Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial
| Autor: | David Fiorella, Adnan H. Siddiqui, Felipe C. Albuquerque, Aaron L. Berez, Matthew B. Potts, David F. Kallmes, Isil Saatci, István Szikora, Christopher J. Moran, Elad I. Levy, Demetrius K. Lopes, Cameron G. McDougall, Giuseppe Lanzino, Maksim Shapiro, Waleed Brinjikji, Henry H. Woo, Daniel J. Cher, Miklos G. Marosfoi, Zsolt Berentei, Peter Kim Nelson, Tibor Becske, Saruhan Cekirge |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Carotid Artery Diseases Male medicine.medical_specialty medicine.medical_treatment 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Aneurysm Modified Rankin Scale Multicenter trial medicine.artery Occlusion Humans Medicine Prospective Studies cardiovascular diseases Embolization Aged medicine.diagnostic_test business.industry Intracranial Aneurysm Middle Aged medicine.disease Embolization Therapeutic Cerebral Angiography Surgery Stenosis Treatment Outcome Female Stents Neurology (clinical) Radiology Internal carotid artery business Carotid Artery Internal 030217 neurology & neurosurgery Cerebral angiography |
| Zdroj: | Neurosurgery. 80:40-48 |
| ISSN: | 1524-4040 0148-396X |
| DOI: | 10.1093/neuros/nyw014 |
| Popis: | Background Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. Objective To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. Methods In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. Results The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed. Conclusion Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events. |
| Databáze: | OpenAIRE |
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