Stent grafts improved patency of ruptured hemodialysis vascular accesses

AbstractThis study aimed to compare stent graft with balloon tamponade for ruptured dialysis access during percutaneous transluminal angioplasty. Patients over an 8-year period (2010–2018) were identified from a database of 11,609 procedures. The primary endpoint was target lesion primary patency at 12 months. A total of 143 patients who had rupture dialysis access were enrolled, of whom 52 were salvaged by stent grafts and 91 were salvaged by balloon tamponade. The 6-month target lesion primary patency was greater in the stent graft group than in the balloon tamponade group (66.7% vs. 29.5%, P < 0.001). The benefit of stent grafts was sustained for 12 months (52.5% vs. 9.0%, P < 0.001). The stent grafts increased the median time from the index procedure to the next intervention in the ruptured area by 171 days (260 vs. 89 days) at 12 months. There was no significant difference in the access circuit patency rates at 6 months (25.5% vs. 19.8%, P = 0.203) and 12 months (12.0% vs. 5.8%, P = 0.052). The patency results of the stent grafts remained after the multivariable adjustment analysis. Compared to balloon tamponade alone, stent grafts provided superior target lesion primary patency at 6 and 12 months. The access circuit patency rates were similar.

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A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas

The Journal of Vascular Access ◽

10.1177/1129729819893205 ◽

2019 ◽

Vol 21 (5) ◽

pp. 596-601

Author(s):

Cemal Kocaaslan ◽

Ahmet Oztekin ◽

Mehmet Senel Bademci ◽

Emine Seyma Denli Yalvac ◽

Nurgul Bulut ◽

...

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Anastomotic Stenosis ◽

Arteriovenous Fistulas ◽

Study Results ◽

Significant Difference ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

Background: Juxta-anastomotic stenosis is a common issue of arteriovenous fistulas. We aimed to evaluate the results of percutaneous transluminal angioplasty with drug-coated balloon versus plain balloon for the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas. Methods: A total of 80 patients with a juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistula in our clinic between January 2016 and September 2017 were retrospectively analyzed. Patients were divided into two groups according to the type of treatment as drug-coated balloon – percutaneous transluminal angioplasty (n = 44) and plain balloon – percutaneous transluminal angioplasty (n = 43). Intra- and post-procedural data were recorded. Target lesion primary patency rate was evaluated at 6 and 12 months. Of all patients, 48 were females and 39 were males with a mean age of 56.3 ± 10.4 (range, 24–75) years. Both groups had mature fistulas, and the mean age of fistula was 11.3 ± 9.1 months in the drug-coated balloon – percutaneous transluminal angioplasty group and 10.3 ± 8.8 months in the plain balloon – percutaneous transluminal angioplasty group (p = 0.24). Results: There was no significant difference in the target lesion stenosis rate and the median lesion length between the groups. Technical and clinical success were achieved in both groups. Target lesion primary patency was similar at 6 months between the two groups (93.1% vs 81.3%, respectively; p = 0.14) but significantly higher for the drug-coated balloon – percutaneous transluminal angioplasty group at 12 months (81.8% vs 51.1%, respectively; p = 0.01). Conclusion: Our study results suggest that the use of drug-coated balloon combined with percutaneous transluminal angioplasty is an effective treatment for juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas with significantly improved target lesion primary patency rates and reduced need for juxta-anastomotic reinterventions.

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Endovascular stent-graft treatment for graft-vein anastomotic stenosis in haemodialysis patients with arteriovenous grafts

VASA ◽

10.1024/0301-1526/a000470 ◽

2015 ◽

Vol 44 (6) ◽

pp. 466-472 ◽

Cited By ~ 1

Author(s):

Chia-Hsun Lin ◽

Yen-Yang Chen ◽

Chai-Hock Chua ◽

Ming-Jen Lu

Keyword(s):

Risk Factors ◽

Stent Graft ◽

Target Lesion ◽

Primary Patency ◽

Anastomotic Stenosis ◽

Secondary Patency ◽

Endovascular Stent ◽

Stent Grafts ◽

Venous Anastomosis ◽

Arteriovenous Grafts

Abstract. Background: In this study, we investigated the patency of endovascular stent grafts in haemodialysis patients with arteriovenous grafts, the modes of patency loss, and the risk factors for re-intervention. Patients and methods: Haemodialysis patients with graft-vein anastomotic stenosis of their arteriovenous grafts who were treated with endovascular stent-grafts between 2008 and 2013 were entered into this retrospective study. Primary and secondary patency, modes of patency loss, and risk factors for intervention were recorded. Results: Cumulative circuit primary patency rates decreased from 40.0 % at 6 months to 7.3 % at 24 months. Cumulative target lesion primary patency rates decreased from 72.1 % at 6 months to 22.0 % at 24 months. Cumulative secondary patency rates decreased from 81.3 % at 12 months to 31.6 % at 36 months. Patients with a history of cerebrovascular accident had a significantly higher risk of secondary patency loss, and graft puncture site stenosis jeopardised the results of stent-graft treatment. Conclusions: Our data can help to improve outcomes in haemodialysis patients treated with stent-grafts for venous anastomosis of an arteriovenous graft.

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Treatment of juxta-anastomotic stenoses for failing distal radiocephalic arteriovenous fistulas: Drug-coated balloons versus angioplasty

The Journal of Vascular Access ◽

10.1177/1129729818793102 ◽

2018 ◽

Vol 20 (2) ◽

pp. 209-216 ◽

Cited By ~ 8

Author(s):

Domenico Patanè ◽

Giovanni Failla ◽

Giovanni Coniglio ◽

Giorgio Russo ◽

Walter Morale ◽

...

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

Type A ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Secondary Patency ◽

Type B ◽

Arteriovenous Fistulas ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

The aim of our study is to report the results of two types (type A, type B) paclitaxel drug-coated balloon compared with standard percutaneous transluminal angioplasty in the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic hemodialysis arteriovenous fistulas. Two groups of 26 and 44 patients treated with two different drug-coated balloon are compared with a control group of 86 treated with standard percutaneous transluminal angioplasty. A color Doppler ultrasound was performed to evaluate stenosis and for treatment planning. We assess primary patency, defined as the absence of dysfunction of the arteriovenous fistulas, patent lesion or residual stenosis < 30% and no need for further reintervention of target lesion. Primary patency and secondary patency are evaluated after 12 months with color Doppler ultrasound for the whole arteriovenous fistulas, defined as absolute (absolute primary patency, absolute secondary patency) and target lesion. Postprocedural technical and clinical success was 100%. After 12 months, absolute primary patency is 81.8% for type A, 84.1% type B, and 54.7% for standard percutaneous transluminal angioplasty; target lesion primary patency is 92% type A, 86.4% type B, and 62.8% standard percutaneous transluminal angioplasty; absolute secondary patency is 95.4% type A, 95.5% type B, and 80.7% standard percutaneous transluminal angioplasty; target lesion secondary patency is 100% type A, 97.7% type B, and 80.7% standard percutaneous transluminal angioplasty. All the patients treated with drug-coated balloon (type A + type B) have an absolute primary patency of 83.3%, a target lesion primary patency of 87.9%, an absolute secondary patency of 95.5%, and a target lesion secondary patency of 98.4%. Our study confirms that the use of drug-coated balloon, indiscriminately among different brands, improves primary patency with statistically significant difference in comparison with standard percutaneous transluminal angioplasty and decreases reintervention of target lesion in juxta-anastomotic stenoses of failing distal arteriovenous fistulas maintaining the radiocephalic fistula as long as possible.

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Predictive value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio for primary patency of percutaneous transluminal angioplasty in hemodialysis arteriovenous fistula stenosis

Vascular ◽

10.1177/17085381211039672 ◽

2021 ◽

pp. 170853812110396

Author(s):

Feng Zhu ◽

Yao Yao ◽

Hongbo Ci ◽

Alimujiang Shawuti

Keyword(s):

Arteriovenous Fistula ◽

Percutaneous Transluminal Angioplasty ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Neutrophil To Lymphocyte Ratio ◽

Platelet To Lymphocyte Ratio ◽

Lymphocyte Ratio ◽

Significant Difference ◽

Percutaneous Transluminal ◽

Hemodialysis Arteriovenous Fistula

Objective The aim of this study is to investigate the potential association of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) with the primary patency of percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistula (AVF) stenosis. Methods This study conducted a retrospective review of patients with end-stage renal disease referred for hemodialysis AVF stenosis in one center. The study consisted of 114 patients with significant (significant stenosis was defined as a reduction in the caliber of the fistula vein of > 50% with respect to the non-aneurysmal venous segment). AVF stenosis patients were treated with PTA, with conventional balloon angioplasty. The NLR and PLR were calculated from the pre-interventional blood samples. The patients were classified into two groups: group A, primary patency < 12 months ( n = 35) and group B, and primary patency ≥ 12 months ( n = 79). Comparisons between the groups were performed using the Mann–Whitney U test. Kaplan–Meier analysis was performed to compare the factors, NLR and PLR, for association with primary patency AVFs. A receiver-operating characteristic curve analysis was performed to identify the sensitivity and specificity of the NLR and PLR cut-off values in the prediction of primary patency time. Results There was no difference in gender; age; side of AVF; AVF type; comorbid diseases such as diabetes mellitus and hypertension; or blood parameters such as white cell count, erythrocytes, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils, basophils, C-reactive protein, NLR, or PLR between the two groups ( p > 0.05). There was also no significant difference in the patency rate between the NLR < 4.13 and NLR ≥ 4.13 groups at 12 months (NLR cut-off point = 4.13, p = 0.273). There were statistically significant differences between the primary patency rates of the PLR < 187.86 and PLR ≥ 187.86 groups at 12 months (PLR cut-off point = 187.86, p = 0.023). The cut-off value for PLR for the determination of primary patency was 187.86, with a sensitivity of 57.0% and specificity of 34.4%. Conclusion An increased level of PLR may be a risk factor for the development of early AVF restenosis after successful PTA. However, more studies are needed to validate this finding.

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Stent grafts for treatment of cannulation zone stenosis and arteriovenous graft venous anastomosis

The Journal of Vascular Access ◽

10.5301/jva.5000680 ◽

2017 ◽

Vol 18 (1_suppl) ◽

pp. S47-S52 ◽

Cited By ~ 3

Author(s):

David Shemesh ◽

Ilya Goldin ◽

Oded Olsha

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

Randomized Trials ◽

Transluminal Angioplasty ◽

Covered Stent ◽

Primary Patency ◽

Arteriovenous Graft ◽

Stent Grafts ◽

Venous Anastomosis ◽

Percutaneous Transluminal ◽

Stent Stenosis

Stent grafts (SGs) are widely used for treatment of failing vascular accesses, fistulas and grafts. The mechanical barrier of the covered stent prevents in-stent stenosis and can be used to effectively correct ruptured vein and aneurysms. Treatment of cannulation zone stenosis with SG can be justified when its use is obligatory, in order to prevent total access loss. Although there are worrying complications attendant on SG insertion and cannulation, including jeopardizing future access creation, most studies report no complications of SG in cannulation zone stenosis. SGs for treatment of arteriovenous graft venous anastomosis stenosis is controversial. Two large randomized trials conclusively demonstrate improved primary patency with SGs at the venous anastomosis of arteriovenous graft at up to two years when compared with percutaneous transluminal angioplasty, sustained for up to 2 years and reducing the number of interventions per patient year. However, the ultimate goal of SG treatment of venous anastomosis stenosis is preventing thrombosis and increasing graft longevity, which was unfortunately not fully achieved.

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Mid-term Outcomes of Patients with Central Venous Occlusive Disease Undergoing Surveillance Venography and Intervention

Annals of the Academy of Medicine, Singapore ◽

10.47102/annals-acadmed.sg.2019199 ◽

2020 ◽

Vol 49 (6) ◽

pp. 360-366

Author(s):

Hui Lin Wong ◽

Shaun Xavier JM Chan ◽

Satheesh Ramamuthy ◽

Kiang Hong Tay ◽

Tze Tec Chong ◽

...

Keyword(s):

Transluminal Angioplasty ◽

Primary Patency ◽

Occlusive Disease ◽

Central Vein ◽

Dialysis Access ◽

Technical Success ◽

Central Venous ◽

Presenting Symptoms ◽

Luminal Narrowing ◽

Significant Difference

Introduction: To evaluate the mid-term outcomes of regular surveillance venography with or without percutaneous transluminal angioplasty in haemodialysis patients presenting with central venous occlusive disease. Materials and Methods: A single-centre retrospective analysis of haemodialysis patients who presented with central vein occlusion (CVO) and central vein stenosis (CVS) between January 2008 and December 2011 was performed. CVO and significant CVS were defined as 100% and >50% luminal narrowing respectively. Upon successful angioplasty on first presentation, patients were followed up with regular surveillance venography within 3–6 months of the intervention and were re-treated when a significant stenosis or occlusion was demonstrated. Data on patient’s demographics, comorbidities, presenting symptoms, type of upper limb dialysis access, lesion characteristics and complications were collected. Technical success, primary patency and primary assisted patency were analysed. Results: Thirty-five patients with CVO and 77 patients with CVS were enrolled. The technical success of initial PTA was 77% and 73% for the CVO and CVS groups, respectively. The primary patency at 3 months was 65% and 55% for the CVO group and CVS group, respectively (P = 0.32). The primary assisted patency at 1 year was 88% and 99% for the CVO group and CVS group, respectively (P = 0.009). At 2 years, the primary assisted patency were 77% and 90%, respectively (P = 0.07). There was significant difference in the overall primary assisted patency (P = 0.048) between the CVO and CVS groups. Conclusion: CVOs are more difficult to treat than CVS. High primary assisted patency rates can be achieved with surveillance venography, albeit at the expense of increased number of interventions. Further cost effectiveness studies need to be performed to study the true benefit of our surveillance programme. Ann Acad Med Singapore 2020;49:360–66 Key words: Dialysis circuit, End stage renal failure, Renal replacement therapy

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Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

Journal of Endovascular Therapy ◽

10.1177/1526602817745565 ◽

2017 ◽

Vol 25 (1) ◽

pp. 109-117 ◽

Cited By ~ 34

Author(s):

Osamu Iida ◽

Yoshimitsu Soga ◽

Kazushi Urasawa ◽

Shigeru Saito ◽

Michael R. Jaff ◽

...

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

De Novo ◽

Target Lesion ◽

Major Amputation ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Lesion Length ◽

Japanese Cohort ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

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Promising results of stent graft placement for cephalic arch stenosis after repeated failure of angioplasty in patients on hemodialysis

Journal of International Medical Research ◽

10.1177/0300060520920419 ◽

2020 ◽

Vol 48 (6) ◽

pp. 030006052092041

Author(s):

Pin-Chao Feng ◽

Chun-Hui Lee ◽

Hung-Chang Hsieh ◽

Po-Jen Ko ◽

Sheng-Yueh Yu ◽

...

Keyword(s):

Stent Graft ◽

Clinical Success ◽

Medical Center ◽

Retrospective Chart Review ◽

Target Lesion ◽

Primary Patency ◽

Secondary Patency ◽

Success Rates ◽

Graft Placement ◽

Significant Difference

Objective Cephalic arch stenosis (CAS) causes repeated dysfunction and failure of arteriovenous access. Percutaneous transluminal angioplasty is the standard initial treatment for CAS, but its outcome is unsatisfactory. This study aimed to evaluate the outcome of stent graft placement for CAS in patients on hemodialysis. Methods A retrospective chart review from a tertiary medical center was performed in patients receiving stent graft placement for CAS between January 2012 and 2016. Patency was analyzed using the Kaplan–Meier method. Results Twenty-one patients received stent graft placement for CAS. Technical and clinical success rates were 100%. Primary target lesion patency was 95% (95% confidence interval [CI], 86%–100%), 76% (95% CI, 58%–94%), and 43% (95% CI, 22%–64%) at 3, 6, and 12 months, respectively. No significant difference in patency was observed between the arteriovenous fistula and arteriovenous graft groups. Assisted primary patency was 95% (95% CI, 86%–100%), 71% (95% CI, 52%–91%), and 57% (95% CI, 36%–78%) at 3, 6, and 12 months, respectively. Secondary patency was 100% at 3, 6, and 12 months. Conclusions After repeated failed angioplasty for cephalic arch stenosis, patients on hemodialysis who receive stent graft placement have effective and durable outcomes.

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Management of Transposed Arteriovenous Fistula Swing Point Stenosis at the Basilic Vein Angle of Transposition by Stent Grafts

The Journal of Vascular Access ◽

10.5301/jva.5000770 ◽

2017 ◽

Vol 18 (6) ◽

pp. 482-487 ◽

Cited By ~ 3

Author(s):

George M. Nassar ◽

Gerald Beathard ◽

Edward Rhee ◽

Abdul Jabbar Khan ◽

Binh Nguyen

Keyword(s):

Stent Placement ◽

Positive Impact ◽

Target Lesion ◽

Primary Patency ◽

Categorical Variables ◽

Dialysis Access ◽

Continuous Variables ◽

Basilic Vein ◽

Stent Grafts ◽

Exact Test

Introduction Transposed basilic vein arteriovenous fistulas suffer from stenosis at their basilic angle of transposition (BAT). This lesion exhibits frequent recurrence after angioplasty. The primary goal of this study was to determine the effect of stent-graft placement on BAT lesion- and access-patency. The secondary goals were to determine the frequency of intervention pre- and post-stent placement and stent-associated stenosis. Methods Thirty-seven cases had stent-grafts placed at their BAT to manage stenosis. Cases served as their own controls by analyzing their lesion- and access-patency pre- and post-stent placement. Student's t-test was used for analysis of continuous variables. Categorical variables were evaluated by Fisher's exact test. Tests were considered significant when p was ≤0.05. Results At 6 and 12 months, pre-stent lesion primary patency rates were 29% and 3%, and post-stent were 57% and 40%, respectively. Lesion primary assisted patency rates were 39% and 13%, and post-stent were 91% and 80%, respectively. At 6 and 12 months, pre-stent access primary patency rates were 29% and 3%, and post-stent were 26% and 19%, respectively. Pre-stent primary access assisted patency rates were 36% and 10%, and post-stent were 82% and 75%, respectively. Lesion intervention rates averaged 0.47/month pre-stent and 0.13/month post-stent. Access intervention rate averaged 0.50/month pre-stent, and 0.15/month post-stent. Stent-associated stenosis was seen in 23 cases. Conclusions Treatment of BAT stenosis with stent-grafts had positive impact on the target lesion and the dialysis access circuit.

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Fatigue Resistance of the Advanta V12/iCast and Viabahn Balloon-Expandable Stent-Graft as Bridging Stents in Experimental Fenestrated Endografting

Journal of Endovascular Therapy ◽

10.1177/1526602821996724 ◽

2021 ◽

pp. 152660282199672

Author(s):

Giovanni Torsello ◽

Marcus Müller ◽

Sarah Litterscheid ◽

Bärbel Berekoven ◽

Martin Austermann ◽

...

Keyword(s):

Stent Graft ◽

Fatigue Resistance ◽

Transluminal Angioplasty ◽

Fatigue Tests ◽

Stent Fracture ◽

Stent Grafts ◽

Radiographic Images ◽

Significant Difference ◽

Prolonged Stress ◽

Layer Defect

Purpose: Bridging stents undergo millions of cycles during respiratory movements of the kidneys throughout the patient’s life. Thus, understanding the response of fabric and endoskeleton of the stent to cyclic loading over the time is crucial. In this study, we compare the fatigue resistance of the Viabahn Balloon-Expandable stent-graft (VBX) with the widely used Advanta V12/iCast under prolonged stress induction. Materials and Methods: A polyester test sheet with 10 fenestrations was used simulating a fenestrated endograft. Five 6×59 mm VBX stent-grafts and five 6×58 mm Advanta stent-grafts were implanted into 6×6 mm fenestrations. The stents were flared with a 10×20 mm PTA (percutaneous transluminal angioplasty) catheter and connected with a fatigue stress machine. All stent-grafts were evaluated by microscopy and radiography at baseline and after regular intervals until 50,000,000 cycles were applied, simulating a life span of approximately 75 months. Freedom from fracture (FF), freedom from initial polytertafluoroethylene (PTFE) changes (FIC), and from PTFE breakpoint (FBP, all-layer defect) were calculated. Results: Digital radiographic images did not show any stent fracture in both groups after 50,000,000 cycles. The VBX stent-graft was free from any all-layer defects at the conclusion of 50,000,00 cycles resulting in a significant higher FBP compared with Advanta V12 (50,000,000 vs 33,400,000; p<0.01). All-layer defects were observed only in the Advanta group. Two of 5 Advanta stents showed early penetration of the nitinol ring causing a defect of PTFE. Regarding FIC, there was no significant difference between the stents (3,400,000 in VBX vs 3,200,000 in Advanta). Conclusions: In fatigue tests simulating respiration movements, VBX and Advanta V12 performed equally well in terms of fracture resistance and freedom from initial PTFE changes. VBX maintained freedom from PTFE breakpoint throughout the full 50,000,000 cycles. All-layers defects were detected only in Advanta and were mainly caused by penetration of the nitinol ring through the PTFE.

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