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      Use of Paclitaxel Eluting Stents in Arteriovenous Fistulas: A Pilot Study

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          Abstract

          Purpose

          We report short-term patency outcomes of a proof of concept study conducted to determine the efficacy of drug-eluting stent (DES) for the treatment of arteriovenous fistula (AVF) stenosis in hemodialysis patients.

          Materials and Methods

          This is a single-center, retrospective observational study involving 10 patients with AVF dysfunction treated with DESs between January 2017 and December 2017. The primary outcome was AVF patency confirmed by sonographic and clinical assessment at 1 month and 6 to 9 months after treatment.

          Results

          A total of 12 DESs were deployed in 10 patients with dysfunctional AVF (radiocephalic: 7, brachiocephalic: 3). During the early follow up (mean: 28.6 days), primary access circuit and DES patency was 100%, with an average volume flow rate of 886.4 mL/min. Nine patients were available for short-term follow up (mean: 202.4 days; 1 unrelated death), with a mean volume flow rate of 1,048.9 mL/min. The primary DES patency was 7/9 (77.8%), and 3 patients required angioplasty at other parts of the circuit (primary access circuit patency: 4/9 [44.4%]). The assisted primary access circuit patency was 77.8%. In 2 patients, the ultrasound revealed that the DESs were thrombosed without any antecedent stenosis; they were salvaged with angioplasty. Both patients previously underwent 2 DESs implanted and recently stopped dual antiplatelet therapy. B-mode sonographic assessment at all timepoints showed minimal intimal ingrowth on the stent struts.

          Conclusion

          This study demonstrates acceptable short-term patency for DESs in the treatment of AVF stenosis. Dual antiplatelet therapy is probably mandatory in the short term.

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          Most cited references28

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          A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

          The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.
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            Recommended standards for reports dealing with arteriovenous hemodialysis accesses.

            The incidence rate of treated end-stage renal disease in the united states is 180 per million and continues to rise at a rate of 7.8% per year. Arteriovenous hemodialysis access (AV access) creation and maintenance are two of the most difficult issues associated with the management of patients on hemodialysis. The 1-year complication rate of a primary prosthetic AV access for hemodialysis ranges from 33% to 99%. Various investigators report on patency and complications of AV access. However, it is rather difficult to compare outcomes because of the wide variety of access materials, configurations, locations, risk factors, and quality of inflow and outflow vessels. Although there have been reporting standards for dialysis access endovascular interventions and for central venous access placement, standards regarding surgical access placement and its revision are lacking. The "Dialysis Outcome Quality Initiative," published by the National Kidney Foundation, provides recommendations for optimal clinical practices aimed at improving dialysis outcome and patient survival. This reporting standards document is not meant to be a "practice guidelines" or "best practices" document. Rather, the purpose of this document is to provide standardized definitions related to AV access procedures and to recommend reporting standards for patency and complications, to be used by surgeons, nephrologists, and interventional radiologists, that will permit meaningful comparisons among AV access procedures. The terms, definitions, and categories featured in this article have been approved by the Committee on Reporting Standards of the Society for Vascular Surgery and the American Association for Vascular Surgery and should be observed in preparing manuscripts on AV accesses for submission to the Journal Of Vascular Surgery.
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              A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial

              The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions.
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                Author and article information

                Journal
                Vasc Specialist Int
                Vasc Specialist Int
                VSI
                Vascular Specialist International
                Vascular Specialist International
                2288-7970
                2288-7989
                December 2019
                31 December 2019
                : 35
                : 4
                : 225-231
                Affiliations
                [1 ]Department of Surgery, Prince of Wales Hospital, Australia
                [2 ]Department of Vascular Surgery, Westmead Hospital, Australia
                [3 ]Faculty of Medicine, University of New South Wales, Australia
                [4 ]The Vascular Institute, Prince of Wales Hospital, Sydney, Australia
                Author notes
                Corresponding author: Shannon D. Thomas, Suite 8 Level 7, Department of Surgery, Prince of Wales Private Hospital, Randwick, NSW 2031, Australia, Tel: 61-2-96504981, Fax: 61-2-96504910, E-mail: shannondthomas@ 123456gmail.com , https://orcid.org/0000-0001-8717-4406
                Author information
                https://orcid.org/0000-0003-4087-6296
                https://orcid.org/0000-0001-8717-4406
                https://orcid.org/0000-0002-5601-8408
                https://orcid.org/0000-0002-2883-3894
                https://orcid.org/0000-0002-0927-3721
                https://orcid.org/0000-0001-5611-6991
                Article
                vsi-35-225
                10.5758/vsi.2019.35.4.225
                6941774
                31915667
                85987e99-f089-46b3-8b0f-40bf92da8700
                Copyright © 2019, The Korean Society for Vascular Surgery

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 05 September 2019
                : 17 November 2019
                : 21 November 2019
                Categories
                Original Article

                arteriovenous fistula,fistula,vascular access,drug-eluting stents

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