Impella® RP with the Automated Impella® Controller
6.7
PRIMARY ENDPOINT RESULTS
The primary endpoint of survival at 30 days or discharge post device removal (whichever is longer), or to
induction of anesthesia for the next longer-term therapy was achieved in 73 % of the study population,
with 83% in cohort A and 58% in cohort B. Patient outcomes are presented in Table 6.5.
Table 6.5 Patient outcome
Event
All Patients
(N=30)
Cohort A
(N=18)
Cohort B
(N=12)
Alive @ 30 days % (N)
73% (22/30)
83.3% (15/18)
58.3% (7/12)
Alive @ Discharge % (N)
70% (21/30)
77.8% (14/18)
58.3% (7/12)
Alive at 30day/DC/next therapy %(N)
73% (22/30)
83.3% (15/18)
58.3% (7/12)
SECONDARY SAFETY ENDPOINT RESULTS
The secondary safety endpoint results are provided in Table 6.6.
Table 6.6 Secondary safety endpoints
Safety Endpoints
All Patients
(N=30)
Cohort A
(N=18)
Cohort B
(N=12)
Death
26.7% (8/30)
16.7% (3/18)
41.7% (5/12)
Major Bleeding
60.0% (18/30)
55.6% (10/18)
66.7% (8/12)
Hemolysis
13.3% (4/30)
16.7% (3/18)
8.3% (1/12)
Pulmonary Embolism
0.0% (0/30)
0.0% (0/18)
0.0% (0/12)
Tricuspid & Pulmonary Valve Dysfunction*
3.3% (1/30)
5.6% (1/18)
0.0% (0/12)
* based on echocardiographic core lab analysis
Major bleeding events, though numerically high (18/30, 60% of patients), were predominantly related to
the surgical procedure with post-cardiotomy surgical bleeding accounting for 83% (15/18: LVAD
implantation n=10, Cohort A; or heart transplant or valve replacement surgery n=5, Cohort B) of major
bleeding events. The post-cardiotomy patients had complex surgical interventions with administration of
blood products. Following these procedures, the chest was often left open and the patients required
repeated wash-outs and surgical exploration to control bleeding prior to chest closure. Post surgical
coagulopathy and need for blood products also contributed to these events. Bleeding events that were
potentially device related were low (3/18 in Cohort B, 1/3 at access site). Overall, the amount of bleeding
during insertion of the device was also low (93% of the patients lost less than 100 mL of blood for the
combined introducer sheath placement and the Impella RP catheter insertion.
SECONDARY EFFECTIVENESS ENDPOINT RESULTS
CVP and CI improvement post initiation of Impella RP support
The hemodynamics improved in the first 24 hours of support when compared with pre-implant in the
overall patient population as seen in Figure 6.2. The CI improved from 1.82±0.04 to 3.3±0.23 L/min/m
2
.
The CVP decreased from 19.2±0.7 to 12.6±1 mmHg.
