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J Neurointerv Surg. 2014 Oct;6(8):584-8. doi: 10.1136/neurintsurg-2013-010895. Epub 2013 Sep 23.

North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results.

Author information

1
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA Department of Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA Department of Radiology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
2
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
3
Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
4
St Luke's Kansas City, Kansas City, Missouri, USA.
5
Department of Neurology, Delray Medical Center, Delray Beach, Florida, USA.
6
California Pacific Medical Center, San Francisco, California, USA.
7
Division of Interventional Neuroradiology, Baptist Cardiac and Vascular Institute, Miami, Florida, USA.
8
Alexian Brothers Medical Center, Elk Grove Village, Illinois, USA.
9
Oregon Health and Science University, Portland, Oregon, USA.
10
Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA.
11
Department of Radiology, West Virginia University Hospital, Morgantown, West Virginia, USA.
12
Departments of Neurology, Neurosurgery, and Radiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
13
Provena Saint Joseph Medical Center, Joliet, Illinois, USA.
14
Departments of Neurology, Neurosurgery, and Radiology, Boston Medical Center, Boston, Massachusetts, USA.
15
Desert Regional Medical Center, Palm Springs, California, USA.
16
University of Kansas Medical Center, Kansas City, Kansas, USA.
17
Texas Stroke Institute, Plano, Texas, USA.
18
University of Texas Health Science Center, Houston, Texas, USA.
19
Departments of Radiology and Neurology, UT Southwestern Medical Center, Dallas, Texas, USA.
20
Department of Radiology, Division of Diagnostic and Interventional Neuroradiology, Massachusetts General Hospital, Boston, Massachusetts, USA.
21
Department of Neurology, University of Louisville Medical School, Louisville, Kentucky, USA.
22
University of Texas, Houston, Texas, USA.
23
Department of Neurosurgery, Methodist Neurological Institute, Houston, Texas, USA.
24
St Louis University, St. Louis, Missouri, USA.
25
University of Missouri, Columbia, Missouri, USA.

Abstract

BACKGROUND:

Limited 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.

METHODS:

The 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.

RESULTS:

354 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).

CONCLUSIONS:

The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

KEYWORDS:

Device; Intervention; Stent; Stroke; Thrombectomy

PMID:
24062252
DOI:
10.1136/neurintsurg-2013-010895
[Indexed for MEDLINE]
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