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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

doi: 10.1227/NEU.0000000000000523
Research-Human-Clinical Studies

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

Capital Health, Capital Institute for Neurosciences, Trenton and Pennington, New Jersey

Correspondence: Mandy J. Binning, MD, Capital Institute for Neurosciences, 2 Capital Way, Ste 456, Pennington, NJ 08534. E-mail: mandyjobinning@yahoo.com

Received May 12, 2014

Accepted July 27, 2014

Copyright © by the Congress of Neurological Surgeons