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The risk of developing colorectal cancer in patients with chronic kidney disease (CKD) is twice that of the general population, but the factors associated with colorectal cancer are poorly understood. The aim of this study was to identify factors associated with advanced colorectal neoplasia in patients with CKD.Prospective cohort study.Patients with CKD stages 3-5, including those treated with maintenance dialysis or transplantation across 11 sites in Australia, New Zealand, Canada, and Spain, were screened for colorectal neoplasia using a fecal immunochemical test (FIT) as part of the Detecting Bowel Cancer in CKD (DETECT) Study.Baseline characteristics for patients at the time of study enrollment were ascertained, including duration of CKD, comorbidities, and medications.Advanced colorectal neoplasia was identified through a 2-step verification process with colonoscopy following positive FIT and 2-year clinical follow-up for all patients.Potential factors associated with advanced colorectal neoplasia were explored using multivariable logistic regression. Sensitivity analyses were performed using grouped LASSO (least absolute shrinkage and selection operator) logistic regression.Among 1,706 patients who received FIT-based screening-791 with CKD stages 3-5 not receiving kidney replacement therapy (KRT), 418 receiving dialysis, and 497 patients with a functioning kidney transplant-117 patients (6.9%) were detected to have advanced colorectal neoplasia (54 with CKD stages 3-5 without KRT, 34 receiving dialysis, and 29 transplant recipients), including 9 colorectal cancers. The factors found to be associated with advanced colorectal neoplasia included older age (OR per year older, 1.05 [95% CI, 1.03-1.07], P0.001), male sex (OR, 2.27 [95% CI, 1.45-3.54], P0.001), azathioprine use (OR, 2.99 [95% CI, 1.40-6.37], P=0.005), and erythropoiesis-stimulating agent use (OR, 1.92 [95% CI, 1.22-3.03], P=0.005). Grouped LASSO logistic regression revealed similar associations between these factors and advanced colorectal neoplasia.Unmeasured confounding factors.Older age, male sex, erythropoiesis-stimulating agents, and azathioprine were found to be significantly associated with advanced colorectal neoplasia in patients with CKD.

Shared decision-making (SDM) is a process of collaborative deliberation in the dyadic patient-physician interaction whereby physicians inform the patients about the pros and cons of all available treatment options and reach an agreement with the patients on their preferred treatment plan. In hemodialysis vascular access practice, SDM advocates a deliberative approach based on the existence of reasonable alternatives-that is, arteriovenous fistula, arteriovenous graft, and central venous catheter-so that patients are able to form and share preferences about access options. In spite of its ethical imperative, SDM is not broadly applied in hemodialysis vascular access planning. Physicians and surgeons commonly deliver prescriptive fistula-centered recommendations concerning the approach to vascular access care. This paternalistic approach has been shaped by directions from long-held clinical practice guidelines and is reinforced by financial payment models linked with the prevalence of arteriovenous fistula in patients on hemodialysis. Awareness is growing that what may have initially seemed a medically and surgically appropriate approach might not always be focused on each individual's goals of care. Clinician's recommendations for vascular access often do not sufficiently consider the uncertainty surrounding the potential benefits of the decision or the cumulative impact of the decision on patient's quality of life. In the evolving health care landscape, it is time for the practice of hemodialysis vascular access to shift from a hierarchical doctor-patient approach to patient-centered care. In this article we review the current state of vascular access practice, present arguments why SDM is necessary in vascular access planning, review barriers and potential solutions to SDM implementation, and discuss future research contingent on an effective system of physician-patient participative decision-making in hemodialysis vascular access practice.

Caffeine is well known for its central nervous system–stimulating effect. Toxicity may occur following high-dose caffeine ingestions. We describe a case of caffeine intoxication secondary to reported ingestion of a large dose of caffeine (60,000 mg in tablet form) with an initial serum caffeine level of 608 μmol/L (known lethal serum level starting from 412 μmol/L). This case demonstrates the key clinical manifestations of caffeine intoxication and the effect of its associated massive adrenergic surge with neurologic symptoms, cardiovascular instability, metabolic abnormalities, and the significant risk of mortality. We highlight important kidney management considerations, including protective measures against electrolyte disturbances such as hypokalemia and hypophosphatemia, and the use of prolonged hemodialysis for caffeine elimination. We share our practical decision making and approach to dialysis discontinuation if serum caffeine level reporting is unavailable or delayed.

Introduction People with chronic kidney disease (CKD) experience reduced quality of life (QoL) because of the high symptom and treatment burden. Limited data exist on the factors associated with overall and domain-specific QoL across all CKD stages. Methods Using data from a prospective, multinational study (Australia, New Zealand, Canada, and Spain) in 1696 participants with CKD, we measured overall and domain-specific QoL (pain, self-care, activity, mobility, anxiety/depression) using the EuroQoL, 5 dimension, 3 level. Multivariable linear regression and logistic modeling were used to determine factors associated with overall and domain-specific QoL. Results QoL for patients with CKD stages 3 to 5 (n = 787; mean, 0.81; SD, 0.20) was higher than in patients on dialysis (n = 415; mean, 0.76; SD, 0.24) but lower than in kidney transplant recipients (n = 494; mean, 0.84; SD, 0.21). Factors associated with reduced overall QoL (β [95% confidence intervals]) included being on dialysis (compared with CKD stages 3–5: –0.06 [–0.08 to –0.03]), female sex (–0.03 [–0.05 to –0.006]), lower educational attainment (– 0.04 [–0.06 to –0.02), lacking a partner (–0.04 [–0.06 to –0.02]), having diabetes (–0.05 [–0.07 to –0.02]), history of stroke (–0.09 [–0.13 to –0.05]), cardiovascular disease (–0.06 [–0.08 to –0.03]), and cancer (–0.03 [–0.06 to –0.009]). Pain (43%) and anxiety/depression (30%) were the most commonly affected domains, with dialysis patients reporting decrements in all 5 domains. Predictors for domain-specific QoL included being on dialysis, presence of comorbidities, lower education, female sex, and lack of a partner. Conclusions Being on dialysis, women with CKD, those with multiple comorbidities, lack of a partner, and lower educational attainment were associated with lower QoL across all stages of CKD., Graphical abstract

Increased left atrial (LA) size predicts cardiovascular events in patients with end-stage kidney disease. There is a paucity of data on LA changes after kidney transplantation (KT). Accordingly, we used cardiac magnetic resonance imaging (CMR) to evaluate LA remodeling after KT, and examined its relationship with left ventricular (LV) measurements, blood pressure and cardiac biomarkers. In this prospective multi-center cohort study, 39 pre-transplant dialysis patients underwent KT and 42 eligible transplant recipients remained on dialysis. CMR, blood pressure and serum measurements for N-terminal pro b-type natriuretic peptide (NT-proBNP), high sensitivity C-reactive protein (hsCRP), and growth differentiation factor-15 (GDF-15) were performed at baseline and 12 months. After 12 months, there were no significant changes in LA end-systolic volume index, LA end-diastolic volume index, or LA ejection fraction (LAEF) within the KT or dialysis group; changes over time did not differ between the 2 groups (all p > 0.25). At baseline and over 12 months, LA volumes and LAEF positively correlated with LV volumes and mass while LAEF positively correlated with LV function. Changes in LA volumes also positively correlated with NT-proBNP and systolic blood pressure (sBP) while LAEF negatively correlated with NT-proBNP. GDF-15 correlated with LA measurements at baseline but not in 12-month changes. hsCRP did not correlate with any LA measurements. LA volumes and function as measured by CMR did not change significantly over 12 months post-KT. There were significant associations between LA and LV remodeling, NT-proBNP and sBP, suggesting common underlying pathophysiological mechanisms.

The new Kidney Disease Outcomes Quality Initiative Vascular Access Guidelines now focus on a more comprehensive overall patient strategy. The patient's vascular access needs are part of a dialysis access strategy, which itself is part of an End Stage Kidney Disease Life-Plan strategy that stems from a unique patient's individualized needs. The End Stage Kidney Disease Life-Plan is an individualized and comprehensive map for dialysis modalities and dialysis access for the lifetime of the patient. New targets are introduced that align with this patient-centered approach. The Guidelines made significant changes to the use of surveillance techniques to detect stenosis and found insufficient evidence to make a recommendation for routine arteriovenous fistula surveillance by measuring access blood flow, pressure monitoring, or imaging for stenosis that was in addition to routine clinical monitoring. Routine surveillance is not recommended in arteriovenous grafts. Similarly, pre-emptive angioplasty of arteriovenous fistulas or arteriovenous grafts with stenosis, not associated with clinical indicators, is not recommended. The Guidelines represent a rigorous review of the evidence; however, the available evidence to guide vascular access practice remains limited. There is a significant need and opportunity for new and ongoing high-quality research to inform best practice.

The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidence-based guidelines for hemodialysis vascular access since 1996. Since the last update in 2006, there has been a great accumulation of new evidence and sophistication in the guidelines process. The 2019 update to the KDOQI Clinical Practice Guideline for Vascular Access is a comprehensive document intended to assist multidisciplinary practitioners care for chronic kidney disease patients and their vascular access. New topics include the end-stage kidney disease "Life-Plan" and related concepts, guidance on vascular access choice, new targets for arteriovenous access (fistulas and grafts) and central venous catheters, management of specific complications, and renewed approaches to some older topics. Appraisal of the quality of the evidence was independently conducted by using a Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, and interpretation and application followed the GRADE Evidence to Decision frameworks. As applicable, each guideline statement is accompanied by rationale/background information, a detailed justification, monitoring and evaluation guidance, implementation considerations, special discussions, and recommendations for future research.

International audience; Blood pressure (BP) and volume control are critical components of dialysis care and have substantial impacts on patient symptoms, quality of life, and cardiovascular complications. Yet, developing consensus best practices for BP and volume control have been challenging, given the absence of objective measures of extracellular volume status and the lack of high-quality evidence for many therapeutic interventions. In February of 2019, Kidney Disease: Improving Global Outcomes (KDIGO) held a Controversies Conference titled Blood Pressure and Volume Management in Dialysis to assess the current state of knowledge related to BP and volume management and identify opportunities to improve clinical and patient-reported outcomes among individuals receiving maintenance dialysis. Four major topics were addressed: BP measurement, BP targets, and pharmacologic management of suboptimal BP; dialysis prescriptions as they relate to BP and volume; extracellular volume assessment and management with a focus on technology-based solutions; and volume-related patient symptoms and experiences. The overarching theme resulting from presentations and discussions was that managing BP and volume in dialysis involves weighing multiple clinical factors and risk considerations as well as patient lifestyle and preferences, all within a narrow therapeutic window for avoiding acute or chronic volume-related complications. Striking this challenging balance requires individualizing the dialysis prescription by incorporating comorbid health conditions, treatment hemodynamic patterns, clinical judgment, and patient preferences into decision-making, all within local resource constraints.

Early mortality rates of female patients on dialysis have been, at times, observed to be higher than rates among male patients. The differences in cause-specific mortality between male and female incident dialysis patients with kidney failure are not well understood and were the focus of this study.Retrospective cohort study.Participants: Incident patients who had initiated dialysis in Australia and New Zealand between 1998-2018.Sex.Cause-specific and all-cause mortality on dialysis, censored for kidney transplantation.Adjusted cause-specific proportional hazards models, focusing on the first 5 years following initiation of dialysis.Among 53,414 patients (20,876 [39%] of whom were female) followed for a median period of 2.8 (IQR 1.3-5.2) years, 27,137 (51%) died, with the predominant cause of death attributed to cardiovascular disease (CVD, 18%), followed by dialysis withdrawal (16%). Compared to male patients, female patients were more likely to die in the first 5 years after dialysis initiation (adjusted hazard ratio (aHR) of 1.06 [95% CI 1.03-1.09]). Even though female patients experienced a lower risk of CVD-related mortality (aHR 0.93 [0.89-0.98]) compared to male patients, they experienced a greater risk of infection-related (aHR 1.20 [1.10-1.32]) and dialysis withdrawal-related mortality (aHR 1.19 [1.13-1.26]).Possibility of residual and unmeasured confounders.Compared with male patients, female patients had a higher risk of all-cause mortality in the first 5 years post-dialysis initiation, a difference driven by higher mortality from infections and dialysis withdrawals. These findings may inform the study of sex differences in mortality in other geographic settings.

Patients with advanced chronic kidney disease (CKD) have been reported to experience profound psychosocial distress. Other work has established that patients with CKD from marginalized populations (including individuals who on the basis of race often face racism and related discrimination, termed "racialization") experience health care inequities. Given limited information on the intersection of these 2 phenomena, we assessed the association of psychosocial distress with racialized status and immigrant status in Canadians with advanced CKD.Secondary analysis of cross-sectional data.536 patients with advanced CKD (estimated glomerular filtration rate30mL/min/1.73mRacialized status (individuals who identify as Asian or as African, Caribbean, or Black Canadian), immigrant status, and combined immigrant-racialized status.Psychosocial distress, defined as the presence of depression, anxiety, or social difficulties (ie, a score of≥10 points on the Patient Health Questionnaire 9, Generalized Anxiety Disorder 7, or Social Distress 16 scales, respectively).The independent associations of racialized status and immigrant status with psychosocial distress, depression, anxiety, and social difficulties were examined using univariable- and multivariable-adjusted logistic regression.Mean age of the 536 participants was 57±16 (SD) years, 62% were male, and 45% were immigrants. Of the sample, 58% were White, 22% were African, Caribbean, or Black Canadian, and 20% were Asian. Psychosocial distress was present in 36% of participants (depression in 19%, anxiety in 12%, and social difficulties in 31%). To assess the combined impact of racialized and immigrant status, we created a variable with mutually exclusive categories: White nonimmigrant, racialized nonimmigrant, White immigrant, and racialized immigrant participants. In our final multivariable-adjusted model, compared with White nonimmigrant participants, racialized immigrant participants were more likely to have psychosocial distress (OR, 2.96 [95% CI, 1.81-4.81]), depression (OR, 1.87 [95% CI, 1.05-3.34]), and social difficulties (OR, 3.36 [95% CI, 2.03-5.57]). Overall similar associations were seen for racialized nonimmigrants and for White immigrants.Convenience sample; small subgroups; combined exposure variable grouping Asian and African, Caribbean, and Black participants together; lack of data about mechanisms.Both racialized and immigrant status based on self-report of demographic characteristics were associated with psychosocial distress among patients with advanced CKD. These patients may benefit from culturally competent psychosocial support.Psychosocial distress is frequent in patients with advanced chronic kidney disease and impacts quality of life and clinical outcomes. Psychosocial distress may be especially scarring in people who are racialized (marginalized on account of their membership in a particular racial group) and/or who are immigrants. We assessed the association of psychosocial distress with racialized and immigrant status in Canadians with advanced chronic kidney disease. Among 536 participants from multiple medical centers in Toronto, we found that racialized and immigrant participants were more likely to have psychosocial distress, depression, and social difficulties compared with White nonimmigrant participants. This is likely related to the multiple intersectional challenges, including experience with racism and discrimination that racialized immigrant patients may face. Further studies are needed to elucidate the specific factors that contribute to more distress. The potential impact of culturally competent and safe support for these patients will also need to be studied.

Background: Thrombolysis for arteriovenous grafts (AVG) yields high technical success rates, however, long-term outcomes are unclear. We conducted a multicenter retrospective cohort study to analyze 5-year patency rates following AVG thrombolysis. Methods: All patients who underwent AVG thrombolysis between 2005 and 2015 at three academic hospitals were included. Prospectively maintained institutional nephrology and radiology databases were used to record demographic, clinical, and AVG characteristics. The primary outcome was primary patency, defined as AVG access survival without re-intervention including angioplasty ± stent with/without re-thrombolysis. Secondary outcomes were assisted primary patency and cumulative patency, defined as AVG access survival until re-thrombosis requiring re-thrombolysis or abandonment, respectively. Technical success was defined as restoration of flow with Results: Seventy-four patients underwent AVG thrombolysis during the study period with a median follow-up period of 21.4 (IQR 8.3–42.8) months. The average age was 58.6 years with a high rate of comorbidities, including hypertension (82.4%) and diabetes (54.1%). Thrombolysis technical success was 96%. There were 147 re-interventions in 46 patients, of which 98 were re-thrombolysis (mean re-intervention rate of 1.27/patient/year). Primary patency at 1, 3, and 5 years were 43.2%, 20.2%, and 7.7%. Assisted primary patency at 1, 3, and 5 years were 47.5%, 20.2%, and 7.7%. Cumulative patency at 1, 3, and 5 years were 75.0%, 38.8%, and 22.6%. Cox proportional hazards analysis demonstrated no associations between demographic, clinical, and procedural characteristics and patency rates. Conclusions: Despite a high technical success rate, thrombolysis for AVG dysfunction is associated with poor long-term patency. Future studies are needed to determine risk factors for re-thrombosis to identify patients who will benefit from AVG thrombolysis in the long-term.

Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) is a 4-year cluster-randomized clinical trial comparing the effect of using a personalized, temperature-reduced dialysate protocol versus a dialysate temperature of 36.5°C on cardiovascular-related death and hospitalization. Randomization was performed at the level of the dialysis center ("the cluster").The objective is to outline the statistical analysis plan for the MyTEMP trial.MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial.A total of 84 dialysis centers in Ontario, Canada.Approximately 13 500 patients will have received in-center hemodialysis at the 84 participating dialysis centers during the trial period (April 3, 2017, to March 1, 2021, with a maximum follow-up to March 31, 2021).Patient identification, baseline characteristics, and study outcomes will be obtained primarily through Ontario administrative health care databases held at ICES. Covariate-constrained randomization was used to allocate the 84 dialysis centers (1:1) to the intervention group or the control group. Centers in the intervention group used a personalized, temperature-reduced dialysate protocol, and centers in the control group used a fixed dialysate temperature of 36.5°C.The primary outcome is a composite of cardiovascular-related death or major cardiovascular-related hospitalization (defined as a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in administrative health care databases. The key secondary outcome is the mean drop in intradialytic systolic blood pressure, defined as the patients' predialysis systolic blood pressure minus their nadir systolic blood pressure during the dialysis treatment. Anonymized data on patients' predialysis and intradialytic systolic blood pressure were collected at monthly intervals from each dialysis center.The primary analysis will follow an intent-to-treat approach. The primary outcome will be analyzed at the patient level as the hazard ratio of time-to-first event, estimated from a subdistribution hazards model. Within-center correlation will be accounted for using a robust sandwich estimator. In the primary analysis, patients' observation time will end if they experience the primary outcome, emigrate from Ontario, or die of a noncardiovascular cause (which will be treated as a competing risk event). The between-group difference in the mean drop in intradialytic systolic blood pressure obtained during the dialysis sessions throughout the trial period will be analyzed at the center level using an unadjusted random-effects linear mixed model.The MyTEMP trial period is April 3, 2017, to March 31, 2021. We expect to analyze and report results by 2023 once the updated data are available at ICES.MyTEMP is registered with the US National Institutes of Health at clincaltrials.gov (NCT02628366).Version 1.1 June 15, 2021.L’essai MyTEMP (Exposer les grandes lignes du plan d’analyse statistique de l’essai MyTEMP.MyTEMP est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes.L’essai est mené dans 84 centres de dialyse en Ontario (Canada).On estime qu’environ 13 500 patients auront reçu des soins d’hémodialyse dans les 84 centres de dialyse participants au cours de la période de l’essai (3 avril 2017 au 1er mars 2021; suivi maximal jusqu’au 31 mars 2021).Les résultats et les données concernant l’identification des patients et leurs caractéristiques initiales seront principalement tirés des bases de données administratives du système de santé ontarien tenues par l’ICES. Une répartition aléatoire restreinte par les covariables a été employée pour classer les 84 centres de dialyse (1:1) dans le groupe d’intervention ou le groupe témoin. Le groupe d’intervention a utilisé un protocole personnalisé de dialysat à température réduite et le groupe témoin un dialysat à température fixe (36,5 °C).Le principal critère d’évaluation est la combinaison d’un décès d’origine cardiovasculaire ou d’une hospitalisation majeure liée à la santé cardiovasculaire (définie comme une hospitalisation pour un infarctus du myocarde, une insuffisance cardiaque congestive ou un AVC ischémique) enregistrée dans les bases de données administratives du système de santé. Le principal critère d’évaluation secondaire est la baisse moyenne de la tension artérielle systolique intradialytique, laquelle est définie comme la tension artérielle systolique du patient avant la dialyse moins la tension artérielle systolique minimale pendant la dialyse. Les données anonymisées sur la tension artérielle systolique initiale et la tension artérielle systolique intradialytique des patients ont été colligées à intervalles mensuels dans chaque centre de dialyse.L’analyse primaire adoptera une approche fondée sur l’intention de traiter. Le principal critère d’évaluation sera analysé au niveau du patient comme le risque relatif de survenue d’un premier événement, estimé à partir d’un modèle de risques de sous-distribution. La corrélation intracentre sera prise en compte à l’aide d’un robuste estimateur sandwich. Dans l’analyse primaire, le temps d’observation des patients prendra fin s’ils présentent le principal critère d’évaluation, s’ils déménagent hors de l’Ontario ou s’ils décèdent d’une cause non cardiovasculaire (qui sera traitée comme un événement à risque concurrentiel). La différence entre les groupes quant à la baisse moyenne de la tension artérielle systolique intradialytique, obtenue pendant les séances de dialyse tout au long de l’essai, sera analysée au niveau du centre avec un modèle linéaire mixte à effets aléatoires non corrigé.L’essai MyTEMP couvre la période du 3 avril 2017 au 31 mars 2021. Nous comptons analyser et rendre compte des résultats d’ici 2023, dès que les données mises à jour seront disponibles à l’ICES.MyTEMP est enregistré auprès du National Institute of Health des États-Unis sur clincaltrials.gov (NCT02628366).

End-stage kidney disease patients who are candidates for surgical arteriovenous fistula creation commonly experience obstacles to a functional surgical arteriovenous fistula, including protracted wait time for creation, poor maturation, and surgical arteriovenous fistula dysfunction that can result in significant patient morbidity. The recent approval of two endovascular devices designed to create a percutaneous arteriovenous fistula enables arteriovenous fistula creation to be placed in the hands of interventionalists, thereby increasing the number of arteriovenous fistula providers, reducing wait times, and allowing the patient to avoid surgery. Moreover, current studies demonstrate that patients with percutaneous arteriovenous fistula experience improved time to arteriovenous fistula maturation. Yet, in order to realize the potential advantages of percutaneous arteriovenous fistula creation within our hemodialysis patient population, it is critical to select appropriate patients, ensure adequate patient and dialysis unit education, and provide sufficient instruction in percutaneous arteriovenous fistula cannulation and monitoring. In this White Paper by the American Society of Diagnostic and Interventional Nephrology, experts in interventional nephrology, surgery, and interventional radiology convened and provide recommendations on the aforementioned elements that are fundamental to a functional percutaneous arteriovenous fistula.

Introduction Mobile health applications offer the potential to help people living with chronic kidney disease (CKD) manage diet-related challenges. This systematic review examined CKD dietary mobile app interventions; specifically, app characteristics, feasibility, and effectiveness in changing user behavior, as well as user satisfaction. Methods This review was reported in accordance with PRISMA guidelines. We searched scholarly databases, as well as the gray literature, for all randomized controlled trials, observational studies, needs assessments, and pilot testing/studies/trials focused on the development or evaluation of CKD dietary mobile app interventions. The characteristics, user satisfaction with, usability/feasibility, and effectiveness in changing dietary behavior of the mobile application were summarized using descriptive statistics and in a narrative manner. Results Thirteen full-text studies were included, of which 11 were single center, with a mean sample size of 23. Of the 7 studies that measured usability/feasibility, all found at least some aspects of the application feasible/useful. Of the 5 studies that reported an evaluation of changes in behavior/diet related to self-management, all reported some positive change. Conclusion According to current studies, nutritional apps show promise in CKD self-management.

Even in the best of circumstances, a significant number of patients will require adjunctive endovascular and/or surgical revision prior to achieving functional patency after endovascular or percutaneous AVF creation, at least within the United States. This rate appears to be higher after percutaneous AVF than after endovascular AVF, although because published reports of the former are mostly derived from American experience and those of the latter derived from experience outside the United States, it is unclear whether these differences are due to the technique itself or cultural and/or anatomic differences in dialysis access practices and patient populations. If arterial inflow is poor, this should be corrected first. When flow is adequate (perhaps 900 cc/min) but no single vein is cannulatable, a dominant suitable vein can be superficialized or transposed. If no suitable vein is dominant (most accurately assessed by using an intraoperative flowmeter), the best vein can be used, with or without occlusion of the other veins or reimplantation into the brachial artery. Finally, if the original anastomosis remains the sole supply to the cannulated vein, the original fistula has achieved assisted primary maturation (and assisted primary patency continues), while if a new arteriovenous anastomosis has been constructed, the original fistula has failed. We point out that for this reason as well as to best utilize the upper arm for later access, endovascular and percutaneous AVFs should be constructed and maintained within an atmosphere where both surgeons and non-surgeons work together on the overall access plan.

Small randomized trials demonstrated that a lower compared with higher dialysate temperature reduced the average drop in intradialytic blood pressure. Some observational studies demonstrated that a lower compared with higher dialysate temperature was associated with a lower risk of all-cause mortality and cardiovascular mortality. There is now the need for a large randomized trial that compares the effect of a low vs high dialysate temperature on major cardiovascular outcomes.The purpose of this study is to test the effect of outpatient hemodialysis centers randomized to (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol for 4 years on cardiovascular-related death and hospitalizations.The design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial.Hemodialysis centers in Ontario, Canada, were randomized on February 1, 2017, for a trial start date of April 3, 2017, and end date of March 31, 2021.In total, 84 hemodialysis centers will care for approximately 15 500 patients and provide over 4 million dialysis sessions over a 4-year follow-up.Hemodialysis centers were randomized (1:1) to provide (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol of 36.5°C. For the personalized protocol, nurses set the dialysate temperature between 0.5°C and 0.9°C below the patient's predialysis body temperature for each dialysis session, to a minimum dialysate temperature of 35.5°C.A composite of cardiovascular-related death or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) captured in Ontario health care administrative databases.The primary analysis will follow an intent-to-treat approach. The hazard ratio of time-to-first event will be estimated from a Cox model. Within-center correlation will be considered using a robust sandwich estimator. Observation time will be censored on the trial end date or when patients die from a noncardiovascular event.www.clinicaltrials.gov; identifier: NCT02628366.De petits essais à répartition aléatoire ont montré que l’utilisation d’un dialysat à basse température réduisait le risque d’hypotension intra-dialytique. De même, certaines études observationnelles ont démontré qu’un dialysat à basse température était associé à un plus faible risque de mortalité toute cause ou d’origine cardiovasculaire. Le temps est venu de procéder à un vaste essai à répartition aléatoire comparant les effets d’un dialysat à basse température et à température standard sur les principaux résultats cardiovasculaires.Répartir aléatoirement des centres d’hémodialyse ambulatoire pour qu’ils suivent pendant quatre ans (i) un protocole personnalisé de dialysat à basse température ou (ii) un protocole de dialysat à température standard, et tester l’effet sur les hospitalisations et la mortalité attribuables à des événements cardiovasculaires.Un essai clinique à répartition aléatoire en grappes.Le 1er février 2017, des centres d’hémodialyse de l’Ontario (Canada) ont été répartis aléatoirement en vue d’un essai qui a débuté le 3 avril 2017 et qui se poursuivra jusqu’au 31 mars 2021.Quatre-vingt-quatre centres d’hémodialyse qui prendront en charge environ 15 500 patients pendant les quatre ans de suivi.Les centres d’hémodialyse ont été répartis aléatoirement (1:1) pour offrir (i) un protocole personnalisé de dialysat à température réduite ou (ii) un protocole de dialysat à 36,5°C. Pour le protocole personnalisé, les infirmières règlent la température du dialysat entre 0,5 et 0,9°C sous la température corporelle du patient mesurée avant la dialyse, jusqu’à une température minimale de 35,5°C.Un ensemble d’hospitalisations attribuables à un événement cardiovasculaire majeur (accident ischémique cérébral non fatal, infarctus du myocarde ou insuffisance cardiaque congestive) et de décès d’origine cardiovasculaire consignés dans les bases de données de santé de l’Ontario.L’analyse primaire adoptera une approche fondée sur l’intention de traiter. Un modèle de Cox servira à estimer le rapport de risque du temps écoulé jusqu’au premier événement. La corrélation intra-centre sera prise en compte à l’aide d’un estimateur sandwich robuste. Le temps d’observation sera censuré à la date de fin de l’essai ou au moment d’un décès non lié à un événement cardiovasculaire.

Background and objectives: Fibrin sheath (FS) formation around tunneled central venous catheters (CVC) increases the risk of catheter-related bloodstream infections due to bacterial adherence to a biofilm. We sought to investigate whether FS disruption (FSD) at the time of CVC removal or exchange affects infectious outcomes in patients with CVC-related infections. Design, setting, participants, and measurements: Retrospective cohort study of 307 adult maintenance hemodialysis patients aged 18 years or older at a single center academic-based hemodialysis program (UHN, Toronto) who developed CVC-related infections requiring CVC removal or exchange between January 2000 and January 2019. Exposure was FSD at the time of CVC removal or exchange. Outcomes were infectious metastatic complications, recurrent infection with the same organism within 1 year, or death due to infection. We created a Markov Multi-State Model (MMSM) to assess patients’ trajectories through time as they transitioned between states. A time-to-event analysis was performed, adjusted for clinically relevant factors. Results: There was no significant relationship between FSD status at the time of CVC removal, the development of infectious complications in the multivariable model (adjusted HR = 0.71, 95% CI 0.09−5.80, p = 0.76), or mortality from infection (HR = 0.84, 95% CI 0.34−2.11, p = 0.73). Conclusions: FSD at the time of CVC removal was not associated with increased risk of infectious complications or death due to infection. Further prospective study is needed to determine whether FSD contributes to reducing CVC infectious related complications.

Recent advances in technology show promise in providing greater vascular access options for hemodialysis patients. This review discusses novel methods for creating an anastomosis for arteriovenous (AV) fistulas and new materials for prosthetic AV grafts. Two technologies for endovascular arteriovenous fistula creation, the Ellipsys and WavelinQ endovascular systems, are discussed. When an AV fistula is not possible, an AV graft or devices to augment the AV fistula may be appropriate. New materials that have been developed that show promise as an alternative to the expanded polytetrafluoroethylene graft are discussed. Such potential conduits include bioengineered vessels and both allogenic or xenogenic biologic grafts. Devices designed to optimize blood flow to reduce maturation failure and improve AV fistula outcomes are explored.

Background Arteriovenous access failure frequently occurs in people on hemodialysis and is associated with morbidity, mortality and large healthcare expenditures. Omega-3 polyunsaturated fatty acids (omega-3 PUFA) may improve access outcomes via pleiotropic effects on access maturation and function, but may cause bleeding complications. Study Design Systematic review with meta-analysis. Setting & Population Adults requiring hemodialysis via arteriovenous fistula or graft. Selection Criteria Trials evaluating omega-3 PUFA for arteriovenous access outcomes identified by searches in CENTRAL, MEDLINE, and Embase to 24 January 2017. Intervention Omega-3 PUFA. Outcomes Primary patency loss, dialysis suitability failure, access abandonment, interventions to maintain patency or assist maturation, bleeding, gastrointestinal side-effects, all-cause and cardiovascular mortality, hospitalization, and treatment adherence. Treatment effects were summarized as relative risks (RR) and 95% confidence intervals (CI). Evidence was assessed using GRADE. Results Five eligible trials (833 participants) with a median follow-up of 12 months compared peri-operative omega-3 PUFA supplementation with placebo. One trial (n=567) evaluated treatment for fistulae and four (n=266) for grafts. Omega-3 PUFA supplementation prevented primary patency loss with moderate certainty (761 participants, RR 0.81, CI 0.68-0.98). Low quality evidence suggested, that omega-3 PUFA may have had little or no effect on dialysis suitability failure (536 participants, RR 0.95, CI 0.73-1.23), access abandonment (732 participants, RR 0.78, CI 0.59-1.03), need for interventions (732 participants, RR 0.82, CI 0.64-1.04), or all-cause mortality (799 participants, RR 0.99, CI 0.51-1.92). Bleeding risk (793 participants, RR 1.40, CI 0.78-2.49) or gastrointestinal side-effects (816 participants, RR 1.22, CI 0.64-2.34) from treatment were uncertain. There was no evidence of different treatment effects for grafts and fistulae. Limitations Small number and methodological limitations of included trials. Conclusions Omega-3 PUFA supplementation probably protects against primary loss of arteriovenous access patency, but may have little or no effect on dialysis suitability failure, access interventions or access abandonment. Potential treatment harms are uncertain.

Background: We assessed the validity of physician billing codes and hospital admission using International Classification of Diseases 10th revision codes to identify vascular access placement, secondary patency, and surgical revisions in administrative data. Methods: We included adults (≥18 years) with a vascular access placed between 1 April 2004 and 31 March 2013 at the University Health Network, Toronto. Our reference standard was a prospective vascular access database (VASPRO) that contains information on vascular access type and dates of placement, dates for failure, and any revisions. We used VASPRO to assess the validity of different administrative coding algorithms by calculating the sensitivity, specificity, and positive predictive values of vascular access events. Results: The sensitivity (95% confidence interval) of the best performing algorithm to identify arteriovenous access placement was 86% (83%, 89%) and specificity was 92% (89%, 93%). The corresponding numbers to identify catheter insertion were 84% (82%, 86%) and 84% (80%, 87%), respectively. The sensitivity of the best performing coding algorithm to identify arteriovenous access surgical revisions was 81% (67%, 90%) and specificity was 89% (87%, 90%). The algorithm capturing arteriovenous access placement and catheter insertion had a positive predictive value greater than 90% and arteriovenous access surgical revisions had a positive predictive value of 20%. The duration of arteriovenous access secondary patency was on average 578 (553, 603) days in VASPRO and 555 (530, 580) days in administrative databases. Conclusion: Administrative data algorithms have fair to good operating characteristics to identify vascular access placement and arteriovenous access secondary patency. Low positive predictive values for surgical revisions algorithm suggest that administrative data should only be used to rule out the occurrence of an event.

Hemodialysis vascular access is the “lifeline” for patients on hemodialysis. Unfortunately, because of its poor patency and significant complication rate, it is also the “Achilles heel” of hemodialysis. For example, the current unassisted arteriovenous fistula (AVF) maturation rate is only

Introduction Chronic kidney disease (CKD) is often accompanied by complications including poor physical activity level. However, only a few studies have objectively characterized physical activity levels in predialysis CKD. Our study sought to measure daily activity levels by accelerometry in individuals with CKD (stages III−V) and to determine the association between daily activity and kidney function. Methods We determined kidney function by means of the estimated glomerular filtration rate (eGFR) using the Modification of Diet and Renal Disease (MDRD) equation. Participants wore an accelerometer for 7 consecutive days, and we measured multiple physical activity outcomes including total daily activity, sedentary, light, and moderate−vigorous activity. Average durations and intensity of activity were determined according to stage of CKD. The association between kidney function and activity level was determined by regression analysis. Results We analyzed data from 110 individuals (60% men and 40% women) with stages III to V CKD. The mean age of our participants was 64 years, mean body mass index was 27.5 kg/m2, and mean eGFR was 23.7 ± 1.2 ml/min/1.73 m2. Our participants were primarily sedentary (mean duration of inactivity = 1152 ± 100 minutes per day; 79% of day). Light activity was performed 280 ± 99 minutes per day, and individuals participated in only 6 ± 9 minutes per day of moderate−vigorous activity. The eGFR did not predict physical activity level (P > 0.05 for all). Discussion Individuals with stages III to V CKD are sedentary, and do not meet the national recommendations of 150 minutes of moderate−vigorous activity per week. Further study is required to determine whether interventions to increase activity levels in patients with CKD are associated with improved health outcomes.

The timing of referral for creation of vascular access in a patient with declining kidney function is difficult to predict. Current methods may result in patients undergoing unnecessary procedures and subsequent interventions on accesses that are never used. Multiple variables, including time for assessment, surgery and follow-up that considers the likelihood of access failure, and the estimated rate of kidney function decline, make vascular access planning challenging and difficult to balance. Better prediction tools that incorporate the risks of progressive decline in kidney function with the risk of access failure and the competing risk of death would facilitate decision-making in vascular access. The kidney failure risk equation is a validated, simple online tool that estimates the probability of the 2- and 5-year risk of reaching end-stage kidney disease. While the use of the kidney failure risk equation has not been validated as an adjunct to planning vascular access, it has potential and may facilitate more individualised care and more appropriate allocation of resources.

Rationale & Objective Optimizing vascular access use is crucial for long-term hemodialysis patient care. Because vascular access use varies internationally, we examined international differences in arteriovenous fistula (AVF) patency and time to becoming catheter-free for patients receiving a new AVF. Study Design Prospective cohort study. Setting & Participants 2,191 AVFs newly created in 2,040 hemodialysis patients in 2009 to 2015 at 466 randomly selected facilities in the Dialysis Outcomes and Practice Patterns Study (DOPPS) from the United States, Japan, and EUR/ANZ (Belgium, France, Germany, Italy, Spain, Sweden, United Kingdom, Australia, and New Zealand). Predictors Demographics, comorbid conditions, dialysis vintage, body mass index, AVF location, and country/region. Outcomes Primary/cumulative AVF patency (from creation), primary/cumulative functional patency (from first use), catheter dependence duration, and mortality. Analytical Approach Outcomes estimated using Cox regression. Results Across regions, mean patient age ranged from 61 to 66 years, with male preponderance ranging from 55% to 66%, median dialysis vintage of 0.3 to 3.2 years, with 84%, 54%, and 32% of AVFs created in the forearm in Japan, EUR/ANZ, and United States, respectively. Japan displayed superior primary and cumulative patencies due to higher successful AVF use, whereas cumulative functional patency was similar across regions. AVF patency associations with age and other patient characteristics were weak or varied considerably between regions. Catheter-dependence following AVF creation was much longer in EUR/ANZ and US patients, with nearly 70% remaining catheter dependent 8 months after AVF creation when AVFs were not successfully used. Not using an arteriovenous access within 6 months of AVF creation was related to 53% higher mortality in the subsequent 6 months. Limitations Residual confounding. Conclusions Our findings highlight the need to reevaluate practices for optimizing long-term access planning and achievable AVF outcomes, especially AVF maturation. New AVFs that are not successfully used are associated with long-term catheter exposure and elevated mortality risk. These findings highlight the importance of selecting the best access type for each patient and developing effective clinical pathways for when AVFs fail to mature successfully.

Chronic kidney disease (CKD) is a major risk factor for valvular heart disease (VHD). Mitral annular and aortic valve calcifications are highly prevalent in CKD patients and commonly lead to valvular stenosis and regurgitation, as well as complications including conduction system abnormalities and endocarditis. VHD, especially mitral regurgitation and aortic stenosis, is associated with significantly reduced survival among CKD patients. Knowledge related to VHD in the general population is not always applicable to CKD patients because the pathophysiology may be different, and CKD patients have a high prevalence of comorbid conditions and elevated risk for periprocedural complications and mortality. This Kidney Disease: Improving Global Outcomes (KDIGO) review of CKD and VHD seeks to improve understanding of the epidemiology, pathophysiology, diagnosis, and treatment of VHD in CKD by summarizing knowledge gaps, areas of controversy, and priorities for research.

While living kidney donation is considered safe in healthy individuals, perioperative complications can occur due to several factors.We explored associations between the incidence of perioperative complications and donor characteristics, surgical technique, and surgeon's experience in a large contemporary cohort of living kidney donors.Living kidney donors enrolled prospectively in a multicenter cohort study with some data collected retrospectively after enrollment was complete (eg, surgeon characteristics).Living kidney donor centers in Canada (n = 12) and Australia (n = 5).Living kidney donors who donated between 2004 and 2014 and the surgeons who performed the living kidney donor nephrectomies.Operative and hospital discharge medical notes were collected prospectively, with data on perioperative (intraoperative and postoperative) information abstracted from notes after enrollment was complete. Complications were graded using the Clavien-Dindo system and further classified into minor and major. In 2016, surgeons who performed the nephrectomies were invited to fill an online survey on their training and experience.Multivariable logistic regression models with generalized estimating equations were used to compare perioperative complication rates between different groups of donors. The effect of surgeon characteristics on the complication rate was explored using a similar approach. Poisson regression was used to test rates of overall perioperative complications between high- and low-volume centers.Of the 1421 living kidney donor candidates, 1042 individuals proceeded with donation, where 134 (13% [95% confidence interval (CI): 11%-15%]) experienced 142 perioperative complications (55 intraoperative; 87 postoperative). The most common intraoperative complication was organ injury and the most common postoperative complication was ileus. No donors died in the perioperative period. Most complications were minor (90% of 142 complications [95% CI: 86%-96%]); however, 12 donors (1% of 1042 [95% CI: 1%-2%]) experienced a major complication. No statistically significant differences were observed between donor groups and the rate of complications. A total of 43 of 48 eligible surgeons (90%) completed the online survey. Perioperative complication rates did not vary significantly by surgeon characteristics or by high- versus low-volume centers.Operative and discharge reporting is not standardized and varies among surgeons. It is possible that some complications were missed. The online survey for surgeons was completed retrospectively, was based on self-report, and has not been validated. We had adequate statistical power only to detect large effects for factors associated with a higher risk of perioperative complications.This study confirms the safety of living kidney donation as evidenced by the low rate of major perioperative complications. We did not identify any donor or surgeon characteristics associated with a higher risk of perioperative complications.Bien que le don vivant d’un rein soit sécuritaire chez un individu en santé, plusieurs facteurs sont susceptibles d’engendrer des complications périopératoires.Nous avons exploré l’association entre l’incidence des complications périopératoires et les caractéristiques du donneur, la technique chirurgicale employée et l’expérience du chirurgien au sein d’une vaste cohorte contemporaine de donneurs vivants d’un rein.Une étude de cohorte multicentrique où certaines données (notamment les renseignements concernant le chirurgien) ont été recueillies rétrospectivement, après l’inclusion complète des sujets (donneurs vivants d’un rein).Des centres de transplantation au Canada (n=12) et en Australie (n=5).Des individus ayant fait don d’un rein entre 2004 et 2014, et les chirurgiens qui ont procédé à la néphrectomie.Les notes médicales au dossier, opératoires et à la sortie de l’hôpital, ont été recueillies de façon prospective; les données concernant les renseignements périopératoires (peropératoires et postopératoires) ayant été extraites des notes une fois l’inclusion du sujet complétée. Les complications ont été catégorisées selon la classification de Clavien-Dindo, puis caractérisées comme étant mineures ou majeures. En 2016, les chirurgiens ayant pratiqué les néphrectomies ont été invités à répondre à un sondage en ligne au sujet de leur formation et de leur expérience.Des modèles de régression logistique multivariée utilisant des équations d’estimation généralisées ont été employés pour comparer les taux de complications périopératoires entre les différents groupes de donneurs. L’effet exercé sur le taux de complications par les caractéristiques du chirurgien a été exploré selon une approche similaire. Une régression de Poisson a été utilisée pour évaluer et comparer les taux globaux de complications entre les centres à volume élevé et les centres à faible volume.Des 1 421 candidats répertoriés, 1 042 individus ont subi une néphrectomie, desquels 134 (13 % [IC 95 %: 11–15 %]) ont vécu un total de 142 complications périopératoires (55 peropératoires; 87 postopératoires). La complication peropératoire la plus fréquente était une lésion à l’organe, alors qu’un iléus s’est avéré la principale complication postopératoire. Aucun donneur n’est décédé en période périopératoire. La plupart des complications rencontrées étaient mineures (90 % des 142 complications répertoriées [IC 95 %: 86–96 %]). Toutefois, 12 donneurs (1 % des 1 042 donneurs [IC 95 %: 1–2 %]) ont souffert de complications majeures. Aucune différence significative du point de vue statistique n’a été observée entre les groupes de donneurs et le taux de complications. Des 48 chirurgiens admissibles, 43 (90 %) ont répondu au sondage en ligne. Les taux de complications périoperatoires n’ont pas varié de façon significative en fonction des caractéristiques des chirurgiens, ou selon le volume de patients de l’hôpital.La façon d’inscrire les renseignements médicaux (opératoires ou à la sortie de l’hôpital) dans les dossiers des patients n’est pas normalisée et varie d’un chirurgien à l’autre. Certaines complications pourraient ne pas avoir été notées. Le sondage en ligne destiné aux chirurgiens a été rempli rétrospectivement, il reposait sur des déclarations volontaires et n’avait pas fait l’objet d’une validation. Nous ne disposions d’une puissance statistique que pour détecter les effets importants des facteurs associés à un risque accru de complications périopératoires.Cette étude confirme le caractère sécuritaire d’un don vivant de rein, comme en témoigne le très faible taux de complications périopératoires majeures. Nous n’avons pu établir de caractéristiques, du donneur ou du chirurgien, qui soit associées à un risque accru de complications périopératoires.

In chronic kidney disease (CKD), phosphate homoeostasis plays a central role in the development of mineral and bone disorder (MBD) together with decreased serum calcium and elevated serum parathyroid hormone, fibroblast growth factor 23 and sclerostin levels. Today there are only a few data exploring the direct role of abnormal phosphate homoeostasis and hyperphosphataemia in the development of CKD-MBD. On the other hand, several studies have looked at the link between hyperphosphataemia and cardiovascular morbidity and mortality in CKD, but there is a lack of evidence to indicate that lowering phosphate levels improves cardiovascular outcomes in this population. Furthermore, the impact of liberalizing phosphate targets on CKD-MBD progression and bone fracture is currently not known. In this review we discuss the central role of phosphate in the pathogenesis of CKD-MBD and how it may be associated with fracture risk, both in hyper- and hypophosphataemia.

Background In patients with CKD, the risk of developing colorectal cancer is high and outcomes are poor. Screening using fecal immunochemical testing (FIT) is effective in reducing mortality from colorectal cancer, but performance characteristics of FIT in CKD are unknown. Methods To determine the detection rates and performance characteristics of FIT for advanced colorectal neoplasia (ACN) in patients with CKD, we used FIT to prospectively screen patients aged 35–74 years with CKD (stages 3–5 CKD, dialysis, and renal transplant) from 11 sites in Australia, New Zealand, Canada, and Spain. All participants received clinical follow-up at 2 years. We used a two-step reference standard approach to estimate disease status. Results Overall, 369 out of 1706 patients who completed FIT (21.6%) tested positive; 323 (87.5%) underwent colonoscopies. A total of 1553 (91.0%) completed follow-up; 82 (4.8%) had died and 71 (4.2%) were lost. The detection rate of ACN using FIT was 6.0% (5.6%, 7.4%, and 5.6% for stages 3–5 CKD, dialysis, and transplant). Sensitivity, specificity, and positive and negative predictive values of FIT for ACN were 0.90, 0.83, 0.30, and 0.99, respectively. Of participants who underwent colonoscopy, five (1.5%) experienced major colonoscopy-related complications, including bowel perforation and major bleeding. Conclusions FIT appears to be an accurate screening test for patients with CKD, such that a negative test may rule out the diagnosis of colorectal cancer within 2 years. However, the risk of major complications from work-up colonoscopy are at least ten-fold higher than in the general population.

Globally, the number of patients undergoing maintenance dialysis is increasing, yet throughout the world there is significant variability in the practice of initiating dialysis. Factors such as availability of resources, reasons for starting dialysis, timing of dialysis initiation, patient education and preparedness, dialysis modality and access, as well as varied "country-specific" factors significantly affect patient experiences and outcomes. As the burden of end-stage kidney disease (ESKD) has increased globally, there has also been a growing recognition of the importance of patient involvement in determining the goals of care and decisions regarding treatment. In January 2018, KDIGO (Kidney Disease: Improving Global Outcomes) convened a Controversies Conference focused on dialysis initiation, including modality choice, access, and prescription. Here we present a summary of the conference discussions, including identified knowledge gaps, areas of controversy, and priorities for research. A major novel theme represented during the conference was the need to move away from a "one-size-fits-all" approach to dialysis and provide more individualized care that incorporates patient goals and preferences while still maintaining best practices for quality and safety. Identifying and including patient-centered goals that can be validated as quality indicators in the context of diverse health care systems to achieve equity of outcomes will require alignment of goals and incentives between patients, providers, regulators, and payers that will vary across health care jurisdictions.

Although living kidney donation is safe, some donors experience perioperative complications.This study explored how perioperative complications affected donor-reported health-related quality of life, depression, and anxiety.This research was a conducted as a prospective cohort study.Twelve transplant centers across Canada.A total of 912 living kidney donors were included in this study.Short Form 36 health survey, Beck Depression Inventory and Beck Anxiety Inventory.Living kidney donors were prospectively enrolled predonation between 2009 to 2014. Donor perioperative complications were graded using the Clavien-Dindo classification system. Mental and physical health-related quality of life was assessed with the 3 measurements; measurements were taken predonation and at 3- and 12-months postdonation.Seventy-four donors (8%) experienced a perioperative complication; most were minor (n = 67 [91%]), and all minor complications resolved before hospital discharge. The presence (versus absence) of a perioperative complication was associated with lower mental health-related quality of life and higher depression symptoms 3-month postdonation; neither of these differences persisted at 12-month. Perioperative complications were not associated with any changes in physical health-related quality of life or anxiety 3-month postdonation.Minor complications may have been missed and information on complications postdischarge were not collected. No minimal clinically significant change has been defined for kidney donors across the 3 measurements.These findings highlight a potential opportunity to better support the psychosocial needs of donors who experience perioperative complications in the months following donation.NCT00319579 and NCT00936078.Bien que le don vivant d’un rein soit une procédure sécuritaire, certains donneurs souffrent tout de même de complications périopératoires.Cette étude a examiné l’incidence des complications périopératoires sur la qualité de vie liée à la santé et les symptômes de dépression et d’anxiété rapportés par les donneurs.Étude de cohorte prospective.Douze centers de transplantation à travers le Canada.912 donneurs vivants d’un rein.Un questionnaire abrégé de 36 questions sur l’état de santé, l’inventaire de dépression Beck et l’inventaire d’anxiété Beck.Les donneurs ont été inscrits avant le don de façon prospective entre 2009 et 2014. Les complications périopératoires des donneurs ont été classées à l’aide du système de classification Clavien-Dindo. La qualité de vie liée à la santé physique et mentale a été évaluée à l’aide des trois outils de mesure; ces mesures ont été faites avant le don, puis 3 et 12 mois après le don.Au total, 74 donneurs (8 %) ont souffert d’une complication périopératoire; la plupart étaient mineures (n = 67 [91 %]) et ont été résolues avant le congé de l’hôpital. La présence (par rapport à l’absence) d’une complication périopératoire a été associée à une plus faible qualité de vie liée à la santé mentale et à des symptômes de dépression plus graves 3 mois après le don; aucune de ces différences n’a persisté après 12 mois. Les complications périopératoires n’ont pas été associées à des changements dans la qualité de vie liée à la santé physique ou à l’anxiété 3 mois après le don.Certaines complications mineures ont pu être manquées. L’information sur les complications survenues après le congé n’a pas été recueillie. Dans les trois outils de mesure, aucune variation minimale cliniquement significative n’a été définie pour les donneurs d’un rein.Ces résultats soulignent une occasion de mieux répondre aux besoins psychosociaux des donneurs d’un rein qui présentent des complications périopératoires dans les mois suivant le don.

Background and objectives Guideline–recommended diagnostic criteria for hemodialysis (HD) catheter–related bloodstream infections (CRBSIs) are based on data from indwelling central catheters in patients not on HD and non-HD situations, and upon which peripheral vein cultures are the gold standard. We aimed to examine the validity of these criteria in patients on HD. Design, settings, participants, & measurements Adult patients on in-center HD using catheters were prospectively followed from 2011 to 2014 at a large academic–based HD facility (Toronto, Canada). When a CRBSI was suspected, blood culture sets were obtained from four sites (peripheral vein, both catheter hubs, and HD circuit) to determine the guideline–recommended differential time to positivity (DTTP). DTTP criteria were met when catheter hub cultures turned positive ≥120 minutes before peripheral vein cultures. The sensitivity, specificity, and accuracy were first calculated using peripheral vein cultures as the gold standard and then these same calculations were repeated with additional information, including exit site/catheter tip and HD circuit cultures, as the true gold standard. The feasibility of obtaining peripheral vein cultures was determined. Results Of 178 suspected CRBSIs, 100 had peripheral vein blood cultures. Using the true gold standard, sensitivity, specificity, and accuracy of blood culture results were highest in samples from the HD circuit (93.5%, 100%, and 95%, respectively). The guideline recommended combination of peripheral vein and arterial hub blood cultures was the least sensitive, specific, and accurate (91.7%, 93.1%, and 92.7%, respectively). The diagnostic criteria using measured DTTP were met in less than one third of events. Conclusions In patients on HD, blood culture results are the most sensitive, specific, and accurate for diagnosing CRBSIs when taken from the HD circuit and the venous catheter hub, and blood culture results are the least sensitive, specific, and accurate in any combination with peripheral vein cultures. The DTTP does not increase diagnostic accuracy, reducing the necessity for venipuncture and its potential vein damage. Future guidelines should consider the applicability of criterion on specific patient populations and tailor them accordingly.

Worldwide, there is a steady incident rate of patients with end-stage kidney disease (ESKD) who require renal replacement therapy. Of these patients, approximately one-third have an “unplanned” or “urgent” start to dialysis. This can be a very challenging situation where patients have either not had adequate time for education and decision making regarding dialysis modality and appropriate dialysis access, or a decision was made and plans were altered due to unforeseen circumstances. Despite such unplanned starts, clinicians must still consider the patient's ESKD “life-plan”, which includes the best initial dialysis modality and access to suit the patient's individual goals and their medical, social, logistic, and facility circumstances. This paper will discuss the considerations of peritoneal dialysis and a peritoneal dialysis catheter access and hemodialysis and central venous catheter access in patients who require an urgent start to dialysis.

BACKGROUND: Approximately 40% of the kidneys for transplant worldwide come from living donors. Despite advantages of living donor transplants, rates have stagnated in recent years. One possible barrier may be costs related to the transplant process that potential willing donors may incur for travel, parking, accommodation, and lost productivity. METHODS: To better understand and quantify the financial costs incurred by living kidney donors, we conducted a prospective cohort study, recruiting 912 living kidney donors from 12 transplant centers across Canada between 2009 and 2014; 821 of them completed all or a portion of the costing survey. We report microcosted total, out-of-pocket, and lost productivity costs (in 2016 Canadian dollars) for living kidney donors from donor evaluation start to 3 months after donation. We examined costs according to (1) the donor’s relationship with their recipient, including spousal (donation to a partner), emotionally related nonspousal (friend, step-parent, in law), or genetically related; and (2) donation type (directed, paired kidney, or nondirected). RESULTS: Living kidney donors incurred a median (75th percentile) of $1254 ($2589) in out-of-pocket costs and $0 ($1908) in lost productivity costs. On average, total costs were $2226 higher in spousal compared with emotionally related nonspousal donors (P=0.02) and $1664 higher in directed donors compared with nondirected donors (P

Introduction: A proportion of hemodialysis patients exhaust all options for arteriovenous access in upper extremities. Arteriovenous thigh grafts are a potential vascular access option in such patients. Methods: We performed a retrospective study of all thigh arteriovenous access grafts placed between 1995 and 2015. The clinical, demographic patient information and patency of each thigh graft was determined from the time of surgical creation placement until abandonment, transfer to other modality, or center or end of study, and the reason for access failure documented. Results: In total, 44 patients received 49 thigh arteriovenous accesses. The average age was 60 years (13–79 years); Half (53%) of the patients (n = 24) were female and 61% of the patients (n = 30) of arteriovenous accesses were left-sided. The cumulative proportion surviving (primary patency rates) at 12, 24, and 28 months were 43% (standard error = 9%), 33% (standard error = 9%), and 13% (standard error = 9%), respectively. The cumulative proportion of surviving grafts at 12, 24, and 48 months were 61% (standard error = 8%), 58% (standard error = 9%), and 31% (standard error = 13%), respectively. In total, 37 revisions were performed in 22 patients to maintain patency or eradicate infection. Infection occurred in 20 patients (39%) of thigh grafts requiring 16 patients (80% of those affected) to be removed; 14 patients had grafts (33.3%) that served as the lone hemodialysis arteriovenous access during the patients’ lifetime on dialysis. Conclusion: Arteriovenous thigh graft access is used infrequently, but they have an acceptable patency. Some accesses require revisions and they have a high infection rate. Despite this, an acceptable proportion of leg grafts provide durable access for the dialysis lifetime of the patient.

The risks and benefits of hemodialysis arteriovenous (AV) access surveillance have been debated since the introduction of AV access surveillance techniques. The debate is fuelled by the lack of robust, high-quality evidence with consistent and comparable patient-important outcomes. Additionally, there is a lack of clarity regarding the diagnostic cut points for AV access stenosis using the various surveillance techniques, questions about the appropriateness of the ‘knee-jerk’ response to intervention on a stenosis >50% regardless of the presence of clinical indicators and whether the intervention results in desired patient-important outcomes. The physiology of the AV access is complex considering the different hemodynamics within an AV fistula, which vary by time of dialysis, location, size of vessels and location of the stenosis. The current evidence suggests that the use of AV access surveillance in an AV fistula does detect more stenosis compared with clinical monitoring alone and leads to an increased number of procedures. It remains uncertain if that leads to improved patient-important outcomes such as prolonged AV fistula patency. Vascular access is an essential component of hemodialysis and further study is needed to clarify this long-standing debate. There needs to be better distinction between the strategies of vascular access surveillance, clinical monitoring with clinical indictors and preemptive intervention and their respective impacts on patient-important outcomes. Randomized controlled studies must be conducted with defined indications for intervention, reproducible methods of intervention and clinically important AV fistula and patient outcomes. The current guidelines need to be challenged and revised to permit these necessary studies to be done.

Choosing the optimal hemodialysis vascular access for the elderly patient is best achieved by a patient-centered coordinated multidisciplinary team approach that aligns the patient's end-stage kidney disease Life-Plan, i.e., the individual treatment approach (supportive care, time-limited or long-term kidney replacement therapy, or combination thereof) and selection of dialysis modality (peritoneal dialysis versus hemodialysis) with the most suitable dialysis access. Finding the right balance between the patient's preferences, the likelihood of access function and survival, and potential complications in the context of available resources and limited patient survival can be extremely challenging. The framework for choosing the most appropriate vascular access for the elderly presented in this review considers the individual end-stage kidney disease Life-Plan, the patient life expectancy, the likelihood of access function and survival, the timing of dialysis relative to access placement, prior access history, and patient preference. This complex decision-making process should be dynamic in order to accommodate patients' changing needs and life and health circumstances. Effective and timely communication between the patient, their caregivers, and treating team is key to delivering truly patient-centered care. Delivering this care also requires overcoming the limitations of the currently available evidence that is predominantly based on observational data with its inherent risks of bias. While challenging, future randomized controlled studies exploring the risks, benefits, costs, and timing of placement of available access types in the elderly are required to help us "get it right" for our patients.

A 55-year-old right-handed waitress with ESKD secondary to GN had been receiving hemodialysis for 4 years. She initiated dialysis urgently with a right internal jugular catheter. Because of her active ulcerative colitis, peritoneal dialysis is contraindicated. A left snuffbox arteriovenous fistula

Despite its many positive attributes, peritoneal dialysis remains underutilized, particularly in the United States. Urgent-start peritoneal dialysis (PD) has been proposed as a method of increasing PD prevalence. Urgent-start PD has been shown to be safe, feasible, and effective. However, urgent-start PD is also accompanied by several multidimensional challenges. This article is intended to equip the reader with a practical sense of whether an urgent-start PD program would be appropriate in his or her own clinical context and if appropriate, what factors would be necessary for such a program to flourish. As such, we summarize latent factors, which are necessary to consider before instituting an urgent-start PD. Then, using a series of clinical vignettes, highlight the component parts of a successful urgent-start PD program and the patient population who stand to benefit most from this strategy. The discussion is then balanced by presenting limitations to consider in the urgent-start PD approach.

One of the mandates of the Canadian Society of Nephrology's (CSN) Vascular Access Working Group (VAWG) is to inform the nephrology community of the current status of vascular access (VA) practice within Canada. To better understand VA practice patterns across Canada, the CSN VAWG conducted a national survey.(1) To inform on VA practice patterns, including fistula creation and maintenance, within Canada. (2) To determine the degree of consensus among Canadian clinicians regarding patient suitability for fistula creation and to assess barriers to and facilitators of fistula creation in Canada.Development and implementation of a survey.Community and academic VA programs.Nephrologists, surgeons, and nurses who are involved in VA programs across Canada.Practice patterns regarding access creation and maintenance, including indications and contraindications to fistula creation, as well as program-wide facilitators of and barriers to VA.A small group of CSN VAWG members determined the scope and created several VA questions which were then reviewed by 5 additional VAWG members (4 nephrologists and 1 VA nurse) to ensure that questions were clear and relevant. The survey was then tested by the remaining members of the VAWG and refinements were made. The final survey version was submitted electronically to relevant clinicians (nephrologists, surgeons, and nurses) involved or interested in VA across Canada. Questions centered around 4 major themes: (1)Eighty-two percent (84 of 102) of invited participants completed the survey; the majority were nurses or VA coordinators (55%) with the remainder consisting of nephrologists (21%) and surgeons (20%). Variation in practice was noted in utility of preoperative Doppler ultrasound, interventions to assist nonmaturing fistulas, and procedures to salvage failing or thrombosed AV-access. Little consensus was seen regarding potential contraindications to AV-access creation (with the exception of limited life expectancy and poor vasculature on preoperative imaging, which had high agreement). Frequent barriers to fistula utilization were primary failure (77% of respondents) and long maturation times (73%). Respondents from centers with low fistula prevalence also cited long surgical wait times as an important barrier to fistula creation, whereas those from centers with high fistula prevalence cited access to multidisciplinary teams and interventional radiology as keys to successful fistula creation and utilization.There is significant variation in VA practice across Canada and little consensus among Canadian clinicians regarding contraindications to fistula creation. Further high-quality studies are needed with regard to appropriate fistula placement to help guide clinical practice.L’un des mandats du Groupe de travail en accès vasculaire (GTAV) de la Société canadienne de néphrologie consiste à informer la communauté en néphrologie des schémas de pratique actuels en accès vasculaire au Canada. Le GTAV a mené un sondage pancanadien pour mieux comprendre les schémas de pratique existants au pays en matière d’accès vasculaire.(1) Informer la communauté des schémas de pratique canadiens (notamment en ce qui a trait à la création et au maintien fistulaire). (2) Déterminer le niveau de consensus parmi les cliniciens canadiens concernant l’admissibilité d’un patient à la création d’une fistule et les facteurs facilitant ou entravant la procédure.Il s’agit de la conception et de la réalisation d’un sondage.Programmes d’accès vasculaire en milieu universitaire ou communautaire.Ont été invités à participer néphrologues, chirurgiens et membres du personnel infirmier intervenant dans un programme d’accès vasculaire canadien.Nous avons sondé les participants à propos de leur schéma de pratique concernant la création et l’entretien fistulaire, notamment les indications et contre-indications à la création d’une fistule, ainsi que des facteurs facilitant ou entravant la procédure dans leur milieu de pratique.Quelques membres du GTAV ont défini le cadre du sondage et ont rédigé une série de questions. Cinq autres membres du GTAV (quatre néphrologues et un membre du personnel infirmier en accès vasculaire) ont ensuite validé la clarté et la pertinence des questions soumises. Finalement, le sondage a été testé auprès des autres membres du GTAV pour y apporter des ajustements. La version définitive du sondage a été envoyée électroniquement à des cliniciens (néphrologues, chirurgiens et membres du personnel infirmier) canadiens intervenant en accès vasculaire ou qui s’y intéressent. Les questions abordaient quatre thèmes :Des 102 personnes invitées à participer au sondage, 84 (82 %) ont répondu au questionnaire. La majorité (55 %) était constituée de membres du personnel infirmier et de coordonnateurs en accès vasculaire. La différence se composait essentiellement de néphrologues (21 %) et de chirurgiens (20 %). On a noté une variabilité des habitudes de pratique quant au recours à une échographie Doppler en préopératoire, aux interventions en cas de fistules non formées et aux procédures de rétablissement d’un accès artériovasculaire défaillant ou thrombosé. Il n’existe pas de consensus sur les éventuelles contre-indications à la création d’un accès artériovasculaire, à l’exception de deux points : une espérance de vie limitée et une structure vasculaire faible (révélée par imagerie préopératoire). La défaillance primitive et un long délai de maturation ont été cernés comme obstacles au recours à la fistule par une majorité de répondants (77 % et 73 %, respectivement). Les répondants de centres où l’on pratique peu d’interventions fistulaires ont mentionné les longs délais d’attente préopératoire comme entrave; les répondants de centres où l’on pratique fréquemment l’intervention fistulaire ont quant à eux souligné deux facteurs facilitant la création fistulaire et son utilisation : l’accès à des équipes multidisciplinaires et à la radiologie interventionnelle.Au Canada, les schémas de pratique clinique en accès vasculaire varient fortement, et les indications et contre-indications à la création fistulaire ne font pas consensus au sein des cliniciens. D’autres études rigoureuses sur les conditions adéquates pour la pratique d’une intervention fistulaire sont nécessaires afin d’orienter la pratique clinique.

Background and objectives In Canada, approximately 17% of patients use an arteriovenous access (fistula or arteriovenous graft) at commencement of hemodialysis, despite guideline recommendations promoting its timely creation and use. It is unclear if this low pattern of use is attributable to the lack of surgical creation or a high nonuse rate. Design, setting, participants, & measurements Using large health care databases in Ontario, Canada, a population-based cohort of adult patients (≥18 years old) who initiated hemodialysis as their first form of RRT between 2001 and 2010 was studied. The aims were to ( 1 ) estimate the proportion of patients who had an arteriovenous access created before starting hemodialysis and the proportion who successfully used it at hemodialysis start, ( 2 ) test for secular trends in arteriovenous access creation, and ( 3 ) estimate the effect of late nephrology referral and patient characteristics on arteriovenous access creation. Results There were 17,183 patients on incident hemodialysis. The mean age was 65.8 years, 60% were men, and 40% were referred late to a nephrologist; 27% of patients (4556 of 17,183) had one or more arteriovenous accesses created, and the median time between arteriovenous access creation and hemodialysis start was 184 days. When late referrals were excluded, 39% of patients (4007 of 10,291) had one or more arteriovenous accesses created, and 27% of patients (2724 of 10,291) used the arteriovenous access. Since 2001, there has been a decline in arteriovenous access creation before hemodialysis initiation. Women, higher numbers of comorbidities, and rural residence were consistently associated with lower rates of arteriovenous access creation. These results persisted even after removing patients with Conclusions In Canada, arteriovenous access creation before hemodialysis initiation is low, even among patients followed by a nephrologist. Better understanding of the barriers and influencers of arteriovenous access creation is needed to inform both clinical care and guidelines.

Purpose The primary objective of this study is to measure hemodialysis patients' satisfaction with their vascular access. The secondary objective is to evaluate the measurement tool's psychometric properties to assess patient satisfaction with their vascular access. Methods We generated a comprehensive list of survey items related to patients' views and satisfaction with their vascular access and administered it to participating in-center hemodialysis patients over 4 months. Following a factor analysis, the items were reduced and rescaled to generate the final short-form vascular access questionnaire (SF-VAQ). The SF-VAQ was then administered to a new cohort of hemodialysis patients on two occasions 1 week apart from February 1, 2012, to April 1, 2014. A repeated measures analysis of variance and psychometric evaluation was conducted. Results The final SF-VAQ with 13 items and four domains was administered to 132 patients (35 fistulas, 14 grafts and 83 catheters). The mean Likert value for overall satisfaction on a scale of 1 (low) to 7 (high) was 5.98, with catheters, fistulas and grafts with values of 5.92, 6.46 and 5.21, respectively. The test–retest reliability for two occasions is 0.92 and the internal consistency for the first administration is high at 0.84. Conclusions The SF-VAQ is a short, simple to administer vascular access-specific questionnaire with robust psychometric properties that can be used to obtain the patient's views on their vascular access. Based on the newly developed SF-VAQ, patients were the most satisfied with fistulas, scores.

Hemodialysis vascular access recommendations promote arteriovenous (AV) fistulas first; however, it may not be the best approach for all hemodialysis patients, because likelihood of successful fistula placement, procedure-related and subsequent costs, and patient survival modify the optimal access choice. We performed a decision analysis evaluating AV fistula, AV graft, and central venous catheter (CVC) strategies for patients initiating hemodialysis with a CVC, a scenario occurring in over 70% of United States dialysis patients. A decision tree model was constructed to reflect progression from hemodialysis initiation. Patients were classified into one of three vascular access choices: maintain CVC, attempt fistula, or attempt graft. We explicitly modeled probabilities of primary and secondary patency for each access type, with success modified by age, sex, and diabetes. Access-specific mortality was incorporated using preexisting cohort data, including terms for age, sex, and diabetes. Costs were ascertained from the 2010 USRDS report and Medicare for procedure costs. An AV fistula attempt strategy was found to be superior to AV grafts and CVCs in regard to mortality and cost for the majority of patient characteristic combinations, especially younger men without diabetes. Women with diabetes and elderly men with diabetes had similar outcomes, regardless of access type. Overall, the advantages of an AV fistula attempt strategy lessened considerably among older patients, particularly women with diabetes, reflecting the effect of lower AV fistula success rates and lower life expectancy. These results suggest that vascular access-related outcomes may be optimized by considering individual patient characteristics.

In a recent randomized trial, weekly recombinant tissue plasminogen activator (rt-PA), 1 mg per lumen, once per week, and twice-weekly heparin as a locking solution (rt-PA/heparin) resulted in lower risks of hemodialysis catheter malfunction and catheter-related bacteremia compared with thrice-weekly heparin (heparin alone). We collected detailed costs within this trial to determine how choice of locking solution would affect overall health care costs, including the cost of locking solutions and all other relevant medical costs over the course of the 6-month trial. Nonparametric bootstrap estimates were used to derive 95% confidence intervals (CIs) and mean cost differences between the treatment groups. The cost of the locking solution was higher in patients receiving rt-PA/heparin, but this was partially offset by lower costs for managing complications. Overall, the difference in unadjusted mean cost for managing patients with rt-PA/heparin versus heparin alone was Can$323 (95% CI, −$935 to $1581; P =0.62). When the costs were extrapolated over a 1-year time horizon using decision analysis, assuming ongoing rt-PA effectiveness, the overall costs of the strategies were similar. This finding was sensitive to plausible variation in the frequency and cost of managing patients with catheter-related bacteremia, and whether the benefit of rt-PA on catheter-related bacteremia was maintained in the long term. In summary, we noted no significant difference in the mean overall cost of an rt-PA/heparin strategy as a locking solution for catheters compared with thrice-weekly heparin. Cost savings due to a lower risk of hospitalization for catheter-related bacteremia partially offset the increased cost of rt-PA.

Establishing permanent vascular access is a significant management step in the clinical pathway for patients with progressive stages 4 and 5 CKD. Although clinical practice guidelines are unified in the recommendation for the native arteriovenous fistula (AVF) as the first choice vascular access for

Introduction: Hemodialysis catheter malfunction is problematic. We aimed to determine clinical, catheter, and hemodialysis variables that predict: (i) catheter malfunction requiring recombinant tissue-plasminogen activator (TPA) treatment and (ii) the success of TPA administration. Methods: Clinical, catheter, and hemodialysis variables were collected from a cohort of 559 catheters (141,526 catheter days) in 175 hemodialysis patients (2008-2011). Time to, and predictors of, catheter malfunction were determined for all catheters and primary catheters only, analyzed by Cox-proportional hazard model, multi-variable logistic regression model, and mixed-effect logistic regression models. Success of TPA use was determined immediately, next day, and two weeks after use. Results: Shorter time to first TPA administration in all patient’s catheters was associated with increased body mass index (hazard ratio [HR] = 1.06, 1.01-1.11, p = 0.03) and being of black race (HR = 3.05, 1.65-5.67, pConclusions: Both patient and dialysis predictors of TPA use and success were identified in this study, which may be useful for fine-tuning catheter management protocols to target hemodialysis patients at high risk of catheter malfunction.

This paper is part of the Clinical Trial Endpoints for Dialysis Vascular Access Project of the American Society of Nephrology Kidney Health Initiative. The purpose of this project is to promote research in vascular access by clarifying trial end points which would be best suited to inform decisions in those situations in which supportive clinical data are required. The focus of a portion of the project is directed toward arteriovenous access. There is a potential for interventional studies to be directed toward any of the events that may be associated with an arteriovenous access’ evolution throughout its life cycle, which has been divided into five distinct phases. Each one of these has the potential for relatively unique problems. The first three of these correspond to three distinct stages of arteriovenous access development, each one of which has been characterized by objective direct and/or indirect criteria. These are characterized as: stage 1—patent arteriovenous access, stage 2—physiologically mature arteriovenous access, and stage 3—clinically functional arteriovenous access. Once the requirements of a stage 3—clinically functional arteriovenous access have been met, the fourth phase of its life cycle begins. This is the phase of sustained clinical use from which the arteriovenous access may move back and forth between it and the fifth phase, dysfunction. From this phase of its life cycle, the arteriovenous access requires a maintenance procedure to preserve or restore sustained clinical use. Using these definitions, clinical trial end points appropriate to the various phases that characterize the evolution of the arteriovenous access life cycle have been identified. It is anticipated that by using these definitions and potential end points, clinical trials can be designed that more closely correlate with the goals of the intervention and provide appropriate supportive data for clinical, regulatory, and coverage decisions.