Positive six-month results were maintained a year after TIF procedure; all control patients crossed over to receive TIF procedure and achieved similar results to original treatment group
Data Presented at DDW® 2014
CHICAGO (May 5, 2014)—EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced that new data show that a vast majority of patients with GERD who underwent the Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device continued to report complete elimination of all troublesome regurgitation and esophagitis for a full year after the procedure.
This new 12-month analysis of the prospective, randomized, multicenter clinical trial known as TEMPO also showed that all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm.
The new 12-month analysis was presented by principal investigator, Karim S. Trad, MD, as part of an American Gastroenterological Association (AGA) research forum earlier today at Digestive Disease Week® (DDW®) 2014 (Abstract #724), taking place here through May 6.
“This study confirms that in well-selected GERD patients with incomplete symptom control on high-dose PPI therapy, the TIF procedure is capable of dramatically and durably eliminating GERD symptoms, healing esophagitis and improving quality of life,” said Dr. Trad, a surgeon at George Washington University School of Medicine and Health Sciences who reported on the 12 months follow-up data at DDW. “This incisionless, endoluminal approach offers a subgroup of patients who are dissatisfied with PPIs a less invasive option than current surgical approaches, with minimal or no side-effects. We are planning to follow our study patients for up to three years.”
Seventy-seven percent of patients in original treatment arm (n-39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Esophagatis, or inflammation of the esophagus, remained healed in 100% of the patients in the original treatment arm.
At the end of the first six months of the study, only 5% (1/21) of patients in the control group who received maximum-dose PPI therapy reported global elimination of regurgitation and atypical symptoms; this proportion increased to 67% (14/21) six months after these patients crossed over and had the TIF procedure (P < 0.001). Additionally, 71% (15/21) of the cross-over patients were completely off PPIs six months following the TIF procedure.
“These results add to the growing body of Tier-1 clinical data supporting use of the TIF procedure as an important therapeutic option for many long-term GERD sufferers, particularly those who no longer respond to drug therapy, but aren’t prepared for the risk and recovery time of traditional open or laparoscopic surgery,” said Skip Baldino, President and CEO of EGS.
“The presentation of the one-year outcomes from this important study represents one of the most important clinical milestones for EGS and the entire endoluminal procedure category to date. This is just one of many presentations and publications we expect during 2014. I believe this evidence will have a substantial impact on the utilization of and reimbursement for endoluminal approaches for GERD – and is one of the key reasons why I wanted to join EGS at this time,” continued Baldino.
The primary outcome of TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial was elimination of daily troublesome regurgitation and atypical symptoms as evaluated by two validated instruments—Reflux Disease Questionnaire and Reflux Symptom Index; secondary outcomes included healing of esophagitis, normalization of esophageal acid exposure and PPI use in the TIF treated patients at 6 and 12 months.
This TEMPO data presented at the American Gastroenterological Association’s session GERD: Complications and Extraesophageal Presentations at the 2014 DDW® Annual Meeting in Chicago, Illinois include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices.
EndoGastric Solutions did not provide financial support for the following scientific sessions and did not influence the content in any way. However, research presented within these scientific sessions may have been supported by EndoGastric Solutions.