North American multicenter experience with the Flow Redirection Endoluminal Device in the treatment of intracranial aneurysms

Author:

Khorasanizadeh MirHojjat1,Shutran Max1,Schirmer Clemens M.2,Salem Mohamed M.3,Ringer Andrew J.4,Grandhi Ramesh5,Mitha Alim P.6,Levitt Michael R.7,Jankowitz Brian T.3,Taussky Philipp5,Thomas Ajith J.8,Moore Justin M.1,Ogilvy Christopher S.1

Affiliation:

1. Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts;

2. Department of Neurosurgery, Geisinger, Danville, Pennsylvania;

3. Department of Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania;

4. Mayfield Clinic, TriHealth Neuroscience Institute, Good Samaritan Hospital, Cincinnati, Ohio;

5. Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah;

6. Department of Clinical Neurosciences, Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada;

7. Department of Neurological Surgery, University of Washington, Seattle, Washington; and

8. Department of Neurological Surgery, Cooper University Health Care, Cooper Medical School of Rowan University, Camden, New Jersey

Abstract

OBJECTIVE Flow diverters have revolutionized the endovascular treatment of intracranial aneurysms. Here, the authors present the first large-scale North American multicenter experience using the Flow Redirection Endoluminal Device (FRED) in the treatment of cerebral aneurysms. METHODS Consecutive cerebral aneurysms treated with FRED at 7 North American centers between June 2020 and November 2021 were included. Data collected included patient demographic characteristics, aneurysm characteristics, periprocedural and long-term complications, modified Rankin Scale (mRS) scores, and radiological follow-up. RESULTS In total, 133 aneurysms in 116 patients were treated with 123 FRED deployment procedures and included in this study. One hundred twenty-six aneurysms (94.7%) were unruptured, 117 (88.0%) saccular, and 123 (92.5%) located in anterior circulation. The mean (range) aneurysm maximal width and neck width sizes were 7.2 (1.5–42.5) mm and 4.1 (1.0–15.1) mm, respectively. Successful FRED deployment was achieved in 122 procedures (99.2%). Adjunctive coiling was used in 4 procedures (3.3%). Radiological follow-up was available for 101 aneurysms at a median duration of 7.0 months. At last follow-up, complete occlusion was observed in 55.4% of patients, residual neck in 8.9%, and filling aneurysm in 35.6%; among cases with radiological follow-up duration > 10 months, these values were 21/43 (48.8%), 3/43 (7.0%), and 19/43 (44.2%), respectively. On multivariate regression analysis, age (OR 0.93, p = 0.001) and aneurysm neck size (OR 0.83, p = 0.048) were negatively correlated with odds of complete occlusion at latest follow-up. The retreatment rate was 6/124 (4.8%). The overall complication rate was 31/116 (26.7%). Parent vessel occlusion, covered branch occlusion, and in-stent stenosis were detected in 9/99 (9.1%), 6/63 (9.5%), and 15/99 (15.2%) cases, respectively. The FRED-related, symptomatic, thromboembolic, and hemorrhagic complication rates were 22.4%, 12.9%, 6.9%, and 0.9% respectively. The morbidity rate was 10/116 patients (8.6%). There was 1 death due to massive periprocedural internal carotid artery stroke, and 3.6% of the patients had an mRS score > 2 at the last follow-up (vs 0.9% at baseline). CONCLUSIONS As the first large-scale North American multicenter FRED experience, this study confirmed the ease of successful FRED deployment but suggested lower efficacy and a higher rate of complications than reported by previous European and South American studies on FRED and other flow-diverting devices. The authors recommend judicious use of this device until future studies can better elucidate the long-term outcomes of FRED treatment.

Publisher

Journal of Neurosurgery Publishing Group (JNSPG)

Subject

Genetics,Animal Science and Zoology

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