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E-250 eTICI 2b67–3 is an optimal reperfusion benchmark and is achieved on the first pass in two out of every three cases in the NeVa clear study
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  1. A Yoo1,
  2. S Geyik2,
  3. M Froehler3,
  4. C Maurer4,
  5. T Kass-Hout5,
  6. O Zaidat6,
  7. R Nogueira7,
  8. R Hanel8,
  9. L Pierot9,
  10. L Spelle10,
  11. D Lopes11,
  12. A Hassan12,
  13. Š Audrius13,
  14. E Lin6,
  15. M Ribó14,
  16. J Blasco15,
  17. M Taqi16,
  18. A Badruddin17,
  19. A Siddiqui18,
  20. T Miller19,
  21. S Hussain20,
  22. D Haussen21,
  23. K Woodward22,
  24. C Groden23,
  25. A Consoli24,
  26. I Chaudry25,
  27. C Ramsey26,
  28. A Maud27,
  29. J Bentley28,
  30. W Brinjikji29,
  31. A Bajrami2,
  32. M Sahnoun9,
  33. J Fiehler30,
  34. R Gupta31
  1. 1Texas Stroke, Plano, TX, USA
  2. 2Istanbul Aydin University, İstanbul, Turkey
  3. 3Vanderbilt, Nashville, TN, USA
  4. 4Augsburg, Augsburg, Germany
  5. 5University of Chicago, Chicago, IL, USA
  6. 6Mercy St. Vincent, Toledo, OH, USA
  7. 7UPMC Stroke Institute, Pittsburgh, PA, USA
  8. 8Baptist Health, Jacksonville, FL, USA
  9. 9CHU Reims, Reims, France
  10. 10Hopital Bicêtre, Le Kremlin-Bicêtre, France
  11. 11Advocate Lutheran General Hospital, Park Ridge, IL, USA
  12. 12Valley Baptist Medical Center, Harlingen, TX, USA
  13. 13Republican Vilnius University Hospital, Vilnius, Lithuania
  14. 14Vall d’Hebron University Hospital, PlanoBarcelona, Spain
  15. 15Hospital Clínic de Barcelona, Barcelona, Spain
  16. 16Vascular Neurology of Southern California, Thousand Oaks, CA, USA
  17. 17Community Hospital, Munster, IN, USA
  18. 18Neurosurgery, University at Buffalo, Buffalo, NY, USA
  19. 19University of Maryland Medical Center, Baltimore, MD, USA
  20. 20Cleveland Clinic, Cleveland, OH, USA
  21. 21Grady Memorial Hospital, Atlanta, TX, USA
  22. 22Fort Sanders Regional Medical, Knoxville, TN, USA
  23. 23Universitätsklinik Mannheim, Mannheim, Germany
  24. 24Hospital Foch, Suresnes, France
  25. 25Greenville Memorial Hospital, Greenville, SC, USA
  26. 26Baptist Health Lexington, Lexington, KY, USA
  27. 27Texas Tech University, El Paso, TX, USA
  28. 28Southeast Health, Dothan, AL, USA
  29. 29Mayo Clinic, Rochester, MN, USA
  30. 30University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  31. 31Wellstar Kennestone Hospital, Marietta, GA, USA

Abstract

Introduction/Purpose Rapid reperfusion is associated with the best clinical outcomes following thrombectomy. Multiple first pass effect (FPE) definitions exist based on the extent of reperfusion, with previous work showing that first pass eTICI (expanded Treatment in Cerebral Ischemia) 2c-3 is the optimal discriminator of good outcome. Emerging data suggest an equally beneficial effect of eTICI 2b67 compared to eTICI 2c. Using data from the CLEAR study of the NeVa device, we sought to compare outcomes following eTICI 2b67 reperfusion to determine whether it should be included into the optimal FPE definition.

Materials and Methods A secondary analysis of the prospective, multicenter, FDA-regulated CLEAR trial was conducted on the Intention to Treat (ITT) study population of 139 patients. An independent core lab prospectively adjudicated eTICI including the 2b67 threshold during the trial. Good outcome (90-day mRS 0-2) rates were compared between individual eTICI score levels at procedure end (final eTICI). The association between the number of passes to achieve eTICI 2b67 or greater and the likelihood of a good clinical outcome at 90 days (mRS 0-2) was assessed with logistic regression. Significance was taken at P<0.05.

Results The proportion of final eTICI scores were 2a in 2 patients (1.4%), 2b50 in 11 (7.9%), 2b67 in 20 (14.4%), 2c in 45 (32.4%), and 3 in 61 (43.9%). Good outcomes were seen in none of the final 2a patients, 45.5% (5/11) of 2b50, 60% (12/20) of 2b67, 59.1% (26/44) of 2c, and 72.1% (44/61) of 3 (P=0.02, Cochran-Armitage trend test) (see figure). First pass eTICI 2b67-3 was seen in 64.0% (89/139). Good outcome rate was 73.0% (65/89) with FP 2b67-3 versus 44.9% (22/49) without (P=0.001, Chi-squared). For the 125 subjects that achieved an eTICI score of 2b67-3, the odds of a good outcome decreased by a multiple of 0.545 for each additional pass completed (p-value = 0.005).

Conclusion Core lab-adjudicated data from CLEAR reveal equivalent rates of good outcome between final eTICI 2b67 and final eTICI 2c reperfusion, supporting eTICI 2b67-3 as an optimal benchmark of treatment success. NeVa results in eTICI 2b67-3 in almost two-thirds of patients after a single pass.

Disclosures A. Yoo: 1; C; Medtronic, Cerenovus, Penumbra, Stryker, Genentech. 2; C; Vesalio, Cerenovus, Penumbra, Zoll Circulation, Philips Neurovascular. 4; C; Insera Therapeutics, Nicolab. S. Geyik: 2; C; Stryker, Microvention, Medtronic. M. Froehler: 1; C; Genentech, Vesalio, Siemens. 2; C; Cerenovus, Balt, Jacobs Institute, Kai Medical, Oculus. C. Maurer: None. T. Kass-Hout: None. O. Zaidat: None. R. Nogueira: 1; C; Cereous, Viz-AI, Qu’Appelle Medical, Turvi, Vastrad, Vision. 2; C; Anaconda, Biogen, Cereous, Genentech, Philips, Hibernia, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, Synchrony. 4; C; Astrocyte, Brain mix, Cerebrates, Retrieve, Corinda’s Vascular Robotics, Vesalio, Viz-AI, Rapid Pulse, Perfuse. R. Hanel: 2; C; Vesalio, Rapid Medical, Medtronic, Stryker, Cerenovous, Balt, Phenox, Elum, MIVI. 4; C; ThromX,, Cerebrotech, Endostream, RIST, REIST, Serenity, BendIT. L. Pierot: None. L. Spelle: 1; C; Philips. 2; C; Balt, Medtronic, Microvention, Stryker. D. Lopes: None. A. Hassan: 2; C; Medtronic, Microvention, Cerenovus, Stryker, Penumbra, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care. Š. Audrius: 2; C; Microvention, Vesalio, Stryker. E. Lin: None. M. Ribó: None. J. Blasco: None. M. Taqi: None. A. Badruddin: None. A. Siddiqui: 1; C; NIH - 1R01EB030092-01. 2; C; Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200 LLC, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Inc.. 4; C; Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd., BlinkTBI, Inc., Borvo Medical, Inc., Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, Collavidence. 6; C; Brain Aneurysm Foundation Carol W. Harvey Chair of Research. T. Miller: 2; C; CARPL.ai. S. Hussain: 1; C; Medtronic Neurovascular, Stryker Neurovascular, Rapid Medical. 2; C; Cerenovus. D. Haussen: 2; C; Cerenovus, Stryker Neurovascular, Chiesi USA, Brainomix, Poseydon Medical. 4; C; VizAI and Motif. 6; C; Jacobs Institute/Medtronic, Vesalio, Frontiers in Neurology. K. Woodward: 2; C; Cerenovus, Medtronic, Microvention, Penumbra, Stryker. C. Groden: None. A. Consoli: None. I. Chaudry: 2; C; Celt/Vasorum, Microvention, Medtronic, Imperative Care, Q’Apel. 4; C; Imperative Care, Celt/Vasorum, Synchron, Endostream, Cerebrotech, Q’Apel, RIST, Three Rivers Medical, Neuolutions, Radical Medical, Tulavi, viseon, VMT, Vastrax, Serenity Medical. C. Ramsey: None. A. Maud: None. J. Bentley: None. W. Brinjikji: None. A. Bajrami: None. M. Sahnoun: 2; C; Vesalio. J. Fiehler: None. R. Gupta: 1; C; Vesalio, Rapid Medical, Cerenovous, Medtronic, Stryker, Zoll.

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