A 99-patient study confirms that a laparo-endoluminal approach reduces proton pump inhibitor medication use and significantly improves quality-of-life scores
REDMOND, Wash – EndoGastric Solutions® today announced the publication of new clinical data confirming that concomitantly performed hiatal hernia (HH) repair and the Transoral Incisionless Fundoplication (TIF® 2.0) procedure using the EsophyX® device, is an effective treatment for patients with a HH larger than 2 cm contributing to their gastroesophageal reflux disease (GERD). These data appear in the current issue of Surgical Innovation and includes the largest prospective series of patients who have undergone this concomitant approach (HH + TIF 2.0).
GERD, a chronic condition affecting almost 60 million Americans, is one of the most frequent disorders presenting in primary care and community practice settings. (1,2) Many of these patients also present with a HH, a weakening in the diaphragm resulting in a portion of the stomach protruding into the thorax. The patient’s diaphragm along with the gastroesophageal valve (GEV) is known to contribute to the body’s natural anti-reflux barrier. Previous studies have shown that both TIF 2.0 and laparoscopic HH repair each contribute about 50% to the reflux barrier. (3,4)
“The results of this study, which comprised the largest patient cohort and longest follow-up time for the evaluation of HH+TIF, further confirm that the combined approach is safe and effective in addressing both aspects of the anti-reflux barrier,” said Peter Janu, MD, a general and vascular surgeon at Ascension Medical Group in Wisconsin and lead author on the publication. “In addition, our data suggest that combining the two procedures and definitively addressing any hiatal defect may have a positive impact on efficacy and durability of reflux control.”
The study evaluated 99 patients enrolled at one of two community practices who were followed for 12 months post-HH+TIF. Key findings include:
- Decreased use of PPI’s – daily proton pump inhibitor (PPI) usage declined from 60% at baseline to 11% at 6 months. At 6 and 12 months, 70% and 74% of subjects, respectively, reported never using PPIs.
- Symptoms of heartburn, regurgitation, and difficulty swallowing improved following HH+TIF.
- GERD Health-Related Quality of Life (GERD-HRQL) scores improved by 19 and 17 points at 6 months and 12 months post-HH+TIF, respectively, indicating no symptoms or noticeable but not bothersome symptoms.
- The median Gastro-Esophageal Reflux Symptom Score (GERSS) decreased from 25.0 at baseline to 2.0 and 1.0 with 86% and 90% of subjects reporting effective control of their symptoms (GERSS < 18) at 6 and 12 months of follow-up, respectively.
- Median Reflux Symptom Index (RSI) scores decreased from 26 points at baseline to 15 and 16 points at 6 and 12 months, indicating a return to normal reflux status. At 6 and 12 months, 60% and 77% of subjects, respectively, reported effective control of laryngopharyngeal reflux symptoms.
- The proportion of subjects satisfied with their health condition increased from 8% at baseline to 70% at both 6 and 12 months.
- No adverse events were reported and subjects did not report any increase in side effects that typically occur with traditional surgical fundoplication, including gas bloat, inability to belch, or inability to vomit.
“The subject-reported symptoms of GERD were significantly reduced across all validated questionnaires used to assess effectiveness, demonstrating greater symptom control following HH+TIF,” said Peter Mavrelis, MD, a gastroenterologist at Methodist Hospital in Indiana and senior author on the publication. “Our study confirmed the efficacy of this approach with regard to quality-of-life improvement, symptom control, and reduction in PPI use.”
“The results of this study further support that concomitant laparoscopic HH repair and endoscopic TIF 2.0 valve reconstruction provide an effective solution for treating reflux without the adverse events associated with traditional surgical antireflux procedures,” said Skip Baldino, President, and CEO of EndoGastric Solutions. “These findings are important because they demonstrate that a larger population of patients (those with HH >2cm) could benefit from and should be considered candidates for surgical treatment of their refractory reflux disease.”
- Kahrilas PJ, Shaheen NJ, Vaezi MF. American Gastroenterological Association Institute technical review on the management of gastroesophageal reflux disease. Gastroenterology 2008;135:1392-1413.
- Peery AF, Crockett SD, Barritt AS, et al. Burden of Gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology 2015;149:1731-1741.
- Woodward ER, Thomas HF, McAlhany JC. Comparison of crural repair and Nissen fundoplication in the treatment of esophageal hiatus hernia with peptic esophagitis. Ann Surg 1971;173(5):782-92.
- Müller-Stich BP, Achtstatter V, Diener MK, Gondan M, Warschkow R, Marra F, et al. Repair of paraesophageal hiatal hernias – is a fundoplication needed? A randomized controlled pilot trial. J Am Coll Surg 2015;221:602-610.
- Data Slides for Healthcare professional Education
- Patient Education Material for English and Spanish patient brochures
- Dr. Peter Janu 8 min presentation at DDW Product Theater
- Dr. Peter Janu 57-min Webinar
- Dr. Peter Janu 37-min TIF Talk
- Publication Abstract
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.
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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