Transoral Incisionless Fundoplication: Initial Experience in Patients Referred to an Integrated Academic Institution ALLAN NGUYEN, B.S.,*† THOMAS VO, B.S.,* XUAN-MAI T. NGUYEN, PH.D.,* BRIAN R. SMITH, M.D.,*† KEVIN M. REAVIS, M.D.*† From the *University of California, Irvine Medical Center, Orange, California and the †VA Healthcare System Long Beach, Long Beach, California Transoral incisionless fundoplication is a new treatment for patients with gastroesophageal reflux disease. We present our initial experience with 10 patients undergoing this procedure with varying past surgical histories. All procedures were performed under general nasotracheal anesthesia. RAND-36 and Visual Analog Scale symptom scores were collected at pre and postoperative ap- pointments for a mean of 9.2 months. The mean procedure time was 68 minutes. There were no intraoperative or postoperative complications. Patients with prior pancreaticoduodenectomy had observed reduced working space due to prior distal gastrectomy and required additional in- sufflation due to no pyloric resistance to insufflation of the small bowel. The patient with prior fundoplication required additional time and force for fastener penetration of the resultant scar from the partially disrupted fundoplication. All patients were discharged within 23 hours of the procedure. Throughout the follow-up period, patients reported gradual changes in medication requirements and symptom scores. There were no late complications. Transoral incisionless fundoplication is technically safe in well-selected patients including those with prior esophageal and gastric surgery. G ASTROESOPHAGEAL REFLUX Disease (GERD) is typically treated with antisecretory pharmaceu- ticals due to the prolonged symptom relief and in- creased rate of mucosal healing. However, 30 to 40 per cent of patients presenting with GERD are un- responsive to standard medical therapy. 1 Laparoscopic Nissen fundoplication is considered to be the standard surgical treatment for GERD with 90 to 94 per cent overall patient satisfaction with overall outcomes during long-term follow-up. 2 There is however repor- ted surgical morbidity including potential dysphagia, bloating, and increased flatulence. 3 In search of an alternative and less-invasive ap- proach, the EsophyX Ò device (EndoGastric Solutions, Inc., Redmond, WA) has been developed which creates a transoral-incisionless fundoplication (TIF Ò ). The device uses polypropylene H-fasteners to reconstruct the gastroesophageal valve and restore the antireflux barrier. The device functions by grasping the esoph- agogastric junction endoluminally, pulling it into a tis- sue mold and placing transmural fasteners for creation of a 270 to 320° fundoplication. Since its clinical in- troduction in the United States in 2007, there have only been a few small case series reported from academic centers. 4–6 This study incorporates our initial experience with TIF at an integrated academic institution. The aim of this study was to: 1) evaluate the efficacy and safety of TIF in our initial experience with 10 patients with varying past surgical histories, and 2) to assess the outcomes of the treatment of GERD in these patients through the reporting of medication use and symptom control as well as validated health-related quality- of-life surveys and a Visual Analog Scale (VAS). Materials and Methods Patient Selection All patients that were referred to our institution for the surgical treatment of GERD underwent standard preoperative evaluation, which includes two or more of the following: contrast esophagram, upper endoscopy, Presented at the 22nd Annual Scientific Meeting of the Southern California Chapter of the American College of Surgeons, Santa Barbara, CA, January 21–23, 2011. Address correspondence and reprint requests to Kevin M. Reavis, M.D., Assistant Professor of Clinical Surgery, Department of Surgery, Division of Gastrointestinal Surgery, University of California, Irvine Medical Center, 333 City Boulevard West, Suite 850, Orange, CA 92868. E-mail: kreavis@uci.edu. 1386