生物瓣主动脉瓣叶可能存在亚临床血栓。

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.

机构信息

From Cedars-Sinai Heart Institute (R.R.M., H.J., T.C., A.T., J.F., D.B., W.C., M.K.) and Cedars-Sinai Medical Center (G.F.) - both in Los Angeles; Rigshospitalet, University of Copenhagen, Copenhagen (K.F.K., O.B., N.T.O., L.S.); MedStar Health Research Institute, Washington, DC (F.M.A., A.D.P., N.J.W.); Hackensack University Medical Center and Joseph M. Sanzari Children's Hospital, Hackensack, NJ (C.E.R., V.J.); Lenox Hill Heart and Vascular Institute of New York (C.A.K.) and Columbia University Medical Center-New York Presbyterian Hospital (M.B.L.) - both in New York; St. Jude Medical, Plymouth, MN (H.G., E.M.); Cleveland Clinic, Cleveland (S.K.); and Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School - both in Boston (D.L.B.).

出版信息

N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

DOI:10.1056/NEJMoa1509233

PMID:26436963

Abstract

BACKGROUND

A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation.

METHODS

We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]).

RESULTS

Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007).

CONCLUSIONS

Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).

摘要

背景

在一项正在进行的临床试验中，一名接受经导管主动脉瓣置换术（TAVR）治疗的患者在计算机断层扫描（CT）中发现主动脉瓣叶活动减少，这一发现引发了对可能存在亚临床瓣叶血栓形成的担忧，并促使进一步调查。

方法

我们分析了临床试验中的 55 名患者和两个单中心注册中心的 132 名患者的数据，这些患者接受了 TAVR 或外科主动脉瓣生物假体植入术。我们获得了 4 维、容积渲染 CT 扫描，以及抗凝和临床结局数据（包括中风和短暂性脑缺血发作 [TIA]）。

结果

临床试验中 55 名患者中的 22 名（40%）和两个注册中心的 132 名患者中的 17 名（13%）在 CT 上发现瓣叶运动减少。减少的瓣叶运动在多种生物假体类型的患者中均有发现，包括经导管和外科生物假体。与双联抗血小板治疗相比，华法林的治疗性抗凝与减少瓣叶运动的发生率降低相关（临床试验中分别为 0%和 55%，P=0.01；汇总注册中心中分别为 0%和 29%，P=0.04）。在接受后续 CT 评估的患者中，所有 11 名接受抗凝治疗的患者和 10 名未接受抗凝治疗的患者的瓣叶运动均得到恢复（P<0.001）。临床试验中瓣叶运动减少患者与瓣叶运动正常患者的中风或 TIA 发生率无显著差异（分别为 22 名患者中的 2 名和 33 名患者中的 0 名；P=0.16），尽管在汇总注册中心中发现了显著差异（分别为 17 名患者中的 3 名和 115 名患者中的 1 名；P=0.007）。

结论

生物瓣主动脉瓣患者中发现主动脉瓣叶活动减少。这种情况通过治疗性抗凝得到解决。这种发现对包括中风在内的临床结局的影响需要进一步研究。（由圣犹达医疗公司和西达赛奈心脏研究所资助；Portico-IDE ClinicalTrials.gov 编号，NCT02000115；SAVORY 注册中心，NCT02426307；和 RESOLVE 注册中心，NCT02318342）。