Repositionable vascular occluder: experimental comparison with standard Gianturco coils.
OBJECTIVE
To evaluate the efficacy and recanalization rates of a newly designed vascular occlusion device.


METHODS
The self-expanding vascular occluder was braided from fine nitinol wires and filled with polyester fibers. The device was delivered through a 6-F polyethylene introducing sheath with use of a delivery cable with a microscrew adaptor. Comparison was made between one occlusion plug and two Gianturco coils placed in the corresponding contralateral arterial segment in nine dogs and six pigs. The mean diameter of the targeted vessels was 4.8 mm +/- 0.8. Two animals were killed immediately after occlusion, and the remaining 13 animals underwent follow-up angiography at 1 week and/or 1 month, after which the animals were killed and the vessels were explanted for gross and histopathologic examination.


RESULTS
Significantly shorter time-to-occlusion was achieved with the nitinol plug compared with two Gianturco coils (1.73 minutes +/- 1.28 vs 5.73 minutes +/- 6.18; P = .021). The recanalization rate at 1 month was also significantly lower (36.4% vs 81.8%, P = .027). The occlusion time was strongly dependent on the target artery diameter with Gianturco coils (R = .79, P = .0007), and not with the nitinol plug.


CONCLUSIONS
The nitinol vascular occluder appears highly effective and reliable, with one plug resulting in significantly faster and longer lasting occlusions compared with two Gianturco coils. The new device can be repositioned prior to release, therefore allowing optimal positioning.
Department of Radiology, University of Minnesota Hospital and Clinic, Minneapolis 55455, USA.
M J
MJ
Sharafuddin
X
X
Gu
J J
JJ
Cervera-Ceballos
M
M
Urness
K
K
Amplatz
D000497:Alloys; D000792:Angiography; D000818:Animals; D001158:Arteries / Q000473:pathology; D001366:Axillary Artery / Q000473:pathology; D017536:Carotid Artery, Common / Q000473:pathology; D002933:Cineradiography; D004285:Dogs; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005263:Femoral Artery / Q000473:pathology; D005471:Fluoroscopy; D005500:Follow-Up Studies; D007083:Iliac Artery / Q000473:pathology; D008855:Microscopy, Electron, Scanning; D011091:Polyesters; D012039:Regional Blood Flow; D015203:Reproducibility of Results; D013348:Subclavian Artery / Q000473:pathology; D013499:Surface Properties; D013552:Swine; D013556:Swine, Miniature
D000497:Alloys; D011091:Polyesters; C013616:nitinol