EFFICACY ASSESSMENT OF AN ENDOSCOPIC THREADED TACK SYSTEM FOR THE CLOSURE OF MUCOSAL WOUNDS IN AN EX VIVO PORCINE MODEL.
Neil Mitra*4, Hansani N. Angammana1, Timothy Pistell2, Yanni Hedjar3, Giorgio Guiulfo4, Poppy Addison1, Diana Kantarovich1, Richard L. Whelan1
1Surgery, Lenox Hill Hospital/ Northwell Health, New York, NY; 2Rutgers New Jersey Medical School, Newark, NJ; 3Brookdale University Hospital and Medical Center, New York, NY; 4Sentara Healthcare Inc, Norfolk, VA
Introduction: ESD/EMR removal of large sessile colonic adenomas creates mucosal defects not easily closed with clips. A wound closure system that utilizes 4 tacks (=1 card) joined by a suture is now an option. The 0.6 cm cylindrical hollow metal tack is threaded on one end and has an eyelet mid tack through which runs a suture connecting the 4 tacks. Each tack is loaded on a delivery device passed through the scope and positioned. While pushing forward the "Persian drill" handle is closed which "screws" the tack into the wall after which the tack is released. The device is then withdrawn, reloaded, reinserted and the process repeated x 4. Next the suture's outer end is passed through a "cinch" device and then held steady while the cinch is inserted fully through the scope. The suture is pulled tight bringing the tacks together and closing the defect; next, the cinch is fired which secures the closure with a plastic plug. This system allows closure of large wounds. This ex vivo porcine large bowel study was done to assess: 1) this closure system, 2) Z and X tack patterns and 3) 1 and 2 card closures (4 vs 8 tacks). Methods: Prepped and frozen ex vivo colon (+ anus) was used; after thawing, 4 mucosal wounds (~2 cm diameter) were made via colotomy (suture closed) and the colon then was affixed to a PEG board. An endoscope was inserted and the X-tack system (Apollo Corp.) used to close the wounds with an X or Z suture pattern. Device function, integrity of tack placement and the wound closures were assessed.
Results: 9 porcine colons and 57 tack cards were used for 35 wounds (1 card,15; 2 card,18; 3 card,2) using an X pattern (30) or Z pattern(29). Cinch closure was successful (mucosal edges opposed) in 29/35 (82.9%). Two card closures resulted in less exposed submucosa vs 1 card. Longitudinal closure resulted in non-critical luminal narrowing. Closures included the deep bowel wall in 52%; tack penetration depth was: submucosa, 33.8%; muscularis propria, 42.5%; transmural, 21.5%; and mucosa only, 1.8%. The distance from the wound edge to the tacks were: 0-2 mm, 32.6% of tacks; 2.1-4 mm, 37.4%; 4.1-6 mm, 22.5 %; ≥6.1 mm, 7.5%. Issues associated with unsuccessful closure included: suture breakage, mid suture knot, tack dislodgement, and very loose closure. Choice of X and Z suture pattern did not impact results.
Conclusions: This X tack system successfully opposed the edges of 83% of wounds in this model. 64% of tacks extended into muscularis propria or serosa; 52% of closures included deep wall. Transverse closures are recommended. X and Z suture patterns were equivalent and 2 card closures left fewer submucosal gaps. The tack distance from edge goal should be ≥5 mm. Familiarity with the system is needed and best practices and potential pitfalls learned/understood. An ex vivo animal model is advised for initial training. More study is needed.
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