Table 1:

Demographics and baseline characteristics by the randomized group

Variable EDWARDS INTUITY ( N = 46) Control ( N = 48) P -value
Age (years)73.0 ± 5.374.2 ± 5.00.30
BMI (kg/m 2 ) 29.4 ± 5.128.8 ± 5.10.48
Female19/46 (41%)27/48 (56%)0.15
NYHA ≥Class III31/46 (67%)29/48 (60%)0.48
Diabetes15/46 (33%)11/48 (23%)0.29
COPD6/46 (13%)7/48 (15%)0.83
Angina16/46 (345%)18/48 (38%)0.78
Myocardial infarction3/46 (7%)4/48 (8%)0.74
Cardiac rhythm abnormalities/conduction disturbances a11/46 (24%)14/48 (29%)0.56
Permanent pacemaker or ICD2/46 (4%)6/48 (13%)0.16
Myocarditis0/46 (0%)0/48 (0%)
Hyperlipidaemia or hypercholesterolaemia33/46 (72%)23/48 (48%)0.019
Rheumatic fever0/46 (0%)0/48 (0%)
History of smoking22/46 (48%)12/48 (25%)0.021
Alcohol/drug abuse0/46 (0%)0/48 (0%)
Blood diatheses0/46 (0%)0/48 (0%)
Prior cardiovascular surgery0/46 (0%)0/48 (0%)
Calcium metabolic disorders1/46 (2%)0/48 (0%)0.30
Cancer4/46 (9%)3/48 (6%)0.65
Obesity (BMI ≥30)22/46 (48%)14/48 (29%)0.063
Liver disease2/46 (4%)0/48 (0%)0.14
Renal failure/insufficiency7/46 (15%)7/48 (15%)0.93
Dialysis0/46 (0%)0/48 (0%)
Creatinine (mg/dl)1.0 ± 0.31.0 ± 0.30.97
Bicuspid aortic valve (Sievers 1)19/46 (41%)17/48 (35%)0.67
Logistic EuroSCORE6.4 ± 3.76.7 ± 3.60.45
EuroSCORE II38: 1.7 ± 0.940: 1.8 ± 1.00.48
STS score (%)1.6 ± 0.747: 1.7 ± 0.0.21
Variable EDWARDS INTUITY ( N = 46) Control ( N = 48) P -value
Age (years)73.0 ± 5.374.2 ± 5.00.30
BMI (kg/m 2 ) 29.4 ± 5.128.8 ± 5.10.48
Female19/46 (41%)27/48 (56%)0.15
NYHA ≥Class III31/46 (67%)29/48 (60%)0.48
Diabetes15/46 (33%)11/48 (23%)0.29
COPD6/46 (13%)7/48 (15%)0.83
Angina16/46 (345%)18/48 (38%)0.78
Myocardial infarction3/46 (7%)4/48 (8%)0.74
Cardiac rhythm abnormalities/conduction disturbances a11/46 (24%)14/48 (29%)0.56
Permanent pacemaker or ICD2/46 (4%)6/48 (13%)0.16
Myocarditis0/46 (0%)0/48 (0%)
Hyperlipidaemia or hypercholesterolaemia33/46 (72%)23/48 (48%)0.019
Rheumatic fever0/46 (0%)0/48 (0%)
History of smoking22/46 (48%)12/48 (25%)0.021
Alcohol/drug abuse0/46 (0%)0/48 (0%)
Blood diatheses0/46 (0%)0/48 (0%)
Prior cardiovascular surgery0/46 (0%)0/48 (0%)
Calcium metabolic disorders1/46 (2%)0/48 (0%)0.30
Cancer4/46 (9%)3/48 (6%)0.65
Obesity (BMI ≥30)22/46 (48%)14/48 (29%)0.063
Liver disease2/46 (4%)0/48 (0%)0.14
Renal failure/insufficiency7/46 (15%)7/48 (15%)0.93
Dialysis0/46 (0%)0/48 (0%)
Creatinine (mg/dl)1.0 ± 0.31.0 ± 0.30.97
Bicuspid aortic valve (Sievers 1)19/46 (41%)17/48 (35%)0.67
Logistic EuroSCORE6.4 ± 3.76.7 ± 3.60.45
EuroSCORE II38: 1.7 ± 0.940: 1.8 ± 1.00.48
STS score (%)1.6 ± 0.747: 1.7 ± 0.0.21

Continuous variables are expressed as mean ± standard deviation.

Categorical variables were expressed as percentages and number of patients.

BMI: body mass index; STS: The Society of Thoracic Surgeons; NYHA: New York Heart Association; COPD: chronic obstructive pulmonary disease; ICD: internal cardioverter/defibrillator.

a Includes sinus tachycardia, sinus bradycardia, bradycardia–tachycardia, atrial fibrillation/supraventricular tachycardia, atrial flutter, ventricular tachycardia and other cardiac rhythm abnormality.

Table 1:

Demographics and baseline characteristics by the randomized group

Variable EDWARDS INTUITY ( N = 46) Control ( N = 48) P -value
Age (years)73.0 ± 5.374.2 ± 5.00.30
BMI (kg/m 2 ) 29.4 ± 5.128.8 ± 5.10.48
Female19/46 (41%)27/48 (56%)0.15
NYHA ≥Class III31/46 (67%)29/48 (60%)0.48
Diabetes15/46 (33%)11/48 (23%)0.29
COPD6/46 (13%)7/48 (15%)0.83
Angina16/46 (345%)18/48 (38%)0.78
Myocardial infarction3/46 (7%)4/48 (8%)0.74
Cardiac rhythm abnormalities/conduction disturbances a11/46 (24%)14/48 (29%)0.56
Permanent pacemaker or ICD2/46 (4%)6/48 (13%)0.16
Myocarditis0/46 (0%)0/48 (0%)
Hyperlipidaemia or hypercholesterolaemia33/46 (72%)23/48 (48%)0.019
Rheumatic fever0/46 (0%)0/48 (0%)
History of smoking22/46 (48%)12/48 (25%)0.021
Alcohol/drug abuse0/46 (0%)0/48 (0%)
Blood diatheses0/46 (0%)0/48 (0%)
Prior cardiovascular surgery0/46 (0%)0/48 (0%)
Calcium metabolic disorders1/46 (2%)0/48 (0%)0.30
Cancer4/46 (9%)3/48 (6%)0.65
Obesity (BMI ≥30)22/46 (48%)14/48 (29%)0.063
Liver disease2/46 (4%)0/48 (0%)0.14
Renal failure/insufficiency7/46 (15%)7/48 (15%)0.93
Dialysis0/46 (0%)0/48 (0%)
Creatinine (mg/dl)1.0 ± 0.31.0 ± 0.30.97
Bicuspid aortic valve (Sievers 1)19/46 (41%)17/48 (35%)0.67
Logistic EuroSCORE6.4 ± 3.76.7 ± 3.60.45
EuroSCORE II38: 1.7 ± 0.940: 1.8 ± 1.00.48
STS score (%)1.6 ± 0.747: 1.7 ± 0.0.21
Variable EDWARDS INTUITY ( N = 46) Control ( N = 48) P -value
Age (years)73.0 ± 5.374.2 ± 5.00.30
BMI (kg/m 2 ) 29.4 ± 5.128.8 ± 5.10.48
Female19/46 (41%)27/48 (56%)0.15
NYHA ≥Class III31/46 (67%)29/48 (60%)0.48
Diabetes15/46 (33%)11/48 (23%)0.29
COPD6/46 (13%)7/48 (15%)0.83
Angina16/46 (345%)18/48 (38%)0.78
Myocardial infarction3/46 (7%)4/48 (8%)0.74
Cardiac rhythm abnormalities/conduction disturbances a11/46 (24%)14/48 (29%)0.56
Permanent pacemaker or ICD2/46 (4%)6/48 (13%)0.16
Myocarditis0/46 (0%)0/48 (0%)
Hyperlipidaemia or hypercholesterolaemia33/46 (72%)23/48 (48%)0.019
Rheumatic fever0/46 (0%)0/48 (0%)
History of smoking22/46 (48%)12/48 (25%)0.021
Alcohol/drug abuse0/46 (0%)0/48 (0%)
Blood diatheses0/46 (0%)0/48 (0%)
Prior cardiovascular surgery0/46 (0%)0/48 (0%)
Calcium metabolic disorders1/46 (2%)0/48 (0%)0.30
Cancer4/46 (9%)3/48 (6%)0.65
Obesity (BMI ≥30)22/46 (48%)14/48 (29%)0.063
Liver disease2/46 (4%)0/48 (0%)0.14
Renal failure/insufficiency7/46 (15%)7/48 (15%)0.93
Dialysis0/46 (0%)0/48 (0%)
Creatinine (mg/dl)1.0 ± 0.31.0 ± 0.30.97
Bicuspid aortic valve (Sievers 1)19/46 (41%)17/48 (35%)0.67
Logistic EuroSCORE6.4 ± 3.76.7 ± 3.60.45
EuroSCORE II38: 1.7 ± 0.940: 1.8 ± 1.00.48
STS score (%)1.6 ± 0.747: 1.7 ± 0.0.21

Continuous variables are expressed as mean ± standard deviation.

Categorical variables were expressed as percentages and number of patients.

BMI: body mass index; STS: The Society of Thoracic Surgeons; NYHA: New York Heart Association; COPD: chronic obstructive pulmonary disease; ICD: internal cardioverter/defibrillator.

a Includes sinus tachycardia, sinus bradycardia, bradycardia–tachycardia, atrial fibrillation/supraventricular tachycardia, atrial flutter, ventricular tachycardia and other cardiac rhythm abnormality.

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