Efficacy and safety of low dose, weight-based subcutaneous enoxaparin protocol in recurrent arteriovenous access thrombosis.

BACKGROUND: This study aims to evaluate the safety and efficacy of a short-term, low dose, weight-based subcutaneous enoxaparin protocol (SEP) in maintaining the patency of arteriovenous (AV) access with recurrent thrombosis. METHODS: Prospective follow-up of 25 patients who presented to a tertiary institution with recurrent AV access thrombosis and treated with anticoagulation according to SEP following successful thrombectomy. Patency and safety outcomes of SEP were studied. RESULTS: The participants were 66.4 ± 10.2 years old and predominantly male (60%) and of Chinese ethnicity (72%). The AV accesses had a median age of 1.4 (0.6, 5.6) years with 60% being non-autogenous arteriovenous access while 40% were autogenous arteriovenous access. Thrombolytic agents (urokinase (72%) or alteplase (28%)) were used in all procedures while adjunct thrombectomy device was used in only four procedures. The mean dose of enoxaparin was 36.0 ± 8.2 mg or 0.64 ± 0.1 mg/kg/day for a mean duration 30.0 days (Interquartile range: 27.5, 31.0). One patient developed minor bleeding episode. Kaplan-Meier analysis demonstrated that the mean thrombosis-free survival pre- versus post-SEP adoption was 27.3 (95% CI 17.9-36.7) versus 183.5 (95% CI 100.1-266.9) days (p < 0.001). After adjusting for the type of thrombolytic agent, use of adjunct thrombectomy device, cutting balloon, drug-coated balloon, and stent graft, SEP remained a significant factor associated with longer thrombosis-free patency (HR 0.166: 95% CI 0.070-0.392, p < 0.001). DISCUSSION: SEP appears to be a feasible and safe thromboprophylaxis method to improve thrombosis-free patency for AV access with recurrent thrombosis.

Use of the helical SUPERA™ stent and Passeo-18 Lux™ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the Arch V SUPERA-LUX study.

BACKGROUND: Aim of Arch V SUPERA-LUX was to evaluate the safety and efficacy of the combination therapy of SUPERA™ (Abbott Vascular, Santa Clara, CA, USA) helical stent implantation and Passeo-18 Lux™ (Biotronik Asia Pacific Pte Ltd, Singapore) drug coated balloon (DCB) elution to treat recurrent cephalic arch stenosis (CAS) in the setting of AV access dysfunction. METHODS: Investigator-initiated, single-center, single-arm prospective pilot study of 20 end-stage renal failure Asian patients with a dysfunctional brachiocephalic fistula. All had symptomatic recurrent CAS within 6 months of prior intervention. The lesion was pre-dilated with a standard high-pressure balloon (Biotronik Passeo-35 HP balloon). The DCB (Passeo-18 Lux™) is subsequently inflated and the SUPERA™ stent deployed to sit 2 mm distal to the cephalic arch and covering the CAS but within the DCB zone. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 6- and 12-months. RESULTS: There were 9 (45%) males and mean age was 67 ± 11.0 years. Mean time from prior procedure was 113 ± 68 days and main indication for reintervention was high venous pressure (9/20, 45%). Technical success was 100% and there were no peri-procedural complications related to either stent or DCB deployment. Target lesion primary patency at 6- and 12-months was 10/18 (55%) and 5/16 (31%), respectively. Mean time to target lesion re-intervention was 170 ± 82 days. Circuit access patency was 8/18 (44%) and 2/16 (13%) at 6- and 12-months respectively and mortality was 3/20 (15%) attributed to the patients' underlying co-morbidities. CONCLUSION: Dual prong strategy of using SUPERA™ stenting and Passeo-18 Lux™ drug elution for recurrent CAS, although safe, was no more efficacious than conventional balloon angioplasty or stenting alone. Development of an intense inflammatory reaction within the stent led to reinterventions of a number of cases with suboptimal results.

Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results.

BACKGROUND: The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage. METHODS AND RESULTS: This is an investigator-initiated prospective single-center, non-blinded single-arm trial. Forty patients with clinically significant de novo or recurrent stenoses in a mature AVF circuit will be recruited. All stenotic lesions will be prepared with high pressure non-compliant conventional balloon angioplasty (CBA) prior to deployment of the Sustained-Release Selution™ sirolimus drug-eluting balloon. The primary efficacy endpoint is 6-month target lesion primary patency and the primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days. Secondary endpoints of interest include technical and clinical success rates and circuit access patency at 3 and 6 months. Follow-up will occur for 2 years for those patients whose AVFs remain patent. Pharmacokinetic and histological animal safety studies performed with the Selution™ coating formulation showed prolonged arterial tissue retention of sirolimus with therapeutic levels up to 60 days and non-toxic and rapidly declining blood levels. Histological results in animal models demonstrated safety, freedom from intraluminal thrombus, reduction in restenosis by sirolimus elution compared to CBA, and no evidence of embolic phenomena indicative of adverse particulate effects. DISCUSSION: Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas.

Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial.

BACKGROUND: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. METHODS: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. RESULTS: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients' underlying co-morbidities. CONCLUSIONS: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.

Ranger™ paclitaxel-coated balloon versus conventional balloon angioplasty for treatment of failing arteriovenous fistulas and grafts in haemodialysis patients: A retrospective cohort study.

BACKGROUND: Aim was to compare the safety and patency efficacy outcomes between Ranger™ paclitaxel-coated balloon (PCB)- versus conventional balloon angioplasty (POBA) in the treatment of haemodialysis access-related conduit stenosis. METHODS: Retrospective single-centre, multi-investigator, consecutive, double-arm comparative cohort study. About 130 end-stage renal failure Asian patients with dysfunctional arteriovenous fistula (AVF) or arteriovenous graft underwent PCB or POBA fistuloplasty between November 2018 and June 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to PCB angioplasty. All patients received at least one antiplatelet agent for 3 months duration post procedure. RESULTS: Mean age was 66.0 ± 10 years and 79/130 (61%) were males. PCB arm (n = 65) versus POBA arm (n = 65). Majority were AVFs circuits (122/130, 94%). Main indication for intervention was dropping access flow (98/130, 76%). About 172 lesions were treated (56% POBA, 44% PCB), and the juxta-anastomosis (JAS) was the main target lesion (87/172, 51%). There were no significant differences in safety outcomes (30-day adverse events, access thrombosis, abandoned AVF and death) between treatment groups. Mean time to target lesion reintervention (TLR) was longer in PCB-treated lesions (7.1 ± 2.7 vs 5.8 ± 3.2 months, p = 0.03), especially amongst recurrent lesions (7.3 ± 2.4 vs 5.7 ± 3.2, p = 0.02). Mean time to circuit reintervention was also longer in PCB-treated circuits (6.9 ± 2.8 vs 5.8 ± 3.7months, p = 0.04). There were 16 deaths (12%), all attributed to patient's underlying comorbidities. CONCLUSIONS: Fistuloplasty with Ranger™ PCB for failing arteriovenous circuits in end-stage renal failure patients, is a safe and efficacious modality compared to POBA in terms of longer freedom from TLR.

Regional citrate anticoagulation vs systemic heparin anticoagulation for double-filtration plasmapheresis.

INTRODUCTION: Double-filtration plasmapheresis (DFPP) has been utilized for immunomodulation in kidney transplantation. Anticoagulation is important to maintain circuit patency during DFPP. We aimed to compare the efficacy and safety of regional citrate anticoagulation (RCA) with systemic heparin anticoagulation during DFPP in kidney transplant recipients. METHODS: A retrospective cohort study was conducted to compare the efficacy and safety of RCA (RCA-DFPP) to systemic heparin anticoagulation (Hep-DFPP) for DFPP among kidney transplant recipients in a single tertiary center. RESULTS: A total of 112 sessions of DFPP were performed for 23 subjects, of which 62 sessions were RCA-DFPP and 50 sessions were Hep-DFPP. There were 13 sessions (11.6%) of premature circuit clotting, 10 sessions (16.1%) for RCA-DFPP and 3 sessions (6.0%) for Hep-DFPP (P = .10). All premature circuit clotting episodes occurred in subjects who underwent DFPP through a vascular catheter. Premature circuit clotting was associated with the use of a vascular catheter (odds ratio [OR] 14.2, 95% confidence interval [CI] 2.7-73.7; P < .01) and high postfilter ionized calcium (OR 12.7, 95% CI 1.4-112.5; P < .01). There was no major bleeding event. Hep-DFPP was associated with higher occurrence of hypocalcemia (OR 1.1, 95% CI 1.0-1.2; P < .01) and metabolic acidosis (OR 1.4, 95% CI 1.2-2.0; P = .04), while hypomagnesemia was more common for RCA-DFPP (OR 2.9, 95% CI 1.1-7.4; P = .03). CONCLUSION: Amongst kidney transplant patients who receive DFPP therapy, RCA-DFPP may be comparable to Hep-DFPP for the maintenance of circuit patency. Functioning vascular access is vital in avoiding premature clotting of the circuit. Close monitoring of electrolyte imbalances and coagulopathy related to DFPP is recommended.

Study protocol for a Prospective, Randomized controlled trial of stEnt graft and Drug-coated bAlloon Treatment for cephalic arch stenOsis in dysfunctional arteRio-venous fistulas (PREDATOR).

BACKGROUND: Treatment of cephalic arch stenosis (CAS) is associated with high risk of failure and complications. Although stent-graft (SG) placement has improved patency rates, stent edge restenosis has been raised as a potential limiting factor for SG usage in CAS. This study aims to evaluate the safety and efficacy of combining stent graft placement with paclitaxel-coated balloon (PCB) angioplasty versus PCB alone in the treatment of CAS. METHODS: This is an investigator-initiated, prospective, international, multicenter, open-label, randomized control clinical trial that plans to recruit 80 patients, who require fistuloplasty from dysfunctional arteriovenous fistula (AVF) from CAS. Eligible participants are randomly assigned to receive treatment with SG and PCB or PCB alone in a 1:1 ratio post-angioplasty (n = 40 in each arm). Randomization is stratified by de novo or recurrent lesion, and the participants are followed up for 1 year. The primary endpoints of the study are target lesion primary patency (TLPP) and access circuit primary patency (ACPP) rates at 6-months. The secondary endpoints are TLPP and ACPP at 3- and 12-month; target lesion and access circuit assisted primary and secondary patency rates at 3, 6, and 12-months and the total number of interventions; complication rate; and cost-effectiveness. DISCUSSION: This study will evaluate the clinical efficacy and safety of combination SG and PCB implantation compared to PCB alone in the treatment of CAS for hemodialysis patients.

Bibliometric analysis of fibroblast growth factor 21 research over the period 2000 to 2021.

Background: Fibroblast growth factor 21 (FGF-21) is an evolutionarily conserved protein that plays multiple roles in metabolic regulation. Over the past two decades, numerous studies have deepened our understanding of its various functions and its pharmacological value. Nevertheless, most clinical trials have not achieved the desired results, which raises issues regarding its clinical value. In this bibliometric analysis, we evaluated the state of FGF-21 research over the last 20 years and identified important topics, achievements, and potential future directions. Methods: Publications related to FGF-21 were collected from the Web of Science Core Collection-Science Citation Index Expanded. HistCite, VOSviewer, and CiteSpace were used for bibliometric analysis and visualization, including the analysis of annual publications, leading countries, active institutions and authors, core journals, co-cited references, and keywords. Results: Altogether, 2,490 publications related to FGF-21 were obtained. A total of 12,872 authors from 2,628 institutions in 77 countries or regions reported studies on FGF-21. The United States of America was the most influential country in FGF-21 research. Alexei Kharitonenkov, Steven A. Kliewer, and David J. Mangelsdorf were the most influential scholars, and endocrinology journals had a core status in the field. The physiological roles, clinical translation, and FGF-21-based drug development were the main topics of research, and future studies may concentrate on the central effects of FGF-21, FGF-21-based drug development, and the effects of FGF-21 on non-metabolic diseases. Conclusion: The peripheral metabolic effects of FGF-21, FGF-21-based drug development, and translational research on metabolic diseases are the three major topics in FGF-21 research, whereas the central metabolic effects of FGF-21 and the effects of FGF-21 on metabolic diseases are the emerging trends and may become the following hot topics in FGF-21 research.

Sirolimus-coated balloon angioplasty in maintaining the patency of thrombosed arteriovenous graft: 1-year results of a prospective study.

BACKGROUND: A prospective, pilot study was designed to test the feasibility of using sirolimus-coated balloon (SCB) to treat graft vein junction of thrombosed arteriovenous graft (AVG) following successful pharmacomechanical thrombectomy. The present report provides the 1-year results of this study. METHODS: This is a 1-year follow-up of a single, prospective, single-arm study that was conducted from 2018 to 2019 in 20 patients who presented to a tertiary institution with thrombosed AVG. The recruited patients received SCB angioplasty at the graft-vein junction following successful endovascular thrombectomy of a thrombosed AVG. One year after recruitment, there were three deaths, one AVG revision, and one AVG explantation among the participants recruited. The outcomes of 15 subjects at 1-year following the index procedure obtained from electronic medical records were re-examined. RESULTS: The 1-year access circuit primary patency rate was 40%, while assisted primary and secondary patency rates were 46.7% and 73.3%, respectively. A total of 16 interventions (4 angioplasties, 12 thrombectomies) were performed in 9 patients over the 12 months. Four AVGs were abandoned. The median number of interventions per patient was 1 (0-3) per year. Using Kaplan-Meier analysis, the mean estimated post-intervention access circuit primary patency was 230 (95% CI: 162-300) days, while access circuit assisted primary patency was 253 (95% CI: 187-320) days, and access circuit secondary patency was 292 (95% CI: 230-356) days. Sub-group analysis did not show a significant difference in the mean estimated primary patency between AVG with de novo and recurrent stenosis (245 days, 95% CI: 151-339 vs 210 days, 95% CI: 113-307; p = 0.29). CONCLUSIONS: SCB may help sustain the patency of thrombosed AVG following successful thrombectomy.

Estimation of risk for major bleeding in native kidney biopsies in patients with multiple risk factors.

BACKGROUND AND AIMS: Individuals undergoing kidney biopsy are increasingly older and may have concurrent illnesses that cause deranged hematological and renal parameters that are associated with post-biopsy bleeding. We aimed to develop a clinical risk model to quantify bleeding risks in high-risk individuals with multiple risk factors. METHODS: Single-center retrospective cohort study of consecutive adults with serum creatinine ≥ 2 mg/dL (176 µmol/L) and had ultrasound-guided percutaneous native kidney biopsies between June 2011 and July 2015 in our tertiary referral center. The primary outcome was major bleeding, defined as need for red cell transfusion, radiological or surgical intervention, or if bleeding led to death within 7 days after kidney biopsy. RESULTS: Among 184 native kidney biopsies with serum creatinine ≥ 2 mg/dL, median age was 54.1 years and eGFR was 18.8 ml/min/1.73 m2. Major bleeding occurred in 19 biopsies (10.3%). Multivariate analysis accounting for age, weight, hemoglobin, platelet, prothrombin time and urea found that higher hemoglobin (adjusted OR 0.51, 95% CI 0.33-0.79, p = 0.003) and platelet (adjusted OR 0.99, 95% CI 0.98-0.99, p = 0.01) were independently associated with reduced major bleeding. A risk model that included (1) age ≥ 62 years old, (2) hemoglobin < 10 g/dL and (3) platelets ≤ 216 × 109/L as categorical variables predicted major bleeding post-biopsy. CONCLUSION: We developed a risk model that included multiple risk factors to quantify bleeding risks in native kidney biopsies with renal impairment.

SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial.

BACKGROUND: Percutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied. METHODS/DESIGN: This is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical. DISCUSSION: This study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04409912 . Registered on 1 June 2020.

Treatment of cephalic arch stenosis in dysfunctional arteriovenous fistulas with paclitaxel-coated versus conventional balloon angioplasty.

BACKGROUND: Treatment of cephalic arch stenosis (CAS) with standard plain old balloon angioplasty (POBA) in dysfunctional arteriovenous fistulas (AVF), is associated with early re-stenosis and higher failure rates compared to other lesions. Paclitaxel-coated balloons (PCB) may improve patency rates. This is a retrospective cohort study. Patients who underwent POBA or PCB for CAS over a 3-year period were included. Outcomes compared were circuit primary patency rates (patency from index procedure to next intervention), circuit primary assisted-patency rates (patency from index procedure to thrombosis), and target lesion (CAS) patency rates (stenosis > 50%) at 3, 6 and 12 months. RESULTS: Ninety-one patients were included. Sixty-five (71.4%) had POBA, while 26 (28.6%) had PCB angioplasty. There were 62 (68.1%) de-novo lesions. CAS was the only lesion that needed treatment in 24 (26.4%) patients. Circuit primary patency rates for POBA versus PCB groups were 76.2% vs. 60% (p = 0.21), 43.5% vs. 36% (p = 0.69) and 22% vs. 9.1% (p = 0.22) at 3, 6 and 12-months respectively. Circuit assisted-primary patency rates were 93.7% vs. 92% (p = 1.00), 87.1% vs. 80% (p = 0.51) and 76.3% vs. 81.8% (p = 0.77), whilst CAS target lesion intervention-free patency rates were 79.4% vs. 68% (p = 0.40), 51.6% vs. 52% (p = 1.00) and 33.9% vs. 22.7% (p = 0.49) at 3, 6 and 12-months respectively. Estimated mean time to target lesion intervention was 215 ± 183.2 days for POBA and 225 ± 186.6 days for PCB (p = 0.20). CONCLUSION: Treatment of CAS with PCB did not improve target lesion or circuit patency rates compared to POBA.

Outcomes of arteriovenous fistula in elderly patients on maintenance haemodialysis.

BACKGROUND: The optimal vascular access strategy in elderly patients receiving haemodialysis (HD) remains controversial. We aim to report the outcomes of arteriovenous fistula (AVF) in elderly patients initiated on maintenance HD in our centre. METHODS: Medical records of 688 incident patients initiated on HD from 2010 to 2012 in a tertiary centre were retrospectively reviewed. Patients' characteristics and AVF outcomes were compared among those < 65 years (non-elderly), ≥ 65-75 years (early elderly) and ≥ 75 years (late elderly). RESULTS: There were 418 non-elderly, 184 early elderly and 86 late elderly patients. There is a higher proportion of brachiocephalic and brachiobasilic fistula created in the late elderly (24.9% vs. 37.0% vs. 41.8%, p = 0.001). The outcomes of accesses created were comparable in the 3 age groups with similar proportions of functional AVFs (80.4% vs. 79.3% vs. 75.6%, p = 0.832) and comparable 1-, 3- and 5-year primary and secondary patency rates (p = 0.351 and 0.282, respectively). However, a longer maturation time (2.78 vs. 2.86 vs. 3.72 months, p = 0.010) and a higher mean number of interventions to assist maturation of the first AVF were required in late elderly patients (0.19 vs. 0.22 vs. 0.35, p = 0.014). Following AVF creation, median patient survival in the non-elderly, early and late elderly was 65.2 vs. 55.1 vs. 49.8 months respectively. CONCLUSION: AVFs created in elderly patients have comparable outcomes compared to non-elderly patients although more interventions are required to assist maturation with a longer maturation time necessitating early access creation to allow for time needed due to maturation delay.

Single Asian Center Experience Using the Flixene™ Early Cannulation Graft for Hemodialysis Access Creation.

BACKGROUND: The aim of this study was to review the efficacy of the Flixene™ (Atrium™, Hudson, NH, USA) hemodialysis arterio-venous graft (AVG) in a multiethnic Asian cohort of patients with end-stage renal failure (ESRF). Primary outcome was graft primary patency rate and secondary end points included graft usability, time to cannulation, reinterventions required for access salvage, complications, and patient mortality. METHODS: Single-center, single-arm, multi-investigator nonrandomized retrospective study. Patients with ESRF who underwent Flixene™ graft implantation over a two-year period (January 2017 - December 2018) were included to allow at least one-year follow-up. Demographics, procedural and follow-up data were collected from the hospital electronic medical records. RESULTS: About 48 patients (49 AVG) were included. There were 24 (50%) men; mean age 63.7 (IQR 58.2-71.3) years. Technical success rate was 45/49 (91.8%); 4/49 (8.2%) AVG created did not reach cannulation. 11/49 (22.4%) and 28/49 (57.1%) achieved cannulation within 1 and 2 weeks, respectively. 6- and 12- month primary patencies were 33.5% and 19.6%, respectively. Primary-assisted patency rates were 46.6% and 29.6% at the same time intervals. Secondary patency rate was 77.6% and 63.9% at 6 and 12 months, respectively. There were 6 (12.2%) graft infections requiring explant and one-year mortality was 14%. CONCLUSIONS: Our experience with the Flixene™ early cannulation graft is comparable with other AVGs in terms of patency and infection rates. However, early cannulation rates are lower than in other case series.

Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft.

PURPOSE: To investigate the use of a sirolimus drug-coated balloon (DCB) in the management of a thrombosed arteriovenous graft (AVG). MATERIALS AND METHODS: A single-center prospective pilot study was conducted between October 2018 and October 2019. Twenty patients (age = 67.0 years ± 10; male = 35%; mean time on dialysis = 31 months) with thrombosed upper limb AVG were enrolled. After successful pharmacomechanical thrombectomy and adequate treatment of the graft vein junction, sirolimus DCB angioplasty was performed at the graft vein junction. The patients were followed-up for 6 months, and all adverse events occurring during the study period were recorded. RESULTS: The primary circuit patency rates at 3 and 6 months were 76% and 65%, respectively, while the assisted-primary circuit patency rates at 3 and 6 months were 82% and 65%, respectively. The 3- and 6-month secondary circuit patency rates were 88% and 76%, respectively. Using Kaplan-Meier analyses, the estimated mean primary, assisted-primary, and secondary patencies were 285 days (95% confidence interval (CI) = 194-376 days), 319 days (95% CI = 221-416 days), and 409 days (95% CI = 333-485 days). No adverse event directly related to sirolimus DCB use was observed. CONCLUSIONS: The results of this pilot study suggest that the application of sirolimus DCB at the graft vein junction after the successful thrombectomy of AVG may be a feasible option to improve patency outcomes.