This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.
Study Type
OBSERVATIONAL
Enrollment
900
Aortic valve replacement
Sejong Hospital
Bucheon-si, South Korea
Asan Medical Center
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
All-cause death
Time frame: 1 year
Cardiovascular mortality
A. Death due to proximate cardiac cause B. Death caused by noncoronary vascular condition C. All procedure-related/surgery-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Myocardial infarction
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
All stroke and transient ischemic attack
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Bleeding
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Access site complication
Operation site complication Vascular access site and access-related complication Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Acute kidney injury
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Permanent pacemaker insertion
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
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Time frame: 5 years
TAVR-related complication
A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve malpositioning H. TAV-in-TAV deployment Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Prosthetic valve dysfunction
A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Composite event
A. Device success B. Early safety (30 days) * Death, stroke, life-threatening bleeding, acute kidney injury, coronary stenosis requiring intervention, significant vascular complication, valve dysfunction requiring intervention C. Clinical efficacy (30 days) * Death, stroke, deteriorating heart failure or valve function requiring hospitalization, NYHA III or IV dyspnea, valve dysfunction Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
Structural valve deterioration
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years
Time frame: 5 years
NYHA class
New York Heart Association (NYHA) Functional Classification
Time frame: 30 days and 1 year
The change of valve area
Aortic valve area measured by echocardiography (mm2)
Time frame: 30 days and 1 year
New onset atrial fibrillation
Time frame: 30 days and 1 year