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

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 pati...

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Autores principales: Numan, Lieke, Zimpfer, Daniel, Zadok, Osnat Itzhaki Ben, Aarts, Emmeke, Morshuis, Michiel, Guenther, Sabina P.W., Riebandt, Julia, Wiedemann, Dominik, Ramjankhan, Faiz Z., Oppelaar, Anne‐Marie, Ben‐Gal, Tuvia, Ben‐Avraham, Binyamin, Asselbergs, Folkert W., Schramm, Rene, Van Laake, Linda W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192248/
https://www.ncbi.nlm.nih.gov/pubmed/36798028
http://dx.doi.org/10.1002/ehf2.14308
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author Numan, Lieke
Zimpfer, Daniel
Zadok, Osnat Itzhaki Ben
Aarts, Emmeke
Morshuis, Michiel
Guenther, Sabina P.W.
Riebandt, Julia
Wiedemann, Dominik
Ramjankhan, Faiz Z.
Oppelaar, Anne‐Marie
Ben‐Gal, Tuvia
Ben‐Avraham, Binyamin
Asselbergs, Folkert W.
Schramm, Rene
Van Laake, Linda W.
author_facet Numan, Lieke
Zimpfer, Daniel
Zadok, Osnat Itzhaki Ben
Aarts, Emmeke
Morshuis, Michiel
Guenther, Sabina P.W.
Riebandt, Julia
Wiedemann, Dominik
Ramjankhan, Faiz Z.
Oppelaar, Anne‐Marie
Ben‐Gal, Tuvia
Ben‐Avraham, Binyamin
Asselbergs, Folkert W.
Schramm, Rene
Van Laake, Linda W.
author_sort Numan, Lieke
collection PubMed
description 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.
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spelling pubmed-101922482023-05-19 Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices Numan, Lieke Zimpfer, Daniel Zadok, Osnat Itzhaki Ben Aarts, Emmeke Morshuis, Michiel Guenther, Sabina P.W. Riebandt, Julia Wiedemann, Dominik Ramjankhan, Faiz Z. Oppelaar, Anne‐Marie Ben‐Gal, Tuvia Ben‐Avraham, Binyamin Asselbergs, Folkert W. Schramm, Rene Van Laake, Linda W. ESC Heart Fail Original Articles 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. John Wiley and Sons Inc. 2023-02-16 /pmc/articles/PMC10192248/ /pubmed/36798028 http://dx.doi.org/10.1002/ehf2.14308 Text en © 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Numan, Lieke
Zimpfer, Daniel
Zadok, Osnat Itzhaki Ben
Aarts, Emmeke
Morshuis, Michiel
Guenther, Sabina P.W.
Riebandt, Julia
Wiedemann, Dominik
Ramjankhan, Faiz Z.
Oppelaar, Anne‐Marie
Ben‐Gal, Tuvia
Ben‐Avraham, Binyamin
Asselbergs, Folkert W.
Schramm, Rene
Van Laake, Linda W.
Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
title Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
title_full Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
title_fullStr Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
title_full_unstemmed Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
title_short Identifying patients at risk: multi‐centre comparison of HeartMate 3 and HeartWare left ventricular assist devices
title_sort identifying patients at risk: multi‐centre comparison of heartmate 3 and heartware left ventricular assist devices
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192248/
https://www.ncbi.nlm.nih.gov/pubmed/36798028
http://dx.doi.org/10.1002/ehf2.14308
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