Table 1

Demographics of the Roll-In Patients (Cohort A) and the Evaluable Patients (Cohort B)

Training CohortEvaluable Cohortp Value
NN
Characteristic
 Age, yrs2583.2 ± 6.7, 63–957583 ± 5.7, 65–940.88
 Male2548% (12)7550.7% (38)0.82
 STS score239.9 ± 8.9, 3.6–40.1679.7 ± 8.8, 0.3–540.82
 Logistic EuroSCORE2521.8 ± 10.9, 3.5–46.17422.8 ± 11.5, 1.9–55.30.69
 NYHA functional class II2532% (8)7540% (30)0.48
 NYHA functional class III or IV2568% (17)7554.7% (41)0.24
 Coronary artery disease2556% (14)7358.9% (43)0.80
 Previous MI >30 days258% (2)759.3% (7)>0.99
 Previous CABG2524% (6)7522.7% (17)0.89
 Previous PTCA2528% (7)7432.4% (24)0.68
 Previous stroke/TIA (within 6 months)250% (0)750% (0)n/a
 Peripheral arterial disease2416.7% (4)7425.7% (19)0.37
 Chronic lung disease (FEV1 <1)2313% (3)7512% (9)>0.99
 Chronic renal insufficiency2532% (8)7524% (18)0.43
 Atrial fibrillation/flutter2520% (5)7533.3% (25)0.21
 Previous pacemaker implant258% (2)7514.7% (11)0.51
 Hypertension2576% (19)7585.3% (64)0.36
 Congestive heart failure2540% (10)7542.7% (32)>0.99
Comorbidities deeming nonoperable
 Severe COPD2524% (6)7010% (7)0.10
 Porcelain aorta250% (0)708.6% (6)0.34
 Previous thorax irradiation250% (0)700% (0)n/a
 Other2592% (23)7088.6% (62)>0.99
Echocardiographic findings
 Aortic valve area, cm2150.4 ± 0.1, 0.2–0.4560.4 ± 0.1, 0.2–0.60.80
 Mean aortic valve gradient, mm Hg2244.4 ± 106544.1 ± 9.60.92
 Mean LVEF1758.2 ± 4.85156.1 ± 9.90.90
 Moderate or severe mitral regurgitation214.8% (1)646.3% (4)>0.99
 Mean annulus diameter, 25-mm valve1322.6 ± 14522.9 ± 1.30.50
 Mean annulus diameter, 27-mm valve1125.3 ± 1, 24–27.12824.9 ± 1.1, 22.1–26.50.32

Values are mean ± SD, range, or % (n).

CABG = coronary artery bypass grafting; COPD = chronic obstructive pulmonary disease; FEV1 = forced expiratory volume in 1 second. LVEF = left ventricular ejection fraction; MI = myocardial infarction; NYHA = New York Heart Association functional class; PTCA = percutaneous transluminal coronary angioplasty; STS = Society of Thoracic Surgeons; TIA = transient ischemic attack.

  • p Value is based on the nonparametric Wilcoxon rank sum test due to significant departures from normality.