Early experience in the treatment of intra-cranial aneurysms by endovascular flow diversion: a multicentre prospective study.
BACKGROUND
Flow diversion is a new approach to the endovascular treatment of intracranial aneurysms which uses a high density mesh stent to induce sac thrombosis. These devices have been designed for the treatment of complex shaped and large size aneurysms. So far published safety and efficacy data on this approach is sparse.


METHODS
Over 8 months, standardized clinical and angiographic data were collected on 70 patients treated with a flow diverter device (SILK flow diverter (SFD)) in 18 centres worldwide. Treatment and early follow up details were audited centrally. SFDs were deployed alone in 57 (81%) or with endosaccular coils in 10 (14%) aneurysms, which included: 44 (63%) saccular, 26 (37%) fusiform shapes and 18 (26%) small, 37 (53%) large, 15 (21%) giant sizes. Treatment outcome data up to 30 days were reported for all patients, with clinical (50 patients) and imaging (49 patients) follow up (median 119 days) data available.


RESULTS
Difficulties in SFD deployment were reported in 15 (21%) and parent artery thrombosis in 8 (11%) procedures. Procedural complications caused stroke in 1 and serious extracranial bleeding in 3 patients; 2 of whom developed fatal pneumonias. Delayed worsening of symptoms occurred in 5 patients (3 transient, 1 permanent neurological deficit, and 1 death) and fatal aneurysm bleeding in 1 patient. Overall permanent morbidity rates were 2 (4%) and mortality 4 (8%). Statistical analysis revealed no significant association between complications and variables related to treated aneurysm morphology or rupture status.


CONCLUSIONS
This series is the largest reporting outcome of the new treatment approach and provides data for future study design. Procedural difficulties in SFD deployment were frequent and anti-thrombosis prophylaxis appears to reduce the resulting clinical sequelae, but at the cost of morbidity due to extracranial bleeding. Delayed morbidity appears to be a consequence of the new approach and warrants care in selecting patients for treatment and future larger studies.
Byrne
James V
JV
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom. james.byrne@nds.ox.ac.uk
Beltechi
Radu
R
Yarnold
Julia A
JA
Birks
Jacqueline
J
Kamran
Mudassar
M
D001921:Brain / Q000098:blood supply* / Q000000981:diagnostic imaging / Q000601:surgery; D002533:Cerebral Angiography; D057510:Endovascular Procedures / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D012039:Regional Blood Flow; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
J Biomech. 2007;40(6):1268-75
16935291
Stroke. 2007 May;38(5):1538-44
17395870
Neurosurgery. 2002 Feb;50(2):239-49; discussion 249-50
11844258
J Neurosurg. 2008 Jun;108(6):1104-18
18518712
J Neurointerv Surg. 2009 Jul;1(1):56-65
21994109
Acta Neurochir (Wien). 2006 Jul;148(7):711-23; discussion 723
16708169
Neurosurgery. 2009 Apr;64(4):632-42; discussion 642-3; quiz N6
19349825
Radiology. 2009 Nov;253(2):470-7
19789235
AJNR Am J Neuroradiol. 2007 Oct;28(9):1755-61
17885238
J Neurosurg. 2002 Dec;97(6):1306-13
12507128
J Neurosurg. 1997 Dec;87(6):944-9
9384409
J Neurosurg. 2004 Jan;100(1):150-4
14743929
AJNR Am J Neuroradiol. 2010 Jun;31(6):1139-47
20150304
Stroke. 2009 Mar;40(3):952-8
19150864