Skip Navigation LinksHome > November 2014 - Volume 75 - Issue 5 > Early Postmarket Experience After US Food and Drug Administr...
doi: 10.1227/NEU.0000000000000523
Research-Human-Clinical Studies

Early Postmarket Experience After US Food and Drug Administration Approval With the Trevo Device for Thrombectomy for Acute Ischemic Stroke

Binning, Mandy J. MD; Adel, Joseph G. MD; Maxwell, Christina R. PhD; Liebman, Kenneth MD; Hakma, Zakaria MD; Diaz, Cynthia RN, MHA; Silva, Rosemary RN; Veznedaroglu, Erol MD

Collapse Box


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.

ABBREVIATIONS: FDA, US Food and Drug Administration

MCA, middle cerebral artery

mRS, modified Rankin Scale

NIHSS, National Institutes of Health Stroke Scale

sICH, symptomatic intracranial hemorrhage

TICI, Thrombolysis in Cerebral Infarction

tPA, tissue-type plasminogen activator

Copyright © by the Congress of Neurological Surgeons


Article Tools


Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.