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下一代搏动性机械循环辅助对心脏力学的影响:PULSE 试验。

Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial.

机构信息

Department of Cardiology, Thoraxcentrum, Erasmus University Medical Center, Rotterdam, the Netherlands.

Cardiovascular Division, King's College London, St Thomas' Campus, London.

出版信息

Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.

DOI:10.1016/j.carrev.2022.03.013
PMID:35331637
Abstract

OBJECTIVES

To describe hemodynamic effects of iVAC2L mechanical circulatory support (MCS).

BACKGROUND

MCS is increasingly used in the context of high-risk percutaneous coronary intervention (PCI). The effect of the pulsatile iVAC2L MCS on left ventricular loading conditions and myocardial oxygen consumption (MVO) is unknown.

METHODS

This prospective single-arm two-center study included 29 patients who underwent high-risk PCI with iVAC2L MCS using simultaneous invasive pulmonary pressure monitoring and left ventricular pressure-volume analysis. Hemodynamic recordings were performed during steady state conditions with MCS off and on before and after PCI. Pressure-volume variations were analyzed to denote responders and non-responders.

RESULTS

The mean age was 74 (IQR: 70-81) years and the mean SYNTAX score was 31 ± 8.3. Left ventricular unloading with iVAC2L MCS was demonstrated in 22 out of 27 patients with complete PV studies. Patients with moderate or severe mitral regurgitation or presenting with acute coronary syndrome (ACS) had higher filling pressures and volumes and were most responsive to iVAC2L unloading (9/10 patients with moderate or severe MR and 11/11 patients with ACS). Pulsatile MCS activation reduced MAP (-4%), SBP (-9%), ESP (-11%), ESV (-15%) and EDV (-4%) among responders but not among non-responders. Responders experienced significant reductions in afterload (Ea: -19%) with increases in stroke volume (+11%) and cardiac output (+11%).

CONCLUSIONS

Pulsatile iVAC2L MCS in patients with advanced coronary artery disease at high to prohibitive operative risk resulted in LV unloading and reduced myocardial oxygen consumption particularly in patients with ACS or significant MR with higher filling pressures at baseline.

CLINICAL TRIAL REGISTRATION

NCT03200990.

摘要

目的

描述 iVAC2L 机械循环支持(MCS)的血液动力学效应。

背景

MCS 在高危经皮冠状动脉介入治疗(PCI)中越来越多地使用。搏动性 iVAC2L MCS 对左心室负荷条件和心肌耗氧量(MVO)的影响尚不清楚。

方法

本前瞻性单臂两中心研究纳入 29 例接受 iVAC2L MCS 治疗高危 PCI 的患者,同时进行有创性肺动脉压监测和左心室压力-容积分析。在 MCS 关闭和关闭前后进行 PCI 前和 PCI 后进行稳态条件下的血液动力学记录。分析压力-容积变化以表示反应者和非反应者。

结果

平均年龄为 74 岁(IQR:70-81),平均 SYNTAX 评分为 31 ± 8.3。27 例完成 PV 研究的患者中,有 22 例显示左心室卸载。中度或重度二尖瓣反流或出现急性冠状动脉综合征(ACS)的患者具有更高的充盈压和容量,对 iVAC2L 卸载的反应最大(9/10 例中度或重度 MR 和 11/11 例 ACS)。搏动性 MCS 激活可降低 MAP(-4%)、SBP(-9%)、ESP(-11%)、ESV(-15%)和 EDV(-4%)在反应者中,但在非反应者中则不然。反应者的后负荷(Ea:-19%)显著降低,同时心排量(+11%)和心排量(+11%)增加。

结论

在高至禁忌手术风险的晚期冠状动脉疾病患者中,使用搏动性 iVAC2L MCS 可导致左心室卸载和降低心肌耗氧量,特别是在基线时具有较高充盈压的 ACS 或有明显 MR 的患者中。

临床试验注册号

NCT03200990。

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