Primary stenting with balloon expandable stents in the infrapopliteal arteries does not outway the benefit of PTA alone with the application of modern hydrophilic balloon catheters in patients with CLI.
In dialysis access fistulas and grafts, percutaneous transluminal angioplasty (PTA) is frequently followed by restenosis development, which results in repeated periodical re-interventions. The technique of drug-eluting balloon (DEB) angioplasty has shown promising results in the treatment of femoropopliteal arteriosclerotic lesions. In contrast to arteriosclerotic arteries, dialysis access vessels host unfavorable hemodynamics due to the direct conduction of high-pressure fluid into a low-pressure system. Hence, the beneficial effect of DEB angioplasty may be limited in this system. However, a first prospective randomized trial on 40 patients with arteriovenous fistula or graft stenoses exhibited a significantly higher 6-month primary patency of the treated lesions after DEB angioplasty than after uncoated balloon angioplasty. Despite such a positive reference, general recommendations regarding the value of DEBs in dialysis access vessels cannot be considered as serious unless large randomized controlled trials have been performed.
The RFA Guardian is a comprehensive application for high-performance patient-specific simulation of radiofrequency ablation of liver tumors. We address a wide range of usage scenarios. These include pre-interventional planning, sampling of the parameter space for uncertainty estimation, treatment evaluation and, in the worst case, failure analysis. The RFA Guardian is the first of its kind that exhibits sufficient performance for simulating treatment outcomes during the intervention. We achieve this by combining a large number of high-performance image processing, biomechanical simulation and visualization techniques into a generalized technical workflow. Further, we wrap the feature set into a single, integrated application, which exploits all available resources of standard consumer hardware, including massively parallel computing on graphics processing units. This allows us to predict or reproduce treatment outcomes on a single personal computer with high computational performance and high accuracy. The resulting low demand for infrastructure enables easy and cost-efficient integration into the clinical routine. We present a number of evaluation cases from the clinical practice where users performed the whole technical workflow from patient-specific modeling to final validation and highlight the opportunities arising from our fast, accurate prediction techniques.Radiofrequency ablation (RFA) of liver malignancies has become an important alternative therapy for patients who disqualify for standard surgical treatment or are in an early tumor stage 1,2 . When surgical resection is not feasible, RFA is the preferred treatment option for small liver tumors 1,2 . Moreover, patient recovery after surgical resection takes longer and post-procedural quality of life is lower than after RFA 2 .While many more options for local cancer treatment exist (e.g. Cryo Ablation 3 , Irreversible Electroporation 4 or hyperthermia in conjunction with other treatment methods 5,6 ), the clincial routine prefers RFA (or, occasionally, microwave ablation) treatment for smaller liver tumors. Although microwave ablation has become more prevalent in the past years, no statistically significant difference in survival rates compared to RFA of smaller lesions (diameter below 3.5 cm) in the liver could be found 7,8 .In RFA, interventional radiologists (IR) destroy malignant cells using percutaneous probes that induce heating in a locally delimited region around a tumor. Successful treatment is defined as complete ablation of the tumor with a safety margin of destroyed healthy tissue in its immediate vicinity.However, clinical experience with RFA indicates a significant mismatch between expected and observed lesion size, leading to reduced survival rates due to over-treatment with severe injuries (up to 9%) or under-treatment with tumor recurrence 9 (up to 40%). Further, Hildebrand et al. 10 have shown that the survival rates after 1 and 2 years significantly depend on the experience of the IR: Operating experience of 0-2 years resulted in 69...
Bone loss and fractures are common complications after cardiac transplantation (CTP). The aim of this study was to investigate whether intravenous ibandronate is an effective preventive option. Thirtyfive male cardiac transplant recipients received either ibandronate (IBN) 2 mg intravenously every 3 mo or matching placebo (CTR) in addition to 500 mg calcium carbonate and 400 IE vitamin D 3 . Sera were collected at CTP and every 3 mo thereafter. At baseline and 6 and 12 mo, standardized spinal X-rays and BMD measurements were taken. Bone biopsies were taken at CTP and after 6 mo from six patients. In the IBN group, 13% of the patients sustained a new morphometric vertebral fracture compared with 53% in the CTR group (absolute risk reduction [ARR], 40%; relative risk reduction [RRR], 75%; p = 0.04). BMD remained unchanged with IBN treatment but in the CTR group decreased at the lumbar spine by 25% and at the femoral neck by 23% (both p < 0.0001) over the 1-yr period. Serum bone resorption markers carboxyterminal telopeptide region of type I collagen (sCTX) and TRACP 5b were significantly increased in the CTR group and decreased in the IBN group at all time points compared with baseline. In contrast, both osteocalcin and bone-specific alkaline phosphatase levels showed, after a similar decrease over the first 3 mo in both groups, a marked rise in the CTR subjects and steadily declining levels in the IBN patients throughout the remainder of the study period. Three paired biopsies were available from each group. Despite the small sample size, a difference in the relative change of eroded surface (68% in the CTR versus 223% in the IBN group, p < 0.05) could be shown. Intravenous IBN reduced fractures, preserved bone mass, and prevented uncoupling of bone formation and resorption after CTP. The favorable effects on bone turnover were also supported by histomorphometric findings.
A 55-year-old male with peripheral arterial disease underwent angioplasty of the right lower limb arteries via antegrade femoral access. Angio-Seal® closure device was used to treat the puncture site, whereby the intravascular sealing anchor accidentally embolized into the malleolar region of the right posterior tibial artery. Successful retrieval of the anchor was accomplished by a SpiderFX embolic protection device. This technique may be a useful approach to retrieve embolized foreign bodies via endovascular access.
BackgroundPatients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated lipocalin (NGAL), a new biomarker predictive for acute kidney injury (AKI), has been shown to be useful for earlier diagnosis of CIN; however, urinary NGAL values may be markedly increased in chronic renal failure at baseline. Results from those studies suggested that urinary NGAL values may not be helpful for the clinician. An intravenous volume load is a widely accepted prophylactic measure and possibly a reasonable intervention to prevent deterioration of renal function. The aim of our study is to evaluate NGAL as an early predictor of CIN and to investigate the clinical benefit of early post-procedural i.v. hydration.Methods/DesignThe study will follow a prospective, open-label, randomized controlled design. Patients requiring intra-arterial contrast media (CM) application will be included and receive standardized, weight-based, intravenous hydration before investigation. Subjects with markedly increased urinary NGAL values after CM application will be randomized into one of two study groups. Group A will receive 3-4 ml/kg BW/h 0.9% saline intravenously for 6 hours. Group B will undergo only standard treatment consisting of unrestricted oral fluid intake. The primary outcome measure will be CIN defined by an increase greater than 25% of baseline serum creatinine. Secondary outcomes will include urinary NGAL values, cystatin C values, contrast media associated changes in cardiac parameters such as NT-pro-BNP/troponin T, changes in urinary cytology, need for renal replacement treatment, length of stay in hospital and death.We assume that 20% of the included patients will show a definite rise in urinary NGAL. Prospective statistical power calculations indicate that the study will have 80% statistical power to detect a clinically significant decrease of CIN of 40% in the treatment arm if 1200 patients are recruited into the study.DiscussionA volume expansion strategy showing a benefit from earlier intervention for patients with markedly elevated urinary NGAL values, indicating a CIN, might arise from data from this study.Trial registrationClinicalTrials.gov NCT01292317
The aim of the study was to evaluate the diagnostic accuracy of urinary neutrophil gelatinase- associated lipocalin (uNGAL) in patients with chronic kidney disease (CKD) as an early biomarker for contrast induced acute kidney injury (CI-AKI) and to investigate whether patients with an uNGAL increase might benefit from an additional intravenous volume expansion with regard to CI-AKI-incidence. We performed a prospective randomized controlled trial in 617 CKD-patients undergoing intra-arterial angiography. Urinary NGAL was measured the day before and 4–6hrs after angiography. In the event of a significant rise of uNGAL patients were randomized either into Group A, who received intravenous saline post procedure or Group B, who did not receive post-procedural i.v. fluids. Ten patients (1.62%) exhibited a significant rise of uNGAL after angiography and were randomized of whom one developed a CI-AKI. In the entire cohort the incidence of CI-AKI was 9.4% (58 patients) resulting in a specificity of 98.4% (95% CI: 97.0–99.3%) and a sensitivity of 1.72% (95% CI: 0.044–9.2%) of uNGAL for the diagnosis of CI-AKI. In this study uNGAL failed to predict CI-AKI and was an inadequate triage tool to guide an early intervention strategy to prevent CI-AKI. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01292317.
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