Value-Based Approach to AVF Maintenance: Institutional Micro-Costing of Drug-Coated Versus Plain Balloon Angioplasty in a Fixed-Reimbursement System

Value-Based Approach to AVF Maintenance: Institutional Micro-Costing of Drug-Coated Versus Plain Balloon Angioplasty in a Fixed-Reimbursement System | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Value-Based Approach to AVF Maintenance: Institutional Micro-Costing of Drug-Coated Versus Plain Balloon Angioplasty in a Fixed-Reimbursement System Jernej Lučev, Dejan Dinevski, Robert Ekart, Silva Breznik This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8278408/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 28 Feb, 2026 Read the published version in CVIR Endovascular → Version 1 posted 4 You are reading this latest preprint version Abstract Purpose To evaluate the cost-effectiveness of drug-coated balloon (DCB) versus plain balloon (PB) angioplasty for dysfunctional haemodialysis arteriovenous fistulas (AVFs) from the institutional perspective of a high-volume tertiary care centre over 24 months, in order to inform resource allocation policy. Materials and Methods This analysis uses clinical outcomes from a previously published single-centre cohort of 62 patients (31 DCB, 31 PB) treated for dysfunctional AVFs. A detailed institutional micro-costing approach based on self-pay tariffs was applied to quantify direct procedural costs. Total mean cost per patient and cost per year of primary patency (CPYPP) were calculated, and a sensitivity analysis was performed to explore the impact of varying the DCB device price. Results The DCB group demonstrated higher mean target-lesion primary patency (1.46 ± 0.56 vs 0.86 ± 0.59 years) and required fewer AVF-related endovascular interventions per patient over 24 months (1.55 ± 0.81 vs 2.29 ± 0.94). Total mean cost per patient was lower with DCB (€8,496.02 vs €11,324.55), resulting in a lower cost per year of primary patency (CPYPP €5,819 vs €13,168). Sensitivity analysis suggested that this cost-saving profile remained robust across a wide range of DCB device prices. Conclusion Despite the higher device cost, DCB angioplasty appeared to be a cost-saving and clinically more effective alternative to PB angioplasty in this cohort. Lower overall institutional expenditure and reduced reintervention frequency support its consideration for integration into AVF maintenance protocols and value-based care pathways in similar fixed-reimbursement settings. Arteriovenous fistula Hemodialysis Drug-coated balloon Cost-effectiveness Endovascular treatment Primary patency Institutional policy Value-Based Care Introduction Arteriovenous fistulas (AVFs) are recognized by major clinical guidelines, such as the KDOQI and EBPG, as the preferred vascular access modality for patients undergoing chronic hemodialysis (HD) due to superior long-term patency and lower morbidity rates compared to synthetic grafts and central venous catheters [ 1 , 2 ]. Despite this gold-standard status, AVF dysfunction due to stenosis remains a critical clinical challenge, representing the most common cause of access failure and a leading source of hospitalization and healthcare expenditure within the HD population [ 3 ]. In the United States, vascular access-related complications contribute significantly to the total annual cost of dialysis care, exceeding billions of dollars [ 4 ]. The primary pathology driving AVF failure is neointimal hyperplasia (NIH), characterized by the pathological proliferation and migration of vascular smooth muscle cells (VSMCs) into the vessel intima [ 5 ]. This process is triggered by vessel wall injury from surgical anastomosis and repeated needle punctures, exacerbated by the turbulent blood flow and high shear stress environment characteristic of the AVF [ 6 ]. Conventional percutaneous transluminal angioplasty (PTA) using a plain balloon (PB) has long been the primary endovascular solution for stenosis [ 7 ]. However, the mechanical inflation required to open the lesion itself causes additional barotrauma to the vessel wall, accelerating the NIH cycle and resulting in restenosis rates that frequently necessitate multiple reinterventions within the first year [ 8 , 9 ]. Drug-coated balloons (DCBs) were developed to interrupt this inflammatory-proliferative cycle. DCBs deliver a localized, therapeutic dose of an antiproliferative agent (paclitaxel) directly to the vessel wall during balloon inflation [ 9 ]. Paclitaxel acts by interfering with microtubule dynamics, effectively inhibiting the proliferation and migration of VSMCs, thereby slowing the progression of NIH and extending the duration of primary patency [ 10 ]. The success of this pharmacomechanical approach has been demonstrated in multiple clinical trials, including our own initial prospective study, confirming superior patency outcomes for DCBs in AVF interventions [ 11 , 12 , 13 ]. The clinical superiority of DCBs is often challenged by their higher initial device cost. Health systems, particularly those operating under fixed or bundled reimbursement models, require robust economic data to determine if the clinical gain justifies the increased upfront expenditure [ 14 , 15 ]. This is particularly relevant in systems where procedural reimbursement is fixed or bundled, making the cost-saving potential from avoided future procedures critical for budgetary approval. This study provides a rigorous, institution-specific economic evaluation comparing the DCB strategy to the PB strategy, utilizing micro-costing to derive a highly transparent and actionable cost-effectiveness profile over a 24-month horizon. Materials and Methods Study Design, Ethics, and Patient Data This cost-effectiveness analysis is a retrospective economic evaluation based on prospectively collected clinical data from our previously published single-centre study [ 11 ]. That study included 62 consecutive adult patients with dysfunctional native AVFs who underwent angioplasty (31 in the PB group and 31 in the DCB group) and were followed for 24 months. Baseline patient characteristics are summarized in Table 1 . The original study found that the two groups were well-matched across demographic variables like sex and age. However, a significant difference was noted in the median age of the AVF at the time of the index procedure, a factor that is discussed further in the limitations section. Table 1 Baseline Demographic and Clinical Characteristics Characteristic PB Group (n = 31) DCB Group (n = 31) P-value Mean age (years) 67,03 +/- 8,44 62,81 +/- 17,2 0,22 Male gender 15 (48,4%) 16 (51,6%) 1 Hypertension 26 (83,9%) 18 (58,1%) 0,5 Hyperlipidaemia 7 (22,6%) 5 (16,1%) 0,75 Diabetes mellitus 12 (38,7%) 13 (41,9%) 1 Smoking 5 (16,1%) 8 (25,8%) 0,53 AVF median age (days) 609 (294–991) 255 (178–465) 0,013 Radiocephalic fistula 20 (62,5%) 17 (54,8%) 0,6 Brachiocephalic fistula 8 (25,8%) 12 (38,7%) 0,4 Brachiobasilic fistula 3 (9,7%) 2 (6,6%) 1 Juxta-anastomotic stenosis 29 (93,5%) 30 (96,8%) 1 Arterial stenosis 1 (3,2%) 0 (0%) 1 Anastomotic stenosis 1 (3,2%) 1 (3,2%) 1 Stenosis median length (mm) 40 (40–60) 40 (40–80) 0,37 Technical success 31 (100%) 31 (100%) 1 PB, balloon; DCB, drug-coated balloon; AVF, arteriovenous fistula; IQR, interquartile range; SD, standard deviation. A significant difference was observed in the median AVF age between the groups; other AVF anatomical characteristics (type, location and stenosis site) were comparable between groups. The endovascular approach for the DCB group involved a sequential strategy: initial vessel preparation using a standard PB to achieve less than 30% residual stenosis, followed by the use of the DCB for definitive treatment and drug delivery [ 16 ]. This technique aligns with international consensus guidelines which recommend adequate pre-dilation to optimize lesion expansion and promote effective drug transfer to the vessel wall [ 16 ]. Clinical Outcomes The key clinical outcomes were taken directly from the published results of the index study [ 11 ]: Mean number of AVF-related endovascular interventions per patient over 24 months: PB group = 2.29 ± 0.94 (median 2; IQR 2–3); DCB group = 1.55 ± 0.81 (median 1; IQR 1–2). Mean Primary Patency (MPP) of the Index Procedure: Defined as the time from the index intervention to the next clinically indicated repeat intervention or thrombosis. PB group MPP: 315.7 ± 216.8 days (approx. 0.86 ± 0.59 years; median 0.74 years; IQR 0.42–1.05 years). DCB group MPP: 534.2 ± 206.1 days (approx. 1.46 ± 0.56 years; median 1.39 years; IQR 1.09–2.00 years). Economic Analysis and Perspective The economic evaluation was conducted from the Institutional/Provider Perspective over a 24-month time horizon. This perspective is vital for local administrators making resource allocation decisions. Costs were estimated using the hospital’s official self-pay price list, which allows for detailed cost capture. We employed a micro-costing (bottom-up) approach, which utilizes highly detailed, actual institutional costs (devices, labor, consumables, overhead) rather than aggregated national reimbursement rates (e.g., Diagnosis-Related Groups or fixed tariffs) [ 17 ]. This was necessitated because the national health insurance system in our country operates on a fixed, flat-rate reimbursement model that does not account for the actual material consumption [ 25 ]. Using the self-pay list allowed for a superior estimation of the true resource consumption associated with each intervention, thereby avoiding the systematic biases inherent in "flat-rate" payment systems where actual material usage is often obscured [ 18 ]. The direct procedural costs included the components detailed in Table 2 . The standardized hospitalization cost was included to accurately reflect the institutional overhead, interventional suite time, nursing, and recovery resource burden associated with each procedure, irrespective of the patient's actual discharge status. Table 2 Direct Procedural Cost per Intervention by Component Component PB Procedure (€) DCB Procedure (€) PB balloon (vessel preparation) 99.83 99.83 DCB balloon (device) – 536.08 Labor cost per procedure 1,942.51 1,942.51 Additional material 536.00 536.00 Standardized Hospitalization 2,366.88 2,366.88 Total Cost per Procedure 4,945.22 5,481.30 PB, plain balloon; DCB, drug-coated balloon. The cost per procedure includes standardized cost estimates for the interventional suite, staff time, and recovery resources, reflecting the true institutional resource burden. As these values are derived from fixed institutional self-pay tariffs, variability measures (SD or IQR) are not applicable at the single-procedure level. Calculation of Economic Metrics Total Mean Cost per Patient (TMC): Calculated as the mean number of interventions per patient multiplied by the total cost per procedure. TMC = Avg. Interventions X Cost per Procedure Cost per Year of Primary Patency (CPYPP): Calculated as the Total Mean Cost per Patient over the 24-month follow-up divided by the mean primary patency achieved by the index procedure in years. This metric serves as a key indicator of cost-efficiency. CPYPP = Total Mean Cost per Patient / Mean Primary Patency (years) Incremental Cost-Effectiveness Ratio (ICER): Defined as the change in cost divided by the change in effect (ΔCost / ΔEffect). When a strategy achieves better outcomes at a lower cost, it is considered cost-saving (economically dominant) and explicit ICER calculation is not required [19]. Results Clinical Outcomes and Procedure Utilization As previously published, the clinical effectiveness of DCB was superior, leading to a substantial reduction in the rate of reinterventions [ 11 ]. The DCB group required a mean of 1.55 interventions per patient over 24 months, compared to 2.29 in the PB group. The increase in mean primary patency was 0.60 years (approximately 70%) with the use of DCBs. Cost Analysis As detailed in Table 2 , the cost per procedure was €4,945.22 for the PB group and €5,481.30 for the DCB group. The resulting total mean costs per patient are shown in Table 3 . Table 3 Total Cost per Patient over 24 Months Group Avg. Interventions Cost per Procedure (€) Total Cost per Patient (€) PB 2.29 ± 0.94 4,945.22 11,324.55 DCB 1.55 ± 0.81 5,481.30 8,496.02 PB, plain balloon; DCB, drug-coated balloon; Avg. Interventions, Mean number of interventions per patient over 24 months. Total Cost per Patient is calculated as Avg. Interventions x Cost per Procedure. Values are presented as mean estimates per patient; variability in resource use is primarily reflected in the distribution of the number of interventions, while costs are derived deterministically from the fixed per-procedure tariff and the mean number of procedures. Despite the higher device cost for the DCB strategy, the lower reintervention rate resulted in a significantly reduced total mean cost per patient over the 24-month follow-up period (€8,496.02 vs €11,324.55). The total cost savings was €2,828.53 per patient for the DCB strategy. Cost-Effectiveness Analysis The results demonstrate a pronounced difference in cost-efficiency when adjusted for clinical benefit (mean primary patency). The key metric, Cost per Year of Primary Patency (CPYPP), is presented in Table 4 . Table 4 Cost per Year of Primary Patency (CPYPP) Group Total Cost (€) Patency (yrs) CPYPP (€) PB 11,324.55 0.86 ± 0.59 13,168 DCB 8,496.02 1.46 ± 0.56 5,819 PB, plain balloon; DCB, drug-coated balloon; Patency (yrs), Mean primary patency in years derived from the index procedure outcome. CPYPP, Cost per Year of Primary Patency, is calculated as Total Cost (€) / Patency (yrs). Values are calculated from mean total cost per patient and mean primary patency for each group; variability measures for CPYPP are therefore notshown separately. Given that the DCB strategy resulted in a lower total cost (Cost difference: -€2,828.53) and superior clinical outcome (Patency difference: +0.60 years), DCB angioplasty was both less costly and more effective than PB angioplasty in this cohort and can therefore be considered cost-saving from the institutional perspective. Sensitivity Analysis: Cost Threshold for DCB To test the robustness of this cost-saving finding, we performed a threshold analysis to determine the maximum DCB device price at which the DCB strategy would remain cost-saving (i.e., Total DCB Cost ≤ PB Cost). The maximum sustainable DCB device price (D max ) was calculated to be approximately €2,360.94. Since the current DCB device price (€536.08) is substantially below this threshold, the DCB cost could increase by nearly 440% before the strategy would lose its absolute cost-saving advantage, strongly supporting the robustness of this cost-saving profile. Discussion The findings of this study provide real-world evidence for the economic benefit of drug-coated balloon angioplasty in the management of dysfunctional AVFs. In our single-centre cohort, the DCB strategy was associated with both superior mean primary patency and lower cumulative treatment costs over 24 months compared to PB angioplasty. Translating Economic Findings into Clinical Value For interventionalists and hospital administrators, a strategy that is both less costly and more effective is of particular interest from a value-based care perspective. In economic terms, such a strategy can be described as cost-saving (economically dominant), although our results should be interpreted in light of the modest sample size and single-centre design. In our cohort, the primary driver of the observed cost savings was the reduction in the frequency of reinterventions (from 2.29 to 1.55 per patient over 24 months). This reduction not only decreases total expenditure, but also increases intervention-free time for both patients and the interventional suite, potentially improving resource utilisation. Operational Efficiency and Training Impact The observed reduction in reinterventions (0.74 fewer per patient over 24 months) translates directly into increased operational efficiency. By dedicating fewer interventional suite hours to repeat, often routine, AVF procedures, resources (staff time, angiography equipment) are freed up for more complex, urgent, or elective cases. This improved workflow minimizes delays, potentially enhancing the hospital's overall procedural capacity. Furthermore, a stable workload focusing on quality procedures aids in the training of junior interventional radiologists by reducing exposure to repetitive, low-yield reinterventions and allowing more time for critical diagnostic and therapeutic interventions [ 20 ]. This systemic benefit should not be underestimated when evaluating new technologies [ 16 ]. Clinical, Quality of Life, and Financial Implications The nearly 56% reduction in the Cost per Year of Primary Patency (CPYPP) observed in our analysis indicates a substantial improvement in cost-efficiency with the DCB approach (Table 4 ). Beyond the financial savings, reducing the number of interventions from 2.29 to 1.55 procedures per patient over 24 months lowers the procedural burden for patients and may positively influence quality of life, although QoL was not formally measured in this study. Each avoided intervention reduces procedural risk, limits exposure to contrast agents and radiation, and decreases time spent in the hospital or angiography suite. In addition, more stable access may reduce the need for temporary central venous catheters, which are associated with a higher risk of infection and morbidity [ 3 ]. Addressing Technical Approach and Patency The success observed in the DCB group reinforces the importance of the sequential interventional approach (PB pre-dilation followed by DCB). This technique is designed to optimize the delivery of paclitaxel by ensuring full lesion expansion and maximal contact between the drug-coated surface and the arterial wall, facilitating optimal drug absorption into the media layer and enhancing the anti-proliferative effect [ 16 ]. Contextualizing Paclitaxel Safety It is critical for contemporary vascular interventional literature to address the widely discussed topic of paclitaxel safety, which arose following a meta-analysis suggesting a late-term mortality risk associated with paclitaxel-coated devices in the femoropopliteal segment [ 23 ]. While this concern predominantly relates to devices used in the peripheral arterial system, continuous long-term surveillance is necessary. Importantly, subsequent meta-analyses and dedicated studies in vascular access have generally demonstrated that this safety signal is not reproducible in the specific application of DCBs for AVFs, which operate under distinct hemodynamic conditions [ 12 , 24 ]. Our clinical data align with the consensus that DCB use in AVFs is safe, and the economic benefits presented here must be weighed alongside the robust safety data specific to this anatomical application. Limitations and Future Directions The primary limitation remains the single-centre, non-randomized design, which introduces the potential for selection and institutional bias. Specifically, our original cohort showed a statistically significant difference in median AVF age between the groups (Table 1 ). While literature suggests that the age of a mature AVF is not a confounding factor for primary patency, we acknowledge this potential confounder. However, since the cost-saving effect is driven predominantly by the reduction in the number of reinterventions (a consequence of improved patency), rather than the absolute patency duration itself, the core economic finding remains robust. Furthermore, this analysis only considers direct institutional costs. The exclusion of indirect and societal costs, such as patient transportation, lost work productivity, and caregiver burden, likely results in an underestimation of the total benefit of the DCB strategy. Future research should prioritize large-scale, multicenter randomized controlled trials (RCTs) with integrated, long-term economic endpoints. Specifically, incorporating measures of Quality-Adjusted Life Years (QALYs) and conducting probabilistic sensitivity analyses will provide a more comprehensive societal evaluation, fully quantifying the true health and economic value of avoiding repeat procedures over time [ 3 , 19 ]. Sustainable Impact on Institutional Policy The finding that DCB was both less costly and more effective in our setting supports a proactive discussion regarding its implications for institutional purchasing and procedural protocols. When comparing the return on investment (ROI) for a DCB versus a PB, the DCB offers immediate value creation through resource sparing. For high-volume interventional units, the reduced occupancy of angiography suites, decreased inventory turnover of disposable PB supplies, and maximized utilization of specialized staff hours translate into long-term systemic sustainability. The adoption of the DCB strategy moves vascular access maintenance from a reactive, repeated intervention model to a proactive, value-based care model, confirming that adopting higher-cost, high-performance technology may represent a fiscally responsible choice for modern healthcare providers facing similar constraints [ 2 , 14 ]. Conclusion This study demonstrates that, within a single high-volume tertiary centre operating in a fixed-tariff environment, DCB angioplasty was associated with lower total mean institutional cost per patient (€8,496.02 vs €11,324.55) and a lower cost per year of primary patency (€5,819 vs €13,168) than PB angioplasty (Tables 3 and 4 ). These results provide real-world economic justification for considering DCB angioplasty in routine AVF maintenance, particularly in centres with similar organisational and reimbursement structures. The ability of DCBs to deliver sustained clinical improvement while reducing cumulative resource utilisation supports their integration into evidence-based, value-oriented vascular access management pathways, while acknowledging that confirmation in larger, multicentre studies is needed. Declarations Ethics approval and consent to participate: The study was approved by the National Medical Ethics Committee and was conducted in accordance with applicable ethical standards and the Declaration of Helsinki. Written informed consent was obtained from all participants. Consent for publication: Written informed consent for the publication of anonymised clinical data was obtained from all participants. Availability of data and materials: The datasets generated and/or analysed during the study are available from the corresponding author on reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: Not applicable. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Authors’ contributions : All authors contributed to the conception and design of the study, data collection and interpretation, and manuscript preparation. Acknowledgments: The authors would like to thank the interventional radiology and dialysis teams at University Medical Centre Maribor for their support in patient care and data collection. References Daugirdas JT et al (2015) KDOQI clinical practice guideline for hemodialysis adequacy: 2015 update. Am J Kidney Dis 66(5):884–930 Tordoir J et al (2007) EBPG Guideline on Vascular Access. 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OECD/European Observatory on Health Systems and Policies Cite Share Download PDF Status: Published Journal Publication published 28 Feb, 2026 Read the published version in CVIR Endovascular → Version 1 posted Reviewers agreed at journal 13 Dec, 2025 Reviewers invited by journal 11 Dec, 2025 Editor assigned by journal 09 Dec, 2025 First submitted to journal 04 Dec, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8278408","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":558666331,"identity":"f0cbef3e-10ad-4cb1-b39c-c31f53deec6f","order_by":0,"name":"Jernej 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16:52:23","extension":"xml","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":72280,"visible":true,"origin":"","legend":"","description":"","filename":"CIRED25005140enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-8278408/v1/d417dc3b4befffa7ca1e5855.xml"},{"id":98295691,"identity":"1a0fbed1-866d-4463-aa13-d50300a859d8","added_by":"auto","created_at":"2025-12-16 09:17:48","extension":"xml","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":70819,"visible":true,"origin":"","legend":"","description":"","filename":"CIRED25005140structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-8278408/v1/77b6c17d917122bf79690008.xml"},{"id":98295693,"identity":"35eb4bb5-1946-4b84-a8b2-4d5ba726ce93","added_by":"auto","created_at":"2025-12-16 09:17:48","extension":"html","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":79106,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8278408/v1/9fc5feaa84ef3f82792d6c5c.html"},{"id":103765728,"identity":"6f534a81-d4a9-48a4-8dad-f2440c32abc8","added_by":"auto","created_at":"2026-03-02 16:08:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":845406,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8278408/v1/37df51bb-26d3-4595-a048-5ca280c2c227.pdf"}],"financialInterests":"","formattedTitle":"Value-Based Approach to AVF Maintenance: Institutional Micro-Costing of Drug-Coated Versus Plain Balloon Angioplasty in a Fixed-Reimbursement System","fulltext":[{"header":"Introduction","content":"\u003cp\u003eArteriovenous fistulas (AVFs) are recognized by major clinical guidelines, such as the KDOQI and EBPG, as the preferred vascular access modality for patients undergoing chronic hemodialysis (HD) due to superior long-term patency and lower morbidity rates compared to synthetic grafts and central venous catheters [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Despite this gold-standard status, AVF dysfunction due to stenosis remains a critical clinical challenge, representing the most common cause of access failure and a leading source of hospitalization and healthcare expenditure within the HD population [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In the United States, vascular access-related complications contribute significantly to the total annual cost of dialysis care, exceeding billions of dollars [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe primary pathology driving AVF failure is neointimal hyperplasia (NIH), characterized by the pathological proliferation and migration of vascular smooth muscle cells (VSMCs) into the vessel intima [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. This process is triggered by vessel wall injury from surgical anastomosis and repeated needle punctures, exacerbated by the turbulent blood flow and high shear stress environment characteristic of the AVF [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Conventional percutaneous transluminal angioplasty (PTA) using a plain balloon (PB) has long been the primary endovascular solution for stenosis [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, the mechanical inflation required to open the lesion itself causes additional barotrauma to the vessel wall, accelerating the NIH cycle and resulting in restenosis rates that frequently necessitate multiple reinterventions within the first year [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDrug-coated balloons (DCBs) were developed to interrupt this inflammatory-proliferative cycle. DCBs deliver a localized, therapeutic dose of an antiproliferative agent (paclitaxel) directly to the vessel wall during balloon inflation [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Paclitaxel acts by interfering with microtubule dynamics, effectively inhibiting the proliferation and migration of VSMCs, thereby slowing the progression of NIH and extending the duration of primary patency [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. The success of this pharmacomechanical approach has been demonstrated in multiple clinical trials, including our own initial prospective study, confirming superior patency outcomes for DCBs in AVF interventions [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe clinical superiority of DCBs is often challenged by their higher initial device cost. Health systems, particularly those operating under fixed or bundled reimbursement models, require robust economic data to determine if the clinical gain justifies the increased upfront expenditure [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. This is particularly relevant in systems where procedural reimbursement is fixed or bundled, making the cost-saving potential from avoided future procedures critical for budgetary approval. This study provides a rigorous, institution-specific economic evaluation comparing the DCB strategy to the PB strategy, utilizing micro-costing to derive a highly transparent and actionable cost-effectiveness profile over a 24-month horizon.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design, Ethics, and Patient Data\u003c/h2\u003e \u003cp\u003eThis cost-effectiveness analysis is a retrospective economic evaluation based on prospectively collected clinical data from our previously published single-centre study [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. That study included 62 consecutive adult patients with dysfunctional native AVFs who underwent angioplasty (31 in the PB group and 31 in the DCB group) and were followed for 24 months.\u003c/p\u003e \u003cp\u003eBaseline patient characteristics are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The original study found that the two groups were well-matched across demographic variables like sex and age. However, a significant difference was noted in the median age of the AVF at the time of the index procedure, a factor that is discussed further in the limitations section.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline Demographic and Clinical Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePB Group (n\u0026thinsp;=\u0026thinsp;31)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDCB Group (n\u0026thinsp;=\u0026thinsp;31)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean age (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e67,03 +/- 8,44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e62,81 +/- 17,2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,22\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale gender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 (48,4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (51,6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26 (83,9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18 (58,1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHyperlipidaemia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (22,6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (16,1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes mellitus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (38,7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13 (41,9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSmoking\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (16,1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (25,8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,53\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAVF median age (days)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e609 (294\u0026ndash;991)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e255 (178\u0026ndash;465)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,013\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRadiocephalic fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (62,5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17 (54,8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBrachiocephalic fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (25,8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (38,7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBrachiobasilic fistula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (9,7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (6,6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eJuxta-anastomotic stenosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29 (93,5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30 (96,8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArterial stenosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (3,2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnastomotic stenosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (3,2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (3,2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStenosis median length (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40 (40\u0026ndash;60)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40 (40\u0026ndash;80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0,37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical success\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003ePB, balloon; DCB, drug-coated balloon; AVF, arteriovenous fistula; IQR, interquartile range; SD, standard deviation. A significant difference was observed in the median AVF age between the groups; other AVF anatomical characteristics (type, location and stenosis site) were comparable between groups.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe endovascular approach for the DCB group involved a sequential strategy: initial vessel preparation using a standard PB to achieve less than 30% residual stenosis, followed by the use of the DCB for definitive treatment and drug delivery [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. This technique aligns with international consensus guidelines which recommend adequate pre-dilation to optimize lesion expansion and promote effective drug transfer to the vessel wall [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eClinical Outcomes\u003c/h3\u003e\n\u003cp\u003eThe key clinical outcomes were taken directly from the published results of the index study [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eMean number of AVF-related endovascular interventions per patient over 24 months: PB group\u0026thinsp;=\u0026thinsp;2.29\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94 (median 2; IQR 2\u0026ndash;3); DCB group\u0026thinsp;=\u0026thinsp;1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.81 (median 1; IQR 1\u0026ndash;2).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eMean Primary Patency (MPP) of the Index Procedure: Defined as the time from the index intervention to the next clinically indicated repeat intervention or thrombosis.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003ePB group MPP: 315.7\u0026thinsp;\u0026plusmn;\u0026thinsp;216.8 days (approx. 0.86\u0026thinsp;\u0026plusmn;\u0026thinsp;0.59 years; median 0.74 years; IQR 0.42\u0026ndash;1.05 years).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eDCB group MPP: 534.2\u0026thinsp;\u0026plusmn;\u0026thinsp;206.1 days (approx. 1.46\u0026thinsp;\u0026plusmn;\u0026thinsp;0.56 years; median 1.39 years; IQR 1.09\u0026ndash;2.00 years).\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e\n\u003ch3\u003eEconomic Analysis and Perspective\u003c/h3\u003e\n\u003cp\u003eThe economic evaluation was conducted from the Institutional/Provider Perspective over a 24-month time horizon. This perspective is vital for local administrators making resource allocation decisions. Costs were estimated using the hospital\u0026rsquo;s official self-pay price list, which allows for detailed cost capture.\u003c/p\u003e \u003cp\u003eWe employed a micro-costing (bottom-up) approach, which utilizes highly detailed, actual institutional costs (devices, labor, consumables, overhead) rather than aggregated national reimbursement rates (e.g., Diagnosis-Related Groups or fixed tariffs) [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. This was necessitated because the national health insurance system in our country operates on a fixed, flat-rate reimbursement model that does not account for the actual material consumption [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Using the self-pay list allowed for a superior estimation of the true resource consumption associated with each intervention, thereby avoiding the systematic biases inherent in \"flat-rate\" payment systems where actual material usage is often obscured [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe direct procedural costs included the components detailed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The standardized hospitalization cost was included to accurately reflect the institutional overhead, interventional suite time, nursing, and recovery resource burden associated with each procedure, irrespective of the patient's actual discharge status.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDirect Procedural Cost per Intervention by Component\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComponent\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePB Procedure (\u0026euro;)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDCB Procedure (\u0026euro;)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePB balloon (vessel preparation)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e99.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e99.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDCB balloon (device)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026ndash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e536.08\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLabor cost per procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1,942.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1,942.51\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdditional material\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e536.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e536.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandardized Hospitalization\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2,366.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2,366.88\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal Cost per Procedure\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e4,945.22\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e5,481.30\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003ePB, plain balloon; DCB, drug-coated balloon. The cost per procedure includes standardized cost estimates for the interventional suite, staff time, and recovery resources, reflecting the true institutional resource burden. As these values are derived from fixed institutional self-pay tariffs, variability measures (SD or IQR) are not applicable at the single-procedure level.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003ch3\u003eCalculation of Economic Metrics\u003c/h3\u003e\n\u003col\u003e\n \u003cli\u003eTotal Mean Cost per Patient (TMC): Calculated as the mean number of interventions per patient multiplied by the total cost per procedure.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eTMC = Avg. Interventions X Cost per Procedure\u003c/p\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003eCost per Year of Primary Patency (CPYPP): Calculated as the Total Mean Cost per Patient over the 24-month follow-up divided by the mean primary patency achieved by the index procedure in years. This metric serves as a key indicator of cost-efficiency.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eCPYPP = Total Mean Cost per Patient / Mean Primary Patency (years)\u003c/p\u003e\n\u003col start=\"3\"\u003e\n \u003cli\u003eIncremental Cost-Effectiveness Ratio (ICER): Defined as the change in cost divided by the change in effect (\u0026Delta;Cost / \u0026Delta;Effect). When a strategy achieves better outcomes at a lower cost, it is considered cost-saving (economically dominant) and explicit ICER calculation is not required [19].\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eClinical Outcomes and Procedure Utilization\u003c/h2\u003e \u003cp\u003eAs previously published, the clinical effectiveness of DCB was superior, leading to a substantial reduction in the rate of reinterventions [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The DCB group required a mean of 1.55 interventions per patient over 24 months, compared to 2.29 in the PB group. The increase in mean primary patency was 0.60 years (approximately 70%) with the use of DCBs.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eCost Analysis\u003c/h2\u003e \u003cp\u003eAs detailed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the cost per procedure was \u0026euro;4,945.22 for the PB group and \u0026euro;5,481.30 for the DCB group. The resulting total mean costs per patient are shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eTotal Cost per Patient over 24 Months\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvg. Interventions\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCost per Procedure (\u0026euro;)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTotal Cost per Patient (\u0026euro;)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e2.29\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4,945.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e11,324.55\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDCB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5,481.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e8,496.02\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003ePB, plain balloon; DCB, drug-coated balloon; Avg. Interventions, Mean number of interventions per patient over 24 months. Total Cost per Patient is calculated as Avg. Interventions x Cost per Procedure. Values are presented as mean estimates per patient; variability in resource use is primarily reflected in the distribution of the number of interventions, while costs are derived deterministically from the fixed per-procedure tariff and the mean number of procedures.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eDespite the higher device cost for the DCB strategy, the lower reintervention rate resulted in a significantly reduced total mean cost per patient over the 24-month follow-up period (\u0026euro;8,496.02 vs \u0026euro;11,324.55). The total cost savings was \u0026euro;2,828.53 per patient for the DCB strategy.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eCost-Effectiveness Analysis\u003c/h3\u003e\n\u003cp\u003eThe results demonstrate a pronounced difference in cost-efficiency when adjusted for clinical benefit (mean primary patency). The key metric, Cost per Year of Primary Patency (CPYPP), is presented in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCost per Year of Primary Patency (CPYPP)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal Cost (\u0026euro;)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePatency (yrs)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eCPYPP (\u0026euro;)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e11,324.55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e0.86\u0026thinsp;\u0026plusmn;\u0026thinsp;0.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13,168\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDCB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8,496.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e1.46\u0026thinsp;\u0026plusmn;\u0026thinsp;0.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5,819\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003ePB, plain balloon; DCB, drug-coated balloon; Patency (yrs), Mean primary patency in years derived from the index procedure outcome. CPYPP, Cost per Year of Primary Patency, is calculated as Total Cost (\u0026euro;) / Patency (yrs). Values are calculated from mean total cost per patient and mean primary patency for each group; variability measures for CPYPP are therefore notshown separately.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eGiven that the DCB strategy resulted in a lower total cost (Cost difference: -\u0026euro;2,828.53) and superior clinical outcome (Patency difference: +0.60 years), DCB angioplasty was both less costly and more effective than PB angioplasty in this cohort and can therefore be considered cost-saving from the institutional perspective.\u003c/p\u003e\n\u003ch3\u003eSensitivity Analysis: Cost Threshold for DCB\u003c/h3\u003e\n\u003cp\u003eTo test the robustness of this cost-saving finding, we performed a threshold analysis to determine the maximum DCB device price at which the DCB strategy would remain cost-saving (i.e., Total DCB Cost\u0026thinsp;\u0026le;\u0026thinsp;PB Cost).\u003c/p\u003e \u003cp\u003eThe maximum sustainable DCB device price (D\u003csub\u003emax\u003c/sub\u003e) was calculated to be approximately \u0026euro;2,360.94. Since the current DCB device price (\u0026euro;536.08) is substantially below this threshold, the DCB cost could increase by nearly 440% before the strategy would lose its absolute cost-saving advantage, strongly supporting the robustness of this cost-saving profile.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe findings of this study provide real-world evidence for the economic benefit of drug-coated balloon angioplasty in the management of dysfunctional AVFs. In our single-centre cohort, the DCB strategy was associated with both superior mean primary patency and lower cumulative treatment costs over 24 months compared to PB angioplasty.\u003c/p\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eTranslating Economic Findings into Clinical Value\u003c/h2\u003e \u003cp\u003eFor interventionalists and hospital administrators, a strategy that is both less costly and more effective is of particular interest from a value-based care perspective. In economic terms, such a strategy can be described as cost-saving (economically dominant), although our results should be interpreted in light of the modest sample size and single-centre design. In our cohort, the primary driver of the observed cost savings was the reduction in the frequency of reinterventions (from 2.29 to 1.55 per patient over 24 months). This reduction not only decreases total expenditure, but also increases intervention-free time for both patients and the interventional suite, potentially improving resource utilisation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eOperational Efficiency and Training Impact\u003c/h2\u003e \u003cp\u003eThe observed reduction in reinterventions (0.74 fewer per patient over 24 months) translates directly into increased operational efficiency. By dedicating fewer interventional suite hours to repeat, often routine, AVF procedures, resources (staff time, angiography equipment) are freed up for more complex, urgent, or elective cases. This improved workflow minimizes delays, potentially enhancing the hospital's overall procedural capacity. Furthermore, a stable workload focusing on quality procedures aids in the training of junior interventional radiologists by reducing exposure to repetitive, low-yield reinterventions and allowing more time for critical diagnostic and therapeutic interventions [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. This systemic benefit should not be underestimated when evaluating new technologies [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eClinical, Quality of Life, and Financial Implications\u003c/h2\u003e \u003cp\u003eThe nearly 56% reduction in the Cost per Year of Primary Patency (CPYPP) observed in our analysis indicates a substantial improvement in cost-efficiency with the DCB approach (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eBeyond the financial savings, reducing the number of interventions from 2.29 to 1.55 procedures per patient over 24 months lowers the procedural burden for patients and may positively influence quality of life, although QoL was not formally measured in this study. Each avoided intervention reduces procedural risk, limits exposure to contrast agents and radiation, and decreases time spent in the hospital or angiography suite. In addition, more stable access may reduce the need for temporary central venous catheters, which are associated with a higher risk of infection and morbidity [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eAddressing Technical Approach and Patency\u003c/h2\u003e \u003cp\u003eThe success observed in the DCB group reinforces the importance of the sequential interventional approach (PB pre-dilation followed by DCB). This technique is designed to optimize the delivery of paclitaxel by ensuring full lesion expansion and maximal contact between the drug-coated surface and the arterial wall, facilitating optimal drug absorption into the media layer and enhancing the anti-proliferative effect [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eContextualizing Paclitaxel Safety\u003c/h2\u003e \u003cp\u003eIt is critical for contemporary vascular interventional literature to address the widely discussed topic of paclitaxel safety, which arose following a meta-analysis suggesting a late-term mortality risk associated with paclitaxel-coated devices in the femoropopliteal segment [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. While this concern predominantly relates to devices used in the peripheral arterial system, continuous long-term surveillance is necessary. Importantly, subsequent meta-analyses and dedicated studies in vascular access have generally demonstrated that this safety signal is not reproducible in the specific application of DCBs for AVFs, which operate under distinct hemodynamic conditions [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Our clinical data align with the consensus that DCB use in AVFs is safe, and the economic benefits presented here must be weighed alongside the robust safety data specific to this anatomical application.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eLimitations and Future Directions\u003c/h2\u003e \u003cp\u003eThe primary limitation remains the single-centre, non-randomized design, which introduces the potential for selection and institutional bias. Specifically, our original cohort showed a statistically significant difference in median AVF age between the groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). While literature suggests that the age of a mature AVF is not a confounding factor for primary patency, we acknowledge this potential confounder. However, since the cost-saving effect is driven predominantly by the reduction in the number of reinterventions (a consequence of improved patency), rather than the absolute patency duration itself, the core economic finding remains robust.\u003c/p\u003e \u003cp\u003eFurthermore, this analysis only considers direct institutional costs. The exclusion of indirect and societal costs, such as patient transportation, lost work productivity, and caregiver burden, likely results in an underestimation of the total benefit of the DCB strategy. Future research should prioritize large-scale, multicenter randomized controlled trials (RCTs) with integrated, long-term economic endpoints. Specifically, incorporating measures of Quality-Adjusted Life Years (QALYs) and conducting probabilistic sensitivity analyses will provide a more comprehensive societal evaluation, fully quantifying the true health and economic value of avoiding repeat procedures over time [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eSustainable Impact on Institutional Policy\u003c/h2\u003e \u003cp\u003eThe finding that DCB was both less costly and more effective in our setting supports a proactive discussion regarding its implications for institutional purchasing and procedural protocols. When comparing the return on investment (ROI) for a DCB versus a PB, the DCB offers immediate value creation through resource sparing. For high-volume interventional units, the reduced occupancy of angiography suites, decreased inventory turnover of disposable PB supplies, and maximized utilization of specialized staff hours translate into long-term systemic sustainability. The adoption of the DCB strategy moves vascular access maintenance from a reactive, repeated intervention model to a proactive, value-based care model, confirming that adopting higher-cost, high-performance technology may represent a fiscally responsible choice for modern healthcare providers facing similar constraints [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study demonstrates that, within a single high-volume tertiary centre operating in a fixed-tariff environment, DCB angioplasty was associated with lower total mean institutional cost per patient (\u0026euro;8,496.02 vs \u0026euro;11,324.55) and a lower cost per year of primary patency (\u0026euro;5,819 vs \u0026euro;13,168) than PB angioplasty (Tables\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e and \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThese results provide real-world economic justification for considering DCB angioplasty in routine AVF maintenance, particularly in centres with similar organisational and reimbursement structures. The ability of DCBs to deliver sustained clinical improvement while reducing cumulative resource utilisation supports their integration into evidence-based, value-oriented vascular access management pathways, while acknowledging that confirmation in larger, multicentre studies is needed.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e The study was approved by the National Medical Ethics Committee and was conducted in accordance with applicable ethical standards and the Declaration of Helsinki. Written informed consent was obtained from all participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eWritten informed consent for the publication of anonymised clinical data was obtained from all participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eThe datasets generated and/or analysed during the study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u0026nbsp;\u003c/strong\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eNot applicable. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e: All authors contributed to the conception and design of the study, data collection and interpretation, and manuscript preparation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u003c/strong\u003e The authors would like to thank the interventional radiology and dialysis teams at University Medical Centre Maribor for their support in patient care and data collection.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eDaugirdas JT et al (2015) KDOQI clinical practice guideline for hemodialysis adequacy: 2015 update. Am J Kidney Dis 66(5):884\u0026ndash;930\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTordoir J et al (2007) EBPG Guideline on Vascular Access. Nephrol Dial Transpl 22(Suppl 2):ii88\u0026ndash;117\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Kidney Foundation (2006) KDOQI Clinical Practice Guidelines for Vascular Access. Am J Kidney Dis 48(Suppl 1):S1\u0026ndash;S322\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eU.S. Renal Data System (2020) USRDS Annual Data Report: Epidemiology of Kidney Disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHingorani A et al (2004) Cellular proliferation and intimal hyperplasia in arteriovenous fistulas for hemodialysis. J Vasc Surg 39(2):497\u0026ndash;501\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoy-Chaudhury P, Sukhatme VP, Cheung AK (2006) Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol JASN 17(4):1112\u0026ndash;1127\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRajan DK et al (2015) Maintenance of Arteriovenous Fistulas and Grafts: Endovascular vs. Surgical Treatment\u0026mdash;A Systematic Review. J Vasc Interv Radiol 26(10):1478\u0026ndash;1486\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMalka KT, Flahive J, Csizinscky A, Aiello F, Simons JP, Schanzer A et al (2016) Results of repeated percutaneous interventions on failing arteriovenous fistulas and grafts and factors affecting outcomes. J Vasc Surg 63(3):772\u0026ndash;777\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSpear R, Herten M, Drug-Coated, Balloons (2018) Principles of Paclitaxel Transfer to the Vessel Wall. Cardiovasc Intervent Radiol 41(7):1001\u0026ndash;1008\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eScheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G (2004) Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 110(7):810\u0026ndash;814\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLučev J et al (2018) Endovascular treatment of haemodialysis arteriovenous fistula with drug-coated balloon angioplasty: A single-centre study. Cardiovasc Intervent Radiol 41(6):876\u0026ndash;883\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKatsanos K et al (2019) Systematic review and meta-analysis of DCB vs PB in dialysis AVF. Eur J Radiol 117:154\u0026ndash;162\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D (2015) Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol 84(3):418\u0026ndash;423\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTrerotola SO et al (2021) The IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Use. J Vasc Interv Radiol 32(7):981\u0026ndash;987\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBj\u0026ouml;rkman P et al (2020) Cost-effectiveness of DCB in arteriovenous fistula: a Finnish modeling study. Nephrol Dial Transpl 35(2):339\u0026ndash;346\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKleber FX, Mathey DG, Rittger H, Scheller B (2011) How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention 7(Suppl K):K125\u0026ndash;K128\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSkinner J, O'Brien B (2019) Micro-costing: a practical approach for health economic evaluations. Value Health 22(Suppl 1):S1\u0026ndash;S3\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGold MR, Siegel JE, Russell LB, Weinstein MC (1996) Cost-Effectiveness in Health and Medicine. Oxford University Press\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Institute for Health and Care Excellence (NICE) (2013) Guide to the methods of technology appraisal\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Society of Radiology (2022) Interventional Radiology economic guidance. ESR Position Paper\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGouny P, Mounier-V\u0026eacute;hier C, Lermusiaux P, Jean-Baptiste C, Houin-Lemeunier S, Gouny S et al (2020) Impact of endovascular reintervention on the quality of life of patients with dysfunctional vascular access for hemodialysis. J Vasc Access 21(3):363\u0026ndash;368\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePerricone G, Iacono G, Scali S (2019) Quality of life assessment in patients with vascular access failure: a systematic review. J Vasc Access 20(2):125\u0026ndash;131\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKatsanos C, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D (2018) Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc 7(24):e011245\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKlonaris C, Katsaros I, Vlahos I, Georgopoulos S, Gouny P, Giannakas N (2021) Paclitaxel-coated balloon angioplasty for the treatment of failing arteriovenous fistulas in hemodialysis patients: is there a long-term mortality concern? A systematic review and meta-analysis. J Vasc Access 22(2):162\u0026ndash;171\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Commission (2021) State of Health in the EU \u0026ndash; Slovenia, Country Health Profile 2021. OECD/European Observatory on Health Systems and Policies\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"cvir-endovascular","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cire","sideBox":"Learn more about [CVIR Endovascular](https://www.springer.com/journal/42155)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/cire/default.aspx","title":"CVIR Endovascular","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Arteriovenous fistula, Hemodialysis, Drug-coated balloon, Cost-effectiveness, Endovascular treatment, Primary patency, Institutional policy, Value-Based Care","lastPublishedDoi":"10.21203/rs.3.rs-8278408/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8278408/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eTo evaluate the cost-effectiveness of drug-coated balloon (DCB) versus plain balloon (PB) angioplasty for dysfunctional haemodialysis arteriovenous fistulas (AVFs) from the institutional perspective of a high-volume tertiary care centre over 24 months, in order to inform resource allocation policy.\u003c/p\u003e\u003ch2\u003eMaterials and Methods\u003c/h2\u003e \u003cp\u003eThis analysis uses clinical outcomes from a previously published single-centre cohort of 62 patients (31 DCB, 31 PB) treated for dysfunctional AVFs. A detailed institutional micro-costing approach based on self-pay tariffs was applied to quantify direct procedural costs. Total mean cost per patient and cost per year of primary patency (CPYPP) were calculated, and a sensitivity analysis was performed to explore the impact of varying the DCB device price.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe DCB group demonstrated higher mean target-lesion primary patency (1.46\u0026thinsp;\u0026plusmn;\u0026thinsp;0.56 vs 0.86\u0026thinsp;\u0026plusmn;\u0026thinsp;0.59 years) and required fewer AVF-related endovascular interventions per patient over 24 months (1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.81 vs 2.29\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94). Total mean cost per patient was lower with DCB (\u0026euro;8,496.02 vs \u0026euro;11,324.55), resulting in a lower cost per year of primary patency (CPYPP \u0026euro;5,819 vs \u0026euro;13,168). Sensitivity analysis suggested that this cost-saving profile remained robust across a wide range of DCB device prices.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eDespite the higher device cost, DCB angioplasty appeared to be a cost-saving and clinically more effective alternative to PB angioplasty in this cohort. Lower overall institutional expenditure and reduced reintervention frequency support its consideration for integration into AVF maintenance protocols and value-based care pathways in similar fixed-reimbursement settings.\u003c/p\u003e","manuscriptTitle":"Value-Based Approach to AVF Maintenance: Institutional Micro-Costing of Drug-Coated Versus Plain Balloon Angioplasty in a Fixed-Reimbursement System","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-16 09:17:43","doi":"10.21203/rs.3.rs-8278408/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-12-13T07:57:04+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-12-11T08:02:11+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-12-09T06:17:32+00:00","index":"","fulltext":""},{"type":"submitted","content":"CVIR Endovascular","date":"2025-12-05T03:21:19+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"cvir-endovascular","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cire","sideBox":"Learn more about [CVIR Endovascular](https://www.springer.com/journal/42155)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/cire/default.aspx","title":"CVIR Endovascular","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"5fdf385b-c40c-441a-8c0c-5bc0c56166b0","owner":[],"postedDate":"December 16th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T16:05:24+00:00","versionOfRecord":{"articleIdentity":"rs-8278408","link":"https://doi.org/10.1186/s42155-026-00665-z","journal":{"identity":"cvir-endovascular","isVorOnly":false,"title":"CVIR Endovascular"},"publishedOn":"2026-02-28 15:58:51","publishedOnDateReadable":"February 28th, 2026"},"versionCreatedAt":"2025-12-16 09:17:43","video":"","vorDoi":"10.1186/s42155-026-00665-z","vorDoiUrl":"https://doi.org/10.1186/s42155-026-00665-z","workflowStages":[]},"version":"v1","identity":"rs-8278408","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8278408","identity":"rs-8278408","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}