Impella® RP with the Automated Impella® Controller
6.5
Patient Characteristics
All Patients
(N=30)
Cohort A
(N=18)
Cohort B
(N=12)
Heartware HVAD
40.0% (2/5)
N/A
40.0% (2/5)
Other
20.0% (1/5)
N/A
20.0% (1/5)
Valve Replacement/Repair
16.7% (5/30)
16.7% (3/18)
16.7% (2/12)
ICD/Pacemaker Implanted
56.7% (17/30)
72.2% (13/18)
33.3% (4/12)
Subject received any blood products within the past 48 hours
% Received
60.0% (18/30)
61.1% (11/18)
58.3% (7/12)
LVEF (%)
Mean±SD (N)
22.6±16.66 (24)
14.1±7.35 (16)
39.6±17.3 (8)
TAPSE (mm)
Mean±SD (N)
8.9±4.7 (16)
8.1±4.2 (10)
10.3±5.5 (6)
Baseline laboratory parameters are provided in Table 6.2. The test results were similar between the two
cohorts. Overall, patients presented with signs of tissue hypoperfusion and end-organ dysfunction at the
time of implant as demonstrated by the elevated creatinine, bilirubin and lactate dehydrogenase.
Table 6.2 Baseline laboratory parameters
Baseline Characteristics
All Patients
Mean
±
SD (N)
Cohort A
Mean
±
SD (N)
Cohort B
Mean
±
SD (N)
WBC (10
3
)
11.80±6.38 (30)
11.47±7.28 (18)
12.31±5.01 (12)
Platelets (10
3
)
204.09±87.24 (30)
191.76±75.24 (18)
222.58±103.42 (12)
Hemoglobin (g/dL)
10.31±2.01 (30)
10.09±1.79 (18)
10.63±2.35 (12)
Hematocrit (%)
31.40±5.84 (30)
30.84±5.41 (18)
32.24±6.58 (12)
Plasma Free Hemoglobin (mg/dL)
26.22±50.90 (16)
12.42±11.32 (11)
56.58±87.86 (5)
BUN (mg/dL)
24.98±13.47 (30)
23.58±13.19 (18)
27.08±14.19 (12)
Serum Creatinine (mg/dL)
1.40±0.60 (30)
1.37±0.57 (18)
1.43±0.65 (12)
Creatinine Clearance (mL/min)
62.82±25.33 (19)
68.40±26.73 (12)
53.26±21.12 (7)
Total Bilirubin (mg/dL)
1.27±0.84 (29)
1.46±1.04 (17)
0.99±0.32 (12)
LDH (U/L)
441.73±315.57 (21) 452.33±344.74 (15)
415.22±253.73 (6)
BNP (pg/mL)
3867±8483 (16)
1480±2125 (9)
6937±12423 (7)
WBC: White Blood Cells; BUN: Blood Urea Nitrogen; LDH: Lactate Dehydrogenase; BNP: B-type natriuretic
peptide
PROCEDURAL, SUPPORT AND HEMODYNAMIC CHARACTERISTICS
Patients procedural and support characteristics are presented in Table 6.3. Percutaneous placement of
the device was attempted through right femoral vein in 96.7% (29 out of 30) cases and through the left
femoral vein in 3.3 % (1 out of 30) cases. There was minimal blood loss during introducer and catheter
placement with less than 25 mL of blood loss recorded in 89.3% and 60.7% patients, respectively. The
average duration of support with the Impella RP was 3.05±1.5 days for the entire population (ranging
