Background and purpose Flow diverters are sometimes used in the setting of acutely ruptured aneurysms. However, thromboembolic and hemorrhagic complications are feared and evidence regarding safety is limited. Therefore, in this multicenter study we evaluated complications, clinical, and angiographic outcomes of patients treated with a flow diverter for acutely ruptured aneurysms.
Methods We conducted a retrospective observational study of 44 consecutive patients who underwent flow diverter treatment within 15 days after rupture of an intracranial aneurysm at six centers. The primary end point was good clinical outcome, defined as modified Rankin Scale score (mRS) 0–2. Secondary endpoints were procedure-related complications and complete aneurysm occlusion at follow-up.
Results At follow-up (median 3.4 months) 20 patients (45%) had a good clinical outcome. In 20 patients (45%), 25 procedure-related complications occurred. These resulted in permanent neurologic deficits in 12 patients (27%). In 5 patients (11%) aneurysm re-rupture occurred. Eight patients died resulting in an all-cause mortality rate of 18%. Procedure-related complications were associated with a poor clinical outcome (mRS 3–6; OR 5.1(95% CI 1.0 to 24.9), p=0.04). Large aneurysms were prone to re-rupture with rebleed rates of 60% (3/5) vs 5% (2/39) (p=0.01) for aneurysms with a size ≥20 mm and <20 mm, respectively. Follow-up angiography in 29 patients (median 9.7 months) showed complete aneurysm occlusion in 27 (93%).
Conclusion Flow diverter treatment of ruptured intracranial aneurysms was associated with high rates of procedure-related complications including aneurysm re-ruptures. Complications were associated with poor clinical outcome. In patients with available angiographic follow-up, a high occlusion rate was observed.
- endovascular techniques
- flow diversion
- intracranial aneurysm
- subarachnoid hemorrhage
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CAT and HDB contributed equally.
Contributors MFMtB: Design of the work, data acquisition, data analysis and interpretation, drafting the manuscript. MJ: Design of the work, data acquisition, critically revising the work. JdV: Data acquisition, critically revising the work. JAG: Critically revising the work. RA: Data analysis, critically revising the work. SHM: Data acquisition, critically revising the work. RRau: Data acquisition, critically revising the work. JN: Data acquisition, critically revising the work. RRaj: Data acquisition, critically revising the work. AKW: Data acquisition, critically revising the work. ASP: Data acquisition, critically revising the work. CAT: Design of the work, data acquisition, data analysis and interpretation, critically revising the work, drafting the manuscript. HDB: Design of the work, data acquisition, data analysis and interpretation, critically revising the work, drafting the manuscript. All authors gave final approval of the version to be published.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JdV and HDB: consultancy relationships to Stryker Neurovascular. CT: grants, personal fees and non-financial support from Microvention; personal fees and non-financial support from Stryker Neurovascular; grants, personal fees, and non-financial support from Acandis (all outside the presented work). RRau: consultant for Stryker Neurovascular and Microvention. AKW: consultant for Stryker Neurovascular, research grants from Philips Healthcare and Wyss Institute (all outside the presented work). ASP: consultant for Medtronic Neurovascular and Stryker Neurovascular; research grants from Medtronic Neurovascular and Stryker Neurovascular (all outside the presented work).
Ethics approval The study protocol (code 2017-3511) was reviewed and approved by the local institutional review board of the Radboud University Medical Center.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data are available upon reasonable request from the corresponding author.
Presented at Oral presentation at ESMINT, 6-8 September 2018, Nice, France. Oral presentation at the DGNR (Deutsche Gesellschaft für Neuroradiologie eV), 3-6 October 2018, Frankfurt, Germany.
Patient consent for publication Not required.