Hemodynamic Characteristics and Prognostic Implication of Modified Society for Cardiovascular Angiography and Interventions Shock Classification in Comatose Patients With Out-of-Hospital Cardiac Arrest.

Background: Cardiogenic shock complicating acute myocardial infarction is associated with a high mortality rate. Cardiogenic shock after out-of-hospital cardiac arrest (OHCA) can be due to transient myocardial stunning but also reflect the increasing severity of ongoing heart failure. The Society for Cardiovascular Angiography and Interventions (SCAI) proposed a division of cardiogenic shock into 5 phenotypes, with cardiac arrest being a modifier.

Principles for Defining Estimands in Clinical Trials-A Proposal.

The ICH E9(R1) guideline outlines the estimand framework, which aligns planning, design, conduct, analysis, and interpretation of a clinical trial. The benefits and value of using this framework in clinical trials have been outlined in the literature, and guidance has been provided on how to choose the estimand and define the estimand attributes. Although progress has been made in the implementation of estimands in clinical trials, to the best of our knowledge, there is no published discussion on the basic principles that estimands in clinical trials should fulfill to be well defined and consistent with the ideas presented in the ICH E9(R1) guideline.

The Impact of Acute Kidney Injury on Chronic Kidney Disease After Cardiac Surgery: A Systematic Review and Meta-analysis.

Objectives: To evaluate the impact of acute kidney injury on transition to chronic kidney disease (CKD) after cardiac surgery and to determine frequency of incident CKD in these patients.

Design: A systematic review and meta-analysis of observational studies.

Setting: Electronic databases Medline and Embase were systematically searched from 1974 to February 6, 2023.

Familywise error for multiple time-to-event endpoints in a group sequential design.

We investigate the familywise error rate (FWER) for time-to-event endpoints evaluated using a group sequential design with a hierarchical testing procedure for secondary endpoints. We show that, in this setup, the correlation between the log-rank test statistics at interim and at end of study is not congruent with the canonical correlation derived for normal-distributed endpoints. We show, both theoretically and by simulation, that the correlation also depends on the level of censoring, the hazard rates of the endpoints, and the hazard ratio.

Simulation-based sample size calculations of marginal proportional means models for recurrent events with competing risks.

In randomised controlled trials, the outcome of interest could be recurrent events, such as hospitalisations for heart failure. If mortality rates are non-negligible, both recurrent events and competing terminal events need to be addressed when formulating the estimand and statistical analysis is no longer trivial. In order to design future trials with primary recurrent event endpoints with competing risks, it is necessary to be able to perform power calculations to determine sample sizes.

Invasive mechanical ventilation in cardiogenic shock complicating acute myocardial infarction: A contemporary Danish cohort analysis.

Purpose: Invasive mechanical ventilation (IMV) is widely used in patients with cardiogenic shock following acute myocardial infarction (AMICS), but evidence to guide practice remains sparse. We sought to evaluate trends in the rate of IMV utilization, applied settings, and short term-outcome of a contemporary cohort of AMICS patients treated with IMV according to out-of-hospital cardiac arrest (OHCA) at admission.

Methods: Consecutive AMICS patients receiving IMV in an intensive care unit (ICU) at two tertiary centres between 2010 and 2017.

Circulating biomarkers of the CS4P and CLIP scores are not altered in a pig model of acute cardiogenic shock and additional short-term circulatory support.

Background: Cardiogenic shock (CS) is the leading cause of death in patients with myocardial infarction with a mortality rate greater than 50%. Recently, the CS 4 Proteins (CS4P) and CLIP scores have been developed to predict survival in CS patients. However, their impact in acute CS and additional short-term left ventricular (LV) circulatory support as prognostic markers is currently not known.

Case study of semaglutide and cardiovascular outcomes: An application of the C to a hybrid design for augmenting an RCT control arm with real-world data.

Introduction: Increasing interest in real-world evidence has fueled the development of study designs incorporating real-world data (RWD). Using the , we specify three designs to evaluate the difference in risk of major adverse cardiovascular events (MACE) with oral semaglutide versus standard-of-care: (1) the actual sequence of non-inferiority and superiority randomized controlled trials (RCTs), (2) a single RCT, and (3) a hybrid randomized-external data study.

Methods: The hybrid design considers integration of the PIONEER 6 RCT with RWD controls using the experiment-selector cross-validated targeted maximum likelihood estimator.

Cardiac surgery-Associated acute kidney injury - A narrative review.

Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) is a serious complication seen in approximately 20-30% of cardiac surgery patients. The underlying pathophysiology is complex, often involving both patient- and procedure related risk factors. In contrast to AKI occurring after other types of major surgery, the use of cardiopulmonary bypass comprises both additional advantages and challenges, including non-pulsatile flow, targeted blood flow and pressure as well as the ability to manipulate central venous pressure (congestion).

A causal roadmap for generating high-quality real-world evidence.

Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations.

Taxonomic reappraisal of the European fauna of the bark beetle genus (Coleoptera, Curculionidae, Scolytinae).

Species in the genus are small and notoriously difficult to identify. Even among the relatively well studied European species, erroneous identifications are evident from literature and in museum collections. These misidentifications relate to the small size and similar appearance of species but they are also a product of insufficient diagnostic characters.

Climate, host and geography shape insect and fungal communities of trees.

Non-native pests, climate change, and their interactions are likely to alter relationships between trees and tree-associated organisms with consequences for forest health. To understand and predict such changes, factors structuring tree-associated communities need to be determined. Here, we analysed the data consisting of records of insects and fungi collected from dormant twigs from 155 tree species at 51 botanical gardens or arboreta in 32 countries.

Fewer transfusions are still more-red blood cell transfusions affect long-term mortality in cardiac surgery.

Objectives: Previous studies indicated higher long-term mortality after the transfusion of allogeneic red blood cells (RBC); newer recommendations emphasize lower transfusion rates. The consequences of the transfusion of RBCs in cardiac surgery are unclear because later studies focused on transfusion triggers and short-term outcomes. Reports on long-term complications after cardiac surgery are few.

Inflammatory response by 48 h after admission and mortality in patients with acute myocardial infarction complicated by cardiogenic shock.

Aims: Cardiogenic shock (CS) is known to induce an inflammatory response. The prognostic utility of this remains unclear. To investigate the association between C-reactive protein (CRP) levels and leucocyte count and mortality in patients with acute myocardial infarction complicated by CS (AMICS).

Impact of Impella RP Versus Vasoactive Treatment on Right and Left Ventricular Strain in a Porcine Model of Acute Cardiogenic Shock Induced by Right Coronary Artery Embolization.

Background The response of the left ventricle to cardiogenic shock (CS) caused by right ventricular (RV) infarction and the effect of treatment with either vasoactive treatment or Impella RP are not well described. We sought to determine RV and left ventricular longitudinal strain (LS) by echocardiography after initiation of either Impella RP or vasoactive treatment for CS induced by right coronary artery embolization. Methods and Results CS was induced with microsphere embolization in the right coronary artery in 20 pigs.