Cohort I (n=500) % | Cohort II (n=500) % | Cohort III (n=500) % | Cohort IV (n=500) % | Overall P values | |
Access route (%) | <0.001 | ||||
TA | 43.6 | 39.0 | 30.0 | 29.0 | |
TF | 56.4 | 61.0 | 70.0 | 71.0 | |
Valve expansion mechanism (%) | <0.001 | ||||
Balloon-expandable | 85.4 | 77.8 | 75.8 | 89.0 | |
Self-expandable | 14.6 | 22.2 | 24.2 | 11.0 | |
Valve implanted (%) | <0.001 | ||||
SAPIEN | 70.0 | 0.8 | 0.0 | 0.2 | |
SAPIEN XT | 15.6 | 75.0 | 67.4 | 13.2 | |
SAPIEN 3 | 0.0 | 0.0 | 1.0 | 64.4 | |
CoreValve* | 14.4 | 22.2 | 24.2 | 11.0 | |
ACURATE | 0.0 | 2.2 | 7.0 | 7.8 | |
Portico | 0.0 | 0.0 | 0.4 | 2.8 | |
JenaValve | 0.0 | 0.0 | 0.0 | 0.6 | |
Device success (%) | 86.2 | 91.4 | 89.6 | 90.2 | 0.050 |
Reason for device failure (%) | |||||
Procedural mortality | 3.0 | 2.2 | 2.2 | 1.2 | 0.275 |
Mean AV gradient ≥20 mm Hg | 3.2 | 1.6 | 1.8 | 5.6 | 0.001 |
Moderate/severe prosthetic valve regurgitation | 3.2 | 0.6 | 1.8 | 0.0 | <0.001 |
Incorrect positioning | 1.4 | 0.6 | 0.2 | 0.6 | 0.141 |
Second valve required | 3.0 | 3.6 | 4.4 | 2.4 | 0.336 |
Other complications (%) | |||||
Conversion to open surgery | 2.4 | 2.0 | 0.6 | 1.8 | 0.146 |
Unplanned CPB | 4.0 | 2.8 | 0.4 | 1.0 | <0.001 |
Pericardial tamponade | 1.2 | 0.4 | 0.8 | 1.6 | 0.257 |
New pacemaker | 15.8 | 14.5 | 16.4 | 13.9 | 0.708 |
Early safety (30 days) composite endpoint† | 16.2 | 15.4 | 12.4 | 11.8 | 0.068 |
All-cause mortality | 5.4 | 7.0 | 4.4 | 4.4 | 0.212 |
Cardiovascular | 4.4 | 5.4 | 3.4 | 1.8 | 0.018 |
Non-cardiovascular | 1.0 | 1.6 | 1.0 | 2.6 | 0.113 |
Stroke | 2.6 | 1.8 | 1.8 | 4.0 | 0.090 |
Disabling | 2.0 | 1.4 | 1.4 | 2.0 | 0.783 |
Non-disabling | 0.6 | 0.6 | 0.6 | 2.0 | 0.014 |
Life-threatening bleeding | 7.0 | 5.4 | 2.0 | 3.0 | 0.004 |
Acute kidney injury stage 2/3 | 2.3 | 2.5 | 5.3 | 2.7 | 0.021 |
Coronary artery obstruction requiring intervention | 1.2 | 0.4 | 0.0 | 0.6 | 0.077 |
Major vascular complication | 5.2 | 3.4 | 2.0 | 1.8 | 0.002 |
Valve-related dysfunction requiring intervention | 0 | 0 | 0 | 0 |
VARC-2 criteria Kappetein et al.19
*Only CoreValve, but no Evolut or Evolut R were implanted.
†Composite of all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication and valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR).
AV, aortic valve; BAV, balloon aortic valvuloplasty; CBP, cardiopulmonary bypass; SAVR, surgical aortic valve replacement; TA, transapical; TAVI, transcatheter aortic valve implantation; TF, transfemoral; VARC-2, Valve Academic Research Consortium-2.