Interventional Ventricular Assist System for PCI in CHIP Patients

Overview

In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).

During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.

There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.

The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI.

Eligibility

Inclusion Criteria:

1. 18 Years to 90 Years
2. The Heart Team determined that the patients required coronary artery revascularization, but there is a high risk of CABG or the patients refuses CABG. After evaluation by the Heart Team, it was concluded that the patients can benefit from revascularization by undergoing high risk PCI
3. The subject is diagnosed with acute or chronic coronary syndrome, and
   1. LVEF≤ 35% or
   2. LVEF ≤ 40% and NYHA Classification is III or IV
4. Patients who are able to give informed consent and complete the follow-up

Exclusion Criteria:

1. At least two vessel chronic total occlusions (CTOs) (diameter of occluded artery ≥ 2.5mm)
2. Unprotected left main coronary artery disease, and meeting one or more complex PCI maneuver criteria
3. Three-vessel disease and meeting two or more complex PCI criteria

Complex PCI maneuvers are defined as:

1. Bifurcation require the treatment of both branches (including stents or PTCA)
2. Calcification require Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy
3. Severe tortuosity
4. Target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 points)