Solitaire FR thrombectomy for acute ischemic stroke: Retrospective multicenter analysis of early postmarket experience after FDA approval

Maxim Mokin, Travis M. Dumont, Erol Veznedaroglu, Mandy J. Binning, Kenneth M. Liebman, Richard D. Fessler, Chiu Yuen To, Raymond D. Turner IV, Aquilla S. Turk, M. Imran Chaudry, Adam S. Arthur, Benjamin D. Fox, Ricardo A. Hanel, Rabih G. Tawk, Peter Kan, John R. Gaughen, Giuseppe Lanzino, Demetrius K. Lopes, Michael Chen, Roham MoftakharJoshua T. Billingsley, Andrew J. Ringer, Kenneth V. Snyder, L. Nelson Hopkins, Adnan H. Siddiqui, Elad I. Levy

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led toFood and Drug Administration (FDA) approval of theSolitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. OBJECTIVE: To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. METHODS: We conducted aretrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. RESULTS: A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ≤2).Severity of NIHSS score on admission was a strong predictor of poor outcome. CONCLUSION: Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States.Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

Original languageEnglish (US)
JournalNeurosurgery
DOIs
StateAccepted/In press - Feb 25 2013
Externally publishedYes

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Thrombectomy
Stroke
National Institutes of Health (U.S.)
Equipment and Supplies
Endovascular Procedures
Intracranial Hemorrhages
Hospital Mortality
Stents
Myocardial Infarction
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Mokin, M., Dumont, T. M., Veznedaroglu, E., Binning, M. J., Liebman, K. M., Fessler, R. D., ... Levy, E. I. (Accepted/In press). Solitaire FR thrombectomy for acute ischemic stroke: Retrospective multicenter analysis of early postmarket experience after FDA approval. Neurosurgery. https://doi.org/10.1227/NEU.0b013e31828e211d

Solitaire FR thrombectomy for acute ischemic stroke : Retrospective multicenter analysis of early postmarket experience after FDA approval. / Mokin, Maxim; Dumont, Travis M.; Veznedaroglu, Erol; Binning, Mandy J.; Liebman, Kenneth M.; Fessler, Richard D.; To, Chiu Yuen; Turner IV, Raymond D.; Turk, Aquilla S.; Chaudry, M. Imran; Arthur, Adam S.; Fox, Benjamin D.; Hanel, Ricardo A.; Tawk, Rabih G.; Kan, Peter; Gaughen, John R.; Lanzino, Giuseppe; Lopes, Demetrius K.; Chen, Michael; Moftakhar, Roham; Billingsley, Joshua T.; Ringer, Andrew J.; Snyder, Kenneth V.; Hopkins, L. Nelson; Siddiqui, Adnan H.; Levy, Elad I.

In: Neurosurgery, 25.02.2013.

Research output: Contribution to journalArticle

Mokin, M, Dumont, TM, Veznedaroglu, E, Binning, MJ, Liebman, KM, Fessler, RD, To, CY, Turner IV, RD, Turk, AS, Chaudry, MI, Arthur, AS, Fox, BD, Hanel, RA, Tawk, RG, Kan, P, Gaughen, JR, Lanzino, G, Lopes, DK, Chen, M, Moftakhar, R, Billingsley, JT, Ringer, AJ, Snyder, KV, Hopkins, LN, Siddiqui, AH & Levy, EI 2013, 'Solitaire FR thrombectomy for acute ischemic stroke: Retrospective multicenter analysis of early postmarket experience after FDA approval', Neurosurgery. https://doi.org/10.1227/NEU.0b013e31828e211d
Mokin, Maxim ; Dumont, Travis M. ; Veznedaroglu, Erol ; Binning, Mandy J. ; Liebman, Kenneth M. ; Fessler, Richard D. ; To, Chiu Yuen ; Turner IV, Raymond D. ; Turk, Aquilla S. ; Chaudry, M. Imran ; Arthur, Adam S. ; Fox, Benjamin D. ; Hanel, Ricardo A. ; Tawk, Rabih G. ; Kan, Peter ; Gaughen, John R. ; Lanzino, Giuseppe ; Lopes, Demetrius K. ; Chen, Michael ; Moftakhar, Roham ; Billingsley, Joshua T. ; Ringer, Andrew J. ; Snyder, Kenneth V. ; Hopkins, L. Nelson ; Siddiqui, Adnan H. ; Levy, Elad I. / Solitaire FR thrombectomy for acute ischemic stroke : Retrospective multicenter analysis of early postmarket experience after FDA approval. In: Neurosurgery. 2013.
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abstract = "BACKGROUND: The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led toFood and Drug Administration (FDA) approval of theSolitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. OBJECTIVE: To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. METHODS: We conducted aretrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. RESULTS: A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39{\%} of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52{\%}. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88{\%}. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15{\%}. In-hospital mortality was 26{\%}. At 30 days, 38{\%} of patients had favorable functional outcome (modified Rankin scale score ≤2).Severity of NIHSS score on admission was a strong predictor of poor outcome. CONCLUSION: Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States.Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.",
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T1 - Solitaire FR thrombectomy for acute ischemic stroke

T2 - Retrospective multicenter analysis of early postmarket experience after FDA approval

AU - Mokin, Maxim

AU - Dumont, Travis M.

AU - Veznedaroglu, Erol

AU - Binning, Mandy J.

AU - Liebman, Kenneth M.

AU - Fessler, Richard D.

AU - To, Chiu Yuen

AU - Turner IV, Raymond D.

AU - Turk, Aquilla S.

AU - Chaudry, M. Imran

AU - Arthur, Adam S.

AU - Fox, Benjamin D.

AU - Hanel, Ricardo A.

AU - Tawk, Rabih G.

AU - Kan, Peter

AU - Gaughen, John R.

AU - Lanzino, Giuseppe

AU - Lopes, Demetrius K.

AU - Chen, Michael

AU - Moftakhar, Roham

AU - Billingsley, Joshua T.

AU - Ringer, Andrew J.

AU - Snyder, Kenneth V.

AU - Hopkins, L. Nelson

AU - Siddiqui, Adnan H.

AU - Levy, Elad I.

PY - 2013/2/25

Y1 - 2013/2/25

N2 - BACKGROUND: The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led toFood and Drug Administration (FDA) approval of theSolitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. OBJECTIVE: To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. METHODS: We conducted aretrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. RESULTS: A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ≤2).Severity of NIHSS score on admission was a strong predictor of poor outcome. CONCLUSION: Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States.Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

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