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10 年展望:第一代经导管主动脉瓣中生存和结构性瓣膜退化。

The 10-year horizon: Survival and structural valve degeneration in first-generation transcatheter aortic valves.

机构信息

Department of Cardiovascular Surgery, German Heart Centre Munich, 80636 Munich, Germany; INSURE (Institute of Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Centre Munich, Technische Universität München, 80636 Munich, Germany.

TUM Graduate School, Technische Universität München, 85748 Munich, Germany.

出版信息

Arch Cardiovasc Dis. 2022 Jun-Jul;115(6-7):369-376. doi: 10.1016/j.acvd.2022.04.007. Epub 2022 May 26.

Abstract

BACKGROUND

Transcatheter aortic valve replacement is an established treatment for high- or intermediate-risk patients with symptomatic aortic valve stenosis. As more low-risk patients are being treated, transcatheter heart valve durability is gaining importance. Data on structural valve deterioration beyond 8 years after transcatheter aortic valve replacement is limited.

AIM

To evaluate the outcomes of transcatheter aortic valve replacement in high-risk patients with a follow-up of ≥10 years, focusing on survival and structural valve deterioration, according to the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery definitions.

METHODS

Only patients with a follow-up of ≥ 10 years were included in this study (n=510). Using serial echocardiographic data, the cumulative incidences of structural valve deterioration and bioprosthetic valve failure were analysed. Receiver operating characteristic analysis was used for predictor assessment.

RESULTS

Mean age was 79.6±6.7 years, with a mean logistic EuroSCORE of 19.8±12.7%. Immediate procedural mortality was 2.9%, and 30-day mortality was 7.8%. Kaplan-Meier-estimated survival at 10 years was 10.3±1.5%. At 10 years, the cumulative incidences of severe and moderate structural valve deterioration were 4.3% and 13%, respectively, for the total population. The cumulative incidence of bioprosthetic valve failure at 10 years was 9.0%. There was a significant difference in the rates of structural valve deterioration and bioprosthetic valve failure depending on valve type: structural valve deterioration, SAPIEN 8.9% vs CoreValve 2.2% at 10 years (P=0.001); bioprosthetic valve failure, SAPIEN 13.9% vs CoreValve 6.7% at 10 years (P=0.021).

CONCLUSIONS

Structural valve deterioration and bioprosthetic valve failure of early transcatheter heart valves was low at 10 years. The identified differences between valve types must be validated using current-generation devices in younger patients.

摘要

背景

经导管主动脉瓣置换术是治疗有症状的主动脉瓣狭窄高危或中危患者的一种既定疗法。随着越来越多的低危患者得到治疗,经导管心脏瓣膜的耐久性变得越来越重要。关于经导管主动脉瓣置换术 8 年后结构性瓣膜恶化的数据有限。

目的

根据欧洲经皮心血管介入协会/欧洲心脏病学会/欧洲心胸外科学会的定义,评估高危患者经导管主动脉瓣置换术 10 年以上的随访结果,重点关注生存率和结构性瓣膜恶化。

方法

本研究仅纳入随访时间≥10 年的患者(n=510)。使用连续的超声心动图数据,分析结构性瓣膜恶化和生物瓣衰败的累积发生率。采用受试者工作特征分析评估预测因子。

结果

平均年龄为 79.6±6.7 岁,平均 logistic EuroSCORE 为 19.8±12.7%。即刻手术死亡率为 2.9%,30 天死亡率为 7.8%。10 年时的 Kaplan-Meier 估计生存率为 10.3±1.5%。10 年时,总人群严重和中度结构性瓣膜恶化的累积发生率分别为 4.3%和 13%。10 年时生物瓣衰败的累积发生率为 9.0%。根据瓣膜类型,结构性瓣膜恶化和生物瓣衰败的发生率有显著差异:10 年时 SAPIEN 瓣膜为 8.9%,CoreValve 瓣膜为 2.2%(P=0.001);10 年时 SAPIEN 瓣膜为 13.9%,CoreValve 瓣膜为 6.7%(P=0.021)。

结论

早期经导管心脏瓣膜 10 年时结构性瓣膜恶化和生物瓣衰败发生率较低。瓣膜类型之间的差异必须使用当前一代装置在年轻患者中进行验证。

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