Author + information
- Received October 10, 2016
- Accepted October 18, 2016
- Published online October 31, 2016.
- Dagmar M. Ouweneel, MSca,
- Erlend Eriksen, MDb,
- Krischan D. Sjauw, MD, PhDa,
- Ivo M. van Dongen, MDa,
- Alexander Hirsch, MD, PhDa,
- Erik J.S. Packer, MDb,
- M. Marije Vis, MD, PhDa,
- Joanna J. Wykrzykowska, MD, PhDa,
- Karel T. Koch, MD, Phda,
- Jan Baan, MD, PhDa,
- Robbert J. de Winter, MD, PhDa,
- Jan J. Piek, MD, PhDa,
- Wim K. Lagrand, MD, PhDc,
- Bas A.J.M. de Mol, MD, PhDa,
- Jan G.P. Tijssen, PhDa and
- José P.S. Henriques, MD, PhDa,∗ ()
- aAMC Heart Center, Academic Medical Center – University of Amsterdam, Amsterdam, The Netherlands
- bDepartment of Heart Disease, Haukeland University Hospital, Bergen, Norway
- cDepartment of Intensive Care Medicine, Academic Medical Center – University of Amsterdam, Amsterdam, The Netherlands
- ↵∗Address for correspondence: José P.S. Henriques, MD, PhD Academic Medical Center, University of Amsterdam AMC Heart Center Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands Telephone: +31 20 5669111 Fax: +31 20 6962609 (fax).
Background Despite advances in treatment, mortality in acute myocardial infarction complicated by cardiogenic shock remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions. The Impella CP is a new percutaneous circulatory support device that provides more hemodynamic support than the intra-aortic balloon pump (IABP).
Objectives The aim of this study was to determine whether the Impella CP can decrease 30-day mortality when compared with IABP in patients with severe shock complicating acute myocardial infarction.
Methods In a randomized, prospective, open-label, multi-center trial, we assigned 48 patients with severe cardiogenic shock complicating acute myocardial infarction to Impella CP (n=24) or IABP (n=24). Severe cardiogenic shock was defined as systolic blood pressure lower than 90 mmHg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality.
Results At 30 days, mortality in patients treated with either IABP or Impella CP was similar (50% and 46%, respectively, hazard ratio (HR) with Impella CP, 0.96 (95% confidence interval (CI) 0.42 to 2.18; p=0.92). At 6 months, mortality rates for both Impella CP and IABP were 50% (HR 1.04 (95% CI; 0.47-2.32, p=0.923).
Conclusions In this explorative randomized controlled trial involving mechanically ventilated cardiogenic shock patients after acute myocardial infarction, routine treatment with Impella CP was not associated with reduced 30-day mortality compared with IABP.
- mechanical circulatory support
- cardiogenic shock
- acute myocardial infarction
- intra-aortic balloon pump
- randomized controlled trial
Conflicts of interest: The Academic Medical Center has received research grants and speaker honoraria from Abiomed Inc.
Funding: The trial was funded by the Academic Medical Center, Amsterdam
NTR trial register: NTR3450;
- Received October 10, 2016.
- Accepted October 18, 2016.