This study, the first case series evaluating the role of the TIF procedure in the management of GERD post-POEM, was conducted in five consecutive patients 18 years of age or older who underwent POEM and subsequent TIF procedures at a single center between December 2014 and June 2017. The average time between POEM and TIF procedures was 13.5 months (range 4 – 27 months).
Patients enrolled in the study had achieved complete or partial relief of their GERD symptoms with PPIs. Three patients entered the study with esophagitis. The TIF procedure was performed with the EsophyX® Z model device. The primary outcome was discontinuation of PPI use and healing of esophagitis in those patients in which this condition was present at the time of the TIF procedure. At mean follow up of 27 months (range 5 – 34 months) key study findings include:
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Technical success of the TIF procedure was achieved in all five patients.
Complete discontinuation of PPI use was achieved in all five patients (100%).
The three patients with esophagitis saw resolution of inflammation three months following the TIF procedure.
There were no adverse events.
“These findings support the TIF 2.0 procedure with the EsophyX device as an effective and safe treatment in patients who develop GERD following POEM,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We hope that these results will encourage physicians to consider this approach as they treat post-POEM achalasia patients.”
About GERD
Gastroesophageal reflux disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take medications—proton pump inhibitors; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose dependency on PPIs.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
