Alejandro M Spiotta1, Colin P Derdeyn2, Satoshi Tateshima3, Jay Mocco4, R Webster Crowley5, Kenneth C Liu6, Lee Jensen7, Koji Ebersole8, Alan Reeves9, Demetrius K Lopes5, Ricardo A Hanel10, Eric Sauvageau10, Gary Duckwiler3, Adnan Siddiqui11, Elad Levy11, Ajit Puri12, Lee Pride13, Roberta Novakovic13, M Imran Chaudry1, Raymond D Turner1, Aquilla S Turk1. 1. Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina. 2. Department of Radiology, Neurology and Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa. 3. Department of Radiology, UCLA Medical Center, Santa Monica, Cali-fornia. 4. Department of Neurosurgery, Mount Sinai Medical Center, Miami Beach, Florida. 5. Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois. 6. Department of Neurosurgery, University of Virginia School of Medicine, Charlottesville, Virginia. 7. De-partment of Radiology, University of Virginia School of Medicine, Charlottesville, Virginia. 8. Department of Neurosurgery, University of Kansas Medical Center, Kansas City, Kansas. 9. Department of Radiology, University of Kansas Medical Center, Kansas City, Kansas. 10. Department of Neurosurgery, Baptist Health, Jacksonville, Florida. 11. Department of Neurosurgery, University at Buffalo, Buffalo, New York. 12. Department of Radiology, UMass Memorial Medical Cen-ter, Worcester, Massachusetts. 13. Department of Radiology, UT Southwestern Medical Center, Dallas, Texas.
Abstract
BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial-the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS: Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). 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). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.
BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial-the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS:Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). 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). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.
Authors: Tom De Beule; Thierry Boulanger; Sam Heye; Williem J van Rooij; Wim van Zwam; Luc Stockx Journal: Interv Neuroradiol Date: 2021-03-21 Impact factor: 1.764