Novel bone-anchored vascular access on the mastoid for hemodialysis: concept and preclinical trials

GOAL We present the development of a boneanchored port for the painless long-term hemodialytic treatment of patients with renal failure. This port is implanted behind the ear. METHODS The port was developed based on knowledge obtained from long-term experience with implantable hearing devices, which are firmly anchored to the bone behind the ear. This concept of bone anchoring was adapted to the requirements for a vascular access during hemodialysis. The investigational device is comprised of a base plate that is firmly fixed with bone screws to the bone behind the ear (temporal bone). A catheter leads from the base plate valve block through the internal jugular vein and into the right atrium. The valves are opened using a special disposable adapter, without any need to puncture the blood vessels. Between hemodialysis sessions the port is protected with a disposable cover. RESULTS Flow rate, leak tightness and purification were tested on mockups. Preoperative planning and the surgical procedure were verified in 15 anatomical human whole head specimens. CONCLUSION Preclinical evaluations demonstrated the technical feasibility and safety of the investigational device. SIGNIFICANCE Approximately 1.5 million people are treated with hemodialysis worldwide, and 25% of the overall cost of dialysis therapy results from vascular access problems. New approaches towards enhancing vascular access could potentially reduce the costs and complications of hemodialytic therapy.

A non-contrast self-navigated 3-dimensional MR technique for aortic root and vascular access route assessment in the context of transcatheter aortic valve replacement: proof of concept.

OBJECTIVES: Due to the high prevalence of renal failure in transcatheter aortic valve replacement (TAVR) candidates, a non-contrast MR technique is desirable for pre-procedural planning. We sought to evaluate the feasibility of a novel, non-contrast, free-breathing, self-navigated three-dimensional (SN3D) MR sequence for imaging the aorta from its root to the iliofemoral run-off in comparison to non-contrast two-dimensional-balanced steady-state free-precession (2D-bSSFP) imaging. METHODS: SN3D [field of view (FOV), 220-370 mm(3); slice thickness, 1.15 mm; repetition/echo time (TR/TE), 3.1/1.5 ms; and flip angle, 115°] and 2D-bSSFP acquisitions (FOV, 340 mm; slice thickness, 6 mm; TR/TE, 2.3/1.1 ms; flip angle, 77°) were performed in 10 healthy subjects (all male; mean age, 30.3 ± 4.3 yrs) using a 1.5-T MRI system. Aortic root measurements and qualitative image ratings (four-point Likert-scale) were compared. RESULTS: The mean effective aortic annulus diameter was similar for 2D-bSSFP and SN3D (26.7 ± 0.7 vs. 26.1 ± 0.9 mm, p = 0.23). The mean image quality of 2D-bSSFP (4; IQR 3-4) was rated slightly higher (p = 0.03) than SN3D (3; IQR 2-4). The mean total acquisition time for SN3D imaging was 12.8 ± 2.4 min. CONCLUSIONS: Our results suggest that a novel SN3D sequence allows rapid, free-breathing assessment of the aortic root and the aortoiliofemoral system without administration of contrast medium. KEY POINTS: • The prevalence of renal failure is high among TAVR candidates. • Non-contrast 3D MR angiography allows for TAVR procedure planning. • The self-navigated sequence provides a significantly reduced scanning time.

Utilising point of care ultrasound for vascular access in haemodialysis

Learning outcomes: On completion of this continuing professional development activity, participants will be able to: • Discuss basic ultrasound principles; • Define the roles and responsibilities of the nurse in point of care ultrasound; • Identify strategies to utilise ultrasound to provide quality cannulation practice; • Identify anatomic structures on an ultrasound picture; • Identify anomalies in the anatomy such as thrombus, stenosis, aneurysm and pseudoaneurysm; • Describe the advantages and disadvantages of using ultrasound for assessment and cannulation; • Enable staff to reflect on their current approaches to assessment and cannulation.

Efficacité de deux méthodes d'enseignement d'hygiène orale chez les patients atteints de maladies rénales

La maladie rénale peut se manifester avec différents types de pathologies buccales pouvant augmenter les risques de bactériémie. Bien que l’endocardite infectieuse soit une condition rare chez les patients atteints de maladie rénale, elle peut toutefois être retrouvée suite à des infections nosocomiales. Dans le passé, une antibiothérapie prophylactique était prescrite aux patients hémodialysés pour les protéger de l’endocardite infectieuse et de l’infection de l’accès d’hémodialyse. Aujourd’hui, cette recommandation est révolue. Afin de contrer les risques de bactériémie transitoire, une attention particulière doit être apportée aux soins d’hygiène orale à la maison. Le but de l’étude est d’évaluer l’efficacité de deux méthodes d’enseignement d’hygiène orale chez les patients atteints de maladie rénale. Objectifs de recherche Les trois objectifs de recherche sont a) d’évaluer les connaissances des parents de patients atteints de maladies rénales sur l’endocardite infectieuse et le lien avec la santé buccodentaire; b) d’évaluer la perception des parents par rapport à la santé buccodentaire de leur enfant et leurs habitudes d’hygiène orale; et c) de comparer l’influence de deux méthodes d’hygiène orale sur l’indice de plaque chez les enfants atteints de maladies rénales. Hypothèses Les deux hypothèses de recherche sont que a) les parents d’enfants atteints de maladies rénales connaissent et adhèrent aux recommandations émises par l’American Heart Association; et que b) l’amélioration de l’indice de plaque chez les patients atteints de maladies rénales est plus grande pour le groupe recevant des instructions par le matériel audiovisuel par rapport à ceux qui les reçoivent par le néphrologue. Méthodologie Suite à l’obtention d’un certificat d’éthique à la recherche du Centre Hospitalier Universitaire Sainte-Justine, 37 des 38 sujets recrutés âgés entre 6 et 16 ans (19 filles et 18 garçons) ont participé à cette étude transversale. Suite à la signature d’un consentement éclairé, les sujets sont assignés par randomisation à l’un des deux groupes d’instructions d’hygiène orale, soit celui sans instructions spécifiques (groupe 1) ou par matériel audiovisuel (groupe 2). Un questionnaire portant sur les connaissances des parents en rapport avec la santé buccodentaire est remis aux parents. Un indice de plaque initial est noté avant l’application des instructions d’hygiène orale reçues. Un indice de plaque final mis en évidence à l’aide de pastilles révélatrices est documenté avec des photographies intra-orales et mesuré par deux observateurs, testés pour la fiabilité intra et inter-observateurs. Résultats Les analyses statistiques ne démontrent aucune différence significative entre les deux groupes d’instructions d’hygiène orale. Les variables à l’étude (âge, sexe, suivi dentaire, fréquence des soins à la maison, connaissances et motivation) ne montrent aucune influence significative sur la qualité de l’hygiène orale des sujets. Seul l’indice de plaque initial est inversement relié à la perception des parents face à la santé buccodentaire de leur enfant : plus le relevé de plaque est bas, plus la santé buccodentaire est perçue comme bonne. Conclusion Selon les résultats de notre étude, il n’existe pas de différence statistiquement significative entre les deux méthodes d’instructions d’hygiène orale. Néanmoins, les deux techniques permettent de diminuer significativement l’indice de plaque chez les enfants atteints de maladies rénales et de conscientiser cette population à l’importance du maintien d’une bonne santé buccodentaire.

Frequency of dressing changes for central venous access devices on catheter-related infections

Background People admitted to intensive care units and those with chronic health care problems often require long-term vascular access. Central venous access devices (CVADs) are used for administering intravenous medications and blood sampling. CVADs are covered with a dressing and secured with an adhesive or adhesive tape to protect them from infection and reduce movement. Dressings are changed when they become soiled with blood or start to come away from the skin. Repeated removal and application of dressings can cause damage to the skin. The skin is an important barrier that protects the body against infection. Less frequent dressing changes may reduce skin damage, but it is unclear whether this practice affects the frequency of catheter-related infections. Objectives To assess the effect of the frequency of CVAD dressing changes on the incidence of catheter-related infections and other outcomes including pain and skin damage. Search methods In June 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched clinical trials registries for registered trials. There were no restrictions with respect to language, date of publication or study setting. Selection criteria All randomised controlled trials (RCTs) evaluating the effect of the frequency of CVAD dressing changes on the incidence of catheter-related infections on all patients in any healthcare setting. Data collection and analysis We used standard Cochrane review methodology. Two review authors independently assessed studies for inclusion, performed risk of bias assessment and data extraction. We undertook meta-analysis where appropriate or otherwise synthesised data descriptively when heterogeneous. Main results We included five RCTs (2277 participants) that compared different frequencies of CVAD dressing changes. The studies were all conducted in Europe and published between 1995 and 2009. Participants were recruited from the intensive care and cancer care departments of one children's and four adult hospitals. The studies used a variety of transparent dressings and compared a longer interval between dressing changes (5 to15 days; intervention) with a shorter interval between changes (2 to 5 days; control). In each study participants were followed up until the CVAD was removed or until discharge from ICU or hospital. - Confirmed catheter-related bloodstream infection (CRBSI) One trial randomised 995 people receiving central venous catheters to a longer or shorter interval between dressing changes and measured CRBSI. It is unclear whether there is a difference in the risk of CRBSI between people having long or short intervals between dressing changes (RR 1.42, 95% confidence interval (CI) 0.40 to 4.98) (low quality evidence). - Suspected catheter-related bloodstream infection Two trials randomised a total of 151 participants to longer or shorter dressing intervals and measured suspected CRBSI. It is unclear whether there is a difference in the risk of suspected CRBSI between people having long or short intervals between dressing changes (RR 0.70, 95% CI 0.23 to 2.10) (low quality evidence). - All cause mortality Three trials randomised a total of 896 participants to longer or shorter dressing intervals and measured all cause mortality. It is unclear whether there is a difference in the risk of death from any cause between people having long or short intervals between dressing changes (RR 1.06, 95% CI 0.90 to 1.25) (low quality evidence). - Catheter-site infection Two trials randomised a total of 371 participants to longer or shorter dressing intervals and measured catheter-site infection. It is unclear whether there is a difference in risk of catheter-site infection between people having long or short intervals between dressing changes (RR 1.07, 95% CI 0.71 to 1.63) (low quality evidence). - Skin damage One small trial (112 children) and three trials (1475 adults) measured skin damage. There was very low quality evidence for the effect of long intervals between dressing changes on skin damage compared with short intervals (children: RR of scoring ≥ 2 on the skin damage scale 0.33, 95% CI 0.16 to 0.68; data for adults not pooled). - Pain Two studies involving 193 participants measured pain. It is unclear if there is a difference between long and short interval dressing changes on pain during dressing removal (RR 0.80, 95% CI 0.46 to 1.38) (low quality evidence). Authors' conclusions The best available evidence is currently inconclusive regarding whether longer intervals between CVAD dressing changes are associated with more or less catheter-related infection, mortality or pain than shorter intervals.

Renal access coordinators' impact on hemodialysis patient outcomes and associated service delivery: a systematic review

Background
Renal access coordinators contribute specifically to dialysis access care for people with chronic and end stage renal disease. Since the introduction of renal access coordinators into Australia in the early 2000s, there have been anecdotal examples of associated improvements in patient outcomes and service delivery; however scant published quantitative evidence exists. Thus, the impact of the implementation of renal access coordinators has not undergone a rigorous review to date.

Objective
The objective of this systematic review was to critically appraise and synthesize the best available evidence related to the impact of renal access coordinators on dialysis patient outcomes and associated service delivery.

INCLUSION CRITERIA

Types of participants
This review considered studies that included renal access coordinators (noting variations of the titles) and adult hemodialysis patients (aged 18 years and over).

Types of intervention(s)
This review considered studies that evaluated the effectiveness of the renal access coordinator. This role typically consists of clinical and administration duties such as providing pre dialysis access coordination, access surveillance patient education and nurse education.

Types of studies
The types of studies considered within this review included experimental and epidemiological study designs. Thus randomized controlled trials (RCT), non-randomized controlled trials, and quasi-experimental, before and after studies, prospective and retrospective cohort studies were considered as were case control studies, analytical cross sectional studies and descriptive cross sectional studies.

Types of outcomes
Patient outcomes considered included: days to first vascular access complication (such as stenosis or thrombosis) and/or primary intervention (such as angioplasty or surgical intervention); percentage of central line insertions (negative); rate of arteriovenous fistula (AVF)/arteriovenous graft (AVG)/central venous catheter (CVC) at start of dialysis (incidence); prevalent rate of AVF/AVG/CVC; time to occlusion of AVF and time from referral to surgery. Service outcomes included: knowledge/up skilling of renal nurses; cannulation skills, ultrasound skills, knowledge of anatomy and physiology and other access related knowledge.

Search strategy
The search strategy aimed to locate published and unpublished studies, utilizing a three-step searching approach. Studies published in English from 1990 to October 2013 were considered for inclusion in this review.

Methodological quality
The studies were assessed by two independent reviewers using the appropriate standardized critical appraisal instruments from the Joanna Briggs Institute.

Data collection
Data were extracted from papers included in the review using the standardised data extraction tool from the Joanna Briggs Institute, namely JBI Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI).

Data synthesis
This review aimed to conduct meta-analyses of the findings: however, because of the limitations of the data found, this was not possible and so the findings are presented in a narrative format.

Results
Five studies were identified for inclusion in the review. No RCTs were found, therefore four of the five studies were pre-post intervention cohort studies and one was a prospective quality assurance report. Data were heterogeneous and thus did not allow for meta-analysis. All studies included multidisciplinary teams with variable emphasis on the renal access coordinator role. The pre post intervention cohort studies measured incident and/or prevalent AVF, AVG and CVC rates in the hemodialysis population and the quality assurance report measured the difference in patency rates between AVF and AVG. All discussed the role of central coordination as a contributor to the success of vascular access care.

Conclusions
This review found insufficient data to make firm conclusions about the impact that renal access coordinators have on patient outcomes. The results of this review suggest an association between renal access coordinators and improved patient outcomes. These improved patient outcomes were apparent in an increase in incident and prevalent AVFs, and a decrease in the incidence and prevalence of CVCs. Both associations are correlated with a reduction in infection rates, length of hospital stay and healthcare costs.

Do renal access coordinators make a difference? What is the evidence?

Background
Since the introduction of the renal access coordinator (RAC) role into Australia there have been only anecdotal examples of associated improvements in patient outcome and service delivery and scant published quantitative extant evidence exists.

Aim
To review the literature related to the impact of RACs on dialysis patient outcomes and associated service delivery, gauge the level of evidence available and identify gaps in the literature.

Method
A three stage Joanna Briggs Institute (JBI) systematic review process was used to collect and synthesise data. The review considered studies that explored and measured the RAC role in the adult haemodialysis context. All quantitative study designs were considered. Due to lack of homogeneity a narrative synthesis was undertaken.

Results
Five studies met the inclusion criteria for the review. All studies included multidisciplinary teams with variable emphasis on the RAC role. Four pre post intervention cohort studies measured incident and/or prevalent AVF, AVG and CVC rates in the haemodialysis population and the quality assurance report measured differences in patency rates between AVF and AVG and associated hospital length of stay. All discussed the role of central coordination as a contributor to the success of vascular access care.

Conclusion
The available reports do suggest an association between RACs and improved patient outcomes. These improved patient outcomes were apparent in an increase in incident and prevalent AVFs, and a decrease in the incidence and prevalence of CVCs. Both associations are correlated with a reduction in infection rates, length of hospital stay and healthcare costs
 

Acesso vascular para hemodiálise com cateter temporário de duplo lúmen em cães com insuficiência renal aguda

A hemodiálise é uma modalidade terapêutica que pode sustentar a vida do paciente com insuficiência renal aguda (IRA), enquanto este recupera a função renal. Para sua realização, é necessário estabelecer circulação extracorpórea, para que seja realizada a filtração do sangue, impondo a necessidade de um acesso vascular viável e eficiente. O objetivo deste estudo foi avaliar a eficiência e as complicações do acesso vascular para hemodiálise (HD), com cateter temporário de duplo lúmen inserido na veia jugular externa. Foram estudados 10 cães com IRA induzida por gentamicina, submetidos a sessões diárias de HD, com duração de uma hora, até a recuperação da função renal ou óbito. Foram realizadas 104 sessões de HD nos animais estudados, observando-se necessidade de troca do cateter em sete sessões (6,7%), devido à obstrução do lúmen do cateter em seis sessões (5,8%) ou por saída acidental do mesmo em uma sessão (1,0%). Não se observou migração do cateter, infecção, hemorragia ou hematoma no local de entrada do cateter na pele, obtendo-se fluxo sanguíneo patente em 90,4% das sessões. Concluiu-se que o acesso vascular na veia jugular externa com cateter temporário de duplo-lúmen mostrou-se viável, com ocorrência de poucas complicações, sendo, portanto, indicado como forma de acesso para a circulação extracorpórea para HD em cães com IRA.

Polytetrafluoroethylene and bovine mesenterial vein grafts for hemodialysis access: a comparative study

PURPOSE: This study aimed to evaluate the safety and patency rate of bovine mesenterial vein grafts (BMVG) for vascular access (VA) in hemodialysis patients (HDP), compared to expanded polytetrafluorethylene (ePTFE grafts) over a mid- to long-term period. METHODS: Patency and complication rate of 23 consecutive HDP with BMVG for VA were compared to a control group consisting of 23 similar HDP with ePTFE grafts. In both groups, the graft was placed preferably in a forearm loop configuration. The same surgeon performed all procedures. All patients were followed over a period of 4 yrs. RESULTS: Graft placement was successful in all patients. Patency rates did not differ significantly in both groups. However, there were less severe complications in the BMVG group. CONCLUSION: The BMVG is a viable alternative for HD access in patients where autologous construction is not possible, and should be given priority in patients with a failed ePTFE graft or high risk for infection.

Nosocomial infections in dialysis access.

Nosocomial infections in patients requiring renal replacement therapy have a high impact on morbidity and mortality. The most dangerous complication is bloodstream infection (BSI) associated with the vascular access, with a low BSI risk in arteriovenous fistulas or grafts and a comparatively high risk in central venous catheters. The single most important measure for preventing BSI is therefore the reduction of catheter use by means of early fistula formation. As this is not always feasible, prevention should focus on educational efforts, hand hygiene, surveillance of dialysis-associated events, and specific measures at and after the insertion of catheters. Core measures at the time of insertion include choosing the optimal site of insertion, the use of maximum sterile barrier precautions, adequate skin antisepsis, and the choice of catheter type; after insertion, access care needs to ensure hub disinfection and regular dressing changes. The application of antimicrobial locks is reserved for special situations. Evidence suggests that bundling a selection of the aforementioned measures can significantly reduce infection rates. The diagnosis of central line-associated BSI (CLABSI) is based on clinical signs and microbiological findings in blood cultures ideally drawn both peripherally and from the catheter. The prompt installation of empiric antibiotic treatment covering the most commonly encountered organisms is key regarding CLABSI treatment. Catheter removal is recommended in complicated cases or if cultures yield Staphylococcus aureus, enterococci, Pseudomonas or fungi. In other cases, guide wire exchange or catheter salvage strategies with antibiotic lock solutions may be acceptable alternatives.

Intravascular device administration sets: Replacement after standard versus prolonged use in hospitalised patients--a study protocol for a randomised controlled trial (The RSVP Trial)

Introduction Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. Methods and analysis This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.

Infeções em Cateteres de Hemodialisados

Projeto de Pós-Graduação/Dissertação apresentado à Universidade Fernando Pessoa como parte dos requisitos para obtenção do grau de Mestre em Ciências Farmacêuticas

Insuficiência renal crónica e infeções associadas aos diferentes tratamentos

Projeto de Pós-Graduação/Dissertação apresentado à Universidade Fernando Pessoa como parte dos requisitos para obtenção do grau de Mestre em Ciências Farmacêuticas

Caracterización de los pacientes con catéter venoso central en un hospital universitario de cuarto nivel en Bogotá 2011 - 2013

Introducción: La utilización de catéteres venosos centrales (CVC) en la unidad de cuidado intensivo tiene gran importancia y amplio uso, son fuente de apoyo para la realización de varia actividades, pero con un gran potencial de complicaciones, por lo cual es fundamental conocer todos los aspectos relacionados con su uso, para así poder controlarlas. Métodos: Realizamos un estudio descriptivo de corte transversal con el objetivo de caracterizar los pacientes que requirieron CVC en el Hospital Universitario Fundación Santa Fe de Bogotá durante junio de 2011 y mayo de 2013, describimos sus complicaciones asociadas tanto mecánicas como infecciosas, determinamos la tasa de bacteriemia, gérmenes causales y sus patrones de resistencia. Resultados: Se colocaron 2.286 CVC, el 52,9% en hombres, la media de edad fue 58,9 años. El total de las complicaciones ascienden al 4,5%, infecciosas 4,0% y mecánicas 0,6%. Dentro de las mecánicas solo encontramos inmediatas, no tardías. Con respecto a las infecciosas encontramos infección del sitio de inserción y bacteriemia. Se documentó una tasa de bacteriemia de 3,4 por 1000-días catéter en 2013, en disminución con respecto a 2012 (3,9) y 2011 (4,4). El microorganismo mas frecuentemente aislado fue el Staphylococcus Coagulasa Negativo con patrón usual de resistencia. Conclusión: Las complicaciones asociadas al uso de CVC en el HUFSFB, se presentan en menor frecuencia a las descritas internacionalmente; la tasa de bacteriemia asociada al CVC ha disminuido año tras año, posiblemente asociado al cuidado mas estricto posterior a la implementación de protocolos de manejo.