Berlin Heart EXCOR Pediatric VAD, Руководство пользователя

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Chapter 3 Summary of Clinical Studies
3.7.8 Results
3.7.8.1 Primary Safety
The total time on device support for the study subjects was 4216 days. There were
102 SAEs reported for the 39 subjects yielding a rate of 0.024 events per patient-day
(95% Poisson confidence interval: 0.020 – 0.029). The difference between the event
rate in the PAS study and the IDE rate 0.071 was statistically significantly lower
(p-value <0.0001).
The following table summarizes the reported SAEs with their adjudicated results.
Event Category # event # subjects
with event
n (% of 39)
Events /
Subject
# /39
Adjudicated SAEs
Major Bleeding 23 16 (41.0%) 0.59
Major Infection: 20 15 (38.5%) 0.51
Localized non-device
3 3 ( 7.7%) 0.08
Percutaneous Site and/or Pocket
Infection
8 6 (15.4%) 0.21
Internal Pump Component, Inflow
or Outflow Tract Infection
2 2 ( 5.1%) 0.05
Sepsis
7 7 (17.9%) 0.18
Neurological dysfunction:
17 13 (33.3%) 0.44
TIA
0 0 ( 0.0%) 0.00
Ischemic CVA
8 6 (15.4%) 0.21
Hemorrhagic CVA
5 5 (12.8%) 0.13
Ischemic/Hemorrhagic CVA
4 3 ( 7.7%) 0.10
New abnormality of head
ultrasound
0 0 ( 0.0%) 0.00
EEG positive for seizure activity
with or without clinical seizure
0 0 ( 0.0%) 0.00
Other
• Covert stroke
•
Seizure
• Encephalopathy
3
2
1 3 ( 7.7%)
2 ( 5.1%)
1 ( 2.6%) 0.08
0.05
0.03
Tab. 3-16 EXCOR® Pediatric Post Approval Study Serious Adverse Events
1000721x09 Revision 8
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