Pulsatile Left Ventricular Assistance in High-Risk Percutaneous Coronary Interventions: Short-Term Outcomes.

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Mechanical circulatory support (MCS) may reduce major adverse cardiovascular events (MACEs) in high-risk percutaneous coronary interventions (HR-PCIs).
• The PulseCath iVAC2L is a short-term pulsatile transaortic left ventricular assist device used globally since 2014.
• The iVAC2L Registry monitors the safety and efficacy of this device in diverse clinical settings.

Purpose of the Study:

• To evaluate the real-world safety and efficacy of the PulseCath iVAC2L in patients undergoing HR-PCIs.
• To document in-hospital clinical outcomes associated with iVAC2L use.

Main Methods:

• A multicenter, observational registry (iVAC2L Registry) was utilized.
• Data from 293 consecutive patients treated with the iVAC2L were retrospectively analyzed.
• In-hospital clinical endpoints, including all-cause mortality, were assessed.

Main Results:

• The in-hospital all-cause mortality rate was 1.0%, and MACE rate was 3.1%.
• Severe hypotension occurred in 8.9% of patients; major bleeding and vascular complications were 1.0% and 2.1%, respectively.
• Statistically significant improvements in blood pressure were observed upon iVAC2L activation.

Conclusions:

• The PulseCath iVAC2L demonstrates potential for hemodynamic improvement in HR-PCIs with a low adverse event profile.
• Further studies are required to confirm these preliminary findings.