Table 3.
The outcomes of new‐generation devices
| Outcomes | NGDs | On‐label devices | Off‐label devices | P ** | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ES (95% CI) | I 2 (%) | P * | ES (95% CI) | I 2 (%) | P * | ES (95% CI) | I 2 (%) | P * | ||
| 30 day procedural outcomes | ||||||||||
| Device success |
0.945 (0.913–0.971) |
76.8 | 0.000 |
0.978 (0.964–0.989) |
8.2 | 0.358 |
0.899 (0.848–0.941) |
10.3 | 0.350 | <0.001 |
| Permanent pacemaker implantation |
0.088 (0.061–0.119) |
57.0 | 0.000 |
0.069 (0.046–0.095) |
40.0 | 0.041 |
0.184 (0.132–0.242) |
0.0 | 0.928 | <0.001 |
| Conversion to SAVR |
0.022 (0.009–0.038) |
0.0 | 0.981 |
0.025 (0.012–0.042) |
0.0 | 0.957 | NA | NA | NA | NA |
| Annulus rupture |
0.002 (0.000–0.017) |
0.0 | 0.941 | NA | NA | NA | NA | NA | NA | NA |
| Reintervention |
0.023 (0.007–0.045) |
13.9 | 0.324 | NA | NA | NA |
0.028 (0.000–0.114) |
54.6 | 0.111 | NA |
| Greater‐than‐mild PVL |
0.012 (0.004–0.022) |
0.0 | 0.713 |
0.009 (0.002–0.019) |
0.0 | 0.942 |
0.038 (0.012–0.074) |
0.0 | 0.611 | 0.003 |
| Mild PVL |
0.209 (0.176–0.244) |
12.8 | 0.304 |
0.203 (0.165–0.243) |
19.0 | 0.241 | NA | NA | NA | NA |
| None/trace PVL |
0.774 (0.708–0.835) |
71.3 | 0.000 |
0.780 (0.705–0.847) |
73.4 | 0.000 | NA | NA | NA | NA |
| 30 day clinical outcomes | ||||||||||
| 30 day mortality |
0.042 (0.027–0.059) |
43.8 | 0.008 |
0.026 (0.013–0.043) |
22.1 | 0.192 |
0.051 (0.016–0.102) |
30.4 | 0.219 | 0.006 |
| 1 year clinical outcomes | ||||||||||
| 1 year mortality |
0.081 (0.051–0.117) |
67.3 | 0.001 |
0.059 (0.035–0.087) |
23.3 | 0.251 | NA | NA | NA | NA |
CI, confidence interval; ES, effect size; I 2, the variation attributable to heterogeneity; NA, not available; NGDs, new‐generation devices including on‐label devices and off‐label devices; PVL, paravalvular leak; SAVR, surgical aortic valve replacement.
P value for significance of I 2.
P value for significance of the χ 2 or Fisher's exact test between off‐label and on‐label devices.