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TIF procedure

New data on TIF procedure presented at DDW 2019

Concomitant TIF 2.0 procedure is an effective therapeutic option for patients with severe refractory GERD and large hiatal hernias.

EndoGastric Solutions has reported new reporting data that further support the safety, efficacy, and clinical utility of Transoral Incisionless Fundoplication (TIF® 2.0) procedure performed with the EsophyX device, at Digestive Disease Week, 2019.

Dr Barham Abu Dayyeh, Director of Advanced Endoscopy, Consultant, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, MN reviewed recent data in Gastrointestinal Endoscopy that described the evolution of and improvements in TIF techniques and the EsophyX technology. He also outlined a framework to select patients for TIF 2.0 based on medical and anatomical considerations. He emphasized that improved endoscopic interventions and careful patient selection can bridge gaps in treatment and target the underlying cause of gastroesophageal reflux disease (GERD).

Barham Abu Dayyeh

Dr Glenn Ihde, General Surgeon, Matagorda Medical Group in Bay City, TX, reviewed the results of a retrospective study that evaluated subjective and objective effects of TIF 2.0 combined with hiatal hernia repair in patients with GERD. The study, which was published earlier this year in the Journal of the Society of Laparoscopic Surgeons, showed that the combined procedure significantly improved outcomes in GERD patients with respect to subjective assessments (GERD Health-Related Quality of Life [HRQL] questionnaire and Reflux Symptom Index [RSI] measurements) and objective pH scores. Importantly, mean pH scores improved from 35.3 to 10.9 (p<0.001) following TIF 2.0 in combination with hiatal hernia repair. Notably, subjects with intact hiatal hernia repairs showed a 95% normalization of pH, reinforcing the importance of accurately assessing all anatomical components of the anti-reflux barrier.

Kenneth Chang, Professor and Chief, Division of Gastroenterology and Executive Director of the H.H. Chao Comprehensive Digestive Disease Center, UCI School of Medicine Irvine, CA, described his personal experience with state-of-the-art endoscopic foregut surgery and interventions, which had been published in the first 2019 issue of World Journal of Gastroenterology. He set forth a vision for the growing role of interventional endoscopy in enabling minimally invasive alternatives to open or laparoscopic surgery that provide durable results for a variety of GI conditions.

The TIF 2.0 procedure was featured during a podium presentation by the American Society for Gastrointestinal Endoscopy (ASGE) during the New Technology Endoscopic Advancements Session, titled Efficacy and Patient Satisfaction of Single-Session Intraoperative Transoral Incisionless Fundoplication and Laparoscopic Hernia Repair. The study was designed to assess patient satisfaction, symptom resolution, safety, and proton pump inhibitor (PPI) use following the concomitant TIF 2.0 procedure among 33 patients with large hiatal hernias (>2cm). Data was collected pre- and post-procedure from June 2015 to June 2018.

Key findings included:

  • 94% (31/33) of patients reported 75% or greater satisfaction with the procedure and outcomes
  • 81% (27/33) of all patients discontinued the use of daily PPIs due to symptom reduction

Figure 1: Improvements in outcomes

The authors concluded that the concomitant TIF 2.0 procedure is an effective therapeutic option for patients with severe refractory GERD and large hiatal hernias.

A growing body of clinical data supports the safety and efficacy of TIF 2.0 in the treatment of GERD, and two additional studies of TIF 2.0 were presented at DDW. One study, titled ‘Transoral Incisionless Fundoplication: Effectiveness in Improving Typical and Atypical Symptoms of Gastroesophageal Reflux Disease Incompletely Controlled with Medical Therapy,’ evaluated the efficacy of TIF 2.0 in controlling heartburn, regurgitation, dysphagia, or atypical symptoms in patients with chronic refractory GERD. The study, which was conducted in 41 patients and utilised the GERD-HRQL and RSI scores and also assessed the use of anti-acid medications, found significant improvements in heartburn, dysphagia, and regurgitation score pre- and post-TIF (p < 0.001, 0.006 and 0.001, respectively) at a median follow-up of nine months. GERD-HRQL and RSI scores also improved significantly following TIF (p < 0.001 for each assessment).

The study also found that, at short-term follow-up, TIF 2.0 eliminates the need for PPI medications in a majority of patients. These results support the use of TIF 2.0 as an alternative to conventional medical therapy for appropriately selected patients.

The other study, which was presented in a poster titled ‘Transoral Incisionless Fundoplication (TIF) to the Rescue: Is TIF the Answer to Post-POEM GERD?’ evaluated the technical success, safety, and clinical impact of TIF 2.0 used to treat achalasia patients who have GERD following POEM. The study was conducted in four U.S. tertiary care centres and included patients with achalasia (n=8) or jackhammer oesophagus (n=1) who underwent TIF 2.0 to address post-POEM GERD symptoms between December 2016 and October 2018.

The results showed that there were statistically significant improvements in GERD-HRQL score, DeMeester score, and acid exposure time (p=0.001, 0.004, and 0.047, respectively). PPI use also decreased significantly post-TIF (p=0.03). The study also demonstrated that TIF effectively mimics surgical partial fundoplication. The authors conclude that TIF may be an effective treatment for GERD after POEM in patients with primary achalasia and suggest that larger, prospective studies of TIF in this setting are warranted.

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