Percutaneous Arteriovenous Fistula Research Articles

The price of dialysis access: Implications of access type and patient-centric approaches to cost.

This study explores out-of-pocket (OOP) costs for patients and provider reimbursement for dialysis access creation. It aims to illustrate the financial characteristics of four dialysis access modalities to consider in decision-making for clinicians, patients, and payers. Retrospective data from the Merative™ MarketScan Commercial Claims and Encounters Databases from 2017 to 2022 was analyzed for patients who received an arteriovenous fistula (AVF), arteriovenous graft (AVG), peritoneal dialysis catheter (PDC), or percutaneous AVF (pAVF). ANOVA and Tukey HSD were used to assess cost differences among the four access modalities overall and in the context of insurance type and service site. Database extraction resulted in 20,863 unique procedures, comprising of 15,043 AVF, 4759 AVG, 896 PDC, and 165 pAVF. Mean age was 59.2 years (±14.19) and 60.53% of the cohort was male. EPO/PPO plans were the most represented (53.06%) and most procedures were performed in the hospital outpatient department (91.99%). There were significant differences found among OOP cost and reimbursement with respect to procedure type, insurance type, and service site. Overall, pAVF had both the highest cost and reimbursement. Patient OOP costs and provider reimbursement differ significantly based on procedure, insurance type, and service site. While pAVF creation is recognized with high reimbursements due to its complexity and the advanced technology required, it also has the highest OOP costs for patients. To help facilitate adoption of new technologies like pAVF, advocacy efforts should focus on encouraging payers to lower the OOP financial barriers for patients to receive these newer but costlier procedures.

Early and Midterm Outcomes of Percutaneous Arteriovenous Fistula Creation

Early and Midterm Outcomes of Percutaneous Arteriovenous Fistula Creation

Midterm Outcomes of a Novel First-in-Human Percutaneous Arteriovenous Fistula

Midterm Outcomes of a Novel First-in-Human Percutaneous Arteriovenous Fistula

Anatomical Feasibility of Percutaneous Arteriovenous Fistula Formation in Korea.

Currently, there are two types of percutaneous arteriovenous fistula (pAVF) formation systems approved by the FDA: Ellipsys and WavelinQ. Although these systems are already in use in Europe or the United States, they have not been approved for use in Korea yet. For this reason, this study aimed to check anatomical feasibility of these systems for Korean population prior to their actual use. Consecutive patients who received ultrasound vein mapping for arteriovenous fistula formation from June 2021 to June 2022 were included. The anatomical feasibility of each system was confirmed according to the manufacturer's instructions for use (IFU). Upper extremity ultrasonography was performed for a total of 83 patients to determine their feasibility for pAVF formation. Of these patients, 65.1% were feasible for pAVF formation with appropriate deep communicating vein (DCV) and outflow. Among them, 57.8% were feasible for the Ellipsys system and 54.2% were feasible for the WavelinQ system. Most patients who were infeasible for pAVF formation had a DCV of small size. Ulnar vessels were more suitable than radial vessel for WavelinQ (54.2% vs 33.7%, P-value = .012). The most common reason for not meeting the criteria was a small vein size at the access site. More than half of all patients were feasible for pAVF formation in this study. Ellipsys had a higher feasibility than WavelinQ, although they showed no significant difference in the feasibility. If these devices are imported into Korea, it will be a good opportunity for many patients to reduce the surgical burden and create AVFs more easily through these procedures.

Comparison of Outcomes of Drug-Coated Balloons versus Plain Balloons in Secondary Interventions on Percutaneous Arteriovenous Fistulae

PurposeTo compare patency and reintervention outcomes after either plain old balloon angioplasty (POBA) or drug-coated balloon angioplasty (DCBA) for venous stenoses after percutaneous arteriovenous fistula (pAVF) creation. Materials and MethodsOne-hundred ninety-five pAVFs were successfully created during the study period, 141 using Ellipsys and 54 using Wavelinq. After pAVF creation, 95 patients (48.7%) required secondary percutaneous transluminal angioplasty (PTA) with either POBA (n = 55, 58%) or DCBA (n = 40, 42.1%). The most common site for PTA was the juxta-anastomotic segment (75.5%; 74/98). Univariate and multivariate Cox regression analyses were used to compare target lesion primary patency, access circuit primary patency, secondary patency, and reintervention rates in the POBA and DCBA cohorts. ResultsThirty-four of 55 (62%) patients in the POBA cohort and 14 of 40 (35%) patients in the DCBA cohort required reinterventions for pAVF restenosis. Mean number of follow-up days among patients treated with POBA was 1,030.4 (SD ± 342.9) and among those treated with DCBA was 744.4 (SD ± 403.5). The use of POBA compared with DCBA was not associated with target lesion and access circuit primary patency loss in multivariate analysis (hazard ratio [HR], 1.81; 95% CI, 0.93–3.51; P = .080; and HR, 1.77; 95% CI, 0.73–4.28; P = .210, respectively). However, time from fistula creation to the first PTA (days) was statistically significantly associated with both outcomes (HR, 0.997; 95% CI, 0.994–0.999; P = .009; and HR, 0.997; 95% CI, 0.992–0.999; P = .021, respectively). There were no major adverse events. ConclusionsIn this retrospective single-center analysis of pAVFs, considerably more patients who underwent PTA with POBA after pAVF creation required reinterventions compared with PTA using DCBA, although the follow-up time of POBA was longer. In multivariate analysis, no differences were noted in the hazard of patency loss between POBA and DCBA.

Case Series of Real-World Use of Percutaneous Arteriovenous Fistulas in an Urban Predominantly Black US Hemodialysis Population

Case Series of Real-World Use of Percutaneous Arteriovenous Fistulas in an Urban Predominantly Black US Hemodialysis Population

#5918 ENDOVASCULAR CREATION OF AN ARTERIOVENOUS FISTULA (ENDOAVF) FOR HEMODIALYSIS ACCESS: A RETROSPECTIVE MONOCENTRIC EXPERIENCE

Abstract Background and Aims Functioning vascular access is an essential element for life-saving hemodialysis therapy. Surgical creation of a radiocephalic arteriovenous fistula (AVF) is the gold standard of vascular access for hemodialysis. However an endovascular approach to arteriovenous fistula creation (endoAVF) has increasingly gained acceptance over the last years as an alternative to the conventional surgical method. It offers a minimally invasive method for the formation of arteriovenous shunts and allows the creation of fistulas with minimal vessel trauma. There are currently two technologies available for this purpose, the Ellipsys Vascular Access System (Medtronic, Avenu Medical, San Juan Capistrano, Calif) and the Wavelinq endoAVF System (BD Medical, Franklin Lakes, NJ). At our centre (Careggi University Hospital, Florence), we developed an integrated service, based on a multidisciplinary approach between Interventional Radiology and Interventional Nephrology for percutaneous arteriovenous fistulas utilizing both Ellipsys and Wavelinq. We describe our experience with a case series of 39 patients, showing feasibility and outcome of this treatment option. Method Between December 2020 and January 2023 we created an endoAVF in 39 patients. Patients were suitable for the procedure after a pre-therapeutic ultrasound vascular mapping showed adequate brachial, radial and ulnar vessels and no ipsilateral central venous stenosis. After procedure, we performed a regular clinical and ultrasound monitoring. Therefore, we collected data regarding patient characteristics, initial technical success rate, number of access lost and number of endoAVF meeting primary and secondary patency. Results Of the total of 39 patients treated with endoAVF, 29 (74.3%) were male, with a mean age of 60.1 ± 33.9 years. The Wavelinq procedure was performed in 32 patients (82.0%) and the Ellipsys procedure in 7 patients (17.9%). Initial technical success was achieved in 38 (97.4%) cases, while in 1 case we had a primary failure of the fistula (Figure 1). Among these 38 patients, 4 (10.5%) were lost to follow-up because of death from other causes (3 patients) and because of kidney transplantation (1 patient), while 2 other patients (5.2%) have not required hemodialysys yet. Of the remaining 32 patients, we had 2 fistulas lost because of complications and a cumulative functional patency of 93.7% (30 fistulas), with a primary patency rate of 76% (23 fistulas). Conclusion The endoAVF appears to be feasible and safe for the creation of arteriovenous fistula suitable for hemodialysis access. Our data show an high functional cumulative patency of the endoAVF and a good primary patency, reducing the necessity of further interventions. Furthermore, in the prevalent hemodialysis population, the minimally invasive endovascular arteriovenous fistula procedure should help improving long wait times for vascular access creation. Further studies with more patients and multicentric data are needed to assess long-term outcomes.

Percutaneous arteriovenous fistula: Which patient subsets might benefit most and how can we best avoid the potential pitfalls of surgical innovation?

Percutaneous arteriovenous fistula: Which patient subsets might benefit most and how can we best avoid the potential pitfalls of surgical innovation?

Practical guide of vascular ultrasound in arteriovenous fistulae.

The use of vascular ultrasound, especially with the increasing prevalence of percutaneous arteriovenous fistulas, has taken a central role as a diagnostic and therapeutic imaging procedure in vascular access creation. The current review article stresses the importance of vascular ultrasound in arteriovenous fistula, from planning to creation to maintenance. It summarises and gives practical guidance regarding sonographic criteria for vascular access procedure planning, the application of vascular ultrasound intraoperatively and during follow-up. Ultrasound education and training modalities to meet high standards of patient care in hemodialysis are presented.

Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation Simulation Training in a Lifelike Flow Model.

Objectives: To assess the feasibility and training effect of simulation training for ultrasound-guided percutaneous arteriovenous fistula (pAVF) creation in a lifelike flow model. Methods: Twenty vascular trainees and specialists were shown an instructional video on creating a pAVF in a dedicated flow model and then randomized to a study or control group. The procedure was divided into five clearly defined steps. Two observers rated the performance on each step, and the time to perform the exercise was recorded. The study group participants underwent supervised hands-on training on the model before performing a second rated pAVF creation. All participants subsequently completed a feedback questionnaire. Results: After supervised simulation training, the study groups participants increased their mean performance rating from 2.2 ± 0.9 to 3.2 ± 0.7. A mean of 3.8 ± 0.8 procedure steps was accomplished independently (control group 2.1 ± 1.4; p < 0.05). The time taken to perform the procedure was 15.6 ± 3.8 min in the study group (control group 27.2 ± 7.3, p < 0.05). The participants with previous experience in ultrasound-guided vascular procedures (n = 5) achieved higher overall mean scores 3.0 ± 0.8 and accomplished more steps without assistance (2.0 ± 1.0) during the simulation training compared to their inexperienced peers (1.5 ± 0.3 and 0.8 ± 0.4, respectively). The feedback questionnaire revealed that the study group participants strongly agreed (n = 7) or agreed (n = 3) that training on the simulation model improved their skills regarding catheter handling. Conclusions: The study group participants increased their overall performance after training on the simulator. More experienced attendees performed better from the beginning, indicating the model to be lifelike and a potential skill assessment tool. Simulation training for pAVF creation using a lifelike model may be an intermediate step between acquiring ultrasound and theoretical pAVF skills and procedure guidance in theatre. However, this type of training is limited by its reliance on the simulator quality, demonstration devices and costs.

Adapting a Dialysis Service for Delivery of Percutaneous Arteriovenous Fistulas.

The percutaneous arteriovenous fistula (pAVF) is an exciting and novel addition to the vascular access options available to patients with end-stage kidney disease who require dialysis. Early clinical results have been promising, with high rates of maturation and low rates of reintervention. To successfully adapt an existing hemodialysis service to include the provision of pAVF formation, it is essential to identify and align the interests of key clinical and nonclinical stakeholders. Only through strong collaboration can the service be supported. The authors provide a comprehensive overview of the planning fundamentals required, including the referral pathway, screening and clinical assessment, and practical procedural elements and considerations, as well as follow-up requirements such as cannulation, fistula surveillance, and maintenance. Key staffing requirements are highlighted, including those pertaining to vascular US screening and dialysis nurse training. A broad and structured planning approach ensures that the entire network of key stakeholder interests is included and provides a strong foundation for a compelling business plan to attract the necessary funding and managerial support for the service. The authors present a systematic framework of the essential considerations necessary to facilitate the planning, funding, and ultimately delivery of a successful pAVF service. Online supplemental material is available for this article. ©RSNA, 2022.

Early Clinical Experience With Percutaneous Arteriovenous Fistula and Comparison to Surgical Arteriovenous Fistula

Early Clinical Experience With Percutaneous Arteriovenous Fistula and Comparison to Surgical Arteriovenous Fistula

Outcomes of Wrist-Access Deep Venous Embolization Following Percutaneous Fistula Creation: A Two-Year Single Center Experience

During percutaneous arteriovenous (pAVF) fistula creation, deep venous embolization is recommended to encourage superficial venous flow development. The safety of crossing adjacent to the newly formed fistula from wrist venous access has not been established. The purpose of this study was to evaluate the safety and efficacy of antegrade deep venous embolization after creation of the pAVF. A retrospective analysis was performed of all procedural data related to pAVF creation using the Wavelinq device from October 2019 to November 2021. Patient data from the hospital information systems were collected where the venous access for fistula creation was from the wrist-access (ulnar or radial vein) and where deep venous embolization was performed after forming the fistula and crossing adjacent to the anastomosis. Thirty-nine patients were identified. Twenty pAVFs were created from wrist ulnar vein access and 19 from radial vein access. The accessed veins were used for embolization of the brachial veins central to the newly created anastomosis. No pAVFs were lost by crossing adjacent to the anastomotic area to perform deep venous embolization at time of creation. There were no major complications, specifically bleeding, infection, pseudoaneurysm formation. Rates of minor complications consisted of two coil migrations to the right atrium requiring uneventful retrieval (5%). Follow-up ultrasound data showed no evidence of delayed complications. In this single center experience crossing alongside the anastomosis of a newly formed percutaneous fistula from an antegrade venous approach was safe with no risk of loss of the pAVF.

Percutaneous Arteriovenous Fistula Creation with Intended Brachial Vein Outflow and Secondary Brachial Vein Transposition Using the WavelinQ EndoAVF System

PurposeTo assess percutaneous arteriovenous fistula (pAVF) creation with subsequent brachial vein transposition (BVT) using the WavelinQ endoAVF system. Materials and MethodsA pre-existing database was retrospectively reviewed. Nine patients underwent attempted pAVF-BVT creation between December 2017 and November 2021. Study outcomes included technical success, time to maturation, patency rates, adverse events, and secondary interventions. Maturation was defined as a pAVF flow of ≥500 mL/min, outflow vein diameter ≥5 mm, and successful 2-needle cannulations in patients on active hemodialysis (HD). ResultspAVF-BVT creation was technically successful in 8 of 9 patients (89%). Six of 8 created pAVFs remained patent and matured at 4 weeks, subsequently undergoing secondary BVT. Primary patency rates at 6, 12, and 24 months were 37.5%, 12.5%, and 12.5%, respectively. Secondary patency rates at 6, 12, and 24 months were 75%, 37.5%, and 37.5%, respectively. One patient had postprocedural access site bleeding, and 4 required secondary interventions to maintain patency. Two patients with failed pAVFs with BVT were successfully converted to surgical AVFs, probably facilitated by sufficient enlargement of superficial veins following pAVF creation. ConclusionsOff-label use of the WavelinQ system to create brachial vein outflow pAVF with BVT may be an alternative procedure for HD access creation in select patients with exhausted superficial veins.

Long-Term Results from the Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access

PurposeTo report the 5-year results from the Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula (pAVF) Creation for Hemodialysis Access. Materials and MethodsThe retrospective review of 107 intent-to-treat (ITT) patients from the pivotal trial provided a long-term follow-up population (LTP) of 85 patients with a median follow-up duration of 50 months (range, 12–60 months). Data evaluated in the LTP group were fistula maturation and usage, secondary procedures, and complications. The Kaplan-Meier analysis of primary patency, assisted primary patency, cumulative patency, and functional patency (time from 2-needle cannulation to abandonment) were performed for the ITT population. ResultsIn the LTP, 99% (84 of 85) of fistulae were mature, with 99% (78 of 79) of patients requiring hemodialysis using their pAVF. Sustained fistula use (2-needle cannulation at the prescribed rate, 2 of 3 sessions) was achieved in 92% (78 of 85) of patients, with 7 patients not using their pAVF because they were not on dialysis (n = 4), were on peritoneal dialysis (n = 2), and refused to use fistula (n = 1). Fistula maintenance was required in 31.8% (27 of 85) of patients and included fistula dysfunction (21.2%), thrombosis (5.9%), cannulation injury (12.9%), and arm swelling (4.7%). The number of procedures performed per patient per year to maintain function and patency was 0.32 (91 of 288) for years 2–5. The cumulative patency rates were 89.5%, 88.4%, 88.4%, 85.6%, and 82.0% for years 1, 2, 3, 4, and 5, respectively. The functional patency was 91.8% at the end of the study. There were no major complications related to pAVF during the long-term follow-up. ConclusionsPercutaneous fistulae have provided clinically effective and durable access for hemodialysis with low complications. The continued use and evaluation of pAVF are warranted.

Abstract No. 206 Long term results from the pivotal multicenter trial of ultrasound guided percutaneous arteriovenous fistula creation for hemodialysis access

Until recently, all vascular access creations required open surgery. The initial results of the Percutaneous Arteriovenous Fistula (pAVF) created by interventionalist in the office-based laboratory demonstrated safety, efficacy, and high patient satisfaction. However, long-term results are required to assess the role of pAVF in hemodialysis access and overall patient benefit.

Dialysis access-associated steal syndrome with percutaneous endovascular arteriovenous fistula creation

BackgroundDialysis access-associated steal syndrome (DASS) is an infrequent complication after hemodialysis access creation. Clinical symptoms depend on the degree of steal. Percutaneous arteriovenous fistula creation offers a minimally invasive alternative to surgical creation, though complications have been reported. The following presents the first described case of DASS after percutaneous endovascular arteriovenous fistula creation, and discusses risk factors and management.Case PresentationOur case is that of a 27-year-old male with end stage renal disease due to congenital renal dysplasia, who underwent left percutaneous arteriovenous fistula creation for initiation of dialysis. Two months after the procedure the patient complained of coldness, pain, tingling, and numbness in the left arm during dialysis, concerning for steal syndrome. The patient subsequently underwent brachial artery angiogram, which showed minimal antegrade flow through the ulnar and interosseous arteries towards the hand, and a focal, severe stenosis in the distal ulnar artery. Angioplasty of the stenosis was performed, though steal symptoms continued.ConclusionsDASS, though rare, can be seen with percutaneous arteriovenous fistula creation. Identification of the risk factors prior to creation can help avoid this complication. Management is largely guided by clinical presentation. As long as there is adequate collateral supply to the extremity, single vessel occlusion is not a contraindication to percutaneous arteriovenous fistula creation with the use of WavelinQ technology. Careful patient selection with pre-creation angiogram may reduce the risk of symptomatic steal.

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients

PurposeTo retrospectively assess the safety and efficacy of percutaneous arteriovenous fistula (pAVF) creation with the WavelinQ 4-F EndoAVF System. Materials and MethodsFrom February 2018 to June 2020, 30 pAVFs were created in 30 consecutive patients (men; age, 55.3 years ± 13.6). Of the 30 patients, 21 (70%) were already on hemodialysis using a central venous catheter. The primary outcome measures were technical success, complications, and cannulation rate. The secondary outcome measures included the number of secondary procedures needed for cannulation, maintenance time to cannulation, and pAVF survival. ResultsTechnical success was 100%. The adverse event rate was 6.7% (2/30), including a pseudoaneurysm of the brachial artery that developed immediately after sheath removal and an aneurysm of the anastomosis 17 days after the procedure, which was treated with a covered stent placed in the arterial side. The mean follow-up was 547 days ± 315.7 (range, 14–1,071 days). The cannulation rate was 86.7% (26/30). The mean time to cannulation was 61.3 days ± 32.5 (range, 15–135 days). The mean follow-up after cannulation was 566.2 days ± 252.7 (range, 35–1,041 days). Four pAVFs were thrombosed after cannulation, with 2 of them successfully declotted. Sixteen interventions were needed to achieve cannulation after the index procedure in 15 patients (overall, 0.53 procedures/patient). Seven maintenance endovascular interventions (following cannulation) were performed during the follow-up period in 6 patients (overall, 0.27 procedures/patient, 0.17 procedures/patient-years). For the pAVFs that were cannulated, patency was 96% at 1 year, and 82% at 2 and 3 years, according to the Kaplan-Meier survival analysis. ConclusionsThis initial experience suggests that pAVF creation is safe and can be successfully performed with high maturation and long-term patency rates. Larger-scale prospective studies are needed to validate the results.

Research Priorities for Percutaneous Arteriovenous Fistula Creation in Patients with End-Stage Renal Disease: Proceedings and Recommendations from a Multidisciplinary Research Consensus Panel

Recently developed endovascular techniques to create percutaneous arteriovenous fistulas are an alternative to surgical arteriovenous fistula creation, although there is currently a lack of high-level evidence regarding their creation, maturation, utilization, and long-term function. Recognizing this, the Society of Interventional Radiology Foundation sponsored a Research Consensus Panel and Summit for the prioritization of a research agenda to identify and address the gaps in current knowledge.

MO659INITIAL EXPERIENCE OF PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION

Abstract Background Arteriovenous fistulas (AVFs) for hemodialysis are inconstantly used primarily due to problems with maturation and early thrombosis. An endovascular approach -without open surgery- for fistula creation offers another option for establishing a reliable vascular access. By this procedure, a arteriovenous fistula is created in the area of the cubital fossa in the deep vascular system, either between the ulnar artery and the accompanying vein or the radial artery and radial vein and uses the perforating vein at the level of the elbow to transfer blood to the superficial network of the arm. Aim To evaluate the safety, success and maturation rates of percutaneous arteriovenous fistula creation. Materials and Methods From February 2018 to June 2020 (28 months), 30 percutaneous arteriovenous fistulas (pAVF) using the WavelinQ device were created in 30 patients (male: 100%) with end stage kidney disease. Outcome measures were safety, defined as adverse events occurring within the first month of creation, success, defined as the ability to create an anastomosis between the vessels of interest and maturation rates, defined as the ability to perform at least one successful dialysis with the AVF. Secondary outcome measures included procedural complications, secondary procedures, time to cannulation, and AVF survival. Results All cases were performed as day procedures. 23 out of 30 patients (70%) were already on hemodialysis carrying a permanent central venous catheter. Main comorbidities were hypertension (21/30; 70%), diabetes (15/30; 50%) while 11/30 (30.5%) were smokers. Success was 100% (30/30). Mean follow-up was 547 days (range: 14-1071 days). In one case a pseudoaneurysm of the brachial artery was created immediately after sheath removal and in another case, an aneurysm of the AVF anastomosis was observed 17 days post-procedure and AVF was legated with a covered stent placed in the arterial part. In all, 26/30 AVFs (86.6%) were successfully cannulated. Mean time to cannulation was 61.3 days. Another one failed after maturation during the follow-up period. In total, 15 interventions were needed to achieve maturation (15/26; 0.58 procedures per AVF). 5 maintenance endovascular interventions were performed during the follow-up period (5/26; 19.2%). Mean time from cannulation to the end of follow up was 566.2 days (range: 135-1041 days). Conclusion Current analysis suggests that percutaneous AVF creation is safe, successfully performed with high maturation rates. Large scale prospective studies are needed to validate results.