Table 2.
Procedural characteristics and in-hospital complications of the patients treated with PORTICO and of the entire population and the matched population treated with ACURATE neo.
| Matched Population (1:1) | |||
|---|---|---|---|
| PORTICO | ACURATE Neo | p-Value | |
| (n = 344) | (n = 344) | ||
| Procedural data | |||
| Conscious sedation | 308 (89.5%) | 300 (87.2%) | 0.405 |
| THV Size | <0.001 | ||
| 23 | 6 (1.7%) | 49 (14.2%) | |
| 25 | 93 (27.0%) | 148 (43.0%) | |
| 27 | 123 (35.8%) | 147 (42.7%) | |
| 29 | 122 (35.5%) | 0 (0.0%) | |
| Pre-dilatation | 275 (79.9%) | 270 (78.5%) | 0.707 |
| Post-dilatation | 64 (18.6%) | 110 (32.0%) | <0.001 |
| Cerebral protection | 2 (0.6%) | 7 (2.0%) | 0.177 |
| Procedural time (min) | 52.0 (40.0–69.0) | 56.0 (38.0–72.2) | 0.853 |
| Contrast (mL) | 120.0 (100.0–160.0) | 100.0 (80.0–130.0) | <0.001 |
| Fluoroscopy dose (Gy) | 1466.5 (29.1–3463.8) | 1391.0 (27.1–3635.5) | 0.868 |
| Fluoroscopy time (s) | 12.5 (9.2–17.1) | 10.3 (8.0–14.6) | <0.001 |
| Echocardiographic characteristics | |||
| Postprocedural mean gradient (mmHg) | 8.0 (6.0–10.0) | 8.0 (6.0–10.0) | 0.982 |
| Postprocedural max gradient (mmHg) | 13.0 (10.0–18.0) | 14.0 [11.0;18.0] | 0.856 |
| Clinical events | |||
| Major stroke/minor stroke/TIA | 13 (3.8%) | 12 (3.5%) | 1.000 |
| Major vascular complications | 9 (4.5%) | 11 (5.4%) | 0.854 |
| Life-threatening bleeding (VARC) | 2 (1.0%) | 4 (2.0%) | 0.685 |
| Renal failure (AKIN 2/3) | 12 (3.5%) | 13 (3.8%) | 0.994 |
| Coronary artery obstruction with PCI | 0 (0.0%) | 3 (1.5%) | 0.248 |
| Myocardial infarction | 6 (3.0%) | 8 (3.9%) | 0.815 |
| Permanent pacemaker implantation 1 | 52 (18.7%) | 28 (9.5%) | 0.002 |
| Days in hospital | 7.0 (6.0–10.0) | 7.5 (6.0–11.0) | 0.965 |
| Days in the intensive care unit | 2.0 (1.0–3.0) | 2.0 (1.0–3.0) | 0.825 |
| In-hospital mortality | 10 (2.9%) | 10 (2.9%) | 1.000 |
Values are the mean ± SD, n (%) or median (interquartile range). 1 Excluding patients with pacemakers at the baseline (n = 115 in the matched population). VARC = Valve Academic Research Consortium, AKIN = Acute Kidney Injury Network, TIA = transitory ischemic attack.