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.
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| http://dx.doi.org/10.1016/j.ijcard.2020.04.045 | DOI Listing |
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Article Synopsis
- - This study explored how the location of re-entry tears affects blood flow and pressure in uncomplicated type B aortic dissection using computer simulations based on CT images.
- - The simulations showed that models with re-entry tears generally had lower blood pressure and wall shear stress compared to those without, especially when the tear was near the end of the false lumen.
- - The findings could help inform fenestration surgery in these patients, but more research with a larger patient pool is needed to validate the results.
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