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Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support

AIMS: Left ventricular assist device therapy has become the cornerstone in the treatment of end‐stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intra...

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Autores principales: Numan, Lieke, Ramjankhan, Faiz Z., Oberski, Daniel L., Oerlemans, Martinus I.F.J., Aarts, Emmeke, Gianoli, Monica, Van Der Heijden, Joris J., De Jonge, Nicolaas, Van Der Kaaij, Niels P., Meuwese, Christiaan L., Mokhles, Mostafa M., Oppelaar, Anne‐Marie, De Waal, Eric E.C., Asselbergs, Folkert W., Van Laake, Linda W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006731/
https://www.ncbi.nlm.nih.gov/pubmed/33635573
http://dx.doi.org/10.1002/ehf2.13267
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author Numan, Lieke
Ramjankhan, Faiz Z.
Oberski, Daniel L.
Oerlemans, Martinus I.F.J.
Aarts, Emmeke
Gianoli, Monica
Van Der Heijden, Joris J.
De Jonge, Nicolaas
Van Der Kaaij, Niels P.
Meuwese, Christiaan L.
Mokhles, Mostafa M.
Oppelaar, Anne‐Marie
De Waal, Eric E.C.
Asselbergs, Folkert W.
Van Laake, Linda W.
author_facet Numan, Lieke
Ramjankhan, Faiz Z.
Oberski, Daniel L.
Oerlemans, Martinus I.F.J.
Aarts, Emmeke
Gianoli, Monica
Van Der Heijden, Joris J.
De Jonge, Nicolaas
Van Der Kaaij, Niels P.
Meuwese, Christiaan L.
Mokhles, Mostafa M.
Oppelaar, Anne‐Marie
De Waal, Eric E.C.
Asselbergs, Folkert W.
Van Laake, Linda W.
author_sort Numan, Lieke
collection PubMed
description AIMS: Left ventricular assist device therapy has become the cornerstone in the treatment of end‐stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)‐based analysis of long‐term clinical outcome of patients that received HM3 or HVAD in a single centre. METHODS AND RESULTS: Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow‐up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non‐significant difference in survival (P = 0.07). The PS‐adjusted Cox regression showed a worse but non‐significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91–3.24). CONCLUSIONS: Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients.
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spelling pubmed-80067312021-04-01 Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support Numan, Lieke Ramjankhan, Faiz Z. Oberski, Daniel L. Oerlemans, Martinus I.F.J. Aarts, Emmeke Gianoli, Monica Van Der Heijden, Joris J. De Jonge, Nicolaas Van Der Kaaij, Niels P. Meuwese, Christiaan L. Mokhles, Mostafa M. Oppelaar, Anne‐Marie De Waal, Eric E.C. Asselbergs, Folkert W. Van Laake, Linda W. ESC Heart Fail Original Research Articles AIMS: Left ventricular assist device therapy has become the cornerstone in the treatment of end‐stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)‐based analysis of long‐term clinical outcome of patients that received HM3 or HVAD in a single centre. METHODS AND RESULTS: Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow‐up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non‐significant difference in survival (P = 0.07). The PS‐adjusted Cox regression showed a worse but non‐significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91–3.24). CONCLUSIONS: Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients. John Wiley and Sons Inc. 2021-02-26 /pmc/articles/PMC8006731/ /pubmed/33635573 http://dx.doi.org/10.1002/ehf2.13267 Text en © 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Research Articles
Numan, Lieke
Ramjankhan, Faiz Z.
Oberski, Daniel L.
Oerlemans, Martinus I.F.J.
Aarts, Emmeke
Gianoli, Monica
Van Der Heijden, Joris J.
De Jonge, Nicolaas
Van Der Kaaij, Niels P.
Meuwese, Christiaan L.
Mokhles, Mostafa M.
Oppelaar, Anne‐Marie
De Waal, Eric E.C.
Asselbergs, Folkert W.
Van Laake, Linda W.
Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support
title Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support
title_full Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support
title_fullStr Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support
title_full_unstemmed Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support
title_short Propensity score‐based analysis of long‐term outcome of patients on HeartWare and HeartMate 3 left ventricular assist device support
title_sort propensity score‐based analysis of long‐term outcome of patients on heartware and heartmate 3 left ventricular assist device support
topic Original Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006731/
https://www.ncbi.nlm.nih.gov/pubmed/33635573
http://dx.doi.org/10.1002/ehf2.13267
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