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冠状动脉碎石术治疗支架扩张不足:国际多中心 CRUNCH 注册研究。

Coronary lithotripsy for the treatment of underexpanded stents: the international & multicentre CRUNCH registry.

机构信息

Erasmus University Medical Center, Rotterdam, the Netherlands.

Policlinico Umberto I' "Sapienza" University of Rome, Rome, Italy.

出版信息

EuroIntervention. 2022 Sep 20;18(7):574-581. doi: 10.4244/EIJ-D-21-00545.

DOI:10.4244/EIJ-D-21-00545
PMID:35318955
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10241293/
Abstract

BACKGROUND

Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy.

AIMS

We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification.

METHODS

This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE).

RESULTS

Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain.

CONCLUSIONS

Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

摘要

背景

支架扩张不足会增加心脏不良事件的风险。目前,治疗难治性支架扩张不足的选择有限。在这种情况下,血管内碎石术(IVL)系统可能是一种安全有效的策略。

目的

我们旨在评估 IVL 治疗因重度潜在钙化导致的难治性支架扩张不足的安全性和有效性。

方法

这是一项国际多中心注册研究,纳入了 2017 年 12 月至 2020 年 8 月期间接受 IVL 治疗以治疗支架扩张不足的患者。收集了血管造影和冠状动脉内成像数据。疗效终点是器械成功(最终百分比直径狭窄<50%的技术成功)。安全性终点是住院期间的主要不良心脏事件(MACE)。

结果

共纳入 70 例患者,平均年龄为 73±9.2 岁,76%为男性。支架植入至 IVL 治疗的中位时间为 49 天(0-2537)。IVL 治疗前和治疗后分别有 72.3%和 76.8%的患者进行了非顺应性球囊扩张辅助治疗,22.4%的患者进行了额外支架置入。器械成功率为 92.3%。最小管腔直径从 1.49±0.73mm 增加到 2.41±0.67mm(p<0.001),支架扩张增加了 124.93±138.19%(p=0.016)。未观察到与 IVL 相关的手术并发症或 MACE。支架置入后直接使用挽救性 IVL 治疗和开口处未扩张病变与管腔直径增加呈负相关。

结论

在因重度钙化病变导致支架扩张不足的情况下,冠状动脉碎石术增加管腔和支架尺寸是安全有效的。

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