The Christ Hospital Heart and Vascular Institute and Lindner Center for Research and Education, Cincinnati, Ohio, USA.
Center for Heart Valve Innovation, St. Paul's Hospital, Vancouver, British Columbia, Canada.
JACC Cardiovasc Interv. 2023 Aug 28;16(16):1953-1960. doi: 10.1016/j.jcin.2023.05.018. Epub 2023 May 17.
Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR.
The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve).
A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm).
A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days.
The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.
经导管治疗原发性主动脉瓣反流（AR）患者受到解剖因素的限制。没有任何经导管设备获得美国监管机构批准用于治疗 AR 患者。
本研究旨在描述北美专用经导管装置（J-Valve）的同情使用经验。
在北美，为治疗严重症状性 AR 且手术风险高的患者，组建了一个多中心、观察性登记处，对 J-Valve 植入的同情使用病例进行了研究。J-Valve 由一个自扩张的 Nitinol 框架、牛心包瓣叶和一个瓣膜定位特征组成。现有的尺寸矩阵（5 个尺寸）可以治疗广泛的解剖结构（最小和最大瓣环周长 57-104mm）。
在研究期间（2018-2022 年），共有 27 例（中位年龄 81 岁[IQR：72-85 岁]，81%为高手术风险，96%为 NYHA 心功能 III 或 IV 级）原发性瓣膜 AR 患者接受了 J-Valve 治疗。在整体经验中，手术成功率（J-Valve 送达预期位置，无需手术转换或再次行经导管心脏瓣膜治疗）为 81%（27 例中的 22 例），在最后 15 例中为 100%。在早期经验中，有 2 例需要转为手术，导致瓣膜设计发生变化。在 30 天时，有 1 例死亡，1 例中风和 3 例新起搏器（13%），88%的患者心功能处于 NYHA 心功能 I 或 II 级。没有患者在 30 天时存在中度或更严重的 AR。
在纯 AR 且手术风险高或禁忌的患者中，J-Valve 似乎是一种安全有效的手术替代方法。
