Table 1.
Baseline characteristics of the included studies.
|
Author/trial Name |
Year |
Study design |
Sample size |
Follow-up |
Valve generations |
SAA definition used for inclusion |
Device name |
Age-mean ± SD |
Females-n (%) |
BSA, m2- mean ± SD |
BMI Kg/m2- mean ± SD |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BEVs | SEVs | BEVs | SEVs | BEVs | SEVs | BEVs | SEVs | BEVs | SEVs | BEVs | SEVs | ||||||
| Mauri et al. | 2017 | PSM | 92 | 92 | 1-year | new generation | Annulus area < 400 mm2 | SAPIEN 3 | Symetis ACURATE neo | 81.9 ± 5.3 | 82.8 ± 6.5 | 85 (92.4) | 85 (92.4) | 1.71 ± 0.2 | 1.71 ± 0.2 | 26.0 ± 4.7 | 27.3 ± 5.5 |
| Abdel-Wahab (CHOICE) | 2014 | RCT | 43 | 51 | NR | early generation | Mean aortic diameter ≤ 23 mm | SAPIEN XT | CoreValve | 82.0 ± 6.1 | 82.3 ± 6.1 | 37 (86.0) | 47 (92.2) | 1.72 ± 0.15 | 1.73 ± 0.19 | 25.7 ± 4.8 | 26.3 ± 5.6 |
| Guimarães et al. | 2020 | PSM | 52 | 52 | NR | early and new devices | Annular diameter ≤ 21 mm | SAPIEN XT/3 | CoreValve, Evolut R | 80 ± 8 | 80 ± 8 | 80 % | 80 % | 1.7 ± 0.2 | 1.7 ± 0.2 | 27 ± 7 | 27 ± 7 |
| Hase et al. (OCEAN-TAVI) | 2021 | PSM | 69 | 69 | 1 year | new generation | Mean aortic diameter ≤ 23 mm | SAPIEN 3 | Evolut R/Pro | 86 ± 5.3 | 86.3 ± 3.8 | 57 (82.6) | 58 (84.1) | 1.3 (1.3–1.4)* | 1.4 (1.3–1.5)* | 21.4 (19.0–23.3)* | 21.4 (19.5–23.3)* |
| Kornyeva et al. | 2023 | PSM | 192 | 192 | 3 years | new generation | Annular perimeter < 72 mm or aortic annulus area < 400m m2 | SAPIEN 3 | Evolut R/PRO, Acurate neo-2, and Portico THV | 81 ± 6 | 81 ± 7 | 153 (80) | 141 (73 %) | 1.8 ± 0.2 | 1.8 ± 0.2 | 25.96 ± 8.33 | 27.03 ± 8 |
| Okuno et al. (Swiss TAVI) | 2023 | PSM | 171 | 171 | 5 years | early and new devices | Annular area < 430 mm2 | SAPIEN XT/3/3Ultra | CoreValve, Evolut R/PRO/PRO+ | 82.7 ± 6.4 | 82.2 ± 6.2 | 85.40 % | 84.20 % | NR | NR | 26.5 ± 5.6 | 26.9 ± 6.1 |
| Herrmann et al. (SMART Trial) | 2024 | RCT | 361 | 355 | 1 year | new generation | Annulus area of 430 mm2 or less | SAPIEN 3/3 Ultra | Evolut PRO/PRO+/FX | 80.3 ± 6.1 | 80.1 ± 6.3 | 309 (85.6) | 312 (87.9) | 1.8 ± 0.2 | 1.8 ± 0.2 | NR | NR |
| Baudo et al. | 2024 | PSM | 109 | 109 | 2 years | new generation | Annulus area ≤ 430 mm2 | SAPIEN 3/3 Ultra | Evolut PRO/PRO+/FX | 80.5 ± 7.8 | 81.0 ± 7.7 | 83 (76.1) | 91 (83.5) | 1.82 ± 0.27 | 1.80 ± 0.27 | 28.2 ± 6.5 | 28.1 ± 6.9 |
|
Scotti et al. (OPERA-TAVI) |
2024 | PSM | 251 | 251 | 1 year | New generation | aortic annular area < 430 mm2 | SAPIEN Ultra | Evolut PRO/PRO+ | 82.42 (77.97–86.66)* | 82.34 (78.06–86.00)* | 174 (69.3) | 186 (74.1) | NR | NR | 25.78 (23.08–29.38)* | 26.17 (22.92–30.05) |
| Kalogeras et al. | 2023 | PSM | 139 | 139 | 1 year | New generation | Patients treated with an Edwards SAPIEN 3 or Ultra valve ≤ 23 mm or an Evolut PRO/PRO+ ≤26 mm were included in the “small THV” cohort |
SAPIEN S3/Ultra | Evolut PRO/PRO+ | 83 (77–87)* | 83 (78–88)* | 110 (79.1) | 114 (82) | NR | NR | 26.8 (24.4–32)* | 26.6 (23–30.2)* |
BEV: Balloon Expandable Valve; SEV: Self-Expanding Valve; PSM: propensity score matching; RCT: randomized controlled trial; SAA: Small aortic annulus; BSA: body surface area; BMI: body mass index; n: number; NR: not reported.
*
Data are given as median and interquartile range.