Original Article
Stent Graft versus Balloon Angioplasty for Failing Dialysis-Access Grafts
N Engl J Med 2010; 362:494-503February 11, 2010
- Abstract
Background
The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts.
Methods
We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit.
Results
At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence of patency of the access circuit (38% vs. 20%, P=0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32% vs. 16%, P=0.03 by the log-rank test and P=0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001).
Conclusions
In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)
Media in This Article
Figure 1
Estimated Percentages of Patients with Primary Patency during the Study Period, According to Treatment Group.Table 1
Inclusion and Exclusion Criteria in the Study.Article Activity
- Article
By 2008, more than 341,000 patients in the United States were undergoing hemodialysis for treatment of their end-stage renal disease.1 The National Kidney Foundation Kidney Disease Outcomes Quality Initiative seeks to increase the use of autogenous fistulas, yet many patients continue to undergo hemodialysis with the use of prosthetic arteriovenous grafts. The reasons for this discrepancy between the recommendation and practice are multifactorial and continue to be debated.2,3 The costs of maintaining vascular access are substantial; for example, the cost of treating a patient who has failure of a hemodialysis access graft is significantly higher ($62,000 per patient-year) than the cost of treating a patient who does not have access failure.1,4
Many percutaneous techniques and endovascular tools have been used to treat the neointimal stenoses that develop at the site of venous anastomoses of arteriovenous grafts. At best, secondary patency of arteriovenous grafts (i.e., patency after an intervention) is 50% at 3 years after the creation of the vascular access; typically, multiple interventions are required to maintain patency.5,6 No reported mechanical, endovascular, or pharmacologic approaches have improved the patency of arteriovenous grafts as compared with balloon angioplasty alone.7-15 We hypothesized that revision of a venous anastomotic stenosis with a stent graft constructed with the same material as the graft would prevent elastic recoil and tissue ingrowth, thereby improving long-term patency as compared with that afforded by standard balloon angioplasty.
Methods
Study Design
In our prospective, multicenter, randomized, controlled trial, patients were eligible if they had end-stage renal disease and were undergoing long-term hemodialysis with the use of failing, but nonthrombosed, prosthetic arteriovenous grafts. The study was designed to assess the safety and efficacy of an expanded polytetrafluoroethylene stent graft, as compared with balloon angioplasty, for the treatment of hemodynamically significant venous anastomotic stenosis in an arteriovenous graft.
Inclusion and exclusion criteria, listed in Table 1Table 1
Inclusion and Exclusion Criteria in the Study., were developed in accordance with guidelines of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative and the Society of Interventional Radiology.16-18 The study was approved by each center's institutional review board and the Food and Drug Administration and was in compliance with Health Insurance Portability and Accountability Act regulations; all patients provided written informed consent. An independent clinical events committee at Harvard Clinical Research Institute (Boston) adjudicated the clinical data and the Angiographic Core Lab of the Cardiovascular Research Foundation (New York) analyzed the angiographic films. The principal investigator designed the study, with assistance from the sponsor (Bard Peripheral Vascular). The data were collected by on-site investigators under the auspices of the sponsor and principal investigator for analysis; Harvard Clinical Research Institute performed the statistical analyses. The principal investigator prepared the manuscript, which was reviewed by all authors, who vouch for the accuracy and completeness of the reported data.Study End Points
The study objective was to demonstrate that treatment with a stent graft is not inferior to treatment with balloon angioplasty alone regarding the primary end point, the 6-month primary patency of a stenotic venous anastomosis in the treatment area. Secondary end points included safety variables, procedural success (successful percutaneous insertion of the stent graft), primary patency of the access circuit at 2 months and 6 months, the percent stenosis of the treatment area at 2 months and 6 months, and freedom from subsequent intervention. See the Supplementary Appendix (available with the full text of this article at NEJM.org) for definitions of “treatment area” and “primary patency” and measures of successful intervention.
Stent Graft
The investigational device consisted of a self-expanding nitinol stent covered in carbon-impregnated expanded polytetrafluoroethylene (Flair Endovascular Stent Graft, Bard Peripheral Vascular). Two stent-graft configurations were used: tubular (straight) and flared. The flared configuration was used when the diameter of the outflow vein beyond the stenosis was larger than that of the arteriovenous graft. The stent graft was available in diameters of 6 to 9 mm and lengths of 30, 40, and 50 mm. It was deployed through a 9-French delivery catheter.
Randomization and Intervention
Once the enrollment criteria were met, angiography of the graft and treatment area was performed with the use of orthogonal magnified views, each 30 degrees or more apart, and a radiopaque 1-mm graduated ruler in the imaged field of view. The percent stenosis was calculated as follows: [1−(minimal lumen diameter÷nondiseased lumen diameter)]×100, where the minimal lumen diameter was the narrowest lumen diameter within the stenosed area and the nondiseased lumen diameter was the lumen diameter of the nondiseased arteriovenous graft or vein just upstream of the lesion. Remote secondary lesions more than 3 cm from the treatment area were required to have been treated until the stenosis was less than 30%, before randomization.
Randomization was performed with the use of permuted blocks, identified in sealed envelopes that were sent to each site in advance. If the lesion met study criteria, then balloon angioplasty was performed with the use of an appropriately sized conventional (noncutting, noncompliant) angioplasty balloon. After angioplasty, patients were randomly assigned to undergo placement of a stent graft or to receive no other treatment. No patients were excluded before randomization because of resistant stenoses that prevented full expansion of the initial angioplasty balloon. If a patient was randomly assigned to the stent-graft group, a device of appropriate length, configuration, and diameter (≤1 mm greater than the arteriovenous graft, to avoid the use of an oversized device) was chosen. The stent graft was placed and was then dilated, with a balloon diameter equal to that used in the balloon-angioplasty group. Lesions were dilated to reduce the stenosis in the treated area to less than 30%. The angiograms were later sent to the Angiographic Core Lab for analysis.
Clinical and Angiographic Follow-up Regimen
Patients were treated and discharged according to each center's standard of care. Anticoagulation or antiplatelet agents were administered after the procedure at the physician's discretion. A single, intravenous dose of prophylactic antibiotic — usually cefazolin sodium, in patients who did not have an allergy — was administered in the stent-graft group.
Mandatory clinical evaluations and magnified quantitative angiography were performed 2 and 6 months after the index procedure, with the use of similar imaging protocols. Medical events, hospitalizations, access interventions, and adverse events were recorded. Graft function was assessed by means of a clinical evaluation of the same clinical or hemodynamic indicator used to assess graft function during the initial angiographic evaluation (one of the graft-function indicators accepted by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative), as well as by means of angiographic evaluation. Catheter-based interventions were performed in patients who both met clinical criteria for graft dysfunction and had stenoses of more than 50%. In accordance with the National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines, investigators were instructed not to intervene regarding asymptomatic, clinically silent (i.e., incidentally diagnosed) stenoses found in the treatment area during angiography at 2 and 6 months.
Statistical Analysis
We calculated the sample size needed to test the primary noninferiority hypothesis using the methods of Blackwelder.19 The incidence of primary patency at 6 months was estimated as 60% in the stent-graft group and 50% in the balloon-angioplasty group. The two rates were considered clinically noninferior if the difference was 10 percentage points or less (with a significance threshold of P=0.05 on a one-tailed test and 80% statistical power). On this basis, the number of patients required for each of the two treatment groups was calculated to be 76. The target number of patients enrolled in each group was set at 95, to account for a dropout rate of up to 20%. Thus, the total target sample size was 190 patients.
Intention-to-treat analyses were performed to evaluate the 6-month primary patency. The times to the return of symptoms and patency were analyzed with the use of Kaplan–Meier product–limit survival estimates. The data for patients with missed 6-month visits were censored in the estimation of the percentage of patients with graft patency at 6 months.
Continuous secondary variables (e.g., percent stenosis) were analyzed by means of parametric or nonparametric analysis of variance with covariate adjustment. Outcomes for nonprimary effectiveness variables (e.g., primary patency of the access circuit) were analyzed at 2 and 6 months after the procedure. Subgroup analyses were performed to evaluate the influence of concomitant variables. P values less than 0.05 were considered to indicate statistical significance.
Results
Patients
A total of 190 patients at 13 study sites were enrolled: 97 were randomly assigned to undergo implantation of the investigational stent graft and 93 were randomly assigned to undergo the control procedure, balloon angioplasty, only. The study patients consisted of 69 men and 121 women (Table 2Table 2
Characteristics of the Study Patients and Access Grafts at Baseline, According to Treatment Group.). Participating centers were academic, community-based, inpatient, or freestanding outpatient dialysis centers. There were no significant differences between the two treatment groups at baseline with respect to demographic characteristics, relevant medical history, or characteristics of the arteriovenous access graft, with the exception of a higher incidence of axillary venous anastomosis in the balloon-angioplasty group. Nor were there significant differences between the two groups with respect to the nature or prevalence of abnormalities leading to the intervention in the arteriovenous access graft. The three most common triggers for intervention were clinical variables, elevated venous pressure during dialysis, and detection of decreased blood flow.Baseline Angiographic Characteristics of the Lesion
There were no significant differences between the two treatment groups with respect to angiographic characteristics of the target lesion: interpolated reference-vessel diameter, minimum lumen diameter, or percent stenosis (Table 2). The average balloon diameters during dilation were similar in the stent-graft group and the balloon-angioplasty group. The percentage of patients with secondary lesions in the access circuit was similar in the two groups: 39% of patients receiving a stent graft and 41% undergoing balloon angioplasty.
Implantation of Stent Grafts
A total of 125 stent grafts were implanted in 97 patients; 67% of the stent grafts were flared, 16% were straight, and 17% consisted of overlapping straight and flared grafts. Seventy-three patients (75%) received a single device. Stent grafts were overlapped when lesion lengths (including a nondiseased 10-mm “landing zone” between the arteriovenous graft and outflow vein) exceeded the longest available stent-graft length (50 mm). Device deployment was successful in 96 of the 97 patients (99%). A 30-mm stent graft was placed in 28% of the patients, a 40-mm graft in 36%, and a 50-mm graft in 36%.
Follow-up of the Patients
There were no significant differences between the two treatment groups regarding the attendance of patients at follow-up examinations at any study interval. Thirteen patients (6 of the 97 patients [6%] receiving a stent graft and 7 of the 93 patients [8%] undergoing balloon angioplasty) missed either the 2-month or 6-month follow-up evaluation: 2 patients (1 in each group) missed the 2-month follow-up visit and 11 (5 in the stent-graft group and 6 in the balloon-angioplasty group) missed the 6-month follow-up visit. A total of 94% of patients in the stent-graft group and 93% of patients in the balloon-angioplasty group completed the 6-month follow-up visit.
Study End Points
On the basis of an intention-to-treat analysis, at 6 months, the incidence of primary patency of the treatment area was significantly greater in the stent-graft group (51%) than in the balloon-angioplasty group (23%) (P<0.001), as was the incidence of primary patency of the access circuit (38% vs. 20%, P=0.008) (Table 3Table 3
Treatment Success and Patency End Points in the Intention-to-Treat Population, According to Treatment Group.). Forty-five patients in the stent-graft group and 66 patients in the balloon-angioplasty group had loss of primary patency of the treatment area, owing to one or more of the following events: reintervention in the treatment area, thrombotic occlusion, surgical intervention that excluded the treatment area from the access circuit, and abandonment of the graft because of an inability to treat the primary lesions (Table 4Table 4
Adverse Events at 6 Months, According to Treatment Group.). At 6 months, the percentage of patients with freedom from loss of primary patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (P=0.003 by the log-rank test and P=0.008 by the Wilcoxon rank-sum test), as was the percentage with freedom from loss of primary patency of the access circuit (P=0.03 by the log-rank test and P=0.04 by the Wilcoxon rank-sum test) (Figure 1Figure 1Estimated Percentages of Patients with Primary Patency during the Study Period, According to Treatment Group.). At 210 days, the stent-graft group showed superior freedom from subsequent interventions as compared with the balloon-angioplasty group (P=0.03 by the log-rank test and P=0.04 by the Wilcoxon rank-sum test). These findings supported both the primary and secondary study hypotheses: the noninferiority to and superiority of the stent graft as compared with balloon angioplasty.Procedural Success and Restenosis
The rate of procedural success was significantly higher in the stent-graft group than in the percutaneous-transluminal-angioplasty group, with success in 94% versus 73% of patients (P<0.001) (Table 4). At 6 months, the minimum lumen diameter of the treatment area was, on average (mean ±SD), significantly greater with the stent graft than with balloon angioplasty alone: 5.1±1.5 mm vs. 3.3±1.5 mm (P<0.001).
The average percent stenosis was lower in the stent-graft group (32.1±19.8%) than in the balloon-angioplasty group (59.2±19.6%) (P<0.001). At 6 months, the incidence of binary restenosis (stenosis of >50% diameter) was significantly greater in the balloon-angioplasty group (78%) than in the stent-graft group (28%) (P<0.001). Restenotic lesions were, on average, significantly shorter in the stent graft group (18.0±12.5 mm) than in the balloon-angioplasty group (32.1±14.3 mm) (P<0.001).
At 6 months, the presence or absence of remote secondary lesions that were required to have been treated before study enrollment did not negate the patency advantage of the stent graft over balloon angioplasty. The incidence of patency of the treatment area was greater, among patients who had secondary lesions, in the stent-graft group (44%) than in the balloon-angioplasty group (17%) (P=0.02), as well as among patients who did not have secondary lesions (54% vs. 28%) (P=0.006).
Logistic-regression analysis of clinical variables at 6 months failed to identify any distinguishing or significant criteria affecting primary patency — including diabetes, age, sex, history of hypercoagulability or glomerulonephritis, graft site, hypertension, or use of anticoagulation or antiplatelet therapy. By means of multiple logistic-regression analysis, the only criterion that was associated with primary patency at 6 months of follow-up was assignment to the stent-graft group (P<0.001).
Safety and Adverse Events
There was no significant difference in the incidence of reported adverse events between the balloon-angioplasty control group and the stent-graft group, except for the incidence of restenosis, which was higher with balloon angioplasty (77%, vs. 40% with stent graft; P<0.001) (Table 4).
Discussion
Despite nearly universal agreement that native fistulas should be the hemodialysis access of first choice, prosthetic grafts continue to play an important role in the creation of permanent hemodialysis-access circuits in patients in the United States. Though the percentage of patients undergoing dialysis through prosthetic grafts may continue to fall, the total number of patients with end-stage renal disease continues to grow each year.1,3 Thus, hemodialysis grafts are likely to remain important vascular accesses, as “planned bridges” to native fistulas or in patients in whom fistulas have failed or cannot be created.17,20-22
Balloon angioplasty for stenotic arteriovenous grafts has limitations, however: the long-term durability of balloon angioplasty is limited6,9,10 and may necessitate repeated invasive procedures9-11 with attendant complications and costs. From 16 to 25% of hospital admissions of patients with end-stage renal disease in the United States are necessitated by complications related to a vascular access; the associated costs have been estimated at nearly 1 billion dollars per year.1,4 Furthermore, the outpatient costs for patients with graft failure more than doubled between 1991 and 2005.1
Multiple devices and approaches for treating arteriovenous graft–related stenosis have been used and reported on in retrospective series and prospective, randomized trials. To date, none have shown any benefit over balloon angioplasty. These techniques have included angioplasty with cutting or with ultrahigh-pressure balloons, brachytherapy, cryoplasty, anticoagulation therapy, placement of bare-metal stents, modified surgical techniques and graft configurations, and other pharmacologic approaches. Although preliminary research in minimizing the hyperplastic process at the time of graft creation by means of pharmacologic, cellular, or gene therapies appears promising, such efforts are in the early stages of evaluation or development.7-15,23-29
The polytetrafluoroethylene self-expanding stent graft is a less-invasive endovascular approach for revision of failing prosthetic arteriovenous grafts that is intended to mimic open surgical revision of a graft. Unlike surgery, a percutaneous approach optimally allows for immediate use of the graft, which might obviate the need for interim catheter dialysis and its associated costs, risks of bloodstream infection, and other complications. The stent graft used in the present trial was designed to prevent both the elastic recoil that occurs after balloon angioplasty, thus sustaining the short-term gain in luminal patency — an effect similar to that of uncovered (bare-metal) stents used in the access circuit — and the late loss in luminal patency due to trans-stent growth of neointimal tissue.13,28,29 The present endovascular approach also essentially converts the initial surgical end-to-side venous anastomosis into an end-to-end anastomosis, providing more laminar in-line flow and thus potentially reducing the turbulence and shear stress that contribute to the development of venous outflow stenosis.7,8,32-36
Our study involved detailed assessments and definitions of patency. All patients underwent formal angiography at 2 and 6 months, regardless of the clinical graft function, allowing for uniform assessment of stenosis at the Angiographic Core Lab. The angiographic findings were an integral part of the study definition of patency. In contrast, most published studies have used the absence of clinical dysfunction alone as the measure of treatment success.7-15,25-29 The definitions used in our randomized, controlled study may provide a more accurate measure of actual arteriovenous graft patency than previous retrospective studies of arteriovenous grafts. Prospective reports of the patency of autogenous fistulas have noted similar findings: the incidence of patency is lower when prospectively assessed than when retrospectively ascertained.20,37,38
In conclusion, our data indicate that the expanded polytetrafluoroethylene self-expanding stent graft used in the present study is superior to balloon angioplasty for the treatment of arteriovenous access grafts that have venous anastomotic stenosis. As compared with balloon angioplasty, the stent graft was associated with graft function for a longer period before subsequent intervention and a graft lumen that had a greater diameter and had patency for a longer period.
Supported by Bard Peripheral Vascular.
Dr. Haskal reports receiving consulting fees from W.L. Gore and Associates and lecture fees from Bard Peripheral Vascular and holding stock in AngioDynamics; Dr. Trerotola, receiving consulting fees from W.L. Gore and Associates and Bard Peripheral Vascular; Dr. Dolmatch, receiving consulting and lecture fees from Bard Peripheral Vascular and royalties for the Flair Endovascular Stent Graft and serving as an expert witness for testimony concerning the healing characteristics of the Flair Endovascular Stent Graft; Drs. Schuman and Berman, receiving consulting and lecture fees from Bard Peripheral Vascular; Dr. Altman, receiving consulting fees from Bard Peripheral Vascular; Dr. McLennan, receiving consulting fees from Medtronic, Cook, and Bard Peripheral Vascular and grant support from Cook, Boston Scientific, Guerbet, and Medical International Research; Dr. Ross, receiving lecture fees from W.L. Gore and Associates, Hemosphere, Bard Peripheral Vascular, and Medrad Interventional–Possis; and Dr. Vesely, receiving consulting fees from AngioDynamics, Elcam Medical, Spire Biomedical, and W.L. Gore and Associates and lecture fees from AngioDynamics and W.L. Gore and Associates.
No other potential conflict of interest relevant to this article was reported.
Source Information
From the University of Maryland Medical Center, Baltimore (Z.J.K.); the Hospital of the University of Pennsylvania, Philadelphia (S.T.); the University of Texas–Southwestern Medical Center, Dallas (B.D., C.T.); Oregon Surgical Consultants, Portland (E.S.); Open Access Vascular Access Center, Miami (S.A.); Vascular Access Center, Augusta, GA (S.M.); Tucson Vascular Surgery, Tucson, AZ (S.B.); Indiana University School of Medicine, Indianapolis (G.M.); Bamberg County Hospital and Nursing Center, Bamberg, SC (J.R.); and the Vascular Access Center of Frontenac Grove, Frontenac, MO (T.V.).
Address reprint requests to Dr. Haskal at the Division of Vascular and Interventional Radiology, University of Maryland Medical Center, 22 S. Greene St., GK214, Baltimore, MD 21201, or at ziv2@mac.com.
- References
References
1
U.S. Renal Data System. USRDS 2009 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, 2009.
2
Vascular Access Work Group
CrossRef | Medline3
Chan MR ,Sanchez RJ ,Young HN ,Yevzlin AS . Vascular access outcomes in the elderly hemodialysis population: a USRDS study. Semin Dial 2007;20:606-610
CrossRef | Web of Science | Medline4
The economic cost of ESRD, vascular access procedures, and Medicare spending for alternative modalities of treatment. Am J Kidney Dis 1997;30:Suppl 1:S160-S177
CrossRef | Web of Science | Medline5
Schwab SJ ,Harrington JT ,Singh A , et al. Vascular access for hemodialysis. Kidney Int 1999;55:2078-2090
CrossRef | Web of Science | Medline6
NKF-DOQI clinical practice guidelines for vascular access: National Kidney Foundation-Dialysis Outcomes Quality Initiative. Am J Kidney Dis 1997;30:Suppl 3:S150-S191
Web of Science | Medline7
Fillinger MF ,Reinitz ER ,Schwartz RA ,Resetarits DE ,Paskanik AM ,Bredenberg CE . Beneficial effects of banding on venous intimal-medial hyperplasia in arteriovenous loop grafts. Am J Surg 1989;158:87-94
CrossRef | Web of Science | Medline8
Fillinger MF ,Reinitz ER ,Schwartz RA , et al. Graft geometry and venous intimal-medial hyperplasia in arteriovenous loop grafts. J Vasc Surg 1990;11:556-566
CrossRef | Web of Science | Medline9
Kanterman RY ,Vesely TM ,Pilgram TK ,Guy BW ,Windus DW ,Picus D . Dialysis access grafts: anatomic location of venous stenosis and results of angioplasty. Radiology 1995;195:135-139[Erratum, Radiology 1995;196:582.]
Web of Science | Medline10
Lilly RZ ,Carlton D ,Barker J , et al. Predictors of arteriovenous graft patency after radiologic intervention in hemodialysis patients. Am J Kidney Dis 2001;37:945-953
CrossRef | Web of Science | Medline11
Lumsden AB ,MacDonald MJ ,Kikeri D ,Cotsonis GA ,Harker LA ,Martin LG . Prophylactic balloon angioplasty fails to prolong the patency of expanded polytetrafluoroethylene arteriovenous grafts: results of a prospective randomized study. J Vasc Surg 1997;26:382-390
CrossRef | Web of Science | Medline12
Misra S ,Bonan R ,Pflederer T ,Roy-Chaudhury P . BRAVO I: a pilot study of vascular brachytherapy in polytetrafluoroethylene dialysis access grafts. Kidney Int 2006;70:2006-2013
Web of Science | Medline13
Patel RI ,Peck SH ,Cooper SG , et al. Patency of Wallstents placed across the venous anastomosis of hemodialysis grafts after percutaneous recanalization. Radiology 1998;209:365-370
Web of Science | Medline14
Rifkin BS ,Brewster UC ,Aruny JE ,Perazella MA . Percutaneous balloon cryoplasty: a new therapy for rapidly recurrent anastomotic venous stenoses of hemodialysis grafts? Am J Kidney Dis 2005;45:e27-e32
CrossRef | Web of Science | Medline15
Sun S ,Beitler JJ ,Ohki T , et al. Inhibitory effect of brachytherapy on intimal hyperplasia in arteriovenous fistula. J Surg Res 2003;115:200-208
CrossRef | Web of Science | Medline16
Aruny JE ,Lewis CA ,Cardella JF , et al. Quality improvement guidelines for percutaneous management of the thrombosed or dysfunctional dialysis access. J Vasc Interv Radiol 2003;14:S247-S253
CrossRef | Medline17
Clinical practice guidelines and for vascular access. Am J Kidney Dis 2006;48:Suppl 1:S176-S247
CrossRef | Medline18
Gray RJ ,Sacks D ,Martin LG ,Trerotola SO . Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol 2003;14:S433-S442
CrossRef | Medline19
Blackwelder WC . “Proving the null hypothesis” in clinical trials. Control Clin Trials 1982;3:345-353
CrossRef | Medline20
Biuckians A ,Scott EC ,Meier GH ,Panneton JM ,Glickman MH . The natural history of autologous fistulas as first-time dialysis access in the KDOQI era. J Vasc Surg 2008;47:415-421
CrossRef | Web of Science | Medline21
Stevenson KB ,Hannah EL ,Lowder CA , et al. Epidemiology of hemodialysis vascular access infections from longitudinal infection surveillance data: predicting the impact of NKF-DOQI clinical practice guidelines for vascular access. Am J Kidney Dis 2002;39:549-555
CrossRef | Web of Science | Medline22
NKF-K/DOQI clinical practice guidelines for vascular access: update 2000. Am J Kidney Dis 2001;37:Suppl 1:S137-S181
CrossRef | Medline23
Luo Z ,Akita GY ,Date T , et al. Adenovirus-mediated expression of beta-adrenergic receptor kinase C-terminus reduces intimal hyperplasia and luminal stenosis of arteriovenous polytetrafluoroethylene grafts in pigs. Circulation 2005;111:1679-1684
CrossRef | Web of Science | Medline24
Kohler TR ,Toleikis PM ,Gravett DM ,Avelar RL . Inhibition of neointimal hyperplasia in a sheep model of dialysis access failure with the bioabsorbable Vascular Wrap paclitaxel-eluting mesh. J Vasc Surg 2007;45:1029-1037
CrossRef | Web of Science | Medline25
Konner K . Paclitaxel -- a tool to prevent stenosis in vascular access for haemodialysis? Blood Purif 2006;24:287-288
CrossRef | Web of Science | Medline26
Yevzlin AS ,Conley EL ,Sanchez RJ ,Young HN ,Becker BN . Vascular access outcomes and medication use: a USRDS study. Semin Dial 2006;19:535-539
CrossRef | Web of Science | Medline27
Rajan DK ,Platzker T ,Lok CE , et al. Ultrahigh-pressure versus high-pressure angioplasty for treatment of venous anastomotic stenosis in hemodialysis grafts: is there a difference in patency? J Vasc Interv Radiol 2007;18:709-714
CrossRef | Web of Science | Medline28
Hoffer EK ,Sultan S ,Herskowitz MM ,Daniels ID ,Sclafani SJ . Prospective randomized trial of a metallic intravascular stent in hemodialysis graft maintenance. J Vasc Interv Radiol 1997;8:965-973
CrossRef | Web of Science | Medline29
Vogel PM ,Parise C . SMART stent for salvage of hemodialysis access grafts. J Vasc Interv Radiol 2004;15:1051-1060
CrossRef | Web of Science | Medline30
Guiu B ,Loffroy R ,Ben Salem D , et al. Angioplasty of long venous stenoses in hemodialysis access: at last an indication for cutting balloon? J Vasc Interv Radiol 2007;18:994-1000
CrossRef | Web of Science | Medline31
Vesely TM ,Siegel JB . Use of peripheral cutting balloon to treat hemodialysis-related stenoses. J Vasc Interv Radiol 2005;16:1593-1603
CrossRef | Web of Science | Medline32
Roy-Chaudhury P ,Kelly BS ,Miller MA , et al. Venous neointimal hyperplasia in polytetrafluoroethylene dialysis grafts. Kidney Int 2001;59:2325-2334
Web of Science | Medline33
Sottiurai VS ,Yao JS ,Batson RC ,Sue SL ,Jones R ,Nakamura YA . Distal anastomotic intimal hyperplasia: histopathologic character and biogenesis. Ann Vasc Surg 1989;3:26-33
CrossRef | Medline34
Longest PW ,Kleinstreuer C . Numerical simulation of wall shear stress conditions and platelet localization in realistic end-to-side arterial anastomoses. J Biomech Eng 2003;125:671-681
CrossRef | Web of Science | Medline35
Krueger U ,Zanow J ,Scholz H . Computational fluid dynamics and vascular access. Artif Organs 2002;26:571-575
CrossRef | Web of Science | Medline36
Fillinger MF ,Kerns DB ,Bruch D ,Reinitz ER ,Schwartz RA . Does the end-to-end venous anastomosis offer a functional advantage over the end-to-side venous anastomosis in high-output arteriovenous grafts? J Vasc Surg 1990;12:676-690
CrossRef | Web of Science | Medline37
Huijbregts HJ ,Bots ML ,Wittens CH ,Schrama YC ,Moll FL ,Blankestijn PJ . Hemodialysis arteriovenous fistula patency revisited: results of a prospective, multicenter initiative. Clin J Am Soc Nephrol 2008;3:714-719
CrossRef | Web of Science | Medline38
Dixon BS ,Beck GJ ,Vazquez MA , et al. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med 2009;360:2191-2201
Full Text | Web of Science | Medline
- Citing Articles (30)
Citing Articles
1
John D. Kakisis, Efthymios Avgerinos, Triantafyllos Giannakopoulos, Konstantinos Moulakakis, Anastasios Papapetrou, Christos D. Liapis. (2012) Balloon angioplasty vs nitinol stent placement in the treatment of venous anastomotic stenoses of hemodialysis grafts after surgical thrombectomy. Journal of Vascular Surgery 55:2, 472-478
CrossRef2
W. D. Paulson, N. Kipshidze, K. Kipiani, N. Beridze, M. V. DeVita, S. Shenoy, S. S. Iyer. (2012) Safety and efficacy of local periadventitial delivery of sirolimus for improving hemodialysis graft patency: first human experience with a sirolimus-eluting collagen membrane (Coll-R). Nephrology Dialysis Transplantation
CrossRef3
William D Paulson, Louise Moist, Charmaine E Lok. (2012) Vascular access surveillance: an ongoing controversy. Kidney International 81:2, 132-142
CrossRef4
Syed Ahmed, Prabir Roy-Chaudhury. (2012) Radiation Therapy for Dialysis Access Stenosis: Unfulfilled Promise or False Expectations. Seminars in Dialysisno-no
CrossRef5
Ulrike Stampfl, Christof-Matthias Sommer, Nadine Bellemann, Jürgen Weitz, Dittmar Böckler, Götz Martin Richter, Hans-Ulrich Kauczor, Boris Radeleff. (2012) The Use of Balloon-Expandable Stent Grafts for Management of Acute Arterial Bleeding. Journal of Vascular and Interventional Radiology
CrossRef6
Patrick A. Stone, Albeir Y. Mousa, John E. Campbell, Ali F. AbuRahma. (2012) Dialysis Access. Annals of Vascular Surgery
CrossRef7
Bryan Baranowski, Oussama Wazni, Roy Chung, David O. Martin, John Rickard, Christine Tanaka-Esposito, Mohammed Bassiouny, Bruce L. Wilkoff. (2011) Percutaneous extraction of stented device leads. Heart Rhythm
CrossRef8
Byung Seok Shin, Mi-hyun Park, Gyeong Sik Jeon, Byung Mo Lee, Kichang Lee, Dae-Young Kang, Sung Gwon Kang, Young-Min Han. (2011) Use of Covered Stents in the Central Vein: A Feasibility Study in a Canine Model. Journal of Endovascular Therapy 18:6, 802-810
CrossRef9
Tiziano Tallarita, Gustavo S. Oderich, Thanila A. Macedo, Peter Gloviczki, Sanjay Misra, Audra A. Duncan, Manju Kalra, Thomas C. Bower. (2011) Reinterventions for stent restenosis in patients treated for atherosclerotic mesenteric artery disease. Journal of Vascular Surgery 54:5, 1422-1429.e1
CrossRef10
David Shemesh, Ilya Goldin, Ibrahim Zaghal, Daniel Berelowitz, Anthony G. Verstandig, Oded Olsha. (2011) Stent graft treatment for hemodialysis access aneurysms. Journal of Vascular Surgery 54:4, 1088-1094
CrossRef11
Ninos Ayez, Bram Fioole, Ruud A. Aarts, Marinus A. van den Dorpel, George P. Akkersdijk, Maarten K. Dinkelman, André A. de Smet. (2011) Secondary interventions in patients with autologous arteriovenous fistulas strongly improve patency rates. Journal of Vascular Surgery 54:4, 1095-1099
CrossRef12
Sanjoy Kundu, Milad Modabber, John M. You, Paul Tam, Gordon Nagai, Robert Ting. (2011) Use of PTFE Stent Grafts for Hemodialysis-related Central Venous Occlusions: Intermediate-Term Results. CardioVascular and Interventional Radiology 34:5, 949-957
CrossRef13
Robert G. Jones, Andrew P. Willis, Catherine Jones, Ian J. McCafferty, Peter L. Riley. (2011) Long-term Results of Stent-graft Placement to Treat Central Venous Stenosis and Occlusion in Hemodialysis Patients with Arteriovenous Fistulas. Journal of Vascular and Interventional Radiology 22:9, 1240-1245
CrossRef14
Michael J. Costanza, Kwame S. Amankwah, Muhammad Asad Khan, Sriram S. Narsipur, Vivian Gahtan. (2011) Angioaccess for Hemodialysis. Current Problems in Surgery 48:7, 443-517
CrossRef15
William L. Whittier. (2011) Should arteriovenous access flow undergo regular surveillance?. Seminars in Dialysis 24:4, 389-390
CrossRef16
Eric K. Peden. (2011) Role of Stent Grafts for the Treatment of Failing Hemodialysis Accesses. Seminars in Vascular Surgery 24:2, 119-127
CrossRef17
Jack Work. (2011) Role of Access Surveillance and Preemptive Intervention. Seminars in Vascular Surgery 24:2, 137-142
CrossRef18
Michael G. Chan, Frank J. Miller, Karim Valji, Michael D. Kuo. (2011) Evaluation of Expanded Polytetrafluoroethylene–covered Stents for the Treatment of Venous Outflow Stenosis in Hemodialysis Access Grafts. Journal of Vascular and Interventional Radiology 22:5, 647-653
CrossRef19
Shingo Hatakeyama, Terumasa Toikawa, Akiko Okamoto, Hayato Yamamoto, Kengo Imanishi, Teppei Okamoto, Noriko Tokui, Yuichiro Suzuki, Naoki Sugiyama, Atsushi Imai, Yasuhiro Hashimoto, Shigemasa Kudo, Takahiro Yoneyama, Takuya Koie, Noritaka Kamimura, Hisao Saitoh, Tomihisa Funyu, Chikara Ohyama. (2011) Efficacy of SMART Stent Placement for Salvage Angioplasty in Hemodialysis Patients with Recurrent Vascular Access Stenosis. International Journal of Nephrology 2011, 1-6
CrossRef20
R. Kellersmann, V. Mickley. (2010) Aktuelle Studienlage zur Shuntchirurgie. Gefässchirurgie 15:8, 579-588
CrossRef21
Arif Asif. (2010) Nephrologists and interventional nephrology. Dialysis & Transplantation 39:11, 476-480
CrossRef22
K. Kian, A. Asif. (2010) Status of research in vascular access for dialysis. Nephrology Dialysis Transplantation 25:11, 3682-3686
CrossRef23
Neil Dashkoff, George A. Blessios, Matthew R. Cox. (2010) Migration of covered stents from hemodialysis A-V access to the pulmonary artery: Percutaneous stent retrieval and procedural trends. Catheterization and Cardiovascular Interventions 76:4, 595-601
CrossRef24
Arif Asif, Florin Gadalean, Nadia Eid, Donna Merrill, Loay Salman. (2010) Stent Graft Infection and Protrusion Through the Skin: Clinical Considerations and Potential Medico-Legal Ramifications. Seminars in Dialysis 23:5, 540-542
CrossRef25
Loay Salman, Arif Asif. (2010) Dialysis: The stent graft for stenosis: let's appraise before we praise. Nature Reviews Nephrology 6:9, 503-504
CrossRef26
(2010) Scientific Surgery. British Journal of Surgery 97:8, 1313-1313
CrossRef27
Richard A. Sherman. (2010) Briefly Noted. Seminars in Dialysis 23:4, 447-448
CrossRef28
(2010) Stent Graft or Balloon Angioplasty Alone for Dialysis-Access Grafts. New England Journal of Medicine 362:20, 1938-1940
Full Text29
(2010) Journal Club. Kidney International 77:9, 751-752
CrossRef30
Kerlan, Robert K. Jr., LaBerge, Jeanne M., . (2010) Fistula First, Stent Graft Second. New England Journal of Medicine 362:6, 550-552
Full Text
- Letters
