Alyssa Choi, MD1, Mary Kathryn Roccato, MD1, Jason Samarasena, MD2, Robert Lee, MD3, Nabil El Hage Chehade, MD3, Shaun Daly, MD3, Marcelo Hinojosa, MD3, Brian Smith, MD3, Ninh Nguyen, MD3, Kenneth Chang, MD, FACG4; 1University of California Irvine Medical Center, Irvine, CA; 2University of California Irvine, Orange, CA; 3University of California Irvine Medical Center, Orange, CA; 4University of California Irvine, Irvine, CA
Introduction: Transoral incisionless fundoplication (TIF) is an attractive alternative to the traditional surgical fundoplications for the treatment of gastroesophageal reflux disease (GERD). Ideal candidates are limited to patients with hiatal hernia (HH), diaphragmatic hiatus (DH) ≤ 2cm, and Hill Grade (HG) I or II because TIF does not address the HH component of GERD. A novel approach of TIF immediately preceded by HH repair, coined concomitant TIF (cTIF), has emerged as a possible solution to address these limitations. The purpose of this study is to assess the efficacy, safety and feasibility of cTIF using a collaborative approach between Interventional Gastroenterology and Foregut Surgery. Methods: Subjects with a HH or DH too large to undergo TIF ( >2 cm), Barrett’s esophagus, LA class C esophagitis or a DeMeester score >50 were selected for cTIF. Subjects underwent HH repair by a surgeon followed by TIF by a gastroenterologist inone combined procedure. Variables studied included age, BMI, HH size, Proton Pump Inhibitor (PPI) or H2 blocker (H2B) use pre and post procedure, and symptoms based on the Reflux Disease Questionnaire (RDQ), GERD Health Related Quality of Life (HRQL) Index and the Reflux Symptom Index (RSI). Results: 34 subjects underwent cTIF, and of those 18 patients had follow up data greater than 6 months. At the time of cTIF, mean age was 59.8 and 17 were male. Mean HH measurement was 2.7cm. Pre-cTIF, 30 subjects were on PPIs. There was 100% success rate in performing TIF after hiatus repair. 12 months post cTIF, 86% of patients were off PPI. RDQ for symptom frequency was 17.4 pre-cTIF and 4.78 post-cTIF (p< 0.01). RDQ for symptom severity was 16.7 pre-cTIF and 4.56 post-cTIF (p< 0.06). GERD-HRQL for heartburn severity was 23.3 pre-cTIF and 7.37 post-cTIF (p< 0.01). GERD-HRQL for regurgitation severity was 14.3 pre-cTIF and 0 post-cTIF (p=0.05). RSI was 17.7 pre-cTIF and 8.1 post-cTIF (p< 0.01). Discussion: These early results suggest that concomitant HH repair and TIF appear to be safe and effective in patients with HH or diaphragmatic hiatus too large to undergo TIF alone and severe esophagitis. Many of these patients would not have met traditional criteria for complete or even partial fundoplication and so these patients may be receiving surgical therapy earlier in the disease spectrum. Prospective randomized studies comparing cTIF to laparoscopic Nissen Fundoplication are warranted.
Disclosures: Alyssa Choi indicated no relevant financial relationships. Mary Kathryn Roccato indicated no relevant financial relationships. Jason Samarasena indicated no relevant financial relationships. Robert Lee indicated no relevant financial relationships. Nabil El Hage Chehade indicated no relevant financial relationships. Shaun Daly indicated no relevant financial relationships. Marcelo Hinojosa indicated no relevant financial relationships. Brian Smith indicated no relevant financial relationships. Ninh Nguyen: Endogastric Solutions – Consultant. Kenneth Chang: Endogastric Solutions – Consultant.