ASAN Medical Center Aortic Valve Replacement Registry

Study Overview
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Brief Summary
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This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.

Detailed Description
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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).

Official Title
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ASAN Medical Center Aortic Valve Replacement Registry

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: TAVR
* Procedure: SAVR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All successful transcatheter aortic valve replacement or surgical aortic valve replacement Written consent Exclusion Criteria Infective endocarditis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all aortic stenosis<br> | Procedure: TAVR<br>* All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea<br>* Other names: transcatheter aortic valve replacement;Procedure: SAVR<br>* All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 1,6 and 12 months and 5 years | 
| Cardiovascular mortality | Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause | 1,6 and 12 months and 5 years | 
| Myocardial infarction |  | 1,6 and 12 months and 5 years | 
| Stroke | all stroke and TIA | 1,6 and 12 months and 5 years | 
| Bleeding |  | 1,6 and 12 months and 5 years | 
| Operation site complication |  | 1,6 and 12 months and 5 years | 
| Vascular access site and access-related complication |  | 1,6 and 12 months and 5 years | 
| Acute kidney injury |  | at a later date between 30 days or discharge | 
| Event rate of permanent pacemaker insertion |  | 1,6 and 12 months and 5 years | 
| Other TAVR-related complication | 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) | 1,6 and 12 months and 5 years | 
| Prosthetic valve dysfunction | Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation | 1,6 and 12 months and 5 years | 
| Event rate of composite endpoint | 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 | 1,6 and 12 months and 5 years | 
| Structural valve deterioration |  | 1,6 and 12 months and 5 years | 
| Change of NYHA class | the New York Heart Association (NYHA) Functional Classification | 30 days and 1 year | 
| Change of valve area |  | 30 days and 1 year | 
| Free from atrial fibrillation |  | 1,6 and 12 months and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, SAVR, TAVR