Mechanical circulatory support
Incidence and clinical management of life-threatening left ventricular assist device failure

Presented at the annual meeting of the International Society for Heart and Lung Transplantation, San Francisco, California, April 2004.
https://doi.org/10.1016/j.healun.2004.06.024Get rights and content

Background

Mechanical device failure can be life-threatening and is becoming increasingly important as left ventricular assist devices (LVADs) are being used for longer periods as a bridge to transplantation (period lengthening due to donor shortage) or recovery, or as destination therapy. However, its incidence and clinical management have not been widely studied.

Methods

We investigated the incidence and management of major device failure for a total of 102 Thoratec/TCI HeartMate and Thoratec PVAD devices implanted at our institution since 1995.

Results

The cumulative probability of device failure was 6%, 12%, 27% and 64% at 6 months, 1 year, 18 months and 2 years, respectively. Major failure occurred in 8 (7.8%) patients. Four patients presented as emergency cases with vented electric (VE) failure, and 3, with failure due to a seized motor, were supported on the pneumatic driver to explantation, transplantation or device change. Another patient had a ruptured pump diaphragm and was maintained for 12 hours, but died of a Type B aortic dissection. Four patients underwent elective device change, including 2 of a VE pump, 1 with inlet valve regurgitation and fractured power cable at 414 days, and 1 with inlet valve regurgitation at 656 days, all of whom underwent transplantation or explantation. One patient with VE failure was maintained on the pneumatic driver, then underwent Thoratec paracorporeal ventricular assist device (PVAD) implantation and was transplanted. One Thoratec PVAD patient developed LVAD thrombus, underwent pump replacement, and was transplanted. A further patient on the implantable pneumatic (IP) HeartMate developed a pneumoperitoneum due to a leak at the junction of the pneumatic driveline, which was repaired by inserting a new driveline, and underwent heart/kidney transplantation.

Conclusions

Life-threatening mechanical device failure is not uncommon and increases with time, but can be managed successfully in most patients. Improvements in design and manufacture should further enhance outcome with LVADs.

Section snippets

Patients and methods

A total of 102 patients were studied, including 82 Thoratec TCI/HeartMate (54 vented electric [VE0], 8 XVEs and 20 implantable pneumatic [IP] devices) and 20 Thoratec PVAD devices, which were implanted at our institution since 1995. Patient records were reviewed and any incidence of major device failure studied. Major device failure was defined as the need for emergency pump replacement or the need for pneumatic pump actuation. The 54 VE devices were implanted in 45 men and 9 women, mean age

Results

For the whole group, the cumulative support period was 46.3 patient-years. Of the 102 patients, 28 (27.5%) were supported for >200 days. The longest freedom from device failure for an implant was 748 days in a patient successfully bridged to recovery. The total cumulative probability of device failure was 6% at 6 months, 12% at 1 year, 27% at 18 months and 64% at 2 years (Figure 2). Major device failure occurred in a total of 8 (7.8%) patients. Six failures occurred in HeartMate I VEs, 1 in an

Discussion

This study has defined the rate and mode of mechanical failure of left ventricular assist devices and described the methods for dealing with them in a homogeneous series of patients encountered at 1 center over a period of 9 years. In this study the cumulative probability of device failure was 6% at 6 months, 12% at 1 year, 27% at 18 months and 64% at 2 years, with major device failure occurring in a total of 7.8% of patients. Life-threatening mechanical pump failure was therefore not uncommon

Conclusions

Life-threatening mechanical pump failure is not uncommon, but can be managed successfully in most patients. Although designed for short-term use, these devices can be used for longer periods if necessary, although the incidence of device failure does increase with time. Newer devices being developed are likely to have better reliability and durability. It is hoped that a thorough understanding of the mode of failure and its management coupled with improvements in design and manufacture will

References (11)

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