6.6
Instructions for Use & Clinical Reference Manual (US)
from 13 hours to 8 days) and was similar between the two cohorts. The pump flow on support was
3.23±0.35 L (ranging 2.5-4.00 L/min).
Table 6.3 Procedural characteristics
Procedural Characteristics
All Patients
(N=30)
Cohort A
(N=18)
Cohort B
(N=12)
Side of Implantation
Left Femoral Vein
3.3% (1/30)
0.0% (0/18)
8.3% (1/12)
Right Femoral Vein
96.7% (29/30)
100.0% (18/18)
91.7% (11/12)
Estimated Blood Loss during Introducer Insertion
<25mL
89.3% (25/28)
93.8% (15/16)
83.3% (10/12)
25-50 mL
3.6% (1/28)
0.0% (0/16)
8.3% (1/12)
>100 mL
7.1% (2/28)
6.3% (1/16)
8.3% (1/12)
Estimated Blood Loss during Catheter Placement
<25mL
60.7% (17/28)
68.8% (11/16)
50.0% (6/12)
25-50 mL
32.1% (9/28)
25.0% (4/16)
41.7% (5/12)
>100 mL
7.1% (2/28)
6.3% (1/16)
8.3% (1/12)
Duration of Support (hours)
Mean±SD (N)
73.15±37.04 (27)
76.73±31.64 (15)
68.66±43.92 (12)
Average device flow (L/min)
Mean±SD (N)
3.23±0.35 (27)
3.14±0.39 (16)
3.35±0.26 (11)
The hemodynamic characteristics are provided in Table 6.4. All patients presented with RVF and poor
hemodynamics at the time of implant, despite high dose of inotropes/pressors. The hemodynamic profile
was consistent between the two cohorts.
Table 6.4 Support and hemodynamic characteristics
Hemodynamic Characteristics
All Patients
Mean
±
SD (N)
Cohort A
Mean
±
SD (N)
Cohort B
Mean
±
SD (N)
Number of inotropes/pressors (Prior to
device Insertion)
3.23±1.14 (30)
3.56±1.10 (18)
2.75±1.06 (12)
Hemodynamics (Prior to device Insertion)
Cardiac Index (L/min/m
2
)
1.82±0.23 (30)
1.84±0.23 (18)
1.80±0.23 (12)
Cardiac Output (L/min)
3.81±1.13 (28)
4.17±1.32 (16)
3.34±0.60 (12)
Pulmonary Capillary Wedge Pressure
(PCWP)/Left Arterial Pressure (LAP) (mmHg)
17.44±7.28 (16)
14.50±4.60 (8)
20.38±8.53 (8)
Right Arterial Pressure (RAP)/Central
Venous Pressure (CVP) (mmHg)
19.23±3.91 (30)
19.25±4.36 (18)
19.21±3.31 (12)
Pulmonary Artery Pressure (PAP)
PASP (mmHg)
40.38±12.10 (29)
41.50±13.87 (18)
38.55±8.78 (11)
PADP (mmHg)
20.21±8.62 (29)
21.33±9.16 (18)
18.36±7.70 (11)
Mean Arterial Pressure (MAP) (mmHg)
70.46±14.32 (21)
74.08±10.93 (13)
64.59±17.81 (8)
Heart Rate (BPM)
90.21±20.49 (28)
91.71±22.69 (17)
87.91±17.34 (11)
LVAD Flow (L/min) (Cohort A only)
3.96±0.64 (17)
3.96±0.64 (17)
N/A
