Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System

Dataset from Fontana GP, Bedogni F, Groh M, Smith D, Chehab BM, Garrett HE Jr, Yong G, Worthley S, Manoharan G, Walton A, Hermiller J, Dhar G, Waksman R, Ramana RK, Mahoney P, Asch FM, Chakravarty T, Jilaihawi H, Makkar RR. Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2467-2478. doi: 10.1016/j.jcin.2020.06.041. Epub 2020 Jul 20. PMID: 33153563. <strong>Abstract</strong> <strong>Objectives: </strong>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). <strong>Background: </strong>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. <strong>Methods: </strong>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. <strong>Results: </strong>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 cm², and a 4.1% rate of moderate paravalvular leak at 30 days. <strong>Conclusions: </strong>Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.本数据集来自Fontana GP、Bedogni F、Groh M、Smith D、Chehab BM、Garrett HE Jr、Yong G、Worthley S、Manoharan G、Walton A、Hermiller J、Dhar G、Waksman R、Ramana RK、Mahoney P、Asch FM、Chakravarty T、Jilaihawi H、Makkar RR的研究，题为《环内自膨胀式经导管主动脉瓣（Transcatheter Aortic Valve）及新一代低轮廓输送系统（delivery system，DS）的安全性特征》，发表于《JACC Cardiovasc Interv》2020年11月9日，第13卷第21期：2467-2478，DOI: 10.1016/j.jcin.2020.06.041，2020年7月20日在线发表，PMID: 33153563。【摘要】【研究目的】：本研究旨在评估搭载新一代低轮廓输送系统（DS）的环内自膨胀式瓣膜的安全性特征。【研究背景】：FlexNav DS的关键设计改进包括添加亲水性涂层一体化鞘管及稳定层，以实现在直径≥5 mm的血管内逐步、可控的瓣膜释放。【研究方法】：本分析合并了两项同步开展的前瞻性多中心单臂研究的数据：PORTICO IDE试验（Portico可再鞘式经导管主动脉瓣系统美国IDE临床试验）的FlexNav DS组（n = 134）以及FlexNav欧盟CE认证研究（n = 46）。本研究的主要终点为术后30天时按瓣膜学术研究联盟-2（Valve Academic Research Consortium-2，VARC-2）定义的主要血管并发症。临床结局由独立临床事件委员会评估，瓣膜性能由超声心动图核心实验室评估，随访时长均至30天。【研究结果】：本研究纳入了2018年10月15日至2019年12月10日期间，来自美国、澳大利亚及欧洲28个研究中心，接受经股动脉入路Portico瓣膜植入术尝试的140例高危受试者及40例极高危受试者。受试者平均年龄为85.1 ± 5.6岁，女性占比60%，胸外科医师学会（Society of Thoracic Surgeons，STS）平均评分为5.3%，96.1%的受试者存在至少1项衰弱因素。手术技术成功率为96.7%。术后30天时，主要血管并发症发生率为5.0%，其中4.4%的并发症被判定为入路位点相关（3.3%为经导管主动脉瓣置换术（Transcatheter Aortic Valve Replacement，TAVR）DS入路位点相关）。死亡发生率为0.6%，致残性卒中发生率为1.1%，均较为罕见。新发永久性起搏器植入率为15.4%。超声心动图检查显示，术后30天时平均跨瓣压差为7.1 ± 3.2 mmHg，平均瓣膜面积为1.77 ± 0.41 cm²，中度瓣周漏发生率为4.1%。【研究结论】：采用FlexNav DS行Portico瓣膜植入术，在术后30天时展现出优异的安全性特征。