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.

Autologous forearm arteriovenous loop vascular access, an option to be considered.

BACKGROUND: Autologous arteriovenous fistula is usually the vascular access of choice for hemodialysis in patients with chronic kidney disease. Autologous forearm loops with cephalic or basilic vein are an alternative in those cases with a suitable forearm vein but with an unsuitable radial artery; however they are rarely used and there is little reported evidence of their usefulness. Our objective is to report our results on the creation of autogenous forearm loops as vascular access for hemodialysis. METHODS: We present a prospective cohort study of autogenous forearm loop arteriovenous fistula created between 2010 and 2022, in patients with stage 4-5 chronic kidney disease. Demographic data, surgical details, vein used, follow up to 24 months, maturation, utilization, primary, assisted, and secondary patency estimations with Kaplan-Meier curves, as well as complications during follow-up, were recorded. RESULTS: During the study period, 22 autologous forearm loops were created, 14 of them with cephalic, and 8 with basilic vein. Most (59%) of the patients were men, 19 were already on dialysis and the rest started during follow-up. Sixteen patients had previous vascular accesses. One patient was lost during follow-up. Six-week maturation rate was 61.9% and utilization rate was 57.1%. 6, 12, and 24 months primary and secondary patencies were 75.4%, 59.2%, 41.5% and 85.0%, 69.5%, 56.9% respectively. In five patients an access-induced distal ischemia was diagnosed, four successfully treated and only one patient lost the access. No cases of infection or other major complications were reported. CONCLUSION: Autologous forearm loops have acceptable maturation (61.9%) and patency rates at follow-up (56.9% 2-years secondary patency). Although rarely used, they are a vascular access alternative that should be considered to preserve the proximal vasculature of the arm for future accesses.

Inflow Artery Aneurysmal Degeneration After Long Term Native Arteriovenous Fistula for Haemodialysis.

OBJECTIVE: Inflow arterial aneurysms are a rare but serious complication after long term arteriovenous fistulae (AVF), probably due to arterial wall remodelling after an increase in flow and shear stress, and kidney transplantation with immunosuppressive therapy. This study aimed to describe the outcomes of surgical treatment and long term follow up in a large cohort. METHODS: This prospective cohort study collected data from patients with a true inflow artery aneurysm after AVF creation that was surgically repaired between 2010 and 2022. Anastomotic and infected aneurysms or post-puncture pseudoaneurysms were excluded. Demographic data, access characteristics, symptoms, treatment strategies, and long term follow up were recorded; patency was estimated using Kaplan-Meier survival analysis. RESULTS: During the study period, 28 patients (64% men, mean age 60.1 years) were treated surgically for aneurysmal degeneration of the axillary or brachial (n = 23) or radial (n = 5) artery after an AVF (10 distal, 18 proximal) performed a mean of 18.3 ± SD 7.9 years previously. Most AVFs were ligated or thrombosed, while all patients except one had previously received kidney transplants. Most of the cases (n = 18) were symptomatic: 13 with pain or swelling, four with distal embolisation, and one rupture. They were repaired by aneurysm partial excision and graft interposition (11 great saphenous vein, six ipsilateral basilic vein, three cephalic vein, and two PTFE graft), ligation (n = 3), or direct end to end anastomosis (n = 3). No major complications occurred before discharge, after a mean hospital stay of 2.4 days. After a mean follow up of 4.8 ± 3.3 years, three cases presented complications: two recurrent proximal brachial aneurysms were repaired with an additional proximal interposition graft (one with further late infected pseudoaneurysm) and an asymptomatic post-traumatic graft thrombosis. Five year primary and secondary patency was 84% and 96%, respectively. CONCLUSION: Aneurysmal degeneration of the inflow artery is an unusual complication during long term follow up of AVFs. Aneurysm excision and, in general, autogenous graft interposition using the saphenous or ipsilateral arm vein is a safe and effective strategy.

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.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

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.

Impact of Target Visceral Vessel Anatomical Configuration on Early Complications Following Endovascular Repair of Thoracoabdominal Aortic Aneurysms.

BACKGROUND: Fenestrated and branched endovascular aortic repair (fEVAR-bEVAR) is a viable treatment option for thoracoabdominal aortic aneurysms but target visceral stent (TVS) endoleak and thrombosis remain a limiting factor. This study aims to evaluate TVS anatomy impact on 1-year risk of thrombosis and endoleak. METHODS: Patients treated with fEVAR-bEVAR for thoracoabdominal aneurysms between 2008 and 2020 in our centre were enrolled. We recorded comorbidities, operative details, 1-month postoperative CT scan (anatomical reference), and TVS behaviour: thrombosis and endoleak at 1-year follow-up. For each TVS, different points were identified using a centre-lumen-line: (A) TVS origin, (B) end of branch/fenestration, (C) visceral vessel entry, (D) end of TVS, (E) 1-cm distally. We analyzed TVS tortuosity ((centre-lumen-line/straight distance)-1, in %), image vector analysis of each segment in 2D (antero-posterior, left-right) and 3D (craneo-caudal displacement), and centre-lumen-line analysis (bending in ABC and CDE). Three independent observers performed a blind analysis, and anatomical differences between bEVAR/fEVAR, and cases with/without 1-year thrombosis and TVS endoleak, were compared using Kaplan-Meier curves (Log-Rank test), and t-test/Wilcoxon signed-ranks test respectively. RESULTS: Fifty-four patients (72 ± 713 years mean age; 182 TVS: 50 branches, 132 fenestrations) met the inclusion criteria. bEVAR cases had longer stents, with more caudal 3D angulation, and greater ABC angulated segment. After excluding bEVAR cases (low case number), 97 fEVAR TVS were analyzed. Five thrombosis and 7 endoleaks were observed. While anatomical configuration showed no association to thrombosis, it was related to endoleak: these cases presented more tortuous stents (5.97% ± 0.10, 21.40% ± 0,22, P = 0.011), with more angulated centre-lumen-line at ABC segment (5.69° ± 15.77°, 7.18° ± 7.77°, P = 0.012), and more upward-pointing stents in the origin of the stent (AB: 89.07° ± 24.46°, 109.09° ± 16.56°, P = 0.012; BC: 87.86° ± 21.10°, 113.11° ± 22.23°, P = 0.026). CONCLUSIONS: Anatomical configuration of the TVS is associated with type III endoleak, but not thrombosis, at 1-year following fEVAR. Cases with endoleak presented more tortuous stents, with a more angulated exit from the endograft, and upward-pointing of the origin of the stent.

Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae.

OBJECTIVE: To evaluate the outcomes of arteriovenous fistulae (AVF), created with VasQ external support device under standard clinical practice across three vascular access clinics. METHODS: This multinational, retrospective study evaluated prospectively collected clinical outcomes of both forearm and upper arm brachiocephalic AVF (BCAVF) created using the VasQ device. Fifty-one AVF patients were pooled from three different vascular access centers in Germany, Italy, and Spain. Postprocedure outcomes were assessed by flow measurement with ultrasound examination in all centers. Primary failure, usability, patency, and intervention rates during the study period were evaluated. RESULTS: Fifty-one VasQ devices were implanted during 37 forearm (36 radiocephalic and 1 ulnar-basilic AVF) and 14 BCAVF procedures. The study population comprised mostly males (73%) and Caucasians (82%), with a mean age of 62.5 years (range, 38-84 years) and mean body mass index of 29.2. One patient died owing to access-unrelated reasons, and one patient was lost to follow-up without AVF assessment after its creation. From the remaining 49, 3 patients had a follow-up of less than 4 weeks and were excluded from maturation, primary failure, and dialysis initiation analysis (because those factors could not be evaluated yet), leaving 46 patients in this evaluation. Maturation was achieved in 91% of patients. The primary failure rate was 9%. A primary patency rate of 77% was observed at 6, 12, and 18 months. The secondary patency rate was 91% at 6 months, and 85% at 12 months and 18 months. Both primary patency and secondary patency did not differ statistically when comparing forearm AVF with BCAVF (P > .25). Successful cannulation was achieved in 86% of patients (32/37) requiring dialysis with a median time from creation to cannulation of 46 days. Of those patients, the functional patency rate was 94%. Five patients underwent seven interventions to maintain or restore patency or functionality, with an overall rate of 0.248 interventions per patient-year. CONCLUSIONS: AVFs created with VasQ external support device demonstrated promising patency and functionality outcomes in multicentric real-world setting across the two most commonly used anatomic locations.

Linoleic Acid Status in Cell Membranes Inversely Relates to the Prevalence of Symptomatic Carotid Artery Disease.

BACKGROUND AND PURPOSE: The red blood cell fatty acid composition objectively reflects the long-term dietary intake of several fatty acids. In patients undergoing carotid endarterectomy, we explored whether red blood cell status of selected fatty acids related to symptomatic carotid artery disease. METHODS: We included patients with symptomatic (n=22) and asymptomatic (n=23) carotid artery disease. We determined all-C18:1 trans, linoleic acid (LA, C18:2n6), alpha-linolenic acid (C18:3n3), and the omega-3 index (sum of eicosapentaenoic [C20:5n3] and docosahexaenoic [C22:6n3] acids) in both red blood cells and carotid plaque phospholipids by gas-chromatography. RESULTS: In a multivariate logistic regression analysis, we only observed a significant association for LA, whose red blood cell status was inversely related to symptomatic carotid artery disease (odds ratio, 0.116 [95% CI, 0.022-0.607], P=0.011, for each 1-SD increase). A similar result was observed for LA in carotid plaque phospholipids. CONCLUSIONS: Cell membrane enrichment in LA, which reflects its intake, was inversely related to symptomatic carotid disease. This increases evidence supporting a favorable role of dietary LA in vascular health.

Guía de práctica clínica: Utilidad de los ultrasonidos en la creación y mantenimiento de los accesos arteriovenosos. Capítulo de Diagnóstico Vascular. Sociedad Española de Angiología y Cirugía Vascular / Clinical practice guide: utility of ultrasound in the creation and maintenance of arteriovenous access Vascular Diagnosis Chapter. Spanish Society of Angiology and Vascular Surgery

El acceso vascular en los pacientes en programa de hemodiálisis condiciona de forma significativa la calidad de las sesiones de diálisis, su morbimortalidad, complicaciones y necesidad de nuevos procedimientos a lo largo del tiempo, además de importantes implicaciones técnicas y económicas. Se trata de pacientes frágiles, muchas veces reintervenidos, que van a requerir un acceso vascular durante largos periodos de tiempo o para el resto de su vida, por lo que estamos ante una piedra angular que debemos tratar de la mejor forma posible. Y en este campo, los ultrasonidos ofrecen, más que en ninguna otra localización, una inestimable ayuda en todas las etapas del acceso vascular: desde su planificación, creación, seguimiento, o como herramienta intraoperatoria

Vascular access in patients on hemodialysis significantly affects the quality of life, morbidity, mortality, complications and the need for new procedures over time. In addition, they have important technical and economic implications. These are fragile patients, often with many reinterventions, who will require vascular access for long periods of time or for the rest of their lives, so we are facing a big health problem that we must treat in the best possible way. In this framework, ultrasounds offer, more than in any other location, an invaluable help in all stages of vascular disease: from planning the arteriovenous access, creation, follow-up or as intraoperative tool. This document tries to provide an update and help to clinical practice

European Society for Vascular Surgery (ESVS) Certification of Theoretical and Practical Competences in Basic Vascular Ultrasound: Validity Investigation of the Assessment Tools.

OBJECTIVE: The aim of this study was to gather validity evidence for the Assessment of basic Vascular Ultrasound Expertise (AVAUSE) tool, and to establish a pass/fail score for each component, to support decisions for certification. METHODS: A cross sectional validation study performed during the European Society for Vascular Surgery's annual meeting. Validity evidence was sought for the theoretical test and two practical tests based on Messick's framework. The participants were vascular surgeons, vascular surgical trainees, sonographers, and nurses with varying experience levels. Five vascular ultrasound experts developed the theoretical and two practical test components of the AVAUSE tool for each test component. Two stations were set up for carotid examinations and two for superficial venous incompetence (SVI) examinations. Eight raters were assigned in pairs to each station. Three methods were used to set pass/fail scores: contrasting groups' method; rater consensus; and extended Angoff. RESULTS: Nineteen participants were enrolled. Acceptable internal consistency reliability (Cronbach's alpha) for the AVAUSE theoretical (0.93), carotid (0.84), and SVI (0.65) practical test were shown. In the carotid examination, inter-rater reliability (IRR) for the two rater pairs was good: 0.68 and 0.78, respectively. The carotid scores correlated significantly with years of experience (Pearson's r = 0.56, p = .013) but not with number of examinations in the last five years. For SVI, IRR was excellent at 0.81 and 0.87. SVI performance scores did not correlate with years of experience and number of examinations. The pass/fail score set by the contrasting groups' method was 29 points out of 50. The rater set pass/fail scores were 3.0 points for both carotid and SVI examinations and were used to determine successful participants. Ten of 19 participants passed the tests and were certified. CONCLUSION: Validity evidence was sought and established for the AVAUSE comprehensive tool, including pass/fail standards. AVAUSE can be used to assess competences in basic vascular ultrasound, allowing operators to progress towards independent practice.

Climatic influence on the risk of abdominal aortic aneurysm rupture.

Our aim is to examine the effects of climatic conditions on the incidence of ruptured abdominal aortic aneurysms (rAAA) in Catalonia, Spain. We combined clinical data from the Public Health official registries in Catalonia, Spain (HD-MBDS) of all rAAA with local climatic data obtained from the closest meteorological station (69 stations, National Meteorological Service: MeteoCat) from 2008 to 2017. We analyzed the median, maximum, minimum, and variability of atmospheric pressure (hPa) and air temperature (°C), solar irradiation (MJ/m2), humidity (%), accumulated precipitation (mm), median wind, and maximum flaw direction and velocity (°, m/s), recorded on the days of events, the previous day, and mean results for 3, 7, and 30 days before, as well as seasonality. Seventy-five control days were randomly selected in a 1-year period around every rAAA day at the same meteorological station, and compared. A total of 717 days and locations with rAAA were identified, and 53,775 controls were randomly selected. For the rAAA days, there were significantly lower temperatures, lower solar global irradiation, and higher mean humidity levels in all time periods (p < 0.001, p < 0.001, p < 0.05); higher atmospheric pressure variability during 1 week and 1 month before (p = 0.011, p = 0.007); and they often occurred during autumn/winter (57.6%, p < 0.001). Logistic regression identified low mean temperatures on the days of ruptures and high mean humidity the week before as independent rupture predictors. In conclusion, low median temperatures the same day and high humidity during 1 week before were identified as independent predictors of rAAA occurrence. The role of climate on pathophysiologic mechanisms may require further investigation.

Impact of Centralisation on Abdominal Aortic Aneurysm Repair Outcomes: Early Experience in Catalonia.

OBJECTIVE: Several studies have revealed high volume centres have better outcomes in the treatment of abdominal aortic aneurysms (AAAs), thus supporting centralisation of this procedure into selected centres based on volume. To date however, the real benefit of centralisation of this pathology has not been well demonstrated. The aim of this study was to analyse the impact of centralisation in to high volume centres (defined as those performing more than 30 cases per year) on AAA treatment outcomes carried out in Catalonia (Spain). METHODS: Data were collected from official national registries (HDMBD) for AAA treated by endovascular aneurysm repair (EVAR) or open repair (OR) over a nine year period. Two time periods were selected for comparison: before centralisation (2009-2014) and after complete centralisation (2015-2017). The primary objective was to determine short term mortality (in hospital and 30 day mortality) and length of stay (LOS) after intact AAA (iAAA) and ruptured AAA (rAAA) repair, before and after centralisation. Uni- and multivariable analyses were performed in order to identify independent outcomes predictors. RESULTS: A total of 3 501 iAAAs, including 1 124 (32.1%) OR and 2377 (67.9%) EVAR, and 409 rAAAs, including 218 (53.3%) OR and 191 (46.7%) EVAR, were identified. After centralisation, there was a significant decrease in overall mortality in iAAA repair (4.7% vs. 2.0%, p < .001) and rAAA repair (53.1% vs. 41.9%, p = .028). Mortality reduction in iAAAs was significant for OR (8.7% vs. 3.6%, p = .005), but not for EVAR (2.2% vs. 1.5%, p = .25). Overall LOS decreased as well, mainly in iAAAs (9.49 ± 10.84 vs. 7.44 ± 12.23 days, p < .001), and in particular in elective EVAR (7.32 ± 7.73 vs. 6.00 ± 8.97 days, p < .001). Multivariable analysis was identified before the centralisation period as an independent predictor for both mortality (odds ratio 1.484, 95% CI 1.098-2.005, p = .010) and LOS (B coefficient 1.146, 95% CI 0.218-2.073, p = .016). CONCLUSION: The implementation of a country based centralisation programme for AAA treatment led to a significant reduction in short term mortality, for both iAAA and rAAA, and mainly for elective OR. LOS also significantly decreased, mainly for elective EVAR. These results support the benefit of centralisation of AAA repair procedures.