EndoGastric® Solutions today announced the publication of new clinical data demonstrating the safety and efficacy of the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure in patients with achalasia who have undergone Peroral Endoscopic Myotomy (POEM). The TIF 2.0 procedure is a minimally invasive procedure that enables physicians to perform an endoscopic gastric fundoplication.

This study, titled, “Transoral Incisionless Fundoplication for reflux after peroral endoscopic myotomy: a crucial addition to our arsenal” appeared in the May issue of Endoscopy International Open.

Achalasia is a gastroesophageal disorder that causes patients to have difficulty swallowing. Patients may also experience chest pain and regurgitation of food and liquids. The POEM procedure is effective in more than 90% of achalasia patients, but the reduction in lower esophageal sphincter pressure that addresses achalasia symptoms can give rise to increased acid exposure and gastroesophageal reflux disease (GERD) which is associated with an increased prevalence of Barrett’s Esophagus and esophageal cancer.

Many patients often require long-term therapy with proton pump inhibitors (PPI) to address their GERD symptoms following the POEM procedure; however long-term PPI use is associated with several negative side-effects which include increased risk of developing depression, dementia, chronic kidney disease, gastrointestinal infections and vitamin and mineral deficiencies.

“POEM is now clearly established as an effective therapy for achalasia, but it may lead to increased esophageal acid exposure which can be associated with significant long-term health effects,” said Amy Tyberg, MD, Associate Director of Endoscopy at Rutgers Robert Wood Johnson Medical School, Rutgers, New Brunswick, NJ. “There is a robust and growing data set supporting the TIF 2.0 procedure as a durable and safe approach to treating chronic GERD, and the results of this study demonstrate that it can also provide clinical benefit as a minimally invasive intervention following POEM. These findings are an important advance in the care of achalasia patients who are status post POEM, some of whom trade in symptoms of dysphagia for symptoms of GERD.”

[socialpug_tweet tweet=”“POEM is now clearly established as an effective therapy for achalasia, but it may lead to increased esophageal acid exposure which can be associated with significant long-term health effects,” said Amy Tyberg, MD, Associate Director of Endoscopy at Rutgers Robert Wood Johnson Medical School, Rutgers, New Brunswick, NJ. “There is a robust and growing data set supporting the TIF 2.0 procedure as a durable and safe approach to treating chronic GERD, and the results of this study demonstrate that it can also provide clinical benefit as a minimally invasive intervention following POEM. These findings are an important advance in the care of achalasia patients who are status post POEM, some of whom trade in symptoms of dysphagia for symptoms of GERD.”” display_tweet=”“POEM is now clearly established as an effective therapy for achalasia, but it may lead to increased esophageal acid exposure which can be associated with significant long-term health effects,” said Amy Tyberg, MD, Associate Director of Endoscopy at Rutgers Robert Wood Johnson Medical School, Rutgers, New Brunswick, NJ. “There is a robust and growing data set supporting the TIF 2.0 procedure as a durable and safe approach to treating chronic GERD, and the results of this study demonstrate that it can also provide clinical benefit as a minimally invasive intervention following POEM. These findings are an important advance in the care of achalasia patients who are status post POEM, some of whom trade in symptoms of dysphagia for symptoms of GERD.”” style=”3″]

Tyberg continued, “In a recently published meta-analysis, Repici et al. concluded that for achalasia patients, performing myomectomy (laparoscopically or endoscopically) and then a staged antireflux procedure to control GERD symptoms may increase efficacy when treating this challenging condition.”1

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:

  • 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.”


Reference

1 Repici A, et Al., Send to Gastrointest Endosc. 2018 Apr;87(4):934-943.e18. doi: 10.1016/j.gie.2017.10.022.