Dr. Kenneth Chang is a Gastroenterologist and the Chief of the GI Division and Executive Director of the Comprehensive Digestive Disease Center at UCI Medical Center in Irvine, California. Dr. Chang is a fellow of both the ACG and AFGE and a Professor of gastroenterology and hepatology at the UCI School of Medicine. In this webinar, Dr. Chang shares his experience with endoscopic treatment for GERD using transoral incisionless fundoplication, or TIF, focusing on when, why and how this procedure can be successfully accomplished. Highlights of the webinar are broken down into a few short segments below, followed by the webinar in its entirety.

Webinar Highlights

GERD Surgical Candidacy Criteria

While looking at various patient profiles for GERD, Dr. Chang highlights how a great many patients can have a very normal looking anatomy, citing a recent study of 918 patients with a very abnormal DeMeester score and who clinically had GERD, about 40-45 percent had a normal looking anatomy, with a normal ileus, no hiatal hernia, and no open diaphragmatic hiatus. Dr. Chang delves into how determining the appropriate procedure for addressing GERD comes down to two main factors: 1) Baseline endoscopy, where the length of hernia is measured, as well as the Hill grade, or diaphragmatic hiatus and whether there’s the presence of esophagitis and the LA Class A, B, or C. 2) The ambulatory PH study, done through a trans-nasal catheter or, preferably, the wireless telemetry with the Bravo PH capsule to confirm the objective presence of GERD, and to further assist in selecting the appropriate procedure, regarding upright vs. supine reflux, with criteria as to when esophageal manometry can be avoided. Using 3D graphics and endoscopic footage, Dr. Chang walks through Hill grades 1-4, noting the distinctions and endoscopic vs. surgical treatments for each grade. Finally, Dr. Chang demonstrates how to classify patients on the spectrum of GERD and whether an endoscopic TIF would be appropriate, or if a surgical option is required.

Evolution of the TIF procedure

Dr. Chang reviews the current EsophyX® TIF procedure, explaining how the H-shaped fasteners fuse serosa to serosa, so that even if these fasteners come off, the serosal fusion maintains its long durability. Furthermore, the TIF procedure creates about a 270-degree-wrap, and has various similarities in mechanisms to the Nissen Fundoplication, which is a 360-degree-wrap.

Dr. Chang then walks through the evolution of TIF, starting with the ELF procedure, which was mostly done in Europe, and which avoided putting fasteners through the esophagus, but rather in the gastric cardia. Although ELF did produce a high-pressure zone, it was all in the stomach rather than the sweet spot it needs be in at the Ge-junction. He then describes the TIF 1 procedure, which included grabbing the esophagus, pulling it down, and then placing the fasteners through both the esophageal and gastric walls. TIF 1 got the high-pressure zone closer to the Ge-junction, but did not include a wrapping component. With the TIF 2, which is our current technique, it includes both lengthening and coupling the esophagus and the stomach, but also has a wrapping component to it, like the traditional gold standard: the Nissen Fundoplication.

Recurrent GERD Symptoms

Dr. Chang notes that a sizeable majority of patients have positive outcomes with a TIF, where they discontinue PPI therapy (90%), resolve typical symptoms (80%), experience normalized or improved GERD-HRQL and RSI scores (71%) and normalized PH (83%), all without the side effects commonly associated with a Nissen, such as dysphagia, bloating, or flatulence. However, if 2 or 3 years after a successful TIF a patient reports a return of reflux symptoms, Dr. Chang looks at options to reassess and replace some fasteners, which is straightforward. Patients typically have a good response to a redo with a TIF, as opposed to a Nissen redo, which Dr. Chang asserts is a significant advantage of the endoscopic treatment. If the patient didn’t respond to the first TIF, Dr. Chang will then escalate to surgery.

Dr Kenneth Chang Webinar on Treating GERD Symptoms with TIF Procedure

View the full webinar, with the above excerpts in context, as Dr. Chang provides a detailed overview of the TIF procedure with the EsophyX® device as a viable treatment option among a significant portion of GERD patients; yielding excellent results, both initially and in redo situations, without the side effects of Nissen Fundoplication. Dr. Chang denotes his criteria for endoscopic treatment options for patients with varying degrees of symptoms on the GERD spectrum. After his presentation, Dr. Chang fields questions from an audience of predominantly surgeons and gastroenterologists ranging in topics from addressing mild esophagitis, to manometry, to accurately measuring a hiatal hernia and ending with an interesting exchange with Dr. Glenn Ihde MD regarding using cricoid pressure to allow better distension of the Ge-junction for accurate Hill grade measurement.

Dr. Kenneth J. Chang MD, FACG, FASGE is an accomplished Gastroenterologist and the Executive Director of the H.H. Chao Comprehensive Digestive Disease Center as well as Chief and Professor, Division of Gastroenterology and Hepatology, Department of Medicine, UC Irvine School of Medicine, Irvine, California.


About GERD
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.

About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.

Over 25,000 TIF procedures have been performed worldwide. More than 140 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.

About Reimbursement
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.

For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.

About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.

The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.

About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.

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Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867