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Incisionless Procedure Offers Less Invasive Treatment for Reflux

From: ENT Today, November 2012

by Susan Kreimer

A device the size of a toy fishing pole makes it possible to perform less invasive surgery on reflux patients. The procedure—transoral incisionless fundoplication (TIF)—may be an alternative to a more common laparoscopic operation for some sufferers of gastroesophageal reflux disease (GERD).

While the TIF repair is typically undertaken by general surgeons, otolaryngologists are often involved in the care of patients whose reflux problems extend beyond the esophagus and into the upper airway, causing atypical GERD symptoms such as chronic cough, hoarseness, laryngeal nodules, swallowing difficulties, throat pain and persistent sinus infections.

“I’ve been referring patients for the [TIF] procedure for about four years. It’s a great option for those with laryngopharyngeal reflux [LGR],” said Ed Hepworth, MD, an otolaryngologist and director of the Colorado Sinus Institute in Denver. These patients don’t present with the typical esophageal manifestations of GERD, but they may instead experience frequent infections, nasal polyps and sinonasal problems without other explanation. TIF also works well to combat persistent hoarseness and frequent throat clearing in properly selected patients. Several of Dr. Hepworth’s patients who underwent TIF have been relieved of their chronic cough, and some patients have been able to avoid antibiotics and sinus surgery.

Advantages over the Traditional Surgery

During TIF, patients are spared the small but multiple abdominal incisions, as well as the occasional side effects, needed for a laparoscopic Nissen fundoplication, the conventional “gold standard” operation for heartburn control. The EsophyX device, manufactured by EndoGastric Solutions of Redmond, Wash., is maneuvered transorally to the gastroesophageal junction, and a device is inserted that prevents gastroesophageal reflux.

Karim Trad, MD “This procedure really is revolutionary in that it gives us an option to repair small hiatal hernias and refractory GERD. We have found it to be particularly useful for patients with laryngopharyngeal reflux.”

—Karim Trad, MD

“This procedure really is revolutionary in that it gives us an option to repair small hiatal hernias and refractory GERD,” said Karim Trad, MD, an assistant professor in the department of surgery at George Washington University in Washington, D.C., and a general surgeon specializing in minimally invasive techniques. “We have found it to be particularly useful for patients with laryngopharyngeal reflux [LPR]. The traditional medical treatment of using proton-pump inhibitors has been found less than optimal and not very successful. Patients with LPR typically are placed on double-dose proton-pump inhibitors and oftentimes go for many years before the correct diagnosis is made.”

Side effects of the TIF procedure may include a few weeks of bloating, belching or other vague abdominal complaints, and there can be aggravation of esophageal dysmotility. However, these problems generally resolve on their own, said Dr. Hepworth.

Unlike the Nissen procedure, in which 5 to 10 percent of patients develop abdominal side effects, the TIF procedure does not seem to be associated with these drawbacks more than 1 percent of the time, said Reginald C.W. Bell, MD, a gastrointestinal surgeon in private practice in Englewood, Colo., who sees two to four LPR patients referred by otolaryngologists per week. “This is very important for patients with LPR, who often don’t have typical reflux symptoms and for whom the thought of developing GI side effects from a procedure (such as a Nissen) is not very appealing,” said Dr. Bell, who has performed more than 170 TIF procedures since 2009. “These patients with LPR have very good results from the TIF procedure. Symptomatic improvement is almost the same as with the Nissen when it comes to symptoms such as cough, throat clearing and hoarseness.”

Researchers involved in a recent Boston University School of Medicine study of 46 patients described TIF as “a promising approach for gastroesophageal reflux disease (GERD) that may decrease morbidity compared with conventional anti-reflux procedures” (J Thorac Cardiovasc Surg. 2012;143:228-234). They also concluded that TIF is effective at short-term follow-up and safe for patients with GERD, while cautioning that “long-term follow-up and randomized trials are required to assess the efficacy and durability of this approach compared with conventional surgical repair.”

Who Is a Candidate for TIF?

Patients with troublesome symptoms that are not too severe or life-threatening, and those with a hiatal hernia smaller than 2 centimeters, are appropriate candidates for the TIF procedure. “Someone who is bothered by hoarseness or throat clearing but is not a performer who depends on voice for their livelihood, I would consider a good patient for the EsophyX TIF,” Dr. Bell said.

However, for someone with life-threatening complications from reflux—for example, aspiration pneumonias or difficulty breathing—he generally recommends the traditional Nissen procedure.—SK

For about 80 percent of patients undergoing TIF, the positive results mean they can forgo daily acid blockers, which may interfere with the absorption of calcium, amino acids and magnesium, potentially leading to osteoporosis and hypothyroidism after multiple years of use, said Erik Wilson, MD, FACS, division chief of elective general surgery and vice chair for clinical affairs at the University of Texas Medical School at Houston.

“We’re doing more of these procedures than the standard laparoscopic approach more recently,” Dr. Wilson said. Patients typically also follow up with their otolaryngologist for management. “Over time, their voice can slowly improve because there’s less reflux irritating their vocal cords,” he explained, adding that “it’s not an overnight phenomenon.”

A Promising Option

Traditionally, surgery has often been perceived as a last resort for patients with GERD. Physicians commonly viewed this condition as more of a lifestyle issue than a life-threatening illness. “There’s been a reluctance on the part of the ENTs and other health care providers to take the chance of sending someone for surgery,” said Kevin Gillian, MD, of the Virginia Hernia Institute in Lorton, Va., and director of the heartburn treatment center at Virginia Hospital Center in Arlington.

The TIF procedure is less aggressive and patients enjoy an easier recovery, so it is easier for referring doctors—otolaryngologists—to make the leap and offer it as a treatment option for patients with atypical GERD symptoms, said Dr. Gillian. “Surgeons understand that atypical and typical GERD symptoms are usually caused by structural defects, and a proper durable repair can eliminate the symptoms when medical management is not working.”

The recommended surgeon should have experience in performing both the TIF and Nissen procedures, he added, so the patient has a full range of options to make an informed choice. For optimal results, “it’s very important that they go see somebody who is a regional expert in reflux surgery, so they can give the patient the option that is most likely to succeed based on their particular anatomy.”


Disclosures: Dr. Wilson is a consultant for EndoGastric Solutions and is currently participating in one of the company’s research trials. Dr. Trad is on the EndoGastric Solutions speakers’ bureau and receives honoraria from the company for lectures and consultancy work.

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