School of Medicine, "Hippokration" General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Department of Internal Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
Catheter Cardiovasc Interv. 2024 Apr;103(5):710-721. doi: 10.1002/ccd.31006. Epub 2024 Mar 14.
With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed.
The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting.
This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model.
This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I = 84.5%), 5% (95% CI: 2%-8%, I = 85.6%), and 2% (95% CI: 1%-3%, I = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded.
IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.
对于严重钙化的冠状动脉和外周动脉病变，在支架置入前进行病变准备至关重要，以避免扩张不足，这与支架血栓形成或再狭窄以及长期通畅失败有关。血管内碎石术（IVL）技术通过使用局部脉动声压力波来破坏浅表和深部的钙，使其成为冠状动脉严重钙化患者的一种有前途的治疗工具。
本研究旨在系统回顾和总结关于 IVL 用于严重钙化冠状动脉支架置入前病变准备的安全性和有效性的现有数据。
本研究按照 PRISMA 指南进行。我们系统地检索了 PubMed、SCOPUS 和 Cochrane 数据库，从它们的成立到 2023 年 2 月 23 日，以评估接受 IVL 治疗的患者的特征和结局。分析了 IVL 前后血管管腔的直径以及支架植入后的情况。使用随机效应模型评估主要不良心血管事件（MACE）的发生情况。
本荟萃分析包括 38 项研究，共纳入 2977 例严重钙化冠状动脉病变患者。平均年龄为 72.2±9.1 岁，IVL 临床成功率为 93%（95%置信区间[CI]：91%-95%，I=0%），手术成功率为 97%（95%CI：95%-98%，I=73.7%），而住院期间和 30 天的 MACE、心肌梗死（MI）和死亡发生率分别为 8%（95%CI：6%-11%，I=84.5%）、5%（95%CI：2%-8%，I=85.6%）和 2%（95%CI：1%-3%，I=69.3%）。IVL 应用后即刻血管直径显著增加（标准化均数差[SMD]：2.47，95%CI：1.77-3.17，I=96%），直径狭窄程度降低（SMD：-3.44，95%CI：-4.36 至-2.52，I=97.5%），而进一步降低了直径狭窄程度（SMD：-6.57，95%CI：-7.43 至-5.72，I=95.8%）和血管直径增加（SMD：4.37，95%CI：3.63-5.12，I=96.7%）和计算出的管腔面积（SMD：3.23，95%CI：2.10-4.37，I=98%），支架植入后。IVL 和支架植入后的平均急性管腔获得量估计分别为 1.27±0.6 和 1.94±1.1 毫米。围手术期并发症罕见，仅记录了几例穿孔、夹层或无复流现象。
IVL 似乎是一种安全有效的策略，可用于严重钙化病变的冠状动脉支架置入前的病变准备。现在需要进行前瞻性研究来比较 IVL 与其他病变准备策略。
