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Importance: Recent guidelines call for better evidence on health outcomes after living kidney donation., Objective: To determine the risk of hypertension in normotensive adults who donated a kidney compared with nondonors of similar baseline health. Their rates of estimated glomerular filtration rate (eGFR) decline and risk of albuminuria were also compared., Design, Setting, and Participants: Prospective cohort study of 924 standard-criteria living kidney donors enrolled before surgery and a concurrent sample of 396 nondonors. Recruitment occurred from 2004 to 2014 from 17 transplant centers (12 in Canada and 5 in Australia); follow-up occurred until November 2021. Donors and nondonors had the same annual schedule of follow-up assessments. Inverse probability of treatment weighting on a propensity score was used to balance donors and nondonors on baseline characteristics., Exposure: Living kidney donation., Main Outcomes and Measures: Hypertension (systolic blood pressure [SBP] ≥140 mm Hg, diastolic blood pressure [DBP] ≥90 mm Hg, or antihypertensive medication), annualized change in eGFR (starting 12 months after donation/simulated donation date in nondonors), and albuminuria (albumin to creatinine ratio ≥3 mg/mmol [≥30 mg/g])., Results: Among the 924 donors, 66% were female; they had a mean age of 47 years and a mean eGFR of 100 mL/min/1.73 m2. Donors were more likely than nondonors to have a family history of kidney failure (464/922 [50%] vs 89/394 [23%], respectively). After statistical weighting, the sample of nondonors increased to 928 and baseline characteristics were similar between the 2 groups. During a median follow-up of 7.3 years (IQR, 6.0-9.0), in weighted analysis, hypertension occurred in 161 of 924 donors (17%) and 158 of 928 nondonors (17%) (weighted hazard ratio, 1.11 [95% CI, 0.75-1.66]). The longitudinal change in mean blood pressure was similar in donors and nondonors. After the initial drop in donors' eGFR after nephrectomy (mean, 32 mL/min/1.73 m2), donors had a 1.4-mL/min/1.73 m2 (95% CI, 1.2-1.5) per year lesser decline in eGFR than nondonors. However, more donors than nondonors had an eGFR between 30 and 60 mL/min/1.73 m2 at least once in follow-up (438/924 [47%] vs 49/928 [5%]). Albuminuria occurred in 132 of 905 donors (15%) and 95 of 904 nondonors (11%) (weighted hazard ratio, 1.46 [95% CI, 0.97-2.21]); the weighted between-group difference in the albumin to creatinine ratio was 1.02 (95% CI, 0.88-1.19)., Conclusions and Relevance: In this cohort study of living kidney donors and nondonors with the same follow-up schedule, the risks of hypertension and albuminuria were not significantly different. After the initial drop in eGFR from nephrectomy, donors had a slower mean rate of eGFR decline than nondonors but were more likely to have an eGFR between 30 and 60 mL/min/1.73 m2 at least once in follow-up., Trial Registration: ClinicalTrials.gov Identifier: NCT00936078.

Introduction: Many individuals start dialysis in an acute setting with suboptimal pre-dialysis education. These individuals are often treated with central venous catheter insertion and initiation of in-center hemodialysis and only a minority will transfer to a home-based therapy. The dialysis start unit is a program performing in-center hemodialysis in a separate space while providing support and education on chronic kidney disease and treatment options in the initial weeks of kidney replacement therapy. We aimed to assess the uptake of home dialysis therapies between 2013 and 2021 among patients who started acute inpatient hemodialysis at University Health Network, Toronto and underwent dialysis at the dialysis start unit., Methods: This is a retrospective observational cohort study based on prospectively collected data. Patients' demographics were obtained from electronic charts. In the dialysis start unit, all patients received dialysis modality education by a nurse educator, dedicated home dialysis nurses, and the allied health care team., Findings: During 2013-2021, 122 patients were dialyzed in the dialysis start unit and included in the study. Among those patients, 68 patients ultimately chose home dialysis (57 peritoneal dialysis and 11 home hemodialysis). Fifty-four patients continued in-center hemodialysis. Patients adopting home dialysis were less likely to have diabetes and hypertension as the etiology of kidney failure and more likely to have glomerulonephritis or vasculitis., Discussion: Dialysis modality education is implementable in advanced chronic kidney disease. Individualized education and care after unplanned start dialysis can potentially enhance home dialysis choice and utilization., (© 2024 International Society for Hemodialysis.)

Rationale and Objective: This study aimed to develop a cosmesis scale to evaluate the cosmetic appearance of hemodialysis (HD) arteriovenous (AV) accesses from the perspective of the patient and clinician, which could be incorporated into clinical trials., Study Design: Using a modified Delphi process, two AV access cosmesis scale (AVACS) components were developed in a four-round Delphi panel consisting of two surveys and two consensus meetings with two rounds of patient consultation., Setting and Participants: The Delphi panel consisted of 15 voting members including five interventional or general nephrologists, five vascular surgeons, three interventional radiologists, and two vascular access nurse coordinators. Four patients experienced with vascular access were involved in patient question development., Analytical Approach: For a component to be included in the AVACS, it had to meet the prespecified panel consensus agreement of ⩾70%., Results: The clinician component of the AVACS includes nine questions on the following AV access features: scarring, skin discoloration, aneurysm/pseudoaneurysms and megafistula appearance. The patient component includes six questions about future vascular access decisions, interference with work or leisure activities, clothing choices, self-consciousness or attractiveness, emotional impact, and overall appearance., Limitations: Delphi panel methods are subjective by design, but with expert clinical opinion are used to develop classification systems and outcome measures. The developed scale requires further validation testing but is available for clinical trial use., Conclusions: While safety and efficacy are the primary concerns when evaluating AV access for HD, cosmesis is an important component of the ESKD patient experience. The AVACS has been designed to assess this important domain; it can be used to facilitate patient care and education about vascular access choice and maintenance. AVACS can also be used to inform future research on developing new techniques for AV access creation and maintenance, particularly as relates to AV access cosmesis., Competing Interests: Declaration of Conflicting InterestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The authors declare that they have no conflicts of interest regarding patents or royalties, stock/stock options, or first-degree relatives with any of these relationships related to this work. No reimbursement was received for the development of the manuscript.DR, VN, MM, CR, ED, CG, TV, SH, PB, LD and patients CS, DDR, FM, and MB (see acknowledgements) received remuneration from Becton Dickinson (BD) for their participation in the Delphi process.GW, AH, and NF are employees of CRG-EVERSANA Canada Inc., which was contracted by BD to facilitate the Delphi panel process and analyze the results.EK and DC are employees of the American Association of Kidney Patients (AAKP) which was contracted by BD to advise on patient input and recruited the Patient Ambassadors.DR is a consultant for BD and Gore Medical. VN is a consultant for the NACCME – Moderator for AV Access Webcast, supported by an educational grant from Medtronic. SH is a consultant/speaker for BD, Merit Medical, Medtronic, and Gore Medical. ED is a consultant for WL Gore, Angiodynamics, and 3M/KCI. ED is a scientific advisor for Boston Scientific. TY is a consultant for BD, WL Gore and Merit Medical and a scientific advisory board member of BD and Medtronic. CK is a consultant for BD and ACI/Humacyte and advisory board member for Boston Scientific. CL is a consultant for BD, Gore, and Medtronic.Other ConflictsED, KW, and TY are authors and ED is an editor for UpToDate.

Importance: Hemodialysis requires reliable vascular access to the patient's blood circulation, such as an arteriovenous access in the form of an autogenous arteriovenous fistula or nonautogenous arteriovenous graft. This Review addresses key issues associated with the construction and maintenance of hemodialysis arteriovenous access., Observations: All patients with kidney failure should have an individualized strategy (known as Patient Life-Plan, Access Needs, or PLAN) for kidney replacement therapy and dialysis access, including contingency plans for access failure. Patients should be referred for hemodialysis access when their estimated glomerular filtration rate progressively decreases to 15 to 20 mL/min, or when their peritoneal dialysis, kidney transplant, or current vascular access is failing. Patients with chronic kidney disease should limit or avoid vascular procedures that may complicate future arteriovenous access, such as antecubital venipuncture or peripheral insertion of central catheters. Autogenous arteriovenous fistulas require 3 to 6 months to mature, whereas standard arteriovenous grafts can be used 2 to 4 weeks after being established, and "early-cannulation" grafts can be used within 24 to 72 hours of creation. The prime pathologic lesion of flow-related complications of arteriovenous access is intimal hyperplasia within the arteriovenous access that can lead to stenosis, maturation failure (33%-62% at 6 months), or poor patency (60%-63% at 2 years) and suboptimal dialysis. Nonflow complications such as access-related hand ischemia ("steal syndrome"; 1%-8% of patients) and arteriovenous access infection require timely identification and treatment. An arteriovenous access at high risk of hemorrhaging is a surgical emergency., Conclusions and Relevance: The selection, creation, and maintenance of arteriovenous access for hemodialysis vascular access is critical for patients with kidney failure. Generalist clinicians play an important role in protecting current and future arteriovenous access; identifying arteriovenous access complications such as infection, steal syndrome, and high-output cardiac failure; and making timely referrals to facilitate arteriovenous access creation and treatment of arteriovenous access complications.

Introduction: Patients with kidney failure with replacement therapy (KFRT) suffer premature cardiovascular (CV) mortality and events with few proven pharmacological interventions. Omega-3 polyunsaturated essential fatty acids (n-3 PUFAs) are associated with a reduced risk of CV events and death in non-dialysis patients and in patients with established CV disease but n-3 PUFAs have not been evaluated in the high risk KFRT patient population., Methods and Analysis: This multicentre randomised, placebo controlled, parallel pragmatic clinical trial tests the hypothesis that oral supplementation with n-3 PUFA, when added to usual care, leads to a reduction in the rate of serious CV events in haemodialysis patients when compared with usual care plus matching placebo. A target sample size of 1100 KFRT patients will be recruited from 26 dialysis units in Canada and Australia and randomised to n-3 PUFA or matched placebo in a 1:1 ratio with an expected intervention period of at least 3.5 years. The primary outcome to be analysed and compared between intervention groups is the rate of all, not just the first, serious CV events which include sudden and non-sudden cardiac death, fatal and non-fatal myocardial infarction, stroke, and peripheral vascular disease events., Ethics and Dissemination: This study has been approved by all institutional ethics review boards involved in the study. Participants could only be enrolled following informed written consent. Results will be published in peer-reviewed journals and presented at scientific and clinical conferences., Trial Registration Number: ISRCTN00691795., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Rationale & Objective: Early mortality rates of female patients receiving 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., Study Design: Retrospective cohort study., Setting & Participants: Incident patients who had initiated dialysis in Australia and New Zealand in 1998-2018., Exposure: Sex., Outcomes: Cause-specific and all-cause mortality while receiving dialysis, censored for kidney transplant., Analytical Approach: Adjusted cause-specific proportional hazards models, focusing on the first 5 years following initiation of dialysis., Results: Among 53,414 patients (20,876 [39%] 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 (18%), followed by dialysis withdrawal (16%). Compared with male patients, female patients were more likely to die in the first 5 years after dialysis initiation (adjusted hazard ratio [AHR], 1.08 [95% CI, 1.05-1.11]). Even though female patients experienced a lower risk of cardiovascular disease-related mortality (AHR, 0.93 [95% CI, 0.89-0.98]) than male patients, they experienced a greater risk of infection-related (AHR, 1.20 [95% CI, 1.10-1.32]) and dialysis withdrawal-related (AHR, 1.19 [95% CI, 1.13-1.26]) mortality., Limitations: Possibility of residual and unmeasured confounders., Conclusions: Compared with male patients, female patients had a higher risk of all-cause mortality in the first 5 years after dialysis initiation, a difference driven by higher rates of mortality from infections and dialysis withdrawals. These findings may inform the study of sex differences in mortality in other geographic settings., (Copyright © 2022 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Rationale & Objective: 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., Study Design: Secondary analysis of cross-sectional data., Setting & Participants: 536 patients with advanced CKD (estimated glomerular filtration rate<30mL/min/1.73m 2 , with or without kidney replacement therapy) from multiple clinical centers in Toronto., Exposure: Racialized status (individuals who identify as Asian or as African, Caribbean, or Black Canadian), immigrant status, and combined immigrant-racialized status., Outcome: 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)., Analytical Approach: 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., Results: 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., Limitations: Convenience sample; small subgroups; combined exposure variable grouping Asian and African, Caribbean, and Black participants together; lack of data about mechanisms., Conclusions: 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., Plain-Language Summary: 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., (Copyright © 2022 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Rationale & Objective: 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., Study Design: Prospective cohort study., Setting & Participants: 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., Exposure: Baseline characteristics for patients at the time of study enrollment were ascertained, including duration of CKD, comorbidities, and medications., Outcome: 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., Analytical Approach: 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., Results: 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], P<0.001), male sex (OR, 2.27 [95% CI, 1.45-3.54], P<0.001), 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., Limitations: Unmeasured confounding factors., Conclusions: Older age, male sex, erythropoiesis-stimulating agents, and azathioprine were found to be significantly associated with advanced colorectal neoplasia in patients with CKD., (Copyright © 2021 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

The new Kidney Disease Outcomes Quality Initiative (KDOQI) Vascular Access Guidelines have a patient focus for comprehensive vascular access management. The patient's unique circumstances and individualized needs are the foundation of their dialysis access strategy, which is interlinked with the patient's End Stage Kidney Disease (ESKD) Life-Plan. The ESKD Life-Plan is an individualized and comprehensive map for dialysis modalities and vascular access for the lifetime of the patient. New targets are introduced that align with this patient-centered approach. They are less detail prescriptive than prior vascular access guidelines, giving opportunity for vascular access management at the clinician's discretion, partly in consideration of constraints of local resources and available expertise; however, the guidelines also emphasize the importance of high-quality standards with defined targets for achieving the guideline's overarching goal for vascular access care. The guidelines made significant changes relevant to the interventionalist, including selective use of vessel mapping in planning for vascular access, choice of vascular access that allows for considering endovascular access creations, and endovascular treatment (e.g., angioplasty, stent graft insertions) based on clinical indicators found on routine clinical monitoring. To that end, preemptive angioplasty of fistulas and grafts with stenosis, not associated with clinical indicators, is not recommended. New content in these guidelines also includes the use of stent grafts and management of central venous stenosis. The new KDOQI Vascular Access Guidelines 2019 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., Competing Interests: Conflict of Interest None declared., (Thieme. All rights reserved.)

Background: Pretransplant diabetes and new-onset diabetes after transplant (NODAT) are known risk factors for vascular events after kidney transplantation, but the incidence and magnitude of the risk of major adverse cardiovascular events (MACE) and cardiac deaths remain uncertain in recent era., Methods: A population cohort study of kidney transplant recipients identified using data from linked administrative healthcare databases from Ontario, Canada. The incidence rates of MACE (expressed as events with 95% confidence interval [95% CI] per 1000 person-years were reported according to diabetes status of pretransplant diabetes, NODAT, or no diabetes. Extended Cox regression model was used to examine the association between diabetes status, MACE, and cardiac death., Results: Of 5248 recipients, 1973 (38%) had pretransplant diabetes, and 799 (15%) developed NODAT with a median follow-up of 5.5 y. The incidence rates (95% CI) of MACE for recipients with pretransplant diabetes, NODAT, and no diabetes between 1 and 3 y posttransplant were 38.1 (32.1-45.3), 12.6 (6.3-25.2), and 11.8 (9.2-15.0) per 1000 person-years, respectively. Compared with recipients with pretransplant diabetes, recipients with NODAT experienced a lower risk of MACE (adjusted hazard ratio, 0.59; 95% CI, 0.47-0.74) but not cardiac death (adjusted hazard ratio, 0.97; 95% CI, 0.61-1.55). The rate of MACE and cardiac death was lowest in patients without diabetes., Conclusions: Patients with pretransplant diabetes incur the greatest rate of MACE and cardiac deaths after transplantation. Having NODAT also bears high burden of vascular events compared with those without diabetes, but the magnitude of the increased rate remains lower than recipients with pretransplant diabetes., Competing Interests: W.H.L. has received speaking honoraria from Alexion, Astellas and Novartis; and unrestricted educational grants from Astellas and Novartis. The other authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

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., (Copyright © 2021 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Background: 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")., Objective: The objective is to outline the statistical analysis plan for the MyTEMP trial., Design: MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial., Setting: A total of 84 dialysis centers in Ontario, Canada., Patients: 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)., Methods: 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., Outcomes: 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., Analysis Plan: 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., Trial Status: 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., Trial Registration: MyTEMP is registered with the US National Institutes of Health at clincaltrials.gov (NCT02628366)., Statistical Analytic Plan: Version 1.1 June 15, 2021., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: G.N. has received consulting fees from Baxter Healthcare and Amgen. M.J.O. is the owner of Oliver Medical Management Inc, which licenses Dialysis Management Analysis and Reporting System software. He has received honoraria for speaking from Baxter Healthcare and participated on advisory boards for Janssen and Amgen. R.W. has received unrestricted research support from Baxter. The other authors declare no potential conflicts of interest to disclose., (© The Author(s) 2021.)

Background: Although living kidney donation is safe, some donors experience perioperative complications., Objective: This study explored how perioperative complications affected donor-reported health-related quality of life, depression, and anxiety., Design: This research was a conducted as a prospective cohort study., Setting: Twelve transplant centers across Canada., Patients: A total of 912 living kidney donors were included in this study., Measurements: Short Form 36 health survey, Beck Depression Inventory and Beck Anxiety Inventory., Methods: 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., Results: 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., Limitations: 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., Conclusions: These findings highlight a potential opportunity to better support the psychosocial needs of donors who experience perioperative complications in the months following donation., Trial Registration: NCT00319579 and NCT00936078., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.X.G. received operating grant support from the CIHR, which included partnership funding from Astellas for data collection. L.S.F. received investigator-initiated research grants from Merck and Johnson & Johnson and an educational grant from Medtronic., (© The Author(s) 2021.)

Background: 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., Methods: 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., Results: 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., Conclusions: 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.

Worsening renal function in chronic kidney disease correlates with worsening right ventricular (RV) systolic function. We evaluated the association between kidney transplantation (KT) and RV structure and systolic function, and the relationships between RV and left ventricular (LV) changes, blood pressure, and specific cardiac biomarkers, in patients with end-stage kidney disease using cardiac magnetic resonance imaging (CMR). In this prospective, multi-centre, cohort study, 39 adult patients on dialysis receiving KT and 42 patients eligible for, but not yet receiving KT, were recruited. CMR was performed at baseline, and repeated at 12 months. Among 81 patients (mean age 51 years, 30% female), RV end-diastolic volume index (RVEDVi), end-systolic volume index (RVESVi), mass index (RVMi), and ejection fraction (RVEF) did not change significantly within either the dialysis or KT group over 12 months (all p ≥ 0.10). There were no significant differences in the 12-month changes of these parameters between the dialysis and KT groups (all p ≥ 0.10). RVMI demonstrated positive correlations with NT-proBNP and systolic blood pressure, but not GDF-15, at baseline and at 12 months. Changes in RVEDVi, RVESVi, and RVEF were positively correlated with changes in LVEDVi, LVESVi, and LVEF, respectively over 12 months (Spearman r = 0.72, 0.52, and 0.41; all p < 0.001), but not mass index (Spearman r = 0.20, p = 0.078). In conclusion, there were no significant changes in RV mass, volumes, or systolic function 12 months after KT, as compared with continuation of dialysis. The associations between RV and LV remodeling may suggest similar underlying pathophysiologic mechanisms.

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., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

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: 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., (© 2020 International Society of Nephrology. Published by Elsevier Inc.)

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., (Copyright © 2020 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2020 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019. Published by Elsevier Inc.)

Background: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes., Method: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically., Results: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle., Conclusions: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD., (© The Author(s) 2019. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)

Background: Several studies report lower costs associated with attaining and maintaining patency for arteriovenous (AV) fistulas as compared to AV grafts among patients receiving hemodialysis. However, these costs may vary according to the AV access's risk of failure to mature (FTM). The aim of this study was to examine the effect of AV access type and risk of FTM on the total costs of attaining and maintaining AV access patency over 1, 3, and 5 years postcreation, among incident accesses., Methods: All first AV access creations (January 1, 2002-January 1, 2018), revisions/resections, and interventions from a single academic institution were prospectively captured. The units costs (from 2011 in CA$) were estimated primarily through the provincial patient Ontario Case Costing Initiative database. The present value of total vascular access-related costs from a third-party payer perspective was calculated by multiplying specific unit costs by the number of AV access creations, revisions/resections, and interventions from the date of creation to 1, 3, and 5 years post creation. The potential associations of AV access type and FTM risk stratum with AV access cost were examined using log-linear models and generalized estimating equations., Results: A total of 906 patients were included in the study, of which 696 had fistulas and 210 had grafts. The median present value of total costs to attain and maintain AV access over 1, 3, and 5 years was positively associated with the highest FTM risk stratum in all models. It was not associated with AV access type when the interaction between AV access type and FTM risk stratum was considered., Conclusions: The costs of attaining and maintaining AV access were increased among patients with high/very high FTM risk. Risk of FTM, related interventions, and costs should be considered when choosing vascular access type for an individual patient., Competing Interests: A. Gafni, S.D. Kosa, C.E. Lok, and L. Thabane have nothing to disclose., (Copyright © 2020 by the American Society of Nephrology.)

Background: 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., Objective: 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., Design: The design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial., Setting: 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., Participants: 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., Intervention: 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., Primary Outcome: 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., Planned Primary Analysis: 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., Trial Registration: www.clinicaltrials.gov; identifier: NCT02628366., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Zager is the Medical Director for Dialysis Clinic Inc, which provided partial funding for Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP). Dr Wald has received unrestricted research support from Baxter Healthcare. The remaining authors declare they have no other relevant interests., (© The Author(s) 2020.)

Background: Growth differentiation factor 15 (GDF15) is markedly increased in end-stage kidney disease and has been related to increased mortality in patients on dialysis. We hypothesized that kidney transplantation would decrease both GDF15 and N-terminal pro-B-type natriuretic peptide (NT-proBNP) and that GDF-15 decrease relates to post-kidney transplantation allograft function., Methods: End-stage kidney disease patients on dialysis awaiting a living donor kidney transplantation (n = 39), and those expected to be on the deceased donor waitlist for at least 12 months (n = 43) were enrolled at three transplant centers. Serum GDF15 and NT-proBNP were measured at 0, 3, and 12 months post-kidney transplantation or post-enrollment. Change in serum GDF15 and NT-proBNP concentrations, and their relation to estimated glomerular filtration rate (eGFR) were assessed by non-parametric tests and regression analyses., Results: Median baseline GDF15 was 4744 pg/ml and 5451 pg/ml for the kidney transplantation and dialysis groups, respectively (p = 0.09). Kidney transplantation resulted in a significant decrease in GDF15 (month 12 median 1631 pg/ml, p < 0.0001 vs. baseline), whereas there was no change for the dialysis group (month 12 median 5658 pg/ml, p = 0.31). Post-kidney transplantation NT-proBNP highly correlated with GDF15 (ρ = 0.64, p < 0.0001). GDF15 inversely correlated with post-transplant eGFR for the kidney transplantation group (ρ = -0.42, p = 0.0081). Month 12 NT-proBNP explained 15.8% and 40.1% of the variance in month 12 GDF15 in the dialysis and kidney transplantation groups, respectively. The relationship of GDF15 with eGFR was no longer significant when NT-proBNP was included in the models., Conclusions: Kidney transplantation significantly decreases serum GDF15 concentrations. The post-kidney transplantation association of GDF15 with NT-proBNP is consistent with a gradient of post- kidney transplantation cardiovascular risk., (Copyright © 2019 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)

Background: While living kidney donation is considered safe in healthy individuals, perioperative complications can occur due to several factors., Objective: 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., Design: Living kidney donors enrolled prospectively in a multicenter cohort study with some data collected retrospectively after enrollment was complete (eg, surgeon characteristics)., Setting: Living kidney donor centers in Canada (n = 12) and Australia (n = 5)., Patients: Living kidney donors who donated between 2004 and 2014 and the surgeons who performed the living kidney donor nephrectomies., Measurements: 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., Methods: 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., Results: 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., Limitations: 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., Conclusions: 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., Trial Registrations: NCT00319579: A Prospective Study of Living Kidney Donation (https://clinicaltrials.gov/ct2/show/NCT00319579) NCT00936078: Living Kidney Donor Study (https://clinicaltrials.gov/ct2/show/NCT00936078)., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Amit Garg was supported by the Dr Adam Linton Chair in Kidney Health Analytics and a Canadian Investigator Award from the Canadian Institutes of Health Research (CIHR) and received operating grant support from the CIHR, which included partnership funding from Astellas for data collection. Dr Liane S. Feldman received investigator-initiated research grants from Merck and Johnson & Johnson and an educational grant from Medtronic.

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., (© The Author(s) 2019. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)

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., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 by the American Society of Nephrology.)

Background: The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials., Objective: This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting., Methods: The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined., Results: The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p  < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p  < 0.001) were associated with a significantly higher number of CONSORT pilot items reported., Conclusions: Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials., Competing Interests: As this a methodological review and does not involve human subjects, ethics board approval was not sought for this study.As this a methodological review and does not involve human subjects, consent for publication was not sought for this study.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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.

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., (Copyright © 2018 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

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.

Background: Cardiovascular disease is a significant cause of morbidity and mortality in patients with end-stage renal disease (ESRD) and kidney transplant (KT) patients. Compared with left ventricular (LV) ejection fraction (LVEF), LV strain has emerged as an important marker of LV function as it is less load dependent. We sought to evaluate changes in LV strain using cardiovascular magnetic resonance imaging (CMR) in ESRD patients who received KT, to determine whether KT may improve LV function., Methods: We conducted a prospective multi-centre longitudinal study of 79 ESRD patients (40 on dialysis, 39 underwent KT). CMR was performed at baseline and at 12 months after KT., Results: Among 79 participants (mean age 55 years; 30% women), KT patients had significant improvement in global circumferential strain (GCS) (p = 0.007) and global radial strain (GRS) (p = 0.003), but a decline in global longitudinal strain (GLS) over 12 months (p = 0.026), while no significant change in any LV strain was observed in the ongoing dialysis group. For KT patients, the improvement in LV strain paralleled improvement in LVEF (57.4 ± 6.4% at baseline, 60.6% ± 6.9% at 12 months; p = 0.001). For entire cohort, over 12 months, change in LVEF was significantly correlated with change in GCS (Spearman's r = - 0.42, p < 0.001), GRS (Spearman's r = 0.64, p < 0.001), and GLS (Spearman's r = - 0.34, p = 0.002). Improvements in GCS and GRS over 12 months were significantly correlated with reductions in LV end-diastolic volume index and LV end-systolic volume index (all p < 0.05), but not with change in blood pressure (all p > 0.10)., Conclusions: Compared with continuation of dialysis, KT was associated with significant improvements in LV strain metrics of GCS and GRS after 12 months, which did not correlate with blood pressure change. This supports the notion that KT has favorable effects on LV function beyond volume and blood pessure control. Larger studies with longer follow-up are needed to confirm these findings.

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.

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.

Purpose: To compare: (i) rate of arteriovenous fistula (AVF) interventions in both incident and prevalent end-stage kidney disease patients; (ii) their associated costs; and (iii) intervention-free survival between patients with surgical hemodialysis arteriovenous fistula (SAVF) versus those with an endovascularly created fistula (endoAVF)., Materials and Methods: Data from the United States Renal Data System (USRDS) were abstracted to determine the rate of AVF interventions performed in the first year and associated costs (based on Medicare payment rates) for SAVFs created from 2011 to 2013 in the incident and prevalent patient cohorts. Comparative data for endoAVF were obtained from the Novel Endovascular Access Trial (NEAT). Event rates, intervention-free survival, and costs were compared between endoAVF and SAVF cohorts after 1:1 propensity score (PS) matching., Results: In the matched incident patients, the event rate was 0.74 per patient-year (PY) for endoAVF versus 7.22/PY for SAVF (P < .0001), with a difference in expenditures of $16,494. Similarly, in matched prevalent patients the event rate was 0.46/PY for endoAVF vs 4.10/PY for SAVF (P < .0001), resulting in a cost difference of $13,389. Time-to-event analysis showed that at 1 year, 70% of endoAVF patients experienced freedom from intervention versus only 18% of SAVF patients for incident patients; these numbers were 62% and 18% for endoAVF and SAVF prevalent patients, respectively (P < .0001 for both)., Conclusions: Both incident and prevalent patients with endoAVF required fewer interventions and had lower costs within the first year compared with matched patients with SAVF., (Copyright © 2018 SIR. Published by Elsevier Inc. All rights reserved.)

Introduction: Dysfunctional or infected hemodialysis polyester-cuffed catheters often require removal and are dissected out. The DermaPort™, percutaneous vascular access system (PVAS) permanently integrates a titanium mesh with the skin forming a stable, sterile barrier that allows for catheter placement, adjustment, or catheter exchange. This study aimed to describe the use and clinical outcomes of the DermaPort PVAS., Methods: Thirty-eight patients who were receiving hemodialysis via a tunneled catheter were enrolled in this prospective open-label study. Assessments were performed biweekly for the first month and monthly thereafter, which included physical examination of the site of implantation for infection, catheter blood flow, and need for interventions to maintain catheter patency. Patient satisfaction was assessed with a visual analog score., Results: Implantation of technical success was 100% with the implantation site demonstrating early tissue incorporation after 2 weeks and full incorporation within 4 weeks. The DermaPort™ successfully enabled 31 catheter exchanges and 10 repositions thru the port without dissection in 18 patients with nine repositions (90%) performed at bedside. The mean primary patency of the DermaPort™ was 172 ± 150 days, and mean secondary patency was 430 ± 203 days. There were no reportable serious adverse events in 12,100 catheter days of use and zero explantations of the device attributed to infection. The observed catheter infection rate was 0.33/1000 days., Conclusions: The DermaPort™ system can be effectively implanted and facilitates catheter interventions in hemodialysis patients requiring long-term catheter use and has a lower infection rate than historical catheter infection rates. Clinical Trial Protocol Number DermaPort-001 (no clinicaltrials.gov number as study was performed 9 years ago). Health Canada Reference Application Number: 118393.

Background: Deceased donor kidney allocation in the United States is guided by the Kidney Donor Risk Index (KDRI). The generalizability of the KDRI beyond the United States has not been widely studied., Objective: To assess the generalizability of the KDRI in a cohort of non-US (Canadian) deceased donor kidney transplant recipients., Design: Population-based retrospective cohort study., Setting: Ontario, Canada., Patients: Recipients of deceased donor kidneys from January 1, 2005, to March 31, 2011., Methods: Using administrative data, we analyzed a cohort of deceased donor kidney recipients in Ontario, Canada. The Kaplan-Meier method and Cox proportional hazards models were used to assess the relationship between KDRI and the outcomes of graft loss and death. KDRI was modeled continuously and categorically. The ability of models with KDRI to predict recipient outcomes beyond donor age was also explored. Model discrimination was assessed using c -statistics, evaluated at 5 years of follow-up., Results: A total of 1299 consecutive deceased donor kidney transplant recipients were included. The median follow-up was 5.5 years. Mean donor age increased from 27 to 64 years across ascending KDRI quintiles. The adjusted relative hazards (95% confidence interval) for total graft loss from Q2 to Q5 (referent = Q1) were 1.27 (0.89-1.80), 1.58 (1.13-2.22), 1.43 (1.01-2.02), and 2.15 (1.54-2.99), respectively. Increased relative hazards across KDRI quintiles were also observed for death-censored graft loss, but not death with graft function. All-cause mortality was increased for the highest KDRI quintile only. In this cohort, a model with KDRI performed better than a model with donor age alone ( P = .009)., Limitations: Large health care databases may have precluded the complete capture of covariate data., Conclusions: In conclusion, the KDRI is generalizable to Canadian patients in Ontario and may help inform risk assessment beyond donor age. The performance of KDRI in other non-US settings, and the need for additional model refinement, warrants further study., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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., (Copyright © 2018 National Kidney Foundation, Inc. All rights reserved.)

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., (© 2018 Wiley Periodicals, Inc.)

Vascular access outcomes in hemodialysis are critically important for patients and clinicians, but frequently are neither patient relevant nor measured consistently in randomized trials. A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop was convened to discuss the development of a core outcome measure for vascular access. 13 patients/caregivers and 46 professionals (clinicians, policy makers, industry representatives, and researchers) attended. Participants advocated for vascular access function to be a core outcome based on the broad applicability of function regardless of access type, involvement of a multidisciplinary team in achieving a functioning access, and the impact of access function on quality of life, survival, and other access-related outcomes. A core outcome measure for vascular access required demonstrable feasibility for implementation across different clinical and trial settings. Participants advocated for a practical and flexible outcome measure with a simple actionable definition. Integrating patients' values and preferences was warranted to enhance the relevance of the measure. Proposed outcome measures for function included "uninterrupted use of the access without the need for interventions" and "ability to receive prescribed dialysis," but not "access blood flow," which was deemed too expensive and unreliable. These recommendations will inform the definition and implementation of a core outcome measure for vascular access function in hemodialysis trials., (Copyright © 2018 National Kidney Foundation, Inc. All rights reserved.)

Background: Vascular access practice is strongly associated with clinical outcomes. There is substantial international variation in the use of arteriovenous fistulas (AVFs) and grafts (AVGs), as well as AVF maturation time and location., Study Design: Prospective cohort study., Setting & Participants: Hemodialysis patients participating in the prospective Dialysis Outcomes and Practice Patterns Study (DOPPS) from the United States, Japan, and Europe/ANZ (Belgium, France, Germany, Italy, Spain, Sweden, United Kingdom, Australia, and New Zealand), including 3,850 patients receiving 4,247 new AVFs and 842 patients receiving 1,129 new AVGs in 2009 to 2015. AVF location trends were based on 38,868 AVFs recorded in DOPPS 1 to 5 cross-sections (1996-2015)., Predictors: Demographics, comorbid conditions, dialysis vintage, body mass index, facility percentage AVF use, median blood flow rate, and AVF location., Outcomes: AVF location; successful AVF/AVG use (≥30 days of continuous use); time-to-first successful AVF/AVG use (maturation)., Results: During DOPPS 1 to 5, the percentage of AVFs created in the lower arm was consistently ≥93% in Japan and 65% to 77% in Europe/ANZ, but in the United States, this value declined from 70% (DOPPS 1) to 32% (DOPPS 5). Patient characteristics associated with AVF location differed by region. Successful AVF use was 87% in Japan, 67% in Europe/ANZ, and 64% in the United States, whereas successful AVG use was 86%, 75%, and 78%, respectively. Successful AVF use was greater for upper- versus lower-arm AVFs in the United States, with little difference in Europe/ANZ and the opposite pattern in Japan. Median time until first successful AVF use was 10 days in Japan, 46 days in Europe/ANZ, and 82 days in United States; until first successful AVG use: 6, 24, and 29 days, respectively., Limitations: Potential measurement error related to chart data abstraction in multiple hemodialysis facilities., Conclusions: Large international differences exist in AVF location, predictors of AVF location, successful use of AVFs, and time to first AVF/AVG use, challenging what constitutes best practice. The large US shift from lower- to upper-arm AVFs raises serious concerns about long-term health implications for some patients and how policies and practices aimed at increasing AVF use have affected AVF placement location., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 by the American Society of Nephrology.)