Use of the Over-the-Scope-Closure (OTSC) Device: One Year Experience at a U.S. Interventional Endoscopy Center

Abstract

Purpose: To report our initial U.S. experience and to study the technical success, factors predisposing to failure and complications of OTSC. Methods: Retrospective review of a prospectively collected database of all patients treated with OTSC from January 2011 - April 2012 at a single tertiary care referral center. Results: 24 patients underwent placement of 28 OTSC devices. The mean age was 70 years. 14 (58%) patients were female. Indications for OTSC applications included post surgical enterocutaneous fistula (10), spontaneous perforation (1), anastomotic leak (4), perforation post mucosal resection (3), prophylactic closure of mucosal defect post EMR (1), post-polypectomy bleeding (2), post endoscopy perforation (2), tracheo-esophageal fistula (1) and leakage from a percutaneous jejunostomy site (1). Instruments or modalities used to grasp the tissue were dedicated devices (bidirectional forceps or tripronged anchoring device) in 16 and non dedicated devices (rat tooth/alligator forceps or suction alone) in 15. Successful tissue acquisition with these devices was 2/16 for dedicated and 13/15 for the non-dedicated. The non-dedicated devices were superior to the dedicated devices for tissue acquisition (p=0.0004). OTSC was successful in achieving hemostasis on a bleeding stump of a large lipoma and a hyperplastic polyp post polypectomy. It was also successful in preventing a post EMR crater from the high risk of delayed bleeding or perforation. Overall, the OTSC was effective in 15/27 procedures (53%). It was used in 21 procedures for defect closure resulting in instant and complete closure in 12/21 (57.1%) and partial closure in 9/21 (42.9%). Mean follow up was 2.9 months (range 1-8m). Mean size of defect was 10 mm (range 5-25 mm). A trend towards higher success was noted in defects < 10 mm compared to defects > 10 mm (90% vs. 60%; p=0.36). The duration of the defect ranged from <24h to 2 y. No difference was noted in closure of fresh perforations or fistula (<72 hrs) vs chronic fistula (> 1 month) (75 % vs. 67%). Repeat OTSC placement failed to close the defects in 2/2. There were no complications from OTSC device placement. Conclusion: The OTSC provides a safe endoscopic alternative to manage fistula, perforation and bleeding. Our series shows no significant difference for closure of early fistula or perforations as compared to chronic fistula. Rat-tooth forceps or suction was superior to the dedicated devices for tissue acquisition. Our limited experience with repeat OTSC treatment in failed initial attempts have been disappointing.