血管内碎石术及临时机械循环支持治疗严重钙化冠状动脉疾病：比荷卢血管内碎石术注册研究的见解
Intravascular lithotripsy and temporary mechanical circulatory support for the treatment of heavily calcified coronary artery disease: insights from the BENELUX-IVL registry.
作者信息
Oliveri Federico, Merino Isabel, van Oort Martjn J H, Al Amri Ibtihal, Bingen Brian O, Arslan Fatih, Claessen Bimmer E, Dimitriu-Leen Aukelien C, Kefer Joelle, Girgis Hany, Vossenberg Tessel, van der Kley Frank, Jukema J Wouter, Montero-Cabezas Josè
机构信息
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Department of Cardiology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
出版信息
Heart Lung. 2025 Sep-Oct;73:108-113. doi: 10.1016/j.hrtlng.2025.04.030. Epub 2025 May 12.
BACKGROUND
Intravascular lithotripsy (IVL) is increasingly utilized for the treatment of heavily calcified coronary lesions. However its use in conjunction with temporary mechanical circulatory support (tMCS) remains underexplored.
OBJECTIVE
This study aims to evaluate the current use of tMCS and IVL for the treatment of heavily calcified coronary lesions.
METHOD
From the BENELUX-IVL prospective registry, patients who underwent IVL during PCI and required tMCS during the procedure were selected. The primary technical endpoint was procedural success <30%, defined as a composite of device success (the ability to deliver the IVL catheter across the target lesion, and delivery of IVL pulses without angiographic complications) with residual stenosis <30%, final Thrombolysis In Myocardial Infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical outcome was in-hospital MACE, including cardiac death, non-fatal myocardial infarction, or target lesion revascularization.
RESULTS
Between May 2019 and March 2024, a total of 454 patients were included, of whom 12 (2.6%) necessitated tMCS (for a total of 13 tMCS devices). Upon admission, the mean LV-EF was 39.5 ± 11.9%. The median Syntax score was 37 (25-49). A bail-out indication was the most common reason for tMCS initiation (58.3%), even if none was directly started due to IVL-related complications. Microaxial Flow Pump was the main utilized device (75%), followed by VA-ECMO (25%) and IABP (8.3%). One case required both VA-ECMO and Impella due to a coronary perforation complicated by cardiac tamponade. Procedural success < 30% was achieved in 91.6% of the cases. MACE occurred in one patient (8.3%).
CONCLUSION
In a large cohort of patients with complex heavily calcified coronary lesions requiring IVL, the need for tMCS was low (2.6%), with the main indication being bail-out.
背景
血管内碎石术（IVL）越来越多地用于治疗严重钙化的冠状动脉病变。然而，其与临时机械循环支持（tMCS）联合使用的情况仍未得到充分研究。
目的
本研究旨在评估tMCS和IVL目前在治疗严重钙化冠状动脉病变中的应用情况。
方法
从比荷卢经济联盟-IVL前瞻性注册研究中，选取在经皮冠状动脉介入治疗（PCI）期间接受IVL且在手术过程中需要tMCS的患者。主要技术终点为手术成功率<30%，定义为器械成功率（将IVL导管输送穿过靶病变的能力，以及在无血管造影并发症的情况下输送IVL脉冲）与残余狭窄<30%、最终心肌梗死溶栓3级血流以及无院内主要不良心血管事件（MACE）的综合结果。主要临床结局为院内MACE，包括心源性死亡、非致命性心肌梗死或靶病变血运重建。
结果
2019年5月至2024年3月期间，共纳入454例患者，其中12例（2.6%）需要tMCS（共使用13台tMCS设备）。入院时，左心室射血分数（LV-EF）的平均值为39.5±11.9%。Syntax评分中位数为37（25-49）。紧急救助指征是启动tMCS的最常见原因（58.3%），即使没有一例是直接因IVL相关并发症而启动。微轴流泵是主要使用的设备（75%），其次是静脉-动脉体外膜肺氧合（VA-ECMO，25%）和主动脉内球囊反搏（IABP，8.3%）。1例患者因冠状动脉穿孔并发心脏压塞，同时需要VA-ECMO和Impella。91.6%的病例实现了手术成功率<30%。1例患者发生MACE（8.3%）。
结论
在一大群需要IVL治疗的复杂严重钙化冠状动脉病变患者中，tMCS的需求较低（2.6%），主要指征为紧急救助。
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