提示: 手机请竖屏浏览!

经导管主动脉瓣置换术后的瓣叶活动度减小
Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement


Ole De Backer ... 心脑血管疾病 • 2020.01.09
相关阅读
• 经导管主动脉瓣植入术后应用和不应用氯吡格雷的抗凝治疗比较 • 经导管或外科主动脉瓣置换术的5年结局 • 经导管主动脉瓣置换术后应用利伐沙班的对照试验

TAVR术后的抗栓策略:抗凝还是血小板

 

刘巍

首都医科大学附属北京安贞医院心内科

 

随着经皮主动脉瓣植入技术(TAVR)的发展,以及其适应证逐渐向外科手术中到低危的患者中扩展,TAVR围手术期的管理也日益得到重视。在TAVR 术后可出现诸如卒中、体循环栓塞、瓣膜血栓和静脉系统血栓等并发症。植入瓣膜的亚临床瓣叶栓子也可以加速瓣膜的退化,并且有可能导致脑血管事件的风险增加。

查看更多

摘要


背景

主动脉生物瓣的亚临床瓣叶增厚和瓣叶活动度减小已得到四维计算机断层扫描(CT)的证实。抗凝治疗可否减少经导管主动脉瓣置换术(TAVR)后的这些现象尚未明确。

 

方法

在一项大型随机试验的子研究中,我们将已接受成功TAVR并且无长期抗凝治疗适应证的患者随机分组,分别采用基于利伐沙班的抗血栓策略(每日1次、每次10 mg利伐沙班联合75~100 mg阿司匹林)或抗血小板策略(每日1次、每次75 mg氯吡格雷联合75~100 mg阿司匹林)。患者接受四维CT评估的平均(±SD)时间是随机分组后90±15日。主要终点是至少1个人工瓣叶发生3级或更高级别活动度减小(即累及>50%的瓣叶)的患者百分比。本研究还评估了瓣叶增厚情况。

 

结果

共计231例患者被纳入试验。在扫描结果可评估的患者中,利伐沙班组97例患者中的2例(2.1%)和抗血小板组101例患者中的11例(10.9%)有至少1个人工瓣叶发生了3级或更高级别活动度减小(差异,-8.8个百分点;95%置信区间[CI],-16.5~-1.9;P=0.01)。利伐沙班组97例患者中的12例(12.4%)和抗血小板组102例患者中的33例(32.4%)有至少1个瓣叶增厚(差异,-20.0个百分点;95% CI,-30.9~-8.5)。在主体试验中,利伐沙班组的死亡或血栓栓塞事件风险,以及大出血、导致失能的出血或危及生命的出血的风险较高(风险比分别为1.35和1.50)。

 

结论

一项试验纳入了TAVR成功后无长期抗凝治疗适应证的患者,其中的一项子研究显示,在预防亚临床瓣叶活动异常方面,基于利伐沙班的抗血栓策略比抗血小板策略更有效。然而,在主体试验中,基于利伐沙班的策略与抗血小板策略相比,前者与较高的死亡或血栓栓塞并发症风险相关,并且与较高的出血风险相关(由拜耳资助;GALILEO-4D在ClinicalTrials.gov注册号为NCT02833948)。





作者信息

Ole De Backer, M.D., Ph.D., George D. Dangas, M.D., Hasan Jilaihawi, M.D., Jonathon A. Leipsic, M.D., Christian J. Terkelsen, M.D., D.M.Sc., Ph.D., Raj Makkar, M.D., Annapoorna S. Kini, M.D., Karsten T. Veien, M.D., Mohamed Abdel-Wahab, M.D., Ph.D., Won-Keun Kim, M.D., Prakash Balan, M.D., Nicolas Van Mieghem, M.D., Ph.D., Ole N. Mathiassen, M.D., Ph.D., Raban V. Jeger, M.D., Martin Arnold, M.D., Roxana Mehran, M.D., Ana H.C. Guimarães, Ph.D., Bjarne L. Nørgaard, M.D., Ph.D., Klaus F. Kofoed, M.D., D.M.Sc., Philipp Blanke, M.D., Stephan Windecker, M.D., and Lars Søndergaard, M.D., D.M.Sc. for the GALILEO-4D Investigators*
From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) — both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) — both in Denmark; Smidt Heart Institute, Cedars–Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) — all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) — all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) — both in Switzerland. Address reprint requests to Dr. De Backer at Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark, or at ole.de.backer@regionh.dk. *A complete list of the GALILEO-4D Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-2198.

2. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790-1798.

3. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609-1620.

4. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321-1331.

5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695-1705.

6. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019;380:1706-1715.

7. Thyregod HGH, Ihlemann N, Jørgensen TH, et al. Five-year clinical and echocardiographic outcomes from the Nordic Aortic Valve Intervention (NOTION) randomized clinical trial in lower surgical risk patients. Circulation 2019 February 1 (Epub ahead of print).

8. Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med 2015;373:2015-2024.

9. Chakravarty T, Søndergaard L, Friedman J, et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet 2017;389:2383-2392.

10. Pache G, Schoechlin S, Blanke P, et al. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J 2016;37:2263-2271.

11. Hansson NC, Grove EL, Andersen HR, et al. Transcatheter aortic valve thrombosis: incidence, predisposing factors, and clinical implications. J Am Coll Cardiol 2016;68:2059-2069.

12. Fuchs A, De Backer O, Brooks M, et al. Subclinical leaflet thickening and stent frame geometry in self-expanding transcatheter heart valves. EuroIntervention 2017;13(9):e1067-e1075.

13. Dangas GD, Weitz JI, Giustino G, Makkar R, Mehran R. Prosthetic heart valve thrombosis. J Am Coll Cardiol 2016;68:2670-2689.

14. Søndergaard L, De Backer O, Kofoed KF, et al. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J 2017;38:2201-2207.

15. Makkar RR. PARTNER 3 low-risk computed tomography substudy: subclinical leaflet thrombosis in transcatheter and surgical bioprosthetic valves. Presented at Transcatheter Cardiovascular Therapeutics (TCT) 2019, San Francisco, September 25–29, 2019.

16. Ruile P, Jander N, Blanke P, et al. Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation. Clin Res Cardiol 2017;106:85-95.

17. Jose J, Sulimov DS, El-Mawardy M, et al. Clinical bioprosthetic heart valve thrombosis after transcatheter aortic valve replacement: incidence, characteristics, and treatment outcomes. JACC Cardiovasc Interv 2017;10:686-697.

18. Windecker S, Tijssen J, Giustino G, et al. Trial design: rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: rationale and design of the GALILEO study. Am Heart J 2017;184:81-87.

19. Blanke P, Weir-McCall JR, Achenbach S, et al. Computed tomography imaging in the context of transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR): an expert consensus document of the Society of Cardiovascular Computed Tomography. JACC Cardiovasc Imaging 2019;12:1-24.

20. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998;17:873-890.

21. Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2017;38:3382-3390.

22. Yanagisawa R, Hayashida K, Yamada Y, et al. Incidence, predictors, and mid-term outcomes of possible leaflet thrombosis after TAVR. JACC Cardiovasc Imaging 2016;10:1-11.

23. Vollema EM, Kong WKF, Katsanos S, et al. Transcatheter aortic valve thrombosis: the relation between hypo-attenuated leaflet thickening, abnormal valve haemodynamics, and stroke. Eur Heart J 2017;38:1207-1217.

24. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg 2014;148(1):e1-e132.

25. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739-2791.

26. Dangas GD, Tijssen JGP, Wöhrle J, et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020;382:120-129.

服务条款 | 隐私政策 | 联系我们