@article{BlockBonaventuraGrahnetal.2022, author = {Block, Andrea and Bonaventura, Klaus and Grahn, Patricia and Bestgen, Felix and Wippert, Pia-Maria}, title = {Stress management in pre-and postoperative care amongst practitioners and patients in cardiac catheterization laboratory: a study protocol}, series = {Frontiers in Cardiovascular Medicine}, volume = {9}, journal = {Frontiers in Cardiovascular Medicine}, publisher = {Frontiers}, address = {Lausanne, Schweiz}, issn = {2297-055X}, doi = {10.3389/fcvm.2022.830256}, pages = {1 -- 10}, year = {2022}, abstract = {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}, language = {en} } @misc{BlockBonaventuraGrahnetal.2022, author = {Block, Andrea and Bonaventura, Klaus and Grahn, Patricia and Bestgen, Felix and Wippert, Pia-Maria}, title = {Stress management in pre-and postoperative care amongst practitioners and patients in cardiac catheterization laboratory: a study protocol}, series = {Zweitver{\"o}ffentlichungen der Universit{\"a}t Potsdam : Humanwissenschaftliche Reihe}, journal = {Zweitver{\"o}ffentlichungen der Universit{\"a}t Potsdam : Humanwissenschaftliche Reihe}, number = {801}, issn = {1866-8364}, doi = {10.25932/publishup-56698}, url = {http://nbn-resolving.de/urn:nbn:de:kobv:517-opus4-566980}, pages = {10}, year = {2022}, abstract = {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}, language = {en} } @article{BoldtLeberBonaventuraetal.2013, author = {Boldt, Julia and Leber, Alexander W. and Bonaventura, Klaus and Sohns, Christian and Stula, Martin and Huppertz, Alexander and Haverkamp, Wilhelm and Dorenkamp, Marc}, title = {Cost-effectiveness of cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary artery disease in Germany}, series = {Journal of cardiovascular magnetic resonance}, volume = {15}, journal = {Journal of cardiovascular magnetic resonance}, number = {30}, publisher = {BioMed Central}, address = {London}, issn = {1097-6647}, doi = {10.1186/1532-429X-15-30}, pages = {11}, year = {2013}, abstract = {Background: Recent studies have demonstrated a superior diagnostic accuracy of cardiovascular magnetic resonance (CMR) for the detection of coronary artery disease (CAD). We aimed to determine the comparative cost-effectiveness of CMR versus single-photon emission computed tomography (SPECT). Methods: Based on Bayes' theorem, a mathematical model was developed to compare the cost-effectiveness and utility of CMR with SPECT in patients with suspected CAD. Invasive coronary angiography served as the standard of reference. Effectiveness was defined as the accurate detection of CAD, and utility as the number of quality-adjusted life-years (QALYs) gained. Model input parameters were derived from the literature, and the cost analysis was conducted from a German health care payer's perspective. Extensive sensitivity analyses were performed. Results: Reimbursement fees represented only a minor fraction of the total costs incurred by a diagnostic strategy. Increases in the prevalence of CAD were generally associated with improved cost-effectiveness and decreased costs per utility unit (Delta QALY). By comparison, CMR was consistently more cost-effective than SPECT, and showed lower costs per QALY gained. Given a CAD prevalence of 0.50, CMR was associated with total costs of (sic)6,120 for one patient correctly diagnosed as having CAD and with (sic)2,246 per Delta QALY gained versus (sic)7,065 and (sic)2,931 for SPECT, respectively. Above a threshold value of CAD prevalence of 0.60, proceeding directly to invasive angiography was the most cost-effective approach. Conclusions: In patients with low to intermediate CAD probabilities, CMR is more cost-effective than SPECT. Moreover, lower costs per utility unit indicate a superior clinical utility of CMR.}, language = {en} } @misc{BoldtLeberBonaventuraetal.2013, author = {Boldt, Julia and Leber, Alexander W. and Bonaventura, Klaus and Sohns, Christian and Stula, Martin and Huppertz, Alexander and Haverkamp, Wilhelm and Dorenkamp, Marc}, title = {Cost-effectiveness of cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary artery disease in Germany}, series = {Postprints der Universit{\"a}t Potsdam Humanwissenschaftliche Reihe}, journal = {Postprints der Universit{\"a}t Potsdam Humanwissenschaftliche Reihe}, number = {551}, issn = {1866-8364}, doi = {10.25932/publishup-43010}, url = {http://nbn-resolving.de/urn:nbn:de:kobv:517-opus4-430107}, pages = {11}, year = {2013}, abstract = {Background: Recent studies have demonstrated a superior diagnostic accuracy of cardiovascular magnetic resonance (CMR) for the detection of coronary artery disease (CAD). We aimed to determine the comparative cost-effectiveness of CMR versus single-photon emission computed tomography (SPECT). Methods: Based on Bayes' theorem, a mathematical model was developed to compare the cost-effectiveness and utility of CMR with SPECT in patients with suspected CAD. Invasive coronary angiography served as the standard of reference. Effectiveness was defined as the accurate detection of CAD, and utility as the number of quality-adjusted life-years (QALYs) gained. Model input parameters were derived from the literature, and the cost analysis was conducted from a German health care payer's perspective. Extensive sensitivity analyses were performed. Results: Reimbursement fees represented only a minor fraction of the total costs incurred by a diagnostic strategy. Increases in the prevalence of CAD were generally associated with improved cost-effectiveness and decreased costs per utility unit (Delta QALY). By comparison, CMR was consistently more cost-effective than SPECT, and showed lower costs per QALY gained. Given a CAD prevalence of 0.50, CMR was associated with total costs of (sic)6,120 for one patient correctly diagnosed as having CAD and with (sic)2,246 per Delta QALY gained versus (sic)7,065 and (sic)2,931 for SPECT, respectively. Above a threshold value of CAD prevalence of 0.60, proceeding directly to invasive angiography was the most cost-effective approach. Conclusions: In patients with low to intermediate CAD probabilities, CMR is more cost-effective than SPECT. Moreover, lower costs per utility unit indicate a superior clinical utility of CMR.}, language = {en} } @article{BonaventuraLeberSohnsetal.2012, author = {Bonaventura, Klaus and Leber, Alexander W. and Sohns, Christian and Roser, Mattias and Boldt, Leif-Hendrik and Kleber, Franz X. and Haverkamp, Wilhelm and Dorenkamp, Marc}, title = {Cost-effectiveness of paclitaxel-coated balloon angioplasty and paclitaxel-eluting stent implantation for treatment of coronary in-stent restenosis in patients with stable coronary artery disease}, series = {Clinical research in cardiology : official journal of the German Cardiac Society.}, volume = {101}, journal = {Clinical research in cardiology : official journal of the German Cardiac Society.}, number = {7}, publisher = {Springer}, address = {Heidelberg}, issn = {1861-0684}, doi = {10.1007/s00392-012-0428-2}, pages = {573 -- 584}, year = {2012}, abstract = {Recent studies have demonstrated the safety and efficacy of drug-coated balloon (DCB) angioplasty for the treatment of coronary in-stent restenosis (ISR). The cost-effectiveness of this practice is unknown. A Markov state-transition decision analytic model accounting for varying procedural efficacy rates, complication rates, and cost estimates was developed to compare DCB angioplasty with drug-eluting stent (DES) placement in patients with bare-metal stent (BMS)-ISR. Data on procedural outcomes associated with both treatment strategies were derived from the literature, and the cost analysis was conducted from a health care payer perspective. Effectiveness was expressed as life-years gained. In the base-case analysis, initial procedure costs amounted to a,not sign3,604.14 for DCB angioplasty and to a,not sign3,309.66 for DES implantation. Over a 12-month time horizon, the DCB strategy was found to be less costly (a,not sign4,130.38 vs. a,not sign5,305.30) and slightly more effective in terms of life expectancy (0.983 vs. 0.976 years) than the DES strategy. Extensive sensitivity analyses indicated that, in comparison with DES implantation, the cost advantage of the DCB strategy was robust to clinically plausible variations in the values of key model input parameters. The variables with the greatest impact on base-case results were the duration of dual antiplatelet therapy with acetylsalicylic acid and clopidogrel after DCB angioplasty, the use of generic clopidogrel, and variations in the costs associated with the DCB device. DCB angioplasty is a cost-effective treatment option for coronary BMS-ISR. The higher initial costs of DCB are more than offset by later cost-savings, predominantly as a result of reduced medication costs.}, language = {en} } @article{BonaventuraSonntagKleber2011, author = {Bonaventura, Klaus and Sonntag, Steffen and Kleber, Franz X.}, title = {Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons}, series = {EuroIntervention : official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)}, volume = {7}, journal = {EuroIntervention : official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)}, number = {2}, publisher = {Universit{\"a}tsverlag Potsdam}, address = {Toulouse}, issn = {1774-024X}, pages = {K106 -- K111}, year = {2011}, abstract = {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.}, language = {en} } @inproceedings{BonaventuraSonntagKleber2011, author = {Bonaventura, Klaus and Sonntag, Steffen and Kleber, Franz Xayer}, title = {Incidence of acute thrombosis after percutaneous coronary intervention with paclitaxel eluting balloons in a clinical setting and in clinical trials}, series = {Journal of the American College of Cardiology}, volume = {58}, booktitle = {Journal of the American College of Cardiology}, number = {20}, publisher = {Elsevier}, address = {New York}, issn = {0735-1097}, pages = {B78 -- B78}, year = {2011}, language = {en} } @article{ChungVongpatanasinBonaventuraetal.2014, author = {Chung, Oliver and Vongpatanasin, Wanpen and Bonaventura, Klaus and Lotan, Yair and Sohns, Christian and Haverkamp, Wilhelm and Dorenkamp, Marc}, title = {Potential cost-effectiveness of therapeutic drug monitoring in patients with resistant hypertension}, series = {Journal of hypertension}, volume = {32}, journal = {Journal of hypertension}, number = {12}, publisher = {Lippincott Williams \& Wilkins}, address = {Philadelphia}, issn = {0263-6352}, doi = {10.1097/HJH.0000000000000346}, pages = {2411 -- 2421}, year = {2014}, abstract = {Background: Nonadherence to drug therapy poses a significant problem in the treatment of patients with presumed resistant hypertension. It has been shown that therapeutic drug monitoring (TDM) is a useful tool for detecting nonadherence and identifying barriers to treatment adherence, leading to effective blood pressure (BP) control. However, the cost-effectiveness of TDM in the management of resistant hypertension has not been investigated. Results: In the age group of 60-year olds, TDM gained 1.07 QALYs in men and 0.97 QALYs in women at additional costs of (sic)3854 and (sic)3922, respectively. Given a willingness-to-pay threshold of (sic)35 000 per QALY gained, the probability of TDM being cost-effective was 95\% or more in all age groups from 30 to 90 years. Results were influenced mostly by the frequency of TDM testing, the rate of nonresponders to TDM, and the magnitude of effect of TDM on BP. Conclusion: Therapeutic drug monitoring presents a potential cost-effective healthcare intervention in patients diagnosed with resistant hypertension. Importantly, this finding is valid for a wide range of patients, independent of sex and age.}, language = {en} } @article{DorenkampBoldtLeberetal.2013, author = {Dorenkamp, Marc and Boldt, Julia and Leber, Alexander W. and Sohns, Christian and Roser, Mattias and Boldt, Leif-Hendrik and Haverkamp, Wilhelm and Bonaventura, Klaus}, title = {Cost-effectiveness of paclitaxel-coated balloon angioplasty in patients with drug-eluting stent restenosis}, series = {Clinical cardiology : international journal for cardiovascular diseases}, volume = {36}, journal = {Clinical cardiology : international journal for cardiovascular diseases}, number = {7}, publisher = {Wiley-Blackwell}, address = {Hoboken}, issn = {0160-9289}, doi = {10.1002/clc.22130}, pages = {407 -- 413}, year = {2013}, abstract = {BackgroundThe economic impact of drug-eluting stent (DES) in-stent restenosis (ISR) is substantial, highlighting the need for cost-effective treatment strategies. HypothesisCompared to plain old balloon angioplasty (POBA) or repeat DES implantation, drug-coated balloon (DCB) angioplasty is a cost-effective therapy for DES-ISR. MethodsA Markov state-transition model was used to compare DCB angioplasty with POBA and repeat DES implantation. Model input parameters were obtained from the literature, and the cost analysis was conducted from a German healthcare payer's perspective. Extensive sensitivity analyses were performed. ResultsInitial procedure costs amounted to Euro3488 for DCB angioplasty and to Euro2782 for POBA. Over a 6-month time horizon, the DCB strategy was less costly (Euro4028 vs Euro4169) and more effective in terms of life-years (LYs) gained (0.497 versus 0.489) than POBA. The DES strategy incurred initial costs of Euro3167 and resulted in 0.494 LYs gained, at total costs of Euro4101 after a 6-month follow-up. Thus, DCB angioplasty was the least costly and most effective strategy. Base-case results were influenced mostly by initial procedure costs, target lesion revascularization rates, and the costs of dual antiplatelet therapy. ConclusionsDCB angioplasty is a cost-effective treatment option for coronary DES-ISR. The higher initial costs of the DCB strategy compared to POBA or repeat DES implantation are offset by later cost savings.}, language = {en} } @article{DorenkampBonaventuraLeberetal.2013, author = {Dorenkamp, Marc and Bonaventura, Klaus and Leber, Alexander W. and Boldt, Julia and Sohns, Christian and Boldt, Leif-Hendrik and Haverkamp, Wilhelm and Frei, Ulrich and Roser, Mattias}, title = {Potential lifetime cost-effectiveness of catheter-based renal sympathetic denervation in patients with resistant hypertension}, series = {European heart journal}, volume = {34}, journal = {European heart journal}, number = {6}, publisher = {Oxford Univ. Press}, address = {Oxford}, issn = {0195-668X}, doi = {10.1093/eurheartj/ehs355}, pages = {451 -- +}, year = {2013}, abstract = {Aims Recent studies have demonstrated the safety and efficacy of catheter-based renal sympathetic denervation (RDN) for the treatment of resistant hypertension. We aimed to determine the cost-effectiveness of this approach separately for men and women of different ages. Methods and results A Markov state-transition model accounting for costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness was developed to compare RDN with best medical therapy (BMT) in patients with resistant hypertension. The model ran from age 30 to 100 years or death, with a cycle length of 1 year. The efficacy of RDN was modelled as a reduction in the risk of hypertension-related disease events and death. Analyses were conducted from a payer's perspective. Costs and QALYs were discounted at 3\% annually. Both deterministic and probabilistic sensitivity analyses were performed. When compared with BMT, RDN gained 0.98 QALYs in men and 0.88 QALYs in women 60 years of age at an additional cost of (sic)2589 and (sic)2044, respectively. As the incremental cost-effectiveness ratios increased with patient age, RDN consistently yielded more QALYs at lower costs in lower age groups. Considering a willingness-to-pay threshold of (sic)35 000/QALY, there was a 95\% probability that RDN would remain cost-effective up to an age of 78 and 76 years in men and women, respectively. Cost-effectiveness was influenced mostly by the magnitude of effect of RDN on systolic blood pressure, the rate of RDN non-responders, and the procedure costs of RDN. Conclusion Renal sympathetic denervation is a cost-effective intervention for patients with resistant hypertension. Earlier treatment produces better cost-effectiveness ratios.}, language = {en} }