Dvir Danny, Leon Martin B, Abdel-Wahab Mohamed, Unbehaun Axel, Kodali Susheel, Tchetche Didier, Pibarot Philippe, Leipsic Jonathon, Blanke Philipp, Gerckens Ulrich, Manoharan Ganesh, Harari Emanuel, Hellou Elias, Wolak Arik, Ben-Assa Eyal, Jubeh Rami, Shuvy Mony, Koifman Edward, Klein Christoph, Kempfert Joerg
Department of Cardiology, Shaare Zedek Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Israel.
Columbia University Medical Center, NewYork-Presbyterian Hospital, Cardiovascular Research Foundation, New York, USA.
JACC Cardiovasc Interv. 2023 Jan 9;16(1):94-102. doi: 10.1016/j.jcin.2022.10.050.
Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal.
The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow.
The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction.
Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%.
Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.
冠状动脉阻塞是经导管主动脉瓣置换术（TAVR）的一种危及生命的并发症。目前的预防策略并不理想。
本研究旨在描述一种新型装置的台架试验和临床经验，该装置可分离TAVR术后有导致冠状动脉阻塞风险的瓣膜小叶，使冠状动脉血流正常。
ShortCut装置最初在体外进行测试，并在猪模型中进行临床前功能和安全性测试。随后，该装置被提供给冠状动脉阻塞风险较高的患者。冠状动脉阻塞风险基于计算机断层扫描的解剖特征。手术成功的定义为患者在30天时存活，新瓣膜功能正常，无中风或冠状动脉阻塞。
在成功完成台架试验和临床试验后，该装置在2个医疗中心用于8例生物瓣膜功能衰竭的患者（中位年龄81岁；IQR：72 - 85岁；男性占37.5%）。总共分离了11个小叶：5例患者（63.5%）仅被认为有左主干阻塞风险，3例患者（37.5%）有双冠状动脉阻塞风险。所有患者均成功进行了TAVR，无冠状动脉阻塞证据。所有患者均临床状况良好出院，未观察到不良神经事件。手术成功率为100%。
对首个专用经导管小叶分离装置的评估表明，该装置可成功分离退化的生物瓣膜小叶。该手术安全，成功预防了TAVR术后有此并发症风险患者的冠状动脉阻塞。
