[Safety­II: a systemic approach for an effective clinical risk management]. / Safety­II: ein systemischer Ansatz für ein effektives klinisches Risikomanagement.

The healthcare system is an example of a complex sociotechnical system where the goal is the best possible individual treatment together with the cost-effective use of modern technology. Working in anesthesia requires medical knowledge as well as manual skills and the use of specialized technical equipment in an interdisciplinary and interprofessional setting. The susceptibility to errors and adverse events, especially in the care of critically ill patients, is high.In order to avoid unintentional hospital-induced patient harm, the healthcare system has recently taken the path of prescribing the best possible care for a large number of patients with the help of evidence-based guidelines and specific algorithms or instructions for action. Patient safety is defined accordingly as a state in which adverse events occur as rarely as possible (Safety­I).Following this approach clinical risk management is defined as the purposeful planning, coordination, execution and control of all measures that serve to avoid unintended hospital-induced patient harm or to limit its effects. For this purpose, the focus has recently been placed on instruments such as Critical Incident Reporting Systems (CIRS) or Morbidity and Mortality Conferences (M&MC); however, it is increasingly recognized that adverse events in complex sociotechnical systems such as the healthcare system arise situationally from the interaction of numerous components of the system. The effectiveness of CIRS and M&MC is limited because they do not comprehensively take situational effects into account. Thus, only selective changes are possible which, however, do not imply a sustainable improvement of the system. Newer approaches to strengthening safety in complex sociotechnical systems understand positive as well as negative events as being equally caused by the variable adaptation of behavior to daily practice. They therefore focus on the majority of positive courses of treatment and the necessary adaptations of the health professionals involved in daily practice (Safety­II). In this way, the adaptability of the system under unexpected conditions should be increased (Resilience Engineering). Taking this systemic approach into account, the Functional Resonance Analysis Method (FRAM) offers a variety of possibilities for the prospective analysis of a complex sociotechnical system or for retrospective incident analysis through modelling of actual everyday actions (work as done). Through interviews with the health professionals involved, document analyses and work inspections, processes and their functions as well as the associated variability are assessed and graphically presented. The FRAM models the collected information of the process as complexes of interconnected functions represented by hexagonal symbols. Each corner of the hexagon represents a given aspect, which together form the properties of the function (input, output, precondition, resource, time, control). Through this visualization and evaluation of the interview results, the actual everyday actions (work as done) can be compared with the predefined ones (work as imagined). The evaluation of the variability found in this way enables the strengths and weaknesses of processes to be uncovered. As a result, specific measures can be derived to strengthen the system. Increased consideration of the Safety­II approach within clinical risk management can be a valuable addition to existing clinical risk management methods.

Impact of left atrial appendage morphology on thrombus formation after successful left atrial appendage occlusion: Assessment with cardiac-computed-tomography.

A standardized imaging algorithm by cardiac computed tomography angiography (cCTA) (LOVE-view) was used in 30 patients to evaluate the influence of different left atrial appendage (LAA) morphologies on development of thrombosis in the LAA 6 months after implantation of an occlusion device (Watchman or Amplatzer-Cardiac-Plug) in patients with non-valvular atrial fibrillation, CHA2DS2-VASc-Score >1 and a contraindication for oral anticoagulation. The distribution of different LAA morphologies was 40% windsock, 17% broccoli and 43% chicken wing type. There was no significant difference in the level of thrombosis regarding LAA morphology or the type of chosen occlusion device. The rates of complete LAA thrombosis was 40% in broccoli type, 33% in windsock and 15% in chicken wing type. Independently of LAA type, 13% had none and 60% incomplete thrombosis. The ratio of density (LA/LAA) was 0.14 in patients with complete thrombosis and 0.67 in those with none or incomplete thrombosis. cCTA and the LOVE-view-imaging-algorithm were shown to be a valuable method for standardized imaging in clinical routine in a greater set of patients. Surprisingly thrombosis of the occluded LAA was still in progress in most cases at 6 months, whereas further studies are needed defining its clinical consequences, especially for the selection of the optimal post-procedural antithrombotic treatment strategy.

Prevalence of malignant arrhythmia and sudden cardiac death in takotsubo syndrome and its management.

Aims: Recent studies have highlighted that takotsubo syndrome (TTS) is associated with a poor clinical outcome. Our study was conducted to determine the short- and long-term prevalence, recurrence rate and impact of life-threatening arrhythmias (LTA) on the clinical outcome of TTS. Methods and results: Our institutional database constituted a collective of 114 patients diagnosed with TTS between 2003 and 2015. The patient groups, divided according to the presence (n = 13, 11.4%) or absence (n = 101, 88.6%) of LTAs, were followed-up over a period of 3 years so as to determine the clinical outcome. Our analyses suggest that patients comprising the LTA group suffered significantly more often from an acute cardiovascular event including cases of a newly diagnosed atrial fibrillation (38.4% vs. 2.9%), cardiogenic shock with use of inotropic agents (53.8% vs. 14.8%) and cardiopulmonary resuscitation (61.5% vs. 1%). The short-term recurrence rate of a LTA episode was 15.3%, while the long-term recurrence rate of any LTA was around 5%. Whereas, in-hospital mortality was significantly higher in TTS associated with LTAs, the overall survival rate over 3 years was similar. A multivariate Cox regression analysis suggested atrial fibrillation, EF ≤ 35%, cardiogenic shock, and glomerular filtration rate <60 mL/min. as independent predictors of adverse outcome. Conclusion: The short- as well as the long-term prevalence and recurrence of LTAs in TTS patients is high. The long-term mortality rates were similar to the TTS patients presenting without any LTAs. LTAs in TTS could be triggered by a concomitant atrial fibrillation.