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. 2021 Apr;9(4):E572-E577.
doi: 10.1055/a-1370-9256. Epub 2021 Apr 12.

Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video)

Ariosto Hernandez  1   2 , Neil B Marya  1 , Tarek Sawas  1 , Elizabeth Rajan  1   2 , Naomi M Gades  3 , Louis M Wong Kee Song  1 , Barham K Abu Dayyeh  1 , Navtej Buttar  1 , Andrew C Storm  1   2
Affiliations

Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video)

Ariosto Hernandez et al. Endosc Int Open. 2021 Apr.

Erratum in

Abstract

Background and aims Endoscopic resections are associated with bleeding and perforation and may be managed with through-the-scope (TTS) clips, over-the-scope clips and endoscopic suturing. The aim of this preclinical study was to compare technical success of closure using a novel TTS tissue helix tack and suture device (X-Tack) to TTS clips in a porcine model. Materials and methods Four subjects underwent 40 mucosal resections, diameter range 25-50 mm, in the stomach (n = 24) and colon (n = 16). Closures were randomized to X-Tack (n = 24) or clip (n = 16). Animals underwent weekly endoscopic follow-up for 4 weeks. Results Technical closure with X-Tack was successful in 24 of 24 (100 %) cases and with clips in 13 of 16 cases (81.3 %) ( P = 0.0001). One colonic perforation occurred and was successfully managed using X-Tack. The rate of healing was not statistically different between the groups, and all sites healed at 4 weeks including the perforation and were confirmed by histology. Conclusions Compared to TTS clip, X-Tack is superior for effecting large mucosal defect closure, including durable sealing of full-thickness perforation. There was no difference in rate of healing between devices.

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Conflict of interest statement

Competing interests This study was funded by a research grant from Apollo Endosurgery. Dr. Abu Dayyeh has received a research grant from Apollo Endosurgery. Dr. Storm has received a research grant and consulting fees from Apollo Endosurgery and consulting fees from ERBE.

Figures

Fig. 1
Fig. 1
X-Tack device. A series of surgical steel helix tacks strung on a 3–0 polypropylene suture are passed through the scope on a deployment catheter. Each tack is placed sequentially and then the coaxial suture is tightened and cinched to close a gastrointestinal tract defect. (Source: Mayo Foundation for Medical Education and Research)
Fig. 2
Fig. 2
X-Tack procedure. a Open defect after mucosal resection. b Helix coil tacks placed and sequentially drilled into tissue on the periphery of the mucosal defect. c Defect closed after deploying a cinch. d Appearance of the healed ulcer with partially retained X-Tack device on Day 21.
Fig. 3
Fig. 3
Rescue therapy with X-Tack following failed closure with TTS clips and X-Tack closure of a colonic perforation. a Failed closure attempt with TTS clips. b Successful completion of defect closure after with the X-Tack device. c Colonic mucosal resection complicated by a 5-mm perforation. d Closure of the perforation site with X-tack.
Fig. 4
Fig. 4
Kaplan-Meier curves showing a the proportion of lesions achieving stage IV (complete) ulcer healing on weekly examination between endoscopic clips and the X-Tack system and b the same for the largest lesions (> 30 mm).
Fig. 5
Fig. 5
Resection sites at 4 weeks showed similar healing at the defect closure and device implantation sites, with small residual areas devoid of mucosa (arrows) and mild inflammation with a mixed inflammatory cell infiltrate composed mostly of lymphocytes both in a X-Tack and b TTS clip closure sites (H&E stain, 30 × magnification).
See this image and copyright information in PMC

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