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

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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SIroliMus Coated angioPlasty Versus Plain Balloon Angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-746498/v1 ◽

2021 ◽

Author(s):

Suh Chien Pang ◽

Ru Yu Tan ◽

Edward Choke ◽

Jackie Ho ◽

Tay Kiang Hiong ◽

...

Keyword(s):

Arteriovenous Fistula ◽

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Controlled Clinical Trial ◽

Central Vein ◽

Secondary Patency ◽

Dialysis Access ◽

Residual Stenosis ◽

Randomized Controlled

Abstract BackgroundPercutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain old balloon angioplasty (POBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to POBA, concern over its safety profile has recently arisen after 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/DesignThis is an investigator-initiated, prospective, multicenter, doubled blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to POBA 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 POBA at a 1:1 ratio, stratified by location of AVF and followed-up for up to 1 year. Inclusion criteria includes (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, (3) successful angioplasty of the underlying stenosis with POBA, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVF on clinical examination. Exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that require treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary end point of the study is access circuit primary patency at 6 months. The secondary end points are target lesion primary patency, circuit assisted primary patency, 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. DiscussionThis study will evaluate the clinical efficacy and safety of SCB compared to POBA in the treatment of AVF stenosis in hemodialysis patients.Trial registration: ClinicalTrials.gov Identifier: NCT04409912 on 1 June 2020https://clinicaltrials.gov/ct2/show/NCT04409912Protocol Version: 4

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Comparison of drug-coated balloon angioplasty versus conventional angioplasty for arteriovenous fistula stenosis: Systematic review and meta-analysis

The Journal of Vascular Access ◽

10.1177/1129729819878612 ◽

2019 ◽

Vol 21 (3) ◽

pp. 357-365 ◽

Cited By ~ 5

Author(s):

Sohail Abdul Salim ◽

Hong Tran ◽

Charat Thongprayoon ◽

Tibor Fülöp ◽

Wisit Cheungpasitporn

Keyword(s):

Cohort Studies ◽

Randomized Controlled Trials ◽

Arteriovenous Fistula ◽

Balloon Angioplasty ◽

Odds Ratio ◽

Meta Analysis ◽

Target Lesion ◽

Primary Patency ◽

Controlled Trials ◽

Randomized Controlled

Background: Arteriovenous fistula is the most preferred form of vascular access, but stenosis treated by balloon angioplasty is prone to restenosis. Multiple trials have been published with regard to the use of paclitaxel-coated balloon to prolong lesion patency compared to conventional balloon. Although paclitaxel-coated balloon has theoretical appeal, its use has not been widespread nationwide due to cost and lack of large-scale multicenter studies. We performed this meta-analysis to evaluate whether paclitaxel-coated balloon outperforms conventional balloon to prolong target lesion patency. Methods: PubMed/Medline, Clinical Trials.gov, EMBASE, Scopus, Web of Science, and Cochrane Central were searched from inception through April 2019 for studies that investigated the use of paclitaxel-coated balloon in arteriovenous fistula. Results: Ten studies were included in the final meta-analysis: six studies were randomized controlled trials and four studies were cohort studies. There were 911 participants with a mean age of 64.78 (±5.96) years, and 61.89% were male. Outcome of interest was target lesion primary patency, recorded at 1, 3, 6, 7, 12, and 24 months. Meta-analysis of randomized controlled trials shows that paclitaxel-coated balloons did not statistically improve target lesion primary patency compared to conventional balloons at months 1 (odds ratio = 1.54, p = 0.6373), 3 (odds ratio = 0.57, p = 0.0575), 6 (odds ratio = 0.65, p = 0.3644), 7 (odds ratio = 0.63, p = 0.0582), 12 (odds ratio = 0.64, p = 0.0612), and 24 (odds ratio = 0.43, p = 0.3452). Effect of paclitaxel-coated balloons was statistically significant for cohort studies at months 6 (odds ratio = 0.26, p = 0.0007), 12 (odds ratio = 0.21, p = 0.0001), and 24 (odds ratio = 0.23, p = 0.01). Conclusion: Paclitaxel-coated balloon showed no statistically significant improvement over conventional balloons in decreasing fistula stenosis in randomized controlled trial but were significant for cohort studies.

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Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial

Trials ◽

10.1186/s13063-021-05631-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ulf Teichgräber ◽

Maja Ingwersen ◽

Stephanie Platzer ◽

Thomas Lehmann ◽

Thomas Zeller ◽

...

Keyword(s):

Balloon Angioplasty ◽

De Novo ◽

Target Lesion ◽

Primary Patency ◽

Limb Amputation ◽

Current Standard ◽

Femoropopliteal Artery ◽

Randomized Controlled ◽

Link Type ◽

Artery Disease

Abstract Background Endovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty. Methods This randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months. Discussion Although concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated. Trial registration ClinicalTrials.govNCT04475783. Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452

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

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p1329 ◽

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 <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

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

Efficacy and Mechanism Evaluation ◽

10.3310/eme08130 ◽

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.

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Drug‐Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta‐Analysis of Randomized Controlled Trials

Journal of the American Heart Association ◽

10.1161/jaha.121.022060 ◽

2021 ◽

Author(s):

Chenyu Liu ◽

Matthew Wolfers ◽

Bint‐e Zainab Awan ◽

Issa Ali ◽

Adrian Michael Lorenzana ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Drug Coated Balloon

Background Both drug‐coated balloon (DCB) angioplasty and conventional plain balloon angioplasty (PBA) can be implemented to treat hemodialysis dysfunction. The present study aims to compare the safety and efficacy of these 2 approaches by conducting a meta‐analysis of available randomized controlled trials. Methods and Results PubMed, Cochrane Library, and Embase databases were queried from establishment to January 2021. A total of 18 randomized controlled trials including 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta‐analysis. Target lesion primary patency, circuit patency, target lesion revascularization, and mortality were pooled. Odds ratios (ORs) were reported with 95% CIs. Publication bias was analyzed with funnel plot and Egger test. Target lesion primary patency was higher among patients who underwent DCB (OR, 2.93 [95% CI, 2.13–4.03], P <0.001 at 6 months; OR, 2.47 [95% CI, 1.53–3.99], P <0.001 at 1 year). Also, the DCB group had a higher dialysis circuit patency at 6 months (OR, 2.42; 95% CI, 1.56–3.77 [ P <0.001]) and 1 year (OR, 1.91; 95% CI, 1.22–3.00 [ P =0.005]). Compared with the PBA group, the DCB group had lower odds of target lesion revascularization during follow‐up (OR, 0.43 [95% CI, 0.23–0.82], P =0.001 at 6 months; OR, 0.74 [95% CI, 0.32–1.73], P =0.490 at 1 year). The OR of mortality was comparable between 2 groups at 6 months (OR, 1.18; 95% CI, 0.42–3.33 [ P =0.760]) and 1 year (OR, 0.93; 95% CI, 0.58–1.48 [ P =0.750]). Conclusions Based on evidence from 18 randomized controlled trials, DCB angioplasty is superior to PBA in maintaining target lesion primary patency and circuit patency among patients with dialysis circuit stenosis. DCB angioplasty also reduces target lesion revascularization with a similar risk of mortality compared with PBA.

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Angioplasty for dysfunctional arteriovenous fistulas: a meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty

10.21203/rs.3.rs-748410/v1 ◽

2021 ◽

Author(s):

Qin Yang ◽

Yi Zhou ◽

Kui Cai ◽

Yufang Chen ◽

Congying Xia

Keyword(s):

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Neointimal Hyperplasia ◽

Target Lesion ◽

Primary Patency ◽

Controlled Trials ◽

Arteriovenous Fistulas ◽

Randomized Controlled ◽

Conventional Balloon Angioplasty

Abstract Background Stenosis in arteriovenous fistulas (AVF) due to neointimal hyperplasia is one of the most common causes of hemodialysis vascular access dysfunction. Treating patients with dysfunctional AVF with drug-coated balloon (DCB) angioplasty may potentially improve outcomes. This systematic review aimed to compare the effectiveness and safety of DCB angioplasty versus conventional balloon angioplasty by pooling evidence from the most recent randomized controlled trials. Methods We conducted a comprehensive literature search in the Medline, Embase, and Cochrane central databases. Two independent researchers screened the article, extracted interest and evaluated included studies for risk of bias. Pooled estimation was conducted in terms of 6-month target-lesion primary patency (TLPP) and target-lesion reintervention (TLR), as well as other outcomes. Results were expressed with odds ratio (OR) and 95% confidence interval (CI). Results A total of 4 RCTs were identified and included in the meta-analyses, with 911 participants. There was no significant increase in rates of 6-month TLPP (OR 1.63, 95%CI 0.39–6.79, p = 0.35), or decrease in 6-month TLR (OR 0.45, 95%CI 0.17–1.19 p = 0.07) in patients who received DCB as compared to those who received conventional balloon angioplasty. Similarly, we found no difference in the 6-month access circuit primary patency and reinvention between the two groups. Conclusion There was no evidence supporting that DCB has a statistically significant higher rate of TLPP and lower rates of TLR in the treatment of dysfunctional AVF than conventional balloon angioplasty. However, DCB was non-inferior to conventional balloon angioplasty in terms of safety. Therefore, further study is needed to clarify whether DCB angioplasty can benefit hemodialysis patients with dysfunction AVF.

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Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study)

Scandinavian Journal of Surgery ◽

10.1177/1457496918798206 ◽

2018 ◽

Vol 108 (1) ◽

pp. 61-66 ◽

Cited By ~ 13

Author(s):

P. Björkman ◽

E.-M. Weselius ◽

T. Kokkonen ◽

V. Rauta ◽

A. Albäck ◽

...

Keyword(s):

Arteriovenous Fistula ◽

Balloon Angioplasty ◽

Target Lesion ◽

Target Lesion Revascularization ◽

Controlled Study ◽

Technical Failure ◽

Arteriovenous Fistulas ◽

Randomized Controlled ◽

Drug Coated Balloon

Background and Aims: Stenosis due to intimal hyperplasia and restenosis after initially successful percutaneous angioplasty are common reasons for failing arteriovenous fistulas. The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of arteriovenous fistula stenosis. Design: Single-center, parallel group, randomized controlled trial. Block randomized by sealed envelope 1:1. Materials and Methods: A total of 39 patients with primary or recurrent stenosis in a failing native arteriovenous fistulas were randomized to drug-coated balloon (n = 19) or standard balloon angioplasty (n = 20). Follow-up was 1 year. Primary outcome measure was target lesion revascularization. Results: In all, 36 stenoses were analyzed; three patients were excluded due to technical failure after randomization. A total of 88.9% (16/18) in the drug-coated balloon group was revascularized or occluded within 1 year, compared to 22.2% (4/18) of the stenoses in the balloon angioplasty group (relative risk for drug-coated balloon 7.09). Mean time-to- target lesion revascularization was 110 and 193 days after the drug-coated balloon and balloon angioplasty, respectively (p = 0.06). Conclusions: With 1-year follow-up, the target lesion revascularization-free survival after drug-coated balloon-treatment was clearly worse. The reason for this remains unknown, but it may be due to differences in the biological response to paclitaxel in the venous arteriovenous fistula-wall compared to its antiproliferative effect in the arterial wall after drug-coated balloon treatment of atherosclerotic occlusive lesions. Trial registration: ClinicalTrials.gov NCT03036241

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Upper thigh loop prosthetic arterio-venous grafts (AVG) for dialysis access: An Indian perspective

The Journal of Vascular Access ◽

10.1177/11297298211055632 ◽

2021 ◽

pp. 112972982110556

Author(s):

Sekar Natarajan ◽

Jithin Jagan Sebastian

Keyword(s):

Upper Limb ◽

Limb Ischemia ◽

Primary Patency ◽

Central Vein ◽

Secondary Patency ◽

Dialysis Access ◽

Venous Grafts ◽

Vein Stenosis ◽

Central Vein Stenosis

Introduction: Hemodialysis forms the most common replacement therapy for majority of Indians suffering from chronic kidney disease (CKD). Multiple access failure and central vein stenosis has become commonplace in Indian dialysis access patients and there is a burgeoning need for more advanced hemodialysis (HD) access options. Upper thigh arterio-venous grafts (AVG) are seldom inserted due to fear of infection and limb ischemia. Materials and methods: This is a single institutional, retrospective, descriptive case study of consecutive patients who underwent upper thigh prosthetic AVG over a period of 7 years. All these patients had exhausted options of upper limb access and or had central vein stenosis. AVG from the proximal superficial femoral artery (SFA) to the proximal great saphenous vein (GSV) in a loop configuration using polytetrafluoroethylene (PTFE) was carried out in the upper thigh. Results: A total of 24 patients had undergone upper thigh loop AVG. Their age varied from 24 to 77 years. The median follow-up period was 3 years. Five of these grafts developed infection (21%) which led to primary failure. A primary patency of 71% (17/24 patients) was achieved at 1 year. Thrombosis developed at a mean of 16.7 months after the primary procedure. Adjunctive procedures such as thrombectomy, segmental replacement of graft, patch angioplasty, balloon angioplasty, and stenting were required in 75% of patients to achieve a secondary patency of 86% at 1 year. Three grafts were explanted without limb loss. Conclusion: Upper thigh loop AVG forms a reliable alternate dialysis access option for patients with failed upper limb access sites or central vein occlusion. Adjunctive procedures are key to maintaining patency in these grafts. Good secondary patency is achievable, and the infection rates are similar to arm AVG. Close follow-up and timely intervention are key to long term dialysis through these grafts.

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Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2020.0121 ◽

2020 ◽

Vol 102 (8) ◽

pp. 601-605

Author(s):

AG Karmota

Keyword(s):

Vascular Access ◽

Target Lesion ◽

Primary Patency ◽

Secondary Patency ◽

Dialysis Access ◽

Technical Success ◽

Major Complications ◽

Group I ◽

Significant Difference ◽

Group Ii

Introduction This study aimed to evaluate the safety and efficacy of paclitaxel-coated balloon compared with conventional plain balloon for the treatment of failing native dialysis access. Materials and methods This prospective study included 60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access. Dilatation with a plain balloon was done in 30 patients (group I) and with a paclitaxel-coated balloon in 30 patients (group II) with either stenosis or occlusion. The majority were outflow lesions, with 20 (66.7 %) patients in group I and 21 (70%) patients in group II. Mean balloon diameter was 7.1mm (± 1.5mm) compared with 6.5mm (± 1.2mm) and length 66mm (± 19.1mm) compared with 54.6mm (± 15.7mm), respectively. Safety endpoint was reported as 30 day’s freedom from procedure-related major complications and mortality. Procedural technical success was defined as a residual diameter 30% or less for treated lesions. Target lesion primary patency, circuit primary patency and secondary patency were reported at 3, 6 and 12 months. Results There were no 30-day procedure-related major complications or mortality in either group. Procedural technical success of 100% was achieved in both groups. Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group I, especially at 12 months (90% vs 66.7%, 83.3% vs 60% and 96.7% vs 93.3%, respectively). There was a statistically significant difference in target lesion primary patency (p = 0.029) in patients who were treated with paclitaxel-coated balloon angioplasties. Conclusion The paclitaxel-coated balloon proved to be safe and effective, and improved the patency of failing vascular access. Results are comparable with previous studies.

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