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Title Non-randomized safety and performance evaluation of the av-Guardian vascular access system |
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Type Oral Presentation |
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Theme 18th Asian Colloquium in Nephrology (18th ACN 2019) |
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Topic Dialysis: Vascular Access |
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Main Author Chieh Suai Tan1 |
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Presenting Author Chieh Suai Tan1 |
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Co-Author Seck Guan Tan2 Julian Chi Leung Wong3 Bernard Wee4 Weng Kin Wong5 Edward Tieng Chek Choke2 Ru Yu Tan1 Peiyun Liu1 Titus Lau5 Lina Hui Ling Choong1 |
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Department / Institution / Country Department of Renal Medicine / Singapore General Hospital / Singapore1 Department of Vascular Surgery / Singapore General Hospital / Singapore2 Division of Vascular Surgery / CTVS National University Hospital Heart Center / Singapore3 Division of Interventional Radiology / National University Hospital / Singapore4 Division of Nephrology / National University Health System / Singapore5 |
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Abstract Content: Introduction, Method, Result, Conclusion Background: The ability to successfully cannulate the arteriovenous fistula (AVF) reliably is a critical step in the delivery of hemodialysis therapy. The av-Guardian vascular access system (avGD; Advent Access, Singapore) is designed to overcome the technical barrier to establishing reliable blunt needle access in patients with mature AVF. avGD is a single-component titanium device with a palpable entry point that is subcutaneously implanted between the skin and the AVF to allow repeated cannulation through a single puncture site. Methods: This was a first-in-man, prospective, non-randomized trial performed to assess the safety and feasibility of avGD in achieving repeatable successful cannulation via a constant site, to facilitate blunt needling in patients with mature AVF. The primary end points of the study included rate of successful hemodialysis sessions via avGD cannulation over 3 months and changes in AVF flow rates after implantation Results: Six patients were enrolled in the study, of which 5 had AVFs that were difficult to cannulate. A pair of avGD were implanted, one each at the arterial and venous cannulation sites, under local anesthesia. Cannulation via the avGD commenced about 21 days post-implantation. Overall, the rate of successful cannulation through the avGD over 3 months in 216 hemodialysis sessions was 98.1% (212/216) at the arterial site and 94.4% (204/216) at the venous site. Significantly, 90% and 85.5% of the cannulations at the A and V site respectively were successful at first attempt. Blood flow rates within the AVF were unaffected by the devices. The patients were transited to blunt needle cannulation after a median of 15.5 and 18.5 sessions at the A and V site respectively. Conclusion: The results of this first-in-man trial demonstrated the safety and feasibility of a subcutaneously implanted, extravascular device in achieving repeatable successful cannulation via a constant site, to facilitate blunt needling in matured AVF. The device did not adversely affect flows within the AVF after implantation and successful cannulation through the devices can be achieved > 94% of the time. Trial registration: This trial was retrospectively registered on the Australian New Zealand Clinical Trial Registry (ACTRN12617000501347) on 6 April 2017 |