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Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Extracorporeal Life Support in Infarct-Related Cardiogenic Shock
Holger Thiele1, Uwe Zeymer1, Ibrahim Akin1
1From Heart Center Leipzig at University of Leipzig (H.T., H.-J.F., J.P., S.D., A.F.) and Helios Health Institute (E.K.), Leipzig, Institut für Herzinfarktforschung (U.Z., T.O., S.S.) and Klinikum Ludwigshafen (U.Z.), Ludwigshafen, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim (I.A., M.B., D.D.), the West German Heart and Vascular Center, University Hospital Essen (T.R., A.A.M.), and Contilia Elisabeth-Krankenhaus, Essen (I.V.), Essen, Asklepios Clinic Langen, Langen (R.L.), University Heart Center Lübeck and German Center for Cardiovascular Research, Partner Site Hamburg-Kiel-Lübeck, Lübeck (I.E., T. Graf), Heart Center Göttingen, University Medicine Göttingen, Göttingen (T.S., A.S.), Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine (C.S.), and Unfallkrankenhaus Berlin (L.B.), Berlin, University Heart and Vascular Center Hamburg (P.C.) and Asklepios Clinic St. Georg (E.T.), Hamburg, SLK Kliniken Heilbronn, Heilbronn (M.H.), University Heart and Vascular Center Frankfurt, Frankfurt (S.F.), Heart Center Wuppertal, Witten-Herdecke University, Wuppertal (M.S.), Paracelsus Private University, Clinic Nuremberg South, Nuremberg (S.J.), Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg (S.E.), Technische Universität Dresden, Heart Center, Dresden (A.L.), University Clinic Würzburg, Würzburg (P.N.), University Clinic Düsseldorf, Düsseldorf (C.J.), Clinic Winnenden, Winnenden (J.F.), and Zentralklinik Bad Berka, Bad Berka (P.L.) - all in Germany; and University Medical Center Ljubljana, Ljubljana, Slovenia (T. Goslar).
Background:
Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality.
Methods:
In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy.
Results:
A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25).
Conclusions:
In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).
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