Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves PARTNER 3 Cardiac Computed Tomography Substudy
Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves PARTNER 3 Cardiac Computed Tomography Substudy
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DOI：
10.1016/j.jacc.2020.04.043
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发表时间：
2020-06-23
影响因子：
24
通讯作者：
Leon, Martin B.
中科院分区：
文献类型：
--
作者：
Makkar, Raj R.;Blanke, Philipp;Leon, Martin B.
亚临床瓣叶血栓形成的特征在于在4维计算机断层扫描（CT）上观察到的瓣叶减薄增厚（HALT）和瓣叶运动减少，其可能代表生物假体瓣膜功能障碍的一种形式。及其与瓣膜血流动力学和临床结局的关系。（SAPIEN 3经导管心脏瓣膜在低风险主动脉瓣狭窄患者中的安全性和有效性）CT子研究将435例低手术风险主动脉瓣狭窄患者随机分组接受经导管主动脉瓣置换术（n = 221）或手术（n = 214）。在30天和1年时进行系列四维CT检查，并由核心实验室独立分析。结果HALT的发生率从30天时的10%增加到1年时的24%。54%的患者在1年时发生30天HALT自发消退，而21%的患者在1年时出现新的HALT。在30天时，经导管瓣膜的HALT比外科瓣膜更常见（13% vs. 5%; p = 0.03），但在1年时则不然（28% vs. 20%; p = 0.19）。HALT的存在对30天或1年时的主动脉瓣平均压差没有显著影响。与30天和1年时未发生HALT的患者相比，30天和1年时发生HALT的患者1年时的主动脉瓣压差显著增加（17.8 ± 2.2 mm Hg vs. 12.7 ± 2.2 mm Hg）。+/- 0.3 mm Hg; p = 0.04）。结论：30天时，经导管瓣膜的亚临床瓣叶血栓形成比外科瓣膜更频繁，但1年时则不然。HALT对血栓栓塞并发症和结构性瓣膜退化的影响需要进一步评估。（J Am科尔Cardiol 2020;75：3003-15）（c）2020作者。由爱思唯尔代表美国心脏病学会基金会出版。这是一篇基于CC BY-NC-ND许可证的开放获取文章（http：//creativecommons. org/licenses/by-nc-nd/4.0/）。
BACKGROUND Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction.OBJECTIVES The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes.METHODS The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory.RESULTS The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 +/- 2.2 mm Hg vs. 12.7. +/- 0.3 mm Hg; p = 0.04).CONCLUSIONS Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment. (J Am Coll Cardiol 2020;75:3003-15) (c) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).