Article Text
Abstract
Introduction The Flow Re-direction Endoluminal Device (FRED) is a pioneering flow diverter a unique double stent design that recently attained FDA approval. In-stent stenosis (ISS) is a major potential complication following stent implantation. Limited data exists on ISS among FRED patients.
Objective To quantify the rate of ISS in patients treated with FRED devices.
Methods A prospective registry encompassing two North American comprehensive stroke centers formed the basis of this study. We longitudinally assessed patients implanted with FRED devices, emphasizing baseline demographics, aneurysmal characteristics, procedural data, aneurysmal occlusion, and the incidence of ISS.Results: In our cohort, 87 patients underwent FRED placement for 88 aneurysms with a mean age of 56.1 years, predominantly female (19, 78.2%). The majority of aneurysms were unruptured (80, 91.95%) and saccular (77, 89.66%). Internal carotid artery segments were the most frequent locations, with supraclinoid involvement in 36.78% (n=32) of cases. Aneurysms had a mean size of 7.1 mm in the largest dimension and were treated with stents ranging from 11 to 34 mm in length. ISS was noted in 10 patients: 8.0% (7) exhibited mild ISS, 1.15% (1) moderate, and 2.3% (2) severe. At the 6-month follow-up, ISS persisted in 7 patients. Resolution of ISS was observed in 4 patients by the 12-month mark. One patient, initially presenting with moderate ISS on angiography at 6 months, demonstrated mild ISS on subsequent angiography by 12 months. At the 12-month follow-up, 5.7% (3/53) of patients continued to display ISS, as confirmed by angiogram or CTA/MRA. FRED X devices were associated with a 5.8% (2/35) incidence of ISS, while FRED devices exhibited a higher rate of 17.0% (8/47), trending towards significance (p=0.122). Out of the three thrombotic complications, one required stent thrombectomy and balloon angioplasty, while asymptomatic strokes did not require invasive intervention. The Raymond-Roy Scale showed complete occlusion rates of: 52.08% at 3-months, 58.2% at 6-months, and 78.7% at 12-months. Retreatment was necessary in 2.3% (2) of the patients. Median follow-up duration was 11.7 months.96.4% of patients attained an mRS score of 0–2 at last follow up.
Conclusions The study elucidates the efficacy and safety profile of FRED devices, presenting favorable aneurysm occlusion rates and low retreatment needs while underscoring the manageability of ISS.
Disclosures A. Gajjar: None. G. Sioutas: None. N. Field: None. P. Davis: None. A. Custozzo: None. M. Salem: None. B. Jankowitz: None. J. Dalfino: None. A. Boulos: None. J. Burkhardt: 2; C; MicroVention. A. Paul: 2; C; MicroVention. V. Srinivasan: None.