Table 2.
Procedural and clinical outcomes of the matched cohort.
Matched Cohort Myval n = 91 N (%) or Mean ± SD |
Evolut n = 91 N (%) or Mean ± SD |
p-Value | |
---|---|---|---|
Procedural details | |||
Transfemoral approach | 82 (90) | 87 (96) | 0.15 |
Transapical approach | 9 (10) | 0 (0) | NA |
Direct aortic approach | 0 (0) | 4 (4) | NA |
Predilation | 4 (4) | 23 (25) | 0.0001 |
Postdilation | 3 (3) | 24 (26) | <0.00001 |
Second valve prosthesis required | 1 (1) | 1 (1) | 1.00 |
Procedural complications | |||
Valve embolization | 1 (1) | 1 (1) | 1.00 |
Annular rupture | 0 (0) | 0 (0) | NA |
Coronary obstruction | 1 (1) | 2 (2) | 0.56 |
Procedural death | 2 (2) | 1 (1) | 0.56 |
30-day outcomes | |||
All-cause death | 3 (3) | 2 (2) | 0.65 |
Cardiac death | 1 (1) | 2 (2) | 0.56 |
All stroke | 2 (2) | 4 (4) | 0.41 |
Myocardial infarction | 1 (1) | 3 (3) | 0.31 |
Acute kidney injury (2 or 3) | 5 (5) | 6 (7) | 0.76 |
Moderate or severe paravalvular leakage | 1 (1) | 4 (4) | 0.17 |
New permanent pacemaker implantation | 4 (4) | 14 (15) | 0.01 |
Major vascular complications | 0 (0) | 0 (0) | NA |
Major bleeding complications | 0 (0) | 0 (0) | NA |
1-year outcomes | |||
All-cause death | 8 (9) | 7 (8) | 0.79 |
Cardiac death | 2 (2) | 4 (4) | 0.41 |
All stroke | 6 (7) | 5 (5) | 0.76 |
Myocardial infarction | 2 (2) | 4 (4) | 0.41 |