Mechanical circulatory support with the Impella® LP5.0 pump and an intra-aortic balloon pump for cardiogenic shock in acute myocardial infarction: The IMPELLA-STIC randomized study.

Percutaneous assist devices may be used as a bridge to recovery in patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI). To test the hypothesis that the Impella® LP5.0 pump (Abiomed Europe GmbH, Aachen, Germany) provides haemodynamic benefits and improves left ventricular ejection fraction (LVEF) in patients with CS-AMI already managed with an intra-aortic balloon pump (IABP). This was a prospective randomized study. The primary endpoint was change in cardiac power index (CPI) from baseline to 12hours after implantation, measured with a Swan-Ganz catheter. Secondary endpoints included LVEF at 30 days. Fifteen patients with CS-AMI were randomized; 12 were available for primary endpoint analysis (IABP group, n=6; Impella LP5.0+IABP group, n=6). Baseline characteristics were similar in both groups. Change in CPI after 12hours was not significantly different between the two groups (IABP group: ΔCPI=0.08±0.08W/m2; Impella LP5.0+IABP group: ΔCPI=-0.02±0.25W/m2; P=0.4). There was no significant change from baseline CPI in either group over 96hours, and no difference in CPI between groups at each timepoint. In the Impella LP5.0+IABP group, the part of the CPI provided by the native heart decreased from 0.37±0.10 to 0.10±0.20 (P=0.01). LVEF was similar at baseline (29.7%±8.4% and 29.3%±6.7%) and 1 month (40.6%±12.5% and 38.6%±14.4%) in the IABP and Impella LP5.0+IABP groups, respectively. Adverse events, especially major bleeding, were common, and occurred mainly in the Impella LP5.0+IABP group. In patients with CS-AMI stabilized by initial treatment with inotropes and an IABP, the Impella LP5.0 did not provide additional haemodynamic support or improvement in LVEF at 1 month; its use in this setting might be futile and possibly harmful.

Bochaton T ，Huot L ，Elbaz M ，Delmas C ，Aissaoui N ，Farhat F ，Mewton N ，Bonnefoy E ，IMPELLA-STIC investigators ... -  《-》

Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Schrage B ，Ibrahim K ，Loehn T ，Werner N ，Sinning JM ，Pappalardo F ，Pieri M ，Skurk C ，Lauten A ，Landmesser U ，Westenfeld R ，Horn P ，Pauschinger M ，Eckner D ，Twerenbold R ，Nordbeck P ，Salinger T ，Abel P ，Empen K ，Busch MC ，Felix SB ，Sieweke JT ，Møller JE ，Pareek N ，Hill J ，MacCarthy P ，Bergmann MW ，Henriques JPS ，Möbius-Winkler S ，Schulze PC ，Ouarrak T ，Zeymer U ，Schneider S ，Blankenberg S ，Thiele H ，Schäfer A ，Westermann D ... -  《-》

A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction.

Seyfarth M ，Sibbing D ，Bauer I ，Fröhlich G ，Bott-Flügel L ，Byrne R ，Dirschinger J ，Kastrati A ，Schömig A ... -  《-》

Contemporary trends in use of mechanical circulatory support in patients with acute MI and cardiogenic shock.

To describe the contemporary trends in the use of mechanical circulatory support (MCS) in patients with acute myocardial infarction and cardiogenic shock (AMICS). To evaluate survival benefit with early application of intra-aortic balloon pump (IABP) or Impella CP. A cohort study of all consecutive patients with AMICS undergoing percutaneous coronary intervention (PCI) <24 hours of symptom onset (early PCI) in southeastern Denmark from 2010 to 2017. A matched case-control study comparing 30-day mortality between patients receiving early-IABP or early-Impella CP and their respective control group. Controls were matched on age, left ventricular ejection fraction, arterial lactate, estimated glomerular filtration rate and cardiac arrest before PCI. Early-IABP/Impella CP was defined as applied before PCI if shock developed pre-PCI, or immediately after PCI if shock developed during PCI. 903 patients with AMICS undergoing early PCI were identified. Use of MCS decreased from 50% in 2010 to 25% in 2017, p for trend of <0.001. The IABP was abandoned in 2012 and replaced mostly by Impella CP. Patients receiving MCS in 2013-2017 had more compromised haemodynamics compared with patients receiving MCS in 2010-2012. 40 patients received early IABP, and 40 patients received early Impella CP. Only the group receiving early Impella CP was associated with lower 30-day mortality compared with their matched control group (30-day mortality 40% vs 77.5%, plog-rank of<0.001). Use of MCS decreased by 50% from 2010 to 2017. Patients receiving MCS had more compromised haemodynamics in recent years. Early application of Impella CP was associated with reduced 30-day mortality compared with a matched control group.

Helgestad OKL ，Josiassen J ，Hassager C ，Jensen LO ，Holmvang L ，Udesen NLJ ，Schmidt H ，Berg Ravn H ，Moller JE ... -  《Open Heart》

Preliminary experience with Impella Recover(®) LP5.0 in nine patients with cardiogenic shock: a new circulatory support system in the intensive cardiac care unit.

Cardiogenic shock is associated with high mortality. We report our experience with the short-term left ventricular axial pump Impella LP5.0 in nine patients with severe ischaemic heart failure. Six patients (group 1) presented with cardiogenic shock at the acute phase of an ST elevation myocardial infarction. Three patients (group 2) had severe ischaemic cardiomyopathy with temporary contra-indication to LVAD or transplantation. We measured haemodynamic and metabolic variables up to 96hours and recorded morbidity, mechanical pump failures, and mortality up to one year postimplantation. In all patients the Impella LP5.0 was safely placed through the right subclavian artery. Cardiac power output increased from 0.64 (0.07) W to 0.94 (0.44) W and 1.02 (0.30) W at 24 and 72hours, respectively. The Impella LP5.0 remained in place for 12 (7.2) days. In group 1, five patients were in INTERMACS Profile 3 at the time of pump insertion. Three could be weaned and survived. One patient in INTERMACS Profile 1 died of intractable heart failure within hours. In group 2, two of three patients underwent heart transplantation. Haemorrhage requiring transfusions was observed in four patients but only one case was directly related to the Impella LP5.0. Left ventricular assistance with the Impella LP5.0 appears to be well tolerated. It may be especially useful in patients with acute myocardial infarction complicated by cardiogenic shock who achieve INTERMACS Profile 3 with initial treatment.

Bresson D ，Sibellas F ，Farhat F ，Jegaden O ，Kirkorian G ，Bonnefoy E ... -  《-》