Buszman Piotr P, Kachel Mateusz, Milewski Krzysztof P, Michalak Magdalena, Domaradzki Wojciech, Pruski Maciej, Sobota Michał, Fernandez Carlos, Łukasik Karolina, Nożyński Jerzy, Hirnle Piotr, Kaźmierczak Paweł, Bochenek Andrzej, Buszman Paweł E
Department of Cardiology, Andrzej Frycz Modrzewski Krakow University, Bielsko-Biala, Poland.
American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland.
Cardiol J. 2024;31(1):124-132. doi: 10.5603/CJ.a2023.0048. Epub 2023 Jul 31.
The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding.
Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15-16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis.
All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure - the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3-37.7) and 17.5 (13.1-20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in "early" groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic "collar" visible in orthotopically implanted valves.
The study showed good hemodynamic performance, durability and biocompatibility of the novel biological THV.
本研究旨在评估一种新型的、专有的球囊扩张式生物经导管主动脉瓣植入系统（InFlow，CardValve联盟，波兰）在绵羊主动脉缩窄模型中的生物功能。
对21只绵羊进行升主动脉缩窄手术。两周后，使用15 - 16F InFlow经导管主动脉瓣植入系统和颈动脉切开术在模型中植入18个生物瓣膜。在第30、90和180天进行经胸超声心动图随访。在指定时间，对动物实施安乐死并取出瓣膜进行分析。
所有绵羊均在缩窄手术后存活。在7天内有4只（22%）因手术相关死亡。在观察期间，又有2只绵羊死亡。其中1只在术后瓣膜脱位，该动物被排除。2只动物完成了30天随访，5只完成了90天随访，4只完成了180天的终末随访。经食管超声心动图检查的瓣膜显示出良好的血流动力学参数，无瓣膜结构恶化迹象。180天时的最大和平均血流梯度分别为31.4（23.3 - 37.7）mmHg和17.5（13.1 - 20.2）mmHg。有1例中度反流，无瓣周漏病例。组织病理学检查显示，在长期随访中，任何测试瓣膜均无炎症、血栓形成或钙化。支架支柱的新生内膜覆盖从“早期”组的基部随时间增加，在180天组达到支架长度的近3/4。心内膜下组织显示随时间成熟，原位植入瓣膜未见狭窄“环”。
该研究表明新型生物经导管主动脉瓣具有良好的血流动力学性能、耐久性和生物相容性。
