Jan-Peter Braun

Blutungsrisiko und Blutungsnotfälle unter Rivaroxaban

UNLABELLED Rivaroxaban, the first direct factor-Xa inhibitor anticoagulant, has been approved for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery, for stroke prophylaxis in patients with non-valvular atrial fibrillation and for the treatment of deep vein thrombosis. There is no requirement for coagulation monitoring with rivaroxaban in routine clinical practice. However, in certain clinical circumstances such as life-threatening bleeding or an emergency operation the measurement of the thromboplastin time with a sensitive reagent will deliver first information. A quantitative determination of rivaroxaban plasma concentration is possible using an anti-factor Xa assay. In the case of a patient under long-term anticoagulation with rivaroxaban requiring an elective surgery, a discontinuation of rivaroxaban 20 to 30 hours before the operation is sufficient to normalize the associated bleeding risk, as long as the renal and liver function is normal. A longer interval should be taken into consideration, when the patient presents a renal and liver impairment or is of a higher age. In the event of an emergency operation effective rivaroxaban concentrations might be present. Nevertheless, we advise against using a prophylactic dose of factor concentrates. RECOMMENDATIONS From a clinical perspective, in the event of a minor bleeding we recommend a temporary discontinuation of rivaroxaban, whereas for clinically relevant major or severe bleeding events a mechanical compression or a limited surgical i.e. interventional treatment is required. Supportive measures such as the administration of blood products or tranexamic acid might be beneficial. In addition to haemodynamic supportive measures life threatening bleeding events demand a comprehensive haemostasis management, as well as the application of PCC.

Risk of bleeding and haemorrhagic complication with rivaroxaban – Periprocedural management of haemostasis

UNLABELLED Rivaroxaban, the first direct factor-Xa inhibitor anticoagulant, has been approved for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery, for stroke prophylaxis in patients with non-valvular atrial fibrillation and for the treatment of deep vein thrombosis. There is no requirement for coagulation monitoring with rivaroxaban in routine clinical practice. However, in certain clinical circumstances such as life-threatening bleeding or an emergency operation the measurement of the thromboplastin time with a sensitive reagent will deliver first information. A quantitative determination of rivaroxaban plasma concentration is possible using an anti-factor Xa assay. In the case of a patient under long-term anticoagulation with rivaroxaban requiring an elective surgery, a discontinuation of rivaroxaban 20 to 30 hours before the operation is sufficient to normalize the associated bleeding risk, as long as the renal and liver function is normal. A longer interval should be taken into consideration, when the patient presents a renal and liver impairment or is of a higher age. In the event of an emergency operation effective rivaroxaban concentrations might be present. Nevertheless, we advise against using a prophylactic dose of factor concentrates. RECOMMENDATIONS From a clinical perspective, in the event of a minor bleeding we recommend a temporary discontinuation of rivaroxaban, whereas for clinically relevant major or severe bleeding events a mechanical compression or a limited surgical i.e. interventional treatment is required. Supportive measures such as the administration of blood products or tranexamic acid might be beneficial. In addition to haemodynamic supportive measures life threatening bleeding events demand a comprehensive haemostasis management, as well as the application of PCC.

Quality indicators in intensive care medicine: why? Use or burden for the intensivist.

In order to improve quality (of therapy), one has to know, evaluate and make transparent, one’s own daily processes. This process of reflection can be supported by the presentation of key data or indicators, in which the real as-is state can be represented. Quality indicators are required in order to depict the as-is state. Quality indicators reflect adherence to specific quality measures. Continuing registration of an indicator is useless once it becomes irrelevant or adherence is 100%. In the field of intensive care medicine, studies of quality indicators have been performed in some countries. Quality indicators relevant for medical quality and outcome in critically ill patients have been identified by following standardized approaches. Different German societies of intensive care medicine have finally agreed on 10 core quality indicators that will be valid for two years and are currently recommended in German intensive care units (ICUs).

The German quality indicators in intensive care medicine 2013--second edition.

Quality indicators are key elements of quality management. The quality indicators for intensive care medicine of the German Interdisciplinary Society of Intensive Care Medicine (DIVI) from the year 2010 were recently evaluated when their validity time expired after two years. Overall one indicator was replaced and further three were in part changed. The former indicator I “elevation of head of bed” was replaced by the indicator “Daily multi-professional ward rounds with the documentation of daily therapy goals” and added to the indicator IV “Weaning and other measures to prevent ventilator associated pneumonias (short: Weaning/VAP Bundle)” (VAP = ventilator-associated pneumonia) which aims at the reduction of VAP incidence. The indicator VIII “Documentation of structured relative-/next-of-kin communication” was refined. The indicator X “Direction of the ICU by a specially trained certified intensivist with no other clinical duties in a department” was also updated according to recent study results. These updated quality indicators are part of the Peer Review in intensive care medicine. The next update of the quality indicators is due in 2016.

Managing End-Of-Life Decision Making in Intensive Care Medicine – A Perspective from Charité Hospital, Germany

Introduction End-of-life-decisions (EOLD) have become an important part of modern intensive care medicine. With increasing therapeutic possibilities on the one hand and many ICU-patients lacking decision making capacity or an advance directive on the other the decision making process is a major challenge on the intensive care unit (ICU). Currently, data are poor on factors associated with EOLD in Germany. In 2009, a new law on advance directives binding physicians and the patient´s surrogate decision makers was enacted in Germany. So far it is unknown if this law influenced proceedings of EOLD making on the ICU. Methods A retrospective analysis was conducted on all deceased patients (n = 224) in a 22-bed surgical ICU of a German university medical center from 08/2008 to 09/2010. Patient characteristics were compared between patients with an EOLD and those without an EOLD. Patients with an EOLD admitted before and after change of legislation were compared with respect to frequencies of EOLD performance as well as advance directive rates. Results In total, 166 (74.1%) of deaths occurred after an EOLD. Compared to patients without an EOLD, comorbidities, ICU severity scores, and organ replacement technology did not differ significantly. EOLDs were shared within the caregiverteam and with the patient´s surrogate decision makers. After law enacting, no differences in EOLD performance or frequency of advance directives (8.9% vs. 9.9%; p = 0.807) were observed except an increase of documentation efforts associated with EOLDs (18.7% vs. 43.6%; p<0.001). Conclusions In our ICU EOLD proceedings were performed patient-individually. But EOLDs follow a standard of shared decision making within the caregiverteam and the patient´s surrogate decision makers. Enacting a law on advance directives has not affected the decision making-process in EOLDs nor has it affected population´s advance care planning habits. However, it has led to increased EOLD-associated documentation on the ICU. Trail Registration ClinicalTrials.gov NCT01294189.

Levosimendan may improve survival in patients requiring mechanical assist devices for post-cardiotomy heart failure

IntroductionMost case series suggest that less than half of the patients receiving a mechanical cardiac assist device as a bridge to recovery due to severe post-cardiotomy heart failure survive to hospital discharge. Levosimendan is the only inotropic substance known to improve medium term survival in patients suffering from severe heart failure.MethodsThis retrospective analysis covers our single centre experience. Between July 2000 and December 2004, 41 consecutive patients were treated for this complication. Of these, 38 patients are included in this retrospective analysis as 3 patients died in the operating room. Levosimendan was added to the treatment protocol for the last nine patients.ResultsOf 29 patients treated without levosimendan, 20 could be weaned off the device, 9 survived to intensive care unit discharge, 7 left hospital alive and 3 survived 180 days. All 9 patients treated with levosimendan could be weaned, 8 were discharged alive from ICU and hospital, and 7 lived 180 days after surgery (p < 0.002 for 180 day survival). Plasma lactate after explantation of the device was significantly lower (p = 0.002), as were epinephrine doses. Time spent on renal replacement therapy was significantly shorter (p = 0.023).ConclusionLevosimendan seems to improve medium term survival in patients failing to wean off cardiopulmonary bypass and requiring cardiac assist devices as a bridge to recovery. This retrospective analysis justifies prospective randomised investigations of levosimendan in this group of patients.

An Electronic Tool for Visual Feedback to Monitor the Adherence to Quality Indicators in Intensive Care Medicine

Evidence-based medicine is often inadequately implemented in intensive care units (ICU); the aim of this study was to improve its implementation via a technical feedback system, using key performance indicators (KPI). The study evaluated 205 patients treated in a cardiac surgical ICU over a 6-month period (3 months before and 3 months after implementation of the feedback system). KPI adherence rates for sedation, delirium and pain monitoring, and completion of a weaning protocol before and after the implementation of the feedback system, were compared. Adherence rates for pain and delirium monitoring, and implementation of the weaning protocol, were significantly increased by the intervention. Adherence to KPIs for sedation, which were high at baseline, could not be further improved. Daily display of KPI implementation had a positive effect on adherence to standard operating procedures. Adherence to guidelines may be improved by using this feedback system as part of the clinical routine.

Peer reviewing critical care: a pragmatic approach to quality management.

Critical care medicine frequently involves decisions and measures that may result in significant consequences for patients. In particular, mistakes may directly or indirectly derive from daily routine processes. In addition, consequences may result from the broader pharmaceutical and technological treatment options, which frequently involve multidimensional aspects. The increasing complexity of pharmaceutical and technological properties must be monitored and taken into account. Besides the presence of various disciplines involved, the provision of 24-hour care requires multiple handovers of significant information each day. Immediate expert action that is well coordinated is just as important as a professional handling of medicines limitations. Intensivists are increasingly facing professional quality management within the ICU (Intensive Care Unit). This article depicts a practical and effective approach to this complex topic and describes external evaluation of critical care according to peer reviewing processes, which have been successfully implemented in Germany and are likely to gain in significance.

Treatment of severe pulmonary hemorrhage after cardiopulmonary bypass by selective, temporary balloon occlusion.

Severe pulmonary bleeding causes frequent mortality, particularly if this event occurs during separation from extracorporeal circulation during cardiac surgery. We present a new approach to treat this life-threatening complication: temporary balloon occlusion of the pulmonary artery feeding the involved lobe. On attempting to wean a 71-yr-old female patient from cardiopulmonary bypass after aortic valve replacement, she lost more than 2 L of blood through her trachea over approximately 15 min and severe gas embolism into the left atrium was visualized on transesophageal echocardiography. As the bleeding was too vigorous to be localized by fiberoptic bronchoscopy, an interventional cardiologist was consulted. After localizing the affected lobe using fluoroscopy, he inflated a balloon dilating catheter in the lower lobe artery. This effectively stopped the bleeding. Separation from extracorporeal circulation was uneventful using one-lung ventilation to prevent further gas embolism. Sixteen hours after the end of surgery the catheter could be deflated and removed without any further intervention. The patient made an excellent recovery.

Barrier function of the gut and multiple organ dysfunction after cardiac surgery

We studied the influence of sequential involvement of the gastrointestinal (GI) tract on the development of multiple organ dysfunction (MOD) after cardiopulmonary bypass (CPB). One hundred and forty-six patients undergoing elective cardiac surgery were included in this prospective observational study. Standardized oral inert-sugar tests (sucrose, lactulose, mannitol, sucralose) were performed before and after CPB in different patients. Enzyme-linked immunosorbent assay of plasma levels of endotoxin core antibodies (EndoCAb) were performed peri-operatively. The functional mucosal surface was calculated from the amount of mannitol absorbed from the GI tract. Lower urine concentrations of absorbed mannitol were observed pre-operatively in patients developing MOD. In binary logistic regression this was an independent parameter. Decreased plasma concentrations of EndoCAb after surgery were seen in every patient, but were more significant in patients developing MOD. A reduced pre-operative functional mucosal surface may predict the early occurrence of MOD after surgery.