Accuracy and Sterilizability of In-House Printed Patient-Specific Aortic Model for Surgeon-Modified Stent Grafts-A Workflow Description for Emergency Aortic Endovascular Procedures.

Introduction: The use of 3D-printed aortic models for the creation of surgeon-modified endoprostheses represents a promising avenue in aortic surgery. By focusing on the potential impact of sterilization on model integrity and geometry, this report sheds light on the suitability of these models for creating customized endoprostheses. The study presented here aimed to investigate the safety and viability of 3D-printed aortic models in the context of sterilization processes and subsequent remodeling. Methods: The study involved the fabrication of 3D-printed aortic models using patient-specific imaging data and established additive manufacturing techniques. Five identical aortic models of the same patient were printed. Two models were subjected to sterilization and two to disinfection using commonly employed methods, and one model remained untreated. The models were checked by in-house quality control for deformation (heat map analyses) after the sterilization and disinfection processes. Three models (sterilized, disinfected, and untreated) were sent for ex-house (Lufthansa Technik, AG, Materials Technologies and Central Laboratory Services, Hamburg, Germany) evaluation and subsequent quantification of possible structural changes using advanced imaging and measurement technologies (macroscopic and SEM/EDX examinations). After sterilization and disinfection, each aortic model underwent sterility checks. Results: Based on macroscopic and SEM/EDX examinations, distinct evidence of material alterations attributed to a treatment process, such as a cleaning procedure, was not identified on the three implants. Comparative material analyses conducted via the EDX technique yield consistent results for all three implants. Disinfected and sterilized models tested negative for common pathogens. Conclusions: The evaluation of 3D-printed aortic models' safety after sterilization as well as their suitability for surgeon-modified endoprostheses is a critical step toward their clinical integration. By comprehensively assessing changes in model integrity and geometry after sterilization, this research has contributed to the broader understanding of the use of 3D-printed models for tailor-made endovascular solutions. As medical technologies continue to evolve, research endeavors such as this one can serve as a foundation for harnessing the full potential of 3D printing to advance patient-centered care in aortic surgery.

Radiation Exposure and Contrast Agent Use during Endovascular Aortic Repair Using Mobile Versus Fixed Angiography Systems.

BACKGROUND: For (thoracic) endovascular aortic repair ((T)EVAR) procedures, both mobile (standard operating room (SOR)) and fixed C-arm (hybrid operating room (HOR)) systems are available. This study evaluated differences in key procedural parameters, and procedural success for (T)EVAR in the SOR versus the HOR. METHODS: All patients who underwent standard elective (T)EVAR at the Clinic for Vascular and Endovascular Surgery at the University Hospital Duesseldorf, Germany, between 1 January 2012 and 1 January 2019 were included. Data were retrieved from archived medical records. Endpoints were analyzed for SOR versus HOR during (T)EVAR. RESULTS: A total of 93 patients, including 50 EVAR (SOR (n = 20); HOR (n = 30)) and 43 TEVAR (SOR (n = 22); HOR (n= 21)) were included. The dose area product (DAP) for EVAR and TEVAR was lower in the SOR than in the HOR (EVAR, SOR: 1635 ± 1088 cGy·cm2; EVAR, HOR: 7819 ± 8928 cGy·cm2; TEVAR, SOR: 8963 ± 34,458 cGy·cm2; TEVAR, HOR: 14,591 ± 11,584 cGy·cm2 (p < 0.05)). Procedural fluoroscopy time was shorter in the SOR than in the HOR for EVAR and TEVAR (EVAR, SOR: 7 ± 4 min; EVAR, HOR: 18.8 ± 11.3 min; TEVAR, SOR: 6.6 ± 9.6 min; TEVAR, HOR: 13.9 ± 11.8 min (p < 0.05)). Higher volumes of contrast agent were applied during EVAR and TEVAR in the SOR than in the HOR (EVAR, SOR: 57.5 ± 20 mL; EVAR: HOR: 33.3 ± 5 mL (p < 0.05); TEVAR; SOR: 71.5 ± 53.4 mL, TEVAR, HOR: 48.2 ± 27.5 mL (p ≥ 0.05). CONCLUSION: The use of a fixed C-arm angiography system in the HOR results in higher radiation exposure and longer fluoroscopy times but lower contrast agent volumes when compared with mobile C-arm systems in the SOR. Because stochastic radiation sequelae are more likely to be tolerated in an older patient population and, in addition, there is a higher incidence of CKD in this patient population, allocation of patients to the HOR for standard (T)EVAR seems particularly advisable based on our results.

Feasibility of a patient-oriented navigation programme for patients with lung cancer or stroke in Germany: Protocol of the CoreNAVI study.

BACKGROUND: Patient navigation programmes were introduced in the United States and recently gained interest in Germany, where the health care system is fragmented. Navigation programmes aim to decrease barriers to care for patients with age-associated diseases and complex care paths. Here we describe a feasibility study to evaluate a patient-oriented navigation model that was developed in a first project phase by integrating data about barriers to care, vulnerable patient populations and existing support services. METHODS: We designed a mixed-methods feasibility study that consists of two two-arm randomized controlled trials aligned with observational cohorts. The intervention group of the RCTs gets support by personal navigators for 12 months. The control group receives a brochure with regional support offers for patients and caregivers. The feasibility of the patient-oriented navigation model for two prototypic age-associated diseases, lung cancer and stroke, is evaluated with regard to its acceptance, demand, practicality and efficacy. This investigation includes process evaluation measures with detailed documentation of the screening and recruitment process, questionnaires about satisfaction with navigation, observant participation and qualitative interviews. Estimates of efficacy for patient-reported outcomes are obtained at three follow-up time points including satisfaction with care and health-related quality of life. Furthermore, we analyze health insurance data from patients of the RCT insured at a large German health insurance (AOK Nordost) to investigate heath care utilization, costs and cost effectiveness. TRIAL REGISTRATION: The study is registered at the German Clinical Trial Register (DRKS-ID: DRKS00025476).

[Utilization of routine data from different statutory health insurance funds: a practical report of experience from the TIM-HF2 study about data acquisition, validation, and processing]. / Nutzung von Routinedaten unterschiedlicher gesetzlicher Krankenkassen: Ein Erfahrungsbericht aus der TIM-HF2-Studie zur Datenerschließung, -validierung und -aufbereitung.

BACKGROUND: The randomized controlled clinical trial "TIM-HF2" investigated the benefit of telemonitoring in chronic heart failure. The health economic evaluation of this intervention was based on routine data from statutory health insurance (SHI) funds. Since participants were recruited independently of their SHI affiliation, there was a large number of potential data-providing SHI funds. This resulted in both organizational and methodological challenges, from participation of the data providers to data preparation. METHOD: The procedures are described from study planning and data acquisition to data review and processing in the TIM-HF2 trial. Based on the identification of potential problems for data completeness and data quality, possible solutions have been derived. RESULTS: In total, participants were insured with 49 different SHI funds, which provided routine data for a total of 1450 participants. About half of all initial data deliveries were correct. The most common problems in data preparation occurred in the machine readability of the data. Success factors for a high level of data completeness were close communication with the SHI funds and a high level of time and personnel commitment to intensive data checking and preparation. DISCUSSION: Based on the experience of the TIM-HF2 trial, a high heterogeneity has been detected in data management and transmission of routine data. Universally applicable data descriptions are desired to improve data access, quality, and usability for research purposes.

The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design.

BACKGROUND: Advanced ovarian cancer is managed by extensive surgery, which could be associated with high morbidity. A personalized pre-habilitation strategy combined with an 'enhanced recovery after surgery' (ERAS) pathway may decrease post-operative morbidity. PRIMARY OBJECTIVE: To analyze the effects of a combined multi-modal pre-habilitation and ERAS strategy on severe post-operative morbidity for patients with ovarian cancer (primary diagnosis or first recurrence) undergoing cytoreductive surgery. STUDY HYPOTHESIS: A personalized multi-modal pre-habilitation algorithm entailing a physical fitness intervention, nutritional and psycho-oncological support, completed by an ERAS pathway, reduces post-operative morbidity. TRIAL DESIGN: This is a prospective, controlled, non-randomized, open, interventional two-center clinical study. Endpoints will be compared with a three-fold control: (a) historic control group (data from institutional ovarian cancer databases); (b) prospective control group (assessed before implementing the intervention); and (c) matched health insurance controls. INCLUSION CRITERIA: Patients with ovarian, fallopian, or primary peritoneal cancer undergoing primary surgical treatment (primary ovarian cancer or first recurrence) can be included. The intervention group receives an additional multi-level study treatment: (1) standardized frailty assessment followed by (2) a personalized tri-modal pre-habilitation program and (3) peri-operative care according to an ERAS pathway. EXCLUSION CRITERIA: Inoperable disease or neoadjuvant chemotherapy, simultaneous diagnosis of simultaneous primary tumors, in case of interference with the overall prognosis (except for breast cancer); dementia or other conditions that impair compliance or prognosis. PRIMARY ENDPOINT: Reduction of severe post-operative complications (according to Clavien- Dindo Classification (CDC) III-V) within 30 days after surgery. SAMPLE SIZE: Intervention group (n=414, of which approximately 20% insure with the participating health insurance); historic control group (n=198); prospective control group (n=50), health insurance controls (for those intervention patients who are members of the participating health insurance). ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The intervention phase started in December 2021 and will continue until June 2023. As of March 2023, 280 patients have been enrolled in the intervention group. The expected completion of the entire study is September 2024. TRIAL REGISTRATION: NCT05256576.

Cost-effectiveness analysis of multiple imaging modalities in diagnosis and follow-up of intermediate complex cystic renal lesions.

OBJECTIVES: To compare health-economic aspects of multiple imaging modalities used to monitor renal cysts, the present study evaluates costs and outcomes of patients with Bosniak IIF and III renal cysts detected and followed-up by either contrast-enhanced computed tomography (ceCT), contrast-enhanced magnetic resonance imaging (ceMRI), or contrast-enhanced ultrasonography (CEUS). PATIENTS AND METHODS: A simulation using Markov models was implemented and performed with 10 cycles of 1 year each. Proportionate cohorts were allocated to Markov models by a decision tree processing specific incidences of malignancy and levels of diagnostic performance. Costs of imaging and surgical treatment were investigated using internal data of a European university hospital. Multivariate probabilistic sensitivity analysis was performed to confirm results considering input value uncertainties. Patient outcomes were measured in quality-adjusted life years (QALY), and costs as averages per patient including costs of imaging and surgical treatment. RESULTS: Compared to the 'gold standard' of ceCT, ceMRI was more effective but also more expensive, with a resulting incremental cost-effectiveness ratio (ICER) >€70 000 (Euro) per QALY gained. CEUS was dominant compared to ceCT in both Bosniak IIF and III renal cysts in terms of QALYs and costs. Probabilistic sensitivity analysis confirmed these results in the majority of iterations. CONCLUSION: Both ceMRI and CEUS can be used as alternatives to ceCT in the diagnosis and follow-up of intermediately complex cystic renal lesions without compromising effectiveness, while CEUS is clearly cost-effective. The economic results apply to a large university hospital and must be adapted for smaller hospitals.

Cost-effectiveness of real-world administration of chemotherapy and add-on Viscum album L. therapy compared to chemotherapy in the treatment of stage IV NSCLC patients.

BACKGROUND: For stage IV lung cancer patients receiving add-on Viscum album L. (VA) treatment an improved overall survival was detected. Information regarding cost-effectiveness (CE) for comparisons between chemotherapy (CTx) and CTx plus additive VA in stage IV lung cancer treatment is limited. The present study assessed the costs and cost-effectiveness of CTx plus VA (V) compared to CTx alone (C) for stage IV non-small cell lung cancer (NSCLC) patients treatment in a hospital in Germany. METHODS: In the observational real-world data study, data from the Network Oncology clinical registry were utilized. Enrolled stage IV lung cancer patients received the respective therapy (C or V) in a certified German Cancer Center. Cost and cost-effectiveness analyses from the hospital's perspective were investigated on the basis of overall survival (OS) and routine financial controlling data. In addition, the incremental cost-effectiveness ratio (ICER) was calculated. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. RESULTS: 118 patients (C: n = 86, V: n = 32) were included in the analysis, mean age 63.8 years, the proportion of male patients was 55.1%. Adjusted hospital's total mean costs for patients from the C and V group were €16,289, 95%CI: 13,834€-18,744€ (over an adjusted mean OS time of 13.4 months) and €17,992, 95%CI: 13,658-22,326 (over an adjusted mean OS time of 19.1 months), respectively. The costs per additional OS year gained (ICER) with the V-therapy compared to C therapy were €3,586. CONCLUSION: The findings of the present study suggest that the combined use of chemotherapy and VA was clinically effective and comparably cost-effective to chemotherapy alone in our analysed patient sample from the hospital's perspective. Further randomized and prospective cost-effectiveness studies are necessary to complement our findings.

Potential drug-drug interactions in patients with indication for prophylactic implantation of a cardioverter defibrillator: a cross-sectional analysis.

BACKGROUND: Due to demographic transition, multimorbidity and high numbers of medicinal products, polypharmacy rates will presumably further increase. This could lead to higher risks of potentially inappropriate medications with potential drug-drug interactions (PDDI). PDDI has already been investigated by several studies, but not for patients with indication for prophylactic implantation of a cardioverter defibrillator (ICD). Thus, the objective of this analysis was to examine the frequency of PDDI in that specific group of patients and compare patients with or without PDDI regarding potential underlying factors. METHODS: Cross-sectional data analyses were performed using data of the prospective EU-CERT-ICD study that primarily aimed to assess ICD effectiveness in Europe. Self-reported baseline medication data of patients from Germany and Switzerland were used. Patients who reported to take at least two drugs simultaneously for at least 80 days were defined as population at risk. By means of a publicly available interaction checker, we analyzed the medication data regarding occurrence and characteristics of PDDI categorized as minor, moderate, and major PDDI. The analyses were done using descriptive methods and chi square testing. RESULTS: The total population (n = 524) and the population at risk (n = 383) were rather similar with an average age of 64 years and about 80% male. PDDIs were found for 296 patients (in 57% of total population vs. 77% of population at risk). The moderate PDDI category was most frequently with 268 affected patients. Comparing patients with and without any PDDI, the proportion of patients with place of residence in Germany varied distinctly (93% vs. 78%). The frequency of any PDDI for the total population was twice as high in Germany as in Switzerland (p value < 0.001). CONCLUSIONS: PDDIs were frequently observed in this selected patient population and differed markedly between German and Swiss patients. The results should lead to higher awareness of polypharmacy and PDDIs. Adequate cooperation between health care providers should be promoted and new technologies such as drug interaction information systems or digital patient files used. TRIAL REGISTRATION: The EU-CERT-ICD study is registered at www.clinicaltrials.gov (NCT02064192).

Cost-Effectiveness of Real-World Administration of Concomitant Viscum album L. Therapy for the Treatment of Stage IV Pancreatic Cancer.

BACKGROUND: For patients receiving add-on Viscum album L. (VA) treatments for late-stage pancreatic cancer, an improved overall survival (OS) was observed. Only limited information regarding cost-effectiveness (CE) for comparisons between standard of care and standard of care plus add-on VA in stage IV pancreatic cancer treatment is available. The present study assessed the costs and cost-effectiveness of standard of care plus VA (V) compared to standard of care alone (C) for a hospital in Germany. METHODS: An observational study was conducted using data from the Network Oncology clinical registry. Patients included had stage IV pancreatic cancer at diagnosis and received C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. RESULTS: 88 patients (C or n = 34; V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. n = 34; C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. C or. CONCLUSION: Based on this CEA analysis, from the hospital's point of view, the costs per mean month of OS and per mean hospital stay were lower for patients under combinational standard of care plus VA compared to patients receiving standard of care alone for the treatment of stage IV pancreatic cancer. Further prospective cost-effectiveness studies are mandatory to reevaluate our findings.

Cost-Effectiveness of a Team-Based Integrative Medicine Approach to the Treatment of Back Pain.

OBJECTIVES: To report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP). DESIGN: Observational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months. SETTINGS/LOCATION: Osher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH. SUBJECTS: CLBP patients seeking care at OCC or non-OCC BWH clinics. INTERVENTIONS: Integrative or conventional care for CLBP as prescribed by the treating clinician(s). OUTCOME MEASURES: Quality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes. RESULTS: Total adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale. CONCLUSIONS: When adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

Economic burden of deep infiltrating endometriosis of the bowel and the bladder in Germany: The statutory health insurance perspective.

BACKGROUND: Until now, there has been little discussion of the costs of the deep infiltrating endometriosis (DIE) of the bowel or the bladder. The aim of the present secondary data analysis was to describe the population affected by this disease and to determine the economic burden in Germany from a payer's perspective. METHODS: Health claims data of women diagnosed with DIE of the bladder or bowel, who were surgically treated as inpatients between Jan 1, 2008 and Dec 31, 2012, were evaluated retrospectively. All data were extrapolated on a national statutory health insurance (SHI) level and normalized based on the year of surgery (index year). Case-individual information on age, comorbidities and prescribed drugs were presented for the index year. Direct medical cost data were analysed before and after the index year, differentiated by cost sector and age group. RESULTS: The data of 825 women with DIE were analysed. Sample size for different time points varied depending on insurance eligibility and continuous case information. The average age at surgery was 39 years. Besides DIE, 41 % of the women had at least one additional disease of the peritoneum. The mean annual total healthcare costs per DIE case were 12,868 Euros in the index year. Before surgery, mean annual costs varied between 548 and 2,475 Euros per case and after surgery between 1,739 and 2,818 Euros per case. In total, mean costs were higher in younger women as compared to older women, with a cost difference of 616 Euros over all time points. CONCLUSION: Direct costs are highest during the year of surgical treatment, but DIE of the bowel and bladder places a substantial burden on the SHI also before and after surgery. Further studies on indirect costs would be desirable to complete the knowledge on the economic burden of DIE.

Health economic evaluation of vaccination strategies for the prevention of herpes zoster and postherpetic neuralgia in Germany.

BACKGROUND: Herpes zoster (HZ) is a self-limiting painful skin rash affecting mostly individuals from 50 years of age. The main complication is postherpetic neuralgia (PHN), a long-lasting pain after rash has resolved. A HZ-vaccine has recently been licensed in Europe for individuals older than 50 years. To support an informed decision-making for a potential vaccination recommendation, we conducted a health economic evaluation to identify the most cost-effective vaccination strategy. METHODS: We developed a static Markov-cohort model, which compared a vaccine-scenario with no vaccination. The cohort entering the model was 50 years of age, vaccinated at age 60, and stayed over life-time in the model. Transition probabilities were based on HZ/PHN-epidemiology and demographic data from Germany, as well as vaccine efficacy (VE) data from clinical trials. Costs for vaccination and HZ/PHN-treatment (in Euros; 2010), as well as outcomes were discounted equally with 3% p.a. We accounted results from both, payer and societal perspective. We calculated benefit-cost-ratio (BCR), number-needed-to-vaccinate (NNV), and incremental cost-effectiveness ratios (ICERs) for costs per HZ-case avoided, per PHN-case avoided, and per quality-adjusted life-year (QALY) gained. Different target age-groups were compared to identify the most cost-effective vaccination strategy. Base-case-analysis as well as structural, descriptive-, and probabilistic-sensitivity-analyses (DSA, PSA) were performed. RESULTS: When vaccinating 20% of a cohort of 1 million 50 year old individuals at the age of 60 years, approximately 20,000 HZ-cases will be avoided over life-time. The NNV to avoid one HZ (PHN)-case was 10 (144). However, with a BCR of 0.34 this vaccination-strategy did not save costs. The base-case-analysis yielded an ICER of 1,419 (20,809) Euros per avoided HZ (PHN)-case and 28,146 Euros per QALY gained. Vaccination at the age of 60 was identified in most (sensitivity) analyses to be the most cost-effective vaccination strategy. In DSA, vaccine price and VE were shown to be the most critical input-data. CONCLUSIONS: According to our evaluation, HZ-vaccination is expected to avoid HZ/PHN-cases and gain QALYs to higher costs. However, the vaccine price had the highest impact on the ICERs. Among different scenarios, targeting individuals aged 60 years seems to represent the most cost-effective vaccination-strategy.

Process mapping of PTA and stent placement in a university hospital interventional radiology department.

OBJECTIVE: To apply the process mapping technique in an interdisciplinary approach in order to visualize, better understand, and efficiently organize percutaneous transluminal angioplasty (PTA) and stent placement procedures in a university hospital's interventional radiology department. METHODS: After providing an overview of seven established mapping techniques for medical professionals, the process mapping technique was chosen and applied in an interdisciplinary approach including referrers (physicians, nurses, and other staff in referring departments, e.g., vascular surgery), providers (interventional radiologists, nurses, technicians, and staff of the angiography suite), and specialists of the hospital's controlling department. RESULTS: A generally binding and standardized process map was created, describing the entire procedure for a patient in whom the radiological intervention of PTA or stent treatment is contemplated from admission to the department of vascular surgery until discharge after successful treatment. This visualization tool assists in better understanding (especially given natural staff fluctuation over time) and efficiently organizing PTA and stent procedures. CONCLUSION: Process mapping can be applied for streamlining workflow in healthcare, especially in interdisciplinary settings. By defining exactly what a business entity does, who is responsible, to what standard a process should be completed, and how the success can be assessed, this technique can be used to eliminate waste and inefficiencies from the workplace while providing high-quality goods and services easily, quickly, and inexpensively. MAIN MESSAGES: Process mapping can be used in a university hospital's interventional radiology department. • Process mapping can describe the patient's entire process from admission to PTA/stent placement until discharge. • Process mapping can be used in interdisciplinary teams (e.g., referrers, providers, and controlling specialists). • Process mapping can be used in order to more efficiently organize PTA and stent placement procedures. • Process mapping can assist in better understanding and efficiently organizing procedures in standardized fashion.

Limitation of nocturnal ATP import into chloroplasts seems to affect hormonal crosstalk, prime defense, and enhance disease resistance in Arabidopsis thaliana.

When grown under short-day conditions at low light, leaves of an Arabidopsis thaliana (accession Col-0) mutant with defects in the two genes encoding plastid ATP/ADP antiporters (so-called ntt1-2 null mutants) display a variety of physiological changes. These include the formation of necrotic lesions and the accumulation of hydrogen peroxide in the leaves. Here, we show that, under short-day conditions, leaves of the ntt1-2 mutant display enhanced resistance to Hyaloperonospora arabidopsidis, Botrytis cinerea, and Pseudomonas syringae pv. tomato DC3000. Resistance to these pathogens was associated with constitutively elevated levels of the plant hormone salicylic acid and, eventually, jasmonic acid, and constitutive or primed activation after pathogen attack of various defense genes that are dependent on these hormones. In addition, the antagonistic crosstalk between the salicylic acid and jasmonic acid signaling pathways seems to be affected in ntt1-2. Because the enhanced resistance of ntt1-2 to H. arabidopsidis was not seen when the mutant was grown under long-day conditions, our findings argue that nocturnal ATP import into chloroplasts is crucial to keep A. thaliana from runaway activation of pathogen resistance.

The cost of graft failure and other severe complications after liver transplantation - experience from a German Transplant Center.

BACKGROUND: Orthotopic liver transplantation (OLT) is a cost consuming therapy for only a relatively small number of patients. The aim of the present study was to explore specific cost drivers in a German transplant centre. MATERIAL/METHODS: The analysis was done by combination of two separate databases with prospective clinical and case-related cost data. Several complications were compared for their impact on length of stay and on costs by uni- and multivariate analysis. RESULTS: The median cost of OLT was 30,120 Euro (range 18,330-397,450; mean 52,570), the median reimbursement was 33,227 Euro (range 30,879-344,142; mean 59,628) with a significant in-between correlation of r=0.951 (P<0.0001). Post-transplant complications significantly raised cost, with an increase of 62% by vascular complications, 175% by renal failure, 207% by biliary leakage, 227% by graft failure and 234% by sepsis. Multivariate analysis revealed reoperation, hypotension and graft failure as independent cost factors. Graft failure contributed for mean additional costs of 105,911 Euro (95%CI 75,695 to 136,126). In particular, the cost of ICU therapy increased from 16,884 Euro up to 92,239 Euro (P<0.0001). CONCLUSIONS: Cost and reimbursement of OLT are relatively moderate in Germany. Graft failure was identified as the major cost-determining factor. The cost impact of post-transplant complications is mainly caused by the length of stay.

[Is the determination of biomarkers worth its price? Review of the literature taking brain natriuretic peptides (BNP) as an example]. / Sind Biomarker ihr Geld wert? : Literaturreview am Beispiel B-natriuretischer Peptide (BNP).

Heart failure is an important cardiac disease with an increasing prevalence in Western societies. In addition to a significant reduction of the patient's physical capability and quality of life, cardiac insufficiency is associated with considerable expenditure by national health care systems. A number of imaging techniques are available for the detection of heart failure (e.g., echocardiography), and the use of biomarkers such as brain natriuretic peptides (BNP or NT-proBNP) becomes increasingly popular in the process of screening and diagnosis. Until now, there is a lack of information regarding health-economic aspects of this biomarker use. For this reason, a systematic literature search was conducted in MEDLINE including all relevant studies published up to and including August 2009. The primary objective was to summarize the main findings of all relevant investigations which focus on health-economic aspects of BNP use as well as NT-proBNP use. Out of 64 initial search results, 13 relevant studies were identified which met the inclusion criteria. Eleven studies were finally included in this literature review. Although the methodology of these studies was very heterogeneous, the majority of investigations indicate that the use of BNP and NT-proBNP, respectively, is a cost-effective procedure for heart failure diagnosis and prognosis, as well as for heart failure screening. However, keeping in mind that the transferability of economics study results is limited due to a number of differences between national health care systems, there are no investigations with a focus on the financial implications for Germany. Further research is required in this context.

Cost-benefit assessment of antifungal prophylaxis with liposomal amphotericin B in neutropenic patients.

BACKGROUND: In a recently reported randomized trial, low-dose intravenous liposomal amphotericin B (L-AmB) reduced the incidence of invasive fungal infections (20.2 vs. 4.6%, p < 0.001) in high-risk patients with hematological malignancies and prolonged neutropenia. PATIENTS AND METHODS: In the present study, we performed a retrospective cost-benefit analysis of L-AmB prophylaxis from the hospital perspective. RESULTS: Ninety-nine patients were eligible; baseline characteristics were balanced for age, sex, underlying disease, and duration of neutropenia. The mean duration of hospitalization was 42.9 days and 52.3 days in the prophylaxis arm and in patients without antifungal prophylaxis, respectively (p = 0.096). The L-AmB prophylaxis was associated with additional costs of approximately EUR 630 per patient. However, total medication costs (including L-AmB prophylaxis) were EUR 1,219 and EUR 2,815 in patients with L-AmB prophylaxis and in patients in the control arm, respectively (p < 0.001). When involving also costs for medical procedures, the L-AmB prophylaxis reaches a positive net benefit of EUR 1,094 per patient. CONCLUSIONS: Our data shows that antifungal prophylaxis, e.g. with L-AmB, can be a safe and effective strategy to reduce the frequency of invasive fungal infections in selected high-risk patients and to obtain significant cost savings for the hospital.

Medical effectiveness and safety of conventional compared to laparoscopic incisional hernia repair: a systematic review.

BACKGROUND: Incisional hernias are a common complication following abdominal surgery and represent about 80% of all ventral hernia. In uncomplicated postoperative follow-up they develop in about 11% of cases and in up to 23% of cases with wound infections or other forms of wound complications. While conventional mesh repair has been the standard of care in the past, the use of laparoscopic surgery is increasing. It therefore remains uncertain which technique should be recommended as the standard of care. OBJECTIVES: To compare the medical effectiveness and safety of conventional mesh and laparoscopic incisional hernia repair. METHODS: A structured literature search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI) was conducted. English and German literature published until August 2005 was included and their methodological quality assessed. RESULTS: The search identified 17 relevant publications and included 15 studies for final assessment. Among those were one meta-analysis, one randomized clinical trial (RCT) ,and 13 cohort studies. All studies suffered from significant methodological limitations, such as differences in baseline characteristics between treatment groups, small case numbers, and the lack of adjustment for relevant confounders. Overall, medical effectiveness and safety were similar for both surgical approaches. However, there was a trend towards lower recurrence rates, length of hospital stay, and postoperative pain as well as decreased complication rates for the laparoscopic repair in the majority of studies. The impact of the technique of mesh implantation and mesh fixation as well as the impact of certain patient-related factors was not systematically assessed in any of the studies. CONCLUSION: No conclusive differences could be identified between the operative techniques. There was, however, some evidence for a trend towards similar or slightly improved outcomes associated with the laparoscopic procedure. There remains an urgent need for high-quality prospective studies to evaluate this question conclusively.

Limitation of nocturnal import of ATP into Arabidopsis chloroplasts leads to photooxidative damage.

When grown in short day conditions and at low light, leaves of Arabidopsis plants with mutations in the genes encoding two plastidial ATP/ADP transporters (so-called null mutants) spontaneously develop necrotic lesions. Under these conditions, the mutants also display light-induced accumulation of H(2)O(2) and constitutive expression of genes for copper/zinc superoxide dismutase 2 and ascorbate peroxidase 1. In the light phase, null mutants accumulate high levels of phototoxic protoporphyrin IX but have only slightly reduced levels of Mg protoporphyrin IX. The physiological changes are associated with reduced magnesium-chelatase activity. Since the expression of genes encoding any of the three subunits of magnesium-chelatase is similar in wild type and null mutants, decreased enzyme activity is probably due to post-translational modification which might be due to limited availability of ATP in plastids during the night. Surprisingly, the formation of necrotic lesions was absent when null mutants were grown either in long days and low light intensity or in short days and high light intensity. We ascribe the lack of lesion phenotype to increased nocturnal ATP supply due to glycolytic degradation of starch which may lead to additional substrate-level phosphorylation in the stroma. Thus, nocturnal import of ATP into chloroplasts represents a crucial, previously unknown process that is required for controlled chlorophyll biosynthesis and for preventing photooxidative damage.