10
9
8
7
6
5
4
3
2
1
Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
15Introduction
1.7 Pivotal US Clinical Study: Bridge-to-Transplant (continued)
Table 4: INTERMACS Events by Type and Time of Onset (HeartWare
™
HVAD
™
System N=140)
Day of Event Onset
0-30 Days 31-180 Days
Events
Subjects
Events
Subjects
Bleeding
Re Op
1
23 20 (14.3) 0 0
Transfusion Criteria
2
10 10 (7.1) 0 0
Any Units at 7 Days 31 25 (17.9) 46 20 (14.3)
Infections
20 20 (14.3) 17 17 (12.1)
Driveline Exit 5 5 (3.6) 14 11 (7.9)
Sepsis 3 3 (2.1) 8 7 (5.0)
Ischemic CVA 7 7 (5.0) 3 3 (2.1)
Hemorrhagic CVA 2 2 (1.4) 2 2 (1.4)
TIA 2 2 (1.4) 5 4 (2.9)
Respiratory Dysfunction 26 22 (15.7) 8 5 (3.6)
Arrhythmia
Ventricular 15 14 (10.0) 14 11 (7.9)
Supraventricular 25 21 (15.0) 7 6 (4.3)
Right Heart Failure
Inotropes 17 17 (12.1) 8 7 (5.0)
RVAD 3 3 (2.1) 1 1 (0.7)
Arterial Thromboembolism 0 0 2 2 (1.4)
Venous Thromboembolism 4 4( 2.9) 3 3 (2.1)
Renal Dysfunction 8 8 (5.7) 6 5(3.6)
Psychiatric Event 5 5 (3.6) 4 4 (2.9)
Myocardial Infarction Event 0 0 1 1 (0.7)
Hypertension 1 1 (0.7) 0 0
Hepatic Dysfunction 3 3 (2.1) 1 1 (0.7)
Hemolysis Event
3
1 1 (0.7) 1 1 (0.7)
1
4 procedures were not included: elective hysterectomy, elective repair of hemorrhoids, HVAD
®
exchange
and RVAD placement.
2
with the Investigator recording the number of units given.
3
Two cases were excluded: 1 case hemolysis < 72 hours post-implant; 1 case hemolysis occurring in the
presence of tPA/Integrillin for VAD thrombosis
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