Journal article
Early Postmarket Experience After US Food and Drug Administration Approval With the Trevo Device for Thrombectomy for Acute Ischemic Stroke
Neurosurgery, v 75(5), pp 584-589
Nov 2014
PMID: 25121793
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Abstract
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.
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Details
- Title
- Early Postmarket Experience After US Food and Drug Administration Approval With the Trevo Device for Thrombectomy for Acute Ischemic Stroke
- Creators
- Mandy J. Binning - Capital HealthJoseph G. Adel - Capital HealthChristina R. Maxwell - Capital HealthKenneth Liebman - Capital HealthZakaria Hakma - Capital HealthCynthia Diaz - Capital HealthRosemary Silva - Capital HealthErol Veznedaroglu - Capital Health
- Publication Details
- Neurosurgery, v 75(5), pp 584-589
- Publisher
- Oxford University Press
- Number of pages
- 6
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Neurology; Neurosurgery
- Web of Science ID
- WOS:000344121100013
- Scopus ID
- 2-s2.0-84925940794
- Other Identifier
- 991021918104104721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Web of Science research areas
- Clinical Neurology
- Surgery