Dr. Ken Chang is a Gastroenterologist and the Chief of the GI Division and Director of the Comprehensive Digestive Disease Center at UCI Medical Center. Dr. Ninh Nguyen is the Chief of Gastrointestinal Surgery and the chair of the Department of Surgery at the Comprehensive Digestive Disease Center at UCI Medical Center. In this series of videos Drs. Chang and Nguyen discuss an interesting case of a 55-year old female patient with a hiatal hernia repair followed by a transoral incisionless fundoplication (TIF) performed concomitantly. The first series of videos features Drs. Chang and Nguyen discussing various dynamics of the procedures. The final video is the actual two-stage operation they are referring to in the interview segments.

UC Irvine Reflux Center-A Multidisciplinary Patient-Centric Approach (4:09)

G.I. surgeon, Dr. Ninh Nguyen, M.D., and Gastroenterologist, Dr. Kenneth Chang, M.D., discuss the collaborative approach at the University of California Irvine Reflux Center for treating patients who are suffering from both a hiatal hernia and gastroesophageal reflux disease (GERD). Dr. Nguyen explains that the process for a patient admitted to the Reflux Center for surgical consideration starts with patients being taken through an evaluation by a Gastroenterologist. He explains how many patients are well informed regarding the nature and treatment options for their conditions, particularly hiatal hernias and acid reflux issues. Transoral incisionless fundoplication (TIF) can be a good option for treating GERD, but many patients also suffer from a hiatal hernia, which can be effectively treated concomitantly, but requires the G.I. surgeon and the G.I. doctor to closely collaborate. This multidisciplinary approach provides the most effective and efficient patient care. Dr. Chang further explains that there is a great deal of variance between cases, requiring a seamless ebb and flow between the medical specialists to achieve the desired successful outcome and discharge the patient within 24 hours.

Presenting Personalized Treatment Options for Chronic Reflux Patients (2:39)

Drs. Nguyen and Chang identify and explain the selection process for 3 primary treatment options for chronic reflux patients: 1) hiatal hernia repair with a concomitant Linx procedure; 2) hiatal hernia repair with an anti-reflux operation like a Nissen fundoplication; 3) laparoscopic hiatal hernia repair with a TIF procedure. In this example, Dr. Chang has careful consultations with the patient, factoring in her age, which is 55 years-old with 30 years in front of her, and the durability of each treatment option in this time span. Dr. Chang explains that with a Nissen fundoplication the durability is approximately 8-10 years, raising the possibility of a redo, which has a lower success rate and this procedure also has the highest gas-bloat rate. He says a Linx procedure is slightly less prone to gas-bloat issues and is somewhat more durable due to the use of earth magnets, but there are issues of MRI compatibility and the possibility of demagnetization of the device. Dr. Nguyen adds that there is also the issue of authorization, which is not uniform for the Linx procedure. Dr. Change states that the TIF procedure is by far the least susceptible to gas-bloat and that we have good durability data for 5 years, but beyond this timeframe there is some uncertainty; however, TIF allows for maximum flexibility with the option of TIF tightening or other future procedures.

Why Choose A Concomitant Laparoscopic-Endoscopic Approach for GERD patients (1:30)

Dr. Chang asks Dr. Nguyen to explain some of the dynamics of various surgical options to address a GERD condition when a surgeon is already operating on a hiatal hernia. Dr. Nguyen responds by stating that there is an issue with insurance coverage for the Linx procedure, and he further cautions against the Linx procedure for patients with a lot of spinal issues, or some other condition requiring frequent MRIs due to interference from the magnetic bands in Linx, and the dysphasia rate for Linx is higher than a Nissen fundoplication or the TIF procedure. Dr. Nguyen affirms that the Nissen fundoplication is a good procedure, but due to the shortened esophagus resulting from a large hiatal hernia, the option for a TIF in combination with a hiatal hernia repair is very attractive because you don’t have another clear option for an anti-reflux procedure.

Why GERD Patients are Attracted to the TIF Procedure (1:48)

Dr. Chang explains that as a Gastroenterologist, many patients come to him having heard or read about the TIF procedure believing that it will likely be a good fit to address their GERD condition. It is important, however, to inform them that they need to go through a proper endoscopy and PH monitoring evaluation to see if they are indeed a good candidate for TIF. He further explains that the situation can be complicated by a large hernia, for example, which after establishing a comfort level with the Gastroenterologist is a “bit of a downer” for the patient, as they could now be handed off to a surgeon to do something very different. This is where having a colleague who is a surgeon, and who understands that GERD is a spectrum that can have various complicating factors, and who can work concomitantly with the Gastroenterologist is very beneficial both for the effectiveness of the overall procedure and the patient’s comfort level in the operating room.

TIF Procedure Data Overview (0:59)

Dr. Nguyen asks Dr. Chang to go over the best available data regarding the TIF procedure, irrelevant of the hiatal hernia repair. Dr. Chang states that if we look at all the clinical trials, with several level 1B randomized control trials, the data shows that 72 percent of TIF patients can have dramatic relief of symptoms and be completely off their PPIs at one year. The efficacy of TIF is strong, but not as high as a laparoscopic Nissen, but for most patients TIF is enough for them to have relief of troublesome symptoms, get off their PPIs (a concern for many patients) with the added flexibility of options for the future.

Measuring and Documenting Hiatal Hernia Defect (1:56)

Dr. Nguyen opens the discussion regarding a patient who has had an upper GI which indicates that the patient has what looks like a rather large paraesophageal hiatal hernia. On the endoscopy, it’s 3cm, but it also has a Hill-grade 3 which indicates it’s a rather large hiatus. Dr. Nguyen asks Dr. Chang how he considers the Hill-grade vs. the hiatal distance. Dr. Chang explains that physicians can be fooled regarding the severity of the hiatal hernia if they only look at the vertical length measurement of the hernia. The width of the diaphragmatic hiatus opening is as important, or perhaps more important. In this case, with a Hill-grade 3, you’re just getting a snapshot of the hernia in endoscopy. This is a dynamic situation; the hernia could be in its resting state or sliding higher. Dr. Chang places a lot of weight on the Hill-grade. Dr. Nguyen emphasizes that is an important consideration, as a TIF procedure can be applied up to a 2-centimeter hiatal hernia, but in this case, it’s a 3-centimeter hiatal which would rule out a TIF procedure.

Anatomical Considerations Shortened Esophagus in GERD patients (2:56)

Dr. Nguyen asks Dr. Chang to explain the strategic options for a GERD patient with a shortened esophagus. Dr. Chang agrees that patients with chronic GERD or a Barrett’s esophagus, in this case the patient had 1cm of Barrett’s esophagus, it is common to have a foreshortened esophagus which increases the risk of recurrence for a hiatal hernia. In this situation, the TIF procedure may be advantageous, and there are other emerging endoscopic approaches for patients who have failed a Nissen fundoplication due to a foreshortened esophagus. Dr. Nguyen adds that there is only so much that can be done to surgically lengthen the esophagus. He says they can mobilize the esophagus, but with a very large hiatal hernia they cannot always achieve the 3cms they need to create an adequate fundoplication, limiting the surgical options to a Collis gastroplasty. However, this increases the risks of the procedure especially for elderly patients, such as the risk of leakage at the level of the staple line. You must weigh the risks and benefits when considering this procedure.

Logistic Considerations of a Laparoscopic and Endoscopic approach (1:50)

Drs. Chang and Nguyen discuss the logistics of coordinating GI surgery and GI endoscopy as this is a common concern many physicians have expressed. Dr. Nguyen notes that the biggest hurdle is coordinating the schedules for the surgeon and the Gastroenterologist to be in the same room at the same time. He explains that the laparoscopic surgery usually takes about an hour and everything is in place to move the endoscopic cart into position to seamlessly transfer to the TIF procure. Everything is set-up, the patient is under general anesthesia and remains in the supine position. Dr. Chang adds, they tilt the operating table and the head of the patient slightly, there is no need for repositioning and the endoscopic portion is completed within about 25 minutes.

Utilization of Mesh for Hiatal Hernia Repair (1:19)

Dr. Chang asks Dr. Nguyen to explain how the usage of mesh impacts the recurrence rate in a hiatal hernia repair. Dr. Nguyen refers to randomized trials using a biological mesh vs. no mesh and asserts that there is improvement in the earlier recurrence rate; however, at the 5-year mark the recurrence rate is similar using mesh vs. no mesh. Dr. Nguyen feels that the type of mesh used today is an improvement over the type of mesh used in the past, in that is has more integrity to provide a scaffold for tissue growth to develop in the affected region. Dr. Nguyen likes to use bio-absorbable mesh as opposed to synthetic mesh, which has been known to cause erosion of the esophagus.

Chang Nguyen discuss HHR-TIF procedure (19:51)

View the complete interview with Drs. Chang and Nguyen as they discuss the multidisciplinary, patient-centric approach at the University of Southern California Irving Health Center for addressing hiatal hernia repair concomitantly with a transoral incisionless fundoplication (TIF) procedure.

Chang Nguyen HHR-TIF procedure (39:00)

View the actual hiatal hernia repair with a concomitant TIF procedure, referred to in the interview segments above, by Drs. Nguyen and Chang. Note how the hiatal hernia is larger than it appeared in the assessments. Dr. Nguyen exposes the area to be worked on, similar to a Nissen fundoplication, so the bio-degradable mesh can be accurately situated and the esophagus lengthened through elevation. The mesh will be absorbed by the body within about 6 weeks, but will leave a nice “scaffold” of the patient’s own tissue to help prevent a recurrence of the hiatal hernia.

After the hiatal hernia repair is completed, Dr. Chang takes over to conduct the transoral incisionless fundoplication, or TIF 2.0. This patient wanted to avoid the serious side effects of a Nissen fundoplication, opting for a TIF procedure. Dr. Chang deploys the Esophyx® device with a cartridge of 20 SerosaFuse® Fastener implants, inserted through an endoscope for the TIF procedure. Each phase of the TIF procedure is highlighted in detail in this video from the preparation of the device through to the post-TIF EGD; which, is “recreating the valve,” according to Dr. Nguyen, who was observing the procedure, rather than simply creating a “high-pressure zone” as is the case with a Nissen fundoplication. The video concludes with some indications, contraindications and risks associated with a TIF procedure using the Esophyx® device.


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