Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock.
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Schrage Benedikt, Ibrahim Karim, Loehn Tobias, Werner Nikos, Sinning Jan-Malte, Pappalardo Federico, Pieri Marina, Skurk Carsten, Lauten Alexander, Landmesser Ulf, Westenfeld Ralf, Horn Patrick, Pauschinger Matthias, Eckner Dennis, Twerenbold Raphael, Nordbeck Peter, Salinger Tim, Abel Peter, Empen Klaus, Busch Mathias C, Felix Stephan B, Sieweke Jan-Thorben, Møller Jacob Eifer, Pareek Nilesh, Hill Jonathan, MacCarthy Philip, Bergmann Martin W, Henriques José P S, Möbius-Winkler Sven, Schulze P Christian, Ouarrak Taoufik, Zeymer Uwe, Schneider Steffen, Blankenberg Stefan, Thiele Holger, Schäfer Andreas, Westermann Dirk
Аннотация
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.