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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
49Introduction
1.9 Destination Therapy Supplemental Study (continued)
Subgroup Analyses
The following preoperative characteristics were evaluated for potential association with
outcomes: gender, BSA (<1.5 m
2
2
secondary endpoints were found for these two preoperative characteristics.
Conclusions from the ENDURANCE Destination Therapy Supplemental Trial
demonstration of non-inferiority of the HVAD to the control device for freedom from neurologic
(HVAD: 14.7% vs control: 12.1%). The combined rate of stroke and TIA in HVAD patients at
Survival at 1 year free from the composite of disabling stroke or device exchange favored
the HeartWare
™
HVAD
™
System (HVAD: 75.3% vs control: 66.7%), though the trend diminished
in magnitude over time (at 2 years, HVAD: 59.2% vs Control: 55.2%). The HeartWare
™
HVAD
™
System and Control both demonstrated sustained improvements in quality of life, functional
non-inferiority compared to Control for incidence of neurological injury at one year, the
implementation of a blood pressure management strategy for HVAD recipients did demonstrate
a reduction in the overall stroke rates in patients receiving an HeartWare
™
HVAD
™
System.
Overall Conclusions
sintered HVAD and the Control LVAD were similar, but a higher proportion of Control pump
thrombosis events resulted in device exchange. The incidence of stroke was 2.5 times higher in
Supplemental trial, which included implementation of a blood pressure management strategy
for HVAD recipients, demonstrated a reduction in the overall stroke rates in patients receiving
an HeartWare
™
HVAD
™
System, though HVAD failed to demonstrate non-inferiority compared to
Control for incidence of neurological injury at one year.
The data supports the reasonable assurance of safety and effectiveness of the HeartWare
™
HVAD
™
System for hemodynamic support in patients with advanced, refractory left ventricular
heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as
destination therapy (DT) in patients for whom subsequent transplantation is not planned.
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