Procedural and postprocedural results
| Variable | Total | RXT | NRXT | |
|---|---|---|---|---|
| Periprocedural | (n=198) | (n=19) | (n=179) | p Value |
| Type of bioprosthesis | ||||
| Medtronic corevalve | 97 (49%) | 9 (47.4%) | 88 (49.2%) | 0.88 |
| Edwards sapien | 98 (49.5%) | 9 (47.4%) | 89 (49.7%) | 0.85 |
| Implantation failure (no valve implanted) | 3 (1.5%) | 1 (5.3%) | 2 (1.1%) | 0.26 |
| Access route | ||||
| Transfemoral | 153 (77.3%) | 17 (89.5%) | 136 (76%) | 0.25 |
| Transapical | 25 (12.6%) | 1 (5.3%) | 24 (13.4%) | 0.48 |
| Subclavian | 13 (6.6%) | 1 (5.3%) | 12 (6.7%) | 1 |
| Transaortic | 4 (2.0%) | 0 (0%) | 4 (2.2%) | 1 |
| Transcarotid | 3 (1.5%) | 0 (0%) | 3 (1.7%) | 1 |
| Device implantation success composite end point | 186 (94%) | 18 (94.7%) | 168 (93.9%) | 0.9 |
| Postprocedural—30 days | (n=190) | (n=18) | (n=172) | |
| 30-day mortality | 20 (10.5%) | 0 (0%) | 20 (11.6%) | 0.23 |
| CV mortality | 13 (6.8%) | 0 (0%) | 13 (7.6%) | 0.62 |
| Non-CV mortality | 7 (3.7%) | 0 (0%) | 7 (4.1%) | 1 |
| Early safety composite end point | 145 (76.3%) | 15 (83.3%) | 130 (75.6%) | 0.57 |
| Stroke (all types) | 10 (5.3%) | 0 (0%) | 10 (5.81%) | 0.6 |
| Life-threatening or major bleeding | 23 (12.1%) | 0 (0%) | 23 (13.4%) | 0.14 |
| Major vascular complication | 12 (6.3%) | 2 (11.1%) | 10 (5.8%) | 0.32 |
| Acute kidney injury | 21 (11.1%) | 1 (5.6%) | 20 (11.6%) | 0.7 |
| Minor vascular complication | 17 (8.9%) | 3 (16.7%) | 14 (8.1%) | 0.21 |
| Minor bleeding | 21 (11.1%) | 2 (11.1%) | 19 (11%) | 1 |
| New pacemaker implantation | 36 (18.9%) | 5 (27.8%) | 31 (18%) | 0.34 |
| Postprocedural—6 months | ||||
| 6-month mortality | 30/185 (16.2%) | 0 (0%) | 30/167 (18%) | 0.048 |
| CV mortality | 19/185 (10.3%) | 0 (0%) | 19/167 (11.4%) | 0.22 |
| Non-CV mortality | 11/185 (5.9%) | 0 (0%) | 11/167 (6.6%) | 0.6 |
| 6-month clinical efficacy composite end point | 132/185 (71.3%) | 16 (88.9%) | 116/167 (69.5%) | 0.083 |
| NYHA class 3 or 4 at 6 months | 23/155 (14.8%) | 2 (11.1%) | 21/137 (15.3%) | 1 |
| Rehospitalisation for valve-related symptoms | 28/155 (18.1%) | 2 (11.1%) | 26/137 (19%) | 0.53 |
Values are expressed as mean±SD or n (%).
CV, cardiovascular; NRXT, non-radiation-induced valvular disease; NYHA, New York Heart Association; RXT, radiation-induced valvular disease.