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采用FlexNav输送系统的Portico经导管主动脉瓣的实际使用性能和临床结果:来自单中心经验的一年数据。

Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience.

作者信息

Yildirim Abdullah, Genc Omer, Pacaci Emre, Sen Omer, Kurt Ibrahim Halil

机构信息

Department of Cardiology, Adana City Training & Research Hospital, University of Health Sciences, 01230 Adana, Turkey.

Department of Cardiology, Basaksehir Cam & Sakura City Hospital, 34480 Istanbul, Turkey.

出版信息

J Clin Med. 2023 Aug 18;12(16):5373. doi: 10.3390/jcm12165373.

DOI:10.3390/jcm12165373
PMID:37629415
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10455755/
Abstract

Significant progress has been made in both valves and delivery systems (DSs) for transcatheter aortic valve replacement (TAVR) procedures. We aimed to present one-year real-life data regarding TAVR procedures using Portico transcatheter heart valves (THVs) with new-generation, low-profile FlexNav DSs. This retrospective, single-center study enrolled 169 consecutive patients (mean age: 75.8 years, 68% females) with severe aortic stenosis undergoing TAVR with Portico THVs and FlexNav DSs between 2020 and 2021. We evaluated safety and efficacy outcomes, following the VARC-3 consensus, periprocedurally and at 30 days and 1 year. Procedural success was observed in 95.9% of cases, and no procedural mortality occurred. At 30 days, the rates of all-cause mortality, cardiovascular mortality, and neurological events were 4.7%, 3.6%, and 3.0%, respectively. Additionally, major vascular complications, acute kidney injury, and bleeding were recorded at rates of 11.2%, 14.8%, and 7.7%, respectively. The 1-year data showed all-cause mortality, cardiovascular mortality, and neurological event rates of 10.7%, 8.3%, and 7.7%, respectively. The moderate paravalvular leak and permanent pacemaker rates at 1 year were 2.6% and 12.2%, respectively. This real-life data provided evidence of positive outcomes and high technical success with Portico THVs and FlexNav DSs. Furthermore, we found low rates of mortality and neurological events, with satisfactory hemodynamic and functional results.

摘要

经导管主动脉瓣置换术(TAVR)的瓣膜和输送系统(DSs)均取得了重大进展。我们旨在展示使用新一代、低轮廓FlexNav DSs的Portico经导管心脏瓣膜(THVs)进行TAVR手术的一年真实数据。这项回顾性单中心研究纳入了2020年至2021年间连续169例(平均年龄:75.8岁,68%为女性)重度主动脉瓣狭窄患者,他们接受了使用Portico THVs和FlexNav DSs的TAVR手术。我们按照VARC-3共识,在围手术期、30天和1年时评估了安全性和有效性结果。95.9%的病例观察到手术成功,且未发生手术死亡。在30天时,全因死亡率、心血管死亡率和神经系统事件发生率分别为4.7%、3.6%和3.0%。此外,主要血管并发症、急性肾损伤和出血的发生率分别为11.2%、14.8%和7.7%。1年数据显示全因死亡率、心血管死亡率和神经系统事件发生率分别为10.7%、8.3%和7.7%。1年时中度瓣周漏和永久起搏器植入率分别为2.6%和12.2%。这些真实数据证明了Portico THVs和FlexNav DSs取得了积极结果和高技术成功率。此外,我们发现死亡率和神经系统事件发生率较低,血流动力学和功能结果令人满意。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/43805e4d2bf3/jcm-12-05373-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/899df7211041/jcm-12-05373-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/81a37362ceaf/jcm-12-05373-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/f613e67c8190/jcm-12-05373-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/0fe4c152c71b/jcm-12-05373-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/43805e4d2bf3/jcm-12-05373-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/899df7211041/jcm-12-05373-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/81a37362ceaf/jcm-12-05373-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/f613e67c8190/jcm-12-05373-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/0fe4c152c71b/jcm-12-05373-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b01e/10455755/43805e4d2bf3/jcm-12-05373-g002.jpg

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Int J Cardiol. 2022 Mar 15;351:25-31. doi: 10.1016/j.ijcard.2021.12.049. Epub 2022 Jan 1.
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2021 ESC/EACTS Guidelines for the management of valvular heart disease.2021年欧洲心脏病学会/欧洲心胸外科学会瓣膜性心脏病管理指南。
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