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冠状动脉血管内碎石术的应用进展及临床结果:来自一项国际多中心注册研究的见解

Evolving use and clinical outcomes of coronary intravascular lithotripsy: insights from an international, multicentre registry.

作者信息

van Oort Martijn J H, Al Amri Ibtihal, Bingen Brian O, Oliveri Federico, Claessen Bimmer E P M, Dimitriu-Leen Aukelien C, Vossenberg Tessel N, Kefer Joelle, Girgis Hany, van der Kley Frank, Jukema J Wouter, Montero-Cabezas Jose M

机构信息

Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.

Department of Cardiology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.

出版信息

Heart. 2024 Dec 23;111(2):62-68. doi: 10.1136/heartjnl-2024-324703.

Abstract

BACKGROUND

Intravascular lithotripsy (IVL) is increasingly used for treatment of coronary artery calcification. This study aimed to evaluate contemporary utilisation patterns, safety and efficacy of IVL in an unselected real-world patient cohort.

METHODS

We included 454 patients undergoing IVL from May 2019 to February 2024 across seven centres in two European countries. Key endpoints included device success, technical success, procedural success, IVL-related complications and major adverse cardiovascular events (MACE) at 1-year follow-up.

RESULTS

The cohort (mean age 73±9 years, 75% male) had a mean SYNTAX Score of 22.0±13.6. Device, technical and procedural success were achieved in 98%, 91% and 89% of patients, respectively. IVL-related complications occurred in six patients (1%). At 1-year follow-up, MACE was observed in 37 patients (13%). Over time, IVL use increased in patients with acute coronary syndrome (p=0.004) and in combination with intracoronary imaging (p=0.002), while use of other calcium modification devices decreased (p=0.034).

CONCLUSION

In this real-world registry, IVL demonstrated efficacy across diverse clinical and anatomical settings. High success rates, low complication rates and MACE rates were observed acutely and at 1-year follow-up. Utilisation patterns evolved over time, with increased adoption in acute scenarios and alongside intracoronary imaging.

摘要

背景

血管内碎石术(IVL)越来越多地用于治疗冠状动脉钙化。本研究旨在评估在未经选择的真实世界患者队列中IVL的当代使用模式、安全性和有效性。

方法

我们纳入了2019年5月至2024年2月期间在两个欧洲国家的七个中心接受IVL治疗的454例患者。主要终点包括器械成功率、技术成功率、手术成功率、IVL相关并发症以及1年随访时的主要不良心血管事件(MACE)。

结果

该队列(平均年龄73±9岁,75%为男性)的平均SYNTAX评分为22.0±13.6。器械成功率、技术成功率和手术成功率分别在98%、91%和89%的患者中实现。6例患者(1%)发生了IVL相关并发症。在1年随访时,37例患者(13%)出现了MACE。随着时间的推移,急性冠状动脉综合征患者中IVL的使用增加(p=0.004),并且与冠状动脉内成像联合使用时也增加(p=0.002),而其他钙修饰器械的使用减少(p=0.034)。

结论

在这个真实世界注册研究中,IVL在不同的临床和解剖学环境中均显示出疗效。在急性治疗时以及1年随访时均观察到高成功率、低并发症率和MACE发生率。使用模式随时间演变,在急性情况下以及与冠状动脉内成像一起使用时采用率增加。

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