[Valvular heart disease in patients with chronic kidney disease]. / Herzklappenvitien bei chronischer Niereninsuffizienz.

Valvular heart disease is a common comorbidity in patients with impaired renal function, especially in those with end-stage renal disease undergoing dialysis. Sclerosis and calcification of the heart valves and the valve ring are particularly relevant in the etiology of the diseases. These typically occur at the aortic and mitral valves and can lead to both insufficiency and stenosis of the affected valve. In the current guidelines of the European Society for Cardiology published in 2017, surgical treatment remains the standard of care for most forms of severe valvular heart disease; however, the presence of chronic kidney disease impairs clinical outcomes and is associated with higher mortality rates when compared to patients with preserved renal function. Catheter-based treatment options have emerged as an effective and safe alternative for patients >75 years and/or with increased surgical risk. Consequently, in patients with appropriate anatomy and elevated risk, interventional treatment options should also be discussed in the heart team.

[Aggression and subjective risk in emergency medicine : A survey]. / Aggression und subjektive Gefährdung in der Notfallmedizin : Eine Umfrage.

BACKGROUND: Healthcare personnel may be faced with different degrees of violence and aggression, particularly concerning preclinical care. However, systematic data with respect to the frequency and type of violence in emergency medicine in Germany has not been researched. METHODS AND OBJECTIVES: At an anesthesiology congress, an anonymous survey was distributed about the different kinds and extent of violent acts that the participants had experienced during their work in emergency medicine. Moreover, the participants' subjective feelings toward professional and personal safety when handling emergency cases were explored. RESULTS: Every fourth participant in the survey (25.2 %) had experienced occupational physical violence within the last 12 months. Verbal harassment or insults within the last twelve months were reported by 58.2 % of the participants. While 80 % of the participants feel "entirely" or "mostly" safe with regard to the professional aspect of their occupation, personal safety was considered "entirely" in only 9.3 % and "mostly" in 46.4 % of the cases. Nearly every third participant (31.8 %) feels only "partially" safe and every eighth participant feels "rather not" or "not at all" safe during emergency medicine missions. Men appreciate their expertise as well as their personal safety more so than women (p < 0.001). CONCLUSION: Aggression and violence towards healthcare personnel in emergency medicine occur on a regular basis in the German healthcare system. Little research has been conducted in this area, so the issue has not yet been perceived as a relevant problem. Appropriate training for healthcare personnel in emergency medicine should be targeted at developing the skills needed when encountered with aggression and occupational violence.

[Risk estimation of blood-borne infections by emergency room personnel]. / Risikoeinschätzung von blutübertragbaren Infektionen durch die Schockraummitarbeiter.

BACKGROUND: Emergency department personnel are at risk of occupational exposure to blood-borne pathogens. Previous studies have shown that the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) virus infections among trauma patients is higher compared to the general population. OBJECTIVES: The aim of the study was to investigate the compliance rates of trauma team members in applying standard precautions, knowledge about the transmission risk of blood-borne infections and perceived risk of acquiring HIV, HBV and HCV. METHODS: An anonymous questionnaire was distributed to 100 trauma team members including physicians, nurses and medical students from different medical departments (e.g. surgery, radiology, anesthesia and internal medicine). RESULTS: The results of the questionnaire showed that trauma team members had insufficient knowledge of the risk of blood-borne pathogens, overestimated the risk of HCV infection and underused standard precautions during treatment of emergency trauma patients. CONCLUSION: Further educational measures for emergency department personnel are required to increase the knowledge of occupational infections and compliance with standard precautions. Every healthcare worker needs to be sufficiently vaccinated against HBV. In the case of injury awareness of all measures of post-exposure prophylaxis is of utmost importance for affected personnel.

[Prevalence of blood-borne pathogens among 275 trauma patients : A prospective observational study]. / Prävalenz blutübertragbarer Virusinfektionen bei 275 Schockraumpatienten : Eine prospektive Beobachtungsstudie.

BACKGROUND: Previous studies have indicated that the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) virus infections among trauma patients seems to be higher compared to the general population. OBJECTIVE: This study investigated the seroprevalence of blood-borne pathogens among patients with suspected severe multiple trauma in a German university hospital (level I trauma center). METHODS: Routine blood samples taken from trauma patients at the university hospital Frankfurt were tested for HBV, HCV and HIV (from 1 February 2014 to 31 January 2015). RESULTS: Overall, 275 patients with a median injury severity score (ISS) of 9 points (range 0-54) were included in the study representing 84.4 % of all trauma room admissions during this time period. Altogether 3.3 % (n = 9) of the patients were infected with blood-borne pathogens, where 7 patients were infected with HCV and 2 patients had an active HBV infection. None of the patients were tested HIV positive and only one initial diagnosis for HCV was made. A further six samples (five HCV and one HIV) showed a weak reaction in the screening assay that could not be verified by the confirmatory assay. CONCLUSION: To the best of our knowledge this study is the first report on the prevalence of blood-borne infections among trauma patients at a level I trauma center in an urban area in Germany. Compared to the general population the prevalence of blood-borne infections was higher but considerably lower than indicated in previous international studies. Considering the broad implications of occupationally transmitted blood-borne infections occupational safety is of paramount importance.

[Occupational exposure to blood in multiple trauma care]. / Arbeitsbedingte Blutexpositionen in der Polytraumaversorgung.

BACKGROUND: Trauma care personnel are at risk of occupational exposure to blood-borne pathogens. Little is known regarding compliance with standard precautions or occupational exposure to blood and body fluids among multiple trauma care personnel in Germany. AIM: Compliance rates of multiple trauma care personnel in applying standard precautions, knowledge about transmission risks of blood-borne pathogens, perceived risks of acquiring hepatitis B, hepatitis C and human immunodeficiency virus (HIV) and the personal attitude towards testing of the index patient for blood-borne pathogens after a needlestick injury were evaluated. MATERIAL AND METHODS: In the context of an advanced multiple trauma training an anonymous questionnaire was administered to the participants. RESULTS: Almost half of the interviewees had sustained a needlestick injury within the last 12 months. Approximately three quarters of the participants were concerned about the risk of HIV and hepatitis. Trauma care personnel had insufficient knowledge of the risk of blood-borne pathogens, overestimated the risk of hepatitis C infection and underused standard precautionary measures. Although there was excellent compliance for using gloves, there was poor compliance in using double gloves (26.4 %), eye protectors (19.7 %) and face masks (15.8 %). The overwhelming majority of multiple trauma care personnel believed it is appropriate to test an index patient for blood-borne pathogens following a needlestick injury. CONCLUSION: The process of treatment in prehospital settings is less predictable than in other settings in which invasive procedures are performed. Periodic training and awareness programs for trauma care personnel are required to increase the knowledge of occupational infections and the compliance with standard precautions. The legal and ethical aspects of testing an index patient for blood-borne pathogens after a needlestick injury of a healthcare worker have to be clarified in Germany.

[Antithrombocytic therapy and PCI. Duration of therapy after DCB/stents/scaffolds]. / Antithrombozytäre Therapie und PCI. Therapiedauer nach DCB/Stents/Scaffolds.

The duration of dual antiplatelet therapy (DAPT) after percutaneous coronary interventions (PCI) depends on the type of intervention and the clinical situation of the patient. After angioplasty alone (plain old balloon angioplasty, POBA) DAPT is not yet established but does, however, make sense to continue for 4 weeks. The duration of DAPT after placement of bare metal stents (BMS) is 4 weeks, after drug-eluting stents (DES) 6 months, after bioresorbable vascular scaffold (BVS) systems 6-12 months and after drug-coated balloon catheters (DCB) without a new implant 4 weeks.

[Eleven years of core data set in intensive care medicine. Severity of disease and workload are increasing]. / Elf-Jahre-Kerndatensatz in der Intensivmedizin. Zunahmen von Fallschwere und Versorgungsaufwand.

BACKGROUND: In the year 2000 a working group of the German Interdisciplinary Association for Intensive Care Medicine (DIVI) defined a core data set on quality assurance for the first time. In the following years the participating intensive care units sent data to the registry on a voluntary basis and received an annual report on benchmarking data. Alterations in the quality in the field of intensive care medicine have so far only been published to a very low extent. AIM: This study analyzed the core date set of the DIVI between 2000 and 2010 in respect to changes in disease severity using the simplified acute physiology score (SAPS II), the sequential organ failure assessment (SOFA), the need for therapeutic interventions with the therapeutic intervention scoring system (TISS 28) and intensive care unit (ICU) mortality. MATERIAL AND METHODS: Inclusion criteria were participation in the registry for at least 4 years, SAPS II, SOFA, TISS28 scores available and data on ICU discharge. A standardized mortality rate (SMR) was calculated for each year. RESULTS: The mean SAPS II score including 94,398 patients increased by 0.23 points/year with a standard error (SE) of 0.02 to 26.9 ± 12 points (p < 0.001). Similarly, the SOFA score on admission to the ICU increased by 0.14 points/year (SE 0.04) to 3.4 ± 2.7 points (p < 0.001), the proportion of patients with a two organ failure doubled to 7.1 % and the number of patients dependent on ventilation increased by 13.6 % to 59.8 %. The mean time on ventilation increased by 0.17 ventilator days/year (SE 0.01, p < 0.001) to 3.1 ± 7.5 days/patient. The mean number of therapeutic interventions increased by 8.7 % to 26.3 ± 8.3 TISS 28 points/day. The mean length of stay on the ICU (4.3 ± 8 days) and the age of the patients (63.2 ± 17.0 years) remained unchanged. The readmission rate showed no significant changes between the years 2004 and 2010. The readmission rate to the ICU within 48 h after primary discharge was 3.1 % with a 95 % confidence interval (CI) of 3.0-3.3 in contrast to 1.5 % (95 % CI 1.4-1.6) for readmission to the ICU after 48 h. The length of stay in hospital before admission to the ICU decreased for patients with scheduled surgery (6.3 ± 9.7 days vs. 4.2 ± 6.9 days), increased slightly for patients with medically indicated admission to the ICU (2.4 ± 8.2 days 3.1 ± 8.6 days) and remained unchanged for patients with unscheduled admission to the ICU after surgery (4.1 ± 8.6 days). The SMR decreased between 2000 and 2004 from 0.97 to 0.72 and increased again thereafter to 0.99 (ICU mortality 8.5 %). CONCLUSION: The severity of disease on admission to the ICU, the proportion of patients on ventilation and the workload of therapeutic interventions increased between 2000 and 2010 in German ICUs but the length of stay of patients in the ICU remained unchanged. The SMR decreased until 2005 and increased thereafter to return to the initial values. The overall ICU mortality was low compared to international data.

[TEAM®-G (Trauma Evaluation and Management Germany). Serves as a basis for an interdisciplinary training in the emergency room]. / TEAM®-G ("Trauma Evaluation and Management Germany"). Grundlage für ein interdisziplinäres und interprofessionelles Schockraumtraining.

BACKGROUND: The implementation of ATLS® in the daily routine of trauma management in the emergency department is a challenge. This goal cannot be reached by educating ATLS® to a few team members only. In order to enforce the implementation of ATLS® in a level I trauma centre, a generic in-house training was introduced in 2009 with inter-professional integration of all specialists of the trauma team. MATERIALS AND METHODS: The TEAM® course (trauma evaluation and management concept of the American College of Surgeons) was the theoretical basis of the training. This educational program was developed for medical students and multidisciplinary team members. Prior training, a questionnaire for self-assessment was completed by n=84 team members to assess their knowledge about ATLS® principles. The hands-on training time was 90 min. N=10 members of the trauma team worked out three scenarios of multiple injured patients. These were provided as near-reality manikin simulations by a specialist trainer. After the training participants re-evaluated and analysed improvement by the training. Duration of trauma management and the number of missed injuries were analysed one year prior and one year after the training and served as a marker of the process and outcome quality of trauma care. RESULTS: Prior the training, 57% of trainees specified their knowledge related to the ATLS® can be improved. Their expectations were generally satisfied by the training. The mean time of trauma management in the ED could not be reduced one year after the training (36±16 min) compared to one year prior the training (39±18 min), however, the detection of missed injuries (5.6% vs. 3.2%, p<0.05) was significantly diminished after the training. CONCLUSION: Apart form education of ATLS® providers the inauguration of an interdisciplinary and interprofessionel team training may enhance implementation of ATLS- algorithms into daily routine.

Intracoronary local paclitaxel delivery by X-ray contrast media for in-stent restenosis: a clinical pilot study to assess safety and tolerability.

AIM: Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and clinical trials. In the porcine overstretch model paclitaxel dissolved in the contrast medium iopromide inhibited neointimal proliferation in a dose-dependent manner after intracoronary injection and was well tolerated. METHODS: As a first step entering clinical development, a phase I trial was performed using four ascending paclitaxel dose/concentration levels: samples of up to 100 mL of the contrast medium (iopromide) containing 10, 50, 100 or 200 µM paclitaxel or iopromide (controls) were randomly administered to patients assigned to bare metal stent implantation for single de novo coronary artery lesions. Safety variables, tolerability and angiographic parameters were assessed. RESULTS: Adverse events, ECG, systolic and diastolic blood pressure, left ventricular ejection fraction, leukocyte count, other hematological or clinical chemistry data did not reveal any trend which could be related to the study medication. Short-lasting serum paclitaxel concentrations remained significantly below those known from cancer therapy. Angiographic late lumen loss was 0.72±0.50 mm (N.=7) in controls versus 0.45±0.65 mm (N.=17) in all paclitaxel-treated patients; binary restenosis rate was 5/7(63%) versus 6/17 (35%) and target lesion revascularization rate was 4/8 (50%) versus 4/24 (17%). CONCLUSION: Intracoronary infusion of paclitaxel dissolved in an X-ray contrast medium was well tolerated. The results show restenosis inhibition, but the number of patients examined was too small to demonstrate a statistically significant inhibition.

Opportunities and limitations of drug-coated balloons in interventional therapies.

Drug-coated balloons (DCB) represent a novel clinical treatment modality for coronary and peripheral artery disease. Advantages over standard angioplasty and stent technologies including homogeneous drug delivery to the vessel wall, immediate drug release without the use of a polymer, the option of using balloon catheters alone or in combination with a bare metal stent, no foreign object that remains in the body, the potential of reducing antiplatelet therapy, and lower restenosis rates in some indications. As with drug-eluting stents (DES), one cannot assume a class effect for DCB. So far, data from randomized clinical trials identify the treatment of coronary in-stent restenosis (ISR) and of de novo and restenotic lesions in peripheral artery disease as viable options. Furthermore, treatment of de novo lesions in small coronary vessels, bifurcation lesions, long lesions, pediatric interventions, and cerebrovascular applications are potential beneficial indications. In the coronary application, a strategy of DCB angioplasty with provisional spot-stenting in the case of severe dissections may become a better alternative in long and complex lesions, bifurcations, or in patients with contraindications for DES.

Review of clinical data with Paccocath- coated balloon catheters.

The use of drug-coated balloons (DCB) for preventing restenosis in both coronary and peripheral arteries has received increasing attention. The first successful clinical outcomes in inhibiting restenosis have been reported for paclitaxel-coated balloons. Paclitaxel is a lipophilic substance characterized by rapid intracellular uptake and irreversible binding to microtubules. In this way, paclitaxel alters the cell structure, ultimately reducing proliferation, migration, and signaling. These properties make paclitaxel a very potent antiproliferative drug. Paclitaxel admixed to a small amount of the hydrophilic X-ray contrast medium iopromide (Ultravist™) emerged as a very effective coating matrix from numerous in vitro and in vivo experiments and has been denoted as Paccocath™. The randomized controlled ISR I/II-, Thunder- and FEMPAC studies have been conducted using Paccocath™ balloons. Late lumen loss as the primary endpoint at 6 months proved to be statistically significantly reduced in the coated balloon groups in coronary and peripheral arteries. The slightly modified coating on the SeQuent™ Please balloons (B.Braun, Melsungen, Germany) has been clinically studied in the PEPCAD (Paclitaxel-Eluting PTCA-Catheter in Coronary Artery Disease) clinical trial program. Cotavance™ balloons (MEDRAD Inc, Minneapolis, USA) are also coated with the Paccocath™ formulation. In this review we first outline the development of Paccocath™ balloons to then provide an overview of the clinical results obtained with the modified coating. Furthermore we examine possible mechanism of action by which single administration of an antiproliferative drug dose using paclitaxel-coated balloons inhibits restenosis.

[Laryngeal tube II : alternative airway for children?]. / Larynxtubus II : Alternativer Atemweg bei Kindern?

Difficult airway situations both expected and unexpected, present major challenges to every anesthesiologist, especially in pediatric anesthesia. However, the integration of extraglottic airway devices, such as the laryngeal mask, into the algorithm of difficult airways has improved the handling of difficult airway situations. A device for establishing a supraglottic airway, the laryngeal tube (LT), was introduced in 1999. The LT is an extraglottic airway designed to secure a patent airway during either spontaneous breathing or controlled ventilation. The design of the device has been revised several times and a further development is the LTS II/LTS-D, which provides an additional channel for the insertion of a gastric drain tube. This article reports on the successful use of the LTS II in 12 children aged from 2 days to 6 years when endotracheal intubation, alternative mask or laryngeal mask ventilation failed. Use of the LTS II was associated with a high level of success, securing the airway when other techniques had failed. The potential advantage of the LTS II over the standard LT is an additional suction port, which allows gastric tube placement and can be used as an indirect indicator of correct placement. With a modified insertion technique using an Esmarch manoeuvre, placement was simple and fast to perform. In emergency situations when direct laryngoscopy fails or is too time-consuming the LTS II tube is recommended as an alternative device to secure the airway. As with all extraglottic airway devices, familiarity and clinical experience with the respective device and the corresponding insertion technique are essential for safe and successful use, especially in emergency situations.

Advances on drug-coated balloons.

During the last decades considerable advances have been made in intravascular interventions for the treatment of coronary and peripheral arterial disease. However, long-term outcome remains an area of concern in many applications. Restenosis is still a challenge in endovascular medicine and has thus been referred to as the Achilles' heel of percutaneous intervention. Therefore, novel strategies have been developed to overcome this problem. These include drug-eluting stents, though still associated with stent thrombosis and in-stent restenosis, and the more recently introduced non-stent based local drug delivery systems, especially the paclitaxel-eluting balloon. Results of several preclinical and clinical studies indicate that short-term exposure of injured arteries to paclitaxel eluted from regular PTA and PTCA balloons may be sufficient to reduce late lumen loss and restenosis rates during a critical period of time after angioplasty of diseased coronary and peripheral arteries. Although the number of published trials and patients treated is still limited, available data seem to prove that restenosis inhibition by immediate drug release is feasible. This article reviews the rationale for the use of paclitaxel-coated balloons, data from preclinical and clinical studies, and the perspective of drug-coated balloons in peripheral arterial disease.

Contemporary issues in cardiac pacing.

This article addresses current pacing practices and issues. Pacing, sensing, sensing amplifiers, and pacing leads are discussed. Cardiac resynchronization is reviewed. Issues of ventricular pacing avoidance, pacemaker lead infections, ionizing radiation effects on pacing and pacing issues after deterioration and expiration of the patient are considered.

Paclitaxel-coated balloons - Survey of preclinical data.

Restenosis following interventions in the coronary or peripheral arteries develops over weeks to months. In coronary arteries the restenosis rate has been markedly reduced since the advent of drug-eluting stents. Non-stent-based methods for local drug delivery enable restenosis inhibition without the need for stent implantation, does not permanently change the structure of the vessel, are repeatable, and seems to be applicable where drug-eluting stents provide insufficient protection. Preclinical data indicate that short exposure of the vessel wall to a lipophilic inhibitor of cell proliferation is sufficient for preventing restenosis. Initial evidence to this effect emerged from an investigation of paclitaxel embedded in a matrix that enhances the solubility and release of the agent from the balloon coating as well as its transfer to the vessel wall. Further corroborating data from preclinical and clinical studies demonstrating a reduction in late lumen loss and lower restenosis rates led to the market introduction of a variety of paclitaxel-coated angioplasty balloons. The effectiveness of restenosis inhibition is not determined by the active agent alone. Other factors that are crucial for the effectiveness and safety of drug-coated angioplasty balloons are the formulation containing the agent and the coating technique. In this review we first outline the development of paclitaxel-coated balloons to then provide an overview of the preclinical results obtained with different paclitaxel-coated balloons and finally compare these with the outcome in patients. The article concludes with a short outlook on initial results with a zotarolimus-coated angioplasty balloon.

Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon.

Randomized clinical trials investigating the treatment of coronary in-stent restenosis with paclitaxel iopromide coated balloon catheters have shown favorable results. The aim of the present clinical investigation was to assess the efficacy of a novel paclitaxel urea coated angioplasty balloon in the treatment of coronary in-stent restenosis. A total of 26 restenotic bare metal stents in 23 patients with a lesion length of 22.8 ± 11.1 mm and a reference vessel diameter of 2.64 ± 0.31 mm were treated. Up to six months and including the six-month angiographic control, only one target lesion revascularization was necessary; in total, the rate of major adverse cardiovascular events until six-month follow-up was 4.3 %. In-stent late lumen loss was 0.07 ± 0.37 mm, in-segment late lumen loss 0.02 ± 0.50 mm. Binary restenosis was present in one patient (4.3%). The results of this first-in-human series with a paclitaxel urea coated balloon are comparable to paclitaxel iopromide coated balloon catheters. Randomized, controlled clinical trials are warranted to further evaluate this promising approach.

[Laryngeal tube suction]. / Larynxtubus Suction : Temporäres Hilfsmittel bei Notfallpatienten mit schwierigem Atemweg Temporary device for emergency patients with a difficult airway.

BACKGROUND: The difficult airway remains a challenge especially in emergencies. MATERIALS AND METHODS: The use of laryngeal tube suction in 8 cases involving difficult airways in emergencies was reviewed. RESULTS: Use of the laryngeal tube was successful in all cases to bridge patients until a secure airway was established; insertions were successful at the first attempt and classified as easy. In 6 out of 8 patients a secure airway was established by cricothyreotomy or by surgical tracheotomy while using the laryngeal tube for oxygenation and ventilation of the patient. CONCLUSION: The laryngeal tube allows rapid oxygenation in emergency patients with a difficult airway until a secure airway can be established. In cases of potentially life saving operations successful ventilation via the laryngeal tube might allow the priority of establishing a secure airway to be deferred.

[Consensus paper on peri-interventional and postinterventional stroke during cardiac catheter procedures]. / Konsensuspapier "Peri- und postinterventioneller Schlaganfall bei Herzkatheterprozeduren"

Stroke is a serious complication of percutaneous coronary intervention and atrial fibrillation ablation procedures and patients have a high likelihood of persistent neurological deficits. Although formal criteria speak against intravenous or intra-arterial thrombolysis due to pre-existing antithrombotic and anticoagulation therapy, the conditions for recanalizing therapy are optimal due to the occurrence of vessel occlusion in the catheter suite or the chest pain unit. Brain imaging and an interdisciplinary approach are mandatory. In cases of intracerebral vessel occlusion intra-arterial thrombolysis possibly in combination with mechanical clot fragmentation is the first choice therapy. The management of the patient is always an individual therapeutic decision based on stroke severity, the pretreatment with antithrombotic and anticoagulation drugs, the availability of a neuro-interventionalist and the qualification of the local team.

Midlatency auditory evoked potentials in children: effect of age and general anaesthesia.

BACKGROUND: Midlatency auditory evoked potentials (MLAEP) are a promising tool for monitoring suppression of sensory processing during anaesthesia and might help to avoid awareness. MLAEP in children are different to those in adults and the exact changes during general anaesthesia are unknown. METHODS: In 49 children of age between 2 and 12 yr, MLAEP were recorded before anaesthesia, during tracheal intubation, at steady-state balanced anaesthesia, and after extubation. RESULTS: MLAEP were recordable in all children in the awake (premedicated) state with latencies but not amplitudes dependent on children's age. MLAEP latencies significantly increased during tracheal intubation and steady-state anaesthesia. Changes in amplitudes were inconsistent. All MLAEP variables returned to near baseline values after extubation. CONCLUSIONS: The results of this study imply that MLAEP can successfully be recorded during anaesthesia in children above the age of 2 yr. Further studies are necessary before MLAEP might be applicable for monitoring purposes in paediatric anaesthesia.