Table 1

Baseline Patient Characteristics

All Patients
(N = 848)
Sapien
(n = 549)
CoreValve
(n = 299)
p Value
Age, yrs81.8 ± 6.682.7 ± 6.580.1 ± 6.5<0.001
Females452 (53.3)319 (58.1)133 (44.5)<0.001
Height, cm153.7 ± 9.6151.9 ± 9.5157.0 ± 8.8<0.001
Weight, kg54.5 ± 11.252.8 ± 11.457.5 ± 10.3<0.001
Body mass index, kg/m223.0 ± 3.822.8 ± 3.923.4 ± 3.60.03
NYHA functional class III or IV534 (63.0)328 (59.7)206 (68.9)0.008
Logistic EuroSCORE, %16.5 ± 12.016.4 ± 11.216.6 ± 13.20.86
STS score, %5.2 ± 3.85.4 ± 3.85.0 ± 3.80.13
Diabetes mellitus255 (30.1)165 (30.1)90 (30.1)0.99
Renal insufficiency321 (37.9)177 (32.2)144 (48.2)<0.001
Hypertension645 (76.1)432 (78.7)213 (71.2)0.015
Coronary artery disease379 (44.7)223 (40.6)156 (52.2)0.001
Peripheral vascular disease131 (15.4)89 (16.2)42 (14.0)0.41
Prior cerebrovascular accident89 (10.5)50 (9.1)39 (13.0)0.07
Chronic lung disease99 (11.7)67 (12.2)32 (10.7)0.52
Prior PCI276 (32.5)173 (31.5)103 (34.4)0.38
Prior cardiac surgery82 (9.7)60 (10.9)22 (7.4)0.09
Bicuspid aortic valve49 (5.8)8 (1.5)41 (13.7)<0.001
Echocardiographic findings
 Mean gradient, mm Hg51.4 ± 18.750.8 ± 18.652.6 ± 18.90.17
 Aortic valve area, cm20.6 ± 0.20.6 ± 0.20.6 ± 0.20.48
 LVEF, %59.2 ± 12.359.9 ± 11.958.0 ± 12.80.029
 Mitral regurgitation ≥ moderate118 (13.9)52 (9.5)66 (22.1)<0.001
 Pulmonary hypertension108 (12.7)33 (6.0)75 (25.1)<0.001

Values are mean ± SD or n (%).

EuroSCORE = European System for Cardiac Operative Risk Evaluation; LVEF = left ventricular ejection fraction; NYHA = New York Heart Association; PCI = percutaneous coronary intervention; STS = Society of Thoracic Surgeons.

  • Renal insufficiency indicates creatinine clearance <60 ml/min/1.73 m2.

  • Pulmonary hypertension indicates pulmonary artery pressure ≥60 mm Hg.