Early postmarket experience after US Food and Drug Administration approval with the Trevo device for thrombectomy for acute ischemic stroke
| Autor: | Zakaria Hakma, Cynthia Diaz, Mandy J. Binning, Kenneth M. Liebman, Erol Veznedaroglu, Joseph G. Adel, Christina R. Maxwell, Rosemary Silva |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_treatment Revascularization Brain Ischemia Time-to-Treatment Food and drug administration Modified Rankin Scale medicine Humans Symptom onset Stroke Aged Retrospective Studies Thrombectomy Aged 80 and over Cerebral Revascularization Cerebral infarction business.industry United States Food and Drug Administration Thrombolysis Middle Aged medicine.disease United States Anesthesia Ischemic stroke Surgery Female Stents Neurology (clinical) business |
| Zdroj: | Neurosurgery. 75(5) |
| ISSN: | 1524-4040 |
| Popis: | BACKGROUND TREVO 2 showed the Trevo stent retriever to be more successful for revascularization than Merci for acute stroke intervention in patients treated within 8 hours of symptom onset. These results led to US Food and Drug Administration approval of Trevo. OBJECTIVE To report the first postmarket experience with Trevo since US Food and Drug Administration approval at a single high-volume comprehensive stroke center in the United States. METHODS A retrospective analysis of prospectively collected data was conducted in patients who underwent intervention for ischemic stroke with the Trevo device. Trevo was used alone or in conjunction with other intra-arterial devices. Two groups of patients were identified: those with symptom onset within (group 1) and those with symptom onset beyond (group 2) 8 hours. Recanalization, outcome, symptomatic intracranial hemorrhage, and in-hospital and 90-day mortality were assessed. RESULTS Fifty-two patients were identified, 27 in group 1 and 25 in group 2. Thrombolysis in Cerebral Infarction grade 2 to 3 revascularization was achieved in 93% of group 1 and 84% of group 2 patients. In-hospital mortality and symptomatic intracranial hemorrhage rates were 3.8% and 12% for groups 1 and 2, respectively. Ninety-day mortality was 15% and 24% for groups 1 and 2, respectively. In groups 1 and 2, 48% and 42% of patients, respectively, had good outcomes (modified Rankin Scale score, 0-2), and 50% in both groups of patients achieved Thrombolysis in Cerebral Infarction grade 3 revascularization. Group 2 had longer revascularization times and required adjuvant devices more frequently. CONCLUSION Our postmarket experience shows that in highly selected patients Trevo is safe and effective, even beyond 8 hours, despite longer procedure times and the need for adjuvant devices. |
| Databáze: | OpenAIRE |
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