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有长期抗凝指征的生物瓣患者再次手术的风险。观察性回顾性多中心PLECTRUM研究结果。

Risk of reoperation in bioprosthetic valve patients with indication for long-term anticoagulation. Results from the observational retrospective multicentre PLECTRUM study.

作者信息

Poli Daniela, Antonucci Emilia, Pengo Vittorio, Grifoni Elisa, Maggini Niccolò, Testa Sophie, Lodigiani Corrado, Insana Antonio, Marongiu Francesco, Barcellona Doris, Paparo Carmelo, Bucherini Eugenio, Pignatelli Pasquale, Palareti Gualtiero

机构信息

Thrombosis Centre, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.

Arianna Anticoagulazione Foundation, Bologna, Italy.

出版信息

Open Heart. 2018 Aug 27;5(2):e000837. doi: 10.1136/openhrt-2018-000837. eCollection 2018.

Abstract

OBJECTIVE

Several factors should be considered when a prosthetic heart valve, bioprosthetic valve (BV) or mechanical valve is to be implanted: thrombogenicity, life expectancy and the risk of reoperation.

METHODS

We conducted an observational retrospective multicentre study among Italian Thrombosis Centers on patients with BV on long-term vitamin K antagonist (VKA) treatment to evaluate the risk of reoperation and the rate of bleeding and thrombotic events.

RESULTS

We analysed 612 patients (median age 71.8 years) with BV on long-term VKA treatment for the presence of atrial fibrillation (AF) (78.4%) or other indications (21.6%). Thirty-four major bleeding events (rate 1.1×100 patient-years) and 29 thromboembolic events (rate 0.9×100 patient-years) were recorded, and 46 patients (rate 1.5×100 patient-years) underwent reoperation. The rate of reoperation was higher among younger patients: 32.9% in patients <60 years and 3.9% in patients ≥60 years (relative risk (RR) 3.8, 95% CI 2.1 to 7.2; p=0.0001). When patients were analysed according to age <65 or ≥65 years and <75 or ≥70 years, younger patients still were at higher risk for reoperation (RR 3.1, 95% CI 1.7 to 6.0 and 3.7, 95% CI 1.7 to 8.6, respectively).

CONCLUSIONS

Our findings suggest that the threshold of 65 years for implanting a BV should be carefully evaluated, considering the high risk for reoperation and the high risk of AF occurrence with persisting need for long-term anticoagulation. The high risk for reoperation of young patients implanted with BV and the availability of a safer and easier way to conduct VKA treatment, such as the use of point-of-care devices, should be considered when the type of valve must be chosen.

摘要

目的

在植入人工心脏瓣膜,即生物瓣膜(BV)或机械瓣膜时,应考虑几个因素:血栓形成性、预期寿命和再次手术风险。

方法

我们在意大利血栓形成中心对长期接受维生素K拮抗剂(VKA)治疗的BV患者进行了一项观察性回顾性多中心研究,以评估再次手术风险以及出血和血栓形成事件的发生率。

结果

我们分析了612例长期接受VKA治疗的BV患者(中位年龄71.8岁),其中存在心房颤动(AF)的患者占78.4%,其他指征的患者占21.6%。记录到34例严重出血事件(发生率为1.1×100患者年)和29例血栓栓塞事件(发生率为0.9×100患者年),46例患者(发生率为1.5×100患者年)接受了再次手术。年轻患者的再次手术率更高:年龄<60岁的患者中为32.9%,年龄≥60岁的患者中为3.9%(相对风险(RR)3.8,95%置信区间2.1至7.2;p = 0.0001)。当根据年龄<65岁或≥65岁以及<75岁或≥70岁对患者进行分析时,年轻患者再次手术的风险仍然更高(RR分别为3.1,95%置信区间1.7至6.0和3.7,95%置信区间1.7至8.6)。

结论

我们的研究结果表明,考虑到再次手术的高风险以及AF发生的高风险且持续需要长期抗凝,对于植入BV的65岁阈值应进行仔细评估。在必须选择瓣膜类型时,应考虑植入BV的年轻患者再次手术的高风险以及进行VKA治疗的更安全、更简便方法的可用性,例如使用即时检测设备。

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