Long-Term Functional Patency and Cost-Effectiveness of Arteriovenous Fistula Creation under Regional Anesthesia: a Randomized Controlled Trial.

BACKGROUND: Regional anesthesia improves short-term blood flow through arteriovenous fistulas (AVFs). We previously demonstrated that, compared with local anesthesia, regional anesthesia improves primary AVF patency at 3 months. METHODS: To study the effects of regional versus local anesthesia on longer-term AVF patency, we performed an observer-blinded randomized controlled trial at three university hospitals in Glasgow, United Kingdom. We randomly assigned 126 patients undergoing primary radiocephalic or brachiocephalic AVF creation to receive regional anesthesia (brachial plexus block; 0.5% L-bupivacaine and 1.5% lidocaine with epinephrine) or local anesthesia (0.5% L-bupivacaine and 1% lidocaine). This report includes findings on primary, functional, and secondary patency at 12 months; reinterventions; and additional access procedures (primary outcome measures were previously reported). We analyzed data by intention to treat, and also performed cost-effectiveness analyses. RESULTS: At 12 months, we found higher primary patency among patients receiving regional versus local anesthesia (50 of 63 [79%] versus 37 of 63 [59%] patients; odds ratio [OR], 2.7; 95% confidence interval [95% CI], 1.6 to 3.8; P=0.02) as well as higher functional patency (43 of 63 [68%] versus 31 of 63 [49%] patients; OR, 2.1; 95% CI, 1.5 to 2.7; P=0.008). In 12 months, 21 revisional procedures, 53 new AVFs, and 50 temporary dialysis catheters were required. Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon. Results were robust after extensive sensitivity and scenario analyses. CONCLUSIONS: Compared with local anesthesia, regional anesthesia significantly improved both primary and functional AVF patency at 1 year and is cost-effective. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Local Anaesthesia versus Regional Block for Arteriovenous Fistulae, NCT01706354.

How to set up a clinical trial.

Clinical trials are considered the gold-standard method for the evaluation of healthcare interventions. However, randomised control trials are complex to perform and many researchers, especially those in the early stages of their career, can find it challenging to know where to start set up, contribute to or lead a trial. This guide provides an introduction to trials and also practical advice to help potential investigators complete their clinical trial to time and to budget by signposting the pathway through the complex regulatory landscape. The authors draw on their own recent experiences of running clinical trials and provide tips and tricks for troubleshooting common problems encountered including trial design and documentation.

Effect of regional versus local anaesthesia on outcome after arteriovenous fistula creation: a randomised controlled trial.

BACKGROUND: Arteriovenous fistulae are the optimum form of vascular access in end-stage renal failure. However, they have a high early failure rate. Regional compared with local anaesthesia results in greater vasodilatation and increases short-term blood flow. This study investigated whether regional compared with local anaesthesia improved medium-term arteriovenous fistula patency. METHODS: This observer-blinded, randomised controlled trial was done at three university hospitals in Glasgow, UK. Adults undergoing primary radiocephalic or brachiocephalic arteriovenous fistula creation were randomly assigned (1:1; in blocks of eight) using a computer-generated allocation system to receive either local anaesthesia (0·5% L-bupivacaine and 1% lidocaine injected subcutaneously) or regional (brachial plexus block [BPB]) anaesthesia (0·5% L-bupivacaine and 1·5% lidocaine with epinephrine). Patients were excluded if they were coagulopathic, had no suitable vessels, or had a previous failed ipsilateral fistula. The primary endpoint was arteriovenous fistula patency at 3 months. We analysed the data on an intention-to-treat basis. This study was registered with ClinicalTrials.gov (NCT01706354) and is complete. FINDINGS: Between Feb 6, 2013, and Dec 4, 2015, 163 patients were assessed for eligibility and 126 patients were randomly assigned to local anaesthesia (n=63) or BPB (n=63). All patients completed follow-up on an intention-to-treat basis. Primary patency at 3 months was higher in the BPB group than the local anaesthesia group (53 [84%] of 63 patients vs 39 [62%] of 63; odds ratio [OR] 3·3 [95% CI 1·4-7·6], p=0·005) and was greater in radiocephalic fistulae (20 [77%] of 26 patients vs 12 [48%] of 25; OR 3·6 [1·4-3·6], p=0·03). There were no significant adverse events related to the procedure. INTERPRETATION: Compared with local anaesthesia, BPB significantly improved 3 month primary patency rates for arteriovenous fistulae. FUNDING: Regional Anaesthesia UK, Darlinda's Charity for Renal Research.

A randomized controlled trial and cost-effectiveness analysis of early cannulation arteriovenous grafts versus tunneled central venous catheters in patients requiring urgent vascular access for hemodialysis.

OBJECTIVE: Early cannulation arteriovenous grafts (ecAVGs) are proposed as an alternative to tunneled central venous catheters (TCVCs) in patients requiring immediate vascular access for hemodialysis (HD). We compared bacteremia rates in patients treated with ecAVG and TCVC. METHODS: The study randomized 121 adult patients requiring urgent vascular access for HD in a 1:1 fashion to receive an ecAVG with or without (+/-) an arteriovenous fistula (AVF; n = 60) or TCVC+/-AVF (n = 61). Patients were excluded if they had active systemic sepsis, no anatomically suitable vessels, or an anticipated life expectancy <3 months. The primary end point was the culture-proven bacteremia rate at 6 months, with the trial powered to detect a reduction in bacteremia from 24% to 5% (α = .05, ß = .8). Secondary end points included thrombosis, reintervention, and mortality. A cost-effectiveness analysis was also performed. RESULTS: Culture-proven bacteremia developed in 10 patients (16.4%) in the TCVC arm ≤6 months compared with two (3.3%) in the ecAVG+/-AVF arm (risk ratio, 0.2; 95% confidence interval, 0.12-0.56; P = .02). Mortality was also higher in the TCVC+/-AVF cohort (16% [n = 10] vs 5% [n = 3]; risk ratio, 0.3; 95% CI, 0.08-0.45; P = .04). The difference in treatment cost between the two arms was not significant (£11,393 vs £9692; P = .24). CONCLUSIONS: Compared with TCVC+/-AVF, a strategy of ecAVG+/-AVF reduced the rate of culture-proven bacteremia and mortality in patients requiring urgent vascular access for HD. The strategy also proved to be cost-neutral.

The Role of Qutenza® (Topical Capsaicin 8%) in Treating Neuropathic Pain from Critical Ischemia in Patients with End-Stage Renal Disease: An Observational Cohort Study.

Objective: Current treatment strategies for painful critical ischemia in patients with end-stage renal disease (ESRD) are suboptimal. A drug that is non-renally excreted has minimal systemic absorption and does not require dose adjustment in renal failure is attractive. The aim of this study was to evaluate the safety and efficacy of Qutenza® (topical capsaicin 8%) for chronic neuropathic pain from critical ischemia in patients with ESRD. Design and Setting: A prospective cohort study was conducted in a single-center, university teaching hospital. Patients: Twenty patients with ESRD were treated with Qutenza® for neuropathic pain from critical limb ischemia. Methods: Patients were followed-up at 1, 6 and 12 weeks post-treatment. The primary end point was the difference in visual analog scale (VAS) between baseline and week 12. Secondary end points were Brief Pain Inventory questionnaire (BPI) scores, quality of life assessment (EQ-5D) and patient global impression of change (PGIC). Safety and tolerability data were also collected. The trial was prospectively registered with clinical trials databases (EudraCT: 2012-001586-32; NCT01704313). Results: There was significant reduction in VAS from baseline to week 12 (-20+/-7%; P = 0.02). There was a significant reduction in all seven domains of the BPI. Quality of life also improved at 12 weeks following treatment in two of the EQ-5D domains (mobility and pain). Qutenza® was well tolerated with no significant side effects in this patient cohort, which included 20% diabetics. Conclusions: In this small, observational study Qutenza® treatment has been shown to be effective and well-tolerated to treat neuropathic pain from critical ischemia in patients with ESRD.

A comparison of the effects of oral vs. intravenous hydration on subclinical acute kidney injury in living kidney donors: a protocol of a randomised controlled trial.

BACKGROUND: Optimal treatment for established renal failure is living donor kidney transplantation. However this pathway exposes healthy individuals to significant reduction in nephron mass via major surgical procedure. Laparoscopic donor nephrectomy is now the most common method for live donor transplantation, reducing both donor post-operative pain and recovery time. However this procedure exposes kidneys to additional haemodynamic stresses. It has been suggested that donor hydration-particularly the use of preoperative intravenous fluids-may counteract these stresses, reducing subclinical acute kidney injury and ultimately improving long-term renal function. This may be important in both preservation of donor renal function and recipient graft longevity. METHODS/DESIGN: A prospective single-centre single-blinded randomized controlled trial will be carried out to determine the effects of donor preoperative intravenous fluids. The primary outcome is donor subclinical acute kidney injury (defined as plasma NGAL, >153 ng/ml) on day 1 postoperatively. Secondary outcomes include intraoperative haemodynamics, recipient subclinical acute kidney injury, perioperative complications and donor sleep quality. Donors will be randomised into two groups: the intervention group will receive active pre-hydration consisting of three litres of intravenous Hartmann's solution between midnight and 8 am before morning kidney donation, while the control group will not receive this. Both groups will receive unlimited oral fluids until midnight, as is routine. Plasma NGAL will be measured at pre-specified perioperative time points, intraoperative haemodynamic data will be collected using non-invasive cardiac output monitoring and clinical notes will be used to obtain demographic and clinical data. The researcher will be blinded to the donor fluid hydration status. Blinded statistical analysis will be performed on an intention-to-treat basis. A prospective power calculation estimates a required sample size of 86 patients. DISCUSSION: This study will provide important data, as there is currently little evidence about the use of donor preoperative fluids in laparoscopic nephrectomy. It is hoped that the results obtained will guide future clinical practice. TRIAL REGISTRATION: This study has been approved by the West of Scotland Research Ethics Committee 3 (reference no. 14/WS/1160, 27 January 2015) and is registered with the International Standard Randomised Controlled Trial Number Register (reference no. ISRCTN10199225 , 20 April 2015).

Brachiobasilic fistulae: an upper limb autologous option for everyone?

PURPOSE: Autologous arteriovenous fistulae (AVF) are the vascular access option of choice. However, Brachiobasilic fistula (BBF) are complex procedures with variable outcomes reported in the literature. Our aim was to evaluate outcomes and morbidity associated with BBF in our population. METHODS: Retrospective analysis of prospectively collected data was undertaken for all 51 BBF created in our institution between January 2010 and March 2013. These were compared to an age and sex-matched group of brachiocephalic fistula (BCF) created over a similar time period. Demographic, operative and outcome data was collected for all patients. The primary end points were primary functional patency, primary-assisted patency and secondary patency at 3, 6 and 12 months. Continuous data was compared using Student's t-test and categorical data using chi-squared test (p < 0.05 is significant). RESULTS: Mean patient age was 57 years (range: 21-82). About 45% were male. About 73% of patients were already on hemodialysis (HD) at the time of BBF creation. BBF was the secondary or tertiary access procedure in 60.8% of patients (n = 31). BBF were associated with significant operative burden with 82% of patients requiring a general anaesthetic and median hospital admission of 2 days (range: 1-4). About 75% had a single-stage procedure. About 23.5% (n = 12) required operative revision (superficialization or anastomotic revision for stenosis). Patients with BBF spent an additional 3.45 days/year in hospital as a result of access related complications compared to 0.56 days/year in the BCF group. Primary-assisted patency at 3, 6 and 12 months was better in the BCF group than BBF group (86%, 72% and 48% vs. 71%, 59%, 33%, respectively; p < 0.01) Primary functional and secondary patency rates at 3, 6 and 12 months were 74%, 58% and 32% and 78%, 63% and 41%, respectively, with an average of 0.33 procedures per AVF to maintain patency (10 fistuloplasties, 4 IR thrombectomy and 3 surgical thrombectomy). About 32% (n = 17) of BBF were never used for HD (seven patients had a patent AVF but did not require HD >18 months following creation; nine failed to adequately mature and one patient refused second stage superficialization). CONCLUSIONS: BBF are associated with a significant initial operative burden and higher complication and poorer patency rates than BCF. About one-third of BBF created in this series were never used. Given the morbidity associated with this procedure, careful consideration should be given to creation of BBF in pre-dialysis patients particularly those in whom the rate of decline in renal function is slow.

Expanded criteria donor and donation after circulatory death renal allografts in the West of Scotland: Their place in the kidney allocation process.

INTRODUCTION: Due to the rising disparity between demand and availability, organs from expanded criteria donors (ECD) and donors after determination of circulatory death (DCD) are increasingly used. The purpose of this study was to report outcomes in recipients of ECD and DCD renal allografts from a single centre. METHODS: A retrospective analysis from a single centre for all renal transplants performed between 2001 and 2010 inclusive was undertaken. SCD (standard criteria donor) and ECD organs were compared, as were DCD and DBD (donation after determination of brain stem death) organs. Baseline data and predefined standard transplant outcomes were collected and compared using appropriate statistical tests. P < 0.05 was defined as significant. RESULTS: 729 renal transplants were performed. Comparing ECD to SCD organs, there was a significant difference in graft survival between groups (logrank for trend, p = 0.032) with ECD organs doing worse than SCD organs. Short-term outcomes showed a similar disparity with a higher 1-year post-transplant creatinine and delayed graft function (DGF) rate in ECD grafts. Nevertheless, outcomes were still clinically acceptable. When comparing DCD to DBD organs, no such differences were apparent, with DCD organs appearing to perform at least as well as DBD organs. In our cohort, unlike some previous studies, DGF rates were similar in both DCD and DBD groups. CONCLUSIONS: Although ECD organs perform less well than SCD organs, outcomes are still acceptable and our results support their continuing use. When considering DCD organs, our data support the view that they should no longer be necessarily regarded as marginal grafts. Our low DGF rates are perhaps explained by local factors contributing to a short CIT.

A randomized controlled trial of interrupted versus continuous suturing techniques for radiocephalic fistulas.

OBJECTIVE: Continuous suturing techniques have conventionally been used for the end-to-side anastomoses of radiocephalic fistulas (RCFs); however, primary patency rates are poor. Only 50% to 60% of RCFs ever achieve functional patency. We hypothesized that a hybrid interrupted-continuous suturing technique (as used in many microsurgical procedures) may improve outcomes in fistulas constructed from small vessels. METHODS: A randomized controlled trial comparing hybrid interrupted-continuous (n = 42) with continuous (n = 36) suturing techniques for RCF was undertaken. Patients were excluded if vessels were <1.8 mm in diameter or if previous ipsilateral fistula had been attempted. A priori power calculation indicated that a sample size of 78 patients was required to detect an improvement in patency from 50% to 80% (α = .05, ß = .8). The primary end point was primary patency at 6 weeks (assessed by a blinded observer for the presence of thrill and bruit). Secondary end points were immediate patency, functional patency (assessed clinically and by ultrasound) at 6 weeks, and presence of anastomotic stenosis. RESULTS: Groups were comparable for basic patient demographics, operating surgeon, and vessel diameter as measured on preoperative ultrasound (mean age, 58.9 ± 13 years; 68% male). Primary patency at 6 weeks was higher in the hybrid interrupted-continuous suturing technique group (71% vs 47%; P = .01). Immediate patency was also higher in the hybrid interrupted-continuous suturing technique group (93% vs 67%; P < .001). There was no significant difference in functional patency at 6 weeks (52% vs 36%; P = .18). Three patients developed an anastomotic stenosis. All were in the hybrid interrupted-continuous suturing technique group. One patient from the interrupted suturing technique cohort required re-exploration for bleeding. CONCLUSIONS: A hybrid interrupted-continuous suturing technique yielded higher immediate and 6-week primary patency rates for RCF. The hybrid interrupted-continuous suturing technique may improve anastomotic compliance and reduce the narrowing and puckering that can occur on suture tightening in small-caliber vessels. Based on these findings, consideration should be given to performing hybrid interrupted-continuous anastomoses for RCFs.

Predictors of sustained arteriovenous access use for haemodialysis.

BACKGROUND: Guidelines encourage early arteriovenous (AV) fistula (AVF) planning for haemodialysis (HD). The aim of this study was to estimate the likelihood of sustained AV access use taking into account age, sex, comorbidity, anatomical site of first AVF and, for pre-dialysis patients, eGFR and proteinuria. METHODS: 1,092 patients attending our centre who had AVF as their first AV access procedure between January 1, 2000 and August 23, 2012 were identified from the electronic patient record. The primary end-point was time to first sustained AV access use, defined as use of any AV access for a minimum of 30 consecutive HD sessions. RESULTS: 52.9% (n = 578) of the patients ultimately achieved sustained AV access use. The main reasons for AV access non-use were AVF failure to mature and death. The 3-year Kaplan-Meier probability of sustained AV access use was 68.8% for those not on renal replacement therapy (RRT) (n = 688) and 74.2% for those already on RRT (n = 404) at the time of first AVF. By multivariate analysis in patients not on RRT, male sex (HR 2.22; p < 0.001), uPCR (HR 1.03; p = 0.03) and eGFR (hazard ratio, HR 0.85; p < 0.001) were independent predictors of AV access use. In patients already on RRT, age (HR 0.98; p < 0.001) and peripheral vascular disease (HR 0.48; p = 0.02) were independent predictors of AV access use. CONCLUSION: Our data suggest that refinement of the current guideline for timing of AV access creation in planning RRT is justified to take into account individual factors that contribute to the likelihood of technical success and clinical need.

Renal function, uraemia and early arteriovenous fistula failure.

BACKGROUND: Guidance varies regarding the optimal timing of arteriovenous fistula (AVF) creation. The aim of this study was to evaluate the association between uraemia, haemodialysis and early AVF failure. METHODS: Immunoblotting and cell proliferation assays were performed on vascular smooth muscle cells (VSM) cells isolated from long saphenous vein samples to evaluate the cells' ability to proliferate when stimulated with uraemic (post-dialysis) and hyperuraemic (pre-dialysis) serum. Clinical data was collected prospectively for 569 consecutive radiocephalic (RCF) and brachiocephalic (BCF) fistulae. The primary outcome was AVF failure at 6 weeks. Dialysis status (haemodialysis (HD); pre-dialysis (Pre-D)), eGFR and serum urea were evaluated to determine if they affected early AVF failure. RESULTS: Human VSM cells demonstrated increased capacity to proliferate when stimulated with hyperuraemic serum. There was no significant difference in early failure rate of either RCF or BCF depending on dialysis status (pre-D RCF 31.4% (n=188); pre-D BCF 22.4% (n=165); HD RCF 29.3% (n=99); HD BCF 25.9% (n=116); p=0.34). There was no difference in mean eGFR between those patients with early AVF failure and those without (11.2+/-0.2 ml/min/1.73 m2 vs. 11.6+/-0.4 ml/min/1.73 m2; p=0.47). Uraemia was associated with early AVF failure (serum urea: 35.0+/-0.7 mg/dl vs. 26.6+/-0.3 mg/dl (p<0.001)). CONCLUSIONS: We present the first in vivo evidence of an association between adverse early AVF outcomes and uraemia. This is supported mechanistically by in vitro work demonstrating a pro-mitogenic effect of hyperuraemic serum. We hypothesise that uraemia-driven upregulation of VSM cell proliferation at the site of surgical insult in contributes to higher early AVF failure rates.

Cephalic arch stenosis: angioplasty to preserve a brachiocephalic fistula or new brachiobasilic fistula? A cost-effectiveness study.

BACKGROUND: Our aim was to evaluate the cost-effectiveness of repeat angioplasty versus new brachiobasilic fistula (BBF) in patients with symptomatic cephalic arch stenosis (CAS). METHODS: Patients presenting with symptomatic CAS (n = 22) underwent angioplasty. They were compared to patients undergoing BBF creation (n = 51). Primary outcomes were functional primary arteriovenous fistulae patency at 3, 6 and 12 months. Data were collected on number of interventions, alternative accesses and hospital days for access-related complications. Quality of life was assessed using Kidney Disease Quality of Life-36 scores. Decision tree, Monte Carlo simulation and sensitivity analysis permitted cost-utility analysis. Healthcare costs were derived from Department of Health figures and are presented as cost (£)/patient/year, cost/access preserved and cost/quality of life-adjusted year (QALY) for each of the treatment strategies. RESULTS: Functional primary patency rates at 3, 6, 12 months were 87.5%, 81% and 43% for repeated angioplasty and 78%, 63% and 41% for BBF. The angioplasty cohort required 1.64 ± 0.23 angioplasties/patient and 0.64 ± 0.34 lines/patient. BBF required 0.36 ± 0.12 angioplasties/patient and 1.2 ± 0.2 lines/patient. Patients in the BBF cohort spent an additional 0.9 days/year in hospital due to access-related complications. Mean cost/patient/year in the angioplasty group was £5247.72/patient/year versus £3807.55/patient/year in the BBF cohort. Mean cost per access saved was £11,544.98 (angioplasty) versus £4979.10 (BBF). Average cost per QALY was £13,809.79 (angioplasty) versus £10,878.72 per QALY (BBF). CONCLUSIONS: CAS poses a difficult management problem with poor outcomes from conventional angioplasty. Optimal management will depend on patient factors, local outcomes and expertise, but consideration should be given to creation of a new BBF as a cost-effective means to manage this difficult problem.

A practical review of barriers and challenges to a definitive randomised trial of grafts versus fistula.

A definitive randomised controlled trial of arteriovenous fistula (AVF) versus arteriovenous grafts (AVG) has been advocated for more than a decade, but as yet, none has been completed. The aim of this article is to summarise the theoretical barriers, review the difficulties in trial design and practicalities that have thus far prevented this from occurring.

What are the observed procedural costs of vascular access surgery? Protocol for a systematic review.

INTRODUCTION: A central component in the introduction of a novel surgical procedure or technique is an evaluation of its cost efficiency when compared with a benchmark standard of care. Accurate assessment of costs is thus essential in ensuring appropriate allocation of resources within a healthcare system. The treatment of kidney failure requires a significant volume of resources, and vascular access provision is the main modifiable cost. The costs of providing this service are obscured by generic NHS reference costs, which lack adequate granularity to allow meaningful comparisons between treatments. The aim of this systematic review will be to assess the reporting of procedural costs in all published economic analyses of vascular access surgery and perform a comparison of the reported procedural costs involved in arteriovenous fistula (AVF) and arteriovenous graft (AVG) creation. This will provide an estimate as to the accuracy of the NHS reference costs in this field. 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 full-text economic analyses of vascular access for haemodialysis in which the procedural cost of AVF or AVG creation is reported. Publications in English from 1 January 2000 to 30 August 2023, will be eligible for inclusion. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Studies not reporting the procedural costs of surgery will be excluded. Data collected will pertain to procedural costs of AVF and AVG creation. Costs will be adjusted to a common currency using a gross domestic product (GDP) deflator index and conversion rates based on purchasing power parities for GDP. Comparison with NHS reference costs will indicate their reliability for use in future economic analyses in this field. ETHICS AND DISSEMINATION: Ethical approval is not required for this systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42023458779.

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.

Pain resulting from arteriovenous fistulae: prevalence and impact.

INTRODUCTION: The burden of pain from cannulation of arteriovenous fistulae (AVF) and the impact it has on quality of life is poorly described in the literature. METHODOLOGY: A pain score questionnaire was employed for all patients in the West of Scotland dialyzing via AVF (n = 461). Pain was assessed using visual analogue score (VAS) and McGill pain score. Patients with severe pain (VAS > 5) were compared to those with minimal pain. RESULTS: The questionnaire as completed by 97.5% of the patients. Median VAS on cannulation was 3 (IQR 0.5 - 4.5). Of those who had completed the questionnaire, 24.4% had severe pain on cannulation and 3.2% experienced severe chronic pain. 53 patients (11.3%) cut a dialysis session short due to pain. Of the patients with severe chronic pain, 46.7% had a physical complication affecting their AVF (e.g., venous stenosis, pseudoaneurysm). Following treatment of the problem, pain improved in 71.4% and resolved completely in 14.3%. Brachiobasilic AVF was associated with a higher incidence of severe pain than either brachiocephalic or radiocephalic AVF (50%, 23.3% and 24.4% respectively; p = 0.03). There was a trend towards more severe pain with rope-ladder cannulation (27.7%) compared to button-hole cannulation (18.2%); however, this difference did not reach statistical significance (p = 0.09). CONCLUSIONS: Pain from AVF is poorly recognized and an under-reported problem. While severe pain resulting in the avoidance of dialysis is rare, it can lead to significant difficulties and ultimate abandonment of AVF. Pain is often suggestive of an underlying anatomical problem.

Outcomes following renal transplantation in older people: a retrospective cohort study.

BACKGROUND: The mean age of renal transplant recipients is rising, with age no longer considered a contraindication. Outcomes in older patients have not, however, been fully defined. The aim of our study is to evaluate outcomes in older people following renal transplantation at a Scottish regional transplant unit. METHODS: All renal transplants from January 2001 to December 2010 were analysed (n = 762). Outcomes following renal transplantation in people over 65 years old were compared to those in younger patients. Outcome measures were: delayed graft function (DGF), primary non-function (PNF), biopsy proven acute rejection (BPAR), serum creatinine at 1 year and graft and recipient survival. Lengths of initial hospital stay and re-admission rates were also assessed. Student's T-Test was used to analyse continuous variables, Pearson's Chi-Squared test for categorical variables and the Kaplan-Meier estimator for survival analysis. RESULTS: Older recipients received proportionately more kidneys from older donors (27.1% vs. 6.3%; p < 0.001). Such kidneys were more likely to have DGF (40.7% vs. 16.9%; p < 0.001). Graft loss at 1 year was higher in kidneys from older donors (15.3% vs. 7.6%; p = 0.04). There was no significant difference in patient survival at 1 year based on the age of the donor kidney. Recipient age did not affect DGF (16.9% vs. 18.5%; p = 0.77) or graft loss at 1 year (11.9% vs. 7.8%; p = 0.28). Older recipients were, however, more likely to die in the first year post transplant (6.8% vs. 2.1%; p = 0.03). BPAR was less common in older patients (6.8% vs. 22%; p < 0.01). Older recipients were more likely to be readmitted to hospital (31.8% vs. 10.9%; p < 0.001). CONCLUSIONS: Older patients experience good outcomes following renal transplantation and donor or recipient age alone should not preclude this treatment. An awareness of this in clinicians managing older patients is important since the prevalence of End Stage Renal Disease is increasing in this age group.

Early-cannulation arteriovenous grafts: Multidisciplinary learning is essential to optimize outcomes.

BACKGROUND: It is likely that there will be an increasing role for early-cannulation arteriovenous grafts (ecAVG) with a wider recognition of the need to tailor vascular access to avoid futile procedures and unnecessary TCVC. However, experience of these products is not common and limited to early surgical adopters, with little information on the systemic changes and multi-disciplinary care needed to optimize outcomes. The aim of this study was to report the impact of a multi-disciplinary approach on quantifiable outcomes. METHODS: A retrospective analysis of a prospectively maintained database of 295 ecAVG implanted over an 8-year time-period was performed. Indicative outcomes were chosen to reflect nephrology (patient selection), nursing care (cannulation complications of infection and pseudoaneurysm) and radiology (thrombosis) on cumulative impact (functional patency) over three distinct time periods. RESULTS: The incidence of ecAVG increased 10-fold over the three time periods. The use of ecAVG changed significantly from salvage tertiary access to TCVC avoidance and salvage of existing AVF. Nursing complications reduced markedly with significantly fewer over-cannulation episodes and pseudo-aneurysms. With an improved pro-active surveillance programme, the time to first thrombosis doubled and the risk of thrombosis halved. Ultimately this resulted in significantly improved functional patency with a risk of ecAVG loss less than one-third by the last time-period. CONCLUSIONS: All aspects of ecAVG use require scrutiny and critical appraisal. Failure or success is not simply achieved by performing good technical surgery with an efficacious product, but by the care taken across a wide range of elements spanning case selection, implantation, use and maintenance.

Cardiorespiratory Optimisation By Arteriovenous fistula Ligation after renal Transplantation (COBALT): study protocol for a multicentre randomised interventional feasibility trial.

INTRODUCTION: Cardiovascular events are a major cause of mortality following successful kidney transplantation.Arteriovenous fistulas (AVFs) are considered the best option for haemodialysis, but may contribute to this excess mortality because they promote adverse cardiac remodelling and ventricular hypertrophy. This raises the question whether recipients with a well-functioning kidney transplant should undergo elective AVF ligation. METHODS AND ANALYSIS: The COBALT feasibility study is a multicentre interventional randomised controlled trial (RCT) that will randomise renal transplant patients with stable graft function and a working AVF on a 1:1 basis to standard care (continued conservative management) or to AVF ligation. All patients will perform cardiopulmonary exercise testing (CPET) on recruitment and 6 months later. Daily functioning and quality of life will be additionally assessed by questionnaire completion and objective measure of physical activity. The primary outcome-the proportion of approached patients who complete the study (incorporating rates of consent, receipt of allocated intervention and completion of both CPETs without withdrawal)-will determine progression to a full-scale RCT. Design of the proposed RCT will be informed by an embedded qualitative assessment of participant and healthcare professional involvement. ETHICS AND DISSEMINATION: This study has been approved by the East Midlands-Derby Research Ethics Committee (22/EM/0002) and the Health Research Authority. The results of this work will be disseminated academically through presentation at national and international renal meetings and via open access, peer-reviewed outputs. Existing networks of renal patient groups will also be used to disseminate the study findings to other key stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN49033491.