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North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results
- Source :
- Journal of neurointerventional surgery. 6(8)
- Publication Year :
- 2013
-
Abstract
- BackgroundLimited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials.MethodsThe investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage.Results354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2).ConclusionsThe NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.
- Subjects :
- Male
medicine.medical_specialty
Solitaire Cryptographic Algorithm
Mechanical Thrombolysis
medicine.medical_treatment
Revascularization
030218 nuclear medicine & medical imaging
Brain Ischemia
Cohort Studies
03 medical and health sciences
0302 clinical medicine
Modified Rankin Scale
Outcome Assessment, Health Care
medicine
Product Surveillance, Postmarketing
Humans
Registries
Stroke
Retrospective Studies
Thrombectomy
Aged
Aged, 80 and over
business.industry
Cerebral infarction
Stent
General Medicine
Thrombolysis
Middle Aged
medicine.disease
United States
Surgery
Treatment Outcome
Cerebrovascular Circulation
North America
Female
Stents
Neurology (clinical)
business
030217 neurology & neurosurgery
TIMI
Subjects
Details
- ISSN :
- 17598486
- Volume :
- 6
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Journal of neurointerventional surgery
- Accession number :
- edsair.doi.dedup.....856883989944375ea6f5ec6476e14120