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Objectives: This study evaluated the usability and contrast volume savings of the novel DyeVert™ System., Background: During coronary diagnostic and interventional procedures, a substantial portion of injected contrast does not contribute to vessel imaging due to reflux into the ascending aorta. Contrast volume is the primary physician modifiable risk factor for prevention of contrast-induced acute kidney injury CI-AKI which is a frequent complication in patients undergoing coronary angiographic procedures and is related to increases in morbidity, mortality, and healthcare costs., Methods: In this pilot trial, 44 patients undergoing coronary diagnostic and/or percutaneous coronary intervention (PCI) procedures were enrolled in two centers. All procedures were conducted using a manual manifold injection setup and the DyeVert System, which facilitates the diversion of excess contrast volume prior to injection into the patient. Direct measurements of both the amount of contrast that was attempted to be injected and the actual volume injected into the patient were taken., Results: The difference between the two amounts indicated the volume saved. Procedure types included 34 diagnostic studies and 10 PCI. The mean percent volume saved by the DyeVert System was 47%, with a corresponding P value of <0.0001 achieving the pre-specified level of greater than 15% of contrast media being saved. Mean volume savings were similar for both diagnostic (47 ± 9%) and PCI (50 ± 9%) procedures. Image quality was good in 43/44 (98%) patients., Conclusions: The DyeVert System substantially decreases contrast delivered to patients during diagnostic or interventional coronary procedures while maintaining adequate image quality. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: A significant portion of patients with ST-elevation myocardial infarction (STEMI) display multivessel coronary artery disease. However, data on the association of multivessel coronary artery disease and reperfusion success are scarce. The aim of the current study was to analyse the impact of multivessel coronary artery disease on myocardial salvage assessed by cardiac magnetic resonance imaging in a large unselected cohort of STEMI patients., Methods: STEMI patients ( n=738) included in the AIDA STEMI trial underwent primary percutaneous coronary intervention within 12 hours after symptom onset. Cardiac magnetic resonance imaging was performed 3 days after the index event (interquartile range (IQR) 2-4). The severity of coronary artery disease was graded as single-vessel disease compared to multivessel disease. The primary endpoint was defined as a composite of death, non-fatal myocardial re-infarction and congestive heart failure (major adverse cardiac events) at 12 months., Results: Multivessel coronary artery disease was present in 46.3% ( n=342) of all patients. Patients with multivessel coronary artery disease were older and more often had diabetes in comparison to those with single-vessel disease ( P<0.001 and P=0.005). Angiographic and electrocardiographic reperfusion success defined as Thrombolysis in Myocardial Infarction flow III post-percutaneous coronary intervention and ST-segment resolution ⩾70% were similar between both groups ( P=0.48 and P=0.21). Patients with multivessel disease displayed no significant difference with respect to myocardial salvage index (49.8 (IQR 31.4-71.6) versus 52.7 (IQR 35.1-67.1), P=0.81) in comparison to patients with single-vessel disease. The presence of multivessel coronary artery disease was identified as an independent predictor for the time-dependent occurrence of major adverse cardiac events (hazard ratio 3.25, 95% confidence interval 1.53-6.91, P=0.002)., Conclusion: Although multivessel coronary artery disease is not associated with impaired reperfusion success assessed by cardiac magnetic resonance imaging, patients with multivessel disease are at a high risk of adverse clinical outcomes., Clinical Trial Registration: Clinicaltrials.gov NCT00712101.

Primary percutaneous coronary intervention (PCI) is the treatment of choice in patients with ST-elevation myocardial infarction (STEMI) presenting within 12 h of symptom onset. A benefit in the subacute stage is less clear. The aim of the present analysis was to compare myocardial salvage and infarct size between patients with early and late reperfusion after STEMI. We compared cardiac magnetic resonance (CMR) data from a randomized controlled trial (RCT) in STEMI patients presenting within 12 h (n = 695) and a RCT of subacute STEMI patients presenting between 12 and 48 h (n = 93) after symptom onset. CMR imaging was performed 3.9 ± 6.3 days after myocardial infarction. Analyses were performed for an unmatched cohort comprising all patients (n = 788) and a cohort matched for area at risk (n = 186). In the overall cohort, area at risk was similar in both groups [37.1 ± 16.1% of left ventricular mass (%LV) vs. 38.3 ± 16.2%LV; p = 0.50]. Compared to STEMI patients with early reperfusion, patients with late PCI demonstrated larger infarct size (18.0 ± 12.5%LV vs. 28.9 ± 16.9%LV; p < 0.01) and higher extent of microvascular obstruction (1.5 ± 2.9%LV vs. 2.7 ± 4.1%LV; p = 0.01). Myocardial salvage index was significantly smaller in patients with late reperfusion (52.1 ± 25.9 vs. 27.4 ± 26.0; p < 0.01). Analysis of the matched cohorts confirmed the decreased myocardial salvage (p < 0.01) and increased infarct size (p < 0.01) in case of late reperfusion. Compared to patients with timely primary PCI, late reperfusion after STEMI results in decreased myocardial salvage and increased infarct size. However, salvageable myocardium was also found in subacute stages of STEMI.

Background: The current study presents data from a real-world cohort of patients with refractory cardiogenic shock (CS) undergoing extracorporeal life support (ECLS) focusing on the comparison of elderly versus younger patients., Methods and Results: One hundred consecutive patients with refractory CS underwent percutaneous ECLS implantation performed by interventional cardiologists. Follow-up was performed at hospital discharge as well as at a median of 18 months [interquartile range 15-36]. Patients were grouped according to median age (≤60 versus >60 years). ECLS could be weaned in more than half of the cohort (n = 56, 56%) with no differences between the age groups (p = 1.00). Despite similar rates of initial haemodynamic stabilisation, in-hospital mortality was higher in patients >60 years (82% versus 58%, p = 0.02). At mid-term follow-up, only three patients were alive in the group of patients >60 years. This resulted in a mortality rate of 94% in the elderly in comparison with 68% in patients aged ≤60 years (p = 0.001)., Conclusions: Despite a high rate of initial successful ECLS weaning, mid-term prognosis of patients with CS undergoing ECLS above the age of 60 years is poor with superior results in patients aged ≤60 years.

Background: Despite the improvement of therapeutic options for patients in acute myocardial infarction (AMI), cardiogenic shock (CS) remains a complication with high mortality rates. Organ failure centrally determines the prognosis of these high-risk patients. Aim of the current study was to assess the incidence of hypoxic hepatitis (HH) in CS, its laboratory detection evaluating novel and established biomarkers and to estimate the prognostic relevance of HH in current clinical practice., Methods: In 172 patients with CS complicating AMI, blood samples were collected at admission and after 1 day as prespecified subanalysis of the intra-aortic balloon pumping IABP-SHOCK II trial. Classic parameters of HH were measured in addition to argininosuccinate synthase 1 and sulfotransferase isoform SULT2A1 was determined as new biomarker using standard enzyme-linked immunosorbent assay kits. All-cause mortality at 30 days was used for outcome assessment., Results: The overall mortality rate was 40%. The incidence of HH with an increase of aminotransferase levels to be 20 times above the upper normal level was 18%. Patients with HH had a distinctly higher 30-day mortality rate compared to patients without HH (68 vs. 34%; p < 0.001). After multivariable adjustment aspartate-aminotransferase (ASAT) remained an independent predictor of 30-day mortality together with serum lactate and serum creatinine, while the new biomarkers failed to predict outcome. Comparing different liver markers using receiver operating characteristic analysis, ASAT showed the highest area under the curve for the prediction of outcome., Conclusions: HH occurs frequently in CS and is associated with particular poor outcome. As conventional biomarker, ASAT is the strongest laboratory predictor of outcome. ClinicalTrials.gov Identifier: NCT00491036.

Background: Catalytic iron (CI) is unbound ferric iron with the potential to generate reactive oxygen species with further deleterious vascular effects. In acute coronary syndromes, high levels of CI are linked to all-cause mortality. The prognostic impact of CI and iron metabolism in cardiogenic shock (CS) is currently undetermined. Aims of this study were to investigate the prognostic impact of CI and to identify predictors of high CI levels in patients with CS complicating acute myocardial infarction., Methods: The Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial randomized 600 patients with CS to either therapy with intraaortic balloon pump or control. In 185 of these patients, blood samples were systematically collected at baseline and day 3. CI levels were measured using a modified bleomycin detectable iron assay. Furthermore, levels of free hemoglobin, total serum iron, transferrin, total iron binding capacity, ferritin, hepcidin, and transferrin saturation were assessed., Results: Patients with baseline CI levels in the highest quartile had a worse outcome in comparison to patients with lower CI (day 1: HR 1.91 [1.11-3.31], p=0.005; day 3: HR 2.15 [1.06-4.34], p=0.01). In multivariable Cox-regression analysis baseline CI remained an independent predictor of 30-day mortality (HR per 10LOG 2.08 [1.25-3.47], p=0.005). Predictors of CI levels on day 3 were baseline CI, bleeding events, and baseline troponin T., Conclusions: CI levels were associated with increased short-term mortality in CS complicating acute myocardial infarction. High levels of CI at day 3 were associated with bleeding and high troponin levels., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: There is evidence suggesting a positive effect of cigarette smoking on myocardial tissue reperfusion and clinical outcomes in patients with myocardial infarction ('smoker's paradox'). We aimed to evaluate the relationship of smoking with cardiac magnetic resonance (CMR)-determined myocardial salvage and damage as well as clinical outcomes in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI)., Methods and Results: This multicentre study included 727 consecutive STEMI patients reperfused within 12 h after symptom onset. CMR imaging parameters [area at risk (AAR), infarct size (IS), myocardial salvage index (MSI), and microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH)] were compared according to admission smoking status. Major adverse cardiac event (MACE) rates at 12 months after infarction were compared between groups. Three hundred and thirty-nine (46.6%) patients were current smokers. There was no difference in the extent of AAR [35 (24-47) vs. 37 (27-49) % of left ventricular volume (LV), P = 0.10], IS [16 (8-25) vs. 17 (10-26) %LV, P = 0.21], MSI [53 (29-70) vs. 52 (34-71), P = 0.47], MVO [0 (0-1.7) vs. 0 (0-1.6) %LV, P = 0.91], or in the frequency of IMH (42 vs. 39%, P = 0.58) between smokers and non-smokers. Smokers had lower MACE (3.8 vs. 8.2%, P = 0.01) rates. However, adjustment for differences in baseline risk factors attenuated the association of smoking with MACE markedly (hazard ratio = 0.71, 95% confidence interval 0.36-1.38, P = 0.31)., Conclusion: Smoking is not associated with PPCI efficacy (myocardial salvage) or irreversible myocardial damage in patients with STEMI. The lower MACE rate of smokers was entirely explained by differences in baseline risk characteristics, thus challenging the existence of a smoker's paradox., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Background: In myocardial infarction without cardiogenic shock (CS), the affected coronary vessel has significant influence on the final infarct size and patient prognosis. CS data on this relation are scarce. The objective of this study was to determine the prognostic relevance of the culprit lesion location in patients with CS complicating acute myocardial infarction., Methods: In the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial patients with CS were randomized to therapy with intraaortic balloon pump or control. Additional CS patients not eligible for the randomized trial were included in a registry. We compared the location of the culprit lesions in these patients with regard to the affected coronary vessel [left main (LM), left anterior descending (LAD), left circumflex (LCX) and right coronary artery (RCA)] and location within the vessel (proximal, mid or distal) regarding short- and long-term outcome., Results: Of 758 patients, the majority had the culprit lesion in the LAD (44 %) compared to RCA (27 %), LCX (19 %) or LM (10 %). Proximal lesions were more frequent than mid or distal culprit lesions (60 vs. 27 vs. 13 %, p < 0.001). No differences were observed for mortality with respect to either culprit vessel (log-rank p value = 0.54). In contrast, a higher mortality was observed for patients with distal culprit lesions after 1 year (log-rank p value = 0.04). This difference persisted after multivariable adjustment (hazard ratio for distal lesions 1.40; 95 % confidential interval 1.03-1.90; p = 0.03)., Conclusion: For patients with CS complicating myocardial infarction, the culprit vessel seems to be unrelated with mortality whereas distal culprit lesions may have a worse outcome.

Data on the impact of initial Thrombolysis In Myocardial Infarction (TIMI) flow in the culprit coronary artery on myocardial damage after ST-elevation myocardial infarction (STEMI) are limited. Aim of this multicenter study was, therefore, to elucidate the impact of TIMI flow grade before percutaneous coronary intervention (PCI) on infarct size (IS), myocardial salvage index (MSI), and microvascular obstruction (MVO) assessed by cardiac magnetic resonance (CMR) imaging in patients with STEMI. We enrolled 738 patients with STEMI reperfused by primary PCI within 12 hours after symptom onset at 8 centers. Impaired coronary flow was defined as an initial coronary TIMI flow grade ≤1, whereas preserved coronary flow was defined as an initial coronary TIMI flow grade ≥2. CMR was performed in median 3 days (interquartile range 2 to 4 days) after infarction using a standardized infarction protocol. IS, MVO, and MSI were determined in central core laboratory-masked analyses. The primary clinical end point of the study was the time to major adverse cardiac events defined as death, reinfarction, and new onset of heart failure within 12 months after infarction. TIMI flow ≤1 before PCI was present in 507 patients (68.7%) and was significantly associated with larger IS (19% left ventricular [LV] vs 9% LV; p <0.001), less MSI (0.46 vs 0.65; p <0.001), reduced left ventricular ejection fraction (49% vs 55%; p <0.001), and a higher extent of MVO (0.6% LV vs 0.0% LV; p <0.001). Moreover, TIMI flow before PCI was identified as an independent predictor of IS, MVO, and MSI. However, there were no significant differences in major adverse cardiac event rates between groups (6.1% vs 7.5%; p = 0.48). In conclusion, TIMI flow pre-PCI is reversely associated with myocardial injury and is an independent predictor of myocardial damage assessed by CMR., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine whether manual thrombus aspiration reduces microvascular obstruction assessed by cardiac magnetic resonance imaging in patients with ST-segment elevation myocardial infarction (STEMI) presenting late after symptom onset., Background: Thrombus aspiration is an established treatment option in patients with STEMI undergoing primary percutaneous coronary intervention (PCI). However, there are only limited data on the efficacy of thrombus aspiration in patients with STEMI presenting ≥12 h after symptom onset., Methods: Patients with subacute STEMI presenting ≥12 and ≤48 h after symptom onset were randomized to primary PCI with or without manual thrombus aspiration in a 1:1 ratio. Patients underwent cardiac magnetic resonance imaging 1 to 4 days after randomization. The primary endpoint was the extent of microvascular obstruction., Results: A total of 152 patients underwent randomization. The mean time between symptom onset and PCI was 28 ± 12 h. Baseline characteristics were comparable between groups. The majority of patients (60%) showed at least a moderate amount of viable myocardium in the affected region. Extent of microvascular obstruction was not significantly different between patients assigned to thrombus aspiration and the control group (2.5 ± 4.0% vs. 3.1 ± 4.4% of left ventricular mass, p = 0.47). There were also no significant differences in infarct size, myocardial salvage, left ventricular ejection fraction, and angiographic and clinical endpoints between groups., Conclusions: In this first randomized trial of thrombectomy in patients with STEMI presenting late after symptom onset, routine thrombus aspiration before PCI failed to show a benefit for markers of reperfusion success. (Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset; NCT01379248)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Despite successful restoration of epicardial coronary blood flow, a significant proportion of patients with ST-elevation myocardial infarction suffer from an impairment of the microvascular perfusion - a phenomenon termed no-reflow or microvascular injury (MVI). The underlying pathophysiology is complex and likely multifactorial. It is well established that MVI is associated with worse clinical outcome. Although MVI can be detected during coronary intervention and the post-infarction period, its prevention and treatment strategies remain a major challenge since most results of clinical studies have been disappointing so far. This review provides an overview on the main pathophysiological mechanisms of MVI and its diagnostic approaches. Moreover, it will discuss its clinical consequences and current strategies of prevention and treatment.

Background: Data on the prognostic value of the shock index in patients with ST-elevation myocardial infarction (STEMI) are scarce. Furthermore, the relationship of the shock index with myocardial damage is unknown. The aim of this study was to evaluate the association of the shock index with markers of myocardial damage and clinical outcome in patients with STEMI., Methods and results: This multicenter study analyzed 791 patients. Patients were categorized in 2 groups according to the admission shock index (optimized cut-off=0.62). Infarct severity was determined by cardiac magnetic resonance (CMR) imaging. Patients with cardiogenic shock that were unable to undergo CMR acquisition were excluded. Major adverse cardiac events (MACE) were defined as a composite of death, reinfarction and congestive heart failure within 12 months. Patients with elevated admission shock index (n=321 [40.6%]) had a significantly larger area-at-risk (37.6 [27.8-50.4] % of left ventricular volume [LV] vs. 34.3 [24.5-46.0] % LV, P=0.02), larger infarct size (19.5 [10.7-28.0] % LV vs. 14.9 [7.7-22.3] % LV, P<0.001), lower myocardial salvage index (46.2 [27.9-64.5] vs. 53.5 [36.5-75.2], P<0.001), and a larger extent of microvascular obstruction (0.3 [0.0-2.2] % LV vs. 0.0 [0.0-1.4] % LV, P=0.01). An elevated shock index was associated with reduced MACE-free survival (P<0.001). Furthermore, the admission shock index was identified as an independent predictor of MACE (hazard ratio=2.92 [1.24-4.22], P<0.01)., Conclusions: STEMI patients with an elevated admission shock index had more pronounced myocardial and microvascular damage. Moreover, the shock index was independently associated with MACE at 12 months.

Aims: Remote ischaemic conditioning (RIC) and postconditioning (PostC) are both potent activators of innate protection against ischaemia-reperfusion injury and have demonstrated cardioprotection in experimental and clinical ST-elevation myocardial infarction (STEMI) trials. However, their combined effects have not been studied in detail. The aim of this study was to evaluate if the co-application of intrahospital RIC and PostC has a more powerful effect on myocardial salvage compared with either PostC alone or control., Methods and Results: This prospective, controlled, single-centre study randomized 696 STEMI patients to one of the following three groups: (i) combined intrahospital RIC + PostC in addition to primary percutaneous coronary intervention (PCI); (ii) PostC in addition to PCI; and (iii) conventional PCI (control). The primary endpoint myocardial salvage index was assessed by cardiac magnetic resonance (CMR) imaging within 3 days after infarction. Secondary endpoints included infarct size and microvascular obstruction (MVO) assessed by CMR. The combined clinical endpoint consisted of death, reinfarction, and new congestive heart failure within 6 months. The primary endpoint myocardial salvage index was significantly greater in the combined RIC + PostC group when compared with the control group (49 [interquartile range 30-72] vs. 40 [interquartile range 16-68], P = 0.02). Postconditioning alone failed to improve myocardial salvage when compared with conventional PCI (P = 0.39). The secondary endpoints, including infarct size and MVO, showed no significant differences between groups. Clinical follow-up at 6 months revealed no differences in the combined clinical endpoint between groups (P = 0.44)., Conclusion: Combined intrahospital RIC + PostC in conjunction with PCI in STEMI significantly improves myocardial salvage in comparison with control and PostC., Clinicaltrialsgov: NCT02158468., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Aims: Angiopoietin-2 (Ang-2) is a mediator of capillary leakage, and increased Ang-2 levels were associated with poor in-hospital outcome in a pilot study in cardiogenic shock (CS). In this larger study, we followed this hypothesis and aimed at assessing the predictive role of Ang-2 on short- and long-term mortality, investigating the effect of intra-aortic balloon pump (IABP) treatment on Ang-2 levels, and identifying clinical and procedural predictors of increased Ang-2., Methods and Results: In the IABP-SHOCK II-trial, 600 patients with CS complicating acute myocardial infarction were assigned to therapy with or without IABP. This substudy included 189 randomized patients with serial blood sampling performed at days 1, 2, and 3. No significant differences in Ang-2 levels were found between patients with or without IABP. The Ang-2 levels above the median at day 1 were associated with 30-day [hazard ratio (HR) 1.98, 95% confidence interval (CI) 1.26-3.10, P = 0.002) and 1-year mortality (HR 2.21, 95% CI 1.49-3.27, P < 0.001). Stratification of patients according to Ang-2 levels at day 3 increased these associations (30 days HR 5.15, 95% CI 2.80-9.45, P < 0.001; 1 year HR 5.24, 95% CI 3.19-8.58, P < 0.001). The Ang-2 concentrations were independent predictors for mortality in multivariate analysis (30 days HR 4.82, 95% CI 1.52-15.23, P = 0.007; 1 year HR 2.01, 95%CI 1.24-3.24, P = 0.005). Predictors of increased Ang-2 levels at day 3 were baseline Ang-2, development of acute kidney injury, bleeding events or transfusion, and impaired reperfusion., Conclusion: In CS, high levels of Ang-2 are independently associated with poor short- and long-term outcome and associated with the reperfusion success as well as complications., Clinical Trial Registration: URL: www.clinicaltrials.gov; unique identifier: NCT00491036., (© 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.)

Background: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains., Methods: We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90., Results: A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-RIPC group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis. No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium. No RIPC-related adverse events were observed., Conclusions: Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery. (Funded by the German Research Foundation; RIPHeart ClinicalTrials.gov number, NCT01067703.).

Aims: Intravenous (IV) morphine has been shown to be independently associated with adverse clinical outcome in patients with non-STEMI. Currently, there are no data on the association of IV morphine and reperfusion success in STEMI. Thus, we thought to analyse the impact of IV morphine on ischemic injury and salvaged myocardium assessed by cardiac magnetic resonance imaging (CMR) in patients with STEMI reperfused by primary coronary intervention (PCI)., Methods and Results: STEMI patients reperfused by primary PCI (n = 276) within 12 h after symptom onset underwent CMR 3 days after the index event [interquartile range (IQR) 2-4]. IV morphine administration was recorded in all patients. IV morphine was administered in 44.7% (n = 123) of all patients. Patients in the IV morphine group displayed larger infarct size, higher extent of MO and lower myocardial salvage index (MSI) in comparison to the non-IV morphine group (all p < 0.05). In multivariable logistic regression analysis adjusted for TIMI-flow pre-PCI, time from symptom onset to PCI, Killip class and left ventricular ejection fraction, IV morphine was identified as an independent predictor for MSI

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.

Background: In cardiogenic shock (CS) renal dysfunction is an important parameter of inadequate end-organ perfusion and an independent predictor of adverse outcome. Early detection of renal dysfunction is therefore important, and novel biomarkers such as Neutrophil Gelatinase-Associated Lipocalin (NGAL), Kidney Injury Molecule 1 (KIM1) and Cystatin C (CysC) have been suggested. However, in high-risk CS patients their role for assessing renal injury has not yet been investigated in comparison to the most widely used serum creatinine., Methods: This predefined substudy included 190 patients of the randomized Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II)-trial. Blood samples were collected directly during primary percutaneous coronary intervention, one day and two days after randomization. The primary endpoint for outcome assessment was 1 year mortality., Results: Creatinine, NGAL and KIM-1 were significantly higher in non-survivors in comparison to survivors over time in ANOVA (p<0.001; p=0.002 and p=0.04, respectively). In contrast, CysC levels were not associated with the primary endpoint (p=0.15). Receiver operator characteristics revealed that creatinine at any time point had the best predictive value for 1 year mortality. This was also true when comparing creatinine to different equations for glomerular filtration rate. In multivariable Cox-regression analysis creatinine remained the only significant independent predictor of kidney biomarkers of time to death during the first year., Conclusions: Assessment of novel biomarkers such as CysC, NGAL and KIM-1 or calculation of glomerular filtration rate provide no additional prognostic information in patients with CS complicating acute myocardial infarction in comparison to creatinine., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Purpose: Angiopoietin-2 (Ang-2) impairs endothelial integrity. The association of Ang-2 in the presence of oedema and outcome of patients with acute decompensated heart failure (ADHF) has not been investigated., Methods and Results: Angiopoietin-2 was measured in 132 ADHF patients, which were included in a monocentric, prospective trial (Clinicaltrials.gov: NCT01429857). Primary endpoint was all-cause death at 6-months. 20 healthy persons served as control group (HC). In ADHF patients, mean Ang-2 concentration at admission was significantly increased compared to HC (2,111 ± 117 vs. 971 ± 46 pg/ml, p = 0.0002). Ang-2 was increased in patients with compared to those without peripheral oedema (2,294 ± 140 vs. 1,540 ± 170 pg/ml; p = 0.009) and in patients with NYHA class III or IV symptoms compared to those with NYHA class II symptoms (2,256 ± 132 vs. 1,341 ± 380 pg/ml, p = 0.023). During the 6-month follow-up, 10 patients died. In survivors, Ang-2 significantly decreased at discharge compared to admission (2,046 ± 118 vs. 1,431 ± 93 pg/ml; p < 0.0001). Non-survivors showed no difference between Ang-2 concentration at admission and discharge (3,296 ± 594 vs. 2,909 ± 536 pg/ml). Ang-2 concentrations at discharge above 2,500 pg/ml were associated with an increased risk of death compared to Ang-2 concentrations below this threshold (Hazard ratio 8.8; 95 % confidence interval; 2.48-31.16, p < 0.001)., Conclusion: In ADHF patients, Ang-2 is significantly increased compared to healthy controls, shows a relationship in the presence of oedema and is a predictor of poor outcome.

In cardiogenic shock (CS), pathophysiological changes include microcirculatory dysfunction, vascular leakage, and an increase in platelet and leukocyte adhesion to the endothelium, as well as endothelial activation and dysfunction. The endothelial glycocalyx has been recognized as a central modulator of these processes. Glycosaminoglycan heparan sulfate is a major component of the glycocalyx of endothelial cells, and syndecan-1 (S1) represents the most prevalent proteoglycan. The aim of the current study was to investigate circulating levels of the glycocalyx components in patients with infarct-related CS. In 184 patients with CS complicating acute myocardial infarction, blood samples were collected at admission and after one day. Intra-aortic balloon pumping was used in 94 patients (51%). Glycosaminoglycan heparan sulfate and S1 were measured using standard enzyme-linked immunosorbent assay kits. All-cause mortality at 30 days was used for outcome assessment. Levels of S1 decreased between days 1 and 2 (339 [interquartile range [QR], 109-852] vs. 220 [IQR, 57-606] ng/mL; P = 0.01). In contrast, glycosaminoglycan heparan sulfate increased over time (1.9 [IQR, 0.3-6.4] vs. 7.1 [IQR, 3.7-11.7] mg/mL; P < 0.001). Survivors at 30 days had lower admission S1 levels (P < 0.001). In multivariable analysis, S1 remained an independent predictor of 30-day mortality (odds ratio per μg/mL, 2.2 [95% confidence interval, 1.30-3.58]; P = 0.003) together with serum lactate, age, and ejection fraction. Increased levels of S1 are an independent predictor of short-term mortality in patients with acute myocardial infarction and CS.ClinicalTrials.gov Identifier: NCT00491036.

Aims: This study aimed to assess the incidence and impact of cerebral embolic events after the MitraClip procedure., Methods and Results: Twenty-seven high-risk patients (logistic EuroSCORE I 25±15%) underwent the MitraClip procedure and cerebral diffusion-weighted magnetic resonance imaging (MRI) in median two days before and three days after the procedure. On the same day, neurocognitive function was assessed using the Montreal Cognitive Assessment (MoCA) questionnaire and thorough clinical examination. Comparison of pre- and post-interventional MRI showed that 23 of 27 patients (85.7%) had newly acquired microembolic lesions with in median three (interquartile range 1-9) new lesions per patient. Of these, three patients (11.1%) had lesions with diameter >5 mm. Patients with >3 new cerebral embolic lesions (n=13, 48%) had a lower post-interventional MoCA score in comparison to patients with ≤3 embolic lesions (23.6±3.6 vs. 20.3±4.5; p=0.046) in univariate analysis. Multivariate stepwise regression analysis identified device time as an independent predictor of the number of post-procedural new lesions (p=0.003) and, for reduced post-interventional MoCA score, a low MoCA score at baseline (p<0.001)., Conclusions: The MitraClip procedure results in new ischaemic cerebral lesions in the vast majority of patients. Preliminary data suggest that these lesions are clinically without significant impact on global cognitive function. ClinicalTrials.gov: NCT01288976.

Objectives: The aim of this analysis was to assess the 7-year long-term safety and effectiveness of a randomized comparison of percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of isolated proximal left anterior descending lesions., Background: Long-term follow-up data comparing PCI by SES and MIDCAB surgery for isolated proximal left anterior descending lesions are sparse., Methods: Patients were randomized either to PCI with SES (n = 65) or MIDCAB (n = 65). Follow-up data were obtained after 7 years with respect to the primary composite endpoint of death, myocardial infarction, and target vessel revascularization. Angina was assessed by the Canadian Cardiovascular Society classification and quality of life with Short Form 36 and MacNew quality of life questionnaires., Results: Follow-up was conducted in 129 patients at a median time of 7.3 years (interquartile range: 5.7, 8.3). There were no significant differences in the incidence of the primary composite endpoint between groups (22% PCI vs. 12% MIDCAB; p = 0.17) or the endpoints death (14% vs. 17%; p = 0.81) and myocardial infarction (6% vs. 9%, p = 0.74). However, the target vessel revascularization rate was higher in the PCI group (20% vs. 1.5%; p < 0.001). Clinical symptoms and quality of life improved significantly from baseline with both interventions and were similar in magnitude between groups., Conclusions: At 7-year follow-up, PCI by SES and MIDCAB in isolated proximal left anterior descending lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint and quality of life. Target vessel revascularization was more frequent in the PCI group. (MIDCAB Versus DES in Proximal LAD Lesions; NCT00299429)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Introduction: Cardiogenic shock (CS) is the leading cause of death in patients hospitalized with acute myocardial infarction (AMI). Biomarkers might help in risk stratification and understanding of pathophysiology. Preliminary data suggests that patients with CS face a profound increase in the osteocyte-derived hormone fibroblast growth factor 23 (FGF-23), which acts as a negative regulator of serum phosphate levels. The present study aimed to assess the predictive role of FGF-23 for clinical outcome in a large cohort of CS patients with and without renal dysfunction., Methods: In the randomized Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial, 600 patients with CS complicating AMI were assigned to therapy with or without IABP. Our predefined biomarker substudy included 182 patients. Blood sampling was performed in a standardized procedure at three different time points (day 1 (day of admission), day 2 and day 3). Differences in outcome of patients with FGF-23 levelsmedian were compared by log-rank testing. Stepwise logistic regression modeling was performed to identify predictors of death at 30 days and Cox regression analysis for time to death during the first year., Results: At all three time points, nonsurvivors had significantly higher FGF-23 levels compared to survivors (P<0.001 for all). Patients with FGF-23 levels above the median (395 RU/mL [interquartile range 102;2,395]) were characterized by an increased 30-day mortality and 1-year mortality. In multivariable analysis FGF-23 levels remained independent predictors for 30-day (odds ratio per 10log 1.80, 95% confidence interval (CI) 1.11 to 2.92; P=0.02) and 1-year mortality (hazard ratio 1.50, 95% CI 1.11 to 2.04, P=0.009). After stratifying the patients according to their baseline serum creatinine levels, the negative prognostic association of increased FGF-23 was only significant in those with serum creatinine greater than median., Conclusions: In CS, high levels of FGF-23 are independently related to a poor clinical outcome. However, this prognostic association appears only to apply in patients with impaired renal function., Trial Registration: ClinicalTrials.gov NCT00491036. Registered 22 June 2007.

Background: In patients with left-sided native-valve infective endocarditis (IE), the risk of embolism is increased with a vegetation size ≥10 mm. For this reason-according to guidelines-surgery may be considered in patients with isolated large vegetations (without any other indication for surgery). However, the value of surgery in this patient subset has never been systematically studied., Hypothesis: We hypothesized that surgery may be superior to medical therapy in terms of clinical outcome in the aforementioned patients., Methods: All patients who presented at our institution between January 2000 and July 2012 with isolated left-sided native-valve IE and large vegetations (≥10 mm) were examined. Patients with conventional indications for surgical treatment were excluded. Follow-up for clinical events was performed according to predefined definitions., Results: A total of 71 patients with left-sided native-valve IE and isolated large vegetations qualified for inclusion into the study cohort. Mean vegetation length was 17 ± 5 mm. A total of 59 patients underwent surgery after a mean of 5 ± 6 days following the initiation of antibiotic treatment. Mean follow-up duration was 6.0 ± 2.9 years. Surgical compared to purely medical treatment was associated with a significant increase in long-term all-cause mortality (P = 0.03 by log-rank test, unadjusted analysis). Upon multivariable Cox regression analysis, surgical treatment, affection of mitral valve, blood cultures positive for Staphylococcus aureus, and increasing age showed trends as independent predictors of long-term mortality., Conclusions: Surgical treatment in patients with left-sided native-valve IE and isolated large vegetations without any other indication for surgery seems to be associated with excess mortality. A randomized controlled trial of surgery vs conservative treatment in this subset of patients is justified., (© 2014 Wiley Periodicals, Inc.)

Background: Although the prognostic value of findings from cardiac magnetic resonance (CMR) imaging has been established in single-center center studies in patients with ST-segment elevation myocardial infarction (STEMI), a large multicenter investigation to evaluate the prognostic significance of myocardial damage and reperfusion injury is lacking., Objectives: The aim of this study was to assess the prognostic impact of CMR in an adequately powered multicenter study and to evaluate the most potent CMR predictor of hard clinical events in a STEMI population treated by primary percutaneous coronary intervention (PCI)., Methods: We enrolled 738 STEMI patients in this CMR study at 8 centers. The patients were reperfused by primary PCI <12 h after symptom onset. Central core laboratory-masked analyses for quantified left ventricular (LV) function, infarct size (IS), microvascular obstruction (MO), and myocardial salvage were performed. The primary clinical endpoint of the study was the occurrence of major adverse cardiac events., Results: Patients with cardiovascular events had significantly larger infarcts (p < 0.001), less myocardial salvage (p = 0.01), a larger extent of MO (p = 0.009), and more pronounced LV dysfunction (p < 0.001). In a multivariate model that included clinical and other established prognostic parameters, MO remained the only significant predictor in addition to the TIMI (Thrombolysis In Myocardial Infarction) risk score. IS and MO provided an incremental prognostic value above clinical risk assessment and LV ejection fraction (c-index increase from 0.761 to 0.801; p = 0.036)., Conclusions: In a large, multicenter STEMI population reperfused by primary PCI, CMR markers of myocardial damage (IS and especially MO) provide independent and incremental prognostic information in addition to clinical risk scores and LV ejection fraction. (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction [AIDA STEMI]; NCT00712101)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Nonrandomized studies suggested lower mortality rates with statin pretreatment in patients with acute ST elevation myocardial infarction (STEMI). However, clinical data are still inconclusive and the mechanisms of these presumed beneficial effects require further exploration. Cardiac magnetic resonance (CMR) imaging offers the possibility of studying a variety of markers of myocardial damage and reperfusion injury after myocardial infarction. The aim of this study was to assess a possible link of statin pretreatment with myocardial damage in acute STEMI. The multicenter Abciximab i.v. versus i.c. in ST-elevation Myocardial Infarction CMR substudy enrolled 795 consecutive patients with acute STEMI who underwent primary angioplasty within 12 hours of symptom onset. CMR studies assessing left ventricular ejection fraction, infarct size, microvascular obstruction, area at risk, and myocardial salvage index were performed in a median of 3 days after the clinical event. We performed a retrospective analysis to evaluate the impact of statin pretreatment on myocardial damage. Information on statin pretreatment was available in 791 of 795 patients (99%). Of these, 122 (15%) had long-term statin pretreatment. CMR results showed no significant differences in the area at risk, left ventricular ejection fraction, infarct size, microvascular obstruction, and myocardial salvage index between patients with and without statin pretreatment. Furthermore, no differences in short- and long-term outcomes could be observed. In conclusion, in this CMR study, statin pretreatment in patients with STEMI was not associated with lesser myocardial damage., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Aims: This study investigates the role of osteoprotegerin (OPG) and growth-differentiation factor 15 (GDF-15) as predictors of outcome in cardiogenic shock (CS) complicating acute myocardial infarction. The novel biomarkers OPG and GDF-15 have shown prognostic impact in various cardiovascular diseases including myocardial infarction. In acute myocardial infarction complicated by CS, the diagnostic and prognostic impact of these biomarkers has not been investigated yet. OPG and GDF-15 may have additional prognostic impact on early prognosis assessment, being potentially useful for decision-making in CS., Methods and Results: In the randomized Intra-aortic Balloon Pump in cardiogenic Shock II (IABP-SHOCK II)-trial, 600 patients with CS complicating acute myocardial infarction undergoing early revascularization were assigned to therapy with or without IABP. Within a pre-defined substudy, blood samples were collected from 190 patients during PCI. GDF-15 and OPG serum levels were measured with standard enzyme-linked immunosorbent assay kits. Patients with GDF-15 and OPG levels greater than the median showed higher rates of death at 30 days by χ(2) testing (OPG, 51% vs. 32%, P = 0.01; GDF-15, 52% vs. 31%, P = 0.005) and log rank testing [GDF-15, hazard ratio (HR) 1.88, 95% confidence interval (CI) 1.21-2.94; P = 0.005; OPG, HR 1.74, 95% CI 1.11-2.71; P = 0.01]. Both markers were significantly predictive of 30-day mortality in univariable logistic regression analysis. In a multivariable logistic stepwise regression model, GDF-15, TIMI (Thrombolysis In Myocardial Infarction) flow grade <3 after PCI, age, LVEF, and serum lactate remained significant predictors of 30-day mortality., Conclusion: GDF-15 on admission is a significant independent predictor of short-term mortality in infarct-related CS. Trail registration: NCT00491036., (© 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.)

Background: This study aimed to evaluate the incremental prognostic value of infarct size, microvascular obstruction (MO), myocardial salvage index (MSI), and left ventricular ejection fraction (LV-EFCMR) assessed by cardiac magnetic resonance imaging (CMR) in comparison to traditional outcome markers in patients with ST-elevation myocardial infarction (STEMI) reperfused by primary percutaneous intervention (PCI)., Methods: STEMI patients reperfused by primary PCI (n=278) within 12 hours after symptom onset underwent CMR three days after the index event (interquartile range [IQR] two to four). Infarct size and MO were measured 15 minutes after gadolinium injection. T2-weighted and contrast-enhanced CMR were used to calculate MSI. In addition, traditional outcome markers such as ST-segment resolution, pre- and post-PCI Thrombolysis In Myocardial Infarction (TIMI)-flow, maximum level of creatine kinase-MB, TIMI-risk score, and left ventricular ejection fraction assessed by echocardiography were determined in all patients. Clinical follow-up was conducted after 19 months (IQR 10 to 27). The primary endpoint was defined as a composite of death, myocardial reinfarction, and congestive heart failure (MACE)., Results: In multivariable Cox regression analysis, adjusting for all traditional outcome parameters significantly associated with the primary endpoint in univariable analysis, MSI was identified as an independent predictor for the occurrence of MACE (Hazard ratio 0.94, 95% CI 0.92 to 0.96, P<0.001). Further, C-statistics comparing a model including only traditional outcome markers to a model including CMR parameters on top of traditional outcome markers revealed an incremental prognostic value of CMR parameters (0.74 versus 0.94, P<0.001)., Conclusions: CMR parameters such as infarct size, MO, MSI, and LV-EFCMR add incremental prognostic value above traditional outcome markers alone in acute reperfused STEMI., Trial Registration: Clinicaltrials.gov NCT00463749, Clinicaltrials.gov NCT00359918.

Background: The presence of pericardial effusion (PE) is considered to be suggestive of inflammation in suspected myocarditis. However, the incremental value of assessing for PE in addition to comprehensive cardiac magnetic resonance (CMR) imaging remains unclear., Methods: In total, 132 patients with suspected acute (AMC) or chronic myocarditis (CMC) were included. All patients underwent endomyocardial biopsy (EMB) and CMR. Imaging protocols included T2 imaging for the assessment of myocardial oedema (oedema ratio [ER]), T1 imaging before and after contrast agent administration for global relative enhancement (gRE) calculation, and late enhancement (LE). Furthermore, the presence and extent of PE were determined. The potential incremental diagnostic value of PE was determined by applying a two, three, or four out of four criteria approach including ER, gRE, LE, and PE., Results: PE was present in 84 of the 132 patients (63.6%) and was more common in suspected AMC vs. CMC (56 of 70 vs. 28 of 62; P < 0.001). According to EMB results, PE was found in 86% of patients with AMC, 67% with chronic myocarditis, and 56% without evidence of myocardial inflammation. Implementing PE into a three out of four approach did not result in improved accuracy compared with the established two out of three approach using ER, gRE, and LE (59 vs. 68% for the total population, 69 vs. 79% for suspected AMC, and 48 vs. 52% for suspected CMC)., Conclusion: The finding of PE in unselected patients with suspected AMC or CMC is not specific to myocarditis. Therefore, with the currently applied criteria and methods, assessment of PE does not improve the diagnostic performance of CMR in this patient cohort., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013. For permissions please email: journals.permissions@oup.com.)

Background: Current ST-elevation myocardial infarction (STEMI) guidelines recommend initiation of clopidogrel treatment as early as possible before angiography, based on pharmacokinetic and positive registry data. However, the mechanisms of the beneficial effect of clopidogrel pretreatment are unclear. Aim of this study was to investigate the impact of upstream clopidogrel on infarct size and microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in STEMI patients., Methods: STEMI patients reperfused by primary angioplasty (n=423) <12 h after symptom onset underwent CMR 3 days (IQR 2-4) after the index event. Infarct size and MO were measured 15 min after gadolinium injection as percentage of left ventricular mass (%LV). Clopidogrel administration (loading dose pre or post catheterisation laboratory arrival) was recorded., Results: A total of 19.9% (n=84) of patients received clopidogrel prior to catheterisation laboratory arrival. Infarct size did not differ significantly in patients with versus those without upstream clopidogrel treatment (17.0%LV [IQR 6.3-25.1] vs. 17.9%LV [IQR 8.7-28.8]; p=0.13). In contrast, the prevalence and extent of MO were significantly reduced in patients receiving upstream clopidogrel treatment (prevalence of MO: 57.8% vs. 73.8%; p=0.004/ extent of MO: 0.41%LV [IQR 0.00-0.90] vs. 0.80%LV [IQR 0.00-2.55]; p<0.001). After adjustment for baseline characteristics associated with the occurrence of MO, pretreatment with clopidogrel remained significantly associated with the absence of MO (OR 0.39, 95%CI 0.22-0.71; p=0.002)., Conclusions: Upstream clopidogrel treatment prior to catheterisation laboratory arrival is associated with a significant decrease in the prevalence and extent of MO. A randomised trial is warranted to confirm these results.

Intra-aortic balloon pump (IABP) counterpulsation has been the most widely used left ventricular assist device for nearly five decades. Due to diastolic inflation and systolic deflation, coronary blood flow is increased and afterload decreased translating into augmentation of oxygen supply and lowering of oxygen demand. However, IABP may be associated with serious complications, including major bleeding, stroke, local and systemic infections and vascular complications. These might counterbalance the potential beneficial hemodynamic effects. In clinical routine, IABP is mainly used in high-risk patients with acute myocardial infarction, especially when complicated by cardiogenic shock. Further, prophylactic IABP use is frequently performed in patients at high risk for hemodynamic instability undergoing elective percutaneous coronary intervention or coronary artery bypass graft surgery. Current evidence, however, does not fully support routine use of IABP in these settings. This review focuses on the basic principles of IABP and discusses current evidence., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Intra-aortic balloon pump (IABP) counterpulsation has been the most widely used left ventricular assist device for nearly five decades. Due to diastolic inflation and systolic deflation, coronary blood flow is increased and afterload decreased translating into augmentation of oxygen supply and lowering of oxygen demand. However, IABP may be associated with serious complications, including major bleeding, stroke, local and systemic infections and vascular complications. These might counterbalance the potential beneficial hemodynamic effects. In clinical routine, IABP is mainly used in high-risk patients with acute myocardial infarction, especially when complicated by cardiogenic shock. Further, prophylactic IABP use is frequently performed in patients at high risk for hemodynamic instability undergoing elective percutaneous coronary intervention or coronary artery bypass graft surgery. Current evidence, however, does not fully support routine use of IABP in these settings. This review focuses on the basic principles of IABP and discusses current evidence., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results., Methods: The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036., Findings: Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86-1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95-7·10, p=0·05), recurrent revascularisation (0·91, 0·58-1·41, p=0·77), or stroke (1·50, 0·25-8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups., Interpretation: In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality., Funding: German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig--Heart Centre; Maquet Cardiopulmonary; Teleflex Medical., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose of Review: Despite developments in treatment of myocardial infarction, mortality rates in cardiogenic shock remain unacceptably high. Intra-aortic balloon pumping (IABP) is to date the most used device for hemodynamic support, but randomized evidence on survival benefit was lacking., Recent Findings: A recently published meta-analysis with hints for higher mortality after primary percutaneous intervention challenged the previous high-grade recommendations for IABP. Therefore the use in cardiogenic shock was downgraded in the last versions of European and American guidelines from a class I to a class IIa and IIb recommendation, respectively. Furthermore, a large scale randomized trial found no benefit on 30-day mortality in patients with myocardial infarction complicated by cardiogenic shock. This result was supported by a lack of difference in all subgroups and secondary endpoints., Summary: In cardiogenic shock, no general recommendation for IABP can be given. In the next revision of current guidelines, recent randomized trial results should be incorporated. Further research is needed to develop optional treatments in cardiogenic shock or to gain validated algorithms for use of active assist devices.

Background/objectives: For osteoprotegerin (OPG), a cytokine of the tumor necrosis factor superfamily, the prognostic impact in stable coronary artery disease and acute coronary syndromes has been shown recently. In acute ST-elevation myocardial infarction (STEMI) data on the correlation to myocardial damage by cardiac magnetic resonance imaging (CMR) or clinical outcome are lacking., Methods: We studied 221 consecutive patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI) within 12h after symptom onset. Serum levels of OPG were determined from samples collected before PCI (OPG0), at 24 (OPG1) and 48 h (OPG2) after reperfusion. CMR studies for assessment of infarct size, reperfusion injury/microvascular obstruction and myocardial salvage were performed within one week after infarction. Long-term clinical follow-up for major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or new onset of congestive heart failure, was performed 18.2 (interquartile range of 9.2-21.2) months after the index event., Results: OPG levels ≥ 75th percentile were associated with significantly larger infarcts, lower myocardial salvage index and greater extent of microvascular obstruction in CMR as compared to OPG levels <75th percentile. The MACE rate for patients with OPG levels in the highest quartile was also significantly higher. In a multivariable model adjusted for known risk factors, OPG1 as a continuous variable was independently predictive for MACE., Conclusion: OPG serum levels collected 24h after infarction are independent predictors of MACE in acute STEMI patients. High OPG levels are associated with a greater extent of myocardial damage and lower myocardial salvage by CMR., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objectives: The aim of this prospective, randomized trial was to assess the 10-year long-term safety and effectiveness of percutaneous coronary intervention (PCI) and minimally invasive direct coronary artery bypass surgery (MIDCAB) for the treatment of proximal left anterior descending (LAD) lesions., Background: Long-term follow-up data comparing PCI and MIDCAB surgery for isolated proximal LAD lesions are sparse., Methods: Patients with significant isolated proximal LAD stenoses were randomized either to PCI with bare-metal stents (n = 110) or MIDCAB (n = 110). At 10 years, data were obtained with respect to the primary endpoint (death, myocardial infarction, target vessel revascularization). Angina was assessed by the Canadian Cardiovascular Society classification., Results: Follow-up was conducted for 212 patients at a median time of 10.3 years. There were no significant differences in the binary primary composite endpoint (47% vs. 36%; p = 0.12) and hard endpoints (death and infarction) between PCI and MIDCAB. However, a higher target vessel revascularization rate in the PCI group (34% vs. 11%; p < 0.01) was observed. Clinical symptoms improved significantly from baseline and were similar between both treatment groups., Conclusions: At 10-year follow-up, PCI and MIDCAB in isolated proximal LAD lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint. Target vessel revascularization was more frequent in the PCI group., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Hyperglycemia on admission is associated with increased mortality rates in patients with ST-elevation myocardial infarction (STEMI). However, data regarding the relationship between hyperglycemia and myocardial damage in STEMI are scarce. The aim of this study was to determine the relationship of diabetes mellitus status and hyperglycemia on myocardial damage assessed by cardiovascular magnetic resonance imaging and to evaluate the long-term prognostic significance of hyperglycemia in a high-risk STEMI population., Methods and Results: Glucose levels were determined on admission in 411 consecutive STEMI patients reperfused by primary angioplasty. Patients were categorized on the basis of diabetes mellitus status and admission glucose level. Magnetic resonance imaging was performed for assessment of infarct size and microvascular obstruction. The primary clinical end point was the occurrence of major adverse cardiovascular events at long-term follow-up. STEMI patients with pre-existing diabetes mellitus were at greater risk for major adverse cardiovascular events (32% versus 11%; P<0.001) despite having similar infarct sizes and extent of reperfusion injury than nondiabetic patients. Glycemic status on admission was associated with greater myocardial damage and an increased risk for major adverse cardiovascular events (P<0.001). In nondiabetic patients, the risk of severe myocardial injury started to rise once admission glucose exceeded 7.8 mmol/L, whereas the threshold was higher among patients with diabetes mellitus (≥11.1 mmol/L)., Conclusions: The higher mortality rate in diabetic versus nondiabetic STEMI patients is not explained by more pronounced myocardial damage. Hyperglycemia on admission is associated with greater myocardial injury and an increased risk of major adverse cardiovascular events at long-term follow-up. However, hyperglycemia has a stronger relationship to myocardial injury in nondiabetic compared with diabetic patients.

Background: Circulating microRNAs (miRs) have emerged as potential diagnostic markers in patients with myocardial infarction. Previous studies, however, were based on limited patient numbers and could not assess the relation of miRs to myocardial damage. Moreover, the prognostic value of miRs in ST-elevation myocardial infarction (STEMI) is unknown. The aims of this study were (1) to assess the relation between miR-133a and myocardial damage assessed by cardiovascular magnetic resonance (CMR) imaging and (2) to evaluate the prognostic value of miR-133a in reperfused STEMI., Methods: MicroRNA-133a concentrations were determined in 216 consecutive patients with STEMI undergoing primary angioplasty less than 12 hours after symptom onset. Patients were categorized into 2 groups defined by the median miR-133a value on admission. Cardiovascular magnetic resonance was performed for assessment of infarct size, myocardial salvage, and microvascular obstruction. The primary clinical end point was the occurrence of major adverse cardiovascular events defined as a composite of death, reinfarction, and new congestive heart failure within 6 months after infarction., Results: All prognostic relevant CMR markers (infarct size, microvascular obstruction, myocardial salvage index) showed significant correlations with circulating miR-133a concentrations (P < .001 for all).The strongest predictors of miR-133a concentrations were the time from symptom onset to reperfusion and the amount of the salvaged area at risk. Major adverse cardiovascular events occurred significantly more often in the miR-133a ≥ median group (9% vs 20%, P = .025). However, miR-133a concentrations were unable to independently predict clinical events., Conclusions: Elevated levels of circulating miR-133a in patients with STEMI are associated with decreased myocardial salvage, larger infarcts, and more pronounced reperfusion injury. Consequently, miR-133a concentrations can provide prognostic information but do not add independent prognostic information to traditional and CMR markers of clinical prognosis in a high-risk STEMI population., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Background: In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials., Methods: In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke., Results: A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28)., Conclusions: The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.).

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 © 2012 Mosby, Inc. All rights reserved.)

Intraaortic balloon pump (IABP) is the most widely used left ventricular support device in a variety of indications. This review focuses on the current literature and discusses the evidence of IABP in ST-elevation myocardial infarction (STEMI) with and without cardiogenic shock. In high-risk STEMI patients without cardiogenic shock several randomized clinical trials have been performed. The majority of the studies could not demonstrate an efficacy benefit for IABP as adjunctive therapy in comparison to standard treatment alone. Hence, recent meta-analyses could not reveal diverging mortality rates at a higher incidence of stroke and major bleedings with IABP use independent of the type of reperfusion therapy. IABP in STEMI patients with cardiogenic shock is recommended according to current American College of Cardiology/American Heart Association (AHA/ACC) and European Society of Cardiology (ESC) guidelines. In recent meta-analyses, IABP in cardiogenic shock complicated by STEMI has been shown to be associated with decreased mortality. However, these beneficial effects are limited to patients treated with thrombolysis, whereas in patients undergoing mechanical revascularization IABP therapy is associated with an increase in mortality. Nevertheless, these data only arise from prospective and retrospective cohort studies, as up to date only one very small randomized clinical trial has been completed. In summary, in high-risk STEMI patients without cardiogenic shock, current data do not support the use of IABP and should only be considered as a standby and bailout strategy if patients develop haemodynamic instability. Current data on IABP in patients with cardiogenic shock complicated by STEMI are scarce and highly limited due to the nonrandomized design of previous trials. However, according to current AHA/ACC and ESC guidelines its use is recommended. Although recent meta-analyses challenge current AHA/ACC/ESC guidelines, adequately powered randomized studies are needed to elucidate the role of IABP in patients with acute myocardial infarction complicated by cardiogenic shock.

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.

Objectives: The goal of this study was to assess the diagnostic performance of cardiac magnetic resonance (CMR) compared with endomyocardial biopsy in patients with suspected acute myocarditis (AMC) and chronic myocarditis (CMC)., Background: Several studies have reported an encouraging diagnostic performance of CMR in myocarditis. However, the comparison of CMR with clinical data only and the use of preselected patient populations are important limitations of the majority of these reports., Methods: One hundred thirty-two consecutive patients with suspected AMC (defined by symptoms ≤ 14 days; n = 70) and CMC (defined by symptoms >14 days; n = 62) were included. Patients underwent cardiac catheterization with left ventricular endomyocardial biopsy and CMR, including T(2)-weighted imaging for assessment of edema, T(1)-weighted imaging before and after contrast administration for evaluation of hyperemia, and assessment of late gadolinium enhancement. CMR results were considered to be consistent with the diagnosis of myocarditis if 2 of 3 CMR techniques were positive., Results: Within the total population, myocarditis was the most common diagnosis on endomyocardial biopsy analysis (62.9%). Viral genomes were detected in 30.3% (40 of 132) of patients within the total patient population and significantly more often in patients with AMC than CMC (40.0% vs. 19.4%; p = 0.013). For the overall cohort of patients with either suspected AMC or CMC, the diagnostic sensitivity, specificity, and accuracy of CMR were 76%, 54%, and 68%, respectively. The best diagnostic performance was observed in patients with suspected AMC (sensitivity, 81%; specificity, 71%; and accuracy, 79%). In contrast, diagnostic performance of CMR in suspected CMC was found to be unsatisfactory (sensitivity, 63%; specificity, 40%; and accuracy, 52%)., Conclusions: The results of this study underline the usefulness of CMR in patients with suspected AMC. In contrast, the diagnostic performance of CMR in patients with suspected CMC might not be sufficient to guide clinical management., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

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.

Background: There is conflicting evidence regarding sex-based differences in myocardial salvage and clinical outcome in patients after ST-elevation myocardial infarction (STEMI). The aim of this study was to investigate whether there are sex-associated differences in infarct characteristics (myocardial salvage, infarct size, microvascular obstruction) and clinical outcome in STEMI patients who are reperfused by primary angioplasty., Methods and Results: In this study, we included 96 women and 239 men with STEMI undergoing primary angioplasty <12 hours after symptom onset. T2-weighted and contrast-enhanced cardiac MRI was used to assess myocardial salvage, infarct size, and microvascular obstruction. The primary clinical end point was mortality within 6 months after the index event. The amount of myocardium at risk and final infarct size did not differ significantly between women and men. Consequently, myocardial salvage was similar between groups (P=0.36). Women had a higher in-hospital (3% versus 10%; P=0.03) and 30-day (5% versus 11%; P=0.05) mortality rate than did men. Six months after infarction, no significant sex differences in survival were obvious (11% versus 7%; P=0.21). After adjustment for baseline differences (age, diabetes, hypertension), female sex was not an independent predictor of mortality and major adverse cardiac events., Conclusions: The efficacy of primary percutaneous coronary intervention (myocardial salvage) in patients with STEMI is not sex dependent. Although women STEMI patients had worse unadjusted in-hospital and 30-day clinical outcomes than did men, multivariate analysis revealed that the observed sex-based differences in early death after STEMI were likely related to differences in baseline risk and clinical characteristics.

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., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)