Over 80 million people in the United States exhibit pain and discomfort from gastroesophageal reflux at least once per month, and 60 percent of the adult population will experience some type of gastroesophageal reflux disease within a 12-month period.1 Providers often prescribe proton pump inhibitor therapy to treat GERD. However, many patients do not respond to PPIs therapy, and recent studies have shown the Transoral Incisionless Fundoplication (TIF) procedure (with EsophyX device) can not only reduce GERD symptoms, but can eliminate the need for some patients to stop using PPIs medications controlling symptoms up to three years.
"There is a reason PPIs fails," says Anthony D. Starpoli, associate director of esophageal endotherapy; Lenox Hill Hospital, New York; clinical instructor department of medicine, NYU Langone Medical Center; and attending gastroenterology, Mt. Sinai Beth Israel Medical Center, New York. "It does not treat regurgitation, which is a mechanical problem."
First-of-its-kind studies with sham procedure as control groups are yielding promising results for patients suffering from GERD. With limited surgical literature to build upon, researchers had to be pioneers in the field to show the TIF procedure could successfully treat GERD.
"The (RESPECT) study was a big risk," Dr. Starpoli says. "The study was high quality and had very good people involved who really set the bar in reflux research."
Gastroenterology published a study in February 2015 illustrating the TIF procedure’s effectiveness. Researchers analyzed 696 patients with regurgitation despite daily PPIs use with three validated GERD-specific symptom scales. Researchers randomly assigned 129 patients to blinded groups that underwent the TIF procedure and then received six months of placebo or sham procedure with six months of once or twice daily omeprazole. The findings showed that the TIF procedure eliminated troublesome regurgitation in 67 percent of patients, when compared to patients who had sham procedures (45 percent).2
"Studies have paid off in that they have shown efficacy—the placebo effect has been controlled for so this increases the strength of the data," Dr. Starpoli says. "Now, gastroenterologists have a procedural option to treat regurgitation. A lot more surgeons are going to do it because they can reproduce results."
In 2015, the American Medical Association created a Category 1 Current Procedural Terminology code associated with the TIF procedure. The code, 43210: EGD Esophagogastric Fundoplasty, allows more physicians to offer the procedure to patients suffering from GERD, especially with CMS recently posting new payment information for the new code that features a zero day global period and less common determination for foregut procedures.
"It is a big deal to have the CPT Committee recognize Transoral Fundoplasty," Dr. Starpoli adds. "It is now an acceptable procedure with CMS providing appropriate payment levels. It legitimizes things. I think you will see a big change in acceptance because of the code and payment."
Dr. Starpoli believes education is key for the TIF procedure to gain acceptance in the medical community and that the population of gastroenterologists using the TIF procedure continues to expand.
"I believe we need to create a track of training in for interventional gastroenterology procedures," Dr. Starpoli says. "This is really a very unique area that deserves a certain amount of time dedicated to education."
With million of Americans suffering from regurgitation, the TIF procedure may be a game changer. Providers who are well-versed in the TIF procedure can provide patients with more options, which may prove particularly beneficial to patients who do not respond to PPIs. Because of the incisionless nature of the TIF procedures, patients do not have any scars, a benefit that may be appealing to many patients. According to Dr. Starpoli, 80 percent to 90 percent of patients do not need medication following a TIF procedure.
The next piece of the puzzle entails motivating gastroenterologists to learn about the procedure. "It is about education and inspiring the doctors to realize they can have a hand in this," Dr. Starpoli says. "Ultimately, The GI doctor with more options like the TIF procedure can better help more GERD patients."
Learn more about Dr. Starpoli and GERD!
Referennces:
1 Healthline
2 Hunter JG, Kahrilas PJ, Bell RCW, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis K, Turgen TG, Hungness ES, Diggs BS Transoral Fundoplication Provides Better GERD Symptom Control Than PPIs in Patients with Troublesome Regurgitation: A Multicenter Sham Gastroenterology. 2015 Feb;148(1):324-33.