BACKGROUND:To analyze the outcomes of two different patch materials during femoral endarterectomies (FEA). METHODS:It is a ingle center, observational, retrospective cohort study. We identified all patients operated between January 1st, 2016-December 31st, 2023. An exact match analysis was used to identify two groups based on the type of patch: pericardial, and dacron. The primary outcomes were the freedom from patch-related complications and/or reoperations during follow-up. Secondary outcomes were the perioperative complication rate and limb salvage rate. RESULTS:We analyzed 275 patch reconstructions: 139 (50.5%) with pericardial patch, and 136 (49.5%) with dacron patch. There was no difference between the two groups either for the duration of intervention [190 (IQR, 130-262) vs. 172 (IQR, 118.7-257); p = 0.131] or the blood loss [250 (IQR, 150-500) vs. 200 (IQR, 100-500); p = 0.130]. We observed no intraprocedural deaths and only 1 (0.4%) in-hospital death. Overall, we observed 87 (31.3%) complications of which 35 (12.7%) were major. The median follow-up was 32 (IQR, 16-58) months. Overall, estimated cumulative survival was 82% ± 2 at 12 months (95% CI: 79.6-85.2) and 52% ± 3 at 60 months (95% CI: 45.3-58.9) with no difference between the two groups (p = 0.282). We encountered 19 (6.9%) patch-related reinterventions: restenosis in 10 (52.6%) and pseudoaneurysm/infection in 9 (47.4). %) cases. Freedom from patch-related reoperation was estimated 92% ± 9 at 60 months (95% CI: 87.4-94.9) without significant differences between the two groups (p = 0.810). Cox regression did not identify any predictive factors. The need for patch-related reintervention was not associated with an increased mortality (p = 0.972) or risk of major amputation was observed (p = 0.080). CONCLUSIONS:Femoral endarterectomy is safe, and mid-term outcomes are independent of the patch material used for its reconstruction.
BACKGROUND:The configuration of the arterial anastomosis in prosthetic arteriovenous grafts (AVGs) significantly affects hemodynamics, thrombogenicity, and long-term patency. While tapered grafts have been developed to optimize inflow, their use is limited by cost, availability, and reduced adaptability. We evaluated a surgeon-modified beveled end-to-side anastomosis using standard grafts as a simple, cost-neutral alternative for upper-limb AVG creation, including in high-risk and urgent settings. METHODS:We conducted a retrospective single-center study of 46 patients who received AVGs with a beveled anastomosis tailored to ~60°, based on a standardized cutting protocol. Data were collected prospectively. Outcomes included technical and clinical success, thrombosis, patency, and complications. Hemodynamic implications were contextualized using existing computational and clinical models. RESULTS:Technical success was achieved in 100% of cases; clinical success in 93.5%. Early thrombosis occurred in 4.3% and was managed with thrombectomy. Late thrombosis (15.2%) was mainly due to venous outflow stenosis; inflow-related stenosis was rare (4.3%). No cases of hand ischemia, pseudoaneurysm, or suture-related complications were observed. Intraoperative imaging and follow-up ultrasound confirmed stable graft geometry. The technique was feasible across graft types, with trilaminar grafts requiring reduced angles (~45°). In selected cases, it served as a temporary bridge to native AVF maturation. CONCLUSIONS:This beveled anastomosis is a safe, reproducible technique for prosthetic AVG creation, with favorable hemodynamic characteristics and broad adaptability. It may offer specific advantages in complex or urgent cases.
PURPOSE:The algorithm of treatment for dysfunctional haemodialysis vascular access (VA) varies significantly between centres, and the role of stent-grafts is not yet standardised. A multidisciplinary panel of European experts on VA was convened, with the aim of finding consensus on stent-graft strategies in symptomatic dysfunctional VA using a modified Delphi approach. METHODS:A modified 3-round Delphi study was conducted with a panel of 12 European experts from high-volume dialysis access practices across multiple specialties (5 vascular surgeons, 5 interventional radiologists, 1 transplant surgeon and 1 nephrologist). Round 1 involved semi-structured interviews to identify key parameters. Round 2 assessed extent of expert agreement to the statements or if neutral. Round 3 allowed experts to revise responses after viewing anonymised panel results. To highlight gradations of consensus, a grading system (A-D) was applied based on agreement or disagreement, with consensus defined as ≥75% agreement. RESULTS:Each expert voted on the 57 statements on treatment considerations relating to optimal stent-graft utilisation; patient background; vascular occlusive pathology; considerations specific to the graft-venous anastomosis, cephalic arch and thoracic central vein stenoses; general treatment considerations with stent-grafts; and a summary treatment algorithm by anatomical location. The analysis revealed strong consensus across multiple domains, with 81% of statements (46/57) achieving ≥75% agreement. An expert panel consensus (≥75% agreement) on the use of stent-graft was found for the treatment of graft-venous anastomosis, recurrent restenosis in the central venous system, in-stent stenosis in previously-placed bare metal stents, and restenosis of the cannulation zone if to be abandoned. All 12 experts completed 3 rounds (100% retention). Response stability was high with only 3 experts adjusting 11 responses (1.6%) between rounds regarding 9 statements that changed the overall consensus level of the panel. CONCLUSIONS:Based on the elevated strength and high consistency of this international multidisciplinary expert-based Delphi consensus, most of the statements might guide the current stent-graft strategies of dysfunctional VA, including practical recommendations on best practice using stent-grafts.
INTRODUCTION:Arteriovenous fistulas (AVFs) remain the preferred vascular access for hemodialysis, though failure to mature, juxta-anastomotic stenosis, and distal hypoperfusion ischemic syndrome (DHIS) continue to limit their effectiveness. We evaluated a standardized approach combining small-size anastomoses (SSA) and the piggyback Straight-Line Onlay Technique (pSLOT) to improve outcomes in complex AVF creation. MATERIALS AND METHODS:This single-center prospective study included all consecutive patients referred for AVF creation from January 2022 to December 2023. Anastomoses were created using a 3.6 mm punch, and pSLOT was used in all cases. Doppler ultrasound was performed intraoperatively, at discharge, and during follow-up. Primary outcomes included AVF maturation and patency; secondary outcomes included DHIS incidence. RESULTS:A total of 78 AVFs were created (mean age 57 ± 18 years). Primary patency rates at 1, 2, and >4 months were 98.2%, 96.5%, and 94.7%, respectively. Maturation was achieved in 98.2% of cases. No cases of DHIS, thrombosis, or late failure were observed. Mean AVF flow at 12 months was 1080 ± 170 mL/min. DISCUSSION AND CONCLUSIONS:This standardized technique proved safe and effective in a high-risk cohort. The results support its adoption in anatomically complex cases and highlight the value of surgical standardization in VA practice.
Although it is accepted that a functional arteriovenous fistula (AVF) is the optimal vascular access for dialysis, achieving function is difficult as the outcomes of AVF creation are sub-optimal. Many technical steps have been proposed to improve outcomes, but the strength of evidence to support these is unclear. Thus, a systematic review of all randomised controlled trials (RCT) of operative strategies to optimise AVF outcomes was performed to summarise the evidence, review the overall level of standardisation in RCT and thus determine if there was an objective basis for the technical steps in AVF creation. A systematic review of all RCT was performed and studies categorised by intervention type. The rationale for each intervention, outcomes and limitations were described. Most importantly, the completeness of reporting procedural steps was compared for all RCT and the therapeutic impact considered by AVF site. Of 6741 records meeting the search criteria, 31 RCT were included. Most RCT did not control for all technical aspects or fully detail the operative methods, with a mean of 4 technical steps not reported for which other RCT have been performed. Of studies involving a surgical intervention in RCF, 10/13 reported a significant benefit compared to only 5/15 studies in BCF or larger vessels. Overall, the adequacy of reporting the technical details in all RCT of technical steps in AVF creation was poor. Despite this, there was a consistent patency benefit found in RCT performed in smaller vessels although the extent of interaction between these is uncertain. There remain gaps in the literature in defining the optimal steps in fistula creation that, if confirmed, could significantly improve AVF outcomes. This makes it essential that future studies of novel techniques, such as percutaneous AVF creation, incorporate a standardised operating procedure of optimal current practice of surgically created AVF as a meaningful comparator.
Optimizing the longevity of vascular access in hemodialysis patients remains a critical aspect of patient care, given the significant role of arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) in enabling effective dialysis. Vascular access complications, such as stenosis, thrombosis, and cannulation-related damage, continue to challenge both the functionality and the sustainability of these access points. Recent advancements underscore the importance of a robust follow-up strategy, integrating clinical evaluations with diagnostic tools like color Doppler ultrasound (CDU) and emerging interventional approaches such as drug-coated balloon (DCB) angioplasty. Regular CDU surveillance has shown promise in identifying asymptomatic stenosis, providing an opportunity for early intervention and reducing the risk of thrombotic events. This non-invasive imaging modality allows for detailed evaluation of hemodynamic changes within the vascular access, enabling timely detection and monitoring of stenotic lesions. Furthermore, the use of DCBs - angioplasty balloons coated with antiproliferative agents such as paclitaxel - offers a targeted approach to manage intimal hyperplasia and reduce restenosis rates in vascular access sites. Studies indicate that DCBs can mitigate neointimal proliferation, prolonging patency and enhancing long-term access outcomes. In this paper, we explore the synergistic role of clinical follow-up, ultrasound-based diagnostics, and drug-coated technologies in the preservation of vascular access. By examining the impact of these strategies, we aim to provide a comprehensive approach to vascular access maintenance, emphasizing the need for structured surveillance protocols and interventional techniques to optimize the lifespan of hemodialysis access points.
BACKGROUND:Xeltis' aXess hemodialysis (HD) conduit is a novel arteriovenous graft (AVG) made of bioabsorbable polymer, replaced by body-own tissue, through endogenous tissue restoration (ETR). METHODS:An ongoing prospective, single-arm, multi-center first-in-human (FIH) study evaluates safety and performance in hemodialysis patients unsuitable for arteriovenous fistula (AVF) creation. Primary and secondary 12-months outcomes are reported. RESULTS:The aXess conduit was implanted in 20 patients. Freedom from device-related serious adverse events (SAEs) was 100% at 6 months and 95% at 12 months, with no access-related infections. Two unrelated deaths occurred. Primary and secondary patency rates were 80% and 100% at 6 months, 39% and 100% at 12 months. Access-related interventions occurred in 61% of patients, mainly for thrombosis and stenosis (71%), and pseudoaneurysms (29%). Histology showed remodeling at 6 months; the polymer was almost resorbed at 15 months. CONCLUSIONS:This bioengineered conduit shows favorable safety and performance for 1 year. However, long-term validation in a pivotal trial is warranted. TRIAL REGISTRATION:First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess-FIH) (https://www. CLINICALTRIALS:gov); Unique identifier: NCT04898153.
INTRODUCTION:Aneurysmal degeneration of autogenous arteriovenous fistulas represents an increasingly prevalent complication in long-term dialysis patients, often leading to access failure and significant morbidity. Despite the clinical relevance, consensus on optimal surgical management remains limited. METHODS:We present a 10-year single-center experience with a modified stapling technique for AVF aneurysmoplasty, aimed at preserving native access while enabling immediate post-operative cannulation. This retrospective analysis includes 184 patients undergoing reconstruction for AVF aneurysms between 2014 and 2024. RESULTS:Technical success was achieved in 95.7% of cases, with early cannulation feasible in 91.6% of patients. The early failure rate was 2.3%. Primary patency at 1, 3, 5, and 10 years was 91.3%, 87.8%, 80.8%, and 22.6%, respectively; cumulative functional patency was 94%, 91.1%, 83.6%, and 30.5%. Recurrence was observed in 15.2% of cases, strongly associated with high-flow AVFs and central venous stenosis. Targeted intraoperative flow improved outcomes in anatomically complex cases. CONCLUSIONS:Stapled aneurysmoplasty is a safe and durable option for AVF reconstruction, with high success and patency rates. Preoperative flow assessment and individualized hemodynamic correction are crucial to long-term outcomes. In cases of recurrence, conversion to graft-based access may be warranted. These findings support a native access-preserving approach in suitable patients.
INTRODUCTION:The principal challenge in maintaining functional vascular access for hemodialysis is managing outflow stenoses, which are primarily caused by intimal hyperplasia. These stenoses are the leading cause of access dysfunction, leading to inadequate dialysis, increased morbidity, and frequent reinterventions. While drug-coated balloons (DCBs) have emerged as a promising solution by delivering antiproliferative agents to reduce restenosis rates, further clinical insights are needed to establish their role in vascular access management. MATERIALS AND METHODS:We conducted a single-center, retrospective cohort study analyzing 600 DCB angioplasties performed on 234 patients with stenoses or thromboses in arteriovenous fistulas (AVFs) or vascular access grafts (AVGs). Central vein stenoses accounted for 17.5% of cases. Inclusion criteria comprised symptomatic or asymptomatic stenoses >50% detected through Doppler ultrasound. DCBs (Aperto OTW, Cardionovum GmbH, Bonn, Germany) were used following pre-dilatation. Patients were followed for a minimum of 6 months, with functional patency and complications as the primary outcomes. RESULTS:The technical success rate was 95%, with functional patency rates of 82%, 63%, and 42%, at 12, 24, and 36 months, respectively. Freedom from restenosis was 71% in AVFs, 64% in AVGs, and 57% in central vein stenoses at 12 months. The annual reintervention rate was 1.3 (IQR: 0.9-3.1). No major adverse events were reported, and vascular injuries occurred in 1.3% of cases. Univariate analysis revealed no significant impact of comorbidities on outcomes. Our clinical approach prioritizes DCB angioplasty as the first-line treatment, reserving stent grafts for select cases with recurrent or complex stenoses to preserve vascular anatomy and surgical options. CONCLUSION:Drug-coated balloon angioplasty is a safe and effective treatment for vascular access stenoses, demonstrating robust functional patency and low restenosis rates. Our findings support the use of paclitaxel-eluting DCBs as a cornerstone in vascular access management, emphasizing their role in reducing complications and maintaining long-term access functionality.
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.
OBJECTIVES:To analyze how the experience of the surgical team went to impact the outcomes after open surgical repair (OSR) of intact abdominal aortic aneurysms (AAAs). METHODS:This is a single-center, observational cohort study with retrospective analysis of all OR for intact AAA performed between 1 January 2010 and 31 December 2022. The primary outcome was survival at 30 days and in follow-up, and a composite outcome of mortality and major complication. The secondary outcome was freedom from aorta-related reintervention. All outcomes were stratified according to the experience of the operating team (surgeons and anesthesiology). RESULTS:We analyzed 103 (7.2%) patients: 97 (94.2%) males and 6 (5.8%) females. The mean age was 76 ± 8 years (range, 55-93). The best possible team composition was present in 52 (50.5%) interventions. The follow-up index was 0.82 ± 0.18 (range, 0.6-1.0). Mean follow-up duration was 59 ± 43 months (range, 0-158). We observed no differences between teams in major complications (best, 17.3% vs mixed, 21.6%; OR: 0.4, P = 0.622), 30 days mortality (best, 0% vs mixed, 5.9%; OR: 7.6, P = 0.118) and composite outcome (best, 11.5% vs mixed, 17.6%; OR: 0.8, P = 0.416). Cox regression analysis identified the best possible team as a protective factor against the need for reintervention (hazard ratio: 0.2; 95% confidence interval: 0.06-0.88, P = 0.032). CONCLUSIONS:In our experience, OR of AAA yielded satisfactory results in terms of safety and efficacy independently of the team's experience. A more experienced team may protect against aorta-related reintervention.
Recent literature shows how residual renal function (RKF), defined as the urinary clearance of urea and creatinine, is associated with a lower mortality risk in HD patients. The use of non-nephrotoxic contrast media during radiological procedure, may be useful for preservation of RKF in patients with chronic kidney disease not yet in haemodialysis. We describe the case of a 51-year-old male suffering from chronic kidney disease from 2018, due to a right nephrectomy for an adenocarcinoma, who was considered for an endovascular arteriovenous fistula (endoAVF) creation (WavelinQ endoAVF System, Becton Dickinson, Franklin Lakes, New Jersey, US), using Carbon Dioxide as contrast media instead of conventional iodinated ones, with optimal results. CO2 DSA permits to well recognize the patency of target vein, its connection to the perforator vein and finally the endoAVF creation without requiring supplemental iodate contrast medium. We propose, CO2 automated digital subtraction angiography (DSA) as a safer technique that could be substitutive of the standard iodinated ones, in the creation of endo AVF.
Outflow vein stenosis is one of the commonest complications of both native and prosthetic vascular access. Together with angioplasty, first-line treatment is stenting. Although it has been described as a uncommon complication, the risk of stent migration should be always considered. We aimed to conduct a systematic review of literature concerning stents migration in vascular access, the possible outcomes and treatments. This study was performed applying Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches were conducted in PubMed/Medline, Scopus, and Google scholar databases. Studies selection, data abstraction was done by two different reviewers. We identified 17 studies, comprising 18 cases (M:F 1:1, mean age 56 ± 18 (range 33-88)). All the patients underwent stenting for vascular access outflow stenosis. The commonest type of device reported was self expandible bare-metal stent. Intraoperative evidence of stent migration occurred in six cases at the final quality control, or for intraprocedure dyspnea onset. In two patients it was a incidental diagnosis. In the remaining cases, chest pain or dyspnea were the common delayed presentation symptoms. Even if stent migration is an uncommon event, it is burdened with low mortality and morbidity. Literature provide only few and frequently inadequate data. Stent removal is the treatment of choice when severe symptoms or cardiopulmonary complication are present. Endovascular procedures demonstrated to be an effective and safe alternative, while open surgical treatment is preferred whenever endovascular therapy failed or in selected cases.
Introduction: Arteriovenous grafts (AVGs) serve as an alternative to native arteriovenous fistulas (AVFs) in the context of hemodialysis patient life planning. AVGs are more susceptible to developing outflow stenosis (due to intimal hyperplasia), thrombosis, and infections. However, an often overlooked contributor to AVG failure is cannulation damage. The objective of this paper is to assess the impact of cannulations on AVGs. We aim to establish a classification of AVG damage by comparing clinical data and ultrasound images with microscopic morphological findings obtained from explanted grafts. Materials and methods: This study is conducted at a single center. We included all patients who underwent AVG creation between 2011 and 2019. Comprehensive data on clinical history, follow-up, and complications were collected and reviewed. Duplex ultrasound (DUS) characteristics were documented, and all grafts explanted during the analysis period underwent optical microscopy evaluation. Finally, clinical data, along with DUS and microscopic findings, were integrated to derive a damage classification. Results: During the study period, 247 patients underwent 334 early cannulation AVGs. The median follow-up duration was 714 days (IQR 392, 1195). One hundred eleven (33%) grafts were explanted. Clinical data and DUS findings were utilized to formulate a four-grade classification system indicating increasing damage. Conclusion: Cannulation damage alone does not solely account for AVG failure. It results from a biological host-mediated process that promotes the growth of intimal hyperplasia at the cannulation sites. This process is not clinically significant within the initial 2 years after AVG creation.
The Renal Expert in Vascular Access (REVAC) is one of the four modules of the Nephrology Partnership for Advancing Technology in Healthcare (N-PATH) project, the first European-wide advanced training course in diagnostics and interventional nephrology, funded by Erasmus+ Knowledge Alliance, a European Commission program. The N-PATH primary goal was to train 40 young European nephrologists in both theoretical knowledge and practical skills related to interventional nephrology. The REVAC module focused on the crucial aspects of vascular access (VA) care in nephrology practice, as a complementary training path to the actual residency program. The aim was to provide nephrology fellows with comprehensive knowledge and skills related to VA management. The methodology was based on face-to-face meetings and online learning, modern facilities, experienced tutors, cutting edge simulators, augmented reality tools by means of a multidisciplinary international faculty and hands-on-courses. A feedback survey reported the experience of fellows who attended the REVAC module, confirming the positive impact on their ongoing nephrology training. We are confident that this project will revitalize their nephrology careers and will help training the next generation of nephrologists; they will be able to manage VA needs with the help of multi-disciplinary teams to safely optimize the care of hemodialysis patients.
In patients undergoing hemodialytic treatment via intravascular catheters, stenosis or occlusion of central veins is common. Despite an extensive characterization of Superior Vena Cava Syndrome (SVCS) no data is available about CavoAtrial Junction (CAJ) stenosis. We report the case of two patients with a story of multiple catheter failures due to thrombosis or infection. Computed tomography (CT) showed radiological signs of CAJ stenosis confirmed at the following venography. In absence of other feasible options to place a vascular access, the two underwent stenting with Gore Viabahn VBX balloon expandable endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA) of the CAJ stenosis. Completion venography showed complete resolution of the stenosis in both patients. No complications occurred during the procedures. At a mean follow-up of 878 ± 559 days no signs of in-stent restenosis or recoil were found. The present cases emphasize the feasibility and safety of CAJ stenting, underlining the importance of preserving CAJ and upper veins patency in hemodialysis access.