TIF underperforming as long-term GERD treatment

Reuters Health Information: TIF underperforming as long-term GERD treatment

TIF underperforming as long-term GERD treatment

Last Updated: 2015-04-08

By Will Boggs MD

NEW YORK (Reuters Health) - Compared with proton pump inhibitor (PPI) treatment for gastroesophageal reflux disease (GERD), transoral incisionless fundoplication (TIF) produces improvements in quality of life and reflux, but normalization of pH does not persist at 12 months, according to a new trial.

"We were surprised, especially after seeing the promising results in objective reflux control after a 6-month follow-up period," Dr. Bart P. L. Witteman from Maastricht University Medical Center in the Netherlands told Reuters Health by email. "Until durability of TIF has been established, it has in our opinion a very limited role in GERD management."

Antireflux surgery is more effective than antisecretory therapies for GERD, but it is invasive, and its fundoplication-related side effects frequently compromise the otherwise excellent results, Dr. Witteman and colleagues write in The American Journal of Gastroenterology, online March 31.

TIF has emerged as a less invasive alternative intended to mimic antireflux surgery with fewer side effects.

The researchers evaluated the effectiveness of TIF in treating GERD patients who were well controlled on daily PPI therapy. At six months, significantly more patients in the TIF group (55%) than in the PPI group (5%) had experienced at least a 50% improvement in GERD-related quality of life, they found.

Lower esophageal sphincter pressure was higher in the TIF group than in the PPI group, but there was no difference between the groups in the total number of reflux episodes or in overall esophagitis healing rates.

At six months, all 20 patients originally allocated to PPI opted to cross over to TIF, as allowed by the protocol.

By the 12-month follow-up, patients still reported significant improvements over baseline in GERD-related quality of life, but only 29% had normalization of distal esophageal pH and 44% still required PPIs on a daily basis.

"Although a short-term improvement of the anti-reflux barrier was found, which supports the validity of the concept of TIF, no long-term reflux control was achieved and therefore, the study was terminated after interim analysis," Dr. Witteman said. "The endoscopically created anti-reflux barrier deteriorated with increased follow-up duration and therefore, in this form, TIF is no equivalent alternative for PPIs in GERD treatment, even in this highly selected population."

"A next-generation endoscopic fundoplication technique may improve outcomes, if equipped with a more solid suturing or stapling mechanism to better withstand intraabdominal traction forces and warrant durability," he said.

Dr. Robert A. Ganz from Minnesota Gastroenterology and University of Minnesota in Minneapolis told Reuters Health, "Numerous uncontrolled trials have demonstrated rapid deterioration of TIF results. Since the TIF procedure does not allow mobilization of the gastric fundus, tension on the wrap causes the TIF fasteners to pull apart. The TIF procedure has no proven long-term benefit."

"The procedure should not currently be recommended for a GERD patient still symptomatic on PPIs," Dr. Ganz, who was not involved in the new work, said in an email.

He added, "For a GERD patient controlled on PPIs, here's what I would say: 'Look dude, right now you're asymptomatic on PPIs. I could offer you a TIF, but there's a 5-7% chance of a severe complication that could be life-threatening. At 12 months, there's a 60% chance you'll still need meds and only a 30% chance that you'll have a normal pH score. And that's at 1 year. Beyond that, the results are almost certain to deteriorate further. In good conscience, I would not recommend this procedure for you; you should just stay on the meds that completely control your symptoms.'"

Dr. Pier Alberto Testoni, director of gastroenterology and G.I. endoscopy at San Raffaele University in Milan, Italy, told Reuters Health by email, "In my opinion, both surgery, either laparoscopic or transoral, and PPI therapy do not represent the perfect way to treat GERD patients, because symptoms may persist even after surgery in a number of patients and mechanisms involved in the gastroesophageal reflux are different."

"On the other hand, long-term PPI therapy, especially with high dosage, may have side effects or may be difficult to accept," said Dr. Testoni, who was not involved in the trial. "So, once a physician decides on a therapy, pros and cons of every treatment should be weighed with the patient. However, expectations for results of the different therapies should not be very high."

The study had no commercial funding and the researchers declared no conflicts of interest.

SOURCE: http://bit.ly/1akr5Y0

Am J Gastroenterol 2015.

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