Table 2. Clinical data of transcatheter heart valves.
| Manufacturer prosthesis - study | Patients, n | Operative risk | 30-day mortality, % |
PVL ≥2°, % | Pmean, mmHg | PPI, % | Major vasc, % | Major stroke, % |
|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences SAPIEN 3 | ||||||||
| Webb et al. (CE) (8) | 150 | High (STS 7.4%) | 4.7 | 3.5 | 10.6±4.7 | 13.3 | 5.3 | 0 |
| Kodali et al. (Partner 2 S3 HR) (9) | 583 | High (STS 8.7%) | 2.2 | 3.7 | 11.4±4.8 | 13 | 5 | 0.9 |
| Wendler et al. (SOURCE 3) (10) | 1,947 | Intermed (ES I 18.3%) | 2.2 | 3.1 | 11.9±5.2 | 12 | 4.1 | 1.4 |
| Mack et al. (Partner 3) (7) | 496 | Low (STS 1.9%) | 0.4 | 0.8 | 12.8±0.2 | 6.5 | 2.2 | 0.6 |
| Edwards Lifesciences SAPIEN 3 Ultra | ||||||||
| Saia et al. (S3U) (11) | 139 | Intermed (STS 3.8%) | 0 | 1.4 | 11.6±4.3† | 4.4 | 2.2 | 0 |
| Medtronic Evolut R | ||||||||
| Manoharan et al. (CE) (12) | 60 | High (ES I 20.5%) | 0 | 3.4 | 8.1 | 11.7 | 8.3 | 0 |
| Grube et al. (FORWARD) (13) | 1,038 | Intermed (STS 5.5%) | 1.9 | 1.9 | 8.5±5.6 | 17.5 | 6.5 | 2.8 |
| Popma et al. (Low Risk Trial) (6)‡ | 725 | Low (STS 1.7%) | 0.5 | 3.5 | 8.6±3.7 | 17.4 | 3.8 | 3.4 |
| Medtronic Evolut PRO | ||||||||
| Forrest et al. (US Clinical Study) (14) | 60 | Intermed (STS 6.4%) | 1.7 | 0 | 6.4±2.1 | 11.8 | 10 | 1.7 |
| Boston Scientific ACURATE neo | ||||||||
| Möllmann et al. (CE) (15) | 89 | High (ES I 26.5%) | 3.4 | 4.9 | 8.0±2.9 | 8 | 3.4 | 2.2 |
| Kim et al. (SAVI TF) (16) | 1,000 | Intermed (STS 6.0%) | 1.3 | 4.1§ | 8.3±4.0§ | 8.2 | 3.8 | 1.9 |
| Boston Scientific LOTUS/LOTUS Edge | ||||||||
| Meredith et al. (REPRISE II/CE) (17) | 120 | Intermed (STS 7.1%) | 4.2 | 1 | 11.5±5.2 | 28.6 | 0 | 1.7 |
| Montone et al. (RELEVANT) (18) | 208 | High (STS 8.3%) | 2.9 | 1 | 11.6±5.6 | 27.4 | 1.8 | 1 |
| Falk et al. (RESPOND) (19) | 1,014 | Intermed (STS 6.0%) | 2.6 | 0.3 | 10.8±4.6 | 30 | 2.8 | 2.2 |
| Götberg et al. (LOTUS Edge Study) (20) | 36 | Intermed (STS 4.4%) | 0 | 0 | – | 15.2 | – | 5.6 |
| Abbott Vascular Portico | ||||||||
| Willson et al. (FIM) (21) | 10 | High (STS 8.1%) | 0 | 10 | 10.9±3.8 | 0 | 0 | 0 |
| Manoharan et al. (CE) (22) | 102 | Intermed (STS 5.6%) | 2.9 | 3.8 | 8.9±3.8 | 9.8 | 5.9 | 2.9 |
| Maisano et al. (Portico-1) (23) | 941 | Intermed (STS 5.8%) | 2.7 | 3.9 | 8.6±3.9 | 18.7 | 5.5 | 1.6 |
| Fontana et al. (PORTICO IDE) (24) | 381 | Intermed (STS 6.4%) | 3.5 | 6.3 | 8.4 | 27.7 | 9.6 | 1.6 |
| New Valve Technology ALLEGRA | ||||||||
| Wenaweser et al. (Allegra FIM) (25) | 21 | High (ES I 30.4%) | 4.8 | 5.3 | 8.9±3 | 23.8 | 14.3 | 0 |
| Jagielak et al. (Allegra Pilot) (26) | 27 | Intermed (ES I 12.4%) | 0 | 17.4 | 9 | 8 | 0 | 0 |
| Meril Life Sciences MyVal | ||||||||
| Sharma et al. (FIM/CE) (27) | 30 | Intermed (STS 6.4%) | 3.3 | 0 | 8.8±2.5 | 0 | 6.7 | 0 |
Data presented as mean ± standard deviation or median [interquartile range]. †, at discharge; ‡, CoreValve n=26, Evolut R n=537, Evolut PRO n=162; §, at 7 days post TAVR. ES I, Logistic EuroScore; STS, Society of Thoracic Surgeons Risk Score for Mortality; PVL, paravalvular leak; PPI, permanent pacemaker implantation post TAVR; Major vasc, major vascular complication; TAVR, transcatheter aortic valve replacement.