David F Kallmes1, Waleed Brinjikji1, Edoardo Boccardi2, Elisa Ciceri3, Orlando Diaz4, Rabih Tawk5, Henry Woo6, Pascal Jabbour7, Felipe Albuquerque8, Rene Chapot9, Alain Bonafe10, Shervin R Dashti11, Josser E Delgado Almandoz12, Curtis Given13, Michael E Kelly14, DeWitte T Cross15, Gary Duckwiler16, Nasser Razack17, Ciaran J Powers18, Sebastian Fischer19, Demetrius Lopes20, Mark R Harrigan21, Daniel Huddle22, Raymond Turner23, Osama O Zaidat24, Luc Defreyne25, Vitor Mendes Pereira26, Saruhan Cekirge27, David Fiorella28, Ricardo A Hanel29, Pedro Lylyk30, Cameron McDougall31, Adnan Siddiqui32, Istvan Szikora33, Elad Levy32. 1. Department of Radiology, Mayo Clinic, Rochester, Minn., USA. 2. Department of Neuroradiology, Niguarda Ca' Granda Hospital of Milan, Milan, Italy. 3. Department of Radiology, Istituto Neurologico Carlo Besta, Milan, Italy. 4. Department of Radiology, Houston Methodist Hospital, Houston, Tex., USA. 5. Department of Neurosurgery, Mayo Clinic, Jacksonville, Fla., USA. 6. Departments of Neurosurgery at Stony Brook University, Stony Brook, N.Y., USA. 7. Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pa., USA. 8. Departments of Neurosurgery, Phoenix, Ariz., USA. 9. Neurointerventional Services, Department of Interventional Neuroradiology, Alfried Krupp Hospital, Essen, Germany. 10. Department of Radiology, CHU Montpellier, Montpellier, France. 11. Department of Neurosurgery, Norton Neuroscience Institute, Norton Healthcare, Louisville, Ky., USA. 12. Department of Radiology, Neuroscience Institute, Abbott Northwestern Hospital, Minneapolis, Minn., USA. 13. Neurointerventional Services, Baptist Health Lexington, Lexington, Ky., USA. 14. Division of Neurosurgery, Royal University Hospital, University of Saskatchewan, Saskatoon, Sask., Canada. 15. Department of Radiology, Washington University School of Medicine, St. Louis, Mo., USA. 16. Department of Neuroradiology, David Geffen School of Medicine at UCLA, Los Angeles, Calif., USA. 17. Neurointerventional Associates, P.A., St. Petersburg, Fla., USA. 18. Department of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA. 19. Department of Radiology, Klinikum Stuttgart, Stuttgart, Germany. 20. Department of Neurological Surgery, Rush University Medical Center, Chicago, Ill., USA. 21. Department of Neurosurgery, University of Alabama, Birmingham, Ala., USA. 22. Swedish Medical Center/RIA Neurovascular, Englewood, Colo., USA. 23. Department of Neurosurgery, Medical University of South Carolina, Charleston, S.C., USA. 24. Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wis., USA. 25. Department of Interventional Radiology, Ghent University Hospital, Gent, Belgium. 26. Division of Neuroradiology, Joint Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, University Health Network and Departments of Medical Imaging and Surgery, University of Toronto, Toronto, Ont., Canada. 27. Department of Radiology, Koru Hospital and Bayindir Hospitals, Ankara, Turkey. 28. Cerebrovascular Center, Stony Brook University Medical Center, Stony Brook, N.Y., USA. 29. Stroke and Cerebrovascular Surgery, Lyerly Neurosurgery/Baptist Neurological Institute, Jacksonville, Fla., USA. 30. Department of Neurosurgery, Clinica La Sagrada Familia, ENERI, Buenos Aires, Argentina. 31. Endovascular Neurosurgery, Barrow Neurological Institute, Phoenix, Ariz., USA. 32. Department of Neurosurgery, University at Buffalo Neurosurgery, Buffalo, N.Y., Phoenix, Ariz., USA. 33. Department of Neurointerventional Services, National Institute of Clinical Neurosciences, Budapest, Hungary.
Abstract
BACKGROUND AND OBJECTIVE: Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. MATERIALS AND METHODS: We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. RESULTS: One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). CONCLUSIONS: Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.
BACKGROUND AND OBJECTIVE: Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. MATERIALS AND METHODS: We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. RESULTS: One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). CONCLUSIONS: Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.
Entities:
Keywords:
Flow diverter; Intracranial aneurysm; Neurological morbidity and mortality
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