Long-term feasibility of the new sutureless excimer laser-assisted non-occlusive anastomosis clip in a pig model

Background High flow bypass surgery can be a last resort procedure for patients suffering from complex neurovascular pathology. Temporary occlusion of a recipient artery in these patients could result in debilitating neurological deficits. We developed a sutureless, mechanical anastomotic connection device, the SELANA clip (Sutureless Excimer Laser-Assisted Non-occlusive Anastomosis clip: SEcl). In the present study, we aim to determine the long-term non-inferiority of the SEcl technique compared with historical data of the conventional ELANA anastomosis technique. Methods A total of 18 SEcl bypasses were created on the carotid artery in a porcine model in 6 different survival groups. Mean application times, flap retrieval rates, hemostasis, patency, flow, endothelialization, and remodeling were assessed. Results The mean application time of the SEcl anastomoses was 15.2 +/- 9.6 min, which was faster compared with the conventional ELANA anastomoses. The flap retrieval rate of the SEcl anastomoses was 86% (32/37). Direct hemostasis was achieved in 89% (33/37) SEcl anastomoses. Patency in all surviving animals was 94% (17/18). Bypass flow after six months was 156.5 +/- 24.7 mL/min. Full endothelialization of the SEcl pins was observed after 3 weeks. Conclusion The SEcl technique is not inferior to the ELANA technique regarding patency, flap retrieval rate, flow, and endothelialization. On the basis of a significantly shorter application time and superior hemostasis, the SEcl technique could be preferable over the ELANA technique. A pilot study in patients is a logical next step based on our current results.

Automated summary

The study demonstrates that the sutureless, mechanical anastomotic connection device SEcl is non-inferior to the conventional ELANA technique in terms of patency, flap retrieval rate, flow, and endothelialization. The SEcl technique shows advantages in terms of shorter application time and superior hemostasis, suggesting its potential preference over the ELANA technique.