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Multicenter Study
. 2023 Jun;10(3):1656-1665.
doi: 10.1002/ehf2.14308. Epub 2023 Feb 16.

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

Lieke Numan  1 , Daniel Zimpfer  2 , Osnat Itzhaki Ben Zadok  3   4 , Emmeke Aarts  5 , Michiel Morshuis  6 , Sabina P W Guenther  6 , Julia Riebandt  2 , Dominik Wiedemann  2 , Faiz Z Ramjankhan  7 , Anne-Marie Oppelaar  7 , Tuvia Ben-Gal  3   4 , Binyamin Ben-Avraham  3   4 , Folkert W Asselbergs  1   8   9   10 , Rene Schramm  6 , Linda W Van Laake  1
Affiliations
Multicenter Study

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

Lieke Numan et al. ESC Heart Fail. 2023 Jun.

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 results: We 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.

Keywords: Centrifugal continuous flow pump; End-stage heart failure; LVAD; Left ventricular assist device; Mechanical circulatory support.

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Conflict of interest statement

L. N., O. I. B. Z, E. A., M. M, S. P. W. G., J. R., F. R., A.‐M. O., T. B.‐G., B. B.‐A., F. W. A., and R. S. have no conflict of interest. The UMCU, which employs L. W. L. received consultancy fees from Medtronic, Abbott, Vifor, and Novartis, outside the submitted work. MedUni Vienna, which employs D. Z. reports grants, personal fees, and non‐financial support from Medtronic and Abbott, and D. W. reports personal fees from Abbott and Xenios/Fresenius, outside the submitted work.

Figures

Figure 1
Figure 1
Love plot showing the standardized mean difference (SMD) before and after PS‐matching. BMI, body mass index; BSA, body surface area; eGFR, estimated glomerular filtration rate; HDZ NRW, Heart and Diabetes Centre North Rhine‐Westphalia; INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support; MedUni Vienna, Medical University of Vienna; PS, propensity score; RMC, Rabin Medical Centre; RV, right ventricular; UMCU, University Medical Centre Utrecht.
Figure 2
Figure 2
Kaplan–Meier survival of (A) All patients and (B) propensity score matched patients, censoring for non‐urgent transplantation and ongoing support at follow‐up.
Figure 3
Figure 3
Cumulative incidence of propensity‐score matched patients of complications: (A) Major Bleeding. (B) Ischaemic stroke. (C) Haemorrhagic stroke. (D) Pump thrombosis. (E) Right heart failure. (F) Driveline infections. Death, heart transplantation and ongoing support were considered as a competing risk.
See this image and copyright information in PMC

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