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

Wayne L. Monsky, Richard E Latchaw

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

PURPOSE We aimed to evaluate the safety and effectiveness of a novel catheter-based mechanical thrombectomy device, XCOIL™, 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 XCOIL™ (NexGen Medical Systems Inc.) without adjunctive thrombolytic drugs. XCOIL™ 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 XCOIL™ 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%) XCOIL™ 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 XCOIL™ 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 XCOIL™, 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 XCOIL™ use occurred. CONCLUSION XCOIL™ 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.

Original languageEnglish (US)
Pages (from-to)257-262
Number of pages6
JournalDiagnostic and Interventional Radiology
Volume22
Issue number3
DOIs
StatePublished - May 1 2016

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Thrombectomy
Fistula
Renal Dialysis
Thrombosis
Transplants
Equipment and Supplies
Thrombin
Blood Platelets
Angiography
Catheters
Device Removal
Fibrinolytic Agents
Dialysis
Veins
Pathologic Constriction
Therapeutics
Safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

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title = "Initial clinical use of a novel mechanical thrombectomy device, XCOIL™, 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, XCOIL™, 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 XCOIL™ (NexGen Medical Systems Inc.) without adjunctive thrombolytic drugs. XCOIL™ 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 XCOIL™ 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{\%}) XCOIL™ 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 XCOIL™ 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 XCOIL™, 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 XCOIL™ use occurred. CONCLUSION XCOIL™ 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.",
author = "Monsky, {Wayne L.} and Latchaw, {Richard E}",
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T1 - Initial clinical use of a novel mechanical thrombectomy device, XCOIL™, in hemodialysis graft and fistula declot procedures

AU - Monsky, Wayne L.

AU - Latchaw, Richard E

PY - 2016/5/1

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N2 - PURPOSE We aimed to evaluate the safety and effectiveness of a novel catheter-based mechanical thrombectomy device, XCOIL™, 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 XCOIL™ (NexGen Medical Systems Inc.) without adjunctive thrombolytic drugs. XCOIL™ 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 XCOIL™ 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%) XCOIL™ 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 XCOIL™ 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 XCOIL™, 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 XCOIL™ use occurred. CONCLUSION XCOIL™ 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.

AB - PURPOSE We aimed to evaluate the safety and effectiveness of a novel catheter-based mechanical thrombectomy device, XCOIL™, 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 XCOIL™ (NexGen Medical Systems Inc.) without adjunctive thrombolytic drugs. XCOIL™ 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 XCOIL™ 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%) XCOIL™ 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 XCOIL™ 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 XCOIL™, 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 XCOIL™ use occurred. CONCLUSION XCOIL™ 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.

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