Single-Center Mid-term Experience with E-Liac Branched Device from Artivion®.

BACKGROUND: The use of iliac branch device (IBD) is increasing due to the less invasive character and accumulated experience of physicians in this endovascular technique. Clinical data regarding the E-liac stent graft from Artivion®, however, are scarce. This study shows the mid-term outcomes of the E-liac stent graft from a large single center. METHODS: Patients treated with IBD for (aorto-)iliac aneurysms between September 2015 and December 2022 with follow-up in our center were included. (Post)operative (technical success, reintervention, 30-day mortality) and mid-term outcomes (endoleak, reintervention, hypogastric patency, mortality) were analyzed. RESULTS: 63 patients (60 male, median age 70 years (IQR 66-76)) were treated with 82 E-liac stent grafts for aorto-iliac aneurysms with a median follow-up of 38 months (IQR 22-51). The technical success rate was 95%. Ninety-seven point six percent of the interal iliac arteries remained patent during follow-up. No 30-day mortality was encountered. During follow-up one patient had an endoleak type 1b of both hypogastric arteries, however the patient refused additional interventions. One other patient had a type 2 endoleak with contained rupture. Palliative treatment was chosen because of the patient's severe comorbidities. One (1.6%) IBD-related reintervention was performed with relining of the stent graft. Secondary patency of the interal iliac artery was 95.1% and the mortality was 25.4% during follow-up. CONCLUSIONS: This study shows high technical success rates for the E-liac stent graft, with corresponding good mid-term outcomes. The E-liac stent graft is a feasible, safe and effective stent graft in the treatment of aorto-iliac aneurysms.

Editor's Choice - Interventions to Achieve Functionality in Newly Created Arteriovenous Fistulas in the Shunt Simulation Study Cohort.

OBJECTIVE: Although observational cohort studies report that interventions to achieve functionality are clinically successful in 85% of patients, the proportion of newly created autologous arteriovenous fistulas that result in functional vascular access typically is only 70 - 80%. To address this discrepancy, the selection and outcomes of interventions to achieve functionality in a multicentre prospective cohort study were analysed. METHODS: The Shunt Simulation Study enrolled 222 patients who needed a first arteriovenous fistula in nine dialysis units in The Netherlands from 2015 to 2018 and followed these patients until one year after access creation. In this observational study, the technical and clinical success rates of interventions to achieve functionality based on lesion and intervention characteristics were analysed and the clinical outcomes of arteriovenous fistulas with assisted and unassisted functionality were compared. RESULTS: For patients who were on dialysis treatment at the end of the study, unassisted fistula functionality was 54% and overall fistula functionality was 78%. Thirty-four per cent of arteriovenous fistulas required an intervention to achieve functionality, 68% of which eventually became functional. Seventy-five per cent of these interventions were percutaneous balloon angioplasties of vascular access stenoses. Patients with clinically successful interventions to achieve functionality had larger pre-operative vein diameters (2.8 ± 1.0 mm vs. 2.3 ± 0.6 mm, p = .036) and less often presented with thrombosed fistulas than patients with unsuccessful interventions (7% vs. 43%, p = .006). Arteriovenous fistulas with assisted functionality had similar secondary patency as fistulas with unassisted functionality (100% and 98% at six months, p = .44), although they required more interventions to maintain function (2.6 vs. 1.7 per year; rate ratio 1.52, 95% CI 1.04 - 2.18, p = .032). CONCLUSION: Interventions to achieve functionality were needed in about a third of newly created arteriovenous fistulas. Most thrombosed fistulas were abandoned, and when selected for thrombectomy rarely reached clinical success. On the other hand, interventions to achieve functionality of patent fistulas had high clinical success rates and therefore can be done repeatedly until the fistula has become functional.

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.

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.

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.

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.

A realistic arteriovenous dialysis graft model for hemodynamic simulations.

OBJECTIVE: The hemodynamic benefit of novel arteriovenous graft (AVG) designs is typically assessed using computational models that assume highly idealized graft configurations and/or simplified boundary conditions representing the peripheral vasculature. The objective of this study is to evaluate whether idealized AVG models are suitable for hemodynamic evaluation of new graft designs, or whether more realistic models are required. METHODS: An idealized and a realistic, clinical imaging based, parametrized AVG geometry were created. Furthermore, two physiological boundary condition models were developed to represent the peripheral vasculature. We assessed how graft geometry (idealized or realistic) and applied boundary condition models of the peripheral vasculature (physiological or distal zero-flow) impacted hemodynamic metrics related to AVG dysfunction. RESULTS: Anastomotic regions exposed to high WSS (>7, ≤40 Pa), very high WSS (>40 Pa) and highly oscillatory WSS were larger in the simulations using the realistic AVG geometry. The magnitude of velocity perturbations in the venous segment was up to 1.7 times larger in the realistic AVG geometry compared to the idealized one. When applying a (non-physiological zero-flow) boundary condition that neglected blood flow to and from the peripheral vasculature, we observed large regions exposed to highly oscillatory WSS. These regions could not be observed when using either of the newly developed distal boundary condition models. CONCLUSION: Hemodynamic metrics related to AVG dysfunction are highly dependent on the geometry and the distal boundary condition model used. Consequently, the hemodynamic benefit of a novel graft design can be misrepresented when using idealized AVG modelling setups.

Surgical intervention for upper extremity nerve compression related to arteriovenous hemodialysis accesses.

OBJECTIVE: Chronic renal failure patients with arteriovenous hemodialysis access may exhibit pain and neurological complaints due to local nerve compression by the access conduit vessels of autogenous arteriovenous fistulas or the prosthesis of arteriovenous grafts. In this study, we have examined the results of surgical intervention for vascular access-related nerve compression in the upper extremity. METHODS: A single center retrospective study was performed of all patients referred for persistent pain and neurological complaints after vascular access surgery for hemodialysis. There were four brachial-cephalic, three brachial-basilic upper arm arteriovenous fistulas, and three prosthetic arteriovenous grafts. All patients had pain and sensory deficits in a distinct nerve territory (median nerve: 6; median + ulnar nerve: 1; medial cutaneous nerve: 1), and two patients had additional motor deficits (median nerve). RESULTS: A total of 10 patients (mean age: 59 years; range: 25-73 years; 2 men; 4 diabetics) were treated by surgical nerve release alone (2 patients) or in combination with access revision (8 patients). Mean follow-up was 23 months (range: 8-46 months). Direct complete relief of symptoms was achieved in six patients. Three patients had minor complaints, and one patient had a reoperation with good success. CONCLUSION: Vascular access-related nerve compression is an uncommon cause for pain, sensory and motor deficits after vascular access surgery. Surgical nerve release and access revision have good clinical outcome with relief of symptoms and maintenance of the access site in the majority of patients.

Preoperative computer simulation for planning of vascular access surgery in hemodialysis patients.

INTRODUCTION: The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis patients. Unfortunately, 20-40% of all constructed AVFs fail to mature (FTM), and are therefore not usable for hemodialysis. AVF maturation importantly depends on postoperative blood volume flow. Predicting patient-specific immediate postoperative flow could therefore support surgical planning. A computational model predicting blood volume flow is available, but the effect of blood flow predictions on the clinical endpoint of maturation (at least 500 mL/min blood volume flow, diameter of the venous cannulation segment ≥4 mm) remains undetermined. METHODS: A multicenter randomized clinical trial will be conducted in which 372 patients will be randomized (1:1 allocation ratio) between conventional healthcare and computational model-aided decision making. All patients are extensively examined using duplex ultrasonography (DUS) during preoperative assessment (12 venous and 11 arterial diameter measurements; 3 arterial volume flow measurements). The computational model will predict patient-specific immediate postoperative blood volume flows based on this DUS examination. Using these predictions, the preferred AVF configuration is recommended for the individual patient (radiocephalic, brachiocephalic, or brachiobasilic). The primary endpoint is FTM rate at six weeks in both groups, secondary endpoints include AVF functionality and patency rates at 6 and 12 months postoperatively. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02453412), and ToetsingOnline.nl (NL51610.068.14).