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Background: As the number of cardiac diseases continuously increases within the last years in modern society, so does cardiac treatment, especially cardiac catheterization. The procedure of a cardiac catheterization is challenging for both patients and practitioners. Several potential stressors of psychological or physical nature can occur during the procedure. The objective of the study is to develop and implement a stress management intervention for both practitioners and patients that aims to reduce the psychological and physical strain of a cardiac catheterization.
Methods: The clinical study (DRKS00026624) includes two randomized controlled intervention trials with parallel groups, for patients with elective cardiac catheterization and practitioners at the catheterization lab, in two clinic sites of the Ernst-von-Bergmann clinic network in Brandenburg, Germany. Both groups received different interventions for stress management. The intervention for patients comprises a psychoeducational video with different stress management technics and additional a standardized medical information about the cardiac catheterization examination. The control condition includes the in hospitals practiced medical patient education before the examination (usual care). Primary and secondary outcomes are measured by physiological parameters and validated questionnaires, the day before (M1) and after (M2) the cardiac catheterization and at a postal follow-up 6 months later (M3). It is expected that people with standardized information and psychoeducation show reduced complications during cardiac catheterization procedures, better pre- and post-operative wellbeing, regeneration, mood and lower stress levels over time. The intervention for practitioners includes a Mindfulness-based stress reduction program (MBSR) over 8 weeks supervised by an experienced MBSR practitioner directly at the clinic site and an operative guideline. It is expected that practitioners with intervention show improved perceived and chronic stress, occupational health, physical and mental function, higher effort-reward balance, regeneration and quality of life. Primary and secondary outcomes are measured by physiological parameters (heart rate variability, saliva cortisol) and validated questionnaires and will be assessed before (M1) and after (M2) the MBSR intervention and at a postal follow-up 6 months later (M3). Physiological biomarkers in practitioners will be assessed before (M1) and after intervention (M2) on two work days and a two days off. Intervention effects in both groups (practitioners and patients) will be evaluated separately using multivariate variance analysis.
Discussion: This study evaluates the effectiveness of two stress management intervention programs for patients and practitioners within cardiac catheter laboratory. Study will disclose strains during a cardiac catheterization affecting both patients and practitioners. For practitioners it may contribute to improved working conditions and occupational safety, preservation of earning capacity, avoidance of participation restrictions and loss of performance. In both groups less anxiety, stress and complications before and during the procedures can be expected. The study may add knowledge how to eliminate stressful exposures and to contribute to more (psychological) security, less output losses and exhaustion during work. The evolved stress management guidelines, training manuals and the standardized patient education should be transferred into clinical routines
Background Preparticipation examinations (PPE) are frequently used to evaluate eligibility for competitive sports in adolescent athletes. Nevertheless, the effectiveness of these examinations is under debate since costs are high and its validity is discussed controversial.
Purpose To analyse medical findings and consequences in adolescent athletes prior to admission to a sports school.
Methods In 733 adolescent athletes (318 girls, 415 boys, age 12.3+/-0.4, 16 sports disciplines), history and clinical examination (musculoskeletal, cardiovascular, general medicine) was performed to evaluate eligibility. PPE was completed by determination of blood parameters, ECG at rest and during ergometry, echocardiography and x-rays and ultrasonography if indicated. Eligibility was either approved or rated with restriction. Recommendations for therapy and/or prevention were given to the athletes and their parents.
Results Historical (h) and clinical (c) findings (eg, pain, verified pathologies) were more frequent regarding the musculoskeletal system (h: 120, 16.4%; c: 247, 33.7%) compared to cardiovascular (h: 9, 1.2%; c: 23, 3.1%) or general medicine findings (h: 116, 15.8%; c: 71, 9.7%). ECG at rest was moderately abnormal in 46 (6.3%) and severely abnormal in 25 athletes (3.4%). Exercise ECG was suspicious in 25 athletes (3.4%). Relevant echocardiographic abnormalities were found in 17 athletes (2.3%). In 52 of 358 cases (14.5%), x-rays led to diagnosis (eg, Spondylolisthesis). Eligibility was temporarily restricted in 41 athletes (5.6%). Three athletes (0.4%) had to be excluded from competitive sports. Therapy (eg, physiotherapy, medication) and/or prevention (sensorimotor training, vaccination) recommendations were deduced due to musculoskeletal (t:n = 76,10.3%; p:n = 71,9.8%) and general medicine findings (t:n = 80, 10.9%; p:n = 104, 14.1%).
Conclusion Eligibility for competitive sports is restricted in only 5.5% of adolescent athletes at age 12. Eligibility refusals are rare. However, recommendations for therapy and prevention are frequent, mainly regarding the musculoskeletal system. In spite of time and cost consumption, adolescent preparticipation before entering a career in high-performance sports is supported.
Aims The study aims to determine the direct costs and comparative cost-effectiveness of latest-generation dual-source computed tomography (DSCT) and invasive coronary angiography for diagnosing coronary artery disease (CAD) in patients suspected of having this disease.
Methods The study was based on a previously elaborated cohort with an intermediate pretest likelihood for CAD and on complementary clinical data. Cost calculations were based on a detailed analysis of direct costs, and generally accepted accounting principles were applied. Based on Bayes' theorem, a mathematical model was used to compare the cost-effectiveness of both diagnostic approaches. Total costs included direct costs, induced costs and costs of complications. Effectiveness was defined as the ability of a diagnostic test to accurately identify a patient with CAD.
Results Direct costs amounted to (sic)98.60 for DSCT and to (sic)317.75 for invasive coronary angiography. Analysis of model calculations indicated that cost-effectiveness grew hyperbolically with increasing prevalence of CAD. Given the prevalence of CAD in the study cohort (24%), DSCT was found to be more cost-effective than invasive coronary angiography ((sic)970 vs (sic)1354 for one patient correctly diagnosed as having CAD). At a disease prevalence of 49%, DSCT and invasive angiography were equally effective with costs of (sic)633. Above a threshold value of disease prevalence of 55%, proceeding directly to invasive coronary angiography was more cost-effective than DSCT.
Conclusions With proper patient selection and consideration of disease prevalence, DSCT coronary angiography is cost-effective for diagnosing CAD in patients with an intermediate pretest likelihood for it. However, the range of eligible patients may be smaller than previously reported.
Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons
(2011)
The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures can be reduced with the implantation of metallic stents into the stenotic vessels. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES) which require long lasting antiplatelet therapy to avoid thrombotic complications. In the last years, the drug-eluting balloon (DEB) technology has emerged as an alternative option for the treatment of coronary and peripheral arteries. Clinical studies demonstrated the safety and effectiveness of DEB in various clinical scenarios and support the use of paclitaxel-eluting balloons for the treatment of in-stent restenosis, of small coronary arteries and bifurcations lesions. The protocols of DEB studies suggest that the dual antiplatelet therapy with aspirin and clopidogrel of four weeks after DEB is safe and effective.
BACKGROUND: Reduced left ventricular ejection fraction (LVEF) ≤30% is the most powerful prognostic indicator for sudden cardiac death (SCD) in patients after myocardial infarction (MI), but there are little data about long-term changes of LVEF after revascularization and the following implantation of a cardioverter defibrillator (ICD).
METHODS: We performed a retrospective analysis of 277 patients with reduced LVEF at least 1month after MI and complete revascularization. Patients (median time post-MI 23.4months; 74.3% after PCI, 25.7% after CABG were assigned either to group 1 (LVEF<30%) or group 2 (LVEF 30-40%). Biplane echocardiography was redone after a mean follow-up of 441±220days.
RESULTS: LVEF increased significantly in both two groups (group 1: 26.2±4.8% to 32.4±8.5%; p<0.001; group 2: 38.2±2.5% to 44.4±9.6%; p<0.001). However, statistical analysis of first and second LVEF measurement by means of a LOWESS regression and with an appropriate correction of the regression towards the mean effect revealed only a moderate increase of the mean LVEF from 35 to 37% (p<0.001) with a large interindividual variation.
CONCLUSIONS: The impact of early revascularization on LVEF appears to be low in the majority of post-MI heart failure patients. Owing to the high variability, a single measurement may not be reliable enough to justify a decision on ICD indication.
Hintergrund In den letzten Jahrzehnten führte die leitliniengerechte Therapie des akuten Myokardinfarktes (MI) zu einer Mortalitätsreduktion in Deutschland, wobei zwischen einzelnen Bundesländern erhebliche Unterschiede beschrieben werden. Ziel war es daher, die aktuelle Versorgungssituation von Patienten mit MI in der Region Nordost-Deutschland (Berlin, Brandenburg [BRB] und Mecklenburg-Vorpommern [MV]) zu untersuchen und Prädiktoren der 1-Jahresmortalität unter Berücksichtigung der regionalen Zuordnung zu identifizieren.
Methode Auf Basis pseudonymisierter Abrechnungsdaten einer gesetzlichen Krankenversicherung wurden für das Jahr 2012 anhand des ICD 10-Codes I21 und I22 von 1 387 084 Versicherten insgesamt 6733 Patienten mit stationärer Aufnahme bei MI gefiltert. Neben der Krankenhaus- und 1-Jahresmortalität wurden potenzielle Prognoseprädiktoren unter Berücksichtigung von Komorbiditäten, periinfarziellen Prozeduren und sekundärpräventiver Pharmakotherapie erfasst und im Ländervergleich analysiert.
Ergebnisse Sowohl die Krankenhaus- als auch die 1-Jahresmortalitätsrate der einzelnen Länder (Berlin 13,6 resp. 27,5 %, BRB 13,9 resp. 27,9 %, MV 14,4 resp. 29,0 %) war vergleichbar zur Gesamtrate (13,9 % resp. 28,0 %) und im Ländervergleich weitgehend identisch. Die multiple Analyse der Einflussfaktoren auf die 1-Jahresmortalität identifizierte vor allem die Koronarangiografie (OR 0,42, 95 % KI 0,35 – 0,51, p < 0,001) und die Umsetzung der pharmakologischen Leitlinienempfehlungen (OR 0,14, 95 % KI 0,12 – 0,17, p < 0,001) als wesentliche Maßnahmen zur Risikoreduktion. Bei beiden Einflussfaktoren lagen univariat keine statistischen Unterschiede zwischen den drei Bundesländern vor.
Schlussfolgerung Die vorliegenden Daten lassen auf eine vergleichbare stationäre und poststationäre Versorgung und 1-Jahresprognose von Patienten mit akutem MI in den Bundesländern Berlin, Brandenburg und Mecklenburg-Vorpommern in der untersuchten Population schließen, wobei insbesondere der Durchführung einer Koronarangiografie und der adäquaten Umsetzung einer leitliniengerechten Pharmakotherapie prognostische Bedeutung zukommt.
Background: As the number of cardiac diseases continuously increases within the last years in modern society, so does cardiac treatment, especially cardiac catheterization. The procedure of a cardiac catheterization is challenging for both patients and practitioners. Several potential stressors of psychological or physical nature can occur during the procedure. The objective of the study is to develop and implement a stress management intervention for both practitioners and patients that aims to reduce the psychological and physical strain of a cardiac catheterization.
Methods: The clinical study (DRKS00026624) includes two randomized controlled intervention trials with parallel groups, for patients with elective cardiac catheterization and practitioners at the catheterization lab, in two clinic sites of the Ernst-von-Bergmann clinic network in Brandenburg, Germany. Both groups received different interventions for stress management. The intervention for patients comprises a psychoeducational video with different stress management technics and additional a standardized medical information about the cardiac catheterization examination. The control condition includes the in hospitals practiced medical patient education before the examination (usual care). Primary and secondary outcomes are measured by physiological parameters and validated questionnaires, the day before (M1) and after (M2) the cardiac catheterization and at a postal follow-up 6 months later (M3). It is expected that people with standardized information and psychoeducation show reduced complications during cardiac catheterization procedures, better pre- and post-operative wellbeing, regeneration, mood and lower stress levels over time. The intervention for practitioners includes a Mindfulness-based stress reduction program (MBSR) over 8 weeks supervised by an experienced MBSR practitioner directly at the clinic site and an operative guideline. It is expected that practitioners with intervention show improved perceived and chronic stress, occupational health, physical and mental function, higher effort-reward balance, regeneration and quality of life. Primary and secondary outcomes are measured by physiological parameters (heart rate variability, saliva cortisol) and validated questionnaires and will be assessed before (M1) and after (M2) the MBSR intervention and at a postal follow-up 6 months later (M3). Physiological biomarkers in practitioners will be assessed before (M1) and after intervention (M2) on two work days and a two days off. Intervention effects in both groups (practitioners and patients) will be evaluated separately using multivariate variance analysis.
Discussion: This study evaluates the effectiveness of two stress management intervention programs for patients and practitioners within cardiac catheter laboratory. Study will disclose strains during a cardiac catheterization affecting both patients and practitioners. For practitioners it may contribute to improved working conditions and occupational safety, preservation of earning capacity, avoidance of participation restrictions and loss of performance. In both groups less anxiety, stress and complications before and during the procedures can be expected. The study may add knowledge how to eliminate stressful exposures and to contribute to more (psychological) security, less output losses and exhaustion during work. The evolved stress management guidelines, training manuals and the standardized patient education should be transferred into clinical routines