This co-sponsored event (EGS and Medtronic) provided a clinical update on the management of reflux disease from diagnosis to therapy and was led by experts who discussed optimal methods and best practices for patient care. Below are two highlighted segments.

1. Minimally Invasive Fundoplication for Chronic Acid Reflux

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. Abu Dayyeh provides a thorough overview of transoral incisionless fundoplication (TIF) as a safe and effective treatment option for many patients suffering from gastroesophageal reflux disease (GERD), outlining how this increasingly popular procedure fits in the patient’s spectrum of care. He emphasizes that GERD is not a hyper secretory disorder, resulting from parietal cells making too much acid, and that about 10-40% of patients with GERD fail to respond symptomatically, either partially or completely, to standard-dose PPIs. This is because GERD is an anatomical breakdown resulting in a movement of the esophagus both axially and longitudinally creating a gap at the opening of the hiatus, which needs to be addressed with various treatment options depending primarily on size of the opening, or Hill Grade.

If PPIs are not working, or the patient wants to discontinue PPIs, a patient accurately assessed as having a Hill grade 2 is a good candidate for a minimally invasive procedure such as transoral incisionless fundoplication. TIF can also be effective for Hill Grade 3 patients, but patients with a Hill Grade 4 would most likely require a hiatal hernia repair, which can be applied concomitantly with a TIF. Dr. Abu Dayyeh outlines the evolution of treatments leading up to the current version of TIF 2.0 using the latest Esophyx Z device, with detailed demonstrations and highlights of the procedure, and a caveat that some of the literature still has not caught up to the current version of TIF. He provides success rates for TIF, where two thirds of patients stayed off PPIs for at least five years during the span of the supporting data. Dr. Abu Dayyeh concludes by noting that for about 22,000 cases of TIF, the serious adverse event rate (SAE) was 0.4%, which is on par or better than the safety profile of a colonoscopy.

DOWNLOADABLE PDF
View the complete slide deck for Dr. Abu Dayyeh’s presentation including:
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  • Supporting references regarding the failure rates for PPIs
  • Where TIF fits into the spectrum of care for GERD patients
  • Visual representations of Hill Grades 1-4
  • How an endoscopic approach emulates traditional surgical principles
  • Evolution of the TIF procedure, supported by the development of the EsophyX® device
  • Details and images for restoring the GE Junction with a TIF
  • Supporting data on the efficacy and safety of TIF
  • Special considerations and other applications of TIF

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2019 CPT Quick Coding Reference

Minimally Invasive Fundoplication for Chronic Accid Reflux

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2. Clinical Dilemmas in GERD Discussion–Panel Members:

  • Anish Sheth, MD, Chief of Gastroenterology, Director, Digestive Health Center, Penn Medicine, Princeton Health, Plainsboro, NJ
  • Abraham Khan, MD, Director, Center for Esophageal Disease, Assistant Professor of Medicine, NYU Langone Health, New York, NY
  • Amir Masoud, MD, Associate Program Director, Gastroenterology Fellowship Program Director, Temple Endoscopy Center, Yale School of Medicine, New Haven, CT
  • Barham Abu Dayyeh, MD, MPH, FASGE, Director of Advanced Endoscopy, Consultant, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, MN

This panel of leading experts in the field of gastroenterology examined three cases of moderate to severe gastroesophageal reflux disease (GERD) with various symptoms and desired outcomes. The first patient is a 48-year-old male with heartburn who got better with PPIs and had no dysphagia regurgitation, but wanted surgery because he didn’t want to take PPIs long term. The endoscopy showed a 3cm hernia, no esophagitis. EndoFLIP, performed with the endoscopy showed RACs and normal EGJ distensibility. The panel focused on the components of an EndoFlip exam and “the million-dollar question,” regarding the efficacy of forgoing a preoperative manometry in patients with a normal EndoFLIP exam.

The second patient is a 63-year-old female with longstanding heartburn regurgitation. Pre-op-eval has regurgitation, 40-hour pH monitoring shows a 2cm hernia, pH testing, upright supine reflux and good symptom correlation. For this case, the panel explored the nuances associated with ineffective esophageal motility, using the DCI failed swallows and impedance to advise surgeons about what they should do in such cases. The Panel also explored ways to mitigate post-operative dysphagia, questions about additional pre-operative motility workup, and the usage of TIF and LINX devices vs. partial fundoplication.

The final case is a 65-year-old male patient with Barrett’s, having high grade dysplasia, longstanding GERD, AGD 5cm hernia, C4 M5, and some esophagitis. The panel explored various views on how best to manage the patient’s GERD and Barrett’s esophagus, as well as questions about whether he should undergo anti-reflux surgery prior to radio frequency ablation (RFA). These case discussions invoked input from a well-informed audience with an emphasis on effective, yet minimally invasive treatments, such as transoral incisionless fundoplication gearing as much as possible toward 0% complications for the patients, and highlighting the need for more personalized treatment as inter-observable agreement in many such cases can prove to be difficult.

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DOWNLOADABLE PDF
View the slide deck presented by Dr. Anish Sheth to the panel of experts above, underlining the conditions and clinical test results of each patient and the case-specific questions posed to the panel and the medically-informed audience at the Reflux and Motility Symposium in Chicago.
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2019 CPT Quick Coding Reference

Clinical Dilemmas in GERD

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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.

Indications
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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Contact:
Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161
tstephens@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com