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North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results
  1. Osama O Zaidat1,2,3,
  2. Alicia C Castonguay1,
  3. Rishi Gupta4,
  4. Chung-Huan J Sun4,
  5. Coleman Martin5,
  6. William E Holloway5,
  7. Nils Mueller-Kronast6,
  8. Joey D English7,
  9. Italo Linfante8,
  10. Guilherme Dabus8,
  11. Tim W Malisch9,
  12. Franklin A Marden9,
  13. Hormozd Bozorgchami10,
  14. Andrew Xavier11,
  15. Ansaar T Rai12,
  16. Michael T Froehler13,
  17. Aamir Badruddin14,
  18. Thanh N Nguyen15,
  19. M Asif Taqi16,
  20. Michael G Abraham17,
  21. Vallabh Janardhan18,
  22. Hashem Shaltoni19,
  23. Roberta Novakovic20,
  24. Albert J Yoo21,
  25. Alex Abou-Chebl22,
  26. Peng R Chen23,
  27. Gavin W Britz24,
  28. Ritesh Kaushal25,
  29. Ashish Nanda26,
  30. Mohammad A Issa1,
  31. Raul G Nogueira4
  1. 1Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA
  2. 2Department of Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA
  3. 3Department of Radiology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA
  4. 4Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA
  5. 5St Luke's Kansas City, Kansas City, Missouri, USA
  6. 6Department of Neurology, Delray Medical Center, Delray Beach, Florida, USA
  7. 7California Pacific Medical Center, San Francisco, California, USA
  8. 8Division of Interventional Neuroradiology, Baptist Cardiac and Vascular Institute, Miami, Florida, USA
  9. 9Alexian Brothers Medical Center, Elk Grove Village, Illinois, USA
  10. 10Oregon Health and Science University, Portland, Oregon, USA
  11. 11Department of Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA
  12. 12Department of Radiology, West Virginia University Hospital, Morgantown, West Virginia, USA
  13. 13Departments of Neurology, Neurosurgery, and Radiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  14. 14Provena Saint Joseph Medical Center, Joliet, Illinois, USA
  15. 15Departments of Neurology, Neurosurgery, and Radiology, Boston Medical Center, Boston, Massachusetts, USA
  16. 16Desert Regional Medical Center, Palm Springs, California, USA
  17. 17University of Kansas Medical Center, Kansas City, Kansas, USA
  18. 18Texas Stroke Institute, Plano, Texas, USA
  19. 19University of Texas Health Science Center, Houston, Texas, USA
  20. 20Departments of Radiology and Neurology, UT Southwestern Medical Center, Dallas, Texas, USA
  21. 21Department of Radiology, Division of Diagnostic and Interventional Neuroradiology, Massachusetts General Hospital, Boston, Massachusetts, USA
  22. 22Department of Neurology, University of Louisville Medical School, Louisville, Kentucky, USA
  23. 23University of Texas, Houston, Texas, USA
  24. 24Department of Neurosurgery, Methodist Neurological Institute, Houston, Texas, USA
  25. 25St Louis University, St. Louis, Missouri, USA
  26. 26University of Missouri, Columbia, Missouri, USA
  1. Correspondence to Dr O O Zaidat, Departments of Neurology, Radiology, and Neurosurgery, Neurointerventional Division, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI 53226, USA; szaidat{at}mcw.edu

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.

  • Stroke
  • Thrombectomy
  • Device
  • Stent
  • Intervention

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