Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device.

BACKGROUND: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3, Abbott) left ventricular assist device (LVAD), it is unknown how preimplant factors and postimplant index hospitalization events influence 5-year mortality in those able to be discharged. OBJECTIVES: The goal was to identify risk predictors of mortality through 5 years among HM3 LVAD recipients conditional on discharge from index hospitalization in the MOMENTUM 3 pivotal trial. METHODS: This analysis evaluated 485 of 515 (94%) patients discharged after implantation of the HM3 LVAD. Preimplant (baseline), implant surgery, and index hospitalization characteristics were analyzed individually, and as multivariable predictors for mortality risk through 5 years. RESULTS: Cumulative 5-year mortality in the cohort (median age: 62 years, 80% male, 65% White, 61% destination therapy due to transplant ineligibility) was 38%. Two preimplant characteristics (elevated blood urea nitrogen and prior coronary artery bypass graft or valve procedure) and 3 postimplant characteristics (hemocompatibility-related adverse events, ventricular arrhythmias, and estimated glomerular filtration rate <60 mL/min/1.73 m2 at discharge) were predictors of 5-year mortality. In 171 of 485 patients (35.3%) without any risk predictors, 5-year mortality was reduced to 22.6% (95% CI: 15.4%-32.7%). Even among those with 1 or more predictors, mortality was <50% at 5 years (45.7% [95% CI: 39.0%-52.8%]). CONCLUSIONS: Long-term survival in successfully discharged HM3 LVAD recipients is largely influenced by clinical events experienced during the index surgical hospitalization in tandem with baseline factors, with mortality of <50% at 5 years. In patients without identified predictors of risk, long-term 5-year mortality is low and rivals that achieved with heart transplantation, even though most were implanted with destination therapy intent. (MOMENTUM 3 IDE Clinical Study Protocol, NCT02224755; MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS, NCT03982979).

Incidence and clinical correlates of de-novo aortic regurgitation with a fully magnetically levitated left ventricular assist device: a MOMENTUM 3 trial portfolio analysis.

AIMS: We assessed the incidence, predictors and clinical correlates of de-novo aortic regurgitation (AR), which physiologically reduces left ventricular assist device (LVAD) effectiveness due to recirculation syndrome, in the MOMENTUM 3 trial portfolio of the fully magnetically levitated HeartMate 3 (HM3) pump using the randomized pivotal trial (PT) and post-trial continued access protocol (CAP). METHODS AND RESULTS: De-novo aortic regurgitation incidence at 2 years was analysed in the randomized PT and validated in the first 1000 implanted patients of the CAP. Patients with concomitant/prior aortic valve surgery or without baseline or post-implant echocardiograms were excluded from this analysis. AR severity was assessed qualitatively by site-adjudicated echocardiograms (significant AR was defined as moderate or severe grade on echocardiogram). Of 1028 patients enrolled in the PT, 918 were eligible for inclusion in this analysis (HM3, n = 465; HMII, n = 453). At 2 years of LVAD support, freedom from significant AR was greater in the HM3 (92%) than HMII (82%) (hazard ratio 0.45, 95% confidence interval 0.27-0.75, p < 0.01). Of 907 HM3 patients analysed from the first 1000 implanted CAP patients, the rate of freedom from significant AR was 90%, consistent with the PT (p = 0.3). In the combined HM3 group (n = 1372), multivariable Cox modelling identified increasing age and female sex as significant predictors. Survival free of urgent transplant or AR corrective procedure was similar between HM3 patients with and without significant de-novo AR. CONCLUSIONS: The development of moderate or severe grade de-novo AR is reduced with the fully magnetically levitated HM3 LVAD compared to the axial-flow HMII pump. The occurrence of significant de-novo AR with the HM3 pump is not associated with a worse outcome at 2 years of follow-up.

Do patients with the centrifugal flow HeartMate 3 or HeartWare left ventricular assist device have better outcomes compared to those with axial flow HeartMate II?

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.