Four-year outcomes with third-generation centrifugal left ventricular assist devices in an era of restricted transplantation

• Published in: European journal of cardio-thoracic surgery Vol. 46; no. 3; pp. e35 - e40
• Main Authors: Özalp, Faruk, Bhagra, Sai, Bhagra, Catriona, Butt, Tanveer, Ramesh, Bandigowdanapalya, Robinson-Smith, Nicola, Wrightson, Neil, Parry, Gareth, Griselli, Massimo, Hasan, Asif, Schueler, Stephan, MacGowan, Guy A.
• Format: Journal Article
• Language: English
• Published: Germany Oxford University Press 01-09-2014
• Subjects: Adult; Cohort Studies; Female; Heart Transplantation - adverse effects; Heart Transplantation - instrumentation; Heart Transplantation - methods; Heart Transplantation - statistics & numerical data; Heart-Assist Devices - adverse effects; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Thrombosis - etiology; Transplantation and Mechanical Circulatory Support; Treatment Outcome; Ventricular Dysfunction, Left - surgery; Transplantation; Thrombosis; Ventricular assist device; Outcomes
• ISSN: 1010-7940; 1873-734X
• DOI: 10.1093/ejcts/ezu258

OBJECTIVES
Third-generation ventricular assist devices (VADs) are associated with improved outcomes, though in recent clinical trials bridge-to-transplant (BTT) rates are ∼30% at 6 months, so that transplantation can be used as a ‘bail out’ for serious complications. In the UK, there was a significant reduction in heart transplantation rates over the last decade, so that transplantation from VADs is much less frequent. The objective of this study was to determine outcomes and their predictors in this situation of low BTT rates, and as patients were exposed to long-term support, the incidence and outcomes of VAD thrombosis.
METHODS
We analysed outcomes for 102 consecutive patients between 2009 and 2013 (mean age 47 ± 13; VentrAssist n = 6 and HeartWare n = 96). The median duration of support was 462 ± 426 days.
RESULTS
Survival rates on the device were 75 and 66% at 1 and 2 years, respectively. Older age and more acute INTERMACS groups were significantly related to reduced survival within the first 90 days (P = 0.030 and 0.010, respectively). Poor preoperative right ventricular (RV) function had a negative effect on survival after 1 year (P = 0.009), though not earlier. VAD thrombosis (n = 24 HeartWare and n = 1 VentrAssist) occurred at 0.18 events per patient-year for HeartWare and 0.07 for VentrAssist devices at a median time of onset at 404 ± 281 days. There was no significant effect of VAD thrombosis on survival. Only 14 of 102 patients were transplanted at a median of 334 ± 347 days, and only 3 were transplanted within the first 6 months.
CONCLUSIONS
Third-generation left ventricular assist device implants with a low rate of transplantation have similar survival to destination therapy, and are susceptible to long-term complications of VAD thrombosis and right heart failure.