Aortic Valve Stenosis
Conditions
Keywords
TAVR, TAVI, SAVR
Brief summary
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.
Detailed description
All TAVR and SAVR cases will be enrolled retrospectively and prospectively. This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily Living), Nagi & Rosow-Breslau self-reported items, Previous fall events since 6 months (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires), Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale), MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal, motor, motor&counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf, UEF (Upper extremities function).
Interventions
PROCEDURETAVR
All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea
PROCEDURESAVR
All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea
Sponsors
CardioVascular Research Foundation, Korea
Ho-Jin Kim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All successful transcatheter aortic valve replacement or surgical aortic valve replacement * Written consent
Exclusion criteria
* Infective endocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause death | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | at a later date between 30 days or discharge | — |
| Cardiovascular mortality | 1,6 and 12 months and 5 years | — |
| Myocardial infarction | 1,6 and 12 months and 5 years | — |
| Stroke | 1,6 and 12 months and 5 years | all stroke and TIA |
| Bleeding | 1,6 and 12 months and 5 years | — |
| Operation site complication | 1,6 and 12 months and 5 years | — |
| Event rate of permanent pacemaker insertion | 1,6 and 12 months and 5 years | — |
| Vascular access site and access-related complication | 1,6 and 12 months and 5 years | — |
| Prosthetic valve dysfunction | 1,6 and 12 months and 5 years | Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation |
| Event rate of composite endpoint | 1,6 and 12 months and 5 years | Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV |
| Structural valve deterioration | 1,6 and 12 months and 5 years | — |
| Change of NYHA class | 30 days and 1 year | the New York Heart Association (NYHA) Functional Classification |
| Change of valve area | 30 days and 1 year | — |
| Free from atrial fibrillation | 1,6 and 12 months and 5 years | — |
| Other TAVR-related complication | 1,6 and 12 months and 5 years | Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve) |
Countries
South Korea
Outcome results
None listed