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


RESULTS
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.
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.
Osama O
OO
Zaidat
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
Alicia C
AC
Castonguay
Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Rishi
R
Gupta
Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Chung-Huan J
CH
Sun
St Luke's Kansas City, Kansas City, Missouri, USA.
Coleman
C
Martin
St Luke's Kansas City, Kansas City, Missouri, USA.
William E
WE
Holloway
Department of Neurology, Delray Medical Center, Delray Beach, Florida, USA.
Nils
N
Mueller-Kronast
California Pacific Medical Center, San Francisco, California, USA.
Joey D
JD
English
Division of Interventional Neuroradiology, Baptist Cardiac and Vascular Institute, Miami, Florida, USA.
Italo
I
Linfante
Division of Interventional Neuroradiology, Baptist Cardiac and Vascular Institute, Miami, Florida, USA.
Guilherme
G
Dabus
Alexian Brothers Medical Center, Elk Grove Village, Illinois, USA.
Tim W
TW
Malisch
Alexian Brothers Medical Center, Elk Grove Village, Illinois, USA.
Franklin A
FA
Marden
Oregon Health and Science University, Portland, Oregon, USA.
Hormozd
H
Bozorgchami
Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA.
Andrew
A
Xavier
Department of Radiology, West Virginia University Hospital, Morgantown, West Virginia, USA.
Ansaar T
AT
Rai
Departments of Neurology, Neurosurgery, and Radiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Michael T
MT
Froehler
Provena Saint Joseph Medical Center, Joliet, Illinois, USA.
Aamir
A
Badruddin
Departments of Neurology, Neurosurgery, and Radiology, Boston Medical Center, Boston, Massachusetts, USA.
Thanh N
TN
Nguyen
Desert Regional Medical Center, Palm Springs, California, USA.
M Asif
MA
Taqi
University of Kansas Medical Center, Kansas City, Kansas, USA.
Michael G
MG
Abraham
Texas Stroke Institute, Plano, Texas, USA.
Vallabh
V
Janardhan
University of Texas Health Science Center, Houston, Texas, USA.
Hashem
H
Shaltoni
Departments of Radiology and Neurology, UT Southwestern Medical Center, Dallas, Texas, USA.
Roberta
R
Novakovic
Department of Radiology, Division of Diagnostic and Interventional Neuroradiology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Albert J
AJ
Yoo
Department of Neurology, University of Louisville Medical School, Louisville, Kentucky, USA.
Alex
A
Abou-Chebl
University of Texas, Houston, Texas, USA.
Peng R
PR
Chen
Department of Neurosurgery, Methodist Neurological Institute, Houston, Texas, USA.
Gavin W
GW
Britz
St Louis University, St. Louis, Missouri, USA.
Ritesh
R
Kaushal
University of Missouri, Columbia, Missouri, USA.
Ashish
A
Nanda
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
Mohammad A
MA
Issa
Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Raul G
RG
Nogueira
D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000175:diagnosis / Q000401:mortality / Q000601:surgery; D002560:Cerebrovascular Circulation / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D061185:Mechanical Thrombolysis / Q000295:instrumentation / Q000401:mortality / Q000706:statistics & numerical data; D008875:Middle Aged; D009656:North America; D017063:Outcome Assessment, Health Care; D012042:Registries / Q000706:statistics & numerical data*; D015607:Stents / Q000706:statistics & numerical data; D020521:Stroke / Q000175:diagnosis / Q000401:mortality / Q000601:surgery
Device; Intervention; Stent; Stroke; Thrombectomy