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Role of Left Ventricular Ejection Fraction in Modern High-Risk PCI with pLVAD Support

15 Feb 2024

In the early years of percutaneous coronary intervention (PCI), studies indicated a heightened risk of major adverse cardiac events (MACE) in patients with reduced left ventricular ejection fraction (LVEF), involving outcomes such as death, Q-wave myocardial infarction (MI), stent thrombosis, and repeat revascularization. Patients with LV systolic dysfunction often present with multiple comorbidities and complex coronary artery disease (CAD), leading to a greater myocardial jeopardy and increased risk of hemodynamic compromise during PCI. To address this, mechanical circulatory support (MCS) through a percutaneous left ventricular assist device (pLVAD) is frequently employed, demonstrating substantial improvements in systemic and coronary hemodynamics.

The PROTECT II randomized controlled trial compared Impella 2.5 to intra-aortic balloon pump (IABP) for hemodynamic support in patients with LV dysfunction undergoing high-risk PCI (HRPCI). Impella utilization in this trial improved 90-day major adverse events, particularly reducing myocardial infarction (MI) and repeat revascularization events. With the evolution of the field and expanded criteria for HRPCI, including patients with higher LVEF requiring MCS due to anatomical complexity and severe valvular pathologies, the study aimed to investigate how care for these complex patients has evolved. By utilizing data from the PROTECT III study, the research explores procedural and clinical outcomes based on baseline LVEF among patients undergoing Impella-supported HRPCI in current practice.

The study focuses on the impact of left ventricular (LV) systolic dysfunction on outcomes in patients undergoing percutaneous coronary intervention (PCI). Specifically, the objective is to assess the outcomes of patients undergoing high-risk PCI (HRPCI) with percutaneous left ventricular assist device (pLVAD) support, categorized by their LV ejection fraction (LVEF).

The study, based on data from the PROTECT III trial, categorizes patients undergoing pLVAD-supported HRPCI into three groups based on their baseline LVEF: severe LV dysfunction (LVEF < 30%), mild to moderate LV dysfunction (LVEF ≥ 30% to < 50%), and preserved LV function (LVEF ≥ 50%). The evaluation includes major adverse cardiovascular and cerebrovascular events (MACCE), comprising all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization. Additionally, PCI-related complications are assessed at 90 days, while mortality is examined at 1 year.

Between March 2017 and March 2020, the study recorded baseline LVEF data for 940 patients. Patients with preserved LV function tended to be older, presented with myocardial infarction more frequently, and underwent more left main PCI and atherectomy procedures. Immediate PCI-related coronary complications were rare (2.7% overall) and consistent across LVEF groups (p=0.98), showing no association with LVEF. Unadjusted 90-day MACCE rates were comparable across LVEF groups; however, when considering LVEF as a continuous variable, it was found to be associated with both 90-day MACCE (adjusted hazard ratio per 5% increase 0.89, 95% CI [0.80, 0.98], p=0.018) and 1-year mortality (adjusted hazard ratio per 5% increase 0.84 [0.78, 0.90], p<0.0001).

The authors concluded that patients undergoing pLVAD-supported HRPCI experienced low rates of PCI-related complications, irrespective of baseline LVEF. However, LVEF was identified as a significant factor associated with 90-day MACCE and 1-year mortality.

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Original article: Abu-Much A et al. Am Heart J. 2023 Dec 26:269:139-148.

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