• Low rate of serious adverse events less than 0.05%
• Virtual absence of long term side-effects associated with traditional fundoplication techniques

The studies follow patients up to 6-years (see chart below) and include post-market registries and case series. The most academically rigorous study designs are called randomized controlled trials (RCTs) and are generate what’s known as Level I evidence. Two RCTs compared TIF patients with sham/placebo control groups–highly unusual for a medical procedure with a specific device.

The publication of high quality data culminated in March 2015 when the American Medical Association (AMA) created a new Category I Current Procedural Terminology (CPT®) code— 43210: EGD Esophagogastric Fundoplasty procedures. The new CPT code, which includes a procedure descriptor associated with the TIF procedure, took effect January 1, 2016. The application for the new code was jointly sponsored by four key specialty medical societies: American Gastroenterological Association (AGA), American College of Gastroenterology (ACG), American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

The data is now being presented to public (Medicare, Medicaid) and private (Blue Cross/Blue Shield) insurance providers to establish coverage policies.

Here is a comprehensive listing (bibliography) of clinical publications on the TIF procedure.

The studies follow patients up to 6-years (see chart below) and include post-market registries and case series. The most academically rigorous study designs are called randomized controlled trials (RCTs) and are generate what’s known as Level I evidence. Two RCTs compared TIF patients with sham/placebo control groups–highly unusual for a medical procedure with a specific device.

The publication of high quality data culminated in March 2015 when the American Medical Association (AMA) created a new Category I Current Procedural Terminology (CPT®) code— 43210: EGD Esophagogastric Fundoplasty procedures. The new CPT code, which includes a procedure descriptor associated with the TIF procedure, took effect January 1, 2016. The application for the new code was jointly sponsored by four key specialty medical societies: American Gastroenterological Association (AGA), American College of Gastroenterology (ACG), American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

The data is now being presented to public (Medicare, Medicaid) and private (Blue Cross/Blue Shield) insurance providers to establish coverage policies.

References

Trad, KS. Transoral incisionless fundoplication: current status. Curr Opin Gastroenterol. 2016 Jul;32(4):338-43

Data on file at EGS.