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      Causes and predictors of early mortality in patients treated with left ventricular assist device implantation in the European Registry of Mechanical Circulatory Support (EUROMACS)

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          Abstract

          Purpose

          The aim of the study was to analyze early mortality after continuous-flow left ventricular assist device (LVAD) implantation which remains high.

          Methods

          We analyzed consecutive ( n = 2689) patients from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) undergoing continuous-flow LVAD implantation. The primary outcome was early (< 90 days) mortality. Secondary outcomes were differential causes of early post-operative death following LVAD implantation.

          Results

          Univariable and multivariable analysis as well as regression analysis were used to examine determinants and differential causes of early (< 90 days) mortality after LVAD implantation. During the first 90 days, 2160 (80%) patients were alive with ongoing LVAD support, 40(2%) patients underwent heart transplantation, and 487(18%) deceased. The main causes of early death were MOF (36%), sepsis (28%), cardiopulmonary failure (CPF; 10%), CVA (9%), and right-sided heart failure (RHF, 8%). Furthermore, MOF and sepsis are 70% of causes of death in the first week. Independent clinical predictors of early death were age, female sex, INTERMACS profile 1 to 3, and ECMO. Laboratory predictors included elevated serum creatinine, total bilirubin, lactate, and low hemoglobin. Furthermore, hemodynamic predictors included elevated RA-to-PCWP ratio, pulmonary vascular resistance, and low systemic vascular resistance. Longer total implantation time was also independent predictor of early mortality. A simple model of 12 variables predicts early mortality following LVAD implantation with a good discriminative power with area under the curve of 0.75.

          Conclusions

          In the EUROMACS registry, approximately one out of five patients die within 90 days after LVAD implantation. Early mortality is primarily dominated by multiorgan failure followed by sepsis. A simple model identifies important parameters which are associated with early mortality following LVAD implantation.

          Electronic supplementary material

          The online version of this article (10.1007/s00134-020-05939-1) contains supplementary material, which is available to authorized users.

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          Most cited references26

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          Eighth annual INTERMACS report: Special focus on framing the impact of adverse events.

          The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes >20,000 patients from >180 hospitals.
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            A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

            In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.
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              Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.

              Background Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation. Methods We conducted a multicenter randomized trial involving 446 patients who were assigned, in a 2:1 ratio, to the study (centrifugal-flow) device or the control (axial-flow) device. Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial. The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure. The trial was powered to show noninferiority with a margin of 15 percentage points. Results The intention-to treat-population included 297 participants assigned to the study device and 148 participants assigned to the control device. The primary end point was achieved in 164 patients in the study group and 85 patients in the control group. The analysis of the primary end point showed noninferiority of the study device relative to the control device (estimated success rates, 55.4% and 59.1%, respectively, calculated by the Weibull model; absolute difference, 3.7 percentage points; 95% upper confidence limit, 12.56 percentage points; P=0.01 for noninferiority). More patients in the control group than in the study group had device malfunction or device failure requiring replacement (16.2% vs. 8.8%), and more patients in the study group had strokes (29.7% vs. 12.1%). Quality of life and functional capacity improved to a similar degree in the two groups. Conclusions In this trial involving patients with advanced heart failure who were ineligible for heart transplantation, a small, intrapericardial, centrifugal-flow LVAD was found to be noninferior to an axial-flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure. (Funded by HeartWare; ENDURANCE ClinicalTrials.gov number, NCT01166347 .).
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                Author and article information

                Contributors
                k.caliskan@erasmusmc.nl
                Journal
                Intensive Care Med
                Intensive Care Med
                Intensive Care Medicine
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0342-4642
                1432-1238
                3 February 2020
                3 February 2020
                2020
                : 46
                : 7
                : 1349-1360
                Affiliations
                [1 ]GRID grid.5645.2, ISNI 000000040459992X, Thoraxcenter, Department of Cardiology, , Erasmus MC University Medical Centre Rotterdam, ; Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands
                [2 ]GRID grid.413591.b, ISNI 0000 0004 0568 6689, Department of Intensive Care, , Haga Teaching Hospital, ; The Hague, The Netherlands
                [3 ]GRID grid.6142.1, ISNI 0000 0004 0488 0789, Department of Cardiology, College of Medicine, Nursing and Health Sciences, , National University of Ireland Galway, Saolta University Healthcare Group, ; Galway University Road, Galway, Ireland
                [4 ]EUROMACS Registry, EACTS, Windsor, UK
                [5 ]GRID grid.7177.6, ISNI 0000000084992262, Amsterdam University Medical Centers—University of Amsterdam, ; Amsterdam, The Netherlands
                [6 ]GRID grid.491605.f, Cardialysis, , Academic Research Organisation Rotterdam, ; Rotterdam, The Netherlands
                [7 ]GRID grid.452396.f, ISNI 0000 0004 5937 5237, Department of Cardiothoracic and Vascular Surgery, , German Heart Center Berlin, DZHK (German Centre for Cardiovascular Research), ; Berlin, Germany
                [8 ]Department of Cardiac Surgery, University Hospital Leuven, University of Leuven, Leuven, Belgium
                [9 ]GRID grid.5570.7, ISNI 0000 0004 0490 981X, Department for Thoracic and Cardiovascular Surgery, Heart and Diabetes Centre NRW, , Ruhr-University Bochum, ; Bad Oeynhausen, Germany
                [10 ]GRID grid.412004.3, ISNI 0000 0004 0478 9977, Department of Cardiovascular Surgery, , University Hospital Zurich, ; Zurich, Switzerland
                Author information
                http://orcid.org/0000-0002-3293-9261
                Article
                5939
                10.1007/s00134-020-05939-1
                7334284
                32016536
                35be429a-17dd-407d-ba04-e0474aef9d0f
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 18 May 2019
                : 13 January 2020
                Categories
                Original
                Custom metadata
                © Springer-Verlag GmbH Germany, part of Springer Nature 2020

                Emergency medicine & Trauma
                left ventricular assist device,mortality,intensive care,causes,predictors

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