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Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review

Viecelli AK, O'Lone E, Sautenet B, Craig JC, Tong A, Chemla E, et al.

Am J Kidney Dis, 2018 03;71(3):382-391.
PMID: 29203125 DOI: 10.1053/j.ajkd.2017.09.018

BACKGROUND: Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials.
STUDY DESIGN: Systematic review.
SETTING & POPULATION: Adults requiring maintenance hemodialysis.
SELECTION CRITERIA: All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016.
INTERVENTIONS: Any hemodialysis-related intervention.
OUTCOMES: The frequency and characteristics of vascular access outcome measures were analyzed and classified.
RESULTS: From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions.
LIMITATIONS: Restricted sampling frame for feasibility and focus on contemporary trials.
CONCLUSIONS: The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis.
Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop on Establishing a Core Outcome Measure for Hemodialysis Vascular Access

Viecelli AK, Tong A, O'Lone E, Ju A, Hanson CS, Sautenet B, et al.

Am J Kidney Dis, 2018 05;71(5):690-700.
PMID: 29478866 DOI: 10.1053/j.ajkd.2017.12.003

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.
Aetiology, practice patterns and burden of end-stage kidney disease in South Asia and South-East Asia: A questionnaire-based survey

Sahay M, Jasuja S, Tang SCW, Alexander S, Jha V, Vachharajani T, et al.

Nephrology (Carlton), 2021 Feb;26(2):142-152.
PMID: 33169890 DOI: 10.1111/nep.13825

AIM: There is paucity of data on the epidemiology of end-stage kidney disease (ESKD) from South Asia and South-East Asia. The objective of this study was to assess the aetiology, practice patterns and disease burden and growth of ESKD in the region comparing the economies.
METHODS: The national nephrology societies of the region; responded to the questionnaire; based on latest registries, acceptable community-based studies and society perceptions. The countries in the region were classified into Group 1 (High|higher-middle-income) and Group 2 (lower|lowermiddle income). Student t-test, Mann-Whitney U test and Fisher's exact test were used for comparison.
RESULTS: Fifteen countries provided the data. The average incidence of ESKD was estimated at 226.7 per million population (pmp), (Group 1 vs. Group 2, 305.8 vs. 167.8 pmp) and average prevalence at 940.8 pmp (Group 1 vs. Group 2, 1306 vs. 321 pmp). Group 1 countries had a higher incidence and prevalence of ESKD. Diabetes, hypertension and chronic glomerulonephritis were most common causes. The mean age in Group 2 was lower by a decade (Group 1 vs. Group 2-59.45 vs 47.7 years).
CONCLUSION: Haemodialysis was the most common kidney replacement therapy in both groups and conservative management of ESKD was the second commonest available treatment option within Group 2. The disease burden was expected to grow >20% in 50% of Group 1 countries and 78% of Group 2 countries along with the parallel growth in haemodialysis and peritoneal dialysis.
Interventional nephrology and vascular access practice: A perspective from South and Southeast Asia

Ramachandran R, Bhargava V, Jasuja S, Gallieni M, Jha V, Sahay M, et al.

J Vasc Access, 2021 05 03.
PMID: 33934667 DOI: 10.1177/11297298211011375

South and Southeast Asia is the most populated, heterogeneous part of the world. The Association of Vascular Access and InTerventionAl Renal physicians (AVATAR Foundation), India, gathered trends on epidemiology and Interventional Nephrology (IN) for this region. The countries were divided as upper-middle- and higher-income countries as Group-1 and lower and lower-middle-income countries as Group-2. Forty-three percent and 70% patients in the Group 1 and 2 countries had unplanned hemodialysis (HD) initiation. Among the incident HD patients, the dominant Vascular Access (VA) was non-tunneled central catheter (non-TCC) in 70% of Group 2 and tunneled central catheter (TCC) in 32.5% in Group 1 countries. Arterio-Venous Fistula (AVF) in the incident HD patients was observed in 24.5% and 35% of patients in Group-2 and Group-1, respectively. Eight percent and 68.7% of the prevalent HD patients in Group-2 and Group-1 received HD through an AVF respectively. Nephrologists performing any IN procedure were 90% and 60% in Group-2 and Group 1, respectively. The common procedures performed by nephrologists include renal biopsy (93.3%), peritoneal dialysis (PD) catheter insertion (80%), TCC (66.7%) and non-TCC (100%). Constraints for IN include lack of time (73.3%), lack of back-up (40%), lack of training (73.3%), economic issues (33.3%), medico-legal problems (46.6%), no incentive (20%), other interests (46.6%) and institution not supportive (26%). Routine VA surveillance is performed in 12.5% and 83.3% of Group-2 and Group-1, respectively. To conclude, non-TCC and TCC are the most common vascular access in incident HD patients in Group-2 and Group-1, respectively. Lack of training, back-up support and economic constraints were main constraints for IN growth in Group-2 countries.
Fulltext Developing the ethical framework of end-stage kidney disease care: from practice to policy

Luyckx VA, Martin DE, Moosa MR, Bello AK, Bellorin-Font E, Chan TM, et al.

Kidney Int Suppl (2011), 2020 Mar;10(1):e72-e77.
PMID: 32149011 DOI: 10.1016/j.kisu.2019.11.003

Ethical issues relating to end-stage kidney disease (ESKD) care are increasingly being discussed by clinicians and ethicists but are still infrequently considered at a policy level or in the education and training of health care professionals. In most lower-income countries, access to kidney replacement therapies such as dialysis is not universal, leading to overt or implicit rationing of resources and potential exclusion from care of those who are unable to sustain out-of-pocket payments. These circumstances create significant inequities in access to ESKD care within and between countries and impose emotional and moral burdens on patients, families, and health care workers involved in decision-making and provision of care. End-of-life decision-making in the context of ESKD care in all countries may also create ethical dilemmas for policy makers, professionals, patients, and their families. This review outlines several ethical implications of the complex challenges that arise in the management of ESKD care around the world. We argue that more work is required to develop the ethics of ESKD care, so as to provide ethical guidance in decision-making and education and training for professionals that will support ethical practice in delivery of ESKD care. We briefly review steps that may be required to accomplish this goal, discussing potential barriers and strategies for success.
Fulltext Impact of National Economy and Policies on End-Stage Kidney Care in South Asia and Southeast Asia

Alexander S, Jasuja S, Gallieni M, Sahay M, Rana DS, Jha V, et al.

Int J Nephrol, 2021;2021:6665901.
PMID: 34035962 DOI: 10.1155/2021/6665901

Background: The association between economic status and kidney disease is incompletely explored even in countries with higher economy (HE); the situation is complex in lower economies (LE) of South Asia and Southeast Asia (SA and SEA).
Methods: Fifteen countries of SA and SEA categorized as HE and LE, represented by the representatives of the national nephrology societies, participated in this questionnaire and interview-based assessment of the impact of economic status on renal care.
Results: Average incidence and prevalence of end-stage kidney disease (ESKD) per million population (pmp) are 1.8 times and 3.3 times higher in HE. Hemodialysis is the main renal replacement therapy (RRT) (HE-68%, LE-63%). Funding of dialysis in HE is mainly by state (65%) or insurance bodies (30%); out of pocket expenses (OOPE) are high in LE (41%). Highest cost for hemodialysis is in Brunei and Singapore, and lowest in Myanmar and Nepal. Median number of dialysis machines/1000 ESKD population is 110 in HE and 53 in LE. Average number of machines/dialysis units in HE is 2.7 times higher than LE. The HE countries have 9 times more dialysis centers pmp (median HE-17, LE-02) and 16 times more nephrologist density (median HE-14.8 ppm, LE-0.94 ppm). Dialysis sessions >2/week is frequently followed in HE (84%) and <2/week in LE (64%). "On-demand" hemodialysis (<2 sessions/week) is prevalent in LE. Hemodialysis dropout rates at one year are lower in HE (12.3%; LE 53.4%), death being the major cause (HE-93.6%; LE-43.8%); renal transplants constitute 4% (Brunei) to 39% (Hong Kong) of the RRT in HE. ESKD burden is expected to increase >10% in all the HE countries except Taiwan, 10%-20% in the majority of LE countries.
Conclusion: Economic disparity in SA and SEA is reflected by poor dialysis infrastructure and penetration, inadequate manpower, higher OOPE, higher dialysis dropout rates, and lesser renal transplantations in LE countries. Utility of RRT can be improved by state funding and better insurance coverage.
Peritoneal dialysis: Status report in South and South East Asia

Bhargava V, Jasuja S, Tang SC, Bhalla AK, Sagar G, Jha V, et al.

Nephrology (Carlton), 2021 Nov;26(11):898-906.
PMID: 34313370 DOI: 10.1111/nep.13949

BACKGROUND: Peritoneal dialysis (PD) as a modality of kidney replacement therapy (KRT) is largely underutilized globally. We analyzed PD utilization, impact of economic status, projected growth and impact of state policy(s) on PD growth in South Asia and Southeast Asia (SA&SEA) region.
METHODS: The National Nephrology Societies of the region responded to a questionnaire on KRT practices. The responses were based on the latest registry data, acceptable community-based studies and societal perceptions. The representative countries were divided into high income and higher-middle income (HI & HMI) and low income and lower-middle income (LI & LMI) groups.
RESULTS: Data provided by 15 countries showed almost similar percentage of GDP as health expenditure (4%-7%). But there was a significant difference in per capita income (HI & HMI -US$ 28 129 vs. LI & LMI - US$ 1710.2) between the groups. Even after having no significant difference in monthly cost of haemodialysis (HD) and PD in LI & LMI countries, they have poorer PD utilization as compared to HI & HMI countries (3.4% vs. 10.1%); the reason being lack of formal training/incentives and time constraints for the nephrologist while lack of reimbursement and poor general awareness of modalities has been a snag for the patients. The region expects ≥10% PD growth in the near future. Hong Kong and Thailand with 'PD first' policy have the highest PD utilization.
CONCLUSION: Important deterrents to PD underutilization were lack of PD centric policies, lackadaisical patient/physician's attitude, lack of structured patient awareness programs, formal training programs and affordability.
Practice of dialysis access interventional nephrology procedures in the Asia-Pacific region: Getting lay of the land

Jasuja S, Gallieni M, Jha V, Vachharajani T, Bhalla AK, Tan J, et al.

Nephrology (Carlton), 2023 Dec;28(12):672-681.
PMID: 37697492 DOI: 10.1111/nep.14236

AIM: This cross-sectional survey aimed to determine the prevalence of Interventional Nephrology (IN) practice amongst nephrologists in the Asia-Pacific Region (APR), specifically related to dialysis access (DA).
METHODS: The Association of VA and intervenTionAl Renal physicians (AVATAR) Foundation from India conducted a multinational online survey amongst nephrologists from the Asia-Pacific to determine the practice of IN in the planning, creation, and management of dialysis access. The treatment modalities, manpower and equipment availability, monthly cost of treatment, specifics of dialysis access interventions, and challenges in the training and practice of IN by nephrologists were included in the survey.
RESULTS: Twenty-one countries from the APR participated in the survey. Nephrologists from 18 (85.7%) countries reported performing at least one of the basic dialysis access-related IN procedures, primarily the placement of non-tunnelled central catheters (n-TCC; 71.5%). Only 10 countries (47.6%) reported having an average of <4% of nephrologists performing any of the advanced IN access procedures, the most common being the placement of a peritoneal dialysis (PD) catheter (20%). Lack of formal training (57.14%), time (42.8%), incentive (38%), institutional support (38%), medico-legal protection (28.6%), and prohibitive cost (23.8%) were the main challenges to practice IN. The primary obstacles to implementing the IN training were a lack of funding and skilled personnel.
CONCLUSION: The practice of dialysis access-related IN in APR is inadequate, mostly due to a lack of training, backup support, and economic constraints, whereas training in access-related IN is constrained by a lack of a skilled workforce and finances.