Bulum Josko, Bastos Marcelo B, Hlinomaz Ota, Malkin Oren, Pawlowski Tomasz, Dragula Milan, Gil Robert
Department of Internal Medicine, University Hospital Center Zagreb, 10000 Zagreb, Croatia.
Thoraxcentrum, Erasmus Medical Center, 3015 GD Rotterdam, The Netherlands.
J Clin Med. 2024 Sep 10;13(18):5357. doi: 10.3390/jcm13185357.
To document the real-world experience with the use of pneumatic pulsatile mechanical circulatory support (MCS) with the PulseCath iVAC2L during high-risk percutaneous coronary interventions (HR-PCIs). : The use of MCS in HR-PCIs may reduce the rate of major adverse cardiovascular events (MACEs) at 90 days. The PulseCath iVAC2L is a short-term pulsatile transaortic left ventricular (LV) assist device that has been in use since 2014. The iVAC2L Registry tracks its safety and efficacy in a variety of hospitals worldwide. : The iVAC2L Registry is a multicenter, observational registry that aggregates clinical data from patients treated with the iVAC2L worldwide. A total of 293 consecutive cases were retrospectively collected and analyzed. Estimated rates of in-hospital clinical endpoints were described. All-cause mortality was used as the primary endpoint and other outcomes of interest were used as secondary endpoints. The rates obtained were reported and contextualized. : The in-hospital rate of all-cause mortality was 1.0%, MACE was 3.1%. Severe hypotension occurred in 8.9% of patients. Major bleeding and major vascular complications occurred in 1.0% and 2.1%, respectively. Acute myocardial infarction occurred in 0.7% of patients. Cerebrovascular events occurred in 1.4% of patients. Cardiac arrest occurred in 1.7% of patients. A statistically significant improvement in blood pressure was observed with iVAC2L activation. : The results of the present study suggest that the iVAC2L is capable of improving hemodynamics with a low rate of adverse events. However, confirmatory studies are needed to validate these findings.
记录在高危经皮冠状动脉介入治疗（HR-PCI）期间使用带有PulseCath iVAC2L的气动搏动性机械循环支持（MCS）的真实世界经验。：在HR-PCI中使用MCS可能会降低90天时主要不良心血管事件（MACE）的发生率。PulseCath iVAC2L是一种自2014年以来一直在使用的短期搏动性经主动脉左心室（LV）辅助装置。iVAC2L注册研究在全球多家医院追踪其安全性和有效性。：iVAC2L注册研究是一项多中心观察性注册研究，汇总了全球接受iVAC2L治疗患者的临床数据。回顾性收集并分析了总共293例连续病例。描述了院内临床终点的估计发生率。全因死亡率用作主要终点，其他感兴趣的结局用作次要终点。报告并结合背景说明了获得的发生率。：院内全因死亡率为1.0%，MACE为3.1%。8.9%的患者发生严重低血压。主要出血和主要血管并发症分别发生在1.0%和2.1%的患者中。0.7%的患者发生急性心肌梗死。1.4%的患者发生脑血管事件。1.7%的患者发生心脏骤停。激活iVAC2L后观察到血压有统计学意义的改善。：本研究结果表明，iVAC2L能够改善血流动力学，不良事件发生率较低。然而，需要进行验证性研究来证实这些发现。
