Table 1

Patient Characteristics and Outcomes

Female
(n = 1,967)
Male
(n = 2,005)
p Value
Age, yrs84.0 ± 6.681.6 ± 7.5<0.001
Body mass index, kg/m225.7 ± 5.426.3 ± 4.5<0.001
Logistic EuroSCORE, %21.4 ± 13.022.2 ± 15.20.97
Clinical history
 Coronary artery disease918 (47.9%)1341 (69.0%)<0.001
 Chronic obstructive pulmonary disease397 (20.3%)503 (25.1%)0.003
 Peripheral vascular disease278 (14.2%)521 (26.1%)<0.001
 Creatinine before procedure >200 μmol/l120 (6.1%)220 (11.0%)<0.001
 Cerebrovascular disease191 (9.8%)198 (9.9%)0.91
Echocardiographic findings
 Mean gradient, mm Hg51.0 ± 17.745.4 ± 14.8<0.001
 Effective orifice area indexed, cm2/m20.4 ± 0.20.4 ± 0.20.041
 Ejection fraction, %56.6 ± 13.350.1 ± 14.3<0.001
Transfemoral TAVI approach1536 (78.7%)1365 (68.4%)<0.001
Edwards Sapien/Medtronic CoreValve73.2%, 26.8%60.4%, 39.6%<0.001
Echocardiographic findings, post-procedural
 Effective orifice area indexed, cm2/m21.1 ± 0.31.0 ± 0.30.13
 Ejection fraction, %58.2 ± 11.652.9 ± 12.9<0.001
 Pulmonary artery pressure, mm Hg40.5 ± 12.141.2 ± 13.20.31
 Moderate to severe aortic regurgitation196 (11.8%)294 (17.1%)<0.001
Outcomes
 Adverse events <24 h
 Major and life-threatening bleeding85 (4.3%)38 (1.9%)0.001
 Major vascular event90 (4.6%)39 (1.9%)<0.001
Post-procedural pacemaker implantation (before 1 month)
 PPI total184 (9.3%)257 (12.8%)<0.001
 PPI in Medtronic CoreValve prosthesis83 (15.8%)145 (18.2%)0.30
 PPI in Edwards Sapien prosthesis101 (17.0%)112 (9.3%)0.040
Combined safety endpoint at 1 month448 (22.8%)407 (20.3%)0.058
Death
 At 1 month
 From any cause187 (9.5%)184 (9.2%)0.27
 From cardiovascular cause125 (6.4%)133 (6.6%)0.35
 From 1 month to 1 year
 From any cause193 (9.8%)291 (14.5%)<0.001
 From cardiovascular cause95 (4.8%)152 (7.6%)0.004
 At 1 year (cumulative)
 From any cause380 (19.3%)475 (23.7%)0.021
 From cardiovascular cause220 (11.2%)285 (14.2%)0.036

Values are mean ± SD, or n (%).

PPI = post-procedural pacemaker implantation; TAVI = transcatheter aortic valve implantation.