Table 1.
Results of single-arm studies
| Study cohort Author (year) |
Baseline | Procedural outcomes | Echocardiographic outcomes | Mortality | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Age | Surgical score | Annular rupture | Device embolization/dislocation | Coronary obstruction | Major vascular complication | Permanent pacemaker | EOA (cm2) |
Mean PG (mmHg) |
PVL | 30-day mortality | 1-year mortality | ||
|
CE-approval cohort+ Möllman et al. (2017) [10] |
89 | 84 ± 4 | ES I: 26.5 ± 7.7% | 1 (1.1%) | 2 (2.2%) | 0 (0%) | 3 (3.4%) | 8 (10.3%) | 1.8 ± 0.3 | 8.0 ± 2.9 | 3 (4.5%) | 3 (3.4%) | 20 (22.5%) | |
| Hamm et al. (2017)*1 [11] | 219 | 81 ± 4 | LES: 19.3 ± 13.9% | 0 (0%) | 1 (0.5%) | 0 (0%) | 11 (5.0%) | 27 (12.3%) | NA | 10.6 ± 9.2 | 4 (1.9%) | 7 (3.2%) | 5.2% | |
|
Toggweiler et al. (2018)*2 [12] |
175 | 83 ± 6 | STS: 4.1 ± 2.4% | NA | NA | NA | 12 (6.9%) | 4 (2.3%) | 2.0 ± 0.4 | 6.9 ± 3.7 | 8 (4.6%) | 1 (0.6%) | NA | |
|
SAVI TF registry Möllman et al. (2018) [13•] Kim et al. (2018) [14•] |
1000 | 81 ± 5 |
ES II: 6.6 ± 7.5% STS: 6.0 ± 5.6% |
0 (0%) | NA | 0 (0%) | 32 (3.2%) | 83 (8.3%) | 1.8 ± 0.5 | 8.4 ± 4.0 | 35 (4.1%) | 14 (1.4%) | 78 (8.0%) | |
|
Kim et al. (2018) [15] |
500 | 82 (79–85) |
LES: 18.3% (11.9–26.6) STS: 4.4% (3.1–6.6) |
0 (0%) | 6 (1.2%) | 0 (0%) | 46 (9.2%) | 51 (10.2%) | 1.6 (1.4–1.9) | 8.0 (6.0–11.0) | 24 (4.8%) | 16 (3.3%) | NA | |
|
Pellegrini al. (2020) [16] |
151 | 81 ± 6 |
ES II: 5.1% (2.9–7.1) |
NA | NA | NA | 21 (13.9%) | 16 (10.6%) | NA | 7.8 ± 3.3 | 2 (1.4%) | 1 (0.7%) | 5 (3.3%) | |
| Bicuspid aortic valve | ||||||||||||||
|
Mangieri et al. (2018) [17•] |
Tricuspid | 658 | 82 ± 4 |
STS: 5.1 ± 3.6% LES: 20.1 ± 13.4% |
0 (0%) | NA | 1 (0.1%) | 55 (8.3%) | 57 (8.6%) | NA | 8.4 ± 4.2 | 9 (3.1%) | 17 (2.8%) | NA |
| Bicuspid | 54 | 80 ± 5 |
STS: 4.7 ± 2.7% LES: 17.7 ± 10.7% |
0 (0%) | NA | 1 (1.8%) | 6 (11.1%) | 5 (9.2%) | NA | 9.8 ± 4.2 | 4 (7.4%) | 2 (3.7%) | NA | |
| Valve-in-valve | ||||||||||||||
|
Holzamer et al. (2019) [18•] |
85 | 77 ± 8 |
STS: 6.8 ± 6.0% ES II: 11.4 ± 7.9% |
0 (0%) | 2 (2.4%) | 1 (1.2%) | 4 (4.7%) | 1 (1.2%) | 1.5 ± 0.4 | 16 ± 8 | 1 (1.2%) | 4 (4.7%) | NA | |
| Pure aortic regurgitation | ||||||||||||||
|
Toggweiler et al. (2018) [19] |
20 | 79 ± 8 | STS: 8.3 ± 9.3% | NA | 0 (0%) | NA | 1 (5%) | 3 (15%) | 2.2 ± 0.6 | 6 ± 3 | 1 (5%) | 0 (0%) | NA | |
|
Purita et al. (2019) [20] |
24 | 79.4 (50–88) |
ES II: 5 ± 4.05 STS: 3.9 ± 2.37 |
0 (0%) | 2 (8.3%) | 0 (0%) | 1 (4.1%) | 4 (21.1%) | 1.9 (1.2–2.2) | 6.5 (4–16) | 2 (8.3%) | 1 (4.1%) | 2 (11.7%) | |
EOA effective orifice area, PG pressure gradient, PVL paravalvular leak, ES I = Euroscore I, ES II Euroscore II, LES logistic Euroscore, STS Society of Thoracic Surgeons predicted risk of mortality, NA not available/assessed
+ Clinical events were adjudicated according to the VARC-2 criteria (no other studies comprised independent event adjudication or core laboratory echocardiographic assessment)
*1Ninety-nine patients were treated with transapical ACURATE TA
*2Minimizing trauma strategy: pre-dilation with 1–3 mm smaller balloon than perimeter-derived annular diameter, post-dilation with 1–2 mm smaller balloon than perimeter-derived diameter only in case of relevant aortic regurgitation or increased mean gradient > 10 mmHg