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经导管主动脉瓣植入术后中期脑血管事件的预测因素 - EVERY-TAVI 注册研究结果。

Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation - Results from EVERY-TAVI registry.

机构信息

Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University, Germany; DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.

Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University, Germany.

出版信息

Int J Cardiol. 2017 Oct 1;244:106-111. doi: 10.1016/j.ijcard.2017.03.003.

Abstract

BACKGROUND

Clinical relevant cerebrovascular events (CVE) following transcatheter aortic valve implantation (TAVI) still remain a devastating complication associated with mortality and severe impairments. Therefore, identification of particularly modifiable predictors of this complication is clinically relevant and an important step for planning preventive strategies.

METHODS

A total of 985 patients who underwent trans-femoral TAVI for aortic valve stenosis in our institution from February 2008 to January 2015 were considered. The influence of demographics, clinical and procedural data on the occurrence of CVE was assessed with a competing risk model with death as competing event. Clinical events were defined according to VARC-2 criteria.

RESULTS

At a median follow-up of 838days, 95% CI 807-892, 59 patients experienced any CVE (5.9%) and the overall cumulative mortality rate was 46.1%. CVEs mainly occur later than 30days after TAVI (47.5%), 88.1% of them were of ischemic origin and 52.5% were disabling events. Independent predictors of CVEs were age (hazard ratio 1.05; 95% CI 1.01 to 1.09), history of CVE (hazard ratio 2.54; 95% CI 1.39 to 4.63) and use of balloon post-dilation (hazard ratio 1.85; 95% CI 1.08 to 3.18).

CONCLUSION

In patients undergoing TAVI incidence of clinically relevant CVEs is frequent with half of the events occurring after the first 30days post-TAVI. Identification of balloon post-dilation as the only modifiable predictor of CVE risk at mid-term, urges its cautious performance after prosthesis implantation. CLINICALTRIALS.

GOV IDENTIFIER

NCT02289339.

摘要

背景

经导管主动脉瓣植入术(TAVI)后发生临床相关的脑血管事件(CVE)仍然是与死亡率和严重损伤相关的破坏性并发症。因此,确定这种并发症的特定可改变预测因素在临床上是相关的,也是制定预防策略的重要步骤。

方法

本研究共纳入了 985 名 2008 年 2 月至 2015 年 1 月期间在我院接受经股动脉 TAVI 治疗的主动脉瓣狭窄患者。采用竞争风险模型评估人口统计学、临床和手术数据对 CVE 发生的影响,以死亡为竞争事件。根据 VARC-2 标准定义临床事件。

结果

中位随访时间为 838 天(95%CI:807-892),59 名患者发生任何 CVE(5.9%),总累积死亡率为 46.1%。CVE 主要发生在 TAVI 后 30 天以上(47.5%),88.1%为缺血性起源,52.5%为致残性事件。CVE 的独立预测因素为年龄(风险比 1.05;95%CI:1.01-1.09)、CVE 病史(风险比 2.54;95%CI:1.39-4.63)和球囊后扩张的使用(风险比 1.85;95%CI:1.08-3.18)。

结论

在接受 TAVI 的患者中,临床相关 CVE 的发生率较高,其中一半的事件发生在 TAVI 后 30 天内。在中期识别出球囊后扩张是 CVE 风险的唯一可改变的预测因素,这促使在假体植入后谨慎进行。临床试验。

注册号

NCT02289339

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