Failed Dialysis Access Research Articles

Drug-eluting balloon (DEB) versus plain old balloon angioplasty (POBA) in the treatment of failing dialysis access: A prospective randomized trial.

ObjectiveTo compare the efficacy of angioplasty using drug-eluting balloons (DEB) compared with plain old balloon angioplasty (POBA) to reduce the rate of restenosis.MethodsThis prospective, single-centre, single-blinded, 1:1 randomized, clinical trial enrolled patients that had primary or restenotic lesions in native upper extremity arteriovenous (AV) fistulas or at the graft-venous anastomosis. Patients were randomized to angioplasty with a POBA or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR) and functional status of access circuit at 12 months.ResultsA total of 42 (28 male, 14 female; age range, 42–83 years) patients were enrolled. Patients were followed for 12 months. No significant differences were detected between the POBA and DEB groups regarding total number of TLR procedures (31 versus 36, respectively), freedom from TLR (3 versus 4, respectively) and functional status of the access circuit at 12 months (14 of 20 patients [70%] versus 17 of 22 patients [77%], respectively).ConclusionThis clinical trial did not demonstrate any significant differences between DEB angioplasty and standard balloon angioplasty when treating dysfunctional haemodialysis access.

Long-term outcomes of transposed femoral vein arteriovenous fistula for abandoned upper extremity dialysis access

BackgroundThe number and longevity of patients with end-stage renal disease requiring dialysis access have continued to increase, leading to challenging situations, including exhausted upper extremity access and severe central venous stenosis. This has led to an increase in the use of alternative access sites, including the lower extremities. The transposed femoral vein arteriovenous fistula for dialysis access is a previously described alternative, although limited data are available on its long-term patency. MethodsPatients treated with a transposed femoral vein fistula were retrospectively reviewed. A transposed femoral vein fistula was created by harvesting the femoral vein and transposing it to the distal superficial femoral artery at the level of the adductor canal. The demographic information, perioperative characteristics, complications, and long-term outcomes were recorded and analyzed. ResultsA total of 21 patients had undergone transposed femoral vein fistula for dialysis access after an average of 5.3 ± 2.8 failed dialysis access procedures and a duration of 6.1 ± 4.9 years from the initiation of dialysis. The average age at the procedure was 53.5 ± 12.8 years. Ten patients (47.6%) had a history of diabetes mellitus and nine (42.9%) had a history of coronary artery disease. Technical success was achieved in 100% of cases, and 16 patients (76.2%) were discharged with anticoagulation therapy. The primary patency at 1, 3, and 5 years was 93%, 74%, and 74%, respectively. The secondary patency at 1, 3, and 5 years was 100%, 89%, and 89%, respectively. Two patients had compartment syndrome requiring fasciotomy, and six patients experienced wound complications. ConclusionsTransposed femoral vein fistula for dialysis access is a viable alternative for patients with an exhausted upper extremity access, with good long-term patency.

Drug-coated balloon angioplasty for failing arteriovenous fistulae: feasibility and short-term outcomes

Aim To evaluate the feasibility, efficacy, and short-term and mid-term outcomes of drug-coated balloons (DCBs) in salvage of failing dialysis access owing to significant access vein stenosis. Patients and methods DCB angioplasty was used for salvage of failing arteriovenous fistulae in patients with clinical and radiological evidences of recently (within 14 days) failing hemodialysis access between March 2019 and September 2019. Results A total of 23 patients were enrolled, comprising 15 males and eight females, with mean age of 52.9±15.3 years. All lesions were successfully crossed and predilated with plain old balloons sized to the available normal vein diameter before DCB angioplasty, except in one patient with central vein tight stenosis. Technical success was achieved in 21 of 23 patients. At 1 month after angioplasty, among 21 successful angioplasty patients, one patient had died of cause not related to the procedure. For the remaining 20 patients, 17 patients still had a patent access, representing 80.9% success rate; two patients could not show any clinical improvement for their access although remaining patent; and one patient showed early access thrombosis about 1 weak after angioplasty. In the 6-month follow-up, of the remaining 17 patients with successful angioplasty, one patient had died owing to causes not related to the procedure. In the remaining 16 patients, 15 patients still had a patent vascular access with one patient lost to follow-up, thus representing an overall success rate of 71.4%. Conclusion DCB angioplasty is a safe and effective method for salvage of the failing arteriovenous fistulae and could successfully delay recurrence of stenosis.

Outcomes of balloon angioplasty for failing upper extremity dialysis access

Background Percutaneous transluminal angioplasty (PTA) is the mainstay of treatment in stenosed hemodialysis access. Being less invasive and outpatient procedure, PTA is a safe and useful intervention to maintain access patency in patients with failing hemodialysis arteriovenous fistulas (AVFs). The aim of this study was to evaluate the efficacy of balloon angioplasty in treatment of patients with failing upper extremity hemodialysis access. Methods This is a prospective study of all adult patients who underwent balloon angioplasty for the treatment of patients with symptoms of a failing dialysis access due to presence of significant stenosis in dialysis access circuit. The study conducted at the Department of Vascular and Endovascular Surgery, Assiut University Hospital (a tertiary referral hospital), between January 2017 and December 2018. Both the primary and assisted primary patency rates were analyzed by the Kaplan-Meier plot method. Results 149 patients underwent PTA for treatment of failing dialysis access symptoms. The most common site of stenosis in our study was the juxta-anastomotic site (49 %). The overall success rate was 96.6%. Balloon angioplasty was performed in all patients without stent placement. Sixteen (10.7%) complications were encountered in the study. At 1 year, the primary patency and the assisted primary patency rates was 60.5% and 80%, respectively. Age of the fistula (P=0.017), presence of multiple lesions (P=0.016), total lesion length >5cm (P=0.030), and diabetes mellitus (P=0.012) were significant independent predictors of loss of primary patency. Conclusions Balloon angioplasty is safe and effective treatment modality for treatment of stenosis in failing hemodialysis access patients with good technical success and acceptable short-term primary patency rates. Repeated interventions are required to maintain patency.

Mortality After Paclitaxel-Coated Device Use in Dialysis Access: A Systematic Review and Meta-Analysis

Purpose: To report the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon. Materials and Methods: A systematic review and meta-analysis of randomized controlled trials were performed to investigate the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access (last search date February 28, 2019). The primary endpoint was all-cause mortality. This analysis included 8 studies comparing paclitaxel-coated balloon (PCB) angioplasty (n=327) and PTA (n=331) in the treatment of failing dialysis access. None investigated paclitaxel-coated stents. Mortality data were pooled using a random effects model. Statistical heterogeneity was evaluated with a chi-square test and the I2 statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: At the pooled mean follow-up of 13.5 months (median 12, range 6–24) all-cause mortality was similar in the PCB group (13.8%) compared with PTA (11.2%; RR 1.26, 95% CI 0.85 to 1.89, p=0.25; I2=0%). Subgroup analysis, stratified according to length of follow-up, confirmed that there were no statistically significant differences in mortality at short- and midterm follow-up [6-month (8 studies): 5.2% vs 4.8%, RR 1.24, 95% CI 0.62 to 2.47, p=0.55; 12-month (6 studies): 6.3% vs 6.0%, RR 1.06, 95% CI 0.43 to 2.63, p=0.90; and 24-month (3 studies): 19.0% vs 13.5%, RR 1.38, 95% CI 0.90 to 2.12, p=0.14). Conclusion: The analysis found no difference in short- to midterm mortality among patients treated with a drug-coated balloon compared with PTA. With proven benefit and no evidence of harm, the authors recommend ongoing use of PCB for the failing dialysis access.

Stent-Graft Length Is Associated with Decreased Patency in Treatment of Central Venous Stenosis in Hemodialysis Patients

Central venous occlusion may occur in hemodialysis patients, resulting in arm or facial swelling and failure of dialysis access. Endovascular management with balloon angioplasty or stenting has been described, but there are minimal data on the use of covered stents in this pathology. We sought to review a single institution's experience with the use of covered stents for central venous occlusive disease in hemodialysis patients. A retrospective review of all patients undergoing placement of covered stents between April 2014 and December 2016 for central venous occlusive disease to preserve a failing dialysis access was performed. Patients' records were reviewed to identify demographics, medical comorbidities, operative variables, primary patency rates, and secondary interventions. A total of 29 patients were included in the analysis. Viabahn (W.L. Gore and Associates, Flagstaff, AZ) stent grafts were exclusively used in all patients. Technical success rate was 100%. The patients were predominantly female (65.5%), with a mean age of 67.9±12.1 and medical comorbidities of hypertension (86%), diabetes (76%), and tobacco use (7%). The majority (86%) had prior angioplasty and 17 of 29 (59%) patients had previous central venous catheters. The right brachiocephalic vein was the most commonly stented vessel (28%). The median stent length and diameter used were 50millimeters (range 25-100millimeters) and 13millimeters (range: 9-13millimeters), respectively. The majority of patients (83%) received a single stent, with only 2 patients requiring more than one. Median follow-up was 24months (range: 6-41months). Four of 29 (13.8%) patients developed symptomatic stent restenosis requiring secondary intervention, all of which occurred in patients with primary stenosis between 50% and 75%. When compared to the patients without restenosis, longer stents were found to be significantly associated with restenosis (62.5centimeters, interquartile range [IQR]: 0] vs. 50centimeter, IQR: 0, P=0.002). Primary patency rates were 92.9%, 91.7%, and 80.0% at 6, 12, and 24months respectively. Secondary patency rates were 96.4%, 95.8%, and 93.3% at 6months, 12months, and 24months, respectively. The overall primary patency rate was estimated at 86.2% using Kaplan-Meier analysis at 30.5months (95% confidence interval: 26.5-34.5months). Covered stent grafts have reasonable primary patency and excellent secondary patency when used for central venous stenosis in dialysis patients. Stent-graft length is associated with poorer long-term patency rates.

Prospective, Randomized Controlled Study of Paclitaxel-Coated versus Plain Balloon Angioplasty for the Treatment of Failing Dialysis Access

Purpose: To compare primary patency rates and target lesion revascularization of paclitaxel-coated balloon (PCB) versus plain balloon angioplasty (PBA) to preserve the patency of the vascular access circuit in patients undergoing hemodialysis after one year of follow-up. Patients and methods: Within 24-month period, during 2015 and 2016, 96 patients (54 men=56%; mean age 60.3±13.8) with hemodialysis-dependent end-stage renal disease were enrolled in the study. In total, 48 patients were randomly assigned to group PCB (29 AVGs & 19 AVFs) & 48 patients to group PBA (29 AVGs & 19 AVFs). Baseline & procedural variables were comparably distributed in PCB & PBA groups. Results: There were no significant differences in age of the treated vascular access circuit (2.31±1.62 years in PCB group vs. 2.63±1.94 years in PBA group, p=0.483), nor in the overall length of the treated target vein lesion (5.2±1.4 cm in PCB group vs. 5.4±1.6 cm in PBA group, p=0.641). All patients enrolled in the study completed the 1-year follow-up period. Device success rates were 100% in the PBA group and 39.6% in the PCB group, as further dilation with PBA was needed in 29 of 48 cases (60.4%) in the PCB group to achieve acceptable immediate postprocedural residual stenosis less than 30% (p= 0.1). Conclusion: In this three-center study, paclitaxel-coated balloon angioplasty results in improved vessel patency and is superior to plain balloon dilation in the treatment of venous stenoses of failing native or prosthetic arteriovenous shunts used for dialysis access. In the PCBs group, additional HPB postdilatation was required in the majority of cases. These results combined with the “do not leave any metal behind” principle, characteristic in balloon angioplasty, marks paclitaxelballoon as a really promising technology and merits larger-scale trails for PCBs to have a future place in the armamentarium for the treatment of venous stenosis in failing dialysis access.

Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472)

ObjectiveTo report the final results and cost-effectiveness analysis of a prospective randomized controlled trial investigating drug-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of failing dialysis access (NCT01174472). Methods40 patients were randomized to angioplasty with either DEB (n=20) or BA (n=20) for treatment of significant venous stenosis causing a failing dialysis access. Both arteriovenous fistulas (AVF) and synthetic arteriovenous grafts (AVG) were included. Angiographic follow up was scheduled every two months. Primary endpoints were technical success and target lesion primary patency at 1 year. Cumulative and survival analysis was performed. Incremental net benefit (INB) and incremental cost effectiveness ratio (ICER) were calculated and the cost-effectiveness acceptability curve (CEAC) was drawn. ResultsBaseline variables were equally distributed between the two groups. At 1 year, cumulative target lesion primary patency was significantly higher after DEB application (35% vs. 5% after BA, p<0.001). Overall, median primary patency was 0.64 years in case of DEB vs. 0.36 years in case of BA (p=0.0007; unadjusted HR=0.27 [95%CI: 0.13–0.58]; Cox adjusted HR=0.23 [95%CI: 0.10–0.50]). ICER was 2198 Euros (€) per primary patency year of dialysis access gained. INB was 1068€ (95%CI: 31–2105€) for a willingness-to-pay (WTP) threshold of 5000€ (corresponding acceptability probability >97%). ConclusionDEB angioplasty may be a cost-effective option that significantly improves patency after angioplasty of venous stenoses of failing vascular dialysis access. Further large-scale randomized trials are warranted.

Complications of endovascular grafts in the treatment of pseudoaneurysms and stenoses in arteriovenous access

Endovascular stent grafts are utilized in the rescue of failing arteriovenous (AV) access. Reports claim the superiority of stent grafts and recommend these as a first-line treatment. We have observed a rise in the number of complications related to stent grafts in our patients. The following study was undertaken to assess the severity of these complications and their effect on access site maintenance. We reviewed all patients who had endovascular stent grafts placed for treatment of failing dialysis access over the last 44 months. A series of 38 consecutively placed stent grafts was reviewed for stent migration, fracture, erosion, hemorrhage, and rupture at the site of the stent grafts. Hospital charts were reviewed to assess for indications, hemodynamic stability, transfusion requirement, and outcome. Of 38 stent grafts placed, nine were for pseudoaneurysm (PS), 20 for stenosis (ST), and nine for a combination (PS/ST). The average length of follow-up was 218.6 days. Primary patency was 49%, with an assisted primary patency of 76%. Eleven patients (28.9%) presented with complications related to migration, fracture, erosion, or rupture. Six were in the PS, three in the PS/ST, and two in the ST treatment groups. In all cases, migration or fracture of the stent graft led to recurrent pseudoaneurysm formation or erosion. Rupture occurred after a herald bleed in four cases. Once complication occurred, 10 of the 11 access sites had to be abandoned. Significant life-threatening complication can arise when fracture and migration of the stent grafts used for treating AV access occur. Herald bleed with a previously placed stent graft may be a harbinger of future rupture. Complications appear less likely when stent grafts are used to treat stenosis; however, when complications occur, access site salvage is rare. Surgical revision in the case of pseudoaneurysm should be considered for access preservation.

Abstract No LB01 Paclitaxel-coated balloon angioplasty versus plain balloon dilatation for the treatment of failing dialysis access: a prospective randomized controlled trial

Abstract No LB01 Paclitaxel-coated balloon angioplasty versus plain balloon dilatation for the treatment of failing dialysis access: a prospective randomized controlled trial

Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access:6-Month Interim Results From a Prospective Randomized Controlled Trial

To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

Dialysis catheter fibrin sheath stripping: a useful technique after failed catheter exchange.

Fibrin sheath formation around long-term haemodialysis catheter is a common cause of failed dialysis access. Treatment options include pharmacological and mechanical methods. This paper reports a case of failed dialysis access due to fibrin sheath encasement. Pharmacologic thrombolysis, mechanical disruption using guide wire and catheter exchange had failed to address the issue. Eventually, fibrin sheath stripping using the loop snare technique was able to successfully restore the catheter function.

Stent Graft versus Balloon Angioplasty for Failing Dialysis Access Grafts: A Long-Awaited Advance in the Treatment of Permanent Hemodialysis Access

Arteriovenous grafts (AVGs) for hemodialysis have a high failure rate, often due to the development of stenosis at the graft-to-vein anastomosis. Angioplasty (PTA) has been used for over two decades to treat AVG stenosis, with good technical success but limited AVG patency. Results of a prospective multi-center randomized trial, comparing stent graft to PTA in AVGs, has demonstrated superior access circuit patency for the stent graft group. Recent publication of this clinical study brings us into an exciting new era of dialysis access management using covered stents to improve durability of catheter-based therapy.

Failed dialysis access

Failed dialysis access

The Role of Atherectomy in the Failing Dialysis Access

The Role of Atherectomy in the Failing Dialysis Access

A Multidisciplinary Approach to the Treatment of Paget-Schroetter Syndrome

To assess the results of thrombolytic therapy and surgical decompression of the thoracic outlet in the management of spontaneous axillary vein thrombosis (AVT), the records of 38 patients at New York University Medical Center (NYUMC) with AVT were reviewed. Excluded from this report were 20 patients who had AVT secondary to an underlying medical condition, a subclavian catheter, or a failed dialysis access graft. Of the 18 remaining patients with no underlying medical condition, all were found to have effort-related axillo-subclavian thrombosis, Paget-Schroetter syndrome. Urokinase was used for thrombolysis in 17 of the 18 patients, (94.4%) with complete lysis in 14 (82.4%). The remaining patient received anticoagulation only following a favorable response to an initial heparin infusion. Of the patients achieving complete thrombolysis, all but one received urokinase within 8 days of the onset of symptoms. Clot lysis revealed axillary vein compression secondary to a thoracic outlet syndrome in 11 patients, and these underwent staged transaxillary thoracic outlet decompression by first rib resection. All 17 patients have been followed for a mean of 21 months, and none receiving lytic therapy have reoccluded. Review of these data confirms earlier reports showing that with early diagnosis, thrombolysis and, if indicated, thoracic outlet decompression, patients with spontaneous AVT can expect excellent clinical results with a good long-term prognosis.

Fibrinolysis and Angioplasty in the Treatment of Failed Dialysis Access Sites

Fibrinolysis and Angioplasty in the Treatment of Failed Dialysis Access Sites