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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
31Introduction
1.8 US Clinical Study: Destination Therapy (continued)
analyzed and descriptive data include the following:
The incidence of bleeding was 60.1% for the HVAD compared to 60.4% for the Control.
The incidence of major infections was 69.3% for the HVAD and 62.4% for the Control.
Overall survival was 60.2% for the HVAD and 67.6% for the Control.
Table 15.
Table 15: ENDURANCE Expanded Dataset Cause of CEC Adjudicated on Device Death within 730
days (AIP as Received)
Cause of Death
HVAD
Control
Total 38.5% (114) 30.9% (46)
Bleeding 0.3% (1) 0.7% (1)
Cardiovascular procedure 1.4% (4) 1.3% (2)
Heart failure 16.2% (48) 14.8% (22)
Infection 3.0% (9) 2.7% (4)
Malignancy 1.4% (4) 0.7% (1)
Multisystem organ failure 0.0% (0) 0.7% (1)
Respiratory failure 0.0% (0) 0.7% (1)
Stroke 8.4% (25) 6.0% (9)
Sudden death 3.7% (11) 2.0% (3)
Trauma 0.7% (2) 0.0% (0)
Other cardiovascular 2.7% (8) 1.3% (2)
Other non-cardiovascular 0.7% (2) 0.0% (0)
included below in Figure 10
similar.
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