18 HVAD® Instructions for Use
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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)
Quality of Life: KCCQ And EuroQol
Kansas City Cardiomyopathy Questionnaire (KCCQ): At baseline, 128/140 (91.4%) patients were
able to complete the KCCQ and at month 6 there were 88 patients available to complete
the test (39 had received a transplant, six had died, seven had met an endpoint receiving a
device exchange) (Table 7), Of the 88 patients available for assessment, 74 patients had data at
month 6, Reasons for missing the month 6 data included: 9 of 14 with poor compliance/missed
visit (8 of 9 of these from a single site and 1 of 9 had a prior ICVA with MRS score of 2), 2 were too
sick, 1 had no form available, 1 had been transplanted within the 14 day visit window, and 1 had
refused. Seventy patients (70) had both baseline and month 6 data. For these 70 patients who
were on HVAD
®
therapy continuously for 180 days had a 31 point improvement in KCCQ Overall
Summary Score, over the 180 day period.
Table 7: KCCQ - Overall Summary Score
KCCQ Baseline Month 6 Change from Baseline
128 74 70
Mean (SD) 34.9 (18.9) 67.5 (20.4) 30.9 (26.5)
Median 31.5 71.4 34.5
Min, Max 0.0, 84.1 19.3, 100.0 -49.4, 80.5
95% CI 31.6, 38.2 62.8, 72.2 24.6, 37.3
European Quality of Life (EuroQol): At baseline, 130/140 (92.9%) of patients were able to
complete the test, and at month 6 there were 88 patients available to complete the test,
(39 had received a transplant, six had died, seven had met an endpoint receiving a device
exchange) (Table 8). Of the 88 patients available 75 had data at month 6. Reasons for
missing the month 6 data included: 9 of 13 with poor compliance/missed visit (8 of 9 of these
from a single site and 1 of 9 had a prior ICVA with MRS score of 2), 2 were too sick, 1 had been
transplanted within the 14 day visit window, and 1 had refused. Seventy-two patients (72) had
both baseline and month 6 data showing an improvement of 30 points over the 180 day period.
Table 8: EuroQol (EQ-5D) - Summary of Quality of Life
EuroQol Baseline Month 6 Change from Baseline
Overall Summary Score
130 75 72
Mean (SD) 39.7 (23.5) 69.8 (19.8) 29.5 (25.2)
Median 40.0 75.0 30.0
Min, Max 0.0, 92.0 4.0, 100.0 -36.0, 80.0
95% CI 35.6, 43.7 65.2, 74.4 23.6, 35.4
Functional Analyses: 6 Minute Walk
6 Minute Walk: Of the 132 patients assessed for the 6-minute walk test, the mean distance
walked was 89.4 meters. Seventy-Five (75) of the 88 patients on pump at month 6 completed
the test (Table 9 and Figure 3). Reasons for missing the 6 minute walk test at month 6 included: 9
of 14 with poor compliance/missed visit (8 of 9 of these from a single site and 1 of 9 had a prior
ICVA with MRS score of 2), 2 were too sick, 1 had no form available, 1 had been transplanted
within the 14 day visit window, and 1 had refused. These 75 patients showed a mean distance
walked of 246 meters, a mean change of 150 meters from baseline.
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