RT Journal Article
SR Electronic
T1 North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP 584
OP 588
DO 10.1136/neurintsurg-2013-010895
VO 6
IS 8
A1 Osama O Zaidat
A1 Alicia C Castonguay
A1 Rishi Gupta
A1 Chung-Huan J Sun
A1 Coleman Martin
A1 William E Holloway
A1 Nils Mueller-Kronast
A1 Joey D English
A1 Italo Linfante
A1 Guilherme Dabus
A1 Tim W Malisch
A1 Franklin A Marden
A1 Hormozd Bozorgchami
A1 Andrew Xavier
A1 Ansaar T Rai
A1 Michael T Froehler
A1 Aamir Badruddin
A1 Thanh N Nguyen
A1 M Asif Taqi
A1 Michael G Abraham
A1 Vallabh Janardhan
A1 Hashem Shaltoni
A1 Roberta Novakovic
A1 Albert J Yoo
A1 Alex Abou-Chebl
A1 Peng R Chen
A1 Gavin W Britz
A1 Ritesh Kaushal
A1 Ashish Nanda
A1 Mohammad A Issa
A1 Raul G Nogueira
YR 2014
UL http://jnis.bmj.com/content/6/8/584.abstract
AB 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.