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In a randomized trial involving patients with STEMI and cardiogenic shock, mortality at 6 months was lower with mechanical circulatory support with a microaxial flow pump than with standard care alone.

The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far. The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies. As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%). The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

In this trial, patients with acute MI and cardiogenic shock who were expected to undergo coronary revascularization were randomly assigned to receive or not to receive intraaortic balloon support. Balloon support had no effect on 30-day mortality. The rate of death among patients with cardiogenic shock complicating acute myocardial infarction is high even when the patients undergo early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 1 – 4 Intraaortic balloon counterpulsation is the most widely used form of mechanical hemodynamic support in this clinical setting. 5 In U.S. and European guidelines, the use of an intraaortic balloon in the treatment of cardiogenic shock is given a class IB and class IC recommendation, respectively. 6 – 8 However, evidence is based mainly on registry data, and there is a lack of adequately powered randomized trials. A meta-analysis that . . .

In a randomized trial, 706 patients with acute myocardial infarction and cardiogenic shock were assigned to either culprit-lesion-only PCI or immediate multivessel PCI. At 1 year, mortality did not differ significantly between the two groups.

Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).

Objectives This study sought to evaluate the influence of intraaortic balloon pump (IABP) counterpulsation on the microcirculation in patients with cardiogenic shock (CS) complicating acute myocardial infarction. Background In patients with shock profound alterations of the microcirculation have been observed and their clinical relevance has been described. Different treatment strategies exist to improve microvascular perfusion in patients with CS; however, the role of IABP treatment is not clearly defined. Methods A predefined substudy of the randomized Intraaortic Balloon Pump in Cardiogenic Shock II trial (IABP-SHOCK II) investigated the sublingual microcirculation using a sidestream darkfield intravital microscope on days 1, 2 and 4 after the onset of shock. Perfused capillary (<20 µm, PCD) and vessel densities (<100 µm, PVD), total capillary (TCD) and vessel (TVD) densities were determined. In addition, the proportion of perfused vessels was assessed. Results Forty-one patients were included in this substudy ( n  = 24 with IABP support vs. n  = 17 without IABP support). No significant differences between treatment with or without IABP regarding PCD, PVD, TCD, TVD and the proportion of perfused vessels were evident on all three timepoints ( p  = n.s. for all). Microvascular perfusion showed inverse correlation with subsequent serum lactate levels (−0.366; p  = 0.02) without being significantly correlated with lactate levels at the timepoint of the microcirculatory investigation. In Kaplan–Meier analysis microcirculatory parameters showed significant discrimination of prediction for time to death ( p  < 0.05 for all). Conclusions In patients with CS, there is no effect of IABP treatment on microvascular perfusion. Parameters of the microcirculation might be helpful to identify high risk patients.

Among patients who had multivessel coronary disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of death or renal-replacement therapy was lower among those who underwent PCI of the culprit lesion only than among those who underwent multivessel PCI.

Patients with cardiogenic shock were assigned to receive milrinone or dobutamine for inotropic support. There was no significant difference between the two groups in the composite primary outcome of in-hospital death from any cause or cardiovascular or renal events.

Abstract Aims The Society for Cardiovascular Angiography and Interventions (SCAI) Classification provides risk stratification of patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). This sub-study of the ECLS-SHOCK trial investigates the prognostic impact of SCAI stages in AMI-CS and the influence of SCAI stages on the effect of extracorporeal life support (ECLS) therapy in AMI-CS patients. Methods Patients with AMI-CS enrolled in the multicentre, randomized ECLS-SHOCK trial were included. The outcomes, treatment effect and safety of ECLS were stratified according to SCAI stage at admission using a post-hoc classification. Results From a total of 417 patients enrolled in the ECLS-SHOCK trial between June 2019 and November 2022, 51.6% (n = 215), 13.4% (n = 56) and 35.0% (n = 146) presented in SCAI Stages C, D and E, respectively. SCAI stages were associated with the risk of 30 day all-cause mortality (C vs. D vs. E: 32.6% vs. 67.9% vs. 64.4%, P < 0.001), with rates of renal replacement therapy at 30 days (C vs. D vs. E: 7.0% vs. 19.6% vs. 13.7%, P = 0.03) and with poor neurological outcomes (C vs. D vs. E: 17.2% vs. 44.4% vs. 36.5%, P < 0.001). No interaction was observed between SCAI stage and the treatment effect of ELCS on 30 day all-cause mortality (ELCS vs. control SCAI C: 32.7% vs. 32.4%; SCAI D: 68.4% vs. 66.7%; SCAI E: 59.7% vs. 68.4%, P for interaction = 0.65). Conclusions In AMI-CS patients included in the ECLS-SHOCK trial, SCAI stages at admission were predictive for mortality and for the incidence of safety events. The efficacy of ECLS treatment was not affected by SCAI stage. Patients with AMI-CS (lactate >3 mmol/L) enrolled in the multicentre, randomized ECLS-SHOCK trial were included. From a total of 417 patients, 51.6% (n = 215), 13.4% (n = 56) and 35.0% (n = 146) presented in SCAI Stages C, D and E, respectively. SCAI stages were associated with the risk of 30 day all-cause mortality, with rates of renal replacement therapy at 30 days and with poor neurological outcomes. No interaction was observed between SCAI stage and the treatment effect of ELCS on 30 day all-cause mortality.

Background Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is associated with high mortality. Previous studies regarding gender-specific differences in CS are conflicting and there are insufficient data for the presence of gender-associated differences in the contemporary percutaneous coronary intervention era. Aim of this study was therefore to investigate gender-specific differences in a large cohort of AMI patients with CS undergoing contemporary treatment. Methods In the randomized Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial, 600 patients with CS complicating AMI undergoing early revascularization were assigned to therapy with or without intra-aortic balloon pump. We compared sex-specific differences in these patients with regard to baseline and procedural characteristics as well as short- and long-term clinical outcome. Results Of 600 patients 187 (31 %) were female. Women were significantly older than men and had a significantly lower systolic and diastolic blood pressure at presentation ( p  < 0.05 for all). Diabetes mellitus and hypertension were more frequent in women, whereas smoking was more frequent in men ( p  < 0.05 for all). Women showed a higher mortality within the first day after randomization ( p  = 0.004). However, after multivariable adjustment this numerical difference was no longer statistically significant. No gender-related differences in clinical outcome were observed after 1, 6 and 12 months of follow-up. Conclusion In this large-scale multicenter study in patients with CS complicating AMI, women had a worse-risk profile in comparison to men. No significant gender-related differences in treatment as well as short- and long-term outcome were observed.