Table 3.
Clinical outcomes
| All (n = 1069) | Sapien 3 (n = 288) | Evolut (n = 179) | Acurate Neo (n = 428) | Portico (n = 110) | Lotus (n = 64) | p value | |
|---|---|---|---|---|---|---|---|
| Echocardiographic outcome | |||||||
| Moderate PPM | 243 (28.1) | 93 (40.7) | 28 (21.9) | 95 (25.2) | 20 (21.1) | 7 (16.7) | < 0.001 |
| Severe PPM | 91 (10.2) | 38 (15.8) | 12 (8.8) | 26 (7.4) | 4 (4.4) | 11 (22.2) | < 0.001 |
| iEOA (cm2/m2) | 0.9 (0.7–1.1) | 0.8 (0.7–1.0) | 1.0 (0.8–1.1) | 0.9 (0.8–1.1) | 0.9 (0.8–1.1) | 0.9 (0.6–1.1) | < 0.001 |
| Mean gradient (mmHg) | 10.0 (6.8–13.0) | 12.2 (9.0–16.0) | 7.0 (4.9–10.2) | 9.0 (6.0–12.0) | 9.0 (7.0–11.0) | 12.9 (9.8–16.0) | < 0.001 |
| PVL > mild (%) | 51 (4.8) | 7 (2.4) | 7 (3.9) | 30 (7.0) | 6 (5.5) | 1 (1.6) | 0.04 |
| VARC-2 clinical outcome | |||||||
| Major vascular complications (%) | 78 (7.3) | 14 (4.9) | 4 (2.2) | 44 (10.3) | 10 (9.1) | 6 (9.4) | 0.003 |
| Acute kidney injury (%)a | 84 (8.3) | 20 (8.3) | 18 (10.3) | 32 (7.6) | 11 (10.0) | 3 (4.8) | 0.63 |
| Major Bleeding (%) | 67 (6.3) | 17 (5.9) | 5 (2.8) | 30 (7.0) | 9 (8.2) | 6 (9.4) | 0.21 |
| Permanent pacemaker implantation (%) | 134 (13.8) | 43 (16.5) | 16 (9.8) | 41 (10.6) | 18 (17.8) | 16 (27.6) | 0.001 |
| Disabling Stroke (%) | 8 (0.7) | 1 (0.3) | 2 (1.1) | 3 (0.7) | 1 (0.9) | 1 (1.6) | 0.81 |
| Reintervention (%)b | 3 (0.3) | 1 (0.4) | 0 (0) | 2 (0.5) | 0 (0) | 0 (0) | 0.78 |
| 30-day mortality (%) | 33 (3.2) | 9 (3.2) | 7 (4.0) | 9 (2.2) | 5 (4.6) | 3 (4.8) | 0.54 |
| 12-month mortality (%) | 104 (9.9) | 31 (11.0) | 16 (9.1) | 38 (9.1) | 11 (10.1) | 8 (12.9) | 0.84 |
iEOA indexed effective orifice area, PVL paravalvular leakage, PPM prosthesis-patient mismatch
aAcute kidney injury `Kidney Disease—Improving Global Outcomes` stadium I–III
bReasons for reintervention: relevant aortic regurgitation after postdilatation