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Objective: Analysis of safety and efficacy of recombinant activated factor VII (rFVIIa) used as the last resort for refractory bleeding after cardiac surgery.Design: Retrospective cohort analysis and matched pairs analysis with historic controls were performed. In the rFVIIa group, which also received conventional hemostatic therapy, data were collected for a median of 14 hrs from admission to the intensive care unit (ICU) to the administration of rFVIIa and for the following 24 hrs. In the control group, which received only conventional hemostatic therapy, data were collected for 14 and then for 24 hrs after admission to the ICU.Setting: University hospital.Patients: Twenty-four patients matched with historic controls.Interventions: None.Measurements and Main Results: No thromboembolic complications were observed in the rFVIIa group. Blood loss and transfusion requirements were significantly reduced in the period after the administration of rFVIIa. However, in the 24-hr period after rFVIIa administration, blood loss (p = .140) and transfusion of packed red blood cells (p = .442) and fresh frozen plasma (p = .063) were not different between the rFVIIa and control groups. Platelet concentrates (p = .004) were transfused less in the control group. Mortality and 6-month survival rates were not different between the groups.Conclusions: When used as a last resort, rFVIIa was safe but not incrementally efficacious over conventional hemostatic therapy. [ABSTRACT FROM AUTHOR]

Abstract Background While gastrointestinal problems are common in ICU patients with multiple organ failure, gastrointestinal failure has not been given the consideration other organ systems receive. The aim of this study was to evaluate the incidence of gastrointestinal failure (GIF), to identify its risk factors, and to determine its association with ICU mortality. Methods A retrospective analysis of adult patients (n = 2588) admitted to three different ICUs (two ICUs at the university hospital Charité-Universitätsmedizin Berlin, Germany and one at Tartu University Clinics, Estonia) during the year 2002 was performed. Data recorded in a computerized database were used in Berlin. In Tartu, the data documented in the patients' charts was retrospectively transferred into a similar database. GIF was defined as documented gastrointestinal problems (food intolerance, gastrointestinal haemorrhage, and/or ileus) in the patient data at any period of their ICU stay. ICU mortality, length of stay, and duration of mechanical ventilation were assessed as outcome parameters. Results GIF was identified in 252 patients (9.7% of all patients). Only 20% of GIF patients were identifiable at admission. GIF was related to significantly higher mortality (43.7% vs. 5.3% in patients without GIF), as well as prolonged length of ICU stay (10 vs. 2 days) and mechanical ventilation (8 vs. 1 day), p < 0.001, respectively. Patients' profile (emergency surgical or medical), APACHE II and SOFA scores and the use of catecholamines at admission were identified as independent risk factors for the development of GIF. Development of GIF during ICU stay was an independent predictor for death. Conclusion Gastrointestinal failure represents a relevant clinical problem accompanied by an increased mortality, longer ICU stay and mechanical ventilation.

Aim: To illustrate incidence, aetiopathogenesis, symptomatology, diagnostic testing, peri-interventional/-surgical management and outcome of SA based on selective references from the scientific medical literature and our own clinical experiences in diagnostic and therapeutic care., Methods: Narrative overview RESULTS: CONCLUSION: SA as relevant quantity of care has become a substantial part of basic vascular surgical or image-guided radiology treatment. The vascular surgeon or radiologist (for image-guided interventions) needs to be adequately focused on the demanding diagnostic and therapeutic management, demanding her/his complete competence and expertise., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Purpose: The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany., Materials and Methods: Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system., Results: There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA., Conclusions: The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years. ClinicalTrials.gov Identifier NCT01970579.

Objectives: Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions., Background: The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions., Methods: In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA)., Results: The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012)., Conclusion: The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.

Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple stent delivery system in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required stenting, up to six short stents per delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14.5 ± 9.0 cm with reference vessel diameters of 5.6 ± 0.7 mm. Overall 47 ± 18 % of lesion lengths could be saved from stenting. At six months, the patency was 90.7 % (68/75) and all-cause TLR rates were 5.3 % (4/75) in the overall cohort. Conclusions: The first clinical experience at six months suggests that the MSDS strategy was safe and effective to treat femoro-popliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting while patency was high and TLR rates were acceptably low.

Background: The aim of this review is to present the available clinical and surrogate endpoints that may be used in future studies performed in patients with peripheral artery occlusive disease (PAOD). Importantly, we describe statistical limitations of the most commonly used endpoints and offer some guidance with respect to study design for a given sample size. The proposed endpoints may be used in studies using surgical or interventional revascularization and/or drug treatments., Methods: Considering recently published study endpoints and designs, the usefulness of these endpoints for reimbursement is evaluated. Based on these potential study endpoints and patient sample size estimates with different non-inferiority or tests for difference hypotheses, a rating relative to their corresponding reimbursement values is attempted., Results: As regards the benefit for the patients and for the payers, walking distance and the ankle brachial index (ABI) are the most feasible endpoints in a relatively small study samples given that other non-vascular impact factors can be controlled. Angiographic endpoints such as minimal lumen diameter (MLD) do not seem useful from a reimbursement standpoint despite their intuitiveness. Other surrogate endpoints, such as transcutaneous oxygen tension measurements, have yet to be established as useful endpoints in reasonably sized studies with patients with critical limb ischemia (CLI)., Conclusions: From a reimbursement standpoint, WD and ABI are effective endpoints for a moderate study sample size given that non-vascular confounding factors can be controlled.

Purpose: The aim of this prospective study was to examine two port systems for intravenous chemotherapy, authorized for high pressure injection, with respect to implantation, complications, implementation, and patency., Materials and Methods: 40 high pressure port systems of the two available models (20 x Power Port [Bard], 20 x T-Port-Contrast [PFM]) and 20 standard port systems (X-Port [BARD]) as the control group were implanted. Both high pressure systems are authorized for injection with a maximum pressure of 300 PSI. The patient population was comprised of patients with different malignomas and liver metastases. At regular intervals following the protocol of the chemotherapy, multiphasic CT for tumor staging was carried out., Results: The intravenous port systems were implanted without complications under sonographic guidance with transjugular access. The mean implantation time was 30 min (range: 22 - 40 min). After a median follow-up time of 6 months, the port patency was 100%. No port infections and no complications during high pressure injection of contrast agent occurred during this period. The level of contrast measured in the aorta was equivalent to the level of contrast in the vessels when contrast agent is administered over a large peripheral intravenous access., Conclusion: The intravenous high pressure port systems are equivalent to standard systems with regard to implantation and implementation. Intravenous chemotherapy can be performed as usual. The advantage is the possibility of multiphasic CT with authorized flow rates of up to 5 ml/sec.

Not all digital radiography systems allow an unrestricted image postprocessing for the radiologist. Depending on the X-ray system there are restrictions in varying brightness and contrast of the image. We compared grey level information that are given to the radiologist by various digital radiography systems. Histograms of differently postprocessed X-ray images were calculated, which were acquired by three different X-ray systems. We found that every modality has its own way of saving and converting the images into DICOM data. The processed image is either sent into PACS with the initial grey level range (10 or 12 bit) or the image is sent with a reduced grey level range due to windowing. The grey level range is associated with the ability of unrestricted windowing in PACS. So, taking an image with a reduced grey level range, the radiologist will face limited potential to optimise the window setting individually afterwards. The loss of image quality due to image transfer from the modality to PACS can lead to an information loss in the diagnostic relevant range.

Purpose: To compare local tumor control after percutaneous tumor ablation by interstitial laser therapy (ILT) or CT-guided brachytherapy (CTGB)., Patients and Methods: In a matched pair analysis including 18 patients with 36 liver metastases of colorectal primary, both ILT and CTGB were performed in different lesions. The following matching factors were considered: (i) tumor size < or = 5 cm, and (ii) execution of chemotherapy after tumor ablation. Primary endpoint was local tumor control., Results: Treated lesions were identical in terms of tumor size and all matching criteria were fulfilled in all patients except for the performance of adjuvant chemotherapy. Median follow-up was 14 months (3-24 months) for both groups. Only five of 18 patients (28%) demonstrated local tumor progression after CTGB, whereas in ten of 18 patients (56%) tumor progression was found after ILT. Differences encountered were significant for all patients (p = 0.04), whereas in those who fulfilled all matching criteria (n = 14) the level of statistical significance was not reached (p = 0.23)., Conclusion: CTGB demonstrated superior local tumor control compared to ILT in long-term follow-up.

Background: While gastrointestinal problems are common in ICU patients with multiple organ failure, gastrointestinal failure has not been given the consideration other organ systems receive. The aim of this study was to evaluate the incidence of gastrointestinal failure (GIF), to identify its risk factors, and to determine its association with ICU mortality., Methods: A retrospective analysis of adult patients (n = 2588) admitted to three different ICUs (two ICUs at the university hospital Charité-Universitätsmedizin Berlin, Germany and one at Tartu University Clinics, Estonia) during the year 2002 was performed. Data recorded in a computerized database were used in Berlin. In Tartu, the data documented in the patients' charts was retrospectively transferred into a similar database. GIF was defined as documented gastrointestinal problems (food intolerance, gastrointestinal haemorrhage, and/or ileus) in the patient data at any period of their ICU stay. ICU mortality, length of stay, and duration of mechanical ventilation were assessed as outcome parameters., Results: GIF was identified in 252 patients (9.7% of all patients). Only 20% of GIF patients were identifiable at admission. GIF was related to significantly higher mortality (43.7% vs. 5.3% in patients without GIF), as well as prolonged length of ICU stay (10 vs. 2 days) and mechanical ventilation (8 vs. 1 day), p < 0.001, respectively. Patients' profile (emergency surgical or medical), APACHE II and SOFA scores and the use of catecholamines at admission were identified as independent risk factors for the development of GIF. Development of GIF during ICU stay was an independent predictor for death., Conclusion: Gastrointestinal failure represents a relevant clinical problem accompanied by an increased mortality, longer ICU stay and mechanical ventilation.

Purpose: Using a patient study to prove the clinical relevance of a comparison of five different radiographic systems for the chest conducted with an anthropomorphic chest phantom. Depending on the results, it was tested whether the performance of a modern digital system with a transparent imaging plate can be improved by changing the post-processing of the image., Method: Chest radiographs of patients were taken with a CsI/aSi-flat panel detector (FDR), transparent imaging plate (tDLR), selenium drum detector (DSR), conventional storage phosphor plate (DLR) and asymmetrical screen-film-system (aFFS), and compared using image criteria scoring (ICS) and visual grading analysis (VGA) for anatomical structures (modified criterions of the EUR 16 260 EN guidelines). After optimizing the post processing, the images of the tDLR-system were evaluated once more in a phantom ROC study and patient VGA study., Results: The flat panel detector-system proved to meet best the anatomical image quality criteria, followed by DSR, tDLR, aFFS and DLR. The modified post processing of the tDLR-images resulted in a significantly better detection of simulated pathological lung-structures, but improved the perceptibility of anatomical structures only slightly., Conclusions: The results of the patient VGA study and the phantom ROC study are similar and considered valid. The new digital imaging systems with flat panel detector and transparent imaging plate provide the best image quality of the tested radiographic devices for chest imaging, assuming that all system components are attuned and optimized for the type of structure to be detected. Image processing is of primary importance for system optimization.

Introduction: Hospital-acquired pneumonia after surgery is one of the major causes of septic shock. The excessive inflammatory response appears to be responsible for the increased susceptibility to infections and subsequent sepsis. The primary aim of this study was to investigate immune parameters at the onset of pneumonia, before the development of subsequent septic shock. The secondary aim was to investigate the usefulness of these immune parameters in predicting progression from hospital-acquired pneumonia to septic shock., Methods: This prospective clinical study included 76 patients with the diagnosis of hospital-acquired pneumonia. Approval was obtained from the local institutional ethics committee and relatives of the patients gave informed consent. Of the 76 patients, 29 subsequently developed septic shock. All patients were included within 4 h of establishing the diagnosis of hospital-acquired pneumonia (first collection of blood samples and the analysis of immune mediators). In addition, we defined early (within 12 h of onset of septic shock) and late (within 72 to 96 h of onset) stages of septic shock for the collection of blood samples and the analysis of immune mediators. The immune parameters tumor necrosis factor-alpha, IL-1beta, IL-6, IL-8 and IL-10 as well as the endothelial leucocyte adhesion molecule were analyzed., Results: In the pneumonia group with subsequent septic shock, levels of IL-1beta, IL-6, IL-8 and IL-10 were significantly increased before the onset of septic shock compared to patients without subsequent septic shock. This progression was best predicted by IL-1beta, IL-6, IL-8 and IL-10 (area under the curve > or = 0.8)., Conclusion: At the onset of hospital-acquired pneumonia, a significant relevant systemic cytokine mediated response had already been initiated. It might, therefore, be possible to identify patients at risk for septic shock with these predictive markers during early pneumonia. In addition, immune modulating therapy might be considered as adjuvant therapy.

Purpose: To compare the diagnostic quality of five different radiographic systems used in chest radiography for visualization of differently configured, clinically relevant pathologic pulmonary structures., Materials and Methods: Four digital detector systems using as detection unit a CsI/aSi-based flat panel detector, a transparent imaging plate, a selenium detector and a conventional storage phosphor plate were analyzed for this study, as well as an asymmetrical film-screen system. The analyzed imaging material consisted of radiographs of an anthropomorphic chest-phantom with superimposed simulated pulmonary structures. The images were evaluated for different pathologic structures by a newly developed multiple structure ROC (ms-ROC)., Results: The performance of each system was found to have a strong structure-related variability. The flat panel detector system had the best overall performance. The theoretical advantage of the 4k-matrix of the transparent imaging plate over the 3k-matrix of the flat panel detector was only confirmed for reticular structures., Conclusions: In addition to comparing the image quality of the different systems, this study shows that the performance of a radiographic system depends on the structure to be analyzed. The modified ROC (ms-ROC) provides valid results with less effort.

Purpose: To improve the diagnostic quality of lateral radiographs of the cervical spine by pre-processing the image data sets produced by a transparent imaging plate with both-side reading and to evaluate any possible impact on minimizing the number of additional radiographs and supplementary investigations., Material and Methods: One hundred lateral digital radiographs of the cervical spine were processed with two different methods: processing of each data set using the system-imminent parameters and using the manual mode. The difference between the two types of processing is the level of the latitude value. Hard copies of the processed images were judged by five radiologists and three neurosurgeons. The evaluation applied the image criteria score (ICS) without conventional reference images., Results: In 99 % of the lateral radiographs of the cervical spine, all vertebral bodies could be completed delineated using the manual mode, but only 76 % oft the images processed by the system-imminent parameters showed all vertebral bodies. Thus, the manual mode enabled the evaluation of up to two additional more caudal vertebral bodies. The manual mode processing was significantly better concerning object size and processing artifacts. This optimized image processing and the resultant minimization of supplementary investigations was calculated to correspond to a theoretical dose reduction of about 50 %., Conclusion: The introduction of optimized organ programs for the upper and lower cervical spine based on the 12-bit data of the images should improve the evaluation of the lateral radiograph of the cervical spine without reducing the latitude value.

We studied how lowering a syringe pump and changing the outflow pressure could affect syringe pump output. We experimentally reduced the height of three different syringe pump systems by 80 cm (adult setting) or 130 cm (neonatal setting), as can happen clinically, using five flow rates. We measured the time of backward flow, no flow and the total time without flow. An exponential negative correlation was present between infusion rate and time without flow (r2=0.809 to 0.972, P<0.01). Minimum flow rates of 4.4 and 2.6 ml h(-1) respectively were calculated to give 60 and 120 s without infusion. The compliance of the different syringe pumps and their infusion systems was linearly correlated with the effective time without infusion (r2=0.863, P<0.05). We conclude that the height of the syringe pumps should not be changed during transportation. If vertical movement of the syringe pump is necessary, the drugs should be diluted so that the flow rate is at least 5 ml h(-1).