Interventional Ventricular Assist System for PCI in CHIP Patients

Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation

Rehospitalization due to cardiovascular reasons

Bleeding is defined by the "Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium" (MRC-ARC)

Including but not limited to cardiac structural impairment, severe limb ischemia (pale, pulseless, and necrotic), infection, aortic and aortic valve impairment, hemolysis, peri-procedural complications that cause death, permanent/severe disability to the subject, or significantly prolonged hospital stay or need for surgical intervention

Hemodynamic disorder is defined as average arterial pressure (MAP) below 60 mmHg for more than 10 minutes with the requirement of additional vasoactive medications

Transfusion rate is defined as patients who had transfusion / all enrolled patients.

Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation

Major Adverse Cardiovascular and Cerebrovascular Events is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization

Device-related composite endpoint (DoCE), defined as: cardiac death, target-vessel myocardial infarction (TV-MI), clinically and physiologically driven target lesion revascularization (CPI-TLR)

Patient-related composite endpoint (PoCE), defined as: all-cause death, any stroke, any myocardial infarction, and any revascularization

Net adverse clinical events, defined as: PoCE + MCS-ARC defined type 3, 4, 5 bleeding

Puncture complications: Vascular complications or percutaneous vascular suture failure

Aortic valve injury is defined as the occurrence of moderate and severe aortic valve regurgitation in patients with no pre-operative aortic valve regurgitation or mild regurgitation

Active infection refers to an infection accompanied by clinical evidence, including pain, fever, or imaging findings consistent with infection, and requires the use of antimicrobial drugs for treatment. The definition of infection requires positive culture results from the site or organ of infection, unless there is strong clinical evidence indicating the presence of infection and the need for treatment.

Setup time is defined as the time from starting vessel puncture to the time providing cardiac support by the device

Complete revascularization is defined as the residual SYNTAX score ≤ 8 points

The SAQ is a 19-item self-administered disease-specific patient-reported outcome measure with 5 domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception and/or quality of life. It was to identify a conceptual framework with which to elicit the important manifestations of coronary disease from the patient perspective. All SAQ domain scores and the summary score range from 0 to 100 points, with higher scores indicating less angina, fewer functional limitations, and better quality of life.

The KCCQ is a self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. KCCQ scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations.

The EQ-5D is a standardized instrument for use as a measure of health outcome which can be divided into two parts: the EQ-5D health description system and the EQ-vas. EQ-5D-5L questionnaire is a five-item scale assessing five separate dimensions of health: (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has to be answered on a five-level scale (no problems, slight problems, moderate problems, severe problems and extreme problems). The EQ-VAS is a 20 cm long vertical visual scale. A score of 100 at the top represents "best perceived health status" and a score of 0 at the bottom represents "worst perceived health status".