Berlin Heart EXCOR Pediatric VAD, Manual, Page: 61 / 250

Chapter 3 Summary of Clinical Studies
Event Category # event # subjects
with event
n (% of 39)
Events /
Subject
# /39
Other SAEs
Hepatic Dysfunction 2 2 ( 5.1%) 0.05
Hypertension 4 4 (10.3%) 0.10
Pericardial effusion with tamponade 1 1 ( 2.6%) 0.03
Pericardial effusion without
tamponade 3 3 ( 7.7%) 0.08
Psychiatric episode 1 1 ( 2.6%) 0.03
Renal Dysfunction-Chronic 1 1 ( 2.6%) 0.03
Respiratory failure 9 7 (17.9%) 0.23
Right heart failure 3 3 ( 7.7%) 0.08
Venous Thromboembolism 3 2 ( 5.1%) 0.08
Other 9 8 (20.5%) 0.23
TOTAL 102 32 (82.0%) 2.36
Tab. 3-16 EXCOR® Pediatric Post Approval Study Serious Adverse Events
3.7.8.2 Primary Efficacy Endpoints
Twenty-seven (27) of the 39 (69.2%) subjects were successfully transplanted or
weaned from the device. Total support time ranged from 0 to 457 days with an
average time of 108.1 days (standard deviation=118.9) and median of 63 days
(IQR=20, 160).
The following table details the outcomes for the study subjects.
Outcome n (% of 39)
Transplant 25 (64.1%)
Weaned; alive > 30 days 2 ( 5.1%)
Escalated to ECMO
1
2 ( 5.1%)
Death 10 (25.6%)
1
subjects died after transition
Tab. 3-17 EXCOR® Pediatric Post Approval Study Outcomes
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