Abiomed Impella 2.5, Instructions For Use Manual

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6.3 Impella
®
System for Use During Cardiogenic Shock
STUDY POPULATION DEMOGRAPHICS AND BASELINE PARAMETERS
Study population demographics, characteristics and hemodynamics are provided below.
Table 6.1 Baseline demographics and characteristics
Parameter
All
Subjects
IABP
Impella
2.5
p-value
Number of subjects
26 13 13
Age in years (mean ± SD) 65 ± 13 67 ± 15 63 ± 10 0.390
Male %,(number) 73% (19) 85% (11) 62% (8) 0.378
LVEF % (mean ± SD) 27 ± 11 28 ± 12 26 ± 11 0.619
Number of catecholamines at
baseline (mean ± SD)
1.2 ± 0.7 1.0± 0.4 1.3± 0.9 0.253
Diabetes %,(number)
27% (7) 8% (1) 46% (6) 0.030
Smoking %,(number) 42% (11) 46% (6) 38% (5) 1.000
Hypercholesterolemia %,(number) 38% (10) 38% (5) 38% (5) 1.000
Arterial Hypertension %,(number) 38% (10) 54% (7) 23% (3) 0.370
Anterior myocardial infarction
(number) %
50% (13) 54% (7) 46% (6) 1.000
Time from AMI to support device
implant in hours (mean ± SD)
9.9 ± 6.4 9.4 ± 6.6 10.4 ± 6.5 0.696
Table 6.2 Baseline hemodynamics
Parameter
All
(mean ± SD)
(n=25)
IABP
(mean ± SD)
(n=13)
Impella 2.5
(mean ± SD)
(n=12)
p-value
Cardiac Index [l/min/m2]
1.8 ± 0.6 1.8 ± 0.8 1.7 ± 0.5 0.820
Heart rate [bpm] 96.8 ± 24.7 97.9 ± 24.7 95.5 ± 25.8 0.820
Systolic art. pressure [mmHg] 104.0 ± 21.4 98.6 ± 21.5 109.8 ± 20.6 0.196
Diastolic art. pressure [mmHg]
60.8 ± 14.3 56.5 ± 12.4 65.5 ± 15.2 0.117
Mean arterial pressure [mmHg] 74.9 ± 15.9 71.0 ± 15.6 79.2 ± 15.8 0.206
Systemic vasc. resistance
[dyn sec-5]
1605 ± 620 1569 ± 775 1647 ± 399 0.766
Pulmonary capillary wedge
pressure [mmHg]
22.1 ± 7.2 21.5 ± 6.7 22.8 ± 8.0 0.685
Central venous pressure [mmHg]
12.4 ± 6.3 12.3 ± 5.6 12.6 ± 7.3 0.916
Lactate [mmol/l] 6.5 ± 4.3 6.6 ± 4.0 6.5 ± 4.7 0.947
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