Six-Month Outcomes After Treatment of Advanced Heart Failure With a Full Magnetically Levitated Continuous Flow Left Ventricular Assist Device: Report From the ELEVATE Registry
A post-market study (ELEVATE registry) of the fully magnetically levitated continuous flow HeartMate III left ventricular assist device (LVAD) found no pump thrombosis in 463 patients in Europe and Kazakhstan.
Mean age was 55.6 ± 11.7 years, 89% were male, 48% had ischaemic aetiology, and 70% were on inotropes. Indication was bridge-to-transplantation in 66% and destination therapy in 26%. Mean left ventricular ejection fraction was 18.3% and INTERMACS profile was 1–2 in 32%.
In 463 patients, there was no incidence of pump thrombosis; major bleeding was 25%, major infection 35%, and any stroke type 5%. Functional capacity improved significantly (Δ6MWD 230 ± 191 m), as did quality of life (ΔVAS 31 ± 23). Survival at six months was 82 ± 2%. Freedom from unplanned rehospitalizations at six months was 68 ± 2%.
This potential to reduce haemocompatibility-related events is one of the main improvements of HeartMate III over other LVADs.
Too short follow up to glean patient – centered outcomes in comparison with pulsatile VAD