Table 1

Baseline and procedural characteristics of the development and validation cohorts

Development cohort (n=2552)Validation cohort (n=1281)
 Age (years)82.9±7.2 (2552)83.0±7.2 (1281)
 Female sex1264/2552 (49.5)631/1281 (49.3)
 Height (cm)163±8.9 (2549)164±9.1 (1278)
 Weight (kg)70±14 (2551)70±15 (1278)
 Body surface area (m2)1.75±0.20 (2536)1.75±0.21 (1270)
 Body mass index (kg/m2)26.0±5.1 (2549)26.0±4.8 (1278)
High-risk conditions for surgery
 Porcelain aorta201/2548 (7.9)100/1179 (7.8)
 Thoracic deformation53/2548 (2.1)33/1279 (2.6)
 Radiation therapy137/2548 (5.4)86/1279 (6.7)
 Other comorbidities not included in risk scores1520/2548 (59.7)753/1279 (58.9)
 Refusal of surgery243/2548 (9.5)137/1279 (10.7)
Functional status
 NYHA class
  I–II627/2540 (24.7)316/1274 (24.8)
  III1593/2540 (62.7)778/1274 (61.1)
  IV320/2540 (12.6)180/1274 (14.1)
 At least two episodes of APE during the last year289/2545 (11.4)162/1279 (12.7)
 Angina pectoris378/2552 (14.8)231/1281 (18.0)
 Unstable angina*71/2544 (2.8)45/1279 (3.5)
 Syncope221/2552 (8.7)89/1281 (7.0)
ECG
 Atrial fibrillation636/2520 (25.2)340/1264 (26.9)
 Pacemaker359/2541 (14.1)180/1276 (14.1)
 Right bundle branch block243/2497 (9.7)130/1249 (10.4)
 Left bundle branch block298/2497 (11.9)150/1249 (12.0)
Risk factors
 Active smoking77/2552 (3.0)50/1281 (3.9)
 Hypertension1773/2552 (69.5)880/1281 (68.7)
 Diabetes659/2552 (25.8)327/1281 (25.5)
 Dyslipidemia1228/2552 (48.1)608/1281 (47.5)
Comorbidities
 Prior myocardial infarction385/2552 (15.1)182/1281 (14.2)
 Coronary artery stenosis >50%1187/2494 (47.6)579/1256 (46.1)
 Extent of coronary disease
  1-vessel disease497/1182 (42.0)252/577 (43.7)
  2-vessel disease354/1182 (30.0)160/577 (27.7)
  3-vessel disease331/1182 (28.0)165/577 (28.6)
 Prior coronary bypass grafting460/2552 (18.0)218/1281 (16.8)
 Prior cardiac surgery*497/2544 (19.5)239/1279 (18.7)
 Prior balloon aortic valvuloplasty415/2552 (16.3)219/1281 (17.7)
 Lower limb arteritis514 /2552 (20.1)274/1281 (21.4)
 Abdominal aortic aneurysm112/2552 (4.4)62/1281 (4.8)
 Peripheral artery disease*685/2544 (26.9)394/1279 (30.8)
 Respiratory insufficiency†620/2552 (24.3)326/1281 (25.5)
 Chronic obstructive pulmonary disease*587/2545 (23.1)290/1279 (22.7)
 Hemoglobin (g/dL)12.1±1.7 (2468)12.0±1.7 (1230)
 Creatinine clearance (mL/min)‡48.1±24.2 (2471)47.9±23.7 (1233)
 Dialysis56/2552 (2.2)42/1281 (3.3)
 Prior cerebrovascular accident246/2552 (9.6)134/1281 (10.5)
 Neurological dysfunction*198/2544 (7.8)99/1279 (18.7)
 Severe chronic neuropathy32/2552 (1.2)23/1281 (1.8)
 Life expectancy <1 year59/2552 (2.3)31/1281 (2.4)
 Oral anticoagulation611/2552 (23.9)318/1281 (24.8)
 Antiplatelet drug1656/2552 (64.9)824/1281 (64.3)
Echocardiographic data
 Annular diameter (mm)22.1±2.2 (2357)22.1±2.2 (1181)
 Mean gradient (mm  Hg)48±16 (2493)49±17 (1237)
 Valve area (cm2)0.67±0.18 (2416)0.67±0.19 (1210)
 LVEF (%)53±14 (2518)53±14 (1257)
 Aortic regurgitation
  0143/2550 (5.6)71/1281 (5.5)
  1950/2550 (37.2)462/1281 (36.1)
  21027/2550 (40.3)520/1281 (40.6)
  ≥3430/2550 (16.9)228/1281 (17.8)
 Mitral regurgitation
  0135/2550 (5.3)64/1281 (5.0)
  1783/2550 (30.7)425/1281 (33.2)
  21092/2550 (42.8)555/1281 (43.3)
  ≥3540/2550 (21.2)237/1281 (18.5)
 Systolic PAP (mm  Hg)45±14 (1994)45±14 (981)
 Systolic PAP >60 mm  Hg*664/2544 (26.1)317/1279 (24.8)
Procedure
 Critical preoperative state*97/2544 (3.8)59/1279 (4.6)
 Emergency intervention62/2544 (2.4)27/1279 (2.1)
 General anaesthesia1754/2551 (68.8)890/1280 (69.5)
 Prosthesis
  Edwards Sapien1696/2544 (66.7)855/1277 (66.9)
  Medtronic Corevalve848/2544 (33.3)422/1277 (33.1)
 Approach
  Transapical449/2537 (17.7)229/1278 (17.9)
  Transfemoral1866/2537 (73.6)935/1278 (73.2)
  Subclavian142/2537 (5.6)77/1278 (6.0)
  Other 80/2537 (3.1)37/1278 (2.9)
  • Values are mean ± SD (available data) or n (%).

  • *Definitions according to the Euroscore.

  • †Obstructive or non-obstructive symptomatic respiratory disease.

  • ‡According to the Cockroft–Gault formula.

  • APE, acute pulmonary oedema; NYHA, New York Heart Association; PAP, pulmonary artery pressure.