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      Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

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          Abstract

          Is there a difference in clinical outcomes among patients with acute myocardial infarction (AMI) complicated by cardiogenic shock treated with intravascular microaxial left ventricular assist device (LVAD) vs intra-aortic balloon pump (IABP)? In this registry-based retrospective cohort study that included 3360 propensity-matched patients undergoing percutaneous coronary intervention for AMI, treatment with intravascular microaxial LVAD vs IABP was associated with a significantly higher risk of in-hospital death (45.0% vs 34.1%) and in-hospital major bleeding (31.3% vs 16.0%). The use of intravascular microaxial LVAD compared with IABP may be associated with worse in-hospital clinical outcomes among patients with AMI and cardiogenic shock undergoing percutaneous coronary intervention, although study interpretation is limited by the observational design. Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology’s National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. The primary outcomes were in-hospital mortality and in-hospital major bleeding. Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P  < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P  < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients. This study uses registry data to compare risk of in-hospital mortality and major bleeding among patients with acute coronary syndrome and cardiogenic shock managed with an intravascular microaxial left ventricular assist device (LVAD) vs intra-aortic balloon pulsation (IABP).

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          Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association

          Cardiogenic shock is a high-acuity, potentially complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multisystem organ failure. Despite improving survival in recent years, patient morbidity and mortality remain high, and there are few evidence-based therapeutic interventions known to clearly improve patient outcomes. This scientific statement on cardiogenic shock summarizes the epidemiology, pathophysiology, causes, and outcomes of cardiogenic shock; reviews contemporary best medical, surgical, mechanical circulatory support, and palliative care practices; advocates for the development of regionalized systems of care; and outlines future research priorities.
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            Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.

            The use of multiple antithrombotic drugs and aggressive invasive strategies has increased the risk of major bleeding in acute coronary syndrome (ACS) patients. It is not known to what extent bleeding determines clinical outcome. Using Cox proportional-hazards modeling, we examined the association between bleeding and death or ischemic events in 34,146 patients with ACS enrolled in the Organization to Assess Ischemic Syndromes and the Clopidogrel in Unstable Angina to Prevent Recurrent Events studies. Patients with major bleeding were older, more often had diabetes or a history of stroke, had a lower blood pressure and higher serum creatinine, more often had ST-segment changes on the presenting ECG, and had a 5-fold-higher incidence of death during the first 30 days (12.8% versus 2.5%; P < 0.0001) and a 1.5-fold-higher incidence of death between 30 days and 6 months (4.6% versus 2.9%; P = 0.002). Major bleeding was independently associated with an increased hazard of death during the first 30 days (hazard ratio, 5.37; 95% CI, 3.97 to 7.26; P < 0.0001), but the hazard was much weaker after 30 days (hazard ratio, 1.54; 95% CI, 1.01 to 2.36; P = 0.047). The association was consistent across subgroups according to cointerventions during hospitalization, and there was an increasing risk of death with increasing severity of bleeding (minor less than major less than life-threatening; P for trend = 0.0009). A similar association was evident between major bleeding and ischemic events, including myocardial infarction and stroke. In ACS patients without persistent ST-segment elevation, there is a strong, consistent, temporal, and dose-related association between bleeding and death. These data should lead to greater awareness of the prognostic importance of bleeding in ACS and should prompt evaluation of strategies to reduce bleeding and thereby improve clinical outcomes.
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              Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction

              Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions.
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                Author and article information

                Journal
                JAMA
                JAMA
                American Medical Association (AMA)
                0098-7484
                February 10 2020
                Affiliations
                [1 ]University of California, San Francisco School of Medicine, San Francisco
                [2 ]Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California
                [3 ]Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
                [4 ]Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
                [5 ]Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
                [6 ]Department of Computer Science and Engineering, Texas A&M University, College Station
                [7 ]Center for Remote Health Technologies and Systems, Texas A&M University, College Station
                [8 ]Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
                [9 ]Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora
                [10 ]Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
                [11 ]Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
                [12 ]Division of Cardiovascular Diseases, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City
                [13 ]Cardiovascular Division, Washington University School of Medicine in St Louis, St Louis, Missouri
                [14 ]Division of Health Care Policy Research, Mayo Clinic, Rochester, Minnesota
                Article
                10.1001/jama.2020.0254
                7042879
                32040163
                3b0c847e-5304-452a-8eaf-3cd096fed617
                © 2020
                History

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