Efficacy and Safety of CorVad System in Coronary Intervention for Complex High-Risk and Indicated Patients

Guofeng Gao1,2,3, Bowen Li1,2,3, Hongwei Pan4

  • 1State Key Laboratory of Cardiovascular Disease, Beijing, China.

Insights

The CorVad percutaneous ventricular assist system safely and effectively supports high-risk patients undergoing percutaneous coronary intervention (PCI). This novel approach improves left ventricular ejection fraction (LVEF) and shows comparable outcomes to coronary artery bypass grafting (CABG).

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Devices

Background:

  • Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) carry high risks for complex high-risk and indicated patients (CHIPs).
  • Percutaneous ventricular assist systems offer a potential alternative for CHIPs during PCI.

Purpose of the Study:

  • To evaluate the safety and efficacy of the CorVad percutaneous ventricular assist system in CHIPs undergoing PCI.
  • To assess the impact of CorVad support on major adverse cardiovascular and cerebrovascular events (MACCE) and left ventricular ejection fraction (LVEF).

Main Methods:

  • 118 CHIPs with LVEF ≤ 40% received CorVad support during elective PCI.
  • The primary endpoint was MACCE at 30 days, with a performance goal of 22.5%.
  • Outcomes were compared to historical controls who underwent CABG.

Main Results:

  • The study met its primary endpoint, with a 30-day MACCE rate of 4.2% in the intention-to-treat cohort.
  • CorVad system implantation was successful in all patients, with significant improvements in LVEF at 48 hours and 30 days post-PCI.
  • No hemolysis was observed. MACCE rates at 30 and 90 days were comparable to propensity score-matched CABG historical controls.

Conclusions:

  • The CorVad percutaneous ventricular assist system is a safe and effective option for CHIPs undergoing PCI.
  • CorVad support demonstrates favorable hemodynamic effects and comparable clinical outcomes to CABG in this high-risk population.
Abstract

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