Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock

TY - JOUR

T1 - Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock

AU - Schrage, Benedikt

AU - Ibrahim, Karim

AU - Loehn, Tobias

AU - Werner, Nikos

AU - Sinning, Jan-Malte

AU - Pappalardo, Federico

AU - Pieri, Marina

AU - Skurk, Carsten

AU - Lauten, Alexander

AU - Landmesser, Ulf

AU - Westenfeld, Ralf

AU - Horn, Patrick

AU - Pauschinger, Matthias

AU - Eckner, Dennis

AU - Twerenbold, Raphael

AU - Nordbeck, Peter

AU - Salinger, Tim

AU - Abel, Peter

AU - Empen, Klaus

AU - Busch, Mathias C

AU - Felix, Stephan B

AU - Sieweke, Jan-Thorben

AU - Møller, Jacob Eifer

AU - Pareek, Nilesh

AU - Hill, Jonathan

AU - MacCarthy, Philip

AU - Bergmann, Martin W

AU - Henriques, José P S

AU - Möbius-Winkler, Sven

AU - Schulze, P Christian

AU - Ouarrak, Taoufik

AU - Zeymer, Uwe

AU - Schneider, Steffen

AU - Blankenberg, Stefan

AU - Thiele, Holger

AU - Schäfer, Andreas

AU - Westermann, Dirk

PY - 2019/3/5

Y1 - 2019/3/5

N2 - BACKGROUND: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS.METHODS: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality.RESULTS: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results.CONCLUSIONS: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.

AB - BACKGROUND: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS.METHODS: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality.RESULTS: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results.CONCLUSIONS: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.

KW - Aged

KW - Cardiovascular Agents/adverse effects

KW - Europe

KW - Female

KW - Heart-Assist Devices/adverse effects

KW - Humans

KW - Intra-Aortic Balloon Pumping/adverse effects

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/complications

KW - Myocardial Revascularization/adverse effects

KW - Prosthesis Design

KW - Recovery of Function

KW - Registries

KW - Retrospective Studies

KW - Risk Factors

KW - Shock, Cardiogenic/etiology

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1161/CIRCULATIONAHA.118.036614

DO - 10.1161/CIRCULATIONAHA.118.036614

M3 - SCORING: Journal article

C2 - 30586755

VL - 139

SP - 1249

EP - 1258

JO - CIRCULATION

JF - CIRCULATION

SN - 0009-7322

IS - 10

ER -