Table 1. Studies’ and patients’ baseline characteristics.
| First author/year | Study period | Design | Intervention | Cohort | Age (years) |
Females (%) |
BMI (kg/m2) |
NYHA III/IV (%) |
STS-PROM (%) | Logistic EuroSCORE (%) | Mean aortic gradient (mmHg) | Aortic annulus diameter (mm) | Access site |
Follow-up (months) | VARC-2 outcomes definitions | ROBINS-I tool bias assessment |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abdel-Wahab 2016 (20) | 12.2013–10.2015 | SC, RCS, PM | Sapien 3 | 60 | 81.2±5.1 | 56.7 | 28.3±4.9 | NR | 4.9±3.1 | 17.6±10.8 | 46.1±16.1 | 25.0±2.2 | NR | 12 | Yes | Moderate |
| Lotus | 60 | 80.7±5.2 | 56.7 | 28.2±5.6 | NR | 5.4±3.0 | 17.6±10.5 | 46.1±18.5 | 24.7±2.2 | NR | ||||||
| Fovino 2018 (21) | 08.2013–01.2017 | MCR, PCS, PM | Sapien 3 | 93 | 79.8±5.8 | 41.9& | 26.3±4.3 | 53.8 | 8.7±8.0 | 15.3±10.5& | 42.6±16.9 | 24.8±2.1 | Femoral 100% | 1 | Yes | Moderate |
| Lotus | 93 | 80.5±7.0 | 44.1& | 25.9±4.6 | 51.6 | 9.0±5.2 | 15.9±10.2& | 47.8±14.1 | 24.1±2.3 | Femoral 100% | ||||||
| Jarr 2017 (23) | 08.2014–01.2016 | SC, RCS | CoreValve | 36 | 82.3±4.7 | 73.8 | NR | NR | 6.2±4.7 | NR | 38.7±14.0 | 23.5±1.7& | Femoral 100% | 1 | Yes | Serious |
| Evolut R | 109 | |||||||||||||||
| Sapien 3 | 90 | 81.7±7.3 | 26.7 | NR | NR | 5.3±4.8 | NR | 38.3±14.5 | 25.4±2.3& | Femoral 100% | ||||||
| Lotus | 63 | 81.3±5.1 | 33.3 | NR | NR | 5.6±4.5 | NR | 38.1±13.0 | 24.7±1.9& | Femoral 100% | ||||||
| Marzahn 2018 (24) | 07.2008–05.2015 | SC, RCS | CoreValve | 272 | 80.5±6.1 | 55.7 | 27.8±8.7 | NR | NR | 15.9±10.3 | 42.7±16.6 | NR | Femoral 100% | 12 | Nr | Serious |
| Evolut R | 7 | |||||||||||||||
| Portico | 26 | |||||||||||||||
| DFM | 41 | |||||||||||||||
| Sapien XT | 262 | |||||||||||||||
| Sapien 3 | 234 | |||||||||||||||
| Lotus | 14 | |||||||||||||||
| Pilgrim 2016 (25) | 02.2014–09.2015 | MCR, PCS | Sapien 3 | 815 | 81.9±6.4 | 43.2 | 26.9±5.3 | 66.8 | 5.0±3.8& | 18.9±14.8& | 46.1±21.5 | NR | Femoral 100% | 1 | Yes | Moderate |
| Lotus | 140 | 83.0±5.4 | 46.4 | 26.6±4.8 | 58.6 | 4.1±2.4& | 15.0±8.6& | 49.4±19.5 | NR | Femoral 100% | ||||||
| Schofer 2018 (26) | 2014–2015 | SC, RCS | Sapien 3 | 212 | 80.6±7.2 | 48.1 | 27.3±5.7 | 92.9 | 5.9±5.6 | 16.1±11.0 | 35.0±16.8& | 24.6±2.3 | Femoral 100% | 1 | Yes | Moderate |
| Lotus | 61 | 80.5±7.5 | 57.4 | 28.6±6.4 | 86.9 | 4.8±2.6 | 13.4±8.6 | 40.6±14.2& | 24.0±2.0 | Femoral 100% | ||||||
| Seeger 2017 (27) | 06.2014–2016 | SC, PCS, PM | Sapien 3 | 202 | 80.1±6.4 | 57.4 | 27.1±4.8 | 77.2 | 6.5±5.2 | 14.6±13.0 | 35.0±15.0 | 24.6±2.6 | Femoral 100% | 24 | Yes | Moderate |
| Lotus | 202 | 81.2±5.2 | 56.7 | 26.7±4.8 | 73.1 | 6.8±5.0 | 13.2±12.1 | 36.0±16.0 | 24.3±1.7 | Femoral 100% | ||||||
| Sinning 2017 (28) | 2010–2016 | SC, RCS | Direct Flow Medical | 38 | 80.9±6.3 | 49.2 | NR | NR | 5.6±3.6 | NR | NR | NR | NR | 36 | Yes | Serious |
| CoreValve | 400 | |||||||||||||||
| Evolut R | 114 | |||||||||||||||
| Sapien XT | 48 | |||||||||||||||
| Sapien 3 | 101 | |||||||||||||||
| Lotus | 104 | |||||||||||||||
| Soliman 2018 (29)* | 09.2013–12.2015 | SC, PCS | Sapien 3 | 83 | 80.0±8.0 | 46 | 27.1±5.0 | 74.4 | NR | 15.5±9.5 | NR | 24.9±2.3 | Femoral 90%&; apical 10%& | 1 | Yes | Serious |
| Lotus | 79 | 80.0±7.0 | 56 | 28.0±5.3 | 74.7 | NR | 14.0±9.3 | NR | 24.3±1.7 | Femoral 100%& | ||||||
| van Gils 2017 (22)* | 05.2008–02.2016 | MCR, RCS | CoreValve | 130 | 83.0±6.0 | 39 | 26.0±5.0 | 78& | 7.1±4.4 | NR | NR | NR | Femoral 91%&; apical 1%&; subclavian 8%& | 12 | Yes | Serious |
| Sapien XT | 124 | 83.0±8.0 | 33 | 27.0±4.0 | 83& | 7.0±4.6 | NR | NR | NR | Femoral 79%&; apical 10%&; subclavian 11%& | ||||||
| Sapien 3 | 32 | 81.0±6.0 | 37 | 27.0±4.0 | 53& | 6.0±5.8 | NR | NR | NR | Femoral 78%&; apical 19%&; subclavian 3%& | ||||||
| Lotus | 20 | 83.0±6.0 | 40 | 29.0±7.0 | 74& | 6.3±2.1 | NR | NR | NR | Femoral 100%& | ||||||
| Wöhrle 2015 (30) | 01.2014–06.2014 | SC, RCS | Sapien 3 | 52 | 82.6±6.2& | 48 | NR | 79 | 7.3±5.3 | 17.7±11.8 | 35.0±15.0 | 24.6±1.7 | Femoral 100% | 1 | Yes | Moderate |
| Lotus | 26 | 79.3±5.3& | 62 | NR | 62 | 41.0±17.0 | 25.2±1.7 | Femoral 100% |
*, a possibility of insignificantly overlap of van Gils and Soliman studies (22,29) exists. Fifty-two van Gils’ patients were drawn from four centers and 162 Soliman’s exclusively from 1 shared with van Gils’ center; &, variables that differed significantly. SC, single centre; RCS, retrospective cases series; PM, propensity match; MCR, multicentre registry; PCS, prospective cohort study; BMI, body mass index; NYHA, New York Heart Association; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality; EuroSCORE, European System for Cardiac Operative Risk Evaluation; VARC, Valve Academic Research Consortium; NR, not reported.