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


Journal

ESC heart failure
ISSN: 2055-5822
Titre abrégé: ESC Heart Fail
Pays: England
ID NLM: 101669191

Informations de publication

Date de publication:
06 2023
Historique:
revised: 09 12 2022
received: 23 08 2022
accepted: 18 01 2023
medline: 19 5 2023
pubmed: 18 2 2023
entrez: 17 2 2023
Statut: ppublish

Résumé

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. 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. 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.

Identifiants

pubmed: 36798028
doi: 10.1002/ehf2.14308
pmc: PMC10192248
doi:

Types de publication

Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1656-1665

Informations de copyright

© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

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Auteurs

Lieke Numan (L)

Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Daniel Zimpfer (D)

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

Osnat Itzhaki Ben Zadok (OIB)

Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Emmeke Aarts (E)

Department of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.

Michiel Morshuis (M)

Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.

Sabina P W Guenther (SPW)

Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.

Julia Riebandt (J)

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

Dominik Wiedemann (D)

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

Faiz Z Ramjankhan (FZ)

Department of Cardiothoracic Surgery, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands.

Anne-Marie Oppelaar (AM)

Department of Cardiothoracic Surgery, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands.

Tuvia Ben-Gal (T)

Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Binyamin Ben-Avraham (B)

Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Folkert W Asselbergs (FW)

Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London, UK.
Health Data Research UK and Institute of Health Informatics, University College London, 222 Euston Road, London, NW1 2DA, UK.
Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.

Rene Schramm (R)

Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.

Linda W Van Laake (LW)

Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

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