16 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)
The majority of infections did not involve the driveline or cause sepsis. The local, non-device
category encompasses a host of sites, including the urinary tract, lungs, sinuses, IV punctures,
colon and skin. Infections involving the driveline exit site were more common after hospital
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ventricular arrhythmias were ventricular tachycardia. AICD shocks were recorded in 24/29
with a reported episode of ventricular tachycardia were subsequently placed on amiodarone.
Respiratory problems were more common in the perioperative period, declining from 26/34
events at 0-30 days to about one-third that number (8/34) from 31-180 days. Subjects were more
likely to experience right heart failure events in the perioperative period (20/29). The most
common treatment for right heart failure was the use of inotropic drugs and the pulmonary
vascular dilator, nitric oxide (25/29). Three subjects required an RVAD and a fourth was
exchanged for a pneumatic biVAD at 75 days post-implant. Ischemic strokes (ICVA) were more
common overall (10/14 events) and occurred with greater frequency in the perioperative period
(7/9 perioperative strokes). Four hemorrhagic strokes (HCVA) were recorded. Three of these
resulted in deaths. TIAs were more common in the 31-180 day period (5/7 TIA events). While
Overall 70% of the patients who experienced ICVAs were transplanted or remained eligible. It
is noteworthy that 6/10 ICVA events occurred within 48 hours of implant and may have been
insertion or incomplete device de-airing. These issues were addressed by improvements to the
coring tool and by site retraining. The overall stroke survival for the combined ICVAs and HCVAs
on the original device was 77% (10/13 patients).
Venous thrombosis occurred in 5% of subjects. Most of these were cases of DVT in the lower
extremities. In the arterial thromboembolism category, a case of VAD thrombosis was treated
with tPA and resolved and in another case a clot was removed from the left main coronary
artery following cardiac catheterization. A third case appeared to involve a shower of small
emboli to the periphery.
(6.4%). All recovered without sequelae. Two hemolysis events were detected by strict
One subject experienced a myocardial infarction and one subject had a hypertensive event
during the perioperative period. Hepatic dysfunction was noted in four subjects.
Adverse events were generally more common in the perioperative period.
Serious Adverse Events
A total of 452 serious adverse events on the original device occurred in 118 (84.3%) subjects
(Table 5)
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