Berlin Heart EXCOR Pediatric VAD, Manual, Page: 45 / 250

Chapter 3 Summary of Clinical Studies
Tab. 3-7 Pre-implant support
3.6.6 Results
3.6.6.1 Probable Benefit
Efficacy for the IDE trial was assessed by comparing survival (defined by the interval
of time from initiation of mechanical support as a bridge to transplant or recovery) to
the historical ECMO control. Subjects who were transplanted were censored at the
time of explant. Subjects who were explanted due to recovery of their ventricular
function and survived to 30 days or discharged with acceptable neurologic status were
censored at the time of explant. Subjects who were explanted due to recovery of their
ventricular function and died within 30 days or discharge (whichever was longer) were
counted as a failure with time to failure being the explant date.
For the 2 primary cohorts, the rate of successfully bridging the subjects to transplant
was 87.5% for Cohort 1 (21/24) and 91.7% for Cohort 2 (22/24) or 89.6% overall (43/
48). The following table summarizes the survival to transplant/successful recovery for
each primary Cohort ITT and PP as well as their matched ECMO control groups.
Three (3) of the Cohort 1 subjects (12.5%) failed (2 deaths and 1 weaned subject with
unacceptable neurological outcome at 30 days post-explantation) compared to 12 of
the 48 (25%) patients in the matched ECMO control group. The 3 subjects from
Cohort 1 who died or were considered failures were all supported with ECMO at the
time of implant. The failures occurred at day 0 (death), day 38 (death) and day 146
(weaned-failure).
The control group for Cohort 1 was on ECMO for a median of 4.9 days and a maximum
of 20.5 days compared to the primary cohort subjects who were supported a median
of 27.5 days and maximum of 174 days. Seventeen (17) of the 24 (71%) Cohort 1
subjects were supported longer than the entire ECMO control group (i.e. longer than
20.5 days).
Two of the Cohort 2 subjects (8.3%) failed compared to 16 of the 48 (33.3%) patients
in the matched ECMO control group. One of the subjects who died in Cohort 2 was
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