Preclinical evaluation of an endovascular sealing device for distal re-entry tears in type B aortic dissection in a porcine model.

Abstract Objectives The objective of present study was to evaluate the feasibility and safety of a novel endovascular sealing device for distal re-entry tears in type B aortic dissection in a porcine model. Background Distal re-entry tears are a well-recognized risk factor for unfavorable aortic remodeling after thoracic endovascular aortic repair. However, there is currently no device for sealing a distal re-entry tear. Methods We implanted the ENDOPATCH device (Weiqiang Medical, Hangzhou, China) in 15 pigs (40–50 kg) under angiographic guidance. The device can be retrieved and repositioned with an 8–10 French sheath. All pigs were assessed using angiography before sacrifice 1- (n = 1), 3- (n = 1), and 6 months (n = 13) after implantation, which was followed by gross specimen evaluation and histological examination of harvested tissues. Results The ENDOPATCH device was successfully implanted in all 15 pigs. The mean disk diameter of the implant was 10.3 ± 1.7 mm, and the chosen device was 4.4 ± 0.9 mm larger than the measured maximum diameter of the fistula. No device migration or leakage was observed angiographically, before sacrifice. An organized thrombus on the disk surface was found in the inferior vena cava of one pig. Complete sealing of the fistula was confirmed by gross and microscopic examinations in all pigs. Conclusions Our results indicated that the ENDOPATCH device is feasible and safe in a porcine model. Human studies are needed to evaluate the safety and efficacy of the ENDOPATCH.