Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice.

BACKGROUND: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative. METHODS: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors. DISCUSSION: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.

Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals.

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

Natural Vascular Remodelling After Arteriovenous Fistula Creation in Dialysis Patients With and Without Previous Ipsilateral Vascular Access.

OBJECTIVE: The aim of the study was to observe the natural haemodynamic changes after arteriovenous fistula (AVF) creation in haemodialysis patients with and without a previous ipsilateral vascular access. METHODS: This was a retrospective, single centre cohort study. Patient demographics were registered and pre- and post-operative vessel ultrasound examinations were performed at regular follow up intervals. Arteriovenous fistula outcomes in terms of vessel diameter and access flow enhancement were determined for radiocephalic, brachiocephalic, and brachiobasilic AVFs. RESULTS: In total, 331 patients (median age 66 years, 60% male) with 366 new autologous AVFs were studied, of whom 112 patients had a previous ipsilateral vascular access (VA). Patients with a previous ipsilateral VA had a statistically significantly greater pre-operative brachial artery diameter (4.4 mm) and flow (106 mL/min), and basilic vein diameter (4.9 mm), compared with patients without a previous ipsilateral VA (4.0 mm, 54 mL/min, and 4.3 mm, respectively). For all AVF configurations these differences gradually disappeared over three months after AVF creation. The haemodynamic changes reached a plateau at three months, and were statistically significantly accelerated in patients with a previous ipsilateral VA. There were no differences in primary failure or high flow complications between both groups. CONCLUSION: Arteriovenous fistulae show haemodynamic and remodelling changes up to three months post-operatively. Previous ipsilateral VAs may initiate vessel preconditioning, and accelerate the observed haemodynamic changes after AVF creation. However, this preconditioning does not result in a beneficial or detrimental effect on VA function.

Computational Modelling Based Recommendation on Optimal Dialysis Needle Positioning and Dialysis Flow in Patients With Arteriovenous Grafts.

OBJECTIVE: Arteriovenous grafts (AVGs) typically lose patency within two years of creation due to venous neointimal hyperplasia, which is initiated by disturbed haemodynamics after AVG surgery. Haemodialysis needle flow can further disturb haemodynamics and thus impact AVG longevity. In this computational study it was assessed how dialysis flow and venous needle positioning impacts flow at the graft-vein anastomosis. Furthermore, it was studied how negative effects of dialysis needle flow could be mitigated. METHODS: Non-physiological wall shear stress and disturbed blood flow were assessed in an AVG model with and without dialysis needle flow. Needle distance to the venous anastomosis was set to 6.5, 10.0, or 13.5 cm, whereas dialysis needle flow was set to 200, 300 or 400 mL/min. Intraluminal needle tip depth was varied between superficial, central, or deep. The detrimental effects of dialysis needle flow were summarised by a haemodynamic score (HS), ranging from 0 (minimal) to 5 (severe). RESULTS: Dialysis needle flow resulted in increased disturbed flow and/or non-physiological wall shear stress in the venous peri-anastomotic region. Increasing cannulation distance from 6.5 to 13.5 cm reduced the HS by a factor 4.0, whereas a central rather than a deep or superficial needle tip depth reduced the HS by a maximum factor of 1.9. Lowering dialysis flow from 400 to 200 mL/min reduced the HS by a factor 7.4. CONCLUSION: Haemodialysis needle flow, cannulation location, and needle tip depth considerably increase the amount of disturbed flow and non-physiological wall shear stress in the venous anastomotic region of AVGs. Negative effects of haemodialysis needle flow could be minimised by more upstream cannulation, by lower dialysis flow and by ensuring a central needle tip depth. Since disturbed haemodynamics are associated with neointimal hyperplasia development, optimising dialysis flow and needle positioning during haemodialysis could play an important role in maintaining AVG patency.

The Effect of Geometric Graft Modification on Arteriovenous Graft Patency in Haemodialysis Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: Arteriovenous grafts (AVGs) are the second best option for haemodialysis access when native arteriovenous fistulae placement is not possible, because they have a lower patency owing to neointimal hyperplasia at the venous anastomosis. This review aimed to evaluate the effect of geometric graft modification to the graft-vein interface on AVG patency. DATA SOURCES: The MEDLINE and Embase (OvidSP) databases were systematically searched for relevant studies analysing the effect of geometrically modified AVGs on graft patency and stenosis formation (last search July 2019). REVIEW METHODS: Data regarding AVG type, patency, and graft outlet stenosis was extracted for further evaluation. Data were pooled in a random effects model to estimate the relative risk of graft occlusion within one year. Follow up, number of patients, and relevant patient characteristics were extracted for the quality assessment of the included studies using Newcastle-Ottawa Scale and Cochrane Risk of Bias Tool. The quality of the evidence was determined according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. RESULTS: Search strategies produced 2772 hits, of which eight articles met predetermined inclusion criteria. Overall, the included articles had low to moderate risk of bias. In total, 414 expanded polytetrafluoroethylene AVGs (232 geometrically modified and 182 standard) were analysed, comprising two modified AVG types: a prosthetic cuff design (Venaflo®) and grafts with a Tyrell vein patch. Overall, modified grafts did not show a statistically significantly higher one year primary (relative risk [RR] 0.86, 95% confidence interval [CI] 95% 0.64-1.16; GRADE: "low to very low") or secondary patency (RR 0.57, 95% CI 0.32-1.02; GRADE: "low to very low") when compared with standard AVGs. Analysis of prosthetic cuffed grafts (112 patients) separately demonstrated a statistically significantly higher one year primary (RR 0.75, 95% CI 0.61-0.91) and one year secondary patency (RR 0.47, 95% CI 0.30-0.75) compared with standard grafts (92 patients). The results on stenosis formation were inconclusive and inadmissible to quantitative analyses. CONCLUSION: The meta-analysis showed that a prosthetic cuff design significantly improves AVG patency, while a venous cuff does not. Although the heterogeneity and low number of available studies limit the strength of the results, this review shows the potential of grafts with geometric modification to the graft-vein anastomosis and should stimulate further clinical and fundamental research on improving graft geometry to improve graft patency.

Pre-operative Patient Specific Flow Predictions to Improve Haemodialysis Arteriovenous Fistula Maturation (Shunt Simulation Study): A Randomised Controlled Trial.

OBJECTIVE: An arteriovenous fistula (AVF) needs to mature before it becomes suitable to cannulate for haemodialysis treatment. Maturation importantly depends on the post-operative flow increase. Unfortunately, 20-40% of AVFs fail to mature (FTM). A patient specific computational model that predicts immediate post-operative flow was developed, and it was hypothesised that providing information from this model for planning of fistula creation might reduce FTM rates. METHODS: A multicentre, randomised controlled trial in nine Dutch hospitals was conducted in which patients with renal failure who were referred for AVF creation, were recruited. Patients were randomly assigned (1:1) to the control or computer simulation group. Both groups underwent a work up, with physical and duplex ultrasonography (DUS) examination. In the simulation group the data from the DUS examination were used for model simulations, and based on the immediate post-operative flow prediction, the ideal AVF configuration was recommended. The primary endpoint was AVF maturation defined as an AVF flow ≥500 mL/min and a vein inner diameter of ≥4 mm six weeks post-operatively. The secondary endpoint was model performance (i.e. comparisons between measured and predicted flows, and (multivariable) regression analysis for maturation probability with accompanying area under the receiver operator characteristic curve [AUC]). RESULTS: A total of 236 patients were randomly assigned (116 in the control and 120 in the simulation group), of whom 205 (100 and 105 respectively) were analysed for the primary endpoint. There was no difference in FTM rates between the groups (29% and 32% respectively). Immediate post-operative flow prediction had an OR of 1.15 (1.06-1.26; p < .001) per 100 mL/min for maturation, and the accompanying AUC was 0.67 (0.59-0.75). CONCLUSION: Providing pre-operative patient specific flow simulations during surgical planning does not result in improved maturation rates. Further study is needed to improve the predictive power of these simulations in order to render the computational model an adjunct to surgical planning.

Surgical and Endovascular Intervention for Dialysis Access Maturation Failure During and After Arteriovenous Fistula Surgery: Review of the Evidence.

BACKGROUND: Maturation failure is the major obstacle to establishing functional arteriovenous fistulae (AVF) for haemodialysis treatment. Various endovascular and surgical techniques have been advocated to enhance fistula maturation and to increase the number of functional AVFs. This narrative review considers the available evidence of interventional techniques for treatment of AVF non-maturation. RESULTS: Intra-operative vein dilation and anastomosis modification results in a clinical maturation rate of 74-92% and a 6 month cumulative AVF patency of 79-93%. Percutaneous transluminal angioplasty (PTA) with or without accessory vein obliteration is successful in 43-97% of patients. The long-term primary patency of PTA is rather low and multiple re-interventions are needed to achieve an acceptable cumulative fistula patency. The results of surgical revision exceed the results of endovascular intervention, with a mean primary one year patency of 73% (range 68-78%) compared with 49% (range 28-72%), respectively. The role of accessory vein obliteration remains unclear. CONCLUSION: Intervention for autologous arteriovenous fistula non-maturation is worthwhile and results in an increased number of functional fistulae. The outcome of surgical revision is better than endovascular and might be preferable in certain patient populations.

Three Year Patency and Recurrence Rates of Revision Using Distal Inflow with a Venous Interposition Graft for High Flow Brachial Artery Based Arteriovenous Fistula.

OBJECTIVES: Upper arm arteriovenous fistulas (AVF) occasionally develop high flow. Revision using distal inflow (RUDI) effectively reduces flow of high flow accesses (HFA) in the short-term and is also popularised for treatment of haemodialysis access induced distal ischaemia (HAIDI). The long-term efficacy is unknown. The study's aim was to report on 3 year RUDI patency and recurrence rates for HFA with and without HAIDI. MATERIAL AND METHODS: This was a retrospective cohort study of patients with a HFA with or without HAIDI undergoing RUDI using greater saphenous vein (GSV) interposition between March 2011 and October 2017 at three facilities. AVFs were termed HFA if flow volumes exceeded 2 L/min on two consecutive measurements using dilution techniques. HAIDI was diagnosed as recommended. Following RUDI, follow up was not different from standard care in AVF patients. Data on post-operative flows and re-interventions were extracted from electronic patient files. Loss to follow up was avoided. Rates of patency and HFA recurrence were analysed. RESULTS: During the observation period, 21 patients were studied (7 females, 54 years ± 3). Fourteen had uncomplicated HFA whereas seven had additional HAIDI. Immediately post-operatively, flows decreased threefold (3120 mL/min ± 171 vs. 1170 mL/min ± 87, p < .001). Overall 3 year primary patency was 48% ± 12 (HFA, 55% ± 15 vs. HAIDI/HFA, 29% ± 17, p = .042). Secondary patency was identical in both groups (overall, 84% ± 9). Interventions were percutaneous transluminal angioplasty (n = 12, 9 patients), thrombectomy (n = 7, 3 patients), and revision with new interposition grafts (n = 3). After 3 years, 51% ± 12 were free of high flow (HFA, 32% ± 13 vs. HAIDI/HFA, 100%, p = .018). High immediate post-operative access flow predicted recurrence (OR 1.004 [1.000-1.007], p = .044). Patients with recurrence were 12 years younger than those without (p = .055). CONCLUSION: RUDI with GSV interposition for HFA offers acceptable patency rates after 3 years although re-interventions are often required. High immediate post-operative flows and young age are associated with recurrent high flow.

Pre-operative Duplex Ultrasonography in Arteriovenous Fistula Creation: Intra- and Inter-observer Agreement.

OBJECTIVE: Although clinical guidelines on arteriovenous fistula (AVF) creation advocate minimum luminal arterial and venous diameters, assessed by duplex ultrasonography (DUS), the clinical value of routine DUS examination is under debate. DUS might be an insufficiently repeatable and/or reproducible imaging modality because of its operator dependency. The present study aimed to assess intra- and inter-observer agreement of DUS examination in support of AVF surgery planning. METHODS: Ten end stage renal disease patients were included, to assess intra- and inter-observer agreement of pre-operative DUS measurements. All measurements were performed by two trained and experienced vascular technicians, blinded to measurement readings. From the routine DUS protocol, representative measurements (venous diameters, and arterial diameters and volume flow in the upper arm and forearm) were selected. For intra-observer agreement the measurements were performed in triplicate, with the probe released from the skin between each. Intraclass correlation coefficients were calculated for intra- and inter-observer agreement, and Bland-Altman plots used to graphically display mean measurement differences and limits of agreement. RESULTS: Ten patients (6 male, 59.4±19.7 years) consented to participate, and all predefined measurements were obtained. Intraclass correlation coefficients for intra-observer agreement of diameter measurements were at least 0.90 (95% CI 0.74-0.97; radial artery). Inter-observer agreement was at least 0.83 (0.46-0.96; lateral diameter upper arm cephalic vein). The Bland-Altman plots showed acceptable mean measurement differences and limits of agreement. CONCLUSION: In experienced hands, excellent intra- and inter-observer agreement can be reached for the discrete pre-operative DUS measurements advocated in clinical guidelines. DUS is therefore a reliable imaging modality to support AVF surgery planning. The content of DUS protocols, however, needs further standardisation.

Effectiveness of surgical banding for high flow in brachial artery-based hemodialysis vascular access.

OBJECTIVE: Autogenous arteriovenous hemodialysis (HD) access may develop high flow (>2 L/min) over time. Reducing flow volume of a high-flow access (HFA) using a surgical banding technique has been reported to be successful in the short-term. The aim of this study was to evaluate the efficacy of banding in HFAs in terms of freedom from recurrence of high flow during a 1-year follow-up. METHODS: All HD patients undergoing surgical banding of an HFA during an 8-year period in three hospitals were retrospectively studied. Access flow data, freedom of recurrent high flow, and complications were analyzed during a 12-month postoperative observation period. RESULTS: A total of 50 patients (30 males; age, 51 ± 2 years) were available for analysis. Banding was performed 30 ± 6 months after arteriovenous access construction. Most of the HFA patients (56%) required medication for hypertension, but diabetes mellitus and peripheral arterial obstructive disease were seldom observed (6% and 12%, respectively). Most HFAs (96%) were brachial artery-based fistulas (brachiocephalic: 56%, basilic vein transposition: 40%, radiocephalic: 4%). Banding initially reduced access flow by >50% (3070 ± 95 vs 1490 ± 105 mL/min, P < .001). Recurrent high flow (>2 L/min) developed in 52% of the patients during the observation period. Young age (45 ± 3 vs 57 ± 3 years; P = .02) and an access flow >1 L/min immediately after banding (P = .03) were risk factors for recurrent high flow. CONCLUSIONS: An immediate postbanding access flow >1 L/min and young age are risk factors for recurrent high flow in a banded brachial artery-based HD access during a 1-year follow-up.

Vascular access vulnerability in intensive hemodialysis: a significant Achilles' heel?

BACKGROUND: Frequent hemodialysis (HD) may be associated with an increased risk of vascular access complications. Studies addressing vascular access outcomes in frequent HD show conflicting results. METHODS: We searched Medline for trials looking at vascular access outcomes in frequent HD. RESULTS: Nineteen studies met the inclusion criteria; only studies with a control group were included for analysis (n = 15). The vascular access event rate was higher in intensive HD as compared to conventional HD (difference of 6.7 events per 100 patient-years, p = 0.009). Overall event rates were not significantly different between conventional and intensive HD when stratified for access type, but were notably higher in the arteriovenous grafts and catheter group as compared to the arteriovenous fistula (AVF) group. CONCLUSION: Intensive HD is associated with an increased risk of vascular access complications. Overall reported event rates were lower in the AVF group. Further controlled studies should investigate whether a 'fistula first' strategy may be recommended also for intensive HD.

Validation of a patient-specific hemodynamic computational model for surgical planning of vascular access in hemodialysis patients.

Vascular access dysfunction is one of the main causes of morbidity and hospitalization in hemodialysis patients. This major clinical problem points out the need for prediction of hemodynamic changes induced by vascular access surgery. Here we reviewed the potential of a patient-specific computational vascular network model that includes vessel wall remodeling to predict blood flow change within 6 weeks after surgery for different arteriovenous fistula configurations. For model validation, we performed a multicenter, prospective clinical study to collect longitudinal data on arm vasculature before and after surgery. Sixty-three patients with newly created arteriovenous fistula were included in the validation data set and divided into four groups based on fistula configuration. Predicted brachial artery blood flow volumes 40 days after surgery had a significantly high correlation with measured values. Deviation of predicted from measured brachial artery blood flow averaged 3% with a root mean squared error of 19.5%, showing that the computational tool reliably predicted patient-specific blood flow increase resulting from vascular access surgery and subsequent vascular adaptation. This innovative approach may help the surgeon to plan the most appropriate fistula configuration to optimize access blood flow for hemodialysis, potentially reducing the incidence of vascular access dysfunctions and the need of patient hospitalization.

Blood flow dynamics in patients with hemodialysis access-induced hand ischemia.

OBJECTIVE: Hand ischemia may occur in the presence of a hemodialysis arteriovenous fistula (AVF), but its pathophysiology is partly unclear. The aim of this observational study was to investigate flow characteristics of forearm arteries in patients with a brachial artery-based AVF suffering from hemodialysis access-induced distal ischemia (HAIDI). METHODS: A questionnaire scored hand ischemia in patients with HAIDI scheduled for revisional surgery (no symptoms of ischemia, 0 points; maximal ischemia, 500 points). Systolic index finger pressures (Pdig) and digital brachial index (DBI) were determined with open and compressed AVF. Blood flow direction and peak systolic velocity (PSV) were measured in radial and ulnar arteries using Doppler ultrasonography. Age- and sex-matched hemodialysis patients without HAIDI served as controls (CONT). RESULTS: Questionnaire scores were 258 ± 30 in patients with HAIDI (n = 10) compared with 31 ± 16 in CONT (n = 10; P < .01). Pdig and DBI with open AVF were lower in the HAIDI group than the CONT group (Pdig 22 ± 10 vs 102 ± 10 mm Hg; DBI 0.18 ± 0.08 vs 0.70 ± 0.04; both P < .01). Ulnar artery PSV was lower in HAIDI compared with CONT patients (38 ± 4 vs 56 ± 3 cm/s; P < .01). Mean ulnar artery PSV was significantly correlated to Pdig (r = 0.87; P < .01) in contrast to mean radial artery PSV (r = 0.06; P = .81). Ulnar artery blood flow direction was always toward the ischemic hand (n = 20). However, blood flow was reversed in just a short segment of the proximal radial artery in one HAIDI patient but also in two CONT patients. CONCLUSIONS: Hand ischemia in hemodialysis patients with a brachial artery-based AVF is not caused by a reversed blood flow direction in forearm arteries. However, forearm blood flow is diminished in these patients leading to critically reduced arterial pressures in the hand.

Guideline recommendations on minimal blood vessel diameters and arteriovenous fistula outcomes.

OBJECTIVE: Clinical guidelines provide recommendations on the minimal blood vessel diameters required for arteriovenous fistula creation but the evidence for these recommendations is limited. We compared vascular access outcomes of fistulas created in agreement with the ESVS Clinical Practice Guidelines (i.e. arteries and veins >2 mm for forearm fistulas and >3 mm for upper arm fistulas) with fistulas created outside these recommendations. METHODS: The multicenter Shunt Simulation Study cohort contains 211 hemodialysis patients who received a first radiocephalic, brachiocephalic, or brachiobasilic fistula before publication of the ESVS Clinical Practice Guidelines. All patients had preoperative duplex ultrasound measurements according to a standardized protocol. Outcomes included duplex ultrasound findings at 6 weeks after surgery, vascular access function, and intervention rates until 1 year after surgery. RESULTS: In 55% of patients, fistulas were created in agreement with the ESVS Clinical Practice Guidelines recommendations on minimal blood vessel diameters. Concordance with the guideline recommendations was more frequent for forearm fistulas than for upper arm fistulas (65% vs 46%, p = 0.01). In the entire cohort, agreement with the guideline recommendations was not associated with an increased proportion of functional vascular accesses (70% vs 66% for fistulas created within and outside guideline recommendations, respectively; p = 0.61) or with decreased access-related intervention rates (1.45 vs 1.68 per patient-year, p = 0.20). In forearm fistulas, however, only 52% of arteriovenous fistulas created outside these recommendations developed into a timely functional vascular access. CONCLUSIONS: Whereas upper arm arteriovenous fistulas with preoperative blood vessel diameters <3 mm had similar vascular access function as fistulas created with larger blood vessels, forearm arteriovenous fistulas with preoperative blood vessel diameters <2 mm had poor clinical outcomes. These results support that clinical decision-making should be guided by an individual approach.

Determination of brachial artery stiffness prior to vascular access creation: reproducibility of pulse wave velocity assessment.

BACKGROUND: Despite routine ultrasound mapping of upper extremity arteries and veins, early thrombosis and nonmaturation remain frequent complications following vascular access (VA) surgery. Besides vascular diameters, brachial artery stiffness is assumed to play an important role; however, reproducibility of measurements has never been established. The purpose of this study was to determine within-session and between-session variabilities of pulse wave velocity (PWV) assessment by using ultrasonography and blood pressure registration. METHODS: Beat-to-beat changes in brachial artery diameter and pressure were obtained in 21 subjects in measurement sessions on Day 1 and Day 3. Each session consisted of three acquisitions. For each acquisition, systolic and diastolic diameter and pressure were determined and used for calculation of brachial artery PWV. Within-session variability of diameter and pressure, as well as the estimated PWV, was expressed using the intraclass correlation coefficient with corresponding coefficient of variation (CoV). Between-session variability was reported using Bland-Altman analysis in combination with CoV analysis. RESULTS: Significant agreement (P < 0.001) was obtained for all diameter and pressure measurements obtained on Day 1 and Day 3. Within-session CoV of pulse pressure, diastolic diameter and distension were 7.0, 1.6 and 18.3%, respectively. Subsequent estimation of local PWV resulted in a CoV of 10.6%. Between-session CoV was 15.1, 3.8 and 18.9% for pulse pressure, diastolic diameter and distension, respectively. For PWV estimation, this resulted in a CoV of 13.5%. CONCLUSIONS: Diameter and pressure can be recorded accurately over the cardiac cycle, and calculations of distensibility, pulse pressure and PWV show a slight to moderate degree of variation. Larger studies elaborating on interindividual differences need to determine the clinical efficacy of PWV measurements prior to VA creation.