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

EV. Potapov, G. Nersesian, D. Lewin, M. Özbaran, TMMH. de By, J. Stein, Y. Pya, J. Gummert, F. Ramjankhan, MO. Zembala, K. Damman, T. Carrel, B. Meyns, D. Zimpfer, I. Netuka

. 2021 ; 60 (3) : 579-587. [pub] 20210911

Jazyk angličtina Země Německo

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc22003741

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.

Citace poskytuje Crossref.org

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$a Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis / $c EV. Potapov, G. Nersesian, D. Lewin, M. Özbaran, TMMH. de By, J. Stein, Y. Pya, J. Gummert, F. Ramjankhan, MO. Zembala, K. Damman, T. Carrel, B. Meyns, D. Zimpfer, I. Netuka
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$a 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.
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$a Nersesian, Gaik $u Department of Cardiothoracic and Vascular Surgery, German Heart Centre Berlin, Berlin, Germany $u DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany
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$a Lewin, Daniel $u Department of Cardiothoracic and Vascular Surgery, German Heart Centre Berlin, Berlin, Germany
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$a Özbaran, Mustafa $u Department of Cardiovascular Surgery, Ege University, Izmir, Turkey
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$a de By, Theo M M H $u EUROMACS Registry, EACTS, Windsor, UK
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$a Stein, Julia $u Department of Cardiothoracic and Vascular Surgery, German Heart Centre Berlin, Berlin, Germany
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$a Pya, Yuri $u National Research Cardiac Surgery Center, Astana, Kazakhstan
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$a Gummert, Jan $u Department of Thoracic, Cardiac and Vascular Surgery (Heart and Diabetes Centre), North Rhine Westphalia, Bad Oeynhausen, Germany
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$a Ramjankhan, Faiz $u Department of Cardiothoracic Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands
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$a Zembala, Michael O $u Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Silesian Center for Heart Diseases in Zabrze, Zabrze, Poland
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$a Damman, Kevin $u Department of Cardiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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$a Carrel, Thierry $u Department of Cardiovascular Surgery, Insel-Gruppe, University of Bern, Bern, Switzerland
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$a Meyns, Bart $u Department of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium
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$a Zimpfer, Daniel $u Department of Cardiothoracic Surgery, Medical University of Vienna, Vienna, Austria
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$a Netuka, Ivan $u Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
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