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 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.