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The article focuses on the study "Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock," by Holger Thiele et al.

Background: In current guidelines, intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials. Therefore, IABP is currently only used in 20% to 40% of cardiogenic shock cases. The hypothesis of this trial is that IABP in addition to early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting will improve clinical outcome of patients in cardiogenic shock. Study Design: The IABP-SHOCK II study is a 600-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of IABP versus optimal medical therapy on the background of early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of IABP-SHOCK II is 30-day all-cause mortality. Secondary outcome measures, such as hemodynamic, laboratory, and clinical parameters, will serve as surrogate end points for prognosis. Furthermore, an intermediate and long-term follow-up at 6 and 12 months will be performed. Safety will be assessed, by the GUSTO bleeding definition, peripheral ischemic complications, sepsis, and stroke. Conclusions: The IABP-SHOCK II trial addresses important questions regarding the efficacy and safety of IABP in addition to early revascularization in patients with cardiogenic shock complicating myocardial infarction. [Copyright &y& Elsevier]

Background: Both infarct size and microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) are known to be predictors for adverse clinical outcome after ST-elevation myocardial infarction (STEMI). We hypothesized that a ratio of MO and infarct size (MO/infarct size) might be an even stronger predictor for outcome after STEMI, which has not been investigated yet. Methods: STEMI patients reperfused by primary angioplasty ( n = 438) within 12 h after symptom onset underwent contrast-enhanced CMR at a median of 3 days (interquartile range [IQR] 2;4) after the index event. MO and infarct size were measured 15 min after intravenous gadolinium injection. Follow-up was conducted after 19 months (IQR 10;27). The primary end point was defined as a composite of death, non-fatal myocardial reinfarction and congestive heart failure (major adverse cardiac events [MACE]). Results: The extent of MO was only weakly correlated with infarct size ( r = 0.21, p < 0.001). In a first multivariate analysis including extent of MO, infarct size, ejection fraction, end-systolic and end-diastolic volume, the extent of MO was independently associated with MACE (hazard ratio [HR] 1.03, 95%CI 1.02-1.05, p < 0.001). In a second multivariate analysis including MO/infarct size on top of the extent of MO, infarct size, ejection fraction, end-systolic and end-diastolic volume, MO/infarct size was identified as the strongest independent predictor for MACE (HR 2.22 [95%CI 1.60-3.08, p < 0.001]). Conclusions: In contrast to infarct size, MO is associated with adverse clinical outcome after STEMI even after adjustment for other CMR parameters. However, MO/infarct size is a more powerful predictor for long-term outcome after STEMI than either parameter alone. [ABSTRACT FROM AUTHOR]

Previous studies analyzing the relation between time-to-reperfusion, infarct size, microvascular obstruction (MO) and infarct transmurality in patients with ST-elevation myocardial infarction (STEMI) reperfused by primary percutaneous coronary intervention (PCI) reported inconsistent results. Furthermore, it remains unclear, if transmural infarction is associated with adverse clinical outcome. The present study included STEMI patients reperfused by primary PCI ( n = 322) within 720 min after symptom-onset undergoing contrast-enhanced magnetic resonance imaging (CMR) at a median of 3 days after the index event [interquartile range (IQR) 2-4]. Patients were subcategorized into tertiles according to time-to-reperfusion. Infarct size and MO were assessed approximately 15 min after gadolinium-injection. Infarct transmurality was assessed by a score with late-enhancement grading as <25, 25-50, 51-75 and >75% transmurality analyzing all 17 left ventricular segments. Clinical follow-up was performed after 20 months (IQR 13;29). The primary endpoint was defined as a composite of death and congestive heart failure. The median time-to-reperfusion was 230 min (IQR 153;390). Infarct size and MO did not increase significantly with longer time-to-reperfusion ( p = 0.16 and p = 0.44, respectively). In contrast to infarct size and MO, the infarct transmurality score progressed significantly with increasing ischemic time ( p < 0.001). In multivariable logistic regression analysis, time-to-reperfusion was identified as an independent predictor for transmural infarction ( p = 0.03). However, transmural infarction was not predictive of the primary composite clinical endpoint ( p = 0.22). In conclusion, in STEMI patients reperfused by primary PCI, time-to-reperfusion was an independent predictor for transmural infarction but not for infarct size and MO. However, transmural infarction was not predictive of death and congestive heart failure. [ABSTRACT FROM AUTHOR]

Myocardial salvage assessed by cardiac magnetic resonance imaging (CMRI) holds promise as a surrogate endpoint in studies comparing different treatment strategies for ST-elevation myocardial infarction (STEMI). The aim of this study was to evaluate the reliability of salvaged myocardium measurements by CMRI. Twenty patients underwent CMRI on 2 consecutive days early after reperfused STEMI to assess the area at risk (AAR) on T2-weighted and final infarct size (IS) on delayed enhancement images. Myocardial salvage index (MSI) was calculated (AAR minus IS). Agreement between scans 1 and 2 for the AAR, IS and MSI were analyzed using Bland-Altman analyses. Inter- and intraobserver reliability were assessed. Paired t testing revealed a trend for a significant difference for MSI between scans 1 and 2 (scan 1: 43.8 ± 22.5; scan 2: 45.5 ± 22.0; P = 0.052). The average difference for AAR and IS between scan 1 and scan 2 was −0.5 (upper limit of agreement 5.4% of left ventricular [LV] volume; lower limit of agreement −6.4%LV) and 0.1%LV (upper limit of agreement 2.3%LV; lower limit of agreement −2.1%LV). The corresponding calculated MSI measurements showed a mean bias of −1.7 (upper limit of agreement 5.5; lower limit of agreement −8.9). Coefficients of repeatability for interobserver variability were 3.6%LV for AAR, 2.4%LV for IS and 5.4 for MSI. Likewise, for intraobserver variability, coefficients of repeatability were 5.0%LV (AAR), 2.4%LV (IS) and 4.8 (MSI). Assessment of myocardial salvage by CMRI shows acceptable reliability. Further validation studies and trials showing the prognostic value of myocardial salvage by CMRI are needed before routine implementation as a surrogate endpoint in STEMI trials. [ABSTRACT FROM AUTHOR]

Objectives: This study investigated the impact of sheath size on the rate of radial artery occlusions (RAO) (primary objective) and other access site complications (hemorrhage, pseudoaneurysm, arteriovenous fistula) as secondary objectives after transradial coronary catheterization. Background: The number of vascular access complications in the published data ranges from 5% to 38% after transradial catheterization. Methods: Between November 2009 and August 2010, 455 patients 65.3 ± 10.9 years of age (62.2% male) with transradial access with 5-F (n = 153) or 6-F (n = 302) arterial sheaths were prospectively recruited. Duplex sonography was obtained in each patient before discharge. Patients with symptomatic RAO were treated with low-molecular-weight heparin (LMWH), and a follow-up was performed. Results: The incidence of access site complications was 14.4% with 5-F sheaths compared with 33.1% with 6-F sheaths (p < 0.001). Radial artery occlusion occurred in 13.7% with 5-F sheaths compared with 30.5% with 6-F sheaths (p < 0.001). There was no difference between groups with regard to hemorrhage, pseudoaneurysms, or arteriovenous fistulas. Female sex, larger sheath size, peripheral arterial occlusive disease, and younger age independently predicted RAO in multivariate analysis. In total, 42.5% of patients with RAO were immediately symptomatic; another 7% became symptomatic within a mean of 4 days. Of patients with RAO, 59% were treated with LMWH. The recanalization rates were significantly higher in patients receiving LMWH compared with conventional therapy (55.6% vs. 13.5%, p < 0.001) after a mean of 14 days. Conclusions: The incidence of RAO by vascular ultrasound was higher than expected from previous data, especially in patients who underwent the procedure with larger sheaths. [ABSTRACT FROM AUTHOR]

Objective In acute myocardial infarction, cardiovascular magnetic resonance (CMR) allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials. The aim of this study was to investigate whether the early prognostic significance of myocardial salvage assessed by CMR is sustained at long-term clinical follow-up in patients with ST-elevation myocardial infarction (STEMI) undergoing primary angioplasty. Design, setting, patients We analysed 208 consecutive patients with STEMI undergoing primary angioplasty <12 h after symptom onset. T2-weighted and contrast-enhanced CMR was used to calculate the myocardial salvage index (MSI). Patients were categorised into two groups defined by the median MSI. The primary end point was the occurrence of major adverse cardiovascular events defined as death, reinfarction and new congestive heart failure at long-term follow-up. Results The median MSI was 48 (IQR 27 to 73). Longterm follow-up was available in 202 patients (97%) at a median of 18.5 months (IQR 13.8 to 20.8). Major adverse cardiovascular events occurred in 33 patients (16%), with a significantly lower event rate in the MSI ≥ median group (7 vs 26 events, p<0.001). Mortality was significantly reduced in the MSI ≥ median group (2 vs 12 deaths, p=0.001). MSI was a significant independent predictor for a favourable long-term survival on multivariable Cox regression analysis after adjustment for established prognostic markers. Conclusions MSI assessed by CMR predicts long-term clinical outcome in acute reperfused STEMI. Therefore, our data support the use of myocardial salvage as an end point for clinical trials investigating novel reperfusion strategies. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the effects of N-acetylcysteine ( N-ACC) on contrast-induced nephropathy (CIN) defined by Cystatin C (Cys-C) serum levels and to evaluate the influence of Cys-C on clinical outcome in patients with ST-elevation myocardial infarction (STEMI). Methods: In total, 251 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) were randomized to either high-dose N-ACC (2 × 1200 mg/d for 48 h) with optimal hydration or placebo plus optimal hydration. Serum Cys-C was measured at baseline, immediately, 24, 48 and 72 h after PCI. CIN was defined as an increase in serum Cys-C levels of 25% or more from baseline within 72 h after PCI. Major adverse cardiac events (MACE)-defined as death, recurrent infarction and congestive heart failure-within 6 months were recorded. Results: Baseline Cys-C was 1294 ± 611 and 1352 ± 811 ng/mL ( p = 0.54) for the N-ACC and placebo group, respectively. There was a steady increase in Cys-C in both groups within the first 72 h after randomization. CIN occurred in 74.6 and in 70.4% of patients in the N-ACC and placebo group, respectively ( p = 0.46). The magnitude of increase in the serum concentration of Cys-C was an independent predictor for MACE after 6 months of follow-up. Conclusions: High-dose N-ACC does not provide additional benefit over placebo with respect to Cys-C defined CIN in STEMI patients undergoing primary PCI. The magnitude of increase in Cys-C serum levels in the early course after STEMI is a predictor of medium-term MACE. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to assess the area at risk (AAR) in ST-segment elevation myocardial infarction with 2 different cardiac magnetic resonance (CMR) imaging methods and to compare them with the validated angiographic Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease Score (APPROACH-score) in a large consecutive patient cohort. Background: Edema imaging with T2-weighted CMR and the endocardial surface area (ESA) assessed by late gadolinium enhancement have been introduced as relatively new methods for AAR assessment in ST-segment elevation myocardial infarction. However, data on the utility and validation of these techniques are limited. Methods: A total of 197 patients undergoing primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction were included. AAR (assessed with T2-weighted edema imaging and the ESA method), infarct size, and myocardial salvage (AAR minus infarct size) were determined by CMR 2 to 4 days after primary angioplasty. Angiographic AAR scoring was performed by use of the APPROACH-score. All measurements were done offline by blinded observers. Results: The AAR assessed by T2-weighted imaging showed good correlation with the angiographic AAR (r = 0.87; p < 0.001), whereas the ESA showed only a moderate correlation either to T2-weighted imaging (r = 0.56; p < 0.001) or the APPROACH-score (r = 0.44; p < 0.001). Mean AAR by ESA (20.0 ± 11.7% of left ventricular mass) was significantly (p < 0.001) smaller than the AAR assessed by T2-weighted imaging (35.6 ± 10.9% of left ventricular mass) or the APPROACH-score (27.9 ± 10.5% of left ventricular mass) and showed a significant negative dependence on myocardial salvage index. In contrast, no dependence of T2-weighted edema imaging or the APPROACH-score on myocardial salvage index was seen. Conclusions: The AAR can be reliably assessed by T2-weighted CMR, whereas assessment of the AAR by ESA seems to be dependent on the degree of myocardial salvage, thereby underestimating the AAR in patients with high myocardial salvage such as aborted infarction. Thus, assessment of the AAR with the ESA method cannot be recommended. (Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein [LIPSIA-N-ACC]; NCT00463749) [Copyright &y& Elsevier]

Background: Administration of abciximab during primary percutaneous coronary intervention (PCI) reduces major adverse cardiac events (MACE) in patients with ST-elevation myocardial infarction (STEMI). Intracoronary (IC) abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction early after infarction. Aim of this study was to investigate whether the early benefits of an IC abciximab administration in STEMI patients undergoing PCI are sustained at 6 months. Methods: We performed 6-month follow-up of 154 STEMI patients undergoing PCI, who were randomised to either IC ( n = 77) or intravenous (IV) ( n = 77) bolus abciximab administration with subsequent 12-h intravenous infusion. The primary endpoint was infarct size at 6-month follow-up as assessed by delayed enhancement magnetic resonance imaging. Clinical end points were MACEs within 6 months after infarction. Results: The median infarct size after 6 months was significantly reduced in the IC abciximab group (16.7 vs. 24.1%, p = 0.002). A significant recovery of LV function was only observed in the IC abciximab group ( p < 0.001), and IC abciximab group patients had significantly less adverse remodelling as compared to standard IV abciximab treatment ( p = 0.03). These beneficial effects also translated into a strong trend towards a reduced MACE rate in the IC abciximab group at 6-month follow-up (10 vs. 21%, p = 0.07). Conclusions: Intracoronary abciximab application in STEMI patients undergoing PCI is superior to standard IV treatment with respect to infarct size, recovery of LV function and reverse remodelling 6 months after infarction. [ABSTRACT FROM AUTHOR]

Cardiac MRI (CMR) offers the potential to assess valid and reliable parameters associated with cardiac diseases and the corresponding clinical prognosis. It has therefore emerged as a tool for outcome measures, resulting in lower study sample sizes, shorter duration of clinical studies, and subsequently less trial costs. This review focuses on the theoretical and practical background of CMR in measuring treatment effects in clinical trials. [ABSTRACT FROM AUTHOR]

Aims Early and late microvascular obstruction (MO) assessed by magnetic resonance imaging (MRI) are prognostic markers for combined clinical endpoints after ST-elevation myocardial infarction (STEMI). However, there are only limited data for hard endpoints and no consensus exists which of the two best predicts clinical outcome. Furthermore, it is unclear whether the assessment of MO by MRI adds incremental prognostic information independent of traditional outcome markers. Methods and results STEMI patients reperfused by primary angioplasty (n = 438) <12 h after symptom onset underwent MRI at a median of 3 days after the index event. Microvascular obstruction was measured 1 and 15 min after gadolinium injection (early and late MO). Clinical follow-up was conducted after a median of 19 months. The primary endpoint was defined as a composite of death, non-fatal myocardial re-infarction, and congestive heart failure. In contrast to the presence and extent of early MO, the presence and extent of late MO were independently associated with the composite primary endpoint in the multivariable Cox regression analysis adjusting for post-percutaneous coronary intervention TIMI-flow, ST-resolution, TIMI-risk score, ejection fraction, and infarct size. The presence of late MO was identified as the strongest independent predictor for the occurrence of the composite endpoint (hazard ratio 4.23, 95%CI 1.73–10.34, P = 0.002). Furthermore, the presence and extent of late MO provided an incremental prognostic value above the traditional prognostic markers. Conclusion In contrast to early MO, the presence and extent of late MO are strong independent prognosticators after STEMI. [ABSTRACT FROM PUBLISHER]

Background: No-reflow after primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) is associated with poor prognosis. Endothelin-1 (ET-1) is a potent endothelium-derived vasoconstrictor that might aggravate reperfusion injury. The aim of our study was to assess the relationship between systemic ET-1 levels and the occurrence of no-reflow as well as to evaluate the prognostic value of ET-1 in a high-risk STEMI population. Methods: We examined 128 consecutive patients undergoing primary PCI in acute STEMI <12 hours after symptom onset. Endothelin-1 was assessed before and immediately after primary PCI. Patients were categorized into 2 groups defined by the median ET-1 level on admission. No-reflow was assessed by 3 different methods after PCI: angiographic Thrombolysis in Myocardial Infarction (TIMI) flow and myocardial blush grade, electrocardiographic ST-resolution, and microvascular obstruction (MO) measured by cardiac magnetic resonance imaging (MRI). The primary clinical end points were mortality and major adverse cardiovascular events. Clinical follow-up was conducted after a median of 19 months. Results: Patients with angiographically (TIMI flow ≤2 or TIMI flow 3 with final myocardial bush grade ≤2 after PCI), electrocardiographically (ST-resolution <30%), and MRI- (presence of MO) detected no-reflow had significantly higher ET-1 levels on admission. At multivariable logistic regression analysis, ET-1 levels on admission were the only significant predictor of MRI-detected no-reflow (P = .03) together with left ventricular ejection fraction (P = .002). An elevated ET-1 level ≥ the median on admission was a significant predictor of long-term mortality. Conclusions: Endothelin-1 on admission is associated with no-reflow and increased long-term mortality in a high-risk STEMI population reperfused by primary PCI. [Copyright &y& Elsevier]

Background: Aborted myocardial infarction (MI) is defined by major (≥50%) ST-segment resolution and a lack of subsequent cardiac enzyme rise ≥2 the upper normal limit. This ultimate myocardial salvage has been observed in approximately 15% of ST-elevation MI (STEMI) patients after fibrinolysis. So far, the prognostic significance and magnetic resonance imaging (MRI) findings of an aborted MI after primary angioplasty have not been evaluated appropriately. Methods: We examined 420 consecutive STEMI patients undergoing primary angioplasty within 12 hours after symptom onset. All patients underwent MRI within 1 to 4 days. Clinical end points were major adverse cardiovascular events within 6 months after the index event. Results: Of the 420 STEMI patients, 58 (14%) fulfilled aborted MI criteria. As compared with true MI, patients with aborted MI had a significant lower infarct size, shorter pain-to-balloon time, and better left ventricular ejection fraction (P < .001, respectively). Aborted MI patients had a 6-month major adverse cardiovascular event rate of 1.7% versus 19.6% of true MI patients (P = .001). In aborted MI patients, MRI detected no myocardial scar in 30 (56%), and a minor necrosis/scar formation in 24 patients (44%). Conclusion: The proven prognostic relevance of aborted MI makes it a meaningful end point and therapeutic target in future MI studies. MRI can further distinguish between true aborted MI with absence of myocardial scar and aborted MI with scar formations. [Copyright &y& Elsevier]

Supplemental Digital Content is available in the text. Background: The management of patients with acute myocardial infarction complicated by cardiogenic shock is highly complex, and outcomes may depend on the time of hospital admission and subsequent intervention (ie, ON-hours versus OFF-hours). The CULPRIT-SHOCK trial (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) demonstrated superior outcome for culprit-lesion-only versus immediate multivessel percutaneous coronary intervention in patients presenting with acute myocardial infarction, multivessel disease, and cardiogenic shock. However, it is unknown whether the time of hospital admission affects the overall outcome of these high-risk patients. Methods: We analyzed patients from the CULPRIT-SHOCK trial with respect to the time of hospital admission. We divided patients in ON-hours and OFF-hours groups and further stratified them according to their individual revascularization strategy. Outcome measures consisted of a composite end point of death or renal-replacement therapy within 30 days and mortality within 1 year. Results: Out of 686 patients randomized in the CULPRIT-SHOCK trial, 444 patients (64.7%) presented during ON-hours, whereas 242 patients (35.3%) presented during OFF-hours. Death or renal-replacement therapy at 30 days occurred to a similar extent in patients admitted during ON-hours (51.0%) and OFF-hours (50.0%; P =0.80). Similarly, 1-year mortality was not affected by the time of hospital admission (54.4% ON-hours versus 51.7% OFF-hours, P =0.49). Regardless of admission time, patients had a benefit from culprit-lesion-only as compared to immediate multivessel percutaneous coronary intervention. The composite end point at 30 days occurred in 45.1% versus 57.6% of patients admitted ON-hours and in 47.7% versus 51.9% of patients admitted OFF-hours (P interaction=0.29). Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours (P interaction=0.20). Conclusions: Among patients with myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days, and mortality at 1 year did not differ significantly according to the time of hospital admission. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01927549. [ABSTRACT FROM AUTHOR]

Objectives: To analyze the use and prognostic impact of active mechanical circulatory support (MCS) devices in a large prospective contemporary cohort of patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). Background: Although increasingly used in clinical practice, data on the efficacy and safety of active MCS devices in patients with CS complicating AMI are limited. Methods: This is a predefined subanalysis of the CULPRIT-SHOCK randomized trial and prospective registry. Patients with CS, AMI and multivessel coronary artery disease were categorized in two groups: (1) use of at least one active MCS device vs. (2) no active MCS or use of intra-aortic balloon pump (IABP) only. The primary endpoint was a composite of all-cause death or renal replacement therapy at 30 days. Results: Two hundred of 1055 (19%) patients received at least one active MCS device (n = 112 Impella®; n = 95 extracorporeal membrane oxygenation (ECMO); n = 6 other devices). The primary endpoint occurred significantly more often in patients treated with active MCS devices compared with those without active MCS devices (142 of 197, 72% vs. 374 of 827, 45%; p < 0.001). All-cause mortality and bleeding rates were significantly higher in the active MCS group (all p < 0.001). After multivariable adjustment, the use of active MCS was significantly associated with the primary endpoint (odds ratio (OR) 4.0, 95% confidence interval (CI) 2.7–5.9; p < 0.001). Conclusions: In the CULPRIT-SHOCK trial, active MCS devices were used in approximately one fifth of patients. Patients treated with active MCS devices showed worse outcome at 30 days and 1 year. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Women are more likely to suffer and die from cardiogenic shock (CS) as the most severe complication of acute myocardial infarction. Data concerning optimal management for women with CS are scarce. Aim of this study was to better define characteristics of women experiencing CS and to the influence of sex on different treatment strategies. Methods: In the CULPRIT-SHOCK trial (The Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock), patients with CS complicating acute myocardial infarction and multivessel coronary artery disease were randomly assigned to one of the following revascularization strategies: either percutaneous coronary intervention of the culprit-lesion-only or immediate multivessel percutaneous coronary intervention. Primary end point was composite of death from any cause or severe renal failure leading to renal replacement therapy within 30 days. We investigated sex-specific differences in general and according to the revascularization strategies. Results: Among all 686 randomized patients included in the analysis, 24% were women. Women were older and had more often diabetes mellitus and renal insufficiency, whereas they had less often history of previous acute myocardial infarction and smoking. After 30 days, the primary clinical end point was not significantly different between groups (56% women versus 49% men; odds ratio, 1.29 [95% CI, 0.91–1.84]; P =0.15). There was no interaction between sex and coronary revascularization strategy regarding mortality and renal failure (P interaction=0.11). The primary end point occurred in 56% of women treated by the culprit-lesion-only strategy versus 42% men, whereas 55% of women and 55% of men in the multivessel percutaneous coronary intervention group. Conclusions: Although women presented with a different risk profile, mortality and renal replacement were similar to men. Sex did not influence mortality and renal failure according to the different coronary revascularization strategies. Based on these data, women and men presenting with CS complicating acute myocardial infarction and multivessel coronary artery disease should not be treated differently. However, further randomized trials powered to address potential sex-specific differences in CS are still necessary. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01927549. [ABSTRACT FROM AUTHOR]

Background: Little is known about clinical outcomes of patients with acute myocardial infraction (AMI) complicated by cardiogenic shock (CS) requiring mechanical ventilation (MV). The aim of this study was to identify the characteristics, risk factors, and outcomes associated with the provision of MV in this specific high-risk population. Methods: Patients with CS complicating AMI and multivessel coronary artery disease from the CULPRIT-SHOCK trial were included. We explored 30 days of clinical outcomes in patients not requiring MV, those with MV on admission, and those in whom MV was initiated within the first day after admission. Results: Among 683 randomized patients included in the analysis, 17.4% received no MV, 59.7% were ventilated at admission and 22.8% received MV within or after the first day after admission. Patients requiring MV had a different risk-profile. Factors independently associated with the provision of MV on admission included higher body weight, resuscitation within 24 h before admission, elevated heart rate and evidence of triple vessel disease. Conclusions: Requiring MV in patients with CS complicating AMI is common and independently associated with mortality after adjusting for covariates. Patients with delayed MV initiation appear to be at higher risk of adverse outcomes. Further research is necessary to identify the optimal timing of MV in this high-risk population. [ABSTRACT FROM AUTHOR]

Current evidence regarding the effect of intravenous morphine administration on reperfusion injury and/or cardioprotection in patients with myocardial infarction is conflicting. The aim of this study was to evaluate the impact of morphine administration, on infarct size and reperfusion injury assessed by cardiac magnetic resonance imaging (CMR) in a large multicenter ST-elevation myocardial infarction (STEMI) population. In total, 734 STEMI patients reperfused by primary percutaneous coronary intervention <12 h after symptom onset underwent CMR imaging at eight centers for assessment of myocardial damage. Intravenous morphine administration was recorded in all patients. CMR was completed within one week after infarction using a standardized protocol. The clinical endpoint of the study was the occurrence of major adverse cardiac events (MACE) within 12 months after infarction. Intravenous morphine was administered in 61.8% (n = 454) of all patients. There were no differences in infarct size (17%LV, interquartile range [IQR] 8–25%LV versus 16%LV, IQR 8–26%LV, p = 0.67) and microvascular obstruction (p = 0.92) in patients with versus without morphine administration. In the subgroup of patients with early reperfusion within 120 min and reduced flow of the infarcted vessel (TIMI-flow ≤2 before PCI) morphine administration resulted in significantly smaller infarcts (12%LV, IQR 12–19 versus 19%LV, IQR 10–29, p = 0.035) and reduced microvascular obstruction (p = 0.003). Morphine administration had no effect on hard clinical endpoints (log-rank test p = 0.74) and was not an independent predictor of clinical outcome in Cox regression analysis. In our large multicenter CMR study, morphine administration did not have a negative effect on myocardial damage or clinical prognosis in acute reperfused STEMI. In patients, presenting early (≤120 min) morphine may have a cardioprotective effect as reflected by smaller infarcts; but this finding has to be assessed in further well-designed clinical studies [ABSTRACT FROM AUTHOR]

Syndecan-1 (sdc1) is a surface protein part of the endothelial glycocalyx (eGC). Soluble sdc1 is derived from shedding and indicates damaged eGC. We assessed the predictive value of plasma sdc1 concentrations for future cardiovascular events in acute reperfused ST-segment elevation myocardial infarction (STEMI) patients. A total of 206 patients admitted for STEMI were included in this study (29% female; age 65 ± 12 years) and followed-up for six months. Plasma samples were obtained post-intervention and analyzed for sdc1 by Enzyme-linked Immunosorbent Assay (ELISA). Primary outcome was six-month-mortality. Sdc1 did not correlate with biomarkers such as creatine kinase (CK) (r = 0.11; p = 0.01) or troponin (r = −0.12; p = 0.09), nor with infarct size (r = −0.04; p = 0.67) and myocardial salvage index (r = 0.11; p = 0.17). Sdc-1 was associated with mortality (changes per 100 ng/mL sdc-1 concentration; HR 1.08 95% 1.03–1.12; p = 0.001). An optimal cut-off was calculated at >120 ng/mL. After correction for known risk factors sdc1 >120 ng/mL was independently associated with mortality after 6 months. In our study, sdc1 is independently associated with six-month-mortality after STEMI. Combining clinical evaluation and different biomarkers assessing both infarct-related myocardial injury and systemic stress response might improve the accuracy of predicting clinical prognosis in STEMI patients. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: It is unclear whether atrial fibrillation (AF) influences prognosis in patients with cardiogenic shock and multivessel disease. We aimed to investigate the prognostic impact of AF in patients with cardiogenic shock complicating acute myocardial infarction. Methods and Results: In a subanalysis of the CULPRIT-SHOCK trial (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock), patients were grouped according to the presence of AF during index hospital stay. The primary end point was all-cause death at 30 days, and the key secondary end point was all-cause death at 1 year. AF was documented in 142 (21%) of 686 patients. AF was not a significant predictor of 30-day (adjusted odds ratio, 1.01; 95% CI 0.67–1.54; P =0.95) and 1-year (adjusted odds ratio, 0.80; 95% CI, 0.52–1.22; P =0.30) all-cause mortality. Patients with AF already on admission showed higher all-cause mortality at 30 days (52 of 90, 58% versus 19 of 52, 37%; P =0.02) and 1 year (57 of 90, 63% versus 20 of 52, 39%; P =0.004) compared with patients with newly detected AF during hospital stay. AF was associated with a longer time to hemodynamic stabilization (4, interquartile range, 1–8 days versus 3, interquartile range, 1–6 days; P =0.04) at 30 days. Conclusions: In cardiogenic shock complicating acute myocardial infarction, all-cause mortality is similar in patients with and without AF. Adverse outcome was detected in the subgroup of patients showing AF already on hospital admission. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01927549. [ABSTRACT FROM AUTHOR]

Background: We evaluated critically ill patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) due to cardiac arrest (CA) with respect to baseline characteristics and laboratory assessments, including lactate and lactate clearance for prognostic relevance. Methods: The primary endpoint was 30-day mortality. The impact on 30-day mortality was assessed by uni- and multivariable Cox regression analyses. Neurological outcome assessed by Glasgow Outcome Scale (GOS) was pooled into two groups: scores of 1–3 (bad GOS score) and scores of 4–5 (good GOS score). Results: A total of 93 patients were included in the study. Serum lactate concentration (hazard ratio (HR) 1.09; 95% confidence interval (CI) 1.04–1.13; p < 0.001), hemoglobin, (Hb; HR 0.87; 95% CI 0.79–0.96; p = 0.004), and catecholamine use were associated with 30-day-mortality. In a multivariable model, only lactate clearance (after 6 h; OR 0.97; 95% CI 0.94–0.997; p = 0.03) was associated with a good GOS score. The optimal cut-off of lactate clearance at 6 h for the prediction of a bad GOS score was at ≤13%. Patients with a lactate clearance at 6 h ≤13% evidenced higher rates of bad GOS scores (97% vs. 73%; p = 0.01). Conclusions: Whereas lactate clearance does not predict mortality, it was the sole predictor of good neurological outcomes and might therefore guide clinicians when to stop ECPR. [ABSTRACT FROM AUTHOR]

Aims: Anaemia and iron deficiency (ID) are common comorbidities in cardiovascular patients and are associated with a poor clinical status, as well as a worse outcome in patients with heart failure and acute myocardial infarction (AMI). Nevertheless, data concerning the impact of anaemia and ID on clinical outcomes in patients with cardiogenic shock (CS) are scarce. This study aimed to assess the impact of anaemia and ID on clinical outcomes in patients with CS complicating AMI. Methods and results: The presence of anaemia (haemoglobin <13 g/dl in men and <12 g/dl in women) or ID (ferritin <100 ng/ml or transferrin saturation <20%) was determined in patients with CS due to AMI from the CULPRIT‐SHOCK trial. Blood samples were collected in the catheterization laboratory during initial percutaneous coronary intervention. Clinical outcomes were compared in four groups of patients having neither anaemia nor ID, against patients with anaemia with or without ID and patients with ID only. A total of 427 CS patients were included in this analysis. Anaemia without ID was diagnosed in 93 (21.7%), anaemia with ID in 54 study participants (12.6%), ID without anaemia in 72 patients (16.8%), whereas in 208 patients neither anaemia nor ID was present (48.9%). CS patients with anaemia without ID were older (73 ± 10 years, p = 0.001), had more frequently a history of arterial hypertension (72.8%, p = 0.01), diabetes mellitus (47.8%, p = 0.001), as well as chronic kidney disease (14.1%, p = 0.004) compared to CS patients in other groups. Anaemic CS patients without ID presence were at higher risk to develop a composite from all‐cause death or renal replacement therapy at 30‐day follow‐up (odds ratio [OR] 3.83, 95% confidence interval [CI] 2.23–6.62, p < 0.001) than CS patients without anaemia/ID. The presence of ID in CS patients, with and without concomitant anaemia, did not increase the risk for the primary outcome (OR 1.17, 95% CI 0.64–2.13, p = 0.64; and OR 1.01, 95% CI 0.59–1.73, p = 0.54; respectively) within 30 days of follow‐up. In time‐to‐event Kaplan–Meier analysis, anaemic CS patients without ID had a significantly higher hazard ratio (HR) for the primary outcome (HR 2.11, 95% CI 1.52–2.89, p < 0.001), as well as for death from any cause (HR 1.90, 95% CI 1.36–2.65, p < 0.001) and renal replacement therapy during 30‐day follow‐up (HR 2.99, 95% CI 1.69–5.31, p < 0.001). Conclusion: Concomitant anaemia without ID presence in patients with CS at hospital presentation is associated with higher risk for death from any cause or renal replacement therapy and the individual components of this composite endpoint within 30 days after hospitalization. ID has no relevant impact on clinical outcomes in patients with CS. [ABSTRACT FROM AUTHOR]

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Abstract Background The results of studies investigating the clinical benefit of a direct stenting (DS) strategy in ST-elevation myocardial infarction (STEMI) are inconsistent and data regarding cardiac magnetic resonance (CMR) parameters of myocardial injury are lacking. The aim of this study was to investigate the effect of DS on myocardial damage in comparison to a conventional stenting technique (CS) with predilation in patients with reperfused STEMI. Methods In a subanalysis of the randomized LIPSIA CONDITIONING trial (NCT02158468), STEMI patients were stratified according to the percutaneous coronary intervention technique into the DS (n = 171) or CS (n = 171) group after matching the patients for age (±5 years), gender, and TIMI flow before coronary intervention. Patients underwent CMR imaging within one week after infarction. Clinical outcome (death, reinfarction, hospitalization for heart failure) was assessed within 6 months after the index event. Results Patients in the DS group had significantly lower infarct size (16 vs. 19% of left ventricular mass; p = 0.046) and microvascular obstruction with significant improvement of left ventricular parameters, which was associated with favorable clinical outcome with a lower incidence of heart failure hospitalizations (4% vs. 11%, p = 0.011) and mortality (5% vs. 12%, p = 0.034) as compared to patients with CS. In multivariate Cox regression analysis, DS was identified as an independent predictor of reduced mortality (HR 0.30, 95% CI 0.11–0.87, p = 0.026). Conclusion In patients with acute reperfused STEMI, DS is safe and feasible with a significant reduction of infarct size compared to CS and subsequent lower incidence of heart failure hospitalizations and mortality. Highlights • Data comparing direct stenting (DS) to conventional stenting (CS) in STEMI are contradictory. • No available data explain the observed survival benefit of DS in some studies. • In our study, DS was associated with a significant reduction of infarct size and microvascular obstruction. • CMR-markers of myocardial damage explain the strong association with clinical outcome. [ABSTRACT FROM AUTHOR]

An abstract of the conference paper "Impact of CMR parameters on prognosis after ST-elevation myocardial infarction - a comparison to traditional outcome markers," by Ingo Eitel and colleagues is presented.

An abstract of the article "Prognostic significance of papillary muscle infarction detected by late gadolinium-enhanced MRI in acute reperfused ST-segment elevation myocardial infarction," by Ingo Eitel and colleagues is presented.

An abstract of the article "Impact of CMR parameters on clinical outcome after STEMI: data from a large multi-center study," by Suzanne de Waha and colleagues is presented.

Cardiac arrest (CA) is common in patients with infarct-related cardiogenic shock (CS). The goal of this study was to identify the characteristics and outcomes of culprit lesion percutaneous coronary intervention (PCI) of patients with infarct-related CS stratified according to CA in the CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) randomized trial and registry. Patients with CS with and without CA from the CULPRIT-SHOCK study were analyzed. All-cause death or severe renal failure leading to renal replacement therapy within 30 days and 1-year death were assessed. Among 1,015 patients, 550 (54.2%) had CA. Patients with CA were younger, more frequently male, had lower rates of peripheral artery disease, a glomerular filtration rate <30 mL/min, and left main disease, and they presented more often with clinical signs of impaired organ perfusion. The composite of all-cause death or severe renal failure within 30 days occurred in 51.2% of patients with CA vs 48.5% in non-CA patients (P = 0.39) and 1-year death in 53.8% vs 50.4% (P = 0.29), respectively. In a multivariate analysis, CA was an independent predictor of 1-year mortality (HR: 1.27; 95% CI: 1.01-1.59). In the randomized trial, culprit lesion–only PCI was superior to immediate multivessel PCI in patients both with and without CA (P for interaction = 0.6). More than 50% of patients with infarct-related CS had CA. These patients with CA were younger and had fewer comorbidities, but CA was an independent predictor of 1-year mortality. Culprit lesion–only PCI is the preferred strategy, both in patients with and without CA. (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock [CULPRIT-SHOCK]; NCT01927549) [Display omitted] [ABSTRACT FROM AUTHOR]

An abstract of the conference paper "Impact of chronic statin-pretreatment on myocardial damage as assessed by cardiac magnetic resonance findings in patients with acute ST-elevation myocardial infarction," by Ingo Eitel and colleagues is presented.

Cardiac magnetic resonance (CMR) imaging provides valuable prognostic information in patients with ST-elevation myocardial infarction (STEMI). The peri-infarct zone (PIZ) is a potential marker for post-infarction risk stratification. The aim of this study was to assess the prognostic impact of PIZ in a large multicenter STEMI-trial. The study population consisted of 704 consecutive patients undergoing CMR within 10 days after STEMI to assess established parameters of myocardial injury and additionally the extent of PIZ. The primary clinical endpoint was major adverse cardiac events (MACE) consisting of death, re-infarction and new congestive heart failure within 1 year after infarction. The median heterogeneous PIZ-volume in the overall population was 14 ml (interquartile range [IQR] 7 to 24 ml). Male sex, infarct size, and left ventricular ejection fraction were identified as independent predictors of larger PIZ alterations. Patients with MACE had a significantly larger PIZ volume compared to patients without adverse events (21 ml [IQR 12 to 35 ml] versus 14 ml [IQR 7 to 23 ml]; p = 0.001). In stepwise multivariable Cox regression analysis, PIZ > median (>14 ml) emerged as an independent predictor of MACE (hazard ratio [HR] 2.84; 95% confidence interval [CI] 1.34 to 6.00; p = 0.006) in addition to the Thrombolysis In Myocardial Infarction (TIMI) risk score (HR 1.53; 95% CI 1.19 to 1.53; p < 0.001). Addition of PIZ to a CMR risk model comprising LVEF, infarct size and microvascular obstruction resulted in net reclassification improvement of 0.46 (0.19–0.73, p < 0.001). In this currently largest prospective, multicenter CMR study assessing PIZ, the extent of PIZ emerged as an independent predictor of MACE and a potential novel marker for optimized risk stratification in STEMI patients. ClinicalTrials.gov : NCT00712101 • Validated CMR parameters such as infarct size, MO, LVEF and MSI are associated with a larger extent of the PIZ. • Independent predictors of the PIZ volume are male sex, infarct size, and LVEF. • The extent of the PIZ is an independent predictor of MACE in addition to the established TIMI risk score. • Different cutoff values for the detection of PIZ did not show significant differences [ABSTRACT FROM AUTHOR]

The frequency of mechanical circulatory support (MCS) device application has increased in recent years. Besides implantation in the emergency setting, such as circulatory arrest, MCS is also increasingly used electively to ensure hemodynamic stability in high‐risk patients, for example, during percutaneous coronary interventions (PCI), valve interventions or off‐pump coronary bypass surgery. Lifebridge (Zoll Medical GmbH, Germany) is a compact percutaneous MCS device widely used in daily clinical routine. The present study aimed to investigate the indications, feasibility, and outcomes after use of Lifebridge in cardiac interventions, evaluating a large‐scale multicenter database. A total of 60 tertiary cardiovascular centers were questioned regarding application and short‐term outcomes after the use of the Lifebridge system (n = 160 patients). Out of these 60 centers, eight consented to participate in the study (n = 39 patients), where detailed data were collected using standardized questionnaires. Demographic and clinical characteristics of the patient population, procedural as well as follow‐up data were recorded and analyzed. In 60 interrogated centers, Lifebridge was used in 74% of emergency cases and 26% in the setting of planned interventions. The subcohort interrogated in detail displayed the same distribution of application scenarios, while the main cardiovascular procedure was high‐risk PCI (82%). All patients were successfully weaned from the device and 92% (n = 36) of the patients studied in detail survived after 30 days. As assessed 30 days after insertion of the device, bleeding requiring red blood cell (RBC) transfusion constituted the main complication, occurring in 49% of cases. In our analysis of clinical data, the use of Lifebridge in cardiac intervention was shown to be feasible. Further prospective studies are warranted to identify patients who benefit from hemodynamic MCS support despite the increased rate of RBC transfusion due to challenges in access sites during cardiovascular procedures. [ABSTRACT FROM AUTHOR]

Aims: Cangrelor has a potentially favorable pharmacodynamic profile in cardiogenic shock (CS). We aimed to evaluate the clinical course of CS patients undergoing percutaneous coronary intervention (PCI) treated with cangrelor.Methods and Results: We retrospectively identified 136 CS patients treated with cangrelor. Patients were 1:1 matched to CS patients from the IABP-SHOCK II trial not receiving cangrelor by age, sex, cardiac arrest, type of myocardial infarction, culprit lesion, glycoprotein IIb/IIIa inhibitor, and oral P2Y12-receptor inhibitor and followed-up for 12 months. The study cohort consisted of 88 matched pairs. Thirty-day and 12-month mortality was 29.5% and 34.1% in cangrelor-treated patients and 36.4% and 47.1% in control group (P = 0.34 and P = 0.08, respectively). The rate of definite acute stent thrombosis was 2.3% in both groups. Moderate and severe bleeding events occurred in 21.6% in the cangrelor and 19.3% in the control group (P = 0.71). Patients treated with cangrelor more frequently experienced ≥1 TIMI flow grade improvement during PCI (92.9% vs. 81.2%, P = 0.02).Conclusion: Cangrelor treatment was associated with similar bleeding risk and significantly better TIMI flow improvement compared with oral P2Y12 inhibitors in CS patients undergoing PCI. The use of cangrelor in CS offers a potentially safe and effective antiplatelet option and should be evaluated in randomized trials. [ABSTRACT FROM AUTHOR]

Keywords: blood platelets; metoclopramide; myocardial infarction; physiology; ticagrelor EN blood platelets metoclopramide myocardial infarction physiology ticagrelor 1354 1356 3 04/27/20 20200421 NES 200421 Current evidence suggests an adverse effect of morphine on platelet inhibition induced by P2Y SB 12 sb receptor antagonists, which may lead to decreased peak plasma levels and subsequent early treatment failure in patients with acute myocardial infarction (AMI).[[1], [2], [3], [4]] Metoclopramide (MCP) is a prokinetic drug that is usually given in combination with morphine to prevent nausea and vomiting resulting from morphine administration.[5] However, the effect of the coadministration of MCP to morphine on the pharmacokinetics and pharmacodynamics of ticagrelor and its metabolite is unknown. Coadministration of MCP with morphine increased the total exposure to ticagrelor and its active metabolite in blood and resulted in higher concentrations of ticagrelor and AR-C124910XX in comparison with the administration of morphine only. The main finding of the MonAMI trial is that MCP coadministration with morphine positively influences pharmacokinetics and pharmacodynamics of ticagrelor and may have rescue effects on the morphine/ticagrelor interaction. [Extracted from the article]

Aims Studies comparing reperfusion efficacy and myocardial damage between diabetic and non-diabetic patients with ST-elevation myocardial infarction ( STEMI) are scarce and have reported conflicting results. The aim was to investigate the impact of preadmission diabetic status on myocardial salvage and damage as determined by cardiac magnetic resonance ( CMR), and to evaluate its prognostic relevance. Materials and Methods We enrolled 792 patients with STEMI at 8 sites. CMR core laboratory analysis was performed to determine infarct characteristics. Major adverse cardiac events ( MACE), defined as a composite of all-cause death, non-fatal re-infarction and new congestive heart failure, were recorded at 12 months. Patients were categorized according to preexisting diabetes mellitus ( DM), and according to insulin-treated DM ( ITDM) and non-insulin-treated DM ( NITDM). Results One-hundred and sixty (20%) patients had DM and 74 (9%) were insulin-treated. There was no difference in the myocardial salvage index, infarct size, microvascular obstruction and left ventricular ejection fraction between all patient groups (all P > .05). Patients with DM were at higher risk of MACE (11% vs 6%, P = .03) than non- DM patients. After stratification according to preadmission anti-diabetic therapy, MACE rate was comparable between NITDM and non- DM ( P > .05), whereas the group of ITDM patients had significantly worse outcome ( P < .001). Conclusions Diabetic patients with STEMI, especially those having ITDM, had an increased risk of MACE. The adverse clinical outcome was, however, not explained by an impact of DM on reperfusion success or myocardial damage. Clinical trial registry number: NCT00712101. [ABSTRACT FROM AUTHOR]