Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years.
In China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement.
Common pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients.
The aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.
Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).
A last remaining patent coronary artery (the anterior descending artery (LAD) and/or its branches, the circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches).
Saphenous vein graft (SVG) vascular lesions.
Severely calcification, tortuosity.
Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP <90 mmHg for ≥30 min or requiring supportive measures to maintain SBP >90 mmHg and end-organ hypoperfusion (urine output <30 ml/h or cool extremities).
STEMI or CK-MB did not return to the normal range within 24 hours.
Cardiac arrest with cardiopulmonary resuscitation within 24 hours.
Left ventricular mural thrombus.
Parallel
Implantation of the VADLINK Percutaneous Left Ventricular Assist Device
DeviceTo implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).
VA-ECMO
DeviceReceived venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.
30-day Major Adverse Events (MAE) rate
Occurrence of a major adverse event (MAE) up to 30 days post-implantation. Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, Unplanned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation or ventricular arrhythmias after electrical cardioversion.
The MACCE rate
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) within 30 or 90 days after surgery.
Transfusion rate
Transfusion rate within 30 days after surgery.
Mean units transfused
Mean Number of Blood Units Transfused within 30 Days Postoperatively.
Incidence of hemodynamic instability
Incidence of hemodynamic instability within 30 days device implantation.
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