Table 3

Procedural, 30-Day, and 1-Year Outcomes for the Combined S3HR and S3i Cohorts

Women (n = 657)Men (n = 1,004)Comparisonp Value
Procedural outcomes (in hospital)
 Approach
  Transfemoral, %585 (89.0)858 (85.5)3.6 (0.3 to 6.8)0.03
  Transapical, %38 (5.8)100 (10.0)−4.2 (−6.7 to −1.6)0.003
  Transaortic, %34 (5.2)46 (4.6)0.6 (−1.5 to 2.7)0.58
 Valve size
  20 mm, %52 (7.9)1 (0.1)7.8 (5.7 to 9.9)<0.001
  23 mm, %435 (66.2)110 (11.0)55.2 (51.1 to 59.3)<0.001
  26 mm, %161 (24.5)537 (53.8)−29.2 (−33.8 to −24.7)<0.001
  29 mm, %9 (1.4)351 (35.1)−33.8 (−36.9 to −30.7)<0.001
 Major vascular complication, %47 (7.2)42 (4.2)3.0 (0.6 to 5.3)0.009
 Major or disabling bleeding event, %110 (16.7)147 (14.6)2.1 (−1.5 to 5.7)0.25
 Acute kidney injury, %45 (6.8)61 (6.1)0.8 (−1.7 to 3.2)0.53
30-day outcomes
 All-cause mortality, %13 (2.0)12 (1.2)1.67 (0.76 to 3.65)0.20
 Cardiac mortality, %9 (1.4)9 (0.9)1.54 (0.61 to 3.87)0.36
 Rehospitalization, %43 (6.6)52 (5.2)1.28 (0.86 to 1.92)0.23
 Disabling stroke, %6 (0.9)10 (1.0)0.92 (0.33 to 2.53)0.87
 Combined endpoint, %56 (8.5)71 (7.1)1.22 (0.86 to 1.73)0.27
 Myocardial infarction, %4 (0.6)2 (0.2)3.07 (0.56 to 16.75)0.17
 Permanent pacemaker, %63 (9.7)123 (12.3)0.78 (0.57 to 1.05)0.10
 Moderate/severe paravalvular leak, %25 (4.2)28 (3.0)1.36 (0.80 to 2.31)0.25
1-year outcomes
 All-cause mortality, %61 (9.4)103 (10.4)§0.56
 Cardiac mortality, %43 (6.7)53 (5.3)1.27 (0.85 to 1.90)0.24
 Rehospitalization, %98 (15.5)131 (13.5)1.17 (0.90 to 1.52)0.25
 Disabling stroke, %15 (2.4)22 (2.3)1.04 (0.54 to 2.01)0.90
 Combined endpoint, %146 (22.4)208 (20.9)1.09 (0.89 to 1.35)0.40
 Moderate/severe paravalvular leak, %11 (2.2)10 (1.3)1.70 (0.73 to 3.97)0.22

Abbreviations as in Table 1.

  • Values are n (%).

  • Values are event (Kaplan-Meier %) or hazard ratio (95% CI).

  • Combined 30-day and 1-year endpoint includes all-cause mortality, rehospitalization, or disabling stroke.

  • § Hazard ratio was not applicable due to violation of the proportional hazards assumption (p = 0.02).