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Original Investigation
February 10, 2020

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

Author Affiliations
  • 1University of California, San Francisco School of Medicine, San Francisco
  • 2Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California
  • 3Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
  • 4Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 5Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
  • 6Department of Computer Science and Engineering, Texas A&M University, College Station
  • 7Center for Remote Health Technologies and Systems, Texas A&M University, College Station
  • 8Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 9Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora
  • 10Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
  • 11Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
  • 12Division of Cardiovascular Diseases, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City
  • 13Cardiovascular Division, Washington University School of Medicine in St Louis, St Louis, Missouri
  • 14Division of Health Care Policy Research, Mayo Clinic, Rochester, Minnesota
JAMA. Published online February 10, 2020. doi:10.1001/jama.2020.0254
Key Points

Question  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)?

Findings  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%).

Meaning  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.

Abstract

Importance  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.

Objective  To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices.

Design, Setting, and Participants  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.

Exposures  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.

Main Outcomes and Measures  The primary outcomes were in-hospital mortality and in-hospital major bleeding.

Results  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.

Conclusions and Relevance  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.

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