The TIF 2.0 procedure using the EsophyX Z+ device is shaping the future of GERD treatment. Innovators discuss the latest clinical results and how TIF 2.0 can be used in a broader spectrum of patient populations.
This edition of the Digestive Disease Week (DDW) Product Theatre, sponsored by EndoGastric Solutions (EGS), occurred on Sunday, May 19, 2019 with a theme of Shaping the Future of Gastroesophageal Reflux Disease Specifically with Transoral Incisionless Fundoplication using the EsophyX Device. The expert panel was coordinated by Dr. Adrian Lobontiu, Chief Medical Officer at Endogastric Solutions, with the aim to provide an overview of the latest clinical data on the TIF procedure with the EsophyX device. The panel also reviewed the evolution of transoral incisionless fundoplication, not only in terms of symptom control, PPI usage and patient satisfaction, but also looked at an objective measure of pH control, which is very important in the advancement of TIF 2.0 procedures.
Evolution of TIF Procedure and Data
Barham Abu Dayyeh, MD, MPH, FASGE
Director of Advanced Endoscopy, Consultant, Division of Gastroenterology and Hepatology, Department of Internal Medicine
Mayo Clinic, Rochester, MN
Dr. Barham Abu Dayyeh, is a Gastroenterologist from the Mayo Clinic, Division of Gastroenterology and Hepatology, Rochester, Minnesota. He is the Director of Advanced Endoscopy and Associate Professor at the Mayo Clinic.
In this portion of the presentation, Dr. Abu Dayyeh opens by emphasizing that gastrointestinal reflux disease, or GERD, is not a hypersecretory disorder, but rather an anatomical disorder, by way of a defect in the barrier that prevents reflux between the stomach and the esophagus, and needs to be treated as such. He further states that GERD is a spectrum disease, where milder cases can be effectively managed with PPI, unless the patient doesn’t want this as a long-term treatment option, or when anatomical changes of the GE junction increase the severity of GERD and require a procedure to repair the barrier function of the GE junction.
Dr. Abu Dayyeh, goes on to emphasize the importance of accurately classifying the Hill Grade, or shortening of the slip valve function during inspiration/expiration to determine the correct course of treatment. A normal Hill Grade I occurs when GE junction is hugging the endoscope, in a retroflexed, insufflated position, and there are no gaps, indicating the patient could be a good candidate for PPI treatment. A Hill Grade II occurs when there is a slight shortening of the slip valve function, observed through a few cycles of inspiration and expiration, where the valve attempts to intermittently open and shorten, indicating a mild defect in the hiatus, which could likely be successfully addressed with a transoral incisionless fundoplication, or TIF procedure. A Hill Grade III is a gray zone, where there is a complete effacement of the valve function, with a constitutively open valve, meaning that the hiatus may require surgical repair concomitantly with a TIF procedure, if the threshold of the opening is beyond 2cm. With a Hill Grade IV, there is a herniation of this entire complex above the diaphragm, indicating the necessity of a concomitant hiatus repair plus a TIF procedure.
Dr. Abu Dayyeh then looks at the history of the TIF procedure and EsophyX device over time with the first generation producing a gastro-gastric plication. He outlines how the device evolved to the TIF 1.0 procedure that is now enabling a gastroesophageal plication, not just a gastro-gastric plication. The most recent iteration, which is the TIF 2.0, produces a gastroesophageal plication creating a 270 degree wrap function with a 3cm high pressure zone. Dr. Abu Dayyeh cites a round of related studies, including a recently published article in Gastrointestinal Endoscopy of which he is a co-author, demonstrating the increasing efficacy and safety of a TIF 2.0. Most of the literature reports rates of healed erosive esophagitis that have ranged between 70% to 94% and with the rate of PPI discontinuation after the procedure that goes from 59% to upwards of 74% from the trial data. Even with longer term data (up to 10 years), generally the rate of PPI discontinuation continues to be about 60% to 70% and patient satisfaction continues to be high.
pH, Concomitant Hiatal Hernia Repair and Transoral Fundoplication
Glenn Ihde, MD, Board Certified General Surgeon
Matagorda Medical Group
Bay City, TX
Dr. Glenn Ihde is a surgeon in the Houston metro area, Texas. He has significant experience with the transoral incisionless fundoplication (TIF) procedure having performed more than 650 TIF procedures in his career. These are a combination of primarily concomitant hiatal hernia repairs with some straight TIF procedures and revision of failed laparoscopic Nissens.
Dr. Ihde discusses his recent paper focused on the pH score in hiatal hernia repair with transoral incisionless fundoplication and how his team derived this study. He opens by distinguishing that hiatal hernia repair and the TIF are really two procedures. He states that TIF follows the principles of anti-reflux surgery by fixing the fundus to the esophagus without a stricture, because the size of the EsophyX device is made to create a 3 cm fundoplication below the diaphragm creating a Nissen-type wrap that also mimics the pressure characteristics of the Nissen fundoplication.
Like Dr. Abu Dayyeh, Dr. Ihde emphasizes the importance of determining which patients would require hiatal hernia repair, using the Hill Grade as a key indicator, due the fact that GERD is a spectrum disease. However, great care must be taken when assessing the Hill Grade to determine when the hiatal hernia becomes symptomatic as many physicians cannot agree on what constitutes a Hill Grade III, often under-grading or deferring a required hiatal hernia repair. Dr. Ihde asserts that more accurate assessments of the Hill Grade were determined when the endoscopy was performed under IV sedation. He further emphasizes that the scope should be in retroflex, for a more accurate measurement instrument and that the occurrence of regurgitation should bias towards hiatal repair.
Dr. Ihde then proceeds to examine the efficacy and safety of TIF starting with the registry created in 2012 and noting improved patient outcomes in the next 3-5 years as the thinking among physicians matured, giving more consideration to the hiatus, proving TIF to be a safe and cost effective replacement of the Nissen fundoplication. In 2017, there was expanded labelling for the EsophyX device allowing Dr. Ihde and his team to study the effects of TIF following an effective hiatal repair. The study was conducted over 2 years with 97 patients who had been on PPIs for an average of 10 years, 61% were female with a median age of 59 and a median BMI of 28, endoscopically examining the following the criteria: Z-line, LA Grade, Hill Grade, axial displacement and most significantly, the greatest transverse diameter or how wide the hiatus was.
Of the portion of those patients who had a hiatal hernia repair coupled with a TIF procedure (n=55), where the team could match a pre-op and post-operative study (n=29), all patients experienced significant improvement in HRQL, RSI and pH, as a matter of fact, normalizing those patients. No serious adverse events, correlation to bloating or dysphagia were reported, as would often be associated with Nissen fundoplications. For the few patients with abnormal pH, that could be followed up for study, there was a recurrence of the hiatal hernia and one case of gastritis, and after these issues were addressed pH normalized and the anatomy remained intact. Although these were excellent outcomes overall, Dr. Idhe admits that more study needs to be done to determine why the hiatus fails or fails after a repair.
TIF 2.0 and Endoscopic Foregut Surgery: A Broader Perspective
Kenneth Chang, MD, FACG, FASGE
Professor and Chief, Division of Gastroenterology and Executive Director of the H.H. Chao Comprehensive Digestive Disease Center
UCI School of Medicine
Dr. Ken Chang is the Director of the Chao Comprehensive Digestive Disease Center and Professor and Chief of Gastroenterology at UC Irvine Health. He is also Endowed Chair on Gastrointestinal Endoscopic Oncology with a 30-year career in GI.
Dr. Chang opens by stating that everything that a foregut surgeon would traditionally see is going to endoscopy: GERD, achalasia, Barrett’s, gastric cancer, gastric obstruction and obesity. This is allowing gastroenterologists the ability to step much further into the foregut intervention space, which is an exciting aspect of TIF, endoscopy, and endoscopic foregut surgery. He further emphasizes, like Dr. Abu Dayyeh and Dr. Ihde, that GERD is a spectrum disease requiring personalized treatment. Although acknowledging the importance of the lower esophageal sphincter (LES), he states that the crus of the diaphragm is equal, if not more important, to the sphincter acting as an antireflux barrier; which is one of three components that need to be considered to address GERD, along with the presence of a hiatal hernia and an augmentation of the LES. To address a hiatal hernia, the main options considered are the Nissen, LINX, a partial fundoplication, or the increasingly popular hiatal hernia repair concomitantly with a TIF procedure, as discussed by Dr. Ihde.
Dr. Chang then presents a video demonstration where a patient is being assessed for endoscopic treatment, denoting how a Hill Grade I can actually be seen as a Hill II-A or B when air or C02 is continuous blown on it, and ultimately a Hill III when approached closer. For this patient, the crura is defective and needs to be repaired, placing it way beyond an endoscopic approach. For those patients with Hill I and pH study indicating they are a daytime refluxer, or if their LES is slightly loose and a Hill II, they do very well with a TIF procedure.
Dr. Chang then elaborates on the mechanics of the TIF procedure, which is conducted under general anesthesia. The EsophyX device is retroflexed and grabs the GE junction with a helical retractor which then extends the esophagus, creating a little funnel or flap valve with the device. Half of the wall is esophagus and the other half is stomach, held in place by H-shaped fasteners. Over time, the cirrhosis will fuse and the valve usually stays robust for years to come. Aside from using TIF alone, TIF can be applied with a hiatal repair, to Barret’s patients to get them off lifelong PPIs, in conjunction with an endoscopic sleeve gastroplasty to treat obese patients, to achalasia and post-POEM GERD or post-Heller GERD; as well as to Failed Nissen, failed LINX, and failed Stretta procedures.
Dr. Chang then uses another example, depicted again in a video, of a patient who had Barrett’s and T1 cancer. His team did EMR and RFA, and did reach CRIM, but the patient had double dose PPI and still suffered from symptoms of regurgitation and didn’t want to go to surgery. He demonstrates the application of the fasteners, pulling the valve and creating length, typically using up to 20 plications, with the notion that using more fasteners helps to create a very robust and good-looking valve.
Dr. Chang uses yet another video example to demonstrate a hiatal hernia repair, conducted by Dr. Ninh Nguyen (Surgery Chair, UC Irvine) concomitantly with a TIF procedure, conducted by himself. In this example, the patient suffers from longstanding GERD with a Hill grade IV, three-centimeter hernia, but did not want the Nissen fundoplication, and couldn’t afford the LINX procedure. The crura are repaired laparoscopically with three or four interrupted sutures, secured by an absorbable mesh to act as scaffolding to prevent the hernia from opening up again. The hiatal repair is immediately followed by a TIF procedure. Dr. Nguyen compares the final overall result to a Nissen, proclaiming: “It’s not a valve [the Nissen]. It’s just a high-pressure zone. With this [TIF] you’re recreating the valve.”
Dr. Change concludes that TIF can be used to address the issue of GERD post-POEM (pre-oral endoscopic myotomy) which is becoming a real issue as POEM increases in popularity. POEM has shown to be great at relieving dysphagia and possibly even better than the lap-Heller combination with partial fundoplication. Using POEM alone is more likely to develop GERD compared to the Heller myotomy plus fundoplication. In such cases, TIF represents a viable compliment to the endoscopic approach for achalasia, jackhammer esophagus, and so on. In about 10% of our POEM patients, Dr. Chang considers a TIF. He also notes the success of “rescue TIFs” for failed Stretta and LINX procedures. Dr. Change summarizes, “that the endoscopic fundoplication, in and of itself, is exciting, but in the context of endoscopic foregut surgery and interventions, I think it really represents a major step forward for endoscopy.”
Full program recorded at 2019 DDW Product Theater 1 Sunday, May 19, 2019.
View the program in its entirety below, with introductions by Dr. Lobontiu and presentations by Drs. Abu Dayyeh, Ihde, and Chang. At the conclusion of these three presentations, Dr. Lobontiu directs questions from the audience to the panel members pertaining to the necessity for pH studies pre and post TIF. Dr. Ihde sums up the panel conclusion that “symptom control and controllers of esophagitis are really the landmarks,” to indicate as successful and sustainable TIF procedures. Another question comes up regarding the effectiveness and safety of follow-up pH studies post-POEM on patients with aperistalsis. Dr. Chang responds that, “none of us after reaching CRIM will put the patient on PPI and repeat a Bravo to make sure their acid is completely controlled.”