Stability testing of iomeprol and iopamidol formulations subjected to X-ray radiation.

INTRODUCTION: Exposure of iodinated contrast media (ICM) to X-rays is not uncommon, as contrast media are often stored in close proximity to radiological equipment. However, the interaction between X-rays and ICM is not widely investigated in literature. The present study aims to investigate the chemical stability of iomeprol and iopamidol, two commercial iodinated ICM commonly used in diagnostic imaging, under X-rays exposure. METHODS: Different formulations of iopamidol and iomeprol (iodine concentration 9 to 400 mgI/mL, volume 50-500 mL) were exposed to three different conditions of X-ray irradiation: i) 1 month storage in CT room (≈5-15 mGy); (ii) low-dose protocol (≈10 mGy); (ii) stressed protocol (≈100 mGy). Unexposed and exposed solutions were characterized by high-performance liquid chromatography in terms of concentration of active pharmaceutical ingredient (API), iodine species and by products. In addition, appearance and colour of the solutions were inspected and pH measured. RESULTS: API concentrations, appearance, colour and pH of the exposed formulations remained unaffected by X-rays. Measured concentrations of iodine species and by products were observed well within the acceptability criteria, i.e. values turned out to be lower than specifications limits established by the manufacturer, considering both release and shelf-life values. CONCLUSIONS: Up to 100 mGy X-ray exposure did not induce any alteration of iomeprol and iopamidol formulation, nor a detectable increase in the concentration of iodine species or by-products. IMPLICATIONS FOR PRACTICE: Our study strengthens the hypothesis that ICM are stable under X-rays exposure up to 100 mGy.

[Project work: formation of health-care personnel for self-care of tunnelled central venous catheters in hemodialysis patients of the territory]. / Project work: formazione infermieristica per l'autocura educativa dei cateteri venosi tunnellizzati nei pazienti emodializzati del territorio.

BACKGROUND: Scientific data from current literature demonstrate an incidence of bacteraemia due to tunnelled central venous catheter (tCVC) use accounting for 1.6 / 1000 days per tCVC, with a range of 1.5 to 1.8. In Sicily no data on the incidence of tCVC- related bacteraemia are available. In our hospital, tCVC infection occurs 2.4 times in 1000 days during CVC use. A retrospective analysis carried out from 2006 to 2012 was performed on 650 patients with tunnelled catheters. Of the subjects who received tCVC in our hospital, 90% were destined to undergo haemodialysis in a private health care environment outside our hospital. MATERIALS AND METHODS: In order to improve the aforementioned infection outcome, we planned and implemented a specific work project. The work project (WP) was subdivided into two steps: 1) The first step was further subdivided into two sub-phases. The first was principally concerned with the implementation of educational courses, conducted directly on the ward and aimed at the implementation of meticulous nursing regimes for the care of tCVC by our health care nurse. The courses were entitled Management of Vascular Access: from doing - to teaching to do!. These educational courses were organized by the Nephrology Department, which takes care of the management and handling of the major complications of tCVCs for the maintenance of haemodialysis. After this first step, the nurses who had participated became the promoters of the second part of the course, which concerned the development of know-how within an outpatient clinic, which deals exclusively with the nursing management of tCVCs. 2) The title of the second phase was Therapeutic Education: self-Care and understanding and managing your venous access at home. The aim of this step was the integration of correct in-hospital care with that available in outsourced private institutions, via the involvement of the patient in the management of their own central venous access. During our training project, a more detailed analysis of the stakeholder as well as a swot analysis on the feasibility of the project were used to determine ad interim and final targets of the study. A summary of operative planning is included to explain in greater detail the study design, timing and costs of the various phases. Risk management and corrective measures adopted during the project are also mentioned and monitoring of the phases is described in relation to the fulfilling of intermediate goals. The prompt correction of mistakes allows for safer realisation of outcomes. CONCLUSION: From our experience with this work project, we can conclude that a more accurate management of tCVCs can significantly reduce the morbidity and mortality of patients. The project offers a positive cost-benefit balance through a decrease in costs of hospitalisation for tCVC-related infections and other life.threatening conditions related to the use of tCVCs an important goal for any spending review.

[Steno-obstructions of haemodialytic FAV: new aspects of endovascular treatments]. / Trattamento endovascolare delle complicanze steno-ostruttive delle fistole artero-venose emodialitiche: nuovi aspetti di intervento con radiologia interventistica.

Angioplasty is the usual method for the treatment of stenosis of arteriovenous fistulas for hemodialysis, along with fibrinolysis and thrombus aspiration. We evaluated the efficacy and safety of interventional radiology procedures in the treatment of stenosis or occlusion of arteriovenous fistulas. One hundred thirteen patients suffering from malfunction of arteriovenous fistulas underwent interventional radiological procedures (140 treatments). In all patients color-Doppler was performed beforehand. Stenosis at the site of the fistula was found in all patients and was treated with percutaneous transluminal angioplasty (PTA); stenosis at the anastomosis site was found in 63 cases and was treated by angioplasty with a microcatheter. In 40 patients suffering from recent thrombotic occlusion, locoregional thrombolysis and PTA were necessary. Technical and clinical success was achieved in 107 patients (94.6%); in 1 of 6 unsuccessful treatments the procedure had to be interrupted due to the rupture of a vein. Follow-up exams demonstrated primary patency in 92.5%, 71.9% and 49.5% of patients at 6 months, 1 year and 2 years, respectively. In 19 patients (17.7%) hemodynamically significant restenosis was observed, which was treated with multiple PTAs (27 treatments, only 1 of which with a negative outcome), resulting in a 94.2% success rate; only 1 patient had to undergo a fourth PTA. The overall patency rate was 95%, 87.2%, 62.3% at 6 months, 1 year and 2 years, respectively. In our experience immediate success and excellent patency rates were observed, which persisted in the medium and long term. PTA, with thrombolysis and thromboaspiration, is the treatment of choice in cases of malfunctioning arteriovenous fistulas. PTA should always be attempted before making a new surgical access in order to preserve the vascular tree.

[Use of venae comitantes in the creation of arteriovenous fistulas: retrospective evaluation of our experience]. / L'utilizzo della vena comitans nel confezionamento delle fistole artero-venose: valutazione retrospettiva della nostra esperienza.

In order to estimate the outcome of arteriovenous fistula (AVF) for hemodialysis, we reviewed our experience in the construction of AVFs using the venae comitantes in patients without an adequate superficial venous vascular territory. The study included 34 patients affected by end-stage renal disease in whom an AVF was created using the deep venous system. In 26 of them we performed an anastomosis between the brachial artery and its vena comitans. Immediate success, defined by the presence of a thrill at the end of the anastomosis, was obtained in 84%, while primary failure of the AVF (immediate postoperative failure) occurred in 3 patients (12%). Early failure, defined as failure within 6 weeks of AVF placement, occurred in 4% of patients. Of the 22 patients with a functioning AVF, 8 (36%) subsequently requested a second operation to bring the fistula to the surface. Some of these involved the placement of synthetic grafts for better accessibility. The primary patency of the AVFs was equal to 64%, while the patency after a second intervention was 91%. Among the 26 AVFs created with venae comitantes, total patency at 50 weeks was 62%. Our experience with the placement of prosthetic grafts draining into the venae comitantes has not provided encouraging results. We believe that for adequate exploitation of venae comitantes it is important to use native veins that have to meet specific anatomical and functional requirements. The creation of an AVF with a native vein, taking advantage of the deep venous system, is feasible under the right circumstances.