An innovative incisionless surgical solution for patients with chronic GERD
Gastroesophageal Relfux Disease (GERD) effects between 10 percent and 20 percent of Americans. Symptoms vary from classic heartburn and regurgitation to chronic cough, chest pain, hoarseness and even asthma.
Complications of GERD include esophagitis, esophageal stricture, Barrett’s Esophagus and esophageal cancer. There is a wide range of patient responses to medications alone, including failures and partial responders. Others do not wish to accept the albeit small, but long-term, risk of chronic medication use, such as Proton Pump Inhibitors (PPI).
Patients have been considered for surgical management of GERD when they experience persistent symptoms despite medication, develop complications of GERD, have extraesophageal manifestations or wish to discontinue medications. Historically the surgery of choice has been fundoplication.
Fundoplication procedures have been available for more than 50 years. Fundoplication aims to bolster the Lower Esophageal Sphincter (LES) by way of wrapping the gastric fundus, to some degree, around the Gastroesophageal Junction (GEJ) and restoring the physiologic valve to prevent reflux episodes. Along with the standard potential for surgical complications, common side effects of traditional fundoplication include dysphagia and gas/bloat. There is also a 5 percent to 10 percent risk of requiring reoperation and up to a 60 percent likelihood of requiring medication therapy within 5 years postoperatively.
The transoral incisionless fundoplication (TIF) procedure is a novel approach to fundoplication that is performed endoscopically. The EsophyX device is introduced through the patient’s mouth, under general anesthesia, not through an incision.
The TIF procedure performs a partial fundoplication and can reduce a small hiatal hernia, restoring natural anatomical geometry. Under direct visualization, provided endoscopically, the EsophyX device engages the GEJ using a helix. The GEJ is then retracted into the tissue mold as the esophagus is lengthened and any hiatal hernia is reduced. Fasteners are then deployed at various locations around the circumference in order to accomplish an approximate 270 degree wrap.
The procedure generally takes 30 to 60 minutes, and most patients are discharged the same day or within 24 hours. Patients can return to work immediately and most normal activities within a few days. Patients will require a modified diet and some limitations on physical activity during the few weeks following TIF to allow for complete healing.
The TIF procedure has been FDA cleared since 2007 and performed more than 20,000 times across the world. Procedural complication and severe adverse events occur under 0.5 percent. Clinical studies show two-thirds of TIF patients remain off daily PPIs at 5 years following the procedure, with 81 percent showing elimination of regurgitation and 80 percent showing elimination of atypical symptoms. Furthermore, the TIF procedure has repeatedly proven to avoid post-fundoplication symptoms such as gas bloat, flatulence, dysphagia and diarrhea.
The patient’s gastroenterologist can quickly assess the patient’s candidacy for the TIF procedure. Candidacy requires objective documentation of GERD by the presence of erosive esophagitis on endoscopy and/or abnormal pH study. TIF can be performed in a patient with a small hiatal hernia of <2 cm. The hiatal hernia can be assessed at the time of endoscopy and/or with barium swallow.
In summary, the TIF procedure is a novel, effective, safe surgical option for patients with GERD who have difficult symptoms to control, developed complications of the disease and/or wish to discontinue medical therapy.
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EndoGastric Solutions, data on file
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Trad KS et al. The TEMPO Trial at 5 years: Transoral Fundopplication (TIF 2.0) is Safe, Durable, and Cost Effective. Surgical Innovation. 2018