Table 1.
Baseline characteristics
| Study | Device | Access | Country | Patients (n) | Age (years ± SD/IQR) | Male (n, %) | LES I (%) | LES II (%) | STS (%) | Definition | Inclusion criteria |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Vahl et al. (2021) | JenaValve | Transfemoral | The United States | 71 | 74 | NA | NA | NA | NA | VARC‐2 | Symptomatic patients with greater‐than‐moderate AR with high surgical risk |
| Gogia et al. (2020) | JenaValve | Transfemoral | The United States | 11 | 77.6 | NA | NA | NA | NA | NA | Pure severe AR with high surgical risk |
| Silaschi et al. (2018) | JenaValve | Transfemoral | Germany | 30 | 74.4 ± 9.3 | 12 (40) | 17.7 ± 14.8 | 6.9 ± 6.5 | 4.9 ± 3.5 | VARC‐1 | Severe AR with high surgical risk |
| Seiffert et al. (2014) | JenaValve | Transapical | Germany | 31 | 73.8 ± 9.1 | 20 (64.5) | 23.6 ± 14.5 | 9.3 ± 6.4 | 5.4 ± 3.6 | VARC‐2 | Severe AR with high surgical risk |
| Schlingloff et al. (2014) | JenaValve | Transapical | Germany | 10 | 79 ± 9 | 6 | 28.3 ± 17.1 | NA | NA | VARC‐2 | Severe AR with high or prohibitive surgical risk |
| Liu et al. (2022) | J‐Valve | Transapical | China | 161 | NA | NA | NA | NA | NA | NA | Symptomatic severe AR with high surgical risk |
| Liu et al. (2022) | J‐Valve | Transapical | China | 134 | 73.1 ± 6.4 | 100 | NA | 11.5 ± 6.8 | 9.8 ± 5.3 | VARC‐2 | Severe AR with high surgical risk |
| Kong et al. (2022) | J‐Valve | Transapical | China | 69 | 71.46 ± 7.92 | 52 (75.4) | NA | NA | 3.76 ± 3.93 | VARC‐2 | Moderate‐to‐severe AR with high surgical risk |
| Shi et al. (2021) | J‐Valve | Transapical | China | 44 | 76.2 ± 5.5 | 30 (68.2) | 25.3 ± 8.5 | NA | NA | VARC‐2 | Severe AR with high surgical risk |
| Shen et al. (2020) | J‐Valve | Transapical | China | 123 | 72.1 ± 6.4 | NA | NA | NA | NA | VARC‐2 | Pure non‐calcified native AR with high surgical risk |
| Zhu et al. (2018) | J‐Valve | Transapical | China | 44 | 73.8 ± 5.6 | 13 | 25.4 ± 5.3 | NA | 9.1 ± 3.6 | NA | Severe AR with high surgical risk and an annulus diameter within the 19–27 mm range |
| Tung et al. (2018) | J‐Valve | Transapical | China | 43 | 73.8 ± 5.7 | 30 (69.8) | 25.3 ± 5.3 | NA | NA | VARC‐2 | Severe AR with high surgical risk |
| Guo et al. (2018) | J‐Valve | Transapical | China | 58 | 72.3 ± 5.7 | 39 | 20.1 ± 3.3 | NA | NA | VARC‐2 | Severe pure AR with high surgical risk |
| Zhu et al. (2016) | J‐Valve | Transapical | China | 33 | 74.2 ± 5.2 | 26 | 24.4 ± 5.1 | NA | NA | VARC‐2 | Severe pure AR with high surgical risk |
| Zhu et al. (2016) | J‐Valve | Transapical | China | 28 | 74.1 ± 4.6 | NA | 23.2 ± 3.3 | NA | NA | VARC‐2 | Severe pure AR with high surgical risk |
| Zhu et al. (2015) | J‐Valve | Transapical | China | 11 | 74.5 ± 4.7 | NA | NA | NA | NA | NA | Severe pure/dominant AR with high surgical risk |
| Guo et al. (2015) | J‐Valve | Transapical | China | 18 | 73.8 ± 3.7 | NA | 24.1 ± 4.5 | NA | NA | NA | Severe pure AR with high surgical risk |
| Liu et al. (2018) | J‐Valve | Transapical | China | 43 | 73.9 ± 5.7 | 30 (69.8) | 25.5 ± 5.3 | NA | NA | VARC‐2 | Severe pure AR with high surgical risk |
| Liu et al. (2019) | J‐Valve | Transapical | China | 82 | NA | NA | NA | NA | NA | VARC 1 | Severe pure AR with high surgical risk |
| Liu et al. (2019) | J‐Valve | Transapical | China | 53 | 76.4 ± 5.2 | NA | NA | NA | 6.3 ± 1.8 | VARC‐2 | Severe pure AR with high surgical risk |
| Delhomme et al. (2023) | SAPIEN 3 | Transfemoral | France | 37 | 81 (69–85) | 27 | 12.29 (8.1–22.26) | 4.82 (2.46–6.86) | NA | VARC‐2 | Severe pure AR with high or prohibitive surgical risk |
| Yin et al. (2022) | Evolut R, J‐Valve | Transfemoral, transapical | China | 10 | 72.8 ± 11.7 | 7 | NA | NA | 6.2 ± 4.1 | VARC‐2 | Severe pure native AR with high surgical risk |
| Pracon et al. (2022) | Evolut R, SAPIEN 3 | Transfemoral | The United Kingdom | 17 | NA | NA | NA | NA | NA | VARC‐3 | Severe pure aortic regurgitation with high surgical risk |
| Purita et al. (2020) | ACURATE neo | Transfemoral | Italy | 24 | 79.4 (50–88) | 10 (41.6) | NA | 5 ± 4.05 | 3.9 ± 2.37 | VARC‐2 | Severe pure aortic regurgitation with high or prohibitive surgical risk |
| Anwaruddin et al. (2019) | Evolut R | Transfemoral | The United States | 149 | 68.9 ± 15.1 | 80 (54) | NA | NA | 8.6 ± 9.9 | NA | Pure or mixed, with predominantly moderate or severe AR |
| Toggweiler et al. (2018) | ACURATE neo | Transfemoral | Switzerland | 20 | 79 ± 8 | NA | NA | NA | 8.3 ± 9.3 | NA | Severe pure AR with high surgical risk |
| De Backer et al. (2018) | Evolut, ACURATE, Portico, SAPIEN 3, Lotus, Direct Flow, JenaValve, Engager | Transapical, transformal | Denmark | 145 | 75 ± 10 | 69 (49) | NA | NA | 6.2 ± 4.9 | VARC‐2 | Severe native AR without significant stenosis with prohibitive surgical risk |
| De Backer et al. (2017) | JenaValve, Evolut R, Direct Flow, Symetis, Lotus, Engager, SAPIEN 3, Portico | Transapical, transformal | Denmark | 118 | NA | NA | NA | NA | 5.7 ± 5.2 | NA | Severe native AR without significant stenosis |
| Yoon et al. (2017) | SAPIEN 3, Evolut R, JenaValve, Direct Flow, J‐Valve, Engager, Portico, ACURATE, Lotus | Transapical, transformal | The United States | 212 | 74.5 ± 11.6 | 104 | NA | 8.9 ± 9.4 | 6.2 ± 6.7 | VARC‐2 | Severe pure AR with high surgical or prohibitive risk |
| Sawaya et al. (2017) | Evolut R, JenaValve, Direct Flow, Lotus, SAPIEN 3 | Transapical, transformal, transsubclavian | Denmark | 41 | NA | NA | NA | NA | NA | VARC‐2 | Severe pure native AR with high surgical risk |
| Schofer et al. (2015) | Direct Flow | Transfemoral | Germany | 11 | 74.7 ± 12.9 | 4 | 19.9 ± 7.1 | NA | 8.84 ± 8.9 | VARC‐2 | Symptomatic severe pure AR with high or prohibitive surgical risk |
AR, aortic regurgitation; IQR, inter‐quartile range; LES, logistic EuroSCORE; NA, not available; STS, Society of Thoracic Surgeons score; VARC‐1, Valve Academic Research Consortium‐1; VARC‐2, Valve Academic Research Consortium‐2; VARC‐3, Valve Academic Research Consortium‐3.