RATIONALE & OBJECTIVE:Most living kidney donors report normal-to-high self-esteem before donation. Less is known about the longer-term effects of donation on self-esteem, whether certain pre-donation characteristics are associated with lower self-esteem after donation, or how changes in self-esteem are associated with changes in symptoms of depression and anxiety. STUDY DESIGN:Prospective cohort study. SETTING & PARTICIPANTS:Living kidney donors (n=941) were enrolled before donation from 12 Canadian and 5 Australian transplant centers between 2009 and 2014. EXPOSURE:Living kidney donation. OUTCOMES:Self-reported self-esteem was measured using the Rosenberg Self-Esteem Scale (RSES) before donation, 3 months after donation, and then annually for 5 years or until the last follow-up visit (possible scores range from 0-30, with higher scores indicating higher self-esteem). Donors also completed the Beck Depression and Anxiety Inventories at these timepoints. ANALYTICAL APPROACH:Linear and modified Poisson regression models were used to examine whether pre-donation characteristics were associated with lower self-esteem after donation and if changes in self-esteem were associated with changes in symptoms of depression and anxiety. RESULTS:Nearly all donors (98.6%) reported normal-to-high self-esteem before donating (928/941), and only 2-4% had low self-esteem in follow-up (RSES scores <15). On average, donors had a less than 1-point decrement in average self-esteem between pre-donation and follow-up measurements; while these changes were statistically significant, they were not clinically meaningful (all mean changes <5). Donors with RSES scores ≤20 before donation had an approximate 2-point increase in self-esteem in follow-up (P <0.001). More symptoms of depression before donation were associated with lower self-esteem scores 3 months after donation (P = 0.006). An increase in self-esteem scores after donation was associated with concurrent reductions in symptoms of depression and anxiety (P <0.001). LIMITATIONS:We did not examine the association of early recipient allograft failure or death with donor self-esteem. CONCLUSIONS:In this multicenter study of living kidney donors, nearly all donors reported normal-to-high self-esteem before donation and during five years of follow-up. On average, donors with lower self-esteem before donation had a modest increase in self-esteem after donation. Increases in self-esteem after donation were accompanied by modest reductions in symptoms of depression and anxiety.

OBJECTIVES:In a survey of patients with end stage kidney disease treated (ESKD), improvement in sleep was one of the most desired outcomes of an exercise program. In participants with ESKD enrolled in an exercise study, our objectives included: 1) assess sleep quality using objective and subjective measures, 2) determine variables associated with poor sleep and 3) determine correlation between the objective and subjective measures. METHODS:In this cross-sectional study, adult patients with ESKD at 4 academic Canadian hospitals completed objective and subjective sleep using 2 weeks of Fitbit data and the Pittsburgh Sleep Quality Index (PSQI) respectively. Poor sleep was defined as: 1) total sleep <360 min or sleep efficiency <80% with the Fitbit or 2) PSQI >5. Percentage of participants with poor sleep was calculated; variables associated with poor sleep were determined using logistic regression. Correlations between the Fitbit and PSQI for select variables was determined using Pearson correlation coefficients. RESULTS:Ninety-one of 131 patients screened were included in the final analysis. Participants had a mean age of 62.0 (±13.4) years, 48% female. Sixty-eight percent and 66% of the population were considered poor sleepers by Fitbit and PSQI respectively. Male sex was associated with poor sleep with the Fitbit; BMI was associated with poor sleep by PSQI. The correlation between sleep efficiency and hours of true sleep from the Fitbit and PSQI was 0.06 (p = 0.61) and 0.44 (p < 0.0001) respectively. CONCLUSION:Most patients with ESKD experienced poor sleep. Consistent with other populations, the objective and subjective measures of sleep were weakly correlated suggesting instrument choice should align with the specific outcome of interest. Further research is required in the ESKD population is required.

Rationale & objective: Patients on hemodialysis using a central venous catheter (CVC) are often advised not to shower due to infection risk. This study assessed practices and attitudes of patients and health care providers about showering with CVCs. Study design: Survey study. Setting & participants: Online survey administered to members of the Canadian Society of Nephrology (CSN, n=972) and 2 international professional societies (convenience sample). Pen and paper survey administered to patients on maintenance hemodialysis with CVCs able to comprehend English from 2 hemodialysis programs in Ontario, Canada, that advise patients not to shower (St. Joseph's Healthcare Hamilton [SJHH], n=119, and University Health Network, Toronto [number of patients asked to complete surveys unavailable]). Analytical approach: Descriptive statistics. Results: The survey had 304 health care provider respondents (CSN response rate 26%). The most common recommendations were strongly against or against showering (45%). Catheter-related bacteremia (CRB) was ranked as the most important outcome (60%). Most respondents (53%) thought that a well-conducted prospective cohort study demonstrating improvement in a patient-reported outcome with no obvious increase in CRB would reduce the frequency of advice to avoid showering. The survey had 89 patient respondents (SJHH response rate 45%); 69% were currently showering, and 74% reported "strongly agree" or "agree" to the statement "I want to shower." Prevention of infection was most important to patients in terms of catheter care (78%), and 36% of patients would be willing to participate in a shower study. Limitations: Low response rate, response rate unavailable from Toronto dialysis units, and exclusion of non-English-speaking patients. Conclusions: The variability in personal hygiene recommendations to patients with CVCs highlights the need for high-quality evidence in this area. A rigorous prospective study examining patient-reported outcomes and CVC-related infections is needed before recommending to patients with a CVC that showering is safe.

RATIONALE & OBJECTIVE:A key target of the Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 vascular access guidelines is to have ≤3 percutaneous or surgical interventions per year to maintain arteriovenous fistula (AVF) patency. We hypothesized that the number of interventions to maintain long-term AVF patency as conducted in a rigorous clinical trial could be adequately documented and compared against KDOQI targets and that the use of drug-coated balloons (DCB) could reduce the rate of thrombosis and interventions to maintain AVF patency more than the standard percutaneous transluminal angioplasty (PTA) with an uncoated balloon. STUDY DESIGN:Post-hoc analysis of the IN.PACT AV Access randomized clinical trial. SETTING & PARTICIPANTS:Outpatient adult hemodialysis patients with previously matured AVFs that had de novo or nonstented restenotic lesions enrolled between April 2017 and May 2018 in the United States, Japan, and New Zealand. EXPOSURE:Patients were randomized to receive PTA with the IN.PACT AV DCB or a standard balloon. OUTCOME:Rate of interventions to maintain access target lesion and access circuit patency and rate of access circuit thrombosis were calculated in both intervention groups and compared against the KDOQI 2019 guideline targets. RESULTS:Of the 330 participants randomized, 133 patients completed their 3-year visits. The number of interventions per AVF-year to maintain access circuit patency through 36 months was 1.39 for the DCB group and 1.66 for the standard PTA group (rate difference, -0.28 [95% CI, -0.47 to -0.08], P = 0.01). The access circuit thrombosis rate was 0.041 in the DCB group and 0.069 in the standard PTA group (rate difference, -0.028 [95% CI, -0.065 to 0.0082], P = 0.1). LIMITATIONS:Exclusion of AVF with prior thrombosis and small sample size at 36 months. CONCLUSIONS:Both DCB and standard PTA groups met the KDOQI targets of ≤3 percutaneous or surgical interventions per year to maintain AVF patency. The need for reinterventions to maintain patency and thrombosis rate was reduced with the use of DCB compared with standard PTA through 36 months.

Tunneled hemodialysis (HD) central venous catheter (CVC) use is often complicated by CVC dysfunction, typically due to intraluminal or extraluminal thrombus or fibrin sheath formation which interferes with blood flow through the CVC lumen. Interdialytic CVC “locking” with heparin or citrate of various concentrations is commonly used as prophylaxis. Despite this, CVC dysfunction remains common, often requiring repeated installations of thrombolytic agent (r-TPA), CVC exchange or fibrin sheath disruption to manage CVC dysfunction. KiteLock™ (EDTA 4%), is a new CVC locking solution that has anticoagulant and anti-infective properties. We compared the rates of r-TPA use and CVC exchange in patients at high risk of CVC dysfunction who received CVC locking with citrate 4% (Period I) and KiteLock (Period II). This was a prospective cohort study of long-term HD patients (3x/week for 4hours/treatment) in a large academic incentre dialysis facility who required tunneled CVC and deemed at high risk of CVC dysfunction. High risk CVC patients were defined as those who required 3 or more installations of TPA in a 14 day period despite use of citrate 4% lock. Patients’ CVCs were locked with citrate 4% from Dec 19 2022 to Dec 18 2023 (Period I). From January 1 2024 to June 30 2024 (Period II), high risk patients were locked with KiteLock (EDTA 4%). The CVC locking procedure was the same for both citrate 4% and KiteLock (EDTA 4%) solutions, with the venous and arterial ports filled to their volume with the respective locking solutions. In both study periods, patients were followed weekly to capture r-TPA use and CVC exchange (ordered at the discretion of attending nephrologist) and CVC-related bacteremia events (determined by a separate infection control committee). Data was cross checked via nursing flowsheets, and reports in the electronic medical records (EPIC). In the study period, 496 patients used tunnelled CVCs, 106 patients received r-TPA, and 39 patients were deemed high risk. In Period I there were 5021 CVC days and in Period II there were 3768 CVC days. Figure 1 illustrates the rates of r-TPA use and CVC exchanges (in high risk patients) and CVC-related bacteremia (for all patients) in the two study periods. In patients at high risk of CVC dysfunction, compared to CVC locked with citrate, those locked with KiteLock showed: 33% reduction in r-TPA use per 1000 CVC days. 11% reduction in the rate of CVC exchange per 1000 CVC days. This prospective cohort study showed that patients at high risk of CVC dysfunction had a lower rate of r-TPA use and CVC exchange when their CVC were locked with KiteLock (EDTA 4%) compared with citrate 4%. Further study is required in a rigorously conducted clinical trial.

RATIONALE & OBJECTIVE:Female patients treated with dialysis experience poorer health outcomes compared with male patients, but few studies have examined sex differences in all-cause and cause-specific death after return to dialysis after failure of a kidney allograft. This study examined the association between sex and mortality after kidney allograft loss. STUDY DESIGN:Retrospective cohort study. SETTING & PARTICIPANTS:Patients in Australia and New Zealand represented in the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA), who returned to dialysis after loss of their first kidney allograft between 2000 and 2020. EXPOSURE:Sex. OUTCOME:All-cause and cause-specific mortality on dialysis through 2020. ANALYTICAL APPROACH:Flexible parametric survival models that integrated restricted cubic splines to examine the association between sex and mortality after kidney allograft loss. Models included sex by follow-up time interaction to examine whether these associations change over time. Follow-up was censored at the time of repeat transplantation. RESULTS:Of 4,135 patients who lost their first kidney allografts, 1,576 were female (38%). During a median follow-up of 2.7 (IQR, 1.1-5.4) years, 1,476 patients (36%) died on dialysis. Cardiovascular disease (CVD) and dialysis withdrawal were the most common causes of death. Compared with female patients, male patients were less likely to die early after allograft loss, with adjusted HR at 1 year after allograft loss for all-cause mortality of 0.84 (95% CI, 0.70-0.99). The reduced risk of death was attributed to infection and dialysis withdrawal, with adjusted HRs at 1 year after allograft loss of 0.58 (95% CI, 0.35-0.96) and 0.68 (95% CI, 0.47-0.99), respectively. However, we did not observe any significant sex-based differences in all-cause or cause-specific mortality beyond 1 year after allograft loss. LIMITATIONS:Observational study, residual and unmeasured confounding factors. CONCLUSIONS:After kidney allograft loss, female patients experienced a higher initial mortality risk compared with male patients, attributed to early deaths from infection and dialysis withdrawal. PLAIN-LANGUAGE SUMMARY:Sex and gender are known to impact the risk of health outcomes in dialysis patients. In this study, we examined the relationship between sex differences and mortality after the failure of a kidney transplant that necessitated a return to maintenance dialysis. The study examined registry data from 4,135 patients in Australia and New Zealand who returned to dialysis after their first kidney transplant failed between 2000 and 2020. Compared with female patients, male patients were less likely to die early after allograft loss. The reduced risk of death was attributed to infection and dialysis withdrawal. We did not observe any significant sex-based differences in all-cause and cause-specific mortality beyond 1 year after allograft loss.

Background:Some men who donate a kidney have reported testicular pain after donation; however, attribution to donation is not clear as no prior studies included a comparison group of nondonors. Objective:To examine the proportion of male donors who reported testicular pain in the years after nephrectomy compared to male nondonors with similar baseline health characteristics. Design Participants and Setting:We enrolled 1042 living kidney donors (351 male) before nephrectomy from 17 transplant centers (12 in Canada and 5 in Australia) from 2004 to 2014. A concurrent sample of 396 nondonors (126 male) was enrolled. Follow-up occurred until November 2021. Measurements:Donors and nondonors completed the same schedule of measurements at baseline (before nephrectomy) and follow-up. During follow-up, participants completed a questionnaire asking whether they had experienced new pain in their eyes, hands, or testicles; those who experienced pain were asked to indicate on which side of the body the pain occurred (left or right). The pain questionnaire was completed by 290 of 351 male donors (83%) and 97 of 126 male nondonors (77%) a median of 3 years after baseline (interquartile range = 2-6). Methods:Inverse probability of treatment weighting on a propensity score was used to balance donors and nondonors on baseline characteristics. After weighting, the nondonor sample increased to a pseudo sample of 295, and most baseline characteristics were similar between donors and nondonors. Results:At baseline, donors (n = 290) were a mean age of 49 years; 83% were employed, and 80% were married; 246 (84.8%) underwent laparoscopic surgery and 44 (15.2%) open surgery; 253 (87.2%) had a left-sided nephrectomy and 37 (12.8%) a right-sided nephrectomy. In the weighted analysis, the risk of testicular pain was significantly greater among donors than nondonors: 51/290 (17.6%) vs 7/295 (2.3%); weighted risk ratio, 7.8 (95% confidence interval [CI] = 2.7 to 22.8). Donors and nondonors did not differ statistically in terms of self-reported eye pain or hand pain. Among donors, the occurrence of testicular pain was most often unilateral (92.2%) and on the same side as the nephrectomy (90.2%). Testicular pain occurred more often in donors who had laparoscopic vs open surgery: 48/246 (19.5%) vs 3/44 (6.8%) but was similar in those who had a left-sided vs right-sided nephrectomy: 44/253 (17.4%) vs 7/37 (18.9%). Limitations:Participants recalled their symptoms several years after baseline, and we did not assess the timing, severity, or duration of pain or any treatments received for the pain. Conclusion:Unilateral testicular pain on the same side of a nephrectomy is a potential complication of living kidney donation that warrants further investigation.

Background:Patients receiving haemodialysis via a central venous catheter (HD-CVC) have been shown to have an increased risk of all-cause mortality. It is unclear whether death from dialysis withdrawal is associated with the high mortality risk observed in patients initiated on HD-CVC. Methods:Using the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, we examined the association between initial dialysis access [HD-CVC, haemodialysis via arteriovenous fistula (HD-AVF), and peritoneal dialysis (PD) via PD catheter (PD-PDC)] and death from dialysis withdrawal in adult patients starting dialysis in Australia between 2005 and 2022, analysed by time-stratified adjusted Cox regression with propensity score-matched cohorts. Results:Of 47 412 incident patients followed for a median of 2.65 years (interquartile range 1.19-4.87), 8170 (17%) died from dialysis withdrawal. Compared with patients initiated on HD-AVF, patients initiated on HD-CVC were more likely to experience death from dialysis withdrawal in the first 3 years after dialysis initiation, but not after 3 years [adjusted hazard ratios 2.43 (95% confidence interval 1.95-3.02), 2.06 (1.67-2.53), 1.57 (1.40-1.76), and 1.06 (0.97-1.15) for 0-6 months, >6-12 months, >1-3 years, and >3 years after dialysis initiation, respectively]. Comparison between patients initiated on HD-CVD and PD-PDC showed similar estimates. No difference in withdrawal risk was observed between patients initiated on HD-AVF and PD-PDC. Conclusions:Patients initiated on HD-CVC were twice as likely to experience early death from dialysis withdrawal compared with patients who had initiated dialysis with HD-AVF or PD-PDC. The increased risks diminished over time and were not observed after 3 years on dialysis.

INTRODUCTION:Home dialysis modalities offer several clinical and economic benefits compared to facility-based dialysis treatment in patients with kidney failure. Studies have shown that sex and socioeconomic status (SES) disparities exist in access to dialysis and transplantation in patients with kidney failure, but whether similar disparities occur in access to home dialysis after kidney transplant failure is unknown. METHODS:Using data from the ANZDATA registry, patients who commenced dialysis after kidney transplant failure in Australia were included (2000-2020). The associations between sex and uptake of peritoneal dialysis (PD) and home hemodialysis (HHD) at 12 months after kidney transplant failure were examined using adjusted logistic regression, with interactive effect between sex and SES evaluated. RESULTS:Of 3,521 patients who experienced first kidney transplant failure, 1,352 (38%) were females. At 12 months following transplant failure, 483 (14%) were maintained on PD and 425 (12%) on HHD. Compared to females, males were less likely to select PD at 12 months after transplant failure, with an adjusted OR (95% CI) of 0.55 (0.44-0.68). The adjusted OR (95% CI) for the uptake of HHD at 12 months in males was 1.66 (1.29-2.12). There were significant interactions between sex and SES for the 12-month uptake of PD and HHD, such that for patients from socioeconomically disadvantaged areas, the respective adjusted ORs for the uptake of PD and HHD in male patients were 0.61 (0.45-0.84) and 2.25 (1.51-3.51) compared to female patients. CONCLUSION:Males who lost their kidney allografts were more likely to choose HHD over PD compared to female patients. This sex disparity was more pronounced in individuals from socioeconomically disadvantaged areas.

Expansion of home hemodialysis (HHD) provides an opportunity to improve clinical outcomes, reduce cost of care, and address the staffing challenges currently faced in caring for patients with kidney failure on replacement therapy. To increase HHD expansion, current practices and barriers to home dialysis must be examined and addressed. One such barrier is vascular access for HHD; although tunneled hemodialysis central venous catheters (CVCs) have been used for decades, physicians still hesitate to send patients home without a mature, functional arteriovenous access. An expert panel of clinicians was convened by Outset Medical, a manufacturer of hemodialysis systems, to review the literature and generate consensus recommendations regarding the use of CVCs for HHD. Consistent with the most recent Kidney Disease Outcomes vascular access guidelines, the end-stage kidney disease life plan should be created via shared decision making for modality choices, with the corresponding dialysis access individualized for the patient, and for whom a CVC may represent the most appropriate vascular access to provide HHD.

The majority of patients with kidney failure requiring replacement therapy will need the support of hemodialysis during their journey with kidney failure. A reliable functioning vascular access is required to provide hemodialysis. This Core Curriculum reviews the major forms of vascular access (arteriovenous fistula, arteriovenous graft, and central venous catheter) as well as the planning, preparation, creation, use, and maintenance of vascular access, requiring a P-L-A-N (Patient ESKD Life-Plan first then Access Needs) for each patient. The end-stage kidney disease Patient Life-Plan focuses on a strategy for kidney replacement modalities, while the Access Needs are the corresponding dialysis access(es) and management plans. The Access Needs include a vessel preservation plan, creation plan, contingency (complications) plan, and access succession plan. Stenosis and thrombosis are common problems with arteriovenous accesses, and dysfunction and infection are common problems with central venous catheters. Underrecognized and underreported but potentially life-threatening situations include arteriovenous access rupture and high-output cardiac failure. Effective management of these and other vascular access problems requires a coordinated multidisciplinary effort that is patient centered while preserving vascular access.

Millions of patients with kidney failure rely on hemodialysis central venous catheters (CVCs) for their life-sustaining dialysis treatments. CVC dysfunction necessitates removal of up to 20% of CVCs and is an important problem for patients with kidney failure. Thrombosis and fibrin sheath formation are the most common mechanisms of CVC dysfunction beyond the first week after insertion. Factors such as female sex, left-sided CVC placement, and prior CVC dysfunction are associated with a higher risk of dysfunction. Patient-specific factors contribute substantially to variation in the number of CVC dysfunction events. Weekly thrombolytic locks have been shown to improve CVC blood flow rates, prevent infection, and reduce dysfunction requiring removal. However, routine administration may not be cost-effective in hemodialysis units with low infection rates, and targeted use among patients with established CVC dysfunction has not been studied. Concentrated heparin lock ( e.g ., 5000 versus 1000 international unit/ml) has been associated with lower requirements for therapeutic CVC thrombolysis but greater systemic bleeding risks and costs. Citrate 4% was noninferior to standard heparin locks to prevent thrombosis, may cause less bleeding, and is less costly in some countries. Tunneled CVCs with a symmetrical tip have been associated with a lower risk of CVC dysfunction compared with those with a step tip. Multifaceted CVC care interventions can reduce the incidence of dysfunctional CVCs by 33% compared with usual care. Future research to identify patients at high risk of CVC dysfunction will inform individualized vascular access plans, targeted use of preventive strategies, and enrollment criteria for future clinical trials.

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.

A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. VALID (Vascular Access outcome measure for function: a vaLidation study In hemoDialysis) aimed to validate a core outcome measure for VA function established via consensus among 918 health professionals and 237 patients and caregivers from 58 different countries.

Key Points Is performing a large definitive trial to establish the optimal anticoagulation strategy in dialysis recipients with atrial fibrillation feasible?One hundred fifty-one patients at 28 dialysis centers were enrolled and randomized to apixaban (n=51), warfarin (n=52), or no oral anticoagulation (n=48).Despite coronavirus disease–related pauses, recruitment was completed in 30 months, with 83% of participants completing follow-up in their assigned treatment arm. Background Atrial fibrillation is common in individuals receiving dialysis. The role of oral anticoagulation in this population is uncertain given its exclusion from previous seminal clinical trials. Our objective was to determine the feasibility of performing a large definitive trial to establish the optimal anticoagulation strategy in individuals with atrial fibrillation receiving dialysis. Methods The Strategies for the Management of Atrial Fibrillation in Patients Receiving Dialysis trial was a parallel-group, open-label, allocation-concealed, pilot randomized control trial that took place at 28 centers in Canada and Australia. The trial included adults (18 years or older) undergoing dialysis with a history of nonvalvular atrial fibrillation who met the CHADS-65 criteria. Participants were randomized 1:1:1 to receive dose-adjusted warfarin, apixaban 5 mg twice daily, or no oral anticoagulation and followed for 26 weeks. The primary outcomes evaluated the following measures of feasibility: (1) recruitment of the target population within 2 years from the start of the trial and (2) adherence of >80% of randomized patients to the allocated treatment strategy at the conclusion of follow-up. Secondary outcomes included stroke and bleeding. Results From December 2019 to June 2022, 151 patients were enrolled and randomized to apixaban (n=51), warfarin (n=52), or no oral anticoagulation (n=48). Allowing for pauses related to the coronavirus disease pandemic, recruitment was completed in 30 months, and 123 (83%) of participants completed follow-up in their allocated treatment arm. There was one adjudicated stroke event. Eight participants had a major bleeding event (four warfarin, two apixaban, two no oral anticoagulation). Death occurred in 15 participants (nine warfarin, two apixaban, four no oral anticoagulation). Time in the therapeutic range for warfarin recipients was 58% (interquartile range, 47%–70%). Conclusions We have demonstrated the feasibility of recruitment and adherence in a trial that compared different anticoagulation strategies in patients with atrial fibrillation receiving dialysis. Clinical Trial registry name and registration number: Strategies for the Management of Atrial Fibrillation in Patients Receiving Dialysis (SAFE-D), NCT03987711.

Introduction Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis.Methods and analysis This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach.Ethics and dissemination Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings.Protocol version 4 (16 November 2022).Trial registration number NCT05515991.

Background Atrial fibrillation is common in individuals receiving dialysis. The role of oral anticoagulation in this population is uncertain given its exclusion from previous seminal clinical trials. Our objective was to determine the feasibility of performing a large definitive trial to establish the optimal anticoagulation strategy in individuals with atrial fibrillation receiving dialysis. Methods The Strategies for the Management of Atrial Fibrillation in Patients Receiving Dialysis trial was a parallel-group, open-label, allocation-concealed, pilot randomized control trial that took place at 28 centers in Canada and Australia. The trial included adults (18 years or older) undergoing dialysis with a history of nonvalvular atrial fibrillation who met the CHADS-65 criteria. Participants were randomized 1:1:1 to receive dose-adjusted warfarin, apixaban 5 mg twice daily, or no oral anticoagulation and followed for 26 weeks. The primary outcomes evaluated the following measures of feasibility: (1) recruitment of the target population within 2 years from the start of the trial and (2) adherence of >80% of randomized patients to the allocated treatment strategy at the conclusion of follow-up. Secondary outcomes included stroke and bleeding. Results From December 2019 to June 2022, 151 patients were enrolled and randomized to apixaban (n=51), warfarin (n=52), or no oral anticoagulation (n=48). Allowing for pauses related to the coronavirus disease pandemic, recruitment was completed in 30 months, and 123 (83%) of participants completed follow-up in their allocated treatment arm. There was one adjudicated stroke event. Eight participants had a major bleeding event (four warfarin, two apixaban, two no oral anticoagulation). Death occurred in 15 participants (nine warfarin, two apixaban, four no oral anticoagulation). Time in the therapeutic range for warfarin recipients was 58% (interquartile range, 47%-70%). Conclusions We have demonstrated the feasibility of recruitment and adherence in a trial that compared different anticoagulation strategies in patients with atrial fibrillation receiving dialysis.

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.

BACKGROUND:Thrombolysis for arteriovenous grafts (AVG) yields high technical success rates, however, long-term outcomes are unclear. We conducted a multicenter retrospective cohort study to analyze 5-year patency rates following AVG thrombolysis.METHODS:All patients who underwent AVG thrombolysis between 2005 and 2015 at three academic hospitals were included. Prospectively maintained institutional nephrology and radiology databases were used to record demographic, clinical, and AVG characteristics. The primary outcome was primary patency, defined as AVG access survival without re-intervention including angioplasty ± stent with/without re-thrombolysis. Secondary outcomes were assisted primary patency and cumulative patency, defined as AVG access survival until re-thrombosis requiring re-thrombolysis or abandonment, respectively. Technical success was defined as restoration of flow with <30% residual stenosis. Patients were followed until 2017. Patency rates were assessed using Kaplan-Meier survival analysis and Cox proportional hazards were calculated to determine associations between covariates and patency loss.RESULTS:Seventy-four patients underwent AVG thrombolysis during the study period with a median follow-up period of 21.4 (IQR 8.3-42.8) months. The average age was 58.6 years with a high rate of comorbidities, including hypertension (82.4%) and diabetes (54.1%). Thrombolysis technical success was 96%. There were 147 re-interventions in 46 patients, of which 98 were re-thrombolysis (mean re-intervention rate of 1.27/patient/year). Primary patency at 1, 3, and 5 years were 43.2%, 20.2%, and 7.7%. Assisted primary patency at 1, 3, and 5 years were 47.5%, 20.2%, and 7.7%. Cumulative patency at 1, 3, and 5 years were 75.0%, 38.8%, and 22.6%. Cox proportional hazards analysis demonstrated no associations between demographic, clinical, and procedural characteristics and patency rates.CONCLUSIONS:Despite a high technical success rate, thrombolysis for AVG dysfunction is associated with poor long-term patency. Future studies are needed to determine risk factors for re-thrombosis to identify patients who will benefit from AVG thrombolysis in the long-term.