HEART VALVE DISEASE
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age at valve implantation =70 years old; 2. Patients who underwent cardiac valve replacement for the first time (including aortic valve, mitral valve, and combined replacement, etc.) between May 1, 2019 and December 31, 2021; 3.The patients or their guardians (proxies) were informed of the nature of the trial and agreed to all the terms of participation in the trial, and they voluntarily signed an informed consent form that was approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Transcatheter valve implantation; 2. Patients with past or present mental illness; 3. Refusal to participate in the study; 4. Severe hearing or language disorders and communication disorders; 5. Other conditions considered by the investigator to be inappropriate for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 1-year all-cause mortality and major composite cardiovascular and cerebrovascular events (MACCEs) (defined as acute myocardial infarction, stroke (ischemia and bleeding), and rehospitalization for heart failure) were recorded; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early mortality: within 30 days or perioperative or in-hospital death;Valve performance was evaluated, including mean transvalvular pressure gradient, effective valve orifice area, and degree of prosthetic valve regurgitation;Incidence of valve-related complications: including valve thrombosis, paravalvular leak and prosthetic valve failure, myocardial infarction, conduction block, rehospitalization for heart failure, infective endocarditis (inflammation of the heart membrane directly caused by bacterial, fungal, or viral infection).;Valve reintervention: Any valve-related reoperation to repair, alter, adjust, or replace a previously implanted valve.;Major bleeding events included retinal and choroidal hemorrhage, joint hemorrhage, epistaxis, hemoptysis, gastrointestinal hemorrhage, pericardial hemorrhage, and intracerebral hemorrhage;Cardiac function classification (NYHA);Overall survival (person/year);Quality of life assessment (KCCQ, EQ-5D, activities of daily living assessment); | — |
Countries
CHINA
Contacts
The Second Xiangya Hospital of Central South University