Oversized balloon angioplasty for endovascular maturation of arteriovenous fistulae to accelerate cannulation and to decrease the duration of catheter use

2021 ◽  
pp. 112972982110295
Author(s):  
Leonardo de Oliveira Harduin ◽  
Julia Bandeira Guerra ◽  
Carlos Eduardo Virgini-Magalhães ◽  
Felipe Silva da Costa ◽  
Brunno Ribeiro Vieira ◽  
...  
Keyword(s):  
Arteriovenous Fistula ◽  
Balloon Angioplasty ◽  
Clinical Success ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Time Interval ◽  
Flow Volume ◽  
Mean Flow ◽  
Arteriovenous Fistulae ◽  
Mean Time

Background: The functional autologous arteriovenous fistula is considered the best vascular access for patients on hemodialysis. Some fistulae exhibit maturation problems after creation and do not reach adequate vessel diameter and flow in dialysis. The aim of this study was to describe our technique of oversized balloon angioplasty for assisted maturation of arteriovenous fistulae to accelerate the cannulation and to decrease the time of catheter use and its outcome. Methods: A retrospective analysis of balloon-assisted procedures for maturation failure was performed in a single center between October 2011 and January 2019. Patients underwent imaging procedures to identify stenosis, followed by angioplasty using oversized high-pressure balloons from the anastomosis to the deep venous outflow tract. The flow volume, time interval of use of the fistula and removal of the catheter, patency rates, and complications rates were evaluated. Results: Seventy-eight patients underwent 124 balloon angioplasty procedures. Technical and clinical success was achieved in 91% of the cases. In patients in whom maturation was successful, the fistula was cannulated in a mean time of 5 days after the procedure (range, 1–20 days). On average, catheter removal was performed 14 days (range, 5–33 days) after the maturation procedure. The mean flow volume in the fistula before the procedure was 276 ml/min (range, 122–488 ml/min) and 24 h after the maturation was 1014 ml/min (range, 760–1800 ml/min). The primary patency rate at 3, 6, and 12 months was 87.3%, 66.2%, and 50.7%, respectively. Assisted primary patency was 100% at 3 months, 92.9% at 6 months, and 90.0% at 12 months. Minor complications occurred in 18% of cases, and major complications in 4.8%. Conclusions: The oversized balloon-assisted arteriovenous fistula maturation technique is safe and effective, allowing the cannulation of the fistulae a few hours or days after the procedure and decreasing the time of catheter use.

Thrombosed native hemodialysis fistulas: Technical and clinical outcomes of endovascular recanalization and factors influencing patency

2019 ◽  
Vol 20 (6) ◽  
pp. 725-732 ◽  
Author(s):  
Young Ho So ◽  
Young Ho Choi ◽  
Sohee Oh ◽  
In Mok Jung ◽  
Jung Kee Chung ◽  
...  
Keyword(s):  
Arteriovenous Fistula ◽  
Proportional Hazards Model ◽  
Clinical Success ◽  
Clinical Results ◽  
Primary Patency ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Secondary Patency ◽  
Endovascular Recanalization ◽  
Factors Influencing

Purpose: To evaluate the technical and clinical results of endovascular recanalization of thrombosed native hemodialysis fistula and the factors influencing patency. Methods: A retrospective study was conducted with 73 patients who had thrombosed arteriovenous fistulas and were treated with endovascular methods. Patient characteristics, arteriovenous fistula-related characteristics, and endovascular procedures were analyzed. Technical and clinical results and patency rates were evaluated. The factors influencing patency were analyzed using a univariate and multivariate Cox proportional hazards model. Results: Technical and clinical success rates were 93% (68/73) and 85% (62/73), respectively. At 3, 6, and 12 months, the primary patency rates were 87.9%, 73.3%, and 64.8%; assisted primary patency rates were 89.2%, 78.6%, and 70.7%; and secondary patency rates were 90.8%, 87.2%, and 83.1%, respectively. Previous intervention and cephalic arch stenosis were risk factors for lower primary and assisted primary patency ( p < 0.05 for all). Cephalic arch stenosis was the only risk factor for lower secondary patency ( p < 0.05). No major complications associated with the procedures were noticed. Conclusion: Endovascular treatment was effective for the immediate recanalization of thrombosed arteriovenous fistula. In addition, previous intervention and cephalic arch stenosis were significantly related to lower arteriovenous fistula patency.

P1329STENTING VERSUS ISOLATED BALLOON ANGIOPLASTY FOR CENTRAL VEIN STENOSIS IN HEMODIALYSIS PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Aleksei Zulkarnaev ◽  
Zurab Kardanakhishvili ◽  
Boris Baykov
Keyword(s):  
Balloon Angioplasty ◽  
Primary Patency ◽  
Endovascular Intervention ◽  
Time Interval ◽  
Central Vein ◽  
Secondary Patency ◽  
Surgical Interventions ◽  
Endovascular Interventions ◽  
Vein Stenosis ◽  
Central Vein Stenosis

Abstract Background and Aims comparative analysis of the results of isolated balloon angioplasty (BA) and BA with stenting of central veins stenosis in patients on hemodialysis. Method A retrospective study included 62 patients with confirmed stenosis of the central veins: subclavian, brachiocephalic veins, vena cava inferior, or multiple lesions. In 39 patients, stents are not used; isolated balloon angioplasty (BA) was performed. In 23 patients we used bare metal stents. Results Functional primary patency (the time interval between the start of AVF using and the first endovascular intervention) did not differ in the groups – fig. 1A; HR 1.142 [95% CI 0.6875; 1.897], p = 0.5994. The use of stents leads to increase primary patency (the time interval between the first and second endovascular interventions) – fig. 1B; HR 2.064 [95% CI 1.252; 3.404], p = 0.0017. The use of stents allows to increase the functional secondary patency (total duration of use of the AVF) – fig 1C; HR 2.099 [95% CI 1.272; 3.463], p = 0.0016. Secondary patency (the time interval between the first endovascular intervention and the complete cessation of the use of AVF) was higher after BA with stenting: HR 2.03 [95% CI 1.232; 3.347], p = 0.0021; fig 1D. The use of stents allows to increase functional primary assisted patency (non-occlusive period from the start of AVF use) – fig. 1E and primary assisted patency (non-occlusive period from the first surgical intervention) – fig 1F: HR 1.936 [95% CI 1.175; 3.188], p= 0.0053 and HR 2.0 [95% CI 1.213; 3.295], p = 0.0042. The need for open reconstructive interventions after the first BA or BA with stenting was the same 0.374 [95% CI 0.24; 0.556] and 0.45 [95% CI 0.291; 0.664] per 10 patient-months, incidence rate ratio (IRR)= 0.831 [95% CI 0.471; 1.464] р=0.521. The need for endovascular interventions did not differ between isolated BA and BA with stenting 1.137 [95% CI 0.8913; 1.43] and 0.827 [95% CI 0.606; 1.104] per 10 patient-months, IRR=1.374 [95% CI 0.952; 1.999] p=0.09. Total need for surgical interventions (open + endovascular) also did not differ: 1.511 [95% CI 1.225; 1.843] and 1.277 [95% CI 0.997; 1.611] per 10 patient-months, IRR 1.183 [95% CI 0.872; 1.612] p=0.2822. We found a strong negative correlation between functional primary patency and primary patency (r = -0.627; p &lt;0.0001) – fig. 2, as well as a between functional primary patency and secondary patency in patients after isolated BA (= -0.53; p = 0.0005, respectively), but not after stenting (r = -0.351; p = 0.101 and r = -0.304; p = 0.159, respectively). In a case of isolated BA, the success of the first intervention largely determines the secondary patency, which is expressed in a strong, statistically significant positive correlation of primary patency and secondary patency. In a case of BA with stenting, the correlation between these estimates is also statistically significant, but significantly lower. Conclusion 1. The results of balloon angioplasty without stenting are significantly influenced by the duration of the period between the start of AVF use and the manifestation of central vein stenosis. 2. The use of stents can slightly improve the results of endovascular interventions in central vein stenosis, regardless the its time of development. 3. The use of stents leads to a moderate increase in the median patency of AVF and a significant increase in the proportion of patients with functional AVF in the late postoperative period. 4. The use of stents does not reduce the need for surgical interventions

P1319AMBIGUOUS RESULTS OF CENTRAL VEIN STENOSIS ENDOVASCULAR TREATMENT IN HEMODIALYSIS PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Aleksei Zulkarnaev ◽  
Zurab Kardanakhishvili ◽  
Boris Baykov
Keyword(s):  
Blood Flow ◽  
Median Survival ◽  
Balloon Angioplasty ◽  
Primary Patency ◽  
Main Group ◽  
Control Group ◽  
Time Interval ◽  
Central Vein ◽  
Vein Stenosis ◽  
Central Vein Stenosis

Abstract Background and Aims Balloon angioplasty (BA) without the use of stents has unsatisfactory results, which may cast doubt on its expediency. At the same time, BA is a very expensive treatment method. We conducted a comprehensive comparative analysis of the native arteriovenous fistula (AVF) patency rates in hemodialysis patients with central venous stenosis (CVS) after endovascular BA and «open» palliative surgery. Method A retrospective study included 80 patients with confirmed central vein stenosis: subclavian, brachiocephalic veins, vena cava inferior, or multiple lesions. The main group included 39 patients who underwent percutaneous balloon angioplasty. The control group included 41 patients who did not have balloon angioplasty for various reasons. In this patients we performed only «open» palliative interventions: thrombectomy, proximalization of arteriovenous anastomosis, AVF blood flow reduction. Results Functional primary patency (the time interval between the start of AVF using and the first intervention) did not differ: groups were comparable in time of stenosis manifestation (fig. 1A). Primary patency (the time interval between the first and second interventions) after BA was statistically significantly better than in the main group (fig. 1B), but difference was minimal: median survival in the study group of 8 months [95% CI 6; 10] vs. - 6 months [95% CI 4.9; 7.1]. There was the strong negative correlation between the primary patency and functional primary patency in the main group (r = –0.627 [95%CI –0.787; –0.388], p &lt;0.0001) but not in the control group (r = 0.049 [95%CI –0.262; –0.351], p = 0.7599). Thus, the later manifestation of CVS related with lower effectiveness of BA. The functional secondary patency (total duration of AVF use) in the main group was significantly better: median survival was 47 months [95% CI 40.9; 53.1] vs. 34 months [95% CI 29.8; 38.2] as well as secondary patency (the time interval between the first intervention and the complete cessation of AVF use): median survival was 16 months [95% CI 12.5; 19.5] vs. 7 months [95% CI 4.9; 9.1] (fig. 1 C and D). The occlusion-free period from the moment of starting the AVF use (functional primary assisted patency – fig. 1E) was higher in the main group, but difference was minimal: median survival was 39 months [95% CI 36.5; 41.5] vs. 32 months [95% CI 27.5; 36.5], as well as occlusion-free period from the moment of the first surgical intervention (primary assisted patency – fig. 1F) median survival was 9 months [95% CI 7; 11], in the control group - 7 months [95% CI 5.6; 8.4]. The need for open interventions was lower in the main group: 0.374 [95% CI 0.24; 0.556] and 2.451 [95% CI 1.1963; 3.023] per 10 patient-months, incidence rate ratio (IRR)= 0.153 [95% CI 0.095; 0.237], р&lt;0.0001; as well as overall need for interventions: 1.511 [95% CI 1.225; 1.843] and 2.451 [95% CI 1.963; 3.023] per 10 patient-months, IRR 0.617 [95% CI 0.461; 0.825] p=0.0011. The value of AVF volume blood flow had a strong negative correlation with the primary patency in both groups (r = –0.529, p =0.0027; r = –0.419, p =0.0101). Conclusion 1. Central vein stenosis is inevitably leads to loss of vascular access on the ipsilateral side. 2. Balloon angioplasty allows to extend the period of AVF use but it is not a radical treatment method of CVS. 3. The results of balloon angioplasty are significantly affected by the length of the period from the start of AVF use to the CVS manifestation. 4. Multiple repeated BA are apparently justified in patients for whom the possibility of creating a new vascular access is doubtful. 4. The AVF volume blood flow is an important factor determining the severity of CVS clinical manifestations and the need for repeated surgical interventions.

scholarly journals Primary balloon angioplasty of small (≤2 mm) cephalic veins improves primary patency of arteriovenous fistulae and decreases reintervention rates

2013 ◽  
Vol 57 (1) ◽  
pp. 131-136 ◽  
Author(s):  
Pierfrancesco Veroux ◽  
Alessia Giaquinta ◽  
Tiziano Tallarita ◽  
Nunziata Sinagra ◽  
Carla Virgilio ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Primary Patency ◽  
Arteriovenous Fistulae

scholarly journals Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

2021 ◽  
Vol 8 (13) ◽  
pp. 1-36
Author(s):  
Narayan Karunanithy ◽  
Emily J Robinson ◽  
Francis Calder ◽  
Anthony Dorling ◽  
Janet L Peacock ◽  
...  
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Arteriovenous Fistula ◽  
Balloon Angioplasty ◽  
Target Lesion ◽  
Primary Patency ◽  
Hazard Ratio ◽  
End Points ◽  
Multiple Lesions ◽  
Secondary Outcomes

Background Reliable vascular access is essential for patients receiving haemodialysis. An arteriovenous fistula is the preferred option; however, these are prone to developing stenotic segments. These lesions are treated with angioplasty, but there is a high rate of recurrence. When the PAVE (Paclitaxel-assisted balloon Angioplasty of Venous stenosis in haEmodialysis access) trial was conceived, a number of small studies suggested that restenosis may be reduced by paclitaxel-coated balloons. Objective To test the efficacy of paclitaxel-coated balloons in arteriovenous fistulas. Design A randomised controlled trial. Setting Twenty UK centres. Participants Patients (aged ≥ 18 years) referred with a clinical indication for angioplasty of an arteriovenous fistula (212 patients in total, 106 per group). Interventions High-pressure plain balloon fistuloplasty was performed in all patients. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. Main outcome measures The primary end point was time (days) to loss of target lesion primary patency. Secondary patency end points were time to loss of access circuit primary patency and time to loss of access circuit cumulative patency. Other secondary end points included angiographically determined late lumen loss, rate of binary angiographic restenosis, procedural success, number of thrombosis events, fistula interventions, adverse events during follow-up and patient quality of life. Results Primary analysis showed no evidence for a difference in time to end of target lesion primary patency between groups (hazard ratio 1.18, 95% confidence interval 0.78 to 1.79; p = 0.440). An adjusted secondary analysis with prespecified clinical covariates gave similar results (hazard ratio 1.11, 95% confidence interval 0.69 to 1.78; p = 0.664). Prespecified secondary outcomes included the time to intervention anywhere in the access circuit or the time until the fistula was abandoned. There were no differences in these patency-related secondary outcomes or in any other secondary outcomes, such as adverse events. Limitations The PAVE trial was not a fully blinded trial. It was impossible to ensure that treating radiologists were blinded to treatment allocation because of the appearance of the paclitaxel-coated balloon. The extent to which our findings can be generalised to patients with multiple lesions could be questioned, given the proportion randomised. However, if paclitaxel-coated balloons had been effective at a single lesion segment, then there is no plausible reason why they could not be effective in patients with multiple lesions. Conclusions There were no differences in primary or secondary outcomes. Following a plain balloon angioplasty, additional treatment with a paclitaxel-coated balloon does not provide benefit. Future work The reasons for differences between the results of the PAVE trial and of other studies deserve further analysis and consideration. Other interventions to prevent restenosis following a fistuloplasty are needed. Trial registration Current Controlled Trials ISRCTN14284759. Funding This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 13. See the NIHR Journals Library website for further project information.

Outcomes of post-operative duplex ultrasound following arteriovenous fistula formation: A pragmatic single-centre experience

2019 ◽  
Vol 21 (5) ◽  
pp. 623-629
Author(s):  
Andrew TO Nickinson ◽  
Rebecca Rogers ◽  
Ahmed Elbasty ◽  
Ian Nunney ◽  
Philip C Bennett
Keyword(s):  
Confidence Interval ◽  
Arteriovenous Fistula ◽  
Duplex Ultrasound ◽  
Primary Patency ◽  
Hazard Ratio ◽  
Fistula Formation ◽  
Secondary Patency ◽  
Arteriovenous Fistulae ◽  
Standard Practice ◽  
Ultrasound Surveillance

Background: Duplex ultrasound surveillance with pre-emptive treatment of an identified stenosis is increasingly being utilised to help maintain arteriovenous fistula patency. This study aims to determine whether post-operative duplex ultrasound surveillance can improve fistula patency at 12 months and improve the proportion of ‘pre-haemodialysis’ patients commencing haemodialysis via a usable fistula. Methods: All arteriovenous fistulae formed between 1st January 2015 and 31st August 2017 in a single, tertiary vascular centre were included. Primary and secondary patency at 12 months, along with the proportion of pre-haemodialysis patients commencing haemodialysis via a usable arteriovenous fistula, were compared between the fistulae undergoing duplex ultrasound surveillance and ‘standard practice’. Results: Two hundred forty-one arteriovenous fistulae were created in 216 patients. A higher proportion of brachiobasilic transposition arteriovenous fistula and patients undergoing arteriovenous fistula creation following a previously failed access were identified in the duplex ultrasound surveillance group. Primary patency at 12 months (hazard ratio = 0.43, 95% confidence interval = 0.30–0.61, p < .001) was significantly lower in the duplex ultrasound surveillance group compared with the ‘standard practice’ group. Despite this, no difference was identified in secondary patency at 12 months (hazard ratio = 1.82, 95% confidence interval = 0.87–3.80, p = .112). No difference was also identified in the proportion of pre-haemodialysis patients starting haemodialysis with a usable arteriovenous fistula (duplex ultrasound surveillance = 65.0% vs standard practice = 77.8%; odds ratio = 0.53, 95% confidence interval 0.58–1.19, p = .279). Conclusion: Post-operative duplex ultrasound surveillance following arteriovenous fistula formation is associated with higher rates of post-operative intervention; however, this does not translate into improved secondary patency or the proportion of pre-haemodialysis patients commencing HD via their fistula.

Analysis of factors for post–percutaneous transluminal angioplasty primary patency rate in hemodialysis vascular access

2020 ◽  
Vol 21 (6) ◽  
pp. 892-899
Author(s):  
Kanyu Miyamoto ◽  
Takashi Sato ◽  
Keisuke Momohara ◽  
Sumihisa Ono ◽  
Makoto Yamaguchi ◽  
...  
Keyword(s):  
Blood Flow ◽  
Confidence Interval ◽  
Arteriovenous Fistula ◽  
Percutaneous Transluminal Angioplasty ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Hazard Ratio ◽  
Flow Volume ◽  
Blood Flow Volume ◽  
Percutaneous Transluminal

Background: Although percutaneous transluminal angioplasty has been established as a first-line therapy for access failure in dialysis, there are few reports on primary patency after percutaneous transluminal angioplasty. We investigated factors associated with primary patency following the first percutaneous transluminal angioplasty performed after vascular access construction in patients with arteriovenous fistula, including blood flow volume before and after percutaneous transluminal angioplasty and previously reported factors. Methods: We used medical records at six dialysis centers to retrospectively identify and analyze prognostic factors for primary patency after percutaneous transluminal angioplasty in 159 patients with arteriovenous fistula who underwent initial percutaneous transluminal angioplasty after vascular access construction. Results: Multivariate analysis with the Cox proportional hazard model showed that primary patency after percutaneous transluminal angioplasty in patients with arteriovenous fistula was significantly associated with lesion length (hazard ratio, 1.76; 95% confidence interval, 1.01–3.07; P = 0.045), and blood flow volume after percutaneous transluminal angioplasty (hazard ratio, 0.71; 95% confidence interval, 0.60–0.84; P < 0.001). When blood flow volume after percutaneous transluminal angioplasty was classified into three categories, risks of outcome events defining the end of primary patency after percutaneous transluminal angioplasty were significantly lower for 400–630 mL/min (hazard ratio, 0.38; 95% confidence interval, 0.21–0.68; P = 0.001) and >630 mL/min (hazard ratio, 0.16; 95% confidence interval, 0.06–0.40; P < 0.001) compared with <400 mL/min. Conclusion: Our study showed that blood flow volume after percutaneous transluminal angioplasty is an important prognostic factor for primary patency after percutaneous transluminal angioplasty in patients with arteriovenous fistula.

Balloon angioplasty: A promising adjunct to arteriovenous fistula creation compared with hydrostatic dilatation in small-caliber cephalic veins

2021 ◽  
pp. 021849232110415
Author(s):  
Santosh K Tiwari ◽  
Rajendra P Basavanthappa ◽  
Ranjith K Anandasu ◽  
Sanjay C Desai ◽  
Chandrasekhar A Ramswamy ◽  
...  
Keyword(s):  
Arteriovenous Fistula ◽  
Balloon Angioplasty ◽  
Duplex Ultrasound ◽  
Primary Patency ◽  
Maturation Time ◽  
Arteriovenous Access ◽  
Dilatation Group ◽  
Stage Renal Disease ◽  
End Stage ◽  
Venous Segment

Background To maintain the patency and longevity of arteriovenous fistula, the availability of a venous segment with adequate diameter is important. In Indian population, many chronic kidney disease patients have poor caliber veins. The study aimed to evaluate the efficacy of hydrostatic dilatation versus Primary balloon angioplasty of small caliber cephalic veins of (≤2.5 mm) preoperatively in terms of patency rate and maturation time of arteriovenous fistula. Methods Patients ( n = 80) with an end-stage renal disease requiring arteriovenous access surgery for hemodialysis with small caliber cephalic veins were randomized into two groups, i.e., hydrostatic dilatation and primary balloon angioplasty, each with 40 patients. All patients underwent a thorough clinical examination as well as duplex ultrasound vein mapping of both upper extremities. Patients were followed up for six months and primary patency, maturation time, and complications were noted. Results Immediate technical success with good palpable thrill was achieved in 97.5% of patients in the primary balloon angioplasty group and 87.5% in the hydrostatic dilatation group. The fistula maturation time in the primary balloon angioplasty group was 34.41 days and 46.18 days in the hydrostatic dilatation group. In the primary balloon angioplasty group, the primary patency of the fistula was 97.5% and 87.5% in the hydrostatic dilatation group, at six months. The arteriovenous fistula functioning rate was 77.5% in the hydrostatic dilatation group as compared to 92.5% in the primary balloon angioplasty group at six months. The incidence of surgical site infection was 5% in the primary balloon angioplasty group as compared to 10% in the hydrostatic dilatation group. Conclusion Primary balloon angioplasty of small caliber cephalic veins (≤2.5 mm) performed prior to arteriovenous fistula creation for hemodialysis is a beneficial procedure.

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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Suh Chien Pang ◽  
Ru Yu Tan ◽  
Edward Choke ◽  
Jackie Ho ◽  
Kiang Hiong Tay ◽  
...  
Keyword(s):  
Arteriovenous Fistula ◽  
Balloon Angioplasty ◽  
Target Lesion ◽  
Primary Patency ◽  
Central Vein ◽  
Secondary Patency ◽  
Dialysis Access ◽  
Residual Stenosis ◽  
Randomized Controlled ◽  
Link Type

Abstract 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.govNCT04409912. Registered on 1 June 2020

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