Characteristic
Trial Group n=82 Postapproval Group n=92
p-value
Age, years, mean ± SD 55.40 ± 11.54 49.60 ± 13.92 0.01
Gender 0.34
Male 62 (75.6) 75 (81.5)
Female 20 (24.4) 17 (18.5)
Race 0.63
African American 54 (65.9) 59 (64.1)
Caucasian 27 (32.9) 33 (35.9)
Other 1 (1.2) 0
Body mass index, kg/m2, mean ± SD 28.20 ± 6.15 28.50 ± 5.74 0.50
Comorbidities
Diabetes 28 (34.1) 31 (33.7) 0.86
Dyslipidemia 41 (50.0) 47 (51.1) 0.89
Hypertension 71 (86.6) 73 (79.4) 0.21
Chronic obstructive pulmonary disease 11 (13.4) 11 (12.0) 0.77
Cerebrovascular disease 13 (15.9) 15 (16.3) 0.96
Cardiac surgery before the implant 0.23
None 71 (86.6) 85 (92.4)
CABG 7 (8.5) 5 (5.4)
Valvular repair 0 (0) 1 (1.1)
Other 4 (4.9) 1 (1.1)
Preoperative laboratory values, mean ± SD
Total bilirubin, mg/dL 1.10 ± 0.61 1.20 ± 1.05 0.65
Sodium, mEq/L 135 ± 3.10 135 ± 3.60 0.38
Creatinine, mg/dL 1.30 ± 0.34 1.40 ± 0.55 0.22
International normalized ratio 1.08 ± 0.16 1.13 ± 0.18 0.04
Lactate dehydrogenase, U/L 284 ± 95.10 397 ± 310.70 0.06
MELD score, mean ± SD 11.40 ± 4.55 12.80 ± 5.11 0.09
Indication for implant 0.05
Bridge to transplant 11 (13.4) 23 (25.0)
Destination therapy 71 (86.6) 69 (75.0)
Preoperative echocardiogram findings, mean ± SD
Ejection fraction, % 15.80 ± 6.47 15.50 ± 6.09 0.91
Left ventricular end-diastolic diameter, cm 7.30 ± 1.00 7.30 ± 0.87 0.70
Left ventricular end-systolic diameter, cm 6.70 ± 1.04 6.70 ± 0.94 0.91
TAPSE, cm 1.70 ± 0.41 1.70 ± 0.47 0.38
S-prime, cm/s 10.60 ± 2.83 9.80 ± 2.29 0.11
Preoperative right heart catheterization, mean ± SD
CVP, mm Hg 9.10 ± 5.45 9.50 ± 5.80 0.80
PAS, mm Hg 52.70 ± 17.14 52.30 ± 14.64 0.99
PAD, mm Hg 23.80 ± 9.31 23.10 ± 8.19 0.64
PAPi 4.90 ± 4.32 4.70 ± 3.94 0.91
Tandem/Impella/ECMO as assist device 0 (0) 7 (7.6) 0.01
INTERMACS profile 0.17
1 6 (7.3) 17 (18.5) 0.04
2 54 (65.9) 51 (55.4) 0.17
3 21 (25.6) 23 (25.0) 0.99
4 1 (1.2) 1 (1.1) 0.99
New York Heart Association classification 0.69
III 2 (2.4) 4 (4.4) **
IV 80 (97.6) 88 (95.6) **