12 HVAD® Instructions for Use
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
®
Pump Overview
Introduction
1.7 Pivotal US Clinical Study: Bridge-to-Transplant (continued)
Subjects were predominately male (72.1%) and 53.3 ± 10.3 years of age. BSA and BMI were
2.1 ± 0.3 m2 and 28.6 ± 6.1 kg/m2 respectively. The principal etiology of heart failure was
ischemic heart disease (41%) and the average LVEF was 17.8 ± 7.1 %. Pulmonary Capillary
Wedge Pressure (PCWP) was elevated at 23 ± 9 mm Hg and pulmonary artery pressures were
(26 ± 14 mg/dL) and a depressed hematocrit (34 ± 5.8 %).
Eighty percent of subjects in the HeartWare
™
HVAD
™
System treatment group were on inotropic
therapy at baseline. Some (23%) were on more than one inotrope. IABP therapy at baseline
was reported for 25% of subjects and 85% presented with an AICD. Subjects received typical
medications for congestive heart failure with diuretics (82%) most common.
Comparison of Selected Baseline Characteristics between Treatment and Control Groups
The mean age of implant recipients in the HeartWare
™
HVAD
™
System group was 53.3 (range
22-70) and for the control, 52.2. Other parameters available to compare included gender, BSA,
(Table 1).
Table 1: Select Baseline Characteristics for HVAD and INTERMACS Groups
Effectiveness Results
Primary Endpoint
The analysis of the primary endpoint demonstrated HVAD non-inferiority to the control group
(Table 2). The difference in success rates between the HVAD group and controls was less than
the 15% non-inferiority margin (p <0.0001). The 95% one-sided UCL on the difference in success
rates was 4.5% for the Safety (SAF) population analysis and 0.9% for the Per Protocol (PP)
Characteristics
HeartWare
™
HVAD
™
System
p-value
Age (years) 53.3 ± 10.3 52.2 ± 12.2 0.19
Female Gender, n (%) 39 (28%) 120 (24%) 0.36
BSA (m
2
) 2.06 ± 0.28 2.07 ± 0.30 0.59
25.3 ± 13.5 28.9 ± 20.9 0.94
Right atrial pressure
(mmHg)
10.8 ± 3.3 11.5 ± 5.0 0.53
Serum creatinine
(mg/dL)
1.3 ± 0.4 1.4 ± 0.6 0.89
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