Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

BACKGROUND: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. METHOD: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. RESULTS: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. CONCLUSION: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.

Incidental appendicectomy in pancreas transplantation: A single-center study.

BACKGROUND: Appendicitis in pancreatic transplant recipients can be challenging to diagnose and manage. Incidental appendicectomy (IA) during pancreas transplantation obviates the risk of appendicitis but potentially at the cost of increased operating time or early post-operative complications. This study reviewed the value of IA at a single center. METHODS: This was a retrospective study of patients who underwent a pancreas transplant in our unit from January 1st, 2012 to December 31st, 2020, with end of follow-up on May 21st, 2023; recipients were grouped by whether or not an IA was performed during pancreas transplantation. Donor, recipient, operative, and graft outcomes were compared between the two groups. Post-transplant complications related to appendiceal pathology (or IA) were recorded and classified. RESULTS: Two hundred forty-three patients underwent a pancreas transplant; 227 (93%) patients had an appendix in situ at transplantation, and of these 53 (23%) underwent an IA and 174 (77%) did not. There were no statistically significant differences in operative time (p = .06) or hospital stay (p = .50) between the two groups. In the IA cohort, there were no Clavien-Dindo Grade III-V complications relating to the appendicectomy. In those that did not undergo an IA, two patients (1%) subsequently required appendicectomy due to appendicitis. Comparison of pancreatic graft survival showed no statistically significant difference between the groups (p = .44). CONCLUSIONS: This study suggests that IA is effective at reducing risks of post-transplant appendiceal complications without significantly prolonging inpatient stay or impairing graft survival. These data support the consideration of undertaking an IA for all patients undergoing a pancreas transplant.

British Transplantation Society guidelines on abdominal organ transplantation from deceased donors after circulatory death.

The British Transplantation Society (BTS) 'Guideline on transplantation from deceased donors after circulatory death' has recently been updated and this manuscript summarises the relevant recommendations in abdominal organ transplantation from Donation after Circulatory Death (DCD) donors, encompassing the chapters on liver, kidney, pancreas and islet cell transplantation.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.

INTRODUCTION: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data. ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design.

Changing landscape in living kidney donation in Greece.

Patients with end-stage renal disease in Greece are facing long waiting times to receive a kidney transplant from a deceased donor. Living kidney donation offers a valuable alternative that provides optimal outcomes and significantly expands the donor pool but still remains relatively underutilised. Developments around the world in the field of kidney transplantation mandate a change in current practice to include additional options for living donation through paired exchange, antibody-incompatible transplantation and other strategies, following careful consideration of the cultural and ethical factors involved in these complex clinical decisions. An increase in living donation rates may be achieved in several ways, including targeted campaigning to overcome potential barriers. Educating clinicians on transplantation will prove as equally important as informing patients and prospective donors but requires training and resources. Adoption of established practices and implementation of new strategies must be tailored to the needs of the Greek donor and recipient population. Local beliefs about donation, perception of associated risk and other social characteristics must be considered in the design of future strategies. Facilitating living donation in a safe environment with appropriate donor and recipient education will form the solid foundation of a new era of kidney transplantation in Greece.

Recruitment into randomised trials of arteriovenous grafts: A systematic review.

Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.

Crisis Preparedness: A Systems-Based Framework for Avoiding Harm in Surgery.

BACKGROUND: Highly performing healthcare organizations benefit from robust failure management systems. This involves the ability to respond and recover from critical events, as well avoiding harm in the first place (crisis preparedness). Currently, the surgical community may lack an integrated toolbox for crisis readiness. The study aims to create a practical framework for crisis preparedness in surgery. STUDY DESIGN: A multimethod qualitative study was designed to identify and translate crisis preparedness interventions from high-reliability industries to clinical practice. The tools and strategies identified were subsequently developed and clinically adapted for healthcare use. The study used (1) observational fieldwork in commercial aviation; (2) semi-structured interviews with senior airline pilots, and (3) mixed focus groups with healthcare and aviation safety experts. A crisis preparedness framework was derived by thematic analysis using the framework method. Clinical adaptation was achieved using expert consensus methodology. RESULTS: Twenty-two aviation and healthcare experts participated in 17 interviews and 3 focus groups. A framework for crisis preparedness was derived, consisting of 6 behavioral interventions: (1) anticipate threats and errors by building situational awareness using cognitive tools; (2) brief teams about goals, deviations, operational risks, and contingency plans; (3) implement standard operating procedures using checklists; (4) rehearse emergency drills before critical phases of work; (5) set the tone for a positive working environment by establishing cultural norms and empowering individuals to speak up about safety issues; and (6) debrief performance outcomes to derive learning lessons. CONCLUSIONS: Surgical crisis preparedness requires integrated systems rather than isolated safety interventions. This study provides a framework and the tools to achieve this.

How crises work: A model of error cause and effect in surgical practice.

INTRODUCTION: Surgical crises have major consequences for patients, staff and healthcare institutions. Nevertheless, their aetiology and evolution are poorly understood outside the remit of root-cause analyses. AIMS: To develop a crisis model in surgery in order to aid the reporting and management of safety critical events. METHODS: A narrative review surveyed the safety literature on failure causes, mechanisms and effects in the context of surgical crises. Sources were identified using non-probability sampling, with selection and inclusion being determined by author panel consensus. The data underwent thematic analysis and reporting followed the recommendation of the SALSA framework. RESULTS: Data from 133 sources derived five principal themes. Analysis suggested that surgical care processes become destabilized in a step-wise manner. This crisis chain is initiated by four categories of threat or risk: (i) the systems in which surgeons operate; (ii) surgeons' technical, cognitive and behavioural skills; (iii) surgeons' physiological and psychological state (operational condition); and (iv) professional culture. Once triggered, the crisis chain is driven by only three types of errors: Type I. Performance errors consist of failures to diagnose, plan or execute tasks; Type II. Awareness errors are failures to recognise, comprehend or extrapolate the impact of performance failures; Type III. Rescue errors represent failures to correct faulty performance. The co-occurrence of all three error types gives rise to harm, which can lead to a crisis in the absence of mitigating actions. CONCLUSION: Surgical crises may be triggered by four categories of threat and driven by only three types of error. These may represent universal targets for safety interventions that create new opportunities for crisis management.

Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study protocol : a randomised controlled trial comparing primary unassisted patency at 1 year of primary arteriovenous fistulae created under regional compared to local anaesthesia.

INTRODUCTION: Arteriovenous fistulae (AVF) are the 'gold standard' vascular access for haemodialysis. Universal usage is limited, however, by a high early failure rate. Several small, single-centre studies have demonstrated better early patency rates for AVF created under regional anaesthesia (RA) compared with local anaesthesia (LA). The mechanistic hypothesis is that the sympathetic blockade associated with RA causes vasodilatation and increased blood flow through the new AVF. Despite this, considerable variation in practice exists in the UK. A high-quality, adequately powered, multicentre randomised controlled trial (RCT) is required to definitively inform practice. METHODS AND ANALYSIS: The Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study is a multicentre, observer-blinded RCT comparing primary radiocephalic/brachiocephalic AVF created under regional versus LA. The primary outcome is primary unassisted AVF patency at 1 year. Access-specific (eg, stenosis/thrombosis), patient-specific (including health-related quality of life) and safety secondary outcomes will be evaluated. Health economic analysis will also be undertaken. ETHICS AND DISSEMINATION: The ACCess study has been approved by the West of Scotland Research and ethics committee number 3 (20/WS/0178). Results will be published in open-access peer-reviewed journals within 12 months of completion of the trial. We will also present our findings at key national and international renal and anaesthetic meetings, and support dissemination of trial outcomes via renal patient groups. TRIAL REGISTRATION NUMBER: ISRCTN14153938. SPONSOR: NHS Greater Glasgow and Clyde GN19RE456, Protocol V.1.3 (8 May 2021), REC/IRAS ID: 290482.

Crisis Containment: Tools for Harm Mitigation in Surgery.

BACKGROUND: Surgical crises represent unrecognized opportunities for improving patient safety and adding value in healthcare. The first step in a crisis response is to contain and mitigate harm. While the principles of damage control are well established in surgery, methods of containing harm on broader clinical and organizational levels are not clearly defined. STUDY DESIGN: A multimethods qualitative study identified crisis containment strategies and tools in commercial aviation. These were translated and clinically adapted in 3 stages: semi-structured observational fieldwork with commercial airlines, interviews with senior pilots, and focus groups with both healthcare and aviation safety experts. Thematic analysis and expert consensus methods were used to derive a framework for crisis containment. RESULTS: Fieldwork with 2 commercial airlines identified 2 crisis containment concepts: the detrimental impact of surprising or startling events on operator performance; and the use of prioritization tools to take basic but critical actions (Aviate, Navigate and Communicate model). Twenty-two experts in aviation and healthcare practice informed the topic of crisis containment in 17 interviews and 3 focus groups. Three strategies were identified and used to form a crisis containment algorithm: 1. Manage the operators' startle response to facilitate meaningful mitigating actions (STOP tool); 2. Take priority actions to secure core functions. These included managing patients' physiologic shock, optimizing environmental risks, and mobilizing resources (Perfuse, Move and Communicate tool); 3. Deploy well-rehearsed drills targeting case-specific harms or errors (Memory Actions). This model requires validation in clinical practice. CONCLUSIONS: Crisis containment can be achieved by controlling operators' startle response, applying prioritization tools, and deploying drills against specific failures. The application of this model may extend to healthcare areas outside surgery.

Avoid, Trap, and Mitigate: Development of an Evidence-Based Crisis Management Framework in Surgery.

BACKGROUND: Increasingly, surgeons are adopting broader roles in emergency response, on both clinical and executive levels. These have highlighted the need to develop healthcare-specific crisis management systems. Cross-professional research between safety-critical industries is a valuable method for learning crisis control. Commercial aviation, in particular, has been used to drive innovation in surgical safety. This study aimed to identify, adapt, and operationalize a surgical crisis management framework based on current practice in commercial aviation. STUDY DESIGN: A multimethod qualitative study interrogated safety experts in commercial aviation and healthcare. Stage I used immersive observational fieldwork in commercial aviation practice. Stage II performed semi-structured interviews with senior airline pilots. "Snowball" sampling targeted professional networks, recruiting 17 pilots from 4 airlines. Thematic analysis was used to derive a model of crisis management. Stage III undertook 3 focus groups with 5 pilots and 5 healthcare safety specialists. Expert consensus methods were used to adapt the model to clinical practice. RESULTS: Interview data provided 2,698 verbatim quotes on crisis management from aviation experts with a combined flying experience of 188,000 hours. Aviation crisis management was structured in 3 phases: avoid, trap, and mitigate. Adapted to clinical practice, these translated to crisis preparedness, recovery, and containment interventions. Additionally, the study identified 7 types of implementation tools and 9 crisis management skills that could be used to operationalize this framework in surgical practice. CONCLUSIONS: Surgical crisis management can follow the avoid, trap, and mitigate framework used in commercial aviation. Implementation relies on the combined use of crisis skills and performance tools. Crisis management should be delivered as part of a systems-based approach that relies on well-integrated failure management models. Simulation and in-situ validation of this framework is needed.

Outcomes of pregnancy in simultaneous pancreas and kidney transplant recipients: A single-center retrospective study.

Simultaneous pancreas and kidney (SPK) transplantation, in uremic women with insulin-dependent diabetes, increases the chance of a successful pregnancy and minimizes the risk to infants. The aim of this study was to document pregnancy and explore the challenges in this cohort of women. Retrospective analysis of women who underwent pancreas transplantation between January 1, 1998 and 8 January, 2019 was conducted. Seventeen pregnancies were identified in 13 women. Mean transplant-to-pregnancy interval was 4.6 years (range, 1.1-10.2 years). Eleven pregnancies resulted in live birth (65%), and six (35%) ended in miscarriage/fetal loss at a median gestational age of 8.5 weeks. Mean gestational age at delivery was 34.9 weeks (SD ±3 weeks). Preeclampsia and C-section rates were 77% and 67%, respectively. Adverse fetal and graft outcomes were observed in 100% of unplanned pregnancies, compared to 10% of planned pregnancies (P < .001). One kidney allograft was lost during pregnancy; one pancreas and two kidney allografts were lost within 3 years of pregnancy. This is a high-risk group for grafts and offspring. Pre-pregnancy planning is vital. A multidisciplinary approach by obstetric and transplant teams is important pre-pregnancy, antenatally, and peripartum. This is the largest published series of pregnancies in SPK recipients from a single center.

The implications of donor-recipient size mismatch in renal transplantation.

INTRODUCTION: Transplanting kidneys small for recipient's size results in inferior graft function. Body surface area (BSA) is related to kidney size. We used the BSA index (BSAi) (Donor BSA/Recipient BSA) to assess whether the renal graft size is sufficient for the recipient. METHODS: We included 26,223 adult single kidney transplants (01/01/2007-31/12/2019) from the UK Transplant Registry. We divided renal transplants into groups: BSAi ≤ 0.75, 0.75 < BSA ≤ 1, 1 < BSAi ≤ 1.25, BSAi > 1.25. We compared delayed graft function rates, primary non-function rates and graft survival among them. (Reference category: BSAi ≤ 0.75). RESULTS: Cases with BSAi ≤ 0.75 had the highest delayed graft function rates in living-donor renal transplants (11.1%) (0.75 < BSAi ≤ 1: OR = 0.59, 95% CI = 0.32-1.1, p = 0.095, 1 < BSAi ≤ 1.25: OR = 0.46, 95% CI = 0.23-0.89, p = 0.022, BSAi > 1.25: OR = 0.32, 95% CI = 0.13-0.77, p = 0.011) and in renal transplants from donors after brain death (26.2%) (0.75 < BSAi ≤ 1: OR = 0.72, 95% CI = 0.55-0.96, p = 0.024, 1 < BSAi ≤ 1.25: OR = 0.62, 95% CI = 0.47-0.83, p = 0.001, BSAi > 1.25: OR = 0.65, 95% CI = 0.47-0.9, p = 0.01). There were no significant differences in renal transplants from donors after circulatory death regarding delayed graft function rates (~ 40% in all groups). Graft survival was similar among BSAi groups in renal transplants from living donors and donors after brain death. Renal transplants from donors after circulatory death with BSAi ≤ 0.75 had the shortest graft survival (0.75 < BSAi ≤ 1: HR = 0.55, 95% CI = 0.41-0.74, p < 0.001, 1 < BSAi ≤ 1.25: HR = 0.48, 95% CI = 0.35-0.66, p < 0.001, BSAi > 1.25: HR = 0.45, 95% CI = 0.31-0.66, p < 0.001). Ten-year graft survival rate was 58.4% for renal transplants from donors after circulatory death with BSAi ≤ 0.75. CONCLUSIONS: Delayed graft function risk is higher in renal transplants with BSAi ≤ 0.75 coming from living donors and donors after brain death. Graft survival is greatly reduced in renal transplants from donors after circulatory death with BSAi ≤ 0.75.

Outcomes after simultaneous pancreas-kidney transplantation from donation after circulatory death donors: A UK registry analysis.

There are concerns that simultaneous pancreas-kidney (SPK) transplants from donation after circulatory death (DCD) donors have a higher risk of graft failure than those from donation after brain death (DBD) donors. A UK registry analysis of SPK transplants between 2005 and 2018 was performed. Pancreas survivals of those receiving organs from DCD or DBD donors were compared. Multivariable analyses were used to adjust for baseline differences between the two groups and to identify factors associated with pancreas graft loss. A total of 2228 SPK transplants were implanted; 403 (18.1%) were from DCD donors. DCD donors were generally younger, slimmer, less likely to have stroke as a cause of death, with lower terminal creatinines and shorter pancreas cold ischemic times than DBD donors. Median (IQR) follow-up was 4.2 (1.6-8.1) years. On univariable analysis, there were no statistically significant differences in 5-year death-censored pancreas graft survival between the two donor types (79.5% versus 80.4%; p = .86). Multivariable analysis showed no statistically significant differences in 5-year pancreas graft loss between transplants from DCD (n = 343) and DBD (n = 1492) donors (hazard ratio 1.26, 95% CI 0.76-1.23; p = .12). The findings from this study support the increased use of SPK transplants from DCD donors.

Weight trends in living kidney donors suggest predonation counselling alone lacks a sustainable effect on weight loss: a single centre cohort study.

Living kidney donors are at risk of long-term end-stage renal disease, and obesity is an independent risk factor. In our centre, predonation counselling of obese donors concentrates on lifestyle modifications, particularly weight loss and exercise. Whether these recommendations have a sustainable effect after donation remains unknown. We conducted a retrospective analysis of all donors who proceeded to donation between 2012 and 2016. Donors' body mass index (BMI) was compared between predefined time points using matched pair analysis. Among 303 donors included, 15% were obese at initial assessment. Obese donors were observed to lose weight by the time of donation (mean BMI difference 1.32 kg/m2 , P < 0.001), but bounced back to their initial weight at one-year postdonation (mean BMI difference + 1.47 kg/m2 , P < 0.001), which was maintained at two-year postdonation. While 71% of obese donors lost weight by the time of donation, 56% of them gained that weight back at one year. Our findings underline the success of predonation counselling on lifestyle modification in highly motivated obese donors, although additional strategies are required to sustain weight loss. The impact of weight gain on long-term risk needs further evaluation. Living donor programmes should provide continued support with lifestyle modifications after donation.

Hypoperfusion warm ischaemia time in renal transplants from donors after circulatory death.

BACKGROUND: The donor hypoperfusion phase before asystole in renal transplants from donors after circulatory death (DCD) has been considered responsible for worse outcomes than those from donors after brain death (DBD). METHODS: We included 10 309 adult renal transplants (7128 DBD and 3181 DCD; 1 January 2010-31 December 2016) from the UK Transplant Registry. We divided DCD renal transplants into groups according to hypoperfusion warm ischaemia time (HWIT). We compared delayed graft function (DGF) rates, primary non-function (PNF) rates and graft survival among them using DBD renal transplants as a reference. RESULTS: The DGF rate was 21.7% for DBD cases, but ∼40% for DCD cases with HWIT ≤30 min (0-10 min: 42.1%, 11-20 min: 43%, 21-30 min: 38.4%) and 60% for DCD cases with HWIT >30 min (P < 0.001). All DCD groups showed higher DGF risk than DBD renal transplants in multivariable analysis {0-10 min: odds ratio [OR] 2.686 [95% confidence interval (CI) 2.352-3.068]; 11-20 min: OR 2.531 [95% CI 2.003-3.198]; 21-30 min: OR 1.764 [95% CI 1.017-3.059]; >30 min: OR 5.814 [95% CI 2.798-12.081]}. The highest risk for DGF in DCD renal transplants with HWIT >30 min was confirmed by multivariable analysis [versus DBD: OR 5.814 (95% CI 2.798-12.081) versus DCD: 0-10 min: OR 2.165 (95% CI 1.038-4.505); 11-20 min: OR 2.299 (95% CI 1.075-4.902); 21-30 min: OR 3.3 (95% CI 1.33-8.197)]. No significant differences were detected regarding PNF rates (P = 0.713) or graft survival (P = 0.757), which was confirmed by multivariable analysis. CONCLUSIONS: HWIT >30 min increases the risk for DGF greatly, but without affecting PNF or graft survival.

UK renal transplant outcomes in low and high BMI recipients: the need for a national policy.

INTRODUCTION: We assessed the effect of recipient body mass index (BMI) on the outcomes of renal transplantation and the management of obese patients with end-stage renal disease across the UK. METHODS: We analyzed data of 25539 adult renal transplants (2007-2016) from the UK Transplant Registry. Patients were divided in BMI groups [underweight: < 18.5, normal: 18.5-24.9 (reference group), overweight: 25-29.9, class I obese: 30-34.9, class II/III obese: ≥ 35]. We also conducted a national survey of all UK renal transplant centers on the influence of BMI on decisions regarding management of renal transplant candidates. RESULTS: BMI ≥ 25 was an independent risk factor for delayed graft function and primary non-function (p ≤ 0.001). Underweight (p = 0.001), class I obese (p = 0.017) and class II/III obese recipients (p < 0.001) had poorer graft survival, however, 5- and 10-year graft survival rates were good. Patient survival was shorter for underweight recipients (p < 0.001) and longer for overweight (p = 0.028) and class I obese recipients (p = 0.013). The national survey revealed significant variability among transplant centers in BMI threshold for listing patients on transplant waiting list and limited support with conservative or surgical procedures for weight control. CONCLUSIONS: Obesity alone should not be a barrier for renal transplantation. A national strategy is required to give all patients equal chances in transplantation.

An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Reducing turbulent blood flow through dialysis arteriovenous fistulas (AVFs) and radial stretching of their venous wall may attenuate hyperplasia and stenosis and improve AVF outcomes in hemodialysis patients. The goal of this study was to evaluate the safety and efficacy of the VasQ implant, which intervenes on these mechanisms by physically supporting the surgical arteriovenous anastomosis. STUDY DESIGN: Prospective, randomized, controlled, multicenter study. SETTINGS & PARTICIPANTS: 40 consecutive patients with kidney failure referred for creation of a brachiocephalic fistula in 4 vascular access centers in the United Kingdom and Israel. INTERVENTIONS: AVF surgical creation with placement of the VasQ implant (treatment) versus AVF placement without the implant (control). OUTCOMES: Safety assessed as percentage of severe device-related adverse events was the primary outcome. Secondary outcomes were efficacy assessments including: (1) AVF maturation at 3 months, defined as cephalic vein diameter≥5mm and flow≥500mL/min; (2) functional cumulative patency, defined as successful 2-needle cannulation for two-thirds or more of all dialysis runs for 1 month in study participants receiving dialysis; (3) cephalic vein diameter and blood flow; and (4) primary and cumulative patency at 6 months. RESULTS: No severe device-related adverse events were observed. There was no significant difference in maturation at 3 months or primary patency at 6 months between treatment and control (85% vs 80% and 80% vs 66%). Significantly larger vein luminal diameters were observed in the treatment group versus controls at 3 and 6 months (8.27±2.2 vs 6.69±1.8mm [P=0.03] and 9.6±2.5 vs 7.56±2.7mm [P=0.03]). Functional patency at 6 months was significantly greater in the treatment group (100% vs 56% [P = 0.01]). LIMITATIONS: Small sample size, limited power for secondary end points. CONCLUSIONS: No safety signals were detected for the VasQ external support of brachiocephalic AVFs. Higher functional patency and vein luminal diameters were achieved with the device at 3 and 6 months. VasQ may safely intervene on mechanisms associated with the disturbed hemodynamic profile in the juxta-anastomotic region. FUNDING: Funded by Laminate Medical Technologies Ltd. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02112669.