Abstract
A best evidence topic was written according to a structured protocol. The question addressed was ‘Do patients with centrifugal flow HeartMate 3 (HM3) or HeartWare left ventricular assist device (HVAD) have better outcomes compared to those with the axial flow HeartMate II (HMII)?’ Altogether 1791 papers were found using the reported search, of which 21 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. In publications reporting on MOMENTUM 3 randomized control trial (RCT), HM3 had better outcomes compared to HMII with a lower rate of pump thrombosis (1.1% vs 15.7%), stroke events (10.1% vs 19.2%) and ischaemic stroke (6.3% vs 13.4%) at 2-year follow-up. Markers of quality of life and functional capacity were comparable between the 2 devices at 6 months. In publications reporting on ENDURANCE RCTs, compared to HMII, patients with HVAD had poorer outcomes with an increased rate of sepsis (23.6% vs 15.4%), stroke (29.7% vs 12.1%) and right heart failure (38.5% vs 26.8%) postoperatively. Outcomes were improved for the HVAD group in a more recent RCT where strict blood pressure control was instigated postoperatively. Outcomes from retrospective studies comparing HMII with HVAD varied, with some publications reporting higher rates of right ventricular assist device use (29% vs 15%), gastrointestinal bleeding (30% vs 0%), cerebrovascular accident (44% vs 10%), transient ischaemic attack (5% vs 2%) and higher cumulative risk of infection and haemorrhagic cerebrovascular accident with HVAD. This is not consistent across these studies, and 9 studies including a systematic review reported no difference in any outcomes. In conclusion, patients with centrifugal flow HM3 have better outcomes than those with axial flow HMII. Although there is some variability in outcomes in retrospective studies, patients with centrifugal flow HeartWare HVAD have similar outcomes to those with axial flow HMII when strict blood pressure control is instigated postoperatively. By inference, centrifugal flow HM3 would appear to be the superior device, although all conclusions are based on 1 large (industry-sponsored) RCT.
72 Multicenter clinical evaluation of the HeartMate II axial flow left ventricular assist device in patients with severe heart failure: hemodynamic effects, pump performance and quality of life
