Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study

Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study
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DOI:
10.1016/s0140-6736(17)30757-2
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发表时间:
2017-06-17
期刊:
影响因子:
168.9
通讯作者:
Makkar, Raj R.
Makkar, Raj R.
中科院分区:
医学1区
文献类型:
--
作者:
Chakravarty, Tarun;Sondergaard, Lars;Makkar, Raj R.

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背景:经导管主动脉瓣置换术(TAVR)和外科主动脉瓣置换术(SAVR)后,生物瓣的亚临床瓣叶血栓形成已被CT成像发现。本研究的目的是报告手术和经导管主动脉瓣中亚临床瓣叶血栓形成的患病率以及新型口服抗凝剂(NOAC)对亚临床瓣叶血栓形成和后续瓣膜血流动力学和临床结局的影响,基于TAVR或SAVR后进行CT成像的患者的两个登记研究。2017年,在RESOLVE登记研究中,以及2014年6月2日至2016年9月28日期间,在SAVORY登记研究中,在TAVR和SAVR后不同时间间隔使用专用四维容积渲染成像方案进行CT成像。我们将亚临床瓣叶血栓形成定义为瓣叶运动减少,沿着CT显示的相应低衰减病变。我们收集了基线人口统计学、抗血栓治疗和临床结果的数据。结果在931例接受CT成像的患者中(657例[71%]在RESOLVE登记研究中,274例[29%]在SAVORY登记研究中),890例[96%]有可解释的CT扫描(626例[70%]在RESOLVE登记研究中,264例[30%]在SAVORY登记研究中)。890例患者中有106例(12%)发生亚临床瓣叶血栓形成,包括138例外科瓣膜血栓形成中的5例(4%)和752例经导管瓣膜血栓形成中的101例(13%)(p=0.001)。整个队列从主动脉瓣置换到CT的中位时间为83天(IQR 33-281)。接受抗凝剂治疗的患者(8/224)亚临床瓣叶血栓形成的发生率低于接受双重抗血小板治疗的患者(31/208; P
Background Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR.Methods Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion.Findings Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0.001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33-281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p