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      Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation : Results From an International, Multicenter Cohort Study

      research-article
      , MD 1 , 3 , , MD 1 , 3 , , MD 2 , 3 , , MD, PhD 4 , , MD 1 , 3 , , MD 5 , , MD 7 , , MD 8 , , MD 1 , , MD 10 , , MD 3 , 11 , , MD 3 , 12 , , MD 3 , 11 , , MD 3 , 11 , , MD 9 , , BS 1 , , MD 3 , 12 , , MD 6 , , MD 1 , 3 , 13 , , MD 1 , 5 , , MD 14 , 15 , , MD 16 , , MD 17 , , MD 18 , , MD 5 , 19 , , BS 9 , , MD 20 , , MD, MPH 17 , , MD 7 , , MD 3 , 11 , , MD 19 , , MD, , MD 21 , 22 , , MD 23 , , MD 10 , , MD 21 , , MD, PhD 2 , , MD 18 , , MD, PhD 20 , , MD 24 , , MD 25 , , MD 25 , , MD 14 , 15 , , MD 18 , , MD 18 , , MD 18 , , MD 17 , , MD 24 , , MD 3 ,
      Circulation
      Lippincott Williams & Wilkins
      extracorporeal membrane oxygenation, shock, cardiogenic

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          Abstract

          Supplemental Digital Content is available in the text.

          Abstract

          Background:

          Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality.

          Methods:

          Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score–matched cohort.

          Results:

          Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63–0.98]; P=0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site–related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%).

          Conclusions:

          In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

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          Most cited references31

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          2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC.

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            mice: Multivariate Imputation by Chained Equations inR

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              Intraaortic balloon support for myocardial infarction with cardiogenic shock.

              In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials. In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke. A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28). The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.).
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                Author and article information

                Contributors
                Journal
                Circulation
                Circulation
                CIR
                Circulation
                Lippincott Williams & Wilkins (Hagerstown, MD )
                0009-7322
                1524-4539
                09 October 2020
                01 December 2020
                : 142
                : 22
                : 2095-2106
                Affiliations
                [1 ]Departments of Cardiology (B.S., P.M.B., S. Blankenberg, S.D., A.G., P.K., D.W.), University Heart and Vascular Center Hamburg, Germany.
                [2 ]Cardiothoracic Surgery (A.B., H.R.), University Heart and Vascular Center Hamburg, Germany.
                [3 ]German Center for Cardiovascular Research (DZHK), partner site Hamburg/Lübeck/Kiel, Germany (B.S., P.M.B., A.B., S. Blankenberg, S.D., M.E., I.E., D.F., N.F., T.G., P.K., C.N., D.W.).
                [4 ]Tampa General Hospital, University of South Florida (H.B.).
                [5 ]Medizinische Klinik und Poliklinik I (S. Brunner, D.K., M.O.), LMU Klinikum, Munich, Germany.
                [6 ]Herzchirurgische Klinik und Poliklinik (C.H.), LMU Klinikum, Munich, Germany.
                [7 ]Department of Anesthesiology and Critical Care Medicine, CHU Montpellier, University Montpellier, France (P.C., M.M.).
                [8 ]Division of Anesthesia, Critical Care and Pain Medicine (G.C.D.), Massachusetts General Hospital, Boston.
                [9 ]Division of Cardiac Surgery (M.F., D.M.), Massachusetts General Hospital, Boston.
                [10 ]Department of Cardiology, Paracelsus Medical University Nürnberg, Germany (D.E., M.P.).
                [11 ]Department of Internal Medicine III, Cardiology and Angiology, University Hospital Schleswig-Holstein, Kiel, Germany(M.E., D.F., N.F., C.N.).
                [12 ]University Heart Center Lübeck, University Hospital Schleswig-Holstein, Germany (I.E., T.G.).
                [13 ]Institute of Cardiovascular Sciences, University of Birmingham and University Hospitals Birmingham and Sandwell and West Birmingham National Health ServiceTrusts, United Kingdom (P.K.).
                [14 ]Department of Cardiology, Campus Benjamin, Charité Universitätsmedizin Berlin, Germany (U.L., C.S.).
                [15 ]Franklin/German Centre for Cardiovascular Research (DZHK), partner site Berlin/Institute of Health (BIH), Germany (U.L., C.S.).
                [16 ]Department of Internal Medicine, University of California, San Diego (J.L.).
                [17 ]Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (M.L., D.A.M., A.V.).
                [18 ]Department of Internal Medicine and Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Germany (N.M., M.S., L.S., H.T., F.T.).
                [19 ]Department of Internal Medicine I, University Hospital Würzburg, Germany (O.M., P.N.).
                [20 ]Department of Internal Medicine I, University Hospital Jena, Germany (S.M.-W., P.C.S.).
                [21 ]Advanced Heart Failure and Mechanical Circulatory Support Program, Vita Salute University, Milan, Italy (F.P., V.P.).
                [22 ]Department of Anesthesia and Intensive Care, IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) ISMETT (Istituto Mediterraneo trapianti e terapie avanzate), UPMC (University of Pittsburgh Medical Center)Italy, Palermo, Italy (F.P.).
                [23 ]Department of Interventional Cardiology, St. Rita’s Medical Center, Lima, OH (S.M.P.).
                [24 ]Medizinische Klinik II, Klinikum Weiden, Germany (R.H.G.S., L.W.).
                [25 ]University Heart Center Bonn, Department of Cardiology, Germany (J.-M.S., A.A.).
                Author notes
                Dirk Westermann, MD, University Heart and Vascular Center Hamburg, Department of Cardiology, Martinistraße 52, 20246 Hamburg, Germany. Email d.westermann@ 123456uke.de
                Article
                00002
                10.1161/CIRCULATIONAHA.120.048792
                7688081
                33032450
                633592f5-3be9-4388-8ad8-454d9ebbb881
                © 2020 The Authors.

                Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.

                History
                : 17 May 2020
                : 16 September 2020
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                extracorporeal membrane oxygenation,shock, cardiogenic

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