FRED Italian Registry: a multicenter experience with the flow re-direction endoluminal device for intracranial aneurysms

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OBJECTIVE

The introduction of flow-diverter devices (FDDs) has revolutionized the endovascular treatment of intracranial aneurysms. Here the authors present their Italian multicenter experience using the flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms, evaluating both short- and long-term safety and efficacy of this device.

METHODS

Between February 2013 and December 2014, 169 consecutive aneurysms treated using FRED in 166 patients were entered into this study across 30 Italian centers. Data collected included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and posttreatment modified Rankin Scale scores, as well as angiographic and cross-sectional CT/MRI follow-up at 3–6 months and/or 12–24 months per institutional standard of care. All images were reviewed and adjudicated by an independent core lab.

RESULTS

Of the 169 lesions initially entered into the study, 4 were later determined to be extracranial or nonaneurysmal by the core lab and were excluded, leaving 165 aneurysms in 162 patients treated in 163 procedures. Ninety-one (56.2%) patients were asymptomatic with aneurysms found incidentally. Of the 165 aneurysms, 150 (90.9%) were unruptured. One hundred thirty-four (81.2%) were saccular, 27 (16.4%) were fusiform/dissecting, and the remaining 4 (2.4%) were blister-like. One hundred thirty-seven (83.0%) arose from the anterior circulation.

FRED deployment was impossible in 2/163 (1.2%) cases, and in an additional 4 cases (2.5%) the device was misdeployed. Overall mortality and morbidity rates were 4.3% and 7.3%, respectively, with rates of mortality and morbidity potentially related to FRED of up to 2.4% and 6.2%, respectively. Neuroimaging follow-up at 3–6 months showed complete or nearly complete occlusion of the aneurysm in 94% of cases, increasing to 96% at 12–24 months’ follow-up. Aneurysmal sac shrinkage was observed in 78% of assessable aneurysms.

CONCLUSIONS

This preliminary experience using FRED for endovascular treatment of complex unruptured and ruptured aneurysms showed a high safety and efficacy profile that is comparable to those of other FDDs currently in use.

ABBREVIATIONS AChA = anterior choroidal artery; AE = adverse event; AsE = asymptomatic event; BA = basilar artery; DSA = digital subtraction angiography; FDD = flow diverter device; FRED = flow re-direction endoluminal device; GDC = Guglielmi detachable coil; ICA = internal carotid artery; ICH = intracerebral hemorrhage; MCA = middle cerebral artery; mRS = modified Rankin Scale; OKM = O’Kelly-Marotta; PCoA = posterior communicating artery; PICA = posterior inferior cerebellar artery; RROC = Raymond-Roy occlusion classification; SAE = serious AE; SAH = subarachnoid hemorrhage; TIA = transient ischemic attack; VA = vertebral artery.

Article Information

Correspondence Mariangela Piano: Niguarda Hospital, Milan, Italy. mariangela.piano@gmail.com.

INCLUDE WHEN CITING Published online May 10, 2019; DOI: 10.3171/2019.1.JNS183005.

Disclosures Dr. Valvassori and Dr. Boccardi both report having served as consultants to Medtronic, Stryker, Microvention, Phenox, Balt Extrusion, and Acandis.

© AANS, except where prohibited by US copyright law.

Headings

Figures

  • View in gallery

    Images from a case involving a 59-year-old woman who presented with cranial nerve palsy and pituitary dysfunction. A and B: Digital subtraction angiogram (A) and axial T2-weighted MR image (B) showing a giant right cavernous aneurysm, which was treated via implantation of two FREDs. C and D: Unsubtracted (C) and subtracted (D) angiograms showing the telescopic deployment of the 2 devices with stagnation of flow inside the aneurysmal sac. E: Angiogram obtained at 6 months’ follow-up showing exclusion of the aneurysm (OKM grade D). F: Axial T2-weighted MR image obtained at 24 months’ follow-up demonstrating aneurysmal sac shrinkage.

  • View in gallery

    Images from a case involving a 59-year-old woman who presented with headache. A: Digital subtraction angiogram disclosing a giant dissecting, partially thrombosed, aneurysm of the left VA. B: Sagittal T2-weighted MR image showing compression and displacement of the medulla. The patient was treated via implantation of 2 FREDs from the middle third of the BA to the proximal cisternal segment of the VA. C: Six-month follow-up angiogram demonstrating exclusion of the aneurysm (OKM grade D). D: Sagittal T2-weighted MR image obtained 24 months after treatment showing shrinkage of the aneurysmal sac and complete resolution of brainstem compression.

  • View in gallery

    Images from a case involving a symptomatic 70-year-old man with a giant fusiform dissecting aneurysm of the BA. A: Preoperative DS angiogram. B and C: Unsubtracted angiograms obtained during endovascular treatment. D: DS angiogram obtained at the end of the procedure. The aneurysm was treated via implantation of a FRED (B) and platinum coils, released in the aneurysmal sac and in the right VA (C and D). Thirty-five days later the patient died after experiencing a huge SAH followed by intrastent thrombosis.

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