Q&A: TIF may improve quality of life in patients with reflux symptoms
Researchers introduced transoral incisionless fundoplication to treat reflux disease in 2006.
Since then, EndoGastric Solutions developed the EsophyX device, prompting the use of four different procedures with each yielding very different results.
Healio Gastroenterology spoke with Glenn M. Ihde, MD, on the evolution of EsophyX for the treatment of reflux disease and recent developments in the outcomes.
Healio: What stages of evolution has TIF undergone since 2006?
Ihde: Since the initial introduction, there have been changes in both the device and the technique. Device improvements have improved safety, ease of use and reproducibility. The technique has transitioned from endo-luminal fundoplication (ELF) to TIF 1.0 and later TIF 2.0. TIF 2.0 allowed for the creation of a standardized esophago-gastric fundoplication. Studies of ELF in 2006 allowed for introduction into the United States with FDA 510(k) clearance, which was obtained in 2007. Today, with both TIF and TIF concomitantly performed with laparoscopic hiatal hernia repair (LHHR), we are able to adequately control reflux disease across a wide spectrum of patients.
The TIF 1.0 procedure was a longitudinally oriented application of gastric cardia onto the distal esophagus just proximal to the gastroesophageal junction. A later iteration, TIF 2.0, incorporated a rotational wrap of the cardia and fundus around the circumference of the distal esophagus in addition to providing a 2 cm to 4 cm length of the wrap over the intra-abdominal distal esophagus. It was this procedure that was identified as morphologically and physiologically most similar to the Nissen fundoplication. In 2017, the FDA granted a modification of the instructions for use to allow concomitant hiatal hernia repair with TIF. This modification allowed TIF to be performed immediately after hiatal repair, similar to what was routinely performed in any other fundoplication procedures.
Healio: How has the EsophyX device evolved?
Ihde: There are three significant iterations of the device; the original EsophyX device, EsophyX2 and EsophyXZ. Improvements to the design have created an easier to use, more automated device to ensure a uniform, faster and more reproducible fundoplication.
The original device included an over tube body that an endoscope would fit through, to be used for visualization of the device function. A cable with a helical screw was used to engage and hold one of the tissue planes while the end of the device folded upon itself to provide approximation and compression of the second tissue plane to the first just prior to placing a Polypropylene ‘H’-shaped fasteners — now called SerosaFuse fasteners. The next generation, EsophyX2, included a cartridge design that was created to allow the fasteners to be snapped onto a stylet and advanced manually.
The next significant upgrade to the device incorporated a change to the folding end. Previously, the distal end was secured to the endoscope with a silicone retaining cord. A molded plastic tongue projected to one side of the endoscope and is referred to as the “tissue mold.”
This configuration changed with the EsophyXZ device, which tubularized the tissue mold — allowing the endoscope to go through the tissue mold, streamlining the end of the device with the endoscope. This was felt to be a major safety feature as it shielded surrounding tissue from the advancing stylet, which then allowed users to wrap tissue and create a more robust fundoplication.
Healio: What procedures have emerged using this device?
Ihde: Over the years there have been three procedures that evolved from the original ELF procedure: TIF 1.0, TIF 2.0 and the combined laparoscopic hiatal hernia repair with transoral incisionless fundoplication 2.0 (HH-TIF).
The initial device described above was used to perform the endoluminal gastro–gastric fundoplication, ELF. This demonstrated the ability of the device to safely manipulate and suture gastric to gastric tissue but did not yet develop a significant clinical application.
Device improvements and procedure evolution from ELF to TIF 1.0 to the currently performed TIF 2.0 as well as hernia repair plus TIF 2.0 allowed clinicians to create a durable and reproducible esophago-gastric fundoplication.
Healio: What do the results say about TIF 2.0?
Ihde: A review of the studies presented suggests that, compared with traditional laparoscopic fundoplication, TIF 2.0 and hiatal repair with TIF 2.0 offer greater safety and side effect profiles with equivalent outcomes and durability.
These findings indicate that the TIF 2.0 procedure is poised to significantly alter the traditional spectrum of care. For patients who fail to get off of medical therapy after a 6-month trial of increasing medical care, TIF can restore the angle of His and improve the lower esophageal sphincter function necessary to control reflux symptoms, heal esophagitis, and allow discontinuation of medications. Patients who have a hiatus greater than 3 cm in diameter, as measured with a retroflexed endoscope, can undergo laparoscopic HH repair with TIF.
The combined laparoscopic and endoscopic approach has fewer and less comprehensive studies to date, but, in available studies, appears to have similar outcomes in symptom control, safety, and normalization of esophageal pH without causing the bloat syndrome side effects that deterred patients from anatomic repair in the past.
Healio: Will there be future research on the device and procedure?
Ihde: Future research on the procedure will add to the robust and growing body of clinical data that demonstrate that straight TIF and TIF in conjunction with HH repair are shown to improve quality of life and allow most patients to completely come off or significantly reduce their proton pump inhibitor medications.
I, as well as other clinicians, are exploring how the TIF procedure can be used in adjacent patient populations. These include TIF as a revisional procedure in patients with prior reflux surgery, TIF in patients requiring obesity surgery who may suffer from reflux, and TIF in patients who have had a peroral endoscopic myotomy procedure.
These studies and others will continue to provide gastroenterologists and surgeons with up-to-date information on the procedure, and its evolution, which they can use to support clinical decision-making in the treatment of GERD.