Table 3.
Perioperative outcome
| Combined (n = 180) | Transapical (n = 97) | Transfemoral (n = 83) | P | |
|---|---|---|---|---|
| Procedure-related complications | ||||
| Successful termination of procedure | 174 (96.7%) | 93 (95.6%) | 81 (97.6%) | 0.5 |
| Conversion to surgical AVR | 0 | 0 | 0 | 1.0 |
| Unplanned use of cardiopulmonary bypass | 5 (2.8%) | 4 (4.1%) | 1 (1.2%) | 0.2 |
| Ventricular perforation | 1 (0.6%) | 0 | 1 (1.2%) | 0.3 |
| “Valve-in-valve” | 1 (0.6%) | 1 (1.0%) | 0 | 0.4 |
| Coronary obstruction | 2 (1.1%) | 1 (1.0%) | 1 (1.2%) | 0.9 |
| Re-intervention | 2 (1.1%) | 0 | 2 (2.4%) | 0.1 |
| Percutaneous | 2 (1.1%) | 0 | 2 (2.4%) | 0.1 |
| Surgical | 0 | 0 | 0 | – |
| Myocardial infarctiona | 3 (1.7%) | 3 (3.1%) | 0 | 0.1 |
| Strokea | 9 (5.0%) | 4 (4.1%) | 5 (6.0%) | 0.6 |
| TIAa | 2 (1.1%) | 2 (2.1%) | 0 | 0.1 |
| Peri-interventional death (<24 h) | 4 (2.2%) | 2 (2.1%) | 2 (2.4%) | 0.9 |
| 30-day-mortality | 16 (8.9%) | 12 (12.4%) | 4 (4.8%) | 0.08 |
| In-hospital-mortality | 18 (10.0%) | 12 (12.4%) | 6 (7.2%) | 0.25 |
| Bleeding complications combined | 94 (52.2%) | 44 (45.4%) | 50 (60.2%) | 0.046* |
| Life-threatening or disabling bleedinga | 21 (11.7%) | 8 (8.2%) | 13 (15.7%) | 0.1 |
| Major bleedinga | 10 (5.6%) | 3 (3.1%) | 7 (8.4%) | 0.1 |
| Life-threatening + major bleeding combined | 31 (17.2%) | 11 (11.3%) | 20 (24.1%) | 0.02* |
| Minor bleedinga | 63 (35.0%) | 33 (34.0%) | 30 (36.1%) | 0.8 |
| Cardiac tamponade | 3 (1.7%) | 2 (2.1%) | 1 (1.2%) | 0.7 |
| Patients with RBC transfusions | 87 (48.3%) | 42 (43.3%) | 45 (54.2%) | 0.1 |
| Number of units per transfusion | 3.1 ± 2.2 | 2.9 ± 2.0 | 3.3 ± 2.4 | 0.5 |
| Drop in Hb following procedure (g/dL) | 2.9 ± 1.3 | 2.9 ± 1.2 | 2.8 ± 1.4 | 0.4 |
| Acute kidney injury (modified RIFLE classificationa) | ||||
| Stage 1 | 54 (30.0%) | 24 (24.7%) | 30 (36.1%) | 0.1 |
| Stage 2 | 41 (22.8%) | 27 (27.8%) | 14 (16.9%) | 0.08 |
| Stage 3 | 29 (16.1%) | 24 (24.7%) | 5 (6.0%) | 0.001* |
| Patients requiring RRT | 25 (13.9%) | 21 (21.6%) | 4 (4.8%) | 0.001* |
| Patients remaining permanently dependant on RRT | 2 (1.1%) | 1 (1.0%) | 1(1.2%) | 0.9 |
| Creatinine before procedure (mg/dL) | 1.2 ± 0.6 | 1.3 ± 0.7 | 1.2 ± 0.6 | 0.3 |
| Max. creatinine up to 72 h after procedure (mg/dL) | 1.7 ± 1.2 | 2.0 ± 1.3 | 1.4 ± 0.7 | 0.0001* |
| Access-related complicationsa | ||||
| Major access complications | 22 (12.2%) | 2 (2.1%) | 20 (24.1%) | <0.0001* |
| Unplanned surgical intervention | 10 (5.6%) | 1 (1.0%) | 9 (10.8%) | 0.004* |
| Unplanned percutan. intervention | 6 (3.3%) | 0 | 6 (7.2%) | 0.007* |
| Thoracic aortic dissection | 1 (0.6%) | 0 | 1 (1.2%) | 0.3 |
| Minor access complications | 6 (3.3%) | 2 (2.1%) | 4 (4.8%) | 0.3 |
| Prosthetic valve-associated complications | ||||
| New-onset conduction disturbances | ||||
| LBBB | 12 (6.7%) | 0 | 12 (14.5%) | 0.0001* |
| Third degree atrioventricular block | 5 (2.8%) | 1 (1.0%) | 4 (4.8%) | 0.1 |
| New permanent pacemaker | 9 (5.0%) | 1 (1.0%) | 8 (9.6%) | 0.008* |
| Supraventricular arrhythmias | 29 (16.1%) | 16 (16.5%) | 13 (15.7%) | 0.9 |
| Valve endocarditis | 5 (2.8%) | 3 (3.1%) | 2 (2.4%) | 0.7 |
Categorical variables are presented as absolute number and percentage (in parentheses), continuous variables as mean ± SD. For comparison between TA and TF patients, the unpaired t test was used for continuous and the Chi-square test for categorical variables
aDefinitions according to proposed endpoint definitions from the Valve Academic Research Consortium (VARC) [9]