A New Mechanical Device for Declotting of Hemodialysis Access Grafts: First Clinical Experience

Purpose: To review the early clinical experience with a new mechanical thrombectomy device for declotting polytetrafluoroethylene (PTFE) hemodialysis access (HDA) grafts. Methods: The XTD is a 6-F introducer-compatible device that pulverizes clot with a rotating curved tip driven by a flexible spira...

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Veröffentlicht in:Journal of endovascular therapy 2005-04, Vol.12 (2), p.215-223
Hauptverfasser: Yoffe, Boris, Behar, Daniel J., Scheinowitz, Mickey, Rabin, Andrew M.
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container_title Journal of endovascular therapy
container_volume 12
creator Yoffe, Boris
Behar, Daniel J.
Scheinowitz, Mickey
Rabin, Andrew M.
description Purpose: To review the early clinical experience with a new mechanical thrombectomy device for declotting polytetrafluoroethylene (PTFE) hemodialysis access (HDA) grafts. Methods: The XTD is a 6-F introducer-compatible device that pulverizes clot with a rotating curved tip driven by a flexible spiral shaft. Fragments are aspirated into a collection container. Fifty patients (32 women; mean age 66 years) with clotted 6-mm polytetrafluoroethylene HDA grafts were treated at 2 medical centers in a study spanning 22 months. In all, 59 procedures were performed on an outpatient basis under monitored conscious sedation. Ancillary techniques were used as needed to treat the underlying cause of the clot. Technical success was defined on a per-procedure basis as removal of sufficient thrombus to visualize the underlying disease without major device-related complications. Results: Technical success was 100%; no device-related adverse events occurred. Immediate clinical success was achieved in 47/59 (80%) cases. Continued clinical success in survivors was 52% (30/58) at 1 month and 46% (26/56) at 3 months. Eliminating from analysis a high-risk patient subgroup (reocclusions, chronically clotted or unsalvageable grafts, untreatable central venous stenosis, and venous anastomoses resistant to wire/catheter passage) increased the 3-month clinical success to 59% (22/37). Conclusions: The XTD is a promising device capable of safely and effectively declotting PTFE grafts. Further investigation is warranted.
doi_str_mv 10.1583/04-1270R.1
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Methods: The XTD is a 6-F introducer-compatible device that pulverizes clot with a rotating curved tip driven by a flexible spiral shaft. Fragments are aspirated into a collection container. Fifty patients (32 women; mean age 66 years) with clotted 6-mm polytetrafluoroethylene HDA grafts were treated at 2 medical centers in a study spanning 22 months. In all, 59 procedures were performed on an outpatient basis under monitored conscious sedation. Ancillary techniques were used as needed to treat the underlying cause of the clot. Technical success was defined on a per-procedure basis as removal of sufficient thrombus to visualize the underlying disease without major device-related complications. Results: Technical success was 100%; no device-related adverse events occurred. Immediate clinical success was achieved in 47/59 (80%) cases. Continued clinical success in survivors was 52% (30/58) at 1 month and 46% (26/56) at 3 months. Eliminating from analysis a high-risk patient subgroup (reocclusions, chronically clotted or unsalvageable grafts, untreatable central venous stenosis, and venous anastomoses resistant to wire/catheter passage) increased the 3-month clinical success to 59% (22/37). Conclusions: The XTD is a promising device capable of safely and effectively declotting PTFE grafts. 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Eliminating from analysis a high-risk patient subgroup (reocclusions, chronically clotted or unsalvageable grafts, untreatable central venous stenosis, and venous anastomoses resistant to wire/catheter passage) increased the 3-month clinical success to 59% (22/37). Conclusions: The XTD is a promising device capable of safely and effectively declotting PTFE grafts. 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subjects Aged
Angioplasty - instrumentation
Arteriovenous Shunt, Surgical - adverse effects
Catheters, Indwelling - adverse effects
Equipment Design
Female
Follow-Up Studies
Graft Occlusion, Vascular - diagnostic imaging
Graft Occlusion, Vascular - etiology
Graft Occlusion, Vascular - surgery
Humans
Male
Middle Aged
Radiography
Renal Dialysis
Thrombectomy - instrumentation
Treatment Outcome
title A New Mechanical Device for Declotting of Hemodialysis Access Grafts: First Clinical Experience
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