Christoph Rosenthal

Mortality associated with administration of high- dose tranexamic acid and aprotinin in primary open-heart procedures: a retrospective analysis

IntroductionAntifibrinolytic agents are commonly used during cardiac surgery to minimize bleeding. Because of safety concerns, aprotinin was withdrawn from the market in 2007. Since then, tranexamic acid (TXA) has become the antifibrinolytic treatment of choice in many heart centers. The safety profile of TXA has not been extensively studied. Therefore, the aim of this study was to evaluate safety and efficiency of TXA compared with aprotinin in cardiac surgery.MethodsSince July 1, 2006, TXA has been administered at a dose of 50 mg/kg tranexamic acid before cardiopulmonary bypass (CPB) and 50 mg/kg into the priming fluid of the CPB. Prior to this, all patients were treated with aprotinin at a dose of 50,000 KIU per kilogram body weight. Safety was evaluated with mortality, biomarkers, and the diagnosis of myocardial infarction, ischemic stroke, convulsive seizures, and acute renal failure in the intensive care unit (ICU), intermediate care unit (IMCU), and hospital stay. Efficiency was evaluated by the need for transfusion of blood products and total postoperative blood loss.ResultsAfter informed consent, 893 patients were included in our database (557 consecutive patients receiving aprotinin and 336 patients receiving TXA). A subgroup of 320 patients undergoing open-heart procedures (105 receiving TXA and 215 receiving aprotinin) was analyzed separately. In the aprotinin group, a higher rate of late events of ischemic stroke (3.4% versus 0.9%; P = 0.02) and neurologic disability (5.8% versus 2.4%; P = 0.02) was found. The rate of postoperative convulsive seizures was increased in tendency in patients receiving TXA (2.7% versus 0.9%; P = 0.05). The use of TXA was associated with higher cumulative drainage losses (PANOVA < 0.01; Ptime < 0.01) and a higher rate of repeated thoracotomy for bleeding (6.9% versus 2.4%; P < 0.01). In the subgroup of patients with open-chamber procedures, mortality was higher in the TXA group (16.2% TXA versus 7.5% aprotinin; P = 0.02). Multivariate logistic regression identified EURO score II and CPB time as additional risk factors for this increased mortality.ConclusionsThe use of high-dose TXA is questioned, as our data suggest an association between higher mortality and minor efficiency while the safety profile of this drug is not consistently improved. Further confirmatory prospective studies evaluating the efficacy and safety profile of TXA are urgently needed to find a safe dosage for this antifibrinolytic drug.

Successful coronary artery bypass graft surgery in severe congenital factor VII deficiency: Perioperative treatment with factor VII concentrate

Successful coronary artery bypass graft surgery in severe congenital factor VII deficiency: Perioperative treatment with factor VII concentrate -

Management of direct oral anticoagulants-associated bleeding in the trauma patient.

Purpose of review This article emphasizes the differentiated management of direct oral anticoagulants (DOACs)-associated bleeding in trauma patients to generate a severity adjusted treatment protocol. Recent findings The management of DOAC-associated bleeding should take severity, mortality risk, and haemodynamic effects of the trauma-induced bleeding into account. Summary The different pharmacological properties of DOACs are important for the management of trauma-induced bleeding. Comorbidities like renal impairment and liver dysfunction prolong their half-life. Patients with minor bleeding in stable clinical condition can be managed by a ‘wait and see’ approach. Moderate bleeding is suggested to be managed by a primarily conservative approach. In life-threatening bleeding, the administration of activated or nonactivated factor concentrates seems justified, together with supportive measures as part of an advanced management protocol. The administration of specific antidotes may be an alternative in the future. A monoclonal antibody to dabigatran (idarucizumab) has recently been approved by the Food and Drug Administration, whereas antidotes to Factor X activated inhibitors (andexanet and aripazine) are still under development. Sufficiently powered studies with clinical and safety outcome measures are still missing for all specific antidotes at this time.

Der erhöhte intrakranielle Druck – Multimodales Neuromonitoring – Indikationen und Methoden

Managing patients after severe traumatic brain injury and aneurysmal subarachnoid hemorrhage is a challenging task of modern intensive care. Most patients do require sedation for mechanical ventilation due to respiratory distress or treatment of increased intracranial pressure. Besides standard ICP monitoring, a variety of continuous monitoring technologies for bedside use exists. The paper discusses the 5 methods most frequently used and their significance for multimodal neuromonitoring.

Liberal Transfusion Practice or Perioperative Treatment of Anemia to Avoid Transfusion

nonsignificant) excess of patients with diabetes, chronic obstructive pulmonary disease, and congestive heart failure in the restrictive group. Adequate blinding is challenging for this patient group, and treating physicians were not blinded to the randomization. It is therefore possible that the rest of the care delivered was different between the groups. These confounding factors may have contributed toward the worse outcomes in the patients in the restrictive transfusion group. The implications of this study could be substantial, and although the numbers of patients are small compared with other similar studies, the outcomes are apparently significant. However, the evidence that true differences in hemoglobin between the two groups was achieved is lacking, and furthermore, less than half of the patients even in the liberal group required transfusion and less than a third of patients in the study received any blood. This makes it difficult to assign differences in outcomes between the groups to transfusion. Given the unexpected findings of this study, we would advise caution in interpreting the results. We feel differences in outcome cannot be attributed to the transfusion strategy alone. Further randomized studies are needed prior to alterations in clinical practice.

Patient safety in anesthesiology and intensive care medicine. Measures for improvement

ZusammenfassungDank der raschen technischen Entwicklung sowie diverser Strategien zur Fehlerbeobachtung und -vermeidung gilt die Intensivmedizin und Anästhesiologie als ein sicheres Fach. Der Verabschiedung der „Patient Safety in the ICU: The Vienna Declaration“ der ESICM vom Oktober 2009 sowie der „Helsinki Declaration on Patient Safety in Anaesthesiology“ der ESA und EBA vom Juni 2010 ist es zu verdanken, dass europaweit festgelegt wurde, welche der erprobten Sicherheitskonzepte als unerlässlich zu werten sind. Viele der allgemein bekannten Strategien haben ihren Ursprung in primär nichtmedizinischen Bereichen, wie beispielsweise der zivilen Luftfahrt, und sind dort nicht mehr wegzudenken. Solche „high reliability organisations“ können diesbezüglich als Vorbilder für das Gesundheitswesen angesehen werden. Critical-Incident-Reporting-Systeme zur Meldung von Beinahezwischenfällen, Crisis-Resource-Management zur Verbesserung von Teamwork und kommunikativen Fähigkeiten sowie Checklisten, wie die WHO-Checkliste, zählen zu konkreten Umsetzungen dieser Art. Des Weiteren wurden standardisierte Medikamentenbeschriftungen, Händedesinfektion, Techniken für die Patientenübergabe und die realitätsnahe Ausbildung am Simulator als Maßnahmen zur Verbesserung der Patientensicherheit exemplarisch für diesen Beitrag ausgewählt.AbstractTechnical improvements as well as various strategies for error detection and error prevention have made intensive care medicine and anesthesiology a safe medical specialty. Due to the introduction of “Patient safety in the ICU: the Vienna declaration” of the European Society of Intensive Care Medicine (ESICM) from October 2009 and the “Helsinki declaration on patient safety” of the European Society of Anaesthesiology (ESA) and the European Board of Anaesthesiology (EBA) from June 2010, there are now specific recommendations for all hospitals in Europe concerning the safety measures that are considered to be of essential importance. Many of today’s well-known safety strategies have been originally developed in non-medical environments, as for instance civil aviation. Such high reliability organizations may serve as examples in the medical domain. Critical incident reporting systems, crisis resource management and checklists, e.g. the World Health Organization (WHO) checklist, are safety approaches of this kind. In addition to these, standardized drug labelling, hand disinfection, techniques for patient handover and simulation-based training have been exemplarily selected for this article as measures that can increase patient safety.

Patientensicherheit in der Anästhesie und Intensivmedizin

ZusammenfassungDank der raschen technischen Entwicklung sowie diverser Strategien zur Fehlerbeobachtung und -vermeidung gilt die Intensivmedizin und Anästhesiologie als ein sicheres Fach. Der Verabschiedung der „Patient Safety in the ICU: The Vienna Declaration“ der ESICM vom Oktober 2009 sowie der „Helsinki Declaration on Patient Safety in Anaesthesiology“ der ESA und EBA vom Juni 2010 ist es zu verdanken, dass europaweit festgelegt wurde, welche der erprobten Sicherheitskonzepte als unerlässlich zu werten sind. Viele der allgemein bekannten Strategien haben ihren Ursprung in primär nichtmedizinischen Bereichen, wie beispielsweise der zivilen Luftfahrt, und sind dort nicht mehr wegzudenken. Solche „high reliability organisations“ können diesbezüglich als Vorbilder für das Gesundheitswesen angesehen werden. Critical-Incident-Reporting-Systeme zur Meldung von Beinahezwischenfällen, Crisis-Resource-Management zur Verbesserung von Teamwork und kommunikativen Fähigkeiten sowie Checklisten, wie die WHO-Checkliste, zählen zu konkreten Umsetzungen dieser Art. Des Weiteren wurden standardisierte Medikamentenbeschriftungen, Händedesinfektion, Techniken für die Patientenübergabe und die realitätsnahe Ausbildung am Simulator als Maßnahmen zur Verbesserung der Patientensicherheit exemplarisch für diesen Beitrag ausgewählt.AbstractTechnical improvements as well as various strategies for error detection and error prevention have made intensive care medicine and anesthesiology a safe medical specialty. Due to the introduction of “Patient safety in the ICU: the Vienna declaration” of the European Society of Intensive Care Medicine (ESICM) from October 2009 and the “Helsinki declaration on patient safety” of the European Society of Anaesthesiology (ESA) and the European Board of Anaesthesiology (EBA) from June 2010, there are now specific recommendations for all hospitals in Europe concerning the safety measures that are considered to be of essential importance. Many of today’s well-known safety strategies have been originally developed in non-medical environments, as for instance civil aviation. Such high reliability organizations may serve as examples in the medical domain. Critical incident reporting systems, crisis resource management and checklists, e.g. the World Health Organization (WHO) checklist, are safety approaches of this kind. In addition to these, standardized drug labelling, hand disinfection, techniques for patient handover and simulation-based training have been exemplarily selected for this article as measures that can increase patient safety.

Patientensicherheit in der Anästhesie und Intensivmedizin@@@Patient safety in anesthesiology and intensive care medicine: Maßnahmen zur Verbesserung@@@Measures for improvement

ZusammenfassungDank der raschen technischen Entwicklung sowie diverser Strategien zur Fehlerbeobachtung und -vermeidung gilt die Intensivmedizin und Anästhesiologie als ein sicheres Fach. Der Verabschiedung der „Patient Safety in the ICU: The Vienna Declaration“ der ESICM vom Oktober 2009 sowie der „Helsinki Declaration on Patient Safety in Anaesthesiology“ der ESA und EBA vom Juni 2010 ist es zu verdanken, dass europaweit festgelegt wurde, welche der erprobten Sicherheitskonzepte als unerlässlich zu werten sind. Viele der allgemein bekannten Strategien haben ihren Ursprung in primär nichtmedizinischen Bereichen, wie beispielsweise der zivilen Luftfahrt, und sind dort nicht mehr wegzudenken. Solche „high reliability organisations“ können diesbezüglich als Vorbilder für das Gesundheitswesen angesehen werden. Critical-Incident-Reporting-Systeme zur Meldung von Beinahezwischenfällen, Crisis-Resource-Management zur Verbesserung von Teamwork und kommunikativen Fähigkeiten sowie Checklisten, wie die WHO-Checkliste, zählen zu konkreten Umsetzungen dieser Art. Des Weiteren wurden standardisierte Medikamentenbeschriftungen, Händedesinfektion, Techniken für die Patientenübergabe und die realitätsnahe Ausbildung am Simulator als Maßnahmen zur Verbesserung der Patientensicherheit exemplarisch für diesen Beitrag ausgewählt.AbstractTechnical improvements as well as various strategies for error detection and error prevention have made intensive care medicine and anesthesiology a safe medical specialty. Due to the introduction of “Patient safety in the ICU: the Vienna declaration” of the European Society of Intensive Care Medicine (ESICM) from October 2009 and the “Helsinki declaration on patient safety” of the European Society of Anaesthesiology (ESA) and the European Board of Anaesthesiology (EBA) from June 2010, there are now specific recommendations for all hospitals in Europe concerning the safety measures that are considered to be of essential importance. Many of today’s well-known safety strategies have been originally developed in non-medical environments, as for instance civil aviation. Such high reliability organizations may serve as examples in the medical domain. Critical incident reporting systems, crisis resource management and checklists, e.g. the World Health Organization (WHO) checklist, are safety approaches of this kind. In addition to these, standardized drug labelling, hand disinfection, techniques for patient handover and simulation-based training have been exemplarily selected for this article as measures that can increase patient safety.