Deaths (all-cause mortality) at 1 month
Number of deaths from any cause mortality at 1 month
Deaths (all-cause mortality) at 1 year
Deaths (all-cause mortality) at 2 years
Deaths (all-cause mortality) at 3 years
Deaths (all-cause mortality) at 4 years
Deaths (all-cause mortality) at 5 years
All Stroke (disabling and non-disabling) at 1 month
duration of a focal or global neurological deficit >24 h; OR <24 h if available neuroimaging documents a new haemorrhage or infarct; OR the neurological deficit results in death
All Stroke (disabling and non-disabling) at 1 year
All Stroke (disabling and non-disabling) at 2 years
All Stroke (disabling and non-disabling) at 3 years
All Stroke (disabling and non-disabling) at 4 years
All Stroke (disabling and non-disabling) at 5 years
Rate of New permanent pacemaker implantation at 1 month
Rate of New permanent pacemaker implantation (e.g. defibrillator, single vs. dual chamber, biventricular)
Rate of New permanent pacemaker implantation at 1 year
Rate of New permanent pacemaker implantation at 2 years
Rate of New permanent pacemaker implantation at 3 years
Rate of New permanent pacemaker implantation at 4 years
Rate of New permanent pacemaker implantation at 5 years
Rate of Moderate or severe prosthetic valve regurgitation at 1 month
Moderate or severe prosthetic valve regurgitation by transthoracic echocardiography, VARC-2 definition
Rate of Moderate or severe prosthetic valve regurgitation at 1 year
Rate of Moderate or severe prosthetic valve regurgitation at 2 years
Rate of Moderate or severe prosthetic valve regurgitation at 3 years
Rate of Moderate or severe prosthetic valve regurgitation at 4 years
Rate of Moderate or severe prosthetic valve regurgitation at 5 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 month
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications by VARC-2 definition
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 1 year
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 2 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 3 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 4 years
Re-hospitalization for signs and symptoms of aortic valve disease and/or THV related complications at 5 years
Rate of alternating valve of prosthetic valve size during TAVR
Alternating valve of prosthetic valve size during TAVR (up size or down size)
Rate of valve malposition
Valve malposition (migration, embolization, and ectopic deployment)
Rate of TAV-in-TAV deployment
TAV-in-TAV deployment (An additional valve prosthesis is implanted within a previously implanted prosthesis because of suboptimal device position and/or function, during the index procedure)
Rate of device recapture or retrieval
Device recapture or retrieval peri-procedural
Rate of conversion to open surgery
Conversion to open surgery (Conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications)
Rate of unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure
Unplanned use of cardiopulmonary bypass (CPB) for hemodynamic support at any time during the TAVR procedure
Rate of coronary obstruction
Coronary obstruction (Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during the TAVR procedure)
Major vascular complications (VARC 2)
Major vascular complications by VARC 2 definition
Rate of annulus rupture
Procedural-related injuries occur in the region of the aortic root and the left ventricular outflow tract during transcatheter aortic valve replacement.
Rate of structural valve deterioration at 1 month
Structural valve deterioration (2017 EAPCI/ESC/EACTS definition)
Rate of structural valve deterioration at 1 year
Rate of structural valve deterioration at 2 years
Rate of structural valve deterioration at 3 years
Rate of structural valve deterioration at 4 years
Rate of structural valve deterioration at 5 years
New onset complete LBBB before discharge
New onset complete LBBB, by 2009 AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III definition
New onset complete LBBB at 1 month
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at Baseline
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 month
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 1 year
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 2 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 3 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 4 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores at 5 years
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
New York Heart Association (NYHA) Functional Class at baseline
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
New York Heart Association (NYHA) Functional Class at 1 month
New York Heart Association (NYHA) Functional Class at 1 year
New York Heart Association (NYHA) Functional Class at 2 years
New York Heart Association (NYHA) Functional Class at 3 years
New York Heart Association (NYHA) Functional Class at 4 years
New York Heart Association (NYHA) Functional Class at 5 years
Six Minute Walk Test (6MWT Distance or 6MWD) at baseline
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Six Minute Walk Test (6MWT Distance or 6MWD) at 1 month
Six Minute Walk Test (6MWT Distance or 6MWD) at 1 year
Six Minute Walk Test (6MWT Distance or 6MWD) at 2 years
Six Minute Walk Test (6MWT Distance or 6MWD) at 3 years
Six Minute Walk Test (6MWT Distance or 6MWD) at 4 years
Six Minute Walk Test (6MWT Distance or 6MWD) at 5 years
Mini-Mental State Examination score at baseline
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Mini-Mental State Examination score at 1 month
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Mini-Mental State Examination score at 1 year
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Mini-Mental State Examination score at 2 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Mini-Mental State Examination score at 3 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Mini-Mental State Examination score at 4 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Mini-Mental State Examination score at 5 years
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point)
Modified Rankin Scale Score at baseline
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:
0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Modified Rankin Scale Score at 1 month
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Modified Rankin Scale Score at 1 year
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Modified Rankin Scale Score at 2 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Modified Rankin Scale Score at 3 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Modified Rankin Scale Score at 4 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Modified Rankin Scale Score at 5 years
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead