Table 5. Thirty days clinical outcome.
All patients | 23mm | 26mm | 29mm | P-Value | |
---|---|---|---|---|---|
Number of patients, N | 235 | 77 | 91 | 67 | |
Early safety endpoint at 30 days | 19 (8.1%) | 6 (7.8%) | 7 (7.7%) | 6 (8.9%) | 0.95 |
All-cause mortality | 6 (2.6%) | 3 (3.9%) | 2 (2.2%) | 1 (1.5%) | 0.64 |
Stroke disabling and non-disabling | 5 (2.1%) | 2 (2.6%) | 1 (1.1%) | 2 (2.9%) | 0.68 |
Acute kidney injury—stage 2/3 | 5 (2.1%) | 1 (1.3%) | 3 (3.3%) | 1 (1.5%) | 0.59 |
Major vascular complication | 7 (3.0%) | 1 (1.3%) | 5 (5.5%) | 1 (1.5%) | 0.22 |
Valve dysfunction requiring a repeat procedure | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | — |
Endocarditis | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | — |
Valve thrombosis | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | — |
Myocardial infarction | 0 | 0 | 0 | 0 | — |
Implantation of covered stent | 10 (4.3%) | 2 (2.6%) | 6 (6.6%) | 2 (2.9%) | 0.36 |
Surgical repair | 0 | 0 | 0 | 0 | — |
Pacemaker implantation* | 21 (8.9%) | 7 (9.1%) | 6 (6.6%) | 8 (11.9%) | 0.45 |
Values are mean ± SD or n (%).
* Indication for pacemaker based on second degree (type II) or third degree atrioventricular block