Table 2.
Pre-procedural imaging and procedural characteristics
| Overall (n = 94) | SAPIEN 3 (n = 39) | SAPIEN XT (n = 55) | P-value | |
|---|---|---|---|---|
| CT variables | ||||
| Annulus mean diameter, mm | 24.7 ± 2.0 | 25.1 ± 1.6 | 24.5 ± 2.2 | 0.13 |
| Annulus eccentricity, % | 18.1 ± 5.9 | 18.2 ± 6.4 | 18.1 ± 5.6 | 0.97 |
| Annulus area, mm2 | 478.3 ± 74.6 | 495.9 ± 59.9 | 466.2 ± 81.6 | 0.07 |
| Annulus perimeter, mm | 78.5 ± 6.1 | 80.0 ± 5.0 | 77.5 ± 6.6 | 0.05 |
| Aortic valve calcium volume, mm3 | 250.9 ± 216.5 | 252.6 ± 257.1 | 249.7 ± 185.0 | 0.92 |
| Oversizing (by nominal THV area), % | 13.6 ± 10.7 | 7.2 ± 9.0 | 18.1 ± 9.5 | <0.001 |
| Echocardiographic variables | ||||
| Pre EF, % | 58.9 ± 12.9 | 58.8 ± 11.3 | 59.1 ± 14.0 | 0.91 |
| Mean PG, mmHg | 46.4 ± 12.4 | 45.8 ± 10.9 | 46.8 ± 13.4 | 0.71 |
| Pre AVA, cm2 | 0.62 ± 0.14 | 0.60 ± 0.14 | 0.64 ± 0.14 | 0.21 |
| Procedure details | ||||
| THV size | ||||
| 23 mm | 20 (21.3) | 5 (12.8) | 15 (27.3) | 0.13 |
| 26 mm | 44 (46.8) | 22 (56.4) | 22 (40.0) | 0.14 |
| 29 mm | 30 (31.9) | 12 (30.8) | 18 (32.7) | >0.99 |
| Implantation access | ||||
| Transfemoral | 91 (96.8) | 39 (100) | 52 (94.5) | 0.26 |
| Other | 3 (3.2) | 0 (0.0) | 3 (5.5) | 0.26 |
| Pre-dilatation | 46 (48.9) | 24 (61.5) | 22 (40.0) | 0.06 |
| Post-dilatation | 2 (2.1) | 2 (5.1) | 0 (0.0) | 0.17 |
| New pacemaker implantsa | 11 (13.6) | 7 (20.0) | 4 (8.7) | 0.19 |
| Delivery balloon volume | ||||
| Nominal volume | 59 (62.8) | 26 (66.7) | 33 (60.0) | 0.53 |
| Over-filling volume | 17 (18.1) | 7 (17.9) | 10 (18.2) | >0.99 |
| Under-filling volume | 18 (19.1) | 6 (15.4) | 12 (21.8) | 0.60 |
Values are mean ± SD or n (%).
EF, ejection fraction; AVA, aortic valve area; PG, pressure gradient.
aNew pacemaker implants: excludes patients who had previous pacemaker/ICD (S3 = 4, S-XT = 9).