A M Spiotta1, M I Chaudry2, R D Turner2, A S Turk2, C P Derdeyn3, J Mocco4, S Tateshima5. 1. From the Department of Neurosurgery (A.M.S., M.I.C., R.D.T., A.S.T.), Medical University of South Carolina, Charleston, South Carolina spiotta@musc.edu. 2. From the Department of Neurosurgery (A.M.S., M.I.C., R.D.T., A.S.T.), Medical University of South Carolina, Charleston, South Carolina. 3. Department of Radiology (C.P.D.), University of Iowa, Iowa City, Iowa. 4. Department of Neurosurgery (J.M.), Mount Sinai Hospital, New York, New York. 5. Department of Radiology (S.T.), University of California, Los Angeles, Los Angeles, California.
Abstract
BACKGROUND AND PURPOSE: The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data. MATERIALS AND METHODS: Aneurysms treated with the PulseRider among enrolled sites were prospectively studied. Updated 12-month data on clinical and imaging end points are included. RESULTS: Thirty-four patients were enrolled (29 women, 5 men) with a mean age of 60.9 years. The mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range, 2.3-11.6 mm). At 1 year, there were no device migrations or symptomatic in-stent stenoses. Raymond-Roy I occlusion was achieved in 53% of cases at the time of treatment and progressed to 61% and 67% at 6 and 12 months, respectively. Adequate occlusion (Raymond-Roy I/II) progressed from 88% at 6 months to 90% at 12 months. No recanalizations were observed. There was 1 delayed ischemic event. Good outcome (mRS 0-2) was achieved in 90% of patients. CONCLUSIONS: The updated 1-year results from the ANSWER trial demonstrate aneurysm stability and an acceptable safety profile for aneurysms treated at the basilar apex and carotid terminus. Prospective data from a larger set of aneurysms treated at other locations are required to assess how treatment with PulseRider compares with alternatives for treating wide-neck bifurcation aneurysms.
BACKGROUND AND PURPOSE: The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data. MATERIALS AND METHODS:Aneurysms treated with the PulseRider among enrolled sites were prospectively studied. Updated 12-month data on clinical and imaging end points are included. RESULTS: Thirty-four patients were enrolled (29 women, 5 men) with a mean age of 60.9 years. The mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range, 2.3-11.6 mm). At 1 year, there were no device migrations or symptomatic in-stent stenoses. Raymond-Roy I occlusion was achieved in 53% of cases at the time of treatment and progressed to 61% and 67% at 6 and 12 months, respectively. Adequate occlusion (Raymond-Roy I/II) progressed from 88% at 6 months to 90% at 12 months. No recanalizations were observed. There was 1 delayed ischemic event. Good outcome (mRS 0-2) was achieved in 90% of patients. CONCLUSIONS: The updated 1-year results from the ANSWER trial demonstrate aneurysm stability and an acceptable safety profile for aneurysms treated at the basilar apex and carotid terminus. Prospective data from a larger set of aneurysms treated at other locations are required to assess how treatment with PulseRider compares with alternatives for treating wide-neck bifurcation aneurysms.
Authors: Marta Aguilar Pérez; Hans Henkes; Wiebke Kurre; Carlos Bleise; Pedro Nicolás Lylyk; Javier Lundquist; Francis Turjman; Hanan Alhazmi; Christian Loehr; Stephan Felber; Hannes Deutschmann; Stephan Lowens; Luigi Delehaye; Markus Möhlenbruch; Jörg Hattingen; Pedro Lylyk Journal: J Clin Med Date: 2022-02-08 Impact factor: 4.241
Authors: Mehdi Abbasi; Luis E Savasatano; Waleed Brinjikji; Kevin M Kallmes; Nick Mikoff; Natalie Reierson; Mohamed Abdelmegeed; John Pederson; Beth Warren; Jillienne C Touchette; Sarah Khan; Shelby Kamrowski; Averi Barrett; David F Kallmes; Ramanathan Kadirvel Journal: Interv Neuroradiol Date: 2021-06-22 Impact factor: 1.764