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DOI: 10.1055/s-2005-862016
Improved durability of the HeartMate XVE enables longer support times but does not diminish the incidence of life-threatening device failure in German heart transplant candidates
Objectives: Life-threatening device failure of the HeartMate VE due to incompetence of the biological inflow valves or motor failure is a major limitation of long-term mechanical support. Recent technical improvements resulted in the new XVE model. The aim of this study was to compare the clinical performance and the durability of the both HeartMate versions.
Material and Methods: We analysed the incidence of life-threatening device failure and of other device specific complications (infections, bleeding) in 9 VE and 17 XVE patients. Explanted pumps were examined and damage of the biological valves was classified according to a score from 0 (no visible damage) to 3 (severe destruction).
Results: Survival to HTX and the incidence of device failure were similar in both groups (Table). Device failure occurred significantly later in the XVE group. Causes of device failure were incompetence of the inflow valves (n=6) and motor failure (n=2). Acute device failure caused one death in the XVE group. Other causes of death were multiorgan failure (n=2), dissection of the ascending aorta (n=1), acute bleeding from the aortic anastomosis (n=1). Four XVE patients are under mechanical support after 304±148 days. Macroscopic valve status was comparable for VE and XVE.
|
|
VE |
XVE |
p |
|
Patients |
9 |
17 |
|
|
mean support time (days) |
145±92 (25–272) |
244±169 (23–512) |
n.s. |
|
survival to transplant (%) |
89 |
69 |
n.s. |
|
device failure (%) |
44 |
31 |
n.s. |
|
time of device failure (days) |
200±69 |
441±68 |
p<0.01 |
|
infections (%) |
33 |
23 |
n.s. |
|
inflow valve score |
2.2.±1.1 |
2.6±0.5 |
n.s. |
Conclusions: The novel HeartMate XVE version offers increased durability and enabels longer periods of mechanical support. However, there is a high risk of life-threatening device failure after a support time longer than one year. Further technical refinements are necessary to meet the challenges of a save long-term circulatory assistance.