Table 2

Procedural and Clinical Outcomes

OutcomeAll Patients
(N = 848)
Sapien
(n = 549)
CoreValve
(n = 299)
p Value
Procedural outcomes
 Procedural success827 (97.5)534 (97.3)293 (98.0)0.52
 Conversion to open heart surgery15 (1.8)10 (1.8)5 (1.7)0.88
 Coronary obstruction11 (1.3)8 (1.5)3 (1.0)0.76
 Aortic injury7 (0.8)7 (1.3)0 (0.0)0.056
 Aortic root rupture4 (0.5)4 (0.9)0 (0.0)0.30
 Aortic dissection3 (0.4)3 (0.7)0 (0.0)0.56
 Implantation of two valves38 (4.5)4 (0.7)34 (11.4)<0.001
 Permanent pacemaker implantation80 (9.5)22 (4.0)58 (19.4)<0.001
 Paravalvular leak ≥ moderate83 (9.8)40 (7.3)43 (14.4)0.001
 Device success725 (85.5)500 (91.1)225 (75.3)<0.001
Clinical outcomes
 Stroke32 (3.8)24 (4.4)8 (2.7)0.22
 Disabling19 (2.2)14 (2.6)5 (1.7)0.56
 Nondisabling13 (1.5)10 (1.8)3 (1.0)0.41
 Bleeding92 (10.8)59 (10.7)33 (11.0)0.90
 Life-threatening54 (6.4)37 (6.7)17 (5.7)0.55
 Major38 (4.5)22 (4.0)16 (5.4)0.37
 Vascular complications82 (9.7)64 (11.7)18 (6.0)0.008
 Major42 (5.0)33 (6.0)9 (3.0)0.054
 Minor40 (4.7)31 (5.6)9 (3.0)0.08
 Acute kidney injury (stage 2 or 3)28 (3.3)14 (2.6)14 (4.7)0.10
 Early safety endpoints at 30 days124 (14.6)85 (15.5)39 (13.0)0.34
 Death
 At 30 days
  From any cause21 (2.5)17 (3.1)4 (1.3)0.12
  From cardiovascular cause14 (1.7)10 (1.8)4 (1.3)0.78
 At 1 year
  From any cause81 (10.8)47 (9.4)34 (12.2)0.40
  From cardiovascular cause35 (4.6)20 (4.3)15 (5.4)0.48
 At 2 years
  From any cause99 (16.7)52 (13.5)47 (19.5)0.20
  From cardiovascular cause44 (8.0)22 (6.2)22 (9.6)0.25

Values are mean ± SD or n (%).