Initial clinical use of a novel mechanical thrombectomy device, XCOILTM, in hemodialysis graft and fistula declot procedures

Abstract

PURPOSE

We aimed to evaluate the safety and effectiveness of a novel catheter-based mechanical thrombectomy device, XCOILTM, as a first line therapy to restore patency of thrombosed dialysis grafts and fistulae.

METHODS

In 2010, 18 consecutive/sequential patients (11 male, 7 female; median age, 52 years; age range, 32-69 years) with occluded arteriovenous grafts (n=15) or fistulae (n=3) were treated with XCOILTM (NexGen Medical Systems Inc.) without adjunctive thrombolytic drugs. XCOILTM was advanced distal to the thrombus within the outflow vein as well as distal to the arterial inflow platelet thrombin plug, using a 4F angiographic catheter. The percentage of thrombus cleared, primary patency, procedure time, and XCOILTM performance were documented.

RESULTS

Thrombosis occurred 1-30 days prior to the procedure. Thrombosed segments of graft/fistula measured 10-50 cm. Pre- and postprocedure angiography demonstrated that in 15 of 18 cases (83%) XCOILTM removed 80%-100% of the venous outflow thrombus. In 11 of 14 cases (79%), the platelet thrombin plug was also removed. Thrombectomy procedure time averaged 8 min, with one to three passes with the XCOILTM required. No evidence of distal embolization or graft/vessel injury was found on angiography following clot removal. In four cases in whom patency was not restored with XCOILTM, subsequent use of other clot removal devices also failed to restore patency. In one case with severe venous stenosis, the device failed to deploy and the thrombus was not captured. No intraprocedural complications related to XCOILTM use occurred.

CONCLUSION

XCOILTM is an effective and safe first-line therapy option for the treatment of thrombosed hemodialysis grafts/fistulae. Rapid removal of intact thrombus and platelet thrombin plug can be achieved without adjunctive thrombolytics.