Table 2. Procedural data.
| Variable | ACURATE (n=251) | EVOLUT (n=584) | p-value | ACURATE (n=234) | EVOLUT (n=234) | p-value |
|---|---|---|---|---|---|---|
| Prosthesis size | <0.001 | <0.001 | ||||
| Small (23 mm) | 195 (77.7) | 291 (49.8) | 180 (76.9) | 108 (46.2) | ||
| Medium (25, 26 mm) | 47 (18.7) | 234 (40.1) | 45 (19.2) | 105 (44.9) | ||
| Large (27, 29, 34 mm) | 9 (3.6) | 59 (10.1) | 9 (3.8) | 21 (9.0) | ||
| Cover index, % | 8.7 [8.7; 17.4] | 17.4 [11.5; 19.2] | <0.001 | 8.7 [8.7; 17.4] | 17.4 [13.8; 19.2] | <0.001 |
| Early-generation device | 132 (52.6) | 569 (97.4) | <0.001 | |||
| Procedural duration, min | 53 [37;80]; 236 | 74 [55; 105]; 544 | <0.001 | 52 [36; 80] | 74 [56; 100] | <0.001 |
| Fluoroscopy time, min | 12.4 [9.0; 20.3]; 234 | 18 [12.6; 27.5]; 541 | <0.001 | 12.3 [9.0; 19.5] | 18.1 [13.3; 27.1] | <0.001 |
| Contrast agent, ml | 60 [25; 98]; 245 | 95 [50; 146]; 571 | <0.001 | 60 [22; 95] | 96 [50; 140] | <0.001 |
| Predilatation | 111 (44.4) | 42 (7.2) | 0.037 | 102 (43.6) | 19 (8.1) | <0.001 |
| Post-dilatation | 144 (57.4) | 289 (49.5) | 0.195 | 136 (58.1) | 115 (49.1) | 0.064 |
| Attempted BVF | 9 (3.6) | 12 (2.1) | 0.067 | 9 (3.8) | 5 (2.1) | 0.417 |
| BVF timing at predilatation | 8/9 (88.9) | 5/12 (41.7) | 0.171 | 8/9 (88.9) | 1/5 (20.0) | 0.023 |
| BVF successful | 7/9 (77.8) | 12/12 (100) | 0.119 | 7/9 (77.8) | 5/5 (100) | 0.505 |
| Haemodynamic compromise after BVF | 4/9 (44.4) | 1/12 (8.3) | <0.001 | 4/9 (44.4) | 1/5 (20.0) | 0.580 |
| Cerebral protection | 19 (7.6) | 186 (31.9) | <0.001 | 18 (7.7) | 70 (29.9) | <0.001 |
| Commissural alignment | 98 (39.0) | 15 (2.6) | 0.111 | 91 (38.9) | 8 (3.4) | <0.001 |
| Coronary protection | 49 (19.5) | 88 (15.1) | <0.001 | 40 (17.1) | 44 (18.8) | 0.186 |
| Implantation depth, mm | 2.5 [1.0; 4.5]; 240 | 4.7 [2.7; 6.4]; 468 | <0.001 | 2.0 [1.0; 4.2] | 4.0 [3.0; 6.0] | <0.001 |
| Values denote n (%), n/N (%), median [IQR]. ACURATE: ACURATE neo/neo2 group; BVF: bioprosthetic valve fracturing; EVOLUT: Evolut R/PRO/PRO+ group; IQR: interquartile range | ||||||