Article,
Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock
Contributors
Frydland, Martin
0000-0003-1543-8948
[1]
[2]
Udesen, Nanna Louise Junker
0000-0003-1542-3260
[1]
[2]
Wachtell, Kristian
0000-0001-5861-1478
[1]
[2]
Ravn, Hanne Berg
0000-0003-4702-5195
[1]
[2]
Gerke, Oke
0000-0001-6335-3303
[1]
[2]
Hassager, Christian
0000-0002-1199-0981
[1]
[2]
Affiliations
- [1] From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.E.M., T.E., M.F., L.H., J.K., R.S., J.L., S.B., C.H.), and the Department of Clinical Medicine, University of Copenhagen (T.E., L.H., C.H.), Copenhagen, the Departments of Cardiology (J.E.M., L.O.J., N.L.J.U., A.J., J.F.L.), Anesthesiology and Intensive Care (H.S., H.B.R.), and Nuclear Medicine (O.G.), Odense University Hospital, and the Department of Clinical Research, University of Southern Denmark (J.E.M., L.O.J., H.B.R., J.F.L.), Odense, the Departments of Cardiology (H.E., C.J.T., E.H.C.) and Anesthesiology and Intensive Care Medicine (S.C.), Aarhus University Hospital, Aarhus, and the Department of Cardiology, Zealand University Hospital, Roskilde (P.C., M.G.L.) - all in Denmark; the Department of Internal Medicine and Cardiology, Heart Center Dresden, University Hospital, Technische Universität Dresden, Dresden (N.M., A.L., F.J.W.), the Department of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, and the Cardiovascular Research Institute Düsseldorf, Düsseldorf (A.P., R.W.), the Department of Internal Medicine I, Cardiology, Angiology, and Intensive Medical Care, University Hospital Jena, Jena (P.C.S., S.M.-W.), the Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, and Deutsches Zentrum für Herz Kreislauf Forschung, Berlin (C.S.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Cardiology, University Heart and Vascular Center, University Clinic Hamburg-Eppendorf, Hamburg (P.C.), the Department of Cardiology, University Hospital Bonn, Bonn (S.Z.), the Department of Cardiology and Angiology, Hannover Medical School, Hannover (A.S.), and the Department of Internal Medicine III, Heart Center Trier, Krankenhaus der Barmherzigen Brüder, Trier (N.W.) - all in Germany; the Department of Cardiology, Royal Brompton and Harefield Hospitals, Guy's and St. Thomas' NHS Foundation Trust, Harefield Hospital, Harefield, United Kingdom (V.P.); and the Greenberg Division of Cardiology, Department of Medicine, Weill Cornell Medicine, New York (K.W.). [NORA names: Germany; Europe, EU; OECD];
- [2] Rigshospitalet [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD]
Abstract
BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear. METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation. RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09). CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).
