Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices

Abstract

Aims Since the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)-based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk. Methods and resultsWe performed an international multi-centre study (n = 1021) including centres that implanted HVAD and HM3. PS-matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS-adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long-term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre-operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow-up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS-adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14-1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark-analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre-operative variable interactions in the Cox regression were significant. Conclusions HM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post-operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.

Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry

“…Different from our findings, Numan et al [ 17 ] found no differences in the occurrence of haemorrhagic stroke between HVAD and HM3. Conversely, an in-depth analysis of cerebrovascular adverse events from the INTERMACS registry [ 15 ] showed a higher occurrence of both ischaemic and haemorrhagic cerebrovascular adverse events in patients on HVAD support.…”

“…On the contrary, our data agree with the latest report from the STS Intermacs database published by Pagani et al [ 16 ], which identified an important survival benefit at 2 years of follow-up after HM3 implantation compared to HVAD support. Analogous results were also observed by a recent large-scale multicentre study by Numan et al [ 17 ], which confirmed a significantly better survival and a lower occurrence of pump thrombosis for HM3 patients at 2 years of follow-up, in both un-adjusted and adjusted populations. All these results are in line with our findings and suggests that patients on HVAD support have a worse life-expectation than patients on HM3 support, an we also demonstrated that it did not depends by the learning curve time.…”

Electrical storm after left ventricular assist device (LVAD) implantation

“…The complications of those on left ventricular assist device (LVAD) support range from infection and device failure to ventricular arrhythmias (VAs). [4][5][6] Although VAs following the LVAD implantation are well studied, the data remain varying between different population groups. VAs after LVAD implantation can occur anytime from implantation until transplant or death.…”

Incidence and risk factors of late right heart failure in chronic mechanical circulatory support

“…Mechanical circulatory support (MCS) has been established as a valuable treatment option for patients with advanced heart failure 1 . Left ventricular assist device (LVAD) therapy is characterized by a good survival (58% at 5 years), 2–4 improved quality of life, and exercise capacity 5 . Despite this favorable outcome, adverse events in patients on LVAD support, including infection, bleeding, thrombosis, arrhythmias, and right heart failure (RHF), each may occur in up to 40% of patients 6,7 …”