Prognostic Impact of Admission Time in Infarct-Related Cardiogenic Shock: An ECLS-SHOCK Substudy.

BACKGROUND: The outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) and the efficacy and safety of extracorporeal life support (ECLS) may be affected by the timing of hospital admission. OBJECTIVES: The present ECLS-SHOCK substudy sought to investigate the prognostic impact of on-hours vs off-hours admission and the efficacy of ELCS according to the timing of hospital admission time in AMI-CS. METHODS: Patients with AMI-CS enrolled in the multicenter, randomized ECLS-SHOCK trial from 2019 to 2022 were included. The prognosis of patients admitted during regular hours (ie, on-hours) was compared to patients admitted during off-hours. Thereafter, the prognostic impact of ECLS was investigated stratified by the timing of hospital admission. The primary endpoint was 30-day all-cause mortality. Statistical analyses included Kaplan-Meier, univariable, and multivariable logistic regression analyses. RESULTS: Of 417 patients enrolled in the ECLS-SHOCK trial, 48.4% (n = 202) were admitted during off-hours. Patients admitted during off-hours were younger (median age = 62 years [Q1-Q3: 55-69 years] vs 63 years [Q1-Q3: 58-71 years]; P = 0.036) and more commonly treated using initial femoral access for coronary angiography (79.0% [n = 158/200] vs 67.9% [n = 146/215]; P = 0.011). However, off-hours admission was not associated with an increased risk of 30-day all-cause mortality (off-hours vs on-hours: 46.0% [n = 93/202] vs 50.7% [n = 109/215]; OR: 0.83; 95% CI: 0.56-1.22). Furthermore, ECLS had no prognostic impact on 30-day all-cause mortality in patients with AMI-CS admitted during on-hours (50.5% [n = 52/103] vs 50.9% [n = 57/112]; P = 0.95; OR: 0.98; 95% CI: 0.58-1.68) or in patients admitted during off-hours (45.3% [n = 48/106] vs 46.9% [n = 45/96]; P = 0.82; OR: 0.94; 95% CI: 0.54-1.63). Finally, ECLS was associated with an increased risk of bleeding events, especially in patients admitted during on-hours. CONCLUSIONS: The prognosis in AMI-CS was not affected by admission time with a similar effect of ECLS during on- and off-hours.

Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up.

BACKGROUND: Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS. METHODS: In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295. FINDINGS: Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) were more frequent with MCS use than with control. INTERPRETATION: The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only. FUNDING: The Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung.

A Bayesian Reanalysis of the CULPRIT-SHOCK Trial.

BACKGROUND: The optimal revascularization strategy for patients with acute myocardial infarction (AMI), cardiogenic shock (CS), and multivessel disease remains controversial. The CULPRIT-SHOCK trial compared culprit-lesion-only versus immediate multivessel percutaneous coronary intervention (PCI), providing important data but leaving efficacy questions unresolved. To address lingering uncertainties and gain deeper insights, we performed a Bayesian reanalysis of the CULPRIT-SHOCK trial data. METHODS: We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, skeptical, and enthusiastic priors. Relative risks (RR) with 95% highest posterior density intervals were calculated. We defined the Minimally Clinically Important Difference (MCID) as RR <0.84. We performed subgroup analyses for key patient characteristics and assessed secondary outcomes and safety endpoints. Probabilities of benefit, achieving MCID, and harm were computed. Results are presented as median RR with probabilities of effect sizes. RESULTS: Bayesian re-analysis showed a median relative risk of 0.82 (95% HPD: 0.66-1.04) with a non-informative prior, indicating a 95% probability of benefit and 59% probability of achieving MCID. Subgroup analyses revealed potentially stronger effects in males (RR: 0.78, 73% probability of MCID), patients without diabetes (RR: 0.76, 79% probability of MCID), and those with non-anterior STEMI (RR: 0.74, 76% probability of MCID). Secondary outcomes suggested potential benefits in mortality (RR: 0.85) and need for renal replacement therapy (RR: 0.72), but increased risks of recurrent MI (RR: 2.84) and urgent revascularization (RR: 2.88). CONCLUSION: Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favoring the culprit-lesion-only PCI strategy in AMI patients with cardiogenic shock and multivessel disease. The analysis demonstrates a high probability of overall benefit, with a notable chance of achieving a minimally clinically important difference, particularly in specific subgroups. These findings not only support the consideration of culprit-lesion-only PCI in certain patient populations but also underscore the need for careful risk-benefit assessment. Furthermore, our hypothesis-generating subgroup analyses, which show varying probabilities of achieving MCID, illuminate promising avenues for future targeted investigations in this critical patient population.

Ventricular septal defect complicating acute myocardial infarction: diagnosis and management. A Clinical Consensus Statement of the Association for Acute CardioVascular Care (ACVC) of the ESC, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC and the ESC Working Group on Cardiovascular Surgery.

Ventricular septal defects are a rare complication after acute myocardial infarction with a mortality close to 100% if left untreated. However, even surgical or interventional closure is associated with a very high mortality and currently no randomized controlled trials are available addressing the optimal treatment strategy of this disease. This state-of-the-art review and clinical consensus statement will outline the diagnosis, hemodynamic consequences and treatment strategies of ventricular septal defects complicating acute myocardial infarction with a focus on current available evidence and a focus on major research questions to fill the gap in evidence.

ICU management of cardiogenic shock before mechanical support.

PURPOSE OF REVIEW: Treatment of cardiogenic shock remains largely driven by expert consensus due to limited evidence from randomized controlled trials. In this review, we aim to summarize the approach to the management of patients with cardiogenic shock in the ICU prior to mechanical circulatory support (MCS). RECENT FINDINGS: Main topics covered in this article include diagnosis, monitoring, initial management and key aspects of pharmacological therapy in the ICU for patients with cardiogenic shock. SUMMARY: Despite efforts to improve therapy, short-term mortality in patients with cardiogenic shock is still reaching 40-50%. Early recognition and treatment of cardiogenic shock are crucial, including early revascularization of the culprit lesion with possible staged revascularization in acute myocardial infarction (AMI)-CS. Optimal volume management and vasoactive drugs titrated to restore arterial pressure and perfusion are the cornerstone of cardiogenic shock therapy. The choice of vasoactive drugs depends on the underlying cause and phenotype of cardiogenic shock. Their use should be limited to the shortest duration and lowest possible dose. According to recent observational evidence, assessment of the complete hemodynamic profile with a pulmonary artery catheter (PAC) was associated with improved outcomes and should be considered early in patients not responding to initial therapy or with unclear shock. A multidisciplinary shock team should be involved early in order to identify potential candidates for temporary and/or durable MCS.

German Cardiac Arrest Registry (G-CAR)-results of the pilot phase.

BACKGROUND: In Europe, more than 300,000 persons per year experience out-of-hospital cardiac arrest (OHCA). Despite medical progress, only few patients survive with good neurological outcome. For many issues, evidence from randomized trials is scarce. OHCA often occurs for cardiac causes. Therefore, we established the national, prospective, multicentre German Cardiac Arrest Registry (G-CAR). Herein, we describe the first results of the pilot phase. RESULTS: Over a period of 16 months, 15 centres included 559 consecutive OHCA patients aged ≥ 18 years. The median age of the patients was 66 years (interquartile range 57;75). Layperson resuscitation was performed in 60.5% of all OHCA cases which were not observed by emergency medical services. The initial rhythm was shockable in 46.4%, and 29.1% of patients had ongoing CPR on hospital admission. Main presumed causes of OHCA were acute coronary syndromes (ACS) and/or cardiogenic shock in 54.8%, with ST-elevation myocardial infarction being the most common aetiology (34.6%). In total, 62.9% of the patients underwent coronary angiography; percutaneous coronary intervention (PCI) was performed in 61.4%. Targeted temperature management was performed in 44.5%. Overall in-hospital mortality was 70.5%, with anoxic brain damage being the main presumed cause of death (38.8%). Extracorporeal cardiopulmonary resuscitation (eCPR) was performed in 11.0%. In these patients, the in-hospital mortality rate was 85.2%. CONCLUSIONS: G-CAR is a multicentre German registry for adult OHCA patients with a focus on cardiac and interventional treatment aspects. The results of the 16-month pilot phase are shown herein. In parallel with further analyses, scaling up of G-CAR to a national level is envisaged. Trial registration ClinicalTrials.gov identifier: NCT05142124.

Impact of anaemia and iron deficiency on outcomes in cardiogenic shock complicating acute myocardial infarction.

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.

Research Priorities in Critical Care Cardiology: JACC Expert Panel.

Over the last several decades, the cardiac intensive care unit (CICU) has seen a substantial evolution in the patient population, comorbidities, and diagnoses. However, the generation of high-quality evidence to manage these complex and critically ill patients has been slow. Given the scarcity of clinical trials focused on critical care cardiology (CCC), CICU clinicians are often left to extrapolate from studies that either exclude or poorly represent the patient population admitted to CICUs. The lack of high-quality evidence and limited guidance from society guidelines has led to significant variation in practice patterns for many of the most common CICU diagnoses. Several barriers, both common to critical care research and unique to CCC, have impeded progress. In this multinational perspective, we describe key areas of priority for CCC research, current challenges for investigation in the CICU, and essential elements of a path forward for the field.

Percutaneous Left Atrial Appendage Occlusion-Current Evidence and Future Directions.

Over the past two decades, percutaneous left atrial appendage occlusion (LAAO) has proven to be a viable alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF), in particular in those patients who are at increased risk for stroke and bleeding complications. This systematic review provides a comprehensive evaluation of anatomical features, patient selection, procedural planning and execution, complications, medical treatment following the procedure, and contemporary outcome data.

[Prehospital resuscitation : Current status, results and strategies for improvement in Germany]. / Prähospitale Reanimationen : Aktueller Stand, Ergebnisse und Verbesserungsansätze in Deutschland.

Out-of-hospital cardiac arrest (OHCA) is one of the most frequent causes of death in Europe and is associated with a dismal prognosis. The annual incidence in Germany is approximately 100-120 per 100,000 inhabitants (ca. 80,000-100,000 cases). With the use of cardiopulmonary resuscitation (CPR) about 40% of patients have a return of spontaneous circulation (ROSC); however, after OHCA only 15% of patients survive for 30 days and less than 10% survive with no or only minor neurological deficits. Data from the German Resuscitation Register demonstrate that there was no change in the results over the last 15 years, despite all medical innovations, higher rates of coronary interventions, higher use of mechanical support systems and improvement in intensive care treatment. A high proportion of patients with OHCA have a cardiac or coronary cause. As shown by the data from the German Cardiac Arrest Register (G-CAR) an early coronary angiography is often carried out after CPR in Germany; however, in randomized clinical studies an immediate coronary angiography in patients with non-ST segment elevation in the electrocardiogram (ECG) was not associated with an improvement in the prognosis. In large randomized studies the use of mechanical CPR systems and the implantation of mechanical circulatory support devices after OHCA also did not lead to a reduction in mortality. The most important impact factor for the success of CPR is the time interval between collapse and start of CPR, if possible also by bystander resuscitation. Therefore, the focus of efforts for improving CPR should be on increasing the rate of patients with early CPR. Experiences from Denmark and The Netherlands indicate that this can be successful by education and training of the general population, telephone resuscitation and apps for alerting lay persons.

Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction.

AIMS: This study aimed to give contemporary insight into the use of Impella and venoarterial extracorporeal membrane oxygenation (VA-ECMO) in acute myocardial infarction-related cardiogenic shock (AMICS) and into associated outcomes, adverse events, and resource demands. METHODS AND RESULTS: This nationwide observational cohort study describes all AMICS patients treated with Impella (ABIOMED, Danvers, MA, USA) and/or VA-ECMO in 2020-2021. Impella and/or VA-ECMO were used in 20% of all AMICS cases (n = 4088). Impella patients were older (34% vs. 13% >75 years, p < 0.001) and less frequently presented after an out-of-hospital cardiac arrest (18% vs. 40%, p < 0.001). In-hospital mortality was lower in the Impella versus VA-ECMO cohort (61% vs. 67%, p = 0.001). Adverse events occurred less frequently in Impella-supported patients: acute haemorrhagic anaemia (36% vs. 68%, p < 0.001), cerebrovascular accidents (4% vs. 11%, p < 0.001), thromboembolisms of the extremities (5% vs. 8%, p < 0.001), systemic inflammatory response syndrome (21% vs. 25%, p = 0.004), acute kidney injury (44% vs. 53%, p < 0.001), and acute liver failure (7% vs. 12%, p < 0.001). Impella patients were discharged home directly more often (20% vs. 11%, p < 0.001) whereas VA-ECMO patients were more often discharged to another care facility (22% vs. 19%, p = 0.031). Impella patients had shorter hospital stays and lower hospital costs. CONCLUSION: This is the largest, most recent European cohort study describing outcomes, adverse events, and resource demands based on claims data in patients with Impella and/or VA-ECMO. Overall, adverse event rates and resource consumption were high. Given the current lack of beneficial evidence, our study reinforces the need for prospectively established, high-quality evidence to guide clinical decision-making.