Table 3.
TAVI performance-Comparison DirectFlow vs. Edwards Sapien 3 (matched cohort).
| Overall | DirectFlow | Edwards Sapien 3 | P-value | |
|---|---|---|---|---|
| Valve size | N/A | 23 mm n = 1 25 mm n = 21 27 mm n = 19 29 mm n = 1 | 23 mm n = 17 26 mm n = 20 29 mm n = 5 | N/A |
| PGmean prior TAVI (mmHg) | 41.4 ± 17.4 | 42.0 ± 16.1 | 40.1 ± 18.8 | 0.770 |
| PGmean post TAVI (mmHg) | 6.8 ± 5.5 | 11.2 ± 5.3 | 3.5 ± 2.7 | <0.001* |
| PGmean at 6-months FU TAVI (mmHg) | 16.2 ± 7.9 | 20.3 ± 8.8 | 12.3 ± 4.4 | <0.001* |
| NYHA at admission (%) | 0.097 | |||
| II | 13.0 | 10.5 | 15.4 | |
| III | 77.9 | 73.7 | 82.1 | |
| IV | 9.1 | 15.8 | 2.6 | |
| NYHA at 6-months FU (%) | <0.001* | |||
| II | 41.8 | 20.5 | 52.5 | |
| III | 58.2 | 79.5 | 37.5 | |
| IV | 0 | 0 | 0 | |
| NT-proBNP prior TAVI (pg/ml) | 1.819 (IQR 3.498) | 1.840 (IQR 2.631) | 1.669 (IQR 3.689) | 0.847 |
| NT-proBNP at discharge (pg/ml) | 1.576 (IQR 2.740) | 2.230 (IQR 2.986) | 1.169 (IQR 2.296) | 0.226 |
| NT-proBNP at 6-months FU (pg/ml) | 633 (IQR 1.439) | 624 (IQR 2.909) | 681 (IQR 991) | 0.414 |
| Post-procedural AR/PVL (%) | 44.0 | 42.9 | 45.3 | 0.933 |
| Minimal | 21.4 | 16.7 | 26.2 | |
| Mild | 17.9 | 21.4 | 14.3 | |
| Moderate | 4.8 | 4.8 | 4.8 | |
| PPI post TAVI (%) | 13.1 | 7.1 | 19.0 | 0.116 |
| Post-procedural LBBB TAVI (%) | 15.5 | 14.3 | 16.7 | 0.500 |
| Hospital stay (days) | 10.9 ± 6.2 | 10.6 ± 6.1 | 11.2 ± 6.3 | 0.676 |
| Valve in valve re-do procedure (n) | 4 | 3 | 1 | 0.308 |
| MACE (n) | 12 | 10 | 2 | 0.013* |
| All-cause death (n) | 10 | 8 | 2 | 0.044* |
| Stroke (n) | 2 | 2 | 0 | 0.247 |
PG, pressure gradient; TAVI, transcatheter aortic valve implantation; NYHA, New York Health Association functional class; FU, follow-up; AR, aortic regurgitation; PVL, paravalvular leakage; PPI, permanent pacemaker implantation; LBBB. left bundle branch block; MACE, major adverse cardiac event.
*
p-values.