Gastroesophageal Reflux Disease (GERD) specialist company EndoGastric Solutions® (EGS), says newly released data demonstrates that its Transoral Incisionless Fundoplication (TIF®) procedure outperforms proton pump inhibitor (PPI) treatment, while achieving similar normalization rates of distal esophageal acid exposure.
Background
GERD occurs because anatomical changes in the esophageal sphincter start to allow corrosive stomach acid to wash back up into the esophagus. While the stomach is able to resist the effects of hydrochloric acid, the esophageal lining is not, leading to erosion and debilitating pain. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum dose usage of prescription medications has been linked to a variety of other health complications. The challenge of addressing the problem has been addressed in many ways, including the magnetic links of the Torax Linx system, to the Endostim Lower Esophageal Sphincter (LES) stimulation system, which uses electrical impulses to tighten the muscles of the sphincter.
The EndoGastric Solutions offering is called EsophyX® and the associated procedure, Transoral Incisionless Fundoplication (TIF®). The EsophyX device is inserted transorally with visual guidance from an endoscope and used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. The TIF procedure is based on traditional surgical principles and offers similar effectiveness to a surgical repair with the safety profile of an incision-free approach. To date, more than 15,000 patients have been treated worldwide.
The so-called TEMPO randomized, controlled trial is designed to directly compare outcomes from the TIF procedure to maximum-dose proton-pump inhibitor therapy (PPI). Results have been published OnlineFirst (forthcoming articles published ahead of print) in Surgical Innovation as “Transoral Incisionless Fundoplication Effective in Eliminating GERD Symptoms in Partial Responders to Proton Pump Inhibitor Therapy at 6 months: The TEMPO Randomized Clinical Trial.”
The TEMPO data includes six month results from 63 randomized patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. Notably, similar outcomes were achieved by investigators across specialties, suggesting that the TIF procedure can be performed equally well by both foregut surgeons and gastroenterologists with advanced endoscopic skills.
Initial findings showed that 97% of patients reported elimination of regurgitation versus 50% in the PPI arm; troublesome heartburn was eliminated in 90% of TIF patients versus 13% of PPI patients. The TIF procedure was better than PPIs in controlling atypical symptoms as indicated by a significant improvement in RSI score (from 23 on PPIs before TIF to 3 off PPIs at 6-month follow-up); in the PPI group the same score fell insignificantly from 23 to 21 on maximum daily-dose of PPIs.
Patients will continue in the study until they have completed 3-year follow-up.
Investigator comments
“We believe the TIF procedure fills a therapy gap that exists for GERD patients who take daily PPI therapy and who remain unsatisfied because of incomplete symptom control,” said lead investigator, Karim S. Trad, MD, Clinical Professor of Surgery, George Washington University School of Medicine and Health Sciences. “The TIF procedure may offer these patients the opportunity to safely eliminate their troublesome typical and atypical symptoms without the risk of post-laparoscopic fundoplication syndromes like gas bloat and difficulty swallowing.”
Source: EndoGastric Solutions, Inc., Business Wire
published: April 23, 2014 in: Clinical Studies/Trials, Gastroenterology