Small pipes: preliminary experience with 3-mm or smaller pipeline flow-diverting stents for aneurysm repair prior to regulatory approval.
Flow diversion has become an established treatment option for challenging intracranial aneurysms. The use of small devices of ≤3-mm diameter remains unapproved by major regulatory bodies. A retrospective review of patients treated with Pipeline Embolization Devices of ≤3-mm diameter at 3 Canadian institutions was conducted. Clinical and radiologic follow-up data were collected and reported. Twelve cases were treated with ≥1 Pipeline Embolization Device of ≤3-mm diameter, including 2 with adjunctive coiling, with a median follow-up of 18 months (range, 4-42 months). One patient experienced a posttreatment minor complication (8%) due to an embolic infarct. No posttreatment hemorrhage or delayed complications such as in-stent stenosis/thrombosis were observed. Radiologic occlusion was seen in 9/12 cases (75%) and near-occlusion in 2/12 cases (17%). Intracranial aneurysm treatment with small-diameter flow-diverting stents provided safe and effective aneurysm closure in this small selected sample. These devices should be further studied and considered for regulatory approval.
From the Division of Neurosurgery (A.R.M., J.S.), Department of Surgery allan.martin@utoronto.ca.
A R
AR
Martin
Department of Radiology (J.P.C., T.R.M.), University of Toronto, Toronto, Ontario, Canada.
J P
JP
Cruz
Division of Neurosurgery (C.O.), Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.
C
C
O'Kelly
Division of Neurosurgery (M.K.), Department of Surgery, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
M
M
Kelly
From the Division of Neurosurgery (A.R.M., J.S.), Department of Surgery.
J
J
Spears
Department of Radiology (J.P.C., T.R.M.), University of Toronto, Toronto, Ontario, Canada.
T R
TR
Marotta
D000328:Adult; D002170:Canada; D018795:Device Approval; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D057510:Endovascular Procedures / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012189:Retrospective Studies; D015607:Stents; D016896:Treatment Outcome