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亚洲人群冠状动脉腔内碎石术的真实世界经验:回顾性、观察性、单中心、所有患者注册研究。

Real-World Experience of Coronary Intravascular Lithotripsy in an Asian Population: A Retrospective, Observational, Single-Center, All-Comers Registry.

机构信息

Department of Cardiology, National Heart Centre Singapore, 5, Hospital Drive, Singapore 169609.

出版信息

J Invasive Cardiol. 2021 Jun;33(6):E417-E424. doi: 10.25270/jic/20.00526. Epub 2021 Apr 13.

Abstract

OBJECTIVES

To assess the clinical and angiographic outcomes of coronary intravascular lithotripsy (IVL) use in an all-comers population with moderate-to-severely calcified coronary lesions.

BACKGROUND

IVL has been shown to modify coronary calcific plaques with minimal vascular complications.

METHODS

This was a retrospective, observational study of patients treated with IVL. The primary endpoint was in-hospital major adverse cardiovascular event (MACE), which included cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR). Secondary endpoints were clinical success (stent expansion with <30% in-stent residual stenosis and no in-hospital MACE) and angiographic success.

RESULTS

Between August 2019 and December 2019, a total of 50 calcified lesions were treated in 45 patients using the Shockwave C2 IVL catheter (Shockwave Medical). They were further studied in 3 treatment subgroups: (1) primary IVL group with de novo lesions (n = 23 lesions); (2) secondary IVL group in which non-compliant balloon dilation failed (n = 15 lesions); and (3) tertiary IVL group with IVL to underexpanded stents (n = 12 lesions). The mean diameter stenosis of calcified lesions was 63.2 ± 10.2% at baseline, and decreased to 33.5 ± 10.9% immediately post IVL (P<.001) and 15 ± 7.1% post stenting (P<.001). Mean minimal lumen diameter was 1.1 ± 0.3 mm at baseline, and increased to 1.90 ± 0.5 mm post IVL (P<.001) and 2.80 ± 0.50 mm post stenting (P<.001). In-hospital and 30-day MACE occurred in 3 and 4 patients, respectively. Overall, clinical success and angiographic success were achieved in 90% and 94% of cases, respectively.

CONCLUSIONS

IVL appears to be a safe, effective, and feasible strategy for calcium modification in an all-comers cohort with high success rate, minimal procedural complications, and low MACE rates.

摘要

目的

评估冠状动脉内碎石术(IVL)在伴有中重度冠状动脉钙化病变的所有患者人群中的临床和血管造影结果。

背景

IVL 已被证明可对冠状动脉钙化斑块进行修饰,同时血管并发症极小。

方法

这是一项回顾性、观察性研究,纳入了接受 IVL 治疗的患者。主要终点是住院期间主要不良心血管事件(MACE),包括心脏死亡、心肌梗死(MI)和靶血管血运重建(TVR)。次要终点是临床成功(支架扩张后支架内残余狭窄<30%,且无住院期间 MACE)和血管造影成功。

结果

在 2019 年 8 月至 2019 年 12 月期间,使用 Shockwave C2 IVL 导管(Shockwave Medical)共治疗了 45 例患者的 50 个钙化病变,进一步分为 3 个治疗亚组进行研究:(1)初发病变的原发性 IVL 组(n = 23 个病变);(2)因非顺应性球囊扩张失败而进行的继发性 IVL 组(n = 15 个病变);(3)因支架扩张不足而进行的第三代 IVL 组(n = 12 个病变)。在基线时,钙化病变的平均直径狭窄率为 63.2 ± 10.2%,在接受 IVL 治疗后即刻降至 33.5 ± 10.9%(P<.001),在支架置入后降至 15 ± 7.1%(P<.001)。平均最小管腔直径在基线时为 1.1 ± 0.3 mm,在接受 IVL 治疗后增加至 1.90 ± 0.5 mm(P<.001),在支架置入后增加至 2.80 ± 0.50 mm(P<.001)。住院期间和 30 天 MACE 分别发生在 3 例和 4 例患者中。总体而言,临床成功率和血管造影成功率分别达到 90%和 94%。

结论

IVL 似乎是一种安全、有效且可行的策略,可用于治疗伴有高成功率、最小化手术并发症和低 MACE 发生率的所有患者人群中的钙修饰。

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