New Data Confirm Efficacy of Concomitant Hiatal Hernia Repair - October 18, 2019

Courtesy of Medical Product Outsourcing

EndoGastric Solutions has 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). The data appear in 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 percent 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, M.D., 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 percent at baseline to 11 percent at six months. At six and 12 months, 70 percent and 74 percent 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 six 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 at baseline to 2 and 1 with 86 percent and 90 percent of subjects reporting effective control of their symptoms (GERSS < 18) at six 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 six and 12 months, indicating a return to normal reflux status. At six and 12 months, 60 percent and 77 percent of subjects, respectively, reported effective control of laryngopharyngeal reflux symptoms.
  • The proportion of subjects satisfied with their health condition increased from 8 percent at baseline to 70 percent at both six 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, M.D., 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.”

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.

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.

More than 22,000 TIF procedures have been performed worldwide. More than 100 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD.

Learn more about TIF 2.0 here.

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 degree 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.

Based in Redmond, Wash., EndoGastric Solutions Inc. is a medical device company developing and commercializing 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.

References
1 Kahrilas PJ, Shaheen NJ, Vaezi MF. American Gastroenterological Association Institute technical review on the management of gastroesophageal reflux disease. Gastroenterology 2008;135:1392-1413.
2 Peery AF, Crockett SD, Barritt AS, et al. Burden of Gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology 2015;149:1731-1741.
3 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.
4 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.