. | Unmatched ( n = 310) . | Matched ( n = 206) . | ||||
---|---|---|---|---|---|---|
ACURATE ( n = 131) . | SAPIEN ( n = 179) . | P -values . | ACURATE ( n = 103) . | SAPIEN ( n = 103) . | P -values . | |
Demographics and basic clinical data | ||||||
Age (years) | 83 ± 5 | 80 ± 10 | <0.001 | 83 ± 5 | 83 ± 5 | 0.5 |
Male sex (%) | 41 | 54 | 0.03 | 44 | 42 | 0.8 |
BMI (kg/m 2 ) | 27 ± 5 | 27 ± 5 | 0.94 | 27 ± 5 | 27 ± 5 | 0.7 |
GFR (ml/min/1.73 m 2 ) | 62 ± 26 | 60 ± 28 | 0.58 | 62 ± 27 | 62 ± 27 | 1.0 |
NYHA ≥ III (%) | 91 | 93 | 0.44 | 91 | 91 | 1.0 |
STS-PROM (%) | 7.70 ± 4.6 | 8.05 ± 6.0 | 0.56 | 7.95 ± 4.8 | 7.94 ± 5.3 | 1.0 |
Imaging and invasive measurements | ||||||
Pmean (mmHg) | 43 ± 16 | 41 ± 16 | 0.25 | 44 ± 16 | 42 ± 14 | 0.4 |
EF (%) | 55 ± 11 | 51 ± 14 | 0.005 | 55 ± 11 | 55 ± 12 | 1.0 |
Interventricular septum (mm) | 13 ± 2 | 13 ± 3 | 0.93 | 13 ± 2 | 13 ± 2 | 0.9 |
Agatston score (AU) | 2849 ± 1416 | 2864 ± 1422 | 0.93 | 2777 ± 1377 | 2728 ± 1276 | 0.8 |
Effective system annulus (mm) | 23.6 ± 2.0 | 24.3 ± 2.1 | 0.003 | 23.7 ± 2.0 | 23.8 ± 2.0 | 0.7 |
Clinical history | ||||||
s. p. syncope (%) | 13 | 17 | 0.35 | 14 | 16 | 0.5 |
s. p. cardiac decompensation (%) | 34 | 40 | 0.23 | 34 | 36 | 0.8 |
IDDM (%) | 6 | 6 | 0.85 | 8 | 6 | 0.6 |
COPD (%) | 18 | 23 | 0.25 | 20 | 20 | 1.0 |
Atrial fibrillation (%) | 40 | 32 | 0.19 | 37 | 39 | 0.8 |
Hypertension (%) | 96 | 97 | 0.62 | 97 | 97 | 1.0 |
Hypercholesterolaemia (%) | 41 | 51 | 0.09 | 48 | 48 | 0.9 |
CAD (%) | 69 | 76 | 0.21 | 69 | 69 | 1.0 |
Myocardial infarction (%) | 20 | 29 | 0.06 | 24 | 22 | 0.8 |
MR ≥ 2+ (%) | 21 | 18 | 0.64 | 21 | 17 | 0.5 |
AR ≥ 2+ (%) | 15 | 19 | 0.39 | 16 | 12 | 0.3 |
TR ≥ 2+ (%) | 9 | 13 | 0.24 | 11 | 11 | 1.0 |
Stroke (%) | 17 | 16 | 0.89 | 16 | 15 | 0.9 |
ICA stenosis (%) | 12 | 19 | 0.10 | 15 | 14 | 0.7 |
Pacemaker (%) | 14 | 17 | 0.46 | 15 | 15 | 0.8 |
PCI (%) | 41 | 39 | 0.71 | 41 | 43 | 0.8 |
Prior CABG surgery (%) | 22 | 34 | 0.03 | 24 | 23 | 0.9 |
Prior AVR surgery (%) | 0 | 4 | 0.008 | 0 | 0 | 1.0 |
. | Unmatched ( n = 310) . | Matched ( n = 206) . | ||||
---|---|---|---|---|---|---|
ACURATE ( n = 131) . | SAPIEN ( n = 179) . | P -values . | ACURATE ( n = 103) . | SAPIEN ( n = 103) . | P -values . | |
Demographics and basic clinical data | ||||||
Age (years) | 83 ± 5 | 80 ± 10 | <0.001 | 83 ± 5 | 83 ± 5 | 0.5 |
Male sex (%) | 41 | 54 | 0.03 | 44 | 42 | 0.8 |
BMI (kg/m 2 ) | 27 ± 5 | 27 ± 5 | 0.94 | 27 ± 5 | 27 ± 5 | 0.7 |
GFR (ml/min/1.73 m 2 ) | 62 ± 26 | 60 ± 28 | 0.58 | 62 ± 27 | 62 ± 27 | 1.0 |
NYHA ≥ III (%) | 91 | 93 | 0.44 | 91 | 91 | 1.0 |
STS-PROM (%) | 7.70 ± 4.6 | 8.05 ± 6.0 | 0.56 | 7.95 ± 4.8 | 7.94 ± 5.3 | 1.0 |
Imaging and invasive measurements | ||||||
Pmean (mmHg) | 43 ± 16 | 41 ± 16 | 0.25 | 44 ± 16 | 42 ± 14 | 0.4 |
EF (%) | 55 ± 11 | 51 ± 14 | 0.005 | 55 ± 11 | 55 ± 12 | 1.0 |
Interventricular septum (mm) | 13 ± 2 | 13 ± 3 | 0.93 | 13 ± 2 | 13 ± 2 | 0.9 |
Agatston score (AU) | 2849 ± 1416 | 2864 ± 1422 | 0.93 | 2777 ± 1377 | 2728 ± 1276 | 0.8 |
Effective system annulus (mm) | 23.6 ± 2.0 | 24.3 ± 2.1 | 0.003 | 23.7 ± 2.0 | 23.8 ± 2.0 | 0.7 |
Clinical history | ||||||
s. p. syncope (%) | 13 | 17 | 0.35 | 14 | 16 | 0.5 |
s. p. cardiac decompensation (%) | 34 | 40 | 0.23 | 34 | 36 | 0.8 |
IDDM (%) | 6 | 6 | 0.85 | 8 | 6 | 0.6 |
COPD (%) | 18 | 23 | 0.25 | 20 | 20 | 1.0 |
Atrial fibrillation (%) | 40 | 32 | 0.19 | 37 | 39 | 0.8 |
Hypertension (%) | 96 | 97 | 0.62 | 97 | 97 | 1.0 |
Hypercholesterolaemia (%) | 41 | 51 | 0.09 | 48 | 48 | 0.9 |
CAD (%) | 69 | 76 | 0.21 | 69 | 69 | 1.0 |
Myocardial infarction (%) | 20 | 29 | 0.06 | 24 | 22 | 0.8 |
MR ≥ 2+ (%) | 21 | 18 | 0.64 | 21 | 17 | 0.5 |
AR ≥ 2+ (%) | 15 | 19 | 0.39 | 16 | 12 | 0.3 |
TR ≥ 2+ (%) | 9 | 13 | 0.24 | 11 | 11 | 1.0 |
Stroke (%) | 17 | 16 | 0.89 | 16 | 15 | 0.9 |
ICA stenosis (%) | 12 | 19 | 0.10 | 15 | 14 | 0.7 |
Pacemaker (%) | 14 | 17 | 0.46 | 15 | 15 | 0.8 |
PCI (%) | 41 | 39 | 0.71 | 41 | 43 | 0.8 |
Prior CABG surgery (%) | 22 | 34 | 0.03 | 24 | 23 | 0.9 |
Prior AVR surgery (%) | 0 | 4 | 0.008 | 0 | 0 | 1.0 |
CAD: coronary artery disease; ICA: internal carotid artery; s.p.: status post; AR: aortic valve regurgitation; AVR: aortic valve replacement; Pmean : mean transvalvular gradients; BMI: body mass index; CABG: coronary artery bypass crafting; COPD: chronic obstructive pulmonary disease; EF: left ventricular ejection fraction; GFR: glomerular filtration rate; HTN: arterial hypertension; IDDM: insulin-dependent diabetes mellitus; MR: mitral regurgitation; NYHA: New York Heart Association stages of heart failure; PAOD: peripheral arterial occlusive disease; PCI: percutaneous coronary intervention; STS-PROM: Society of Thoracic Surgeons risk predicted risk of mortality; TR: tricuspid regurgitation.
. | Unmatched ( n = 310) . | Matched ( n = 206) . | ||||
---|---|---|---|---|---|---|
ACURATE ( n = 131) . | SAPIEN ( n = 179) . | P -values . | ACURATE ( n = 103) . | SAPIEN ( n = 103) . | P -values . | |
Demographics and basic clinical data | ||||||
Age (years) | 83 ± 5 | 80 ± 10 | <0.001 | 83 ± 5 | 83 ± 5 | 0.5 |
Male sex (%) | 41 | 54 | 0.03 | 44 | 42 | 0.8 |
BMI (kg/m 2 ) | 27 ± 5 | 27 ± 5 | 0.94 | 27 ± 5 | 27 ± 5 | 0.7 |
GFR (ml/min/1.73 m 2 ) | 62 ± 26 | 60 ± 28 | 0.58 | 62 ± 27 | 62 ± 27 | 1.0 |
NYHA ≥ III (%) | 91 | 93 | 0.44 | 91 | 91 | 1.0 |
STS-PROM (%) | 7.70 ± 4.6 | 8.05 ± 6.0 | 0.56 | 7.95 ± 4.8 | 7.94 ± 5.3 | 1.0 |
Imaging and invasive measurements | ||||||
Pmean (mmHg) | 43 ± 16 | 41 ± 16 | 0.25 | 44 ± 16 | 42 ± 14 | 0.4 |
EF (%) | 55 ± 11 | 51 ± 14 | 0.005 | 55 ± 11 | 55 ± 12 | 1.0 |
Interventricular septum (mm) | 13 ± 2 | 13 ± 3 | 0.93 | 13 ± 2 | 13 ± 2 | 0.9 |
Agatston score (AU) | 2849 ± 1416 | 2864 ± 1422 | 0.93 | 2777 ± 1377 | 2728 ± 1276 | 0.8 |
Effective system annulus (mm) | 23.6 ± 2.0 | 24.3 ± 2.1 | 0.003 | 23.7 ± 2.0 | 23.8 ± 2.0 | 0.7 |
Clinical history | ||||||
s. p. syncope (%) | 13 | 17 | 0.35 | 14 | 16 | 0.5 |
s. p. cardiac decompensation (%) | 34 | 40 | 0.23 | 34 | 36 | 0.8 |
IDDM (%) | 6 | 6 | 0.85 | 8 | 6 | 0.6 |
COPD (%) | 18 | 23 | 0.25 | 20 | 20 | 1.0 |
Atrial fibrillation (%) | 40 | 32 | 0.19 | 37 | 39 | 0.8 |
Hypertension (%) | 96 | 97 | 0.62 | 97 | 97 | 1.0 |
Hypercholesterolaemia (%) | 41 | 51 | 0.09 | 48 | 48 | 0.9 |
CAD (%) | 69 | 76 | 0.21 | 69 | 69 | 1.0 |
Myocardial infarction (%) | 20 | 29 | 0.06 | 24 | 22 | 0.8 |
MR ≥ 2+ (%) | 21 | 18 | 0.64 | 21 | 17 | 0.5 |
AR ≥ 2+ (%) | 15 | 19 | 0.39 | 16 | 12 | 0.3 |
TR ≥ 2+ (%) | 9 | 13 | 0.24 | 11 | 11 | 1.0 |
Stroke (%) | 17 | 16 | 0.89 | 16 | 15 | 0.9 |
ICA stenosis (%) | 12 | 19 | 0.10 | 15 | 14 | 0.7 |
Pacemaker (%) | 14 | 17 | 0.46 | 15 | 15 | 0.8 |
PCI (%) | 41 | 39 | 0.71 | 41 | 43 | 0.8 |
Prior CABG surgery (%) | 22 | 34 | 0.03 | 24 | 23 | 0.9 |
Prior AVR surgery (%) | 0 | 4 | 0.008 | 0 | 0 | 1.0 |
. | Unmatched ( n = 310) . | Matched ( n = 206) . | ||||
---|---|---|---|---|---|---|
ACURATE ( n = 131) . | SAPIEN ( n = 179) . | P -values . | ACURATE ( n = 103) . | SAPIEN ( n = 103) . | P -values . | |
Demographics and basic clinical data | ||||||
Age (years) | 83 ± 5 | 80 ± 10 | <0.001 | 83 ± 5 | 83 ± 5 | 0.5 |
Male sex (%) | 41 | 54 | 0.03 | 44 | 42 | 0.8 |
BMI (kg/m 2 ) | 27 ± 5 | 27 ± 5 | 0.94 | 27 ± 5 | 27 ± 5 | 0.7 |
GFR (ml/min/1.73 m 2 ) | 62 ± 26 | 60 ± 28 | 0.58 | 62 ± 27 | 62 ± 27 | 1.0 |
NYHA ≥ III (%) | 91 | 93 | 0.44 | 91 | 91 | 1.0 |
STS-PROM (%) | 7.70 ± 4.6 | 8.05 ± 6.0 | 0.56 | 7.95 ± 4.8 | 7.94 ± 5.3 | 1.0 |
Imaging and invasive measurements | ||||||
Pmean (mmHg) | 43 ± 16 | 41 ± 16 | 0.25 | 44 ± 16 | 42 ± 14 | 0.4 |
EF (%) | 55 ± 11 | 51 ± 14 | 0.005 | 55 ± 11 | 55 ± 12 | 1.0 |
Interventricular septum (mm) | 13 ± 2 | 13 ± 3 | 0.93 | 13 ± 2 | 13 ± 2 | 0.9 |
Agatston score (AU) | 2849 ± 1416 | 2864 ± 1422 | 0.93 | 2777 ± 1377 | 2728 ± 1276 | 0.8 |
Effective system annulus (mm) | 23.6 ± 2.0 | 24.3 ± 2.1 | 0.003 | 23.7 ± 2.0 | 23.8 ± 2.0 | 0.7 |
Clinical history | ||||||
s. p. syncope (%) | 13 | 17 | 0.35 | 14 | 16 | 0.5 |
s. p. cardiac decompensation (%) | 34 | 40 | 0.23 | 34 | 36 | 0.8 |
IDDM (%) | 6 | 6 | 0.85 | 8 | 6 | 0.6 |
COPD (%) | 18 | 23 | 0.25 | 20 | 20 | 1.0 |
Atrial fibrillation (%) | 40 | 32 | 0.19 | 37 | 39 | 0.8 |
Hypertension (%) | 96 | 97 | 0.62 | 97 | 97 | 1.0 |
Hypercholesterolaemia (%) | 41 | 51 | 0.09 | 48 | 48 | 0.9 |
CAD (%) | 69 | 76 | 0.21 | 69 | 69 | 1.0 |
Myocardial infarction (%) | 20 | 29 | 0.06 | 24 | 22 | 0.8 |
MR ≥ 2+ (%) | 21 | 18 | 0.64 | 21 | 17 | 0.5 |
AR ≥ 2+ (%) | 15 | 19 | 0.39 | 16 | 12 | 0.3 |
TR ≥ 2+ (%) | 9 | 13 | 0.24 | 11 | 11 | 1.0 |
Stroke (%) | 17 | 16 | 0.89 | 16 | 15 | 0.9 |
ICA stenosis (%) | 12 | 19 | 0.10 | 15 | 14 | 0.7 |
Pacemaker (%) | 14 | 17 | 0.46 | 15 | 15 | 0.8 |
PCI (%) | 41 | 39 | 0.71 | 41 | 43 | 0.8 |
Prior CABG surgery (%) | 22 | 34 | 0.03 | 24 | 23 | 0.9 |
Prior AVR surgery (%) | 0 | 4 | 0.008 | 0 | 0 | 1.0 |
CAD: coronary artery disease; ICA: internal carotid artery; s.p.: status post; AR: aortic valve regurgitation; AVR: aortic valve replacement; Pmean : mean transvalvular gradients; BMI: body mass index; CABG: coronary artery bypass crafting; COPD: chronic obstructive pulmonary disease; EF: left ventricular ejection fraction; GFR: glomerular filtration rate; HTN: arterial hypertension; IDDM: insulin-dependent diabetes mellitus; MR: mitral regurgitation; NYHA: New York Heart Association stages of heart failure; PAOD: peripheral arterial occlusive disease; PCI: percutaneous coronary intervention; STS-PROM: Society of Thoracic Surgeons risk predicted risk of mortality; TR: tricuspid regurgitation.
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