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Noninvasive TIF procedure effective, safe in some patients with chronic, refractory GERD
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LAS VEGAS — Transoral incisionless fundoplication effectively treated select GERD patients who had been unresponsive to previous treatment, enabling them to discontinue long-term proton pump inhibitor use in a study presented at the 2012 American College of Gastroenterology Annual Scientific Meeting.
Researchers assessed 100 patients with chronic GERD who received transoral incisionless fundoplication (TIF). All participants exhibited extra-esophageal GERD manifestation and/or previously had failed medical management of their condition. Patients were evaluated before the procedure and after 12 months via Gastroesophageal Reflux Disease Health-related Quality of Life (GERD-HRQL), Reflux Symptom Index (RSI) and Gastroesophageal Reflux Symptom Score, in addition to endoscopy, barium swallow, physical examination, history and pH measurement.
Participants had a mean GERD duration of 10 years and a mean of 8 years of proton pump inhibitor (PPI) use prior to TIF. At 12 months after the procedure, 75% of participants were no longer taking PPIs, compared with 92% who previously used PPIs daily (P<.001). Mean GERD-HRQL scores dropped from 23.4 to 6.6, and mean RSI scores decreased from 19.9 to 7.9 (P<.001 for both). Significant reductions also occurred for mean heartburn (16.1 to 4.3) and regurgitation scores (from 13.6 to 3.2) (P<.001 for both).
The majority of patients indicated that daily bothersome heartburn (65% of evaluable participants) and regurgitation symptoms (86% of evaluable participants) had ceased at 12 months. Improvement to or normalization of esophageal acid exposure occurred in 53% of 19 evaluable patients who underwent pH testing at 12 months. The number of patients who reported dissatisfaction with their health decreased from 80% of cases before TIF to 15%.
No intraoperative or postoperative complications were observed. Treatment failure and revision occurred in six patients, one for TIF and five for laparoscopic Nissen fundoplication.
“TIF is a noninvasive way of treating heartburn or regurgitation in patients without having to do surgery,” researcher Peter G. Mavrelis, MD, Internal Medicine Associates in Merrillville, Ind., told Healio.com. “This is a procedure we do on our own patients … with heartburn that’s not treated adequately with medication. We can take these patients we would’ve sent for surgery, and can do this operation ourselves as endoscopists to treat their regurgitation and heartburn so they can completely come off medications.”
Mavrelis said the researchers have since gathered 2-year data that further supports the conclusions reached from their 1-year data. They plan to present their additional findings in the coming year.
Disclosure: Researchers Reginald C.W. Bell and Karim S. Trad serve as consultants for EndoGastric Solutions, which provided a small research grant for data collection.
For more information:
Mavrelis PG. P1049: The Effects of Endoscopic Fundoplication on Chronic GERD Patients: 12 Month Multicenter Experience. Presented at: the 2012 American College of Gastroenterology Annual Scientific Meeting; Oct. 19-24, Las Vegas.