Baseline characteristics, procedural aspects and outcomes
| Study population (n=718) | |
| Clinical baseline characteristics | |
| Age (years) | 81.0 (76.4, 84.7) |
| Male sex | 448 (62.4) |
| BMI (kg/m²) | 25.8 (23.5, 29.4) |
| EuroSCORE II (%) | 7.0 (4.1, 12.4) |
| COPD | 177 (24.7) |
| Diabetes | 240 (33.4) |
| Atrial fibrillation | 382 (53.7) |
| Extracardiac arteriopathy | 277 (38.6) |
| Impaired renal function (GFR <50 mL/min/1.73 m²) | 351 (49.0) |
| Prior myocardial infarction | 226 (31.5) |
| Prior stroke | 128 (17.8) |
| Prior CABG | 130 (22.8) |
| NYHA functional class III | 435 (66.2) |
| NYHA functional class IV | 141 (21.5) |
| Echocardiographic parameters | |
| P mean (mm Hg) | 25.0 (19.0, 31.0) |
| SVI (mL/m²) | 27.1 (23.1, 31.0) |
| AVA (cm²) | 0.8 (0.6, 0.9) |
| Indexed EOA (cm²/m2) | 0.4 (0.3, 0.5) |
| LVEF <30% | 217 (30.2) |
| Pulmonary hypertension (sPAP >55 mm Hg) | 131 (23.4) |
| ≥Moderate MR | 316 (44.3) |
| ≥Moderate TR | 252 (36.2) |
| CT parameters | |
| Perimeter derived diameter (mm) | 25.4 (23.8, 26.8) |
| Annulus area (mm²) | 495.4 (436.5, 557.5) |
| AVC (mm³ calcium) | 392.1 (235.1, 672.0) |
| AVCd (mm³ calcium/cm²) | 80.8 (48.6, 133.6) |
| LVOT calcification (mm³ calcium) | 1.4 (0, 29.7) |
| ≤10 mm³ LVOT calcium | 460 (64.2) |
| Procedural characteristics | |
| TF access | 597 (83.1) |
| Non-TF access | 121 (16.9) |
| TA access | 85 (11.8) |
| TAO access | 14 (1.9) |
| TAX access | 22 (3.1) |
| Balloon-expandable THV | 294 (40.9) |
| Self-expandable THV | 401 (55.8) |
| Mechanically expandable THV | 16 (2.2) |
| Non-metallic THV | 7 (1.0) |
| 30-day VARC-2 outcomes | |
| Disabling stroke | 19 (2.6) |
| New permanent pacemaker implantation | 97 (13.6) |
| Major/life-threatening bleeding | 68 (9.5) |
| Acute renal failure (AKIN ≥2) | 18 (4.7) |
| ≥Moderate PVL | 29 (4.3) |
| Mortality | |
| Procedural mortality (%) | 1.1 |
| 30-day mortality (%) | 7.7 |
| 1-year mortality (%) | 29.1 |
Data presented are the number (%) of patients for categorical variables or median values (25th percentile, 75th percentile) for continuous variables.
AKIN, acute kidney injury network; AVA, aortic valve area; AVC, aortic valve calcification; AVCd, aortic valve calcification density; BMI, body mass index; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; EOA, effective orifice area; EuroSCORE II, European System for Cardiac Operative Risk Evaluation II; GFR, glomerular filtration rate; LVEF, left ventricular ejection fraction; LVOT, left ventricular outflow tract; P mean, mean transvalvular pressure gradient; MR, mitral regurgitation; NYHA, New York Heart Association; PVL, paravalvular leakage; sPAP, systolic pulmonary artery pressure; SVI, stroke volume index; TA, transapical; TAO, transaortic; TAX, transaxillary; TF, transfemoral; THV, transcatheter heart valve; TR, tricuspid regurgitation; VARC-2, valve academic research consortium-2.