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钙化病变的冠状动脉旋磨术:真实世界多中心注册研究。

Coronary lithoplasty for calcified lesions: real-world multicenter registry.

作者信息

Cubero-Gallego Héctor, Millán Raúl, Fuertes Mónica, Amat-Santos Ignacio, Quiroga Xavier, Gómez-Lara Josep, Salvatella Neus, Tizón-Marcos Helena, Negrete Alejandro, Santos-Martínez Sandra, Mohandes Mohsen, Gómez-Hospital Joan A, Morís César, Vaquerizo Beatriz

机构信息

Área del Corazón, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias-ISPA, Universidad de Oviedo, Oviedo, Asturias, Spain.

Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital del Mar, Universidad Autónoma de Barcelona, Barcelona, Spain.

出版信息

Rev Esp Cardiol (Engl Ed). 2020 Dec;73(12):1003-1010. doi: 10.1016/j.rec.2020.02.010. Epub 2020 May 17.

Abstract

INTRODUCTION AND OBJECTIVES

Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population.

METHODS

This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory.

RESULTS

This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization.

CONCLUSIONS

This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.

摘要

引言与目的

冠状动脉旋磨术(CL)是一种基于球囊的治疗钙化病变的技术。本研究报告了在未经选择的高危人群中使用CL治疗钙化病变的初步经验。

方法

这是一项前瞻性多中心注册研究,纳入了2018年8月至2019年8月期间所有接受CL治疗的连续性冠状动脉钙化病变病例。排除标准包括靶病变位于小血管(<2.5mm)以及CL术前存在夹层。定量冠状动脉造影和血管内超声/光学相干断层扫描分析由独立的中央核心实验室完成。

结果

该注册研究纳入了57例患者(66处病变)。患者群体以老年人为主(72.6±9.4岁),糖尿病患者(56%)、慢性肾脏病患者(35%)和多支血管病变患者(84%)比例较高。所有病变均分类为B/C型。超过75%的病变使用非顺应性/半顺应性球囊或切割球囊进行预扩张。旋磨术在5处病变(7.6%)的旋磨术前使用。平均而言,CL需要1.17个球囊,平均发放60次脉冲。CL成功率为98%。13%的病例在治疗过程中旋磨球囊破裂。手术并发症较少:2例严重夹层(均与旋磨球囊破裂无关)通过药物洗脱支架植入成功治疗。1例患者在成功完成靶病变血运重建2天后发生支架血栓形成。

结论

这是一项真实世界的多中心注册研究,支持在未经选择的高危人群中使用CL进行经皮冠状动脉介入治疗钙化冠状动脉病变的可行性、安全性和短期疗效,结果令人满意。

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