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Clinical Trial
. 2010 Sep 2;5(9):e12492.
doi: 10.1371/journal.pone.0012492.

Early experience in the treatment of intra-cranial aneurysms by endovascular flow diversion: a multicentre prospective study

James V Byrne  1 , Radu Beltechi, Julia A Yarnold, Jacqueline Birks, Mudassar Kamran
Affiliations
Clinical Trial

Early experience in the treatment of intra-cranial aneurysms by endovascular flow diversion: a multicentre prospective study

James V Byrne et al. PLoS One. .

Abstract

Introduction: 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.

Material and 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.

Conclusion: 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.

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Conflict of interest statement

Competing Interests: This study was supported by the manufacturer of the SILK flow diverter (Balt Extrusion) through a grant made to the Nuffield Department of Surgery, University of Oxford. They informed the Oxford Neurovascular and Neuroradiology Research Unit (ONNRU) of centres using the Silk Flow Diverter and ONNRU invited the centres to participate, and independently collected and audited data. The sponsor was shown the final manuscript and invited to make comments at the draft stage which the authors were free to accept or reject in drafting the manuscript. The authors declare the following: JV Byrne has acted as an unpaid scientific advisor for Siemens AG, a trainer for Boston Scientific Corporation and is a scientific advisor board member for Codman Corporation. M Kamran is funded by the Rhodes Trust. J Birks is funded by the Oxford Biomedical Research Centre.

Figures

Figure 1
Figure 1. Representative angiograms of aneurysms treated with the SFD.
Fusiform vertebral artery aneurysm (a), giant saccular aneurysm at the vertebro-basilar junction (b), large cavernous carotid artery saccular aneurysm (c) and a recurrent cavernous carotid artery aneurysm (d).
Figure 2
Figure 2. Partially thrombosed aneurysm after treatment with the flow diverter.
CT angiograms showing a residual lumen within a large partially thrombosed fusiform aneurysm of the middle cerebral artery. Follow-up CTA (a) was performed 4 months and (b) 6 months after SFD (arrows) placement. The second follow-up study shows enlargement of the residual aneurysm lumen (arrow heads) and was performed after a new haemorrhage (not shown).
Figure 3
Figure 3. Timings and results of angiographic follow up.
Plot of angiographic outcomes against follow up times in weeks.
See this image and copyright information in PMC

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