Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis

Abstract

OBJECTIVES The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support). METHODS A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed. RESULTS Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112–771) days for HW and 376 (IQR 100–816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56–67%) vs HM3: 68% 95% CI (63–73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83–1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84–1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45–3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02–1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13–2.70), P = 0.012]. CONCLUSIONS Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients.

When Nothing Goes Right: Risk Factors and Biomarkers of Right Heart Failure after Left Ventricular Assist Device Implantation

“…Although it did not reach a statistical level of significance, a trend toward lower daily beta blocker doses were observed in patients with the HM3 compared to those with the HVAD device (3.75 mg vs. 5 mg; p = 0.085). We hypothesized that the results of previous clinical trials demonstrating the superiority of the HM3 device with respect to thromboembolic events [ 11 , 12 , 13 , 14 ] may have led to differences in the stringency of blood pressure management and thus lower doses of beta blockers in patients implanted with the HM3. Thus, our results suggest that it is not the device design per se, but differences in best practices in patient care that lead to a lower incidence of RHF in patients with the HM3 device.…”

“…On the other hand, a less invasive surgical implantation strategy has been suggested to have a protective effect on the development of RHF after LVAD implantation [ 10 ]. Recent studies have suggested the superiority of the HeartMate 3 (HM3) (Abbott Inc., Chicago, IL, USA) over the HVAD (Medtronic Inc., Minneapolis, MN, USA) device in terms of the occurrence of thromboembolic events [ 11 , 12 , 13 , 14 ]; however, other analyses have failed to identify substantial differences [ 15 ]. A possible superiority of the HM3 vs. HVAD device in terms of the development of RHF has not been investigated.…”

Impact of left ventricular inspection employing cardiopulmonary bypass on outcome after implantation of left ventricular assist device

“…Another possible explanation for the increased stroke risk is that anticoagulation to an ACT of 180 s during LVAD implantation on va-ECLS or off-pump may be insufficient. Furthermore, two recent studies based on retrospective analyses of major data registries showed an increased risk for neurological adverse events in patients with HeartWare HVAD LVADs (HW; Medtronic, Minneapolis, MN, USA) compared to HeartMate 3 (HM3; Abbott, Chicago, IL, USA) 13,14 ; however, there was no difference in the incidence of neurological adverse events during the short-term follow up. Our analysis identified female sex as a possible pre-existing risk factor 15 for perioperative or postoperative ischemic stroke (<30 days).…”

The ever‐changing field of mechanical circulatory support: new challenges at the advent of the ‘single device era’

“…6,7 Moreover, HVAD patients experienced more device malfunction, pump thrombosis and neurological dysfunction. 7 These studies comprise the largest propensity matched cohorts of the two LVADs to date. Although sound statistical methods were used, differences in patient selection and management, surgeons' individual preferences and local protocols for the different devices may still have influenced the results.…”

“…However, in the past few years, the amount of de novo HM3 implants have outnumbered the HVAD implants 5 . Recently, two observational studies from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and the European Registry for Patients on Mechanical Circulatory Support (EUROMACS) have described worse outcomes for HVAD vs. HM3 implanted patients 6,7 . In addition, in 2020 Medtronic issued a Safety Notice regarding the HVAD related to a delayed or even failure to restart the LVAD after controller exchange.…”