Axium MicroFX coil for the completing endovascular aneurysm surgery study (ACCESS). A prospective evaluation of the safety and durability of Axium MicroFX PGLA coils.
Recanalization of previously coiled aneurysms remains a major drawback of endovascular aneurysm therapy. We performed a prospective single arm trial to provide early initial data regarding the safety and angiographic durability of a new coil technology, the Axium MicroFX Polyglycolic/polylactic acid (PGLA) coil, which was designed to lower recanalization rates. Fifteen patients (16 aneurysms) were prospectively enrolled. Demographic and peri-procedural data were collected. Angiographic images of the initial coil embolization and three to six month follow-up angiographic images underwent blinded evaluation. Seven (47%) SAH and eight (53%) elective patients were enrolled. Blinded evaluation of the initial embolization demonstrated that 5/16 (31%) aneurysms achieved Raymond grade 1, 5/16 (31%) grade 2 and 6/16 (38%) grade 3. Three to six month angiography was obtained in 12/15 patients (80%); two patients expired (1 SAH, 1 elective) and one was lost to follow-up (SAH). All patients who underwent follow-up angiography had a mRS ≤1. Blinded evaluation of embolization demonstrated 7/13 aneurysms (54%) improved in Raymond grading, five (38%) were stable and one aneurysm (8%) worsened. One patient developed an asymptomatic peri-aneurysmal parent vessel stenosis. Axium MicroFX coils appear to be safe, though the small number of patients in this series obviates comparative analysis with other series. Further studies are needed with more patients to compare the angiographic durability of Axium MicroFX coils to other coils.
Department of Neurosurgery, University of Florida, Gainesville, FL 32610-0265, USA. ben_waldau@hotmail.com
B
B
Waldau
K M
KM
Fargen
W J
WJ
Mack
N M
NM
Wilson
A
A
Khaldi
B L
BL
Hoh
J
J
Mocco
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002533:Cerebral Angiography; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome