Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, California.
IRCCS Policlinico San Donato, Milan Italy.
JACC Cardiovasc Interv. 2020 Nov 9;13(21):2467-2478. doi: 10.1016/j.jcin.2020.06.041. Epub 2020 Jul 20.
The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).
Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.
Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively.
One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm, and a 4.1% rate of moderate paravalvular leak at 30 days.
Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.
本研究旨在描述一种具有下一代低轮廓输送系统（DS）的环形自膨式瓣膜的安全性特征。
FlexNav DS 的关键设计改进包括添加亲水涂层的集成护套和稳定层，以促进在直径≥5mm 的血管中进行逐渐、受控的部署。
来自 2 项同时进行的前瞻性、多中心、单臂研究（PORTICO IDE 的 FlexNav DS 臂[Portico 可重新护套经导管主动脉瓣系统美国 IDE 试验] [n=134]和 FlexNav EU CE 标记研究[n=46]）的患者被汇总进行分析。主要终点为 30 天时 Valve Academic Research Consortium-2 定义的主要血管并发症。临床结局和瓣膜性能分别通过独立临床事件委员会和超声心动图核心实验室在 30 天内进行评估。
2018 年 10 月 15 日至 2019 年 12 月 10 日期间，在美国、澳大利亚和欧洲的 28 个地点，共招募了 140 名高危和 40 名极高危患者，进行了经股 Portico 瓣膜植入术尝试。平均年龄为 85.1±5.6 岁，60%为女性，平均胸外科医师协会评分 5.3%，96.1%有≥1 项衰弱因素。技术设备成功率为 96.7%。30 天时，主要血管并发症发生率为 5.0%，其中 4.4%的并发症被判定为与入路相关（3.3%与经导管主动脉瓣置换 DS 入路相关）。死亡率（0.6%）和致残性中风（1.1%）罕见。新植入永久性起搏器的比例为 15.4%。超声心动图显示平均梯度为 7.1±3.2mmHg，平均瓣膜面积为 1.77±0.41cm，30 天时中度瓣周漏的发生率为 4.1%。
在 30 天时，使用 FlexNav DS 植入 Portico 瓣膜与极佳的安全性相关。
