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: email@example.com
Received May 12, 2014
Accepted July 27, 2014