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O-019 No clot retrieved: patient characteristics, imaging findings and outcomes from the EXCELLENT registry
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  1. A Siddiqui1,
  2. T Andersson2,
  3. D Haussen3,
  4. A Yoo4,
  5. R Hanel5,
  6. O Zaidat6,
  7. W Hacke7,
  8. T Jovin8,
  9. J Fiehler9,
  10. S De Meyer10,
  11. D Liebeskind11,
  12. V Inoa12,
  13. W Humphries13,
  14. K Woodward14,
  15. P Jabbour15,
  16. O Francois16,
  17. E Levy17,
  18. H Bozorgchami18,
  19. S Boor19,
  20. J Cohen20,
  21. S Dashti21,
  22. M Taqi22,
  23. R Budzik23,
  24. C Schirmer24,
  25. M Hussain25,
  26. L Estrade26,
  27. R De Leacy27,
  28. A Puri28,
  29. R Chitale29,
  30. C Brekenfeld30,
  31. R Nogueira31
  1. 1University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY
  2. 2Karolinska University Hospital and Karolinska Institute, Stockholm, SWEDEN
  3. 3Grady Memorial Hospital, Atlanta, GA
  4. 4Texas Stroke Institute, Dallas-Fort Worth, TX
  5. 5Baptist Neurological Institute, Jacksonville, FL
  6. 6Mercy Health St. Vincent Medical Center, Toledo, OH
  7. 7Ruprecht-Karl University of Heidelberg, Heidelberg, Germany
  8. 8Cooper University Hospital, Camden, NJ
  9. 9University Medical Center Hamburg Eppendorf, Hamburg, Germany
  10. 10KU Leuven, Kortrijk, Belguim
  11. 11University of California Los Angeles, Los Angeles, CA
  12. 12University of Tennessee Health Science Center, Memphis, TN
  13. 13Wellstar Health System, Kennestone Hospital, Marietta, GA
  14. 14Fort Sanders Regional Medical Center, Knoxville, TN
  15. 15Thomas Jefferson University Hospital, Philadelphia, PA
  16. 16AZ Groeninge, Kortrijk, Belguim
  17. 17University at Buffalo, State University of New York, Buffalo, NY
  18. 18Oregon Health and Sciences University, Portland, OR
  19. 19University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
  20. 20Hadassah University Medical Center, Jerusalem, Israel
  21. 21Norton Neuroscience Institute, Louisville, KY
  22. 22Los Robles Hospital and Medical Center, Thousand Oaks, CA
  23. 23Riverside Methodist Hospital, Columbus, OH
  24. 24Geisinger Health System, Danville, PA
  25. 25Cleveland Clinic, Cleveland, OH
  26. 26Lille University Hospital, Lille, France, France
  27. 27Icahn School of Medicine at Mount Sinai, New York, NY
  28. 28University of Massachusetts, Worchester, MA
  29. 29Vanderbilt University Medical Center, Nashville, TN
  30. 30University Medical Center Hamburg, Hamburg, Germany
  31. 31Department of Neurology and Neurosurgery, UPMC Stroke Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA

Abstract

Introduction While successful reperfusion is the goal of mechanical thrombectomy (MT), the main mode by which MT devices facilitate this outcome - the ability to physically retrieve clot - is typically not collected directly in clinical series; and even studies reporting clot composition have a common limitation in that they only include patients where clot material was removed and analyzed and leave out the population with no clot retrieved. In contrast, the EXCELLENT neurothrombectomy registry (NCT03685578) captured whether or not any clot material was removed with each MT pass, in addition to angiographic and clinical outcomes. The dataset offers the opportunity to evaluate real-world cases where MT yielded only ‘empty’ passes and to identify potential pre-procedure indicators of clot that is challenging to retrieve using current technology.

Patients and Methods From 09/2018 to 03/2021, 997 ‘all-comer’ patients (mean age: 70.0±14.2, 51.8% female, 19.7% self-reported non-Caucasian) treated with EMBOTRAP in the first MT pass were enrolled at 34 international sites. ‘Was clot retrieved?’ was captured with every MT pass for every participant. The study utilized a core imaging lab blinded to clinical data, an independent 90-day mRS assessment and a Clinical Events Committee.

Results MT yielded no clot in any pass in 120 cases vs 877 with clot removed in at least 1 MT pass. Notable pre-procedure findings include lower% hyperdense vessel sign (HDVS) on CT/susceptibility artery sign (SAS) or MRI at baseline, per core lab (58.9% vs 74.7%; p<0.001), a trend towards lower baseline NIHSS scores (14.8±7.1 vs 15.7±6.8; p=.065) and longer times from stroke onset to puncture (547.8±569.9 vs 457.8±445.4 minutes; p=.053) in the no clot group. Outcomes for the 2 groups are summarized in the table 1, with reperfusion of 2b-3 of 60.8 vs 63.6% with first pass (p=.558), final 2b-3 of 85.8 vs 95.7% (p<.001) in the no clot vs clot groups. NIHSS improvement at 24 hrs was lower (p<.001) and 90-day mortality was higher (p=.035) in the no clot group.

Conclusion This is the first report of cases where MT maneuvers failed to remove any clot material. Although reperfusion may be achieved without clot removal (e.g. compression, fragmentation, autolysis, accidental loss), this population represents a target for improvement in MT technology and can inform future device design. The results provide insight into the characteristics of this population with suboptimal outcomes and support the notion that no retrieval may be correlated with imaging findings suggesting clot lower in RBC. Both trends in lower NIHSS and longer times to treatment, as well as lack of HDVS/SAS on imaging are known to be associated with intracranial atherosclerotic disease, perhaps pointing to underlying vessel disease as target for technological improvement in some of the cases with no clot retrieved.

Abstract O-019 Table 1

Outcomes

Disclosures A. Siddiqui: 2; C; Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovus, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra LifeSciences Corp, Medtronic, Microvention, Northwest University DSMB, Cerenovus (NAPA and ARISE II), Medtronic (SWIFT PRIME and SWIFT DIRECT), MicroVention (FRED and CONFIDENCE), MUSC POSITIVE, Penumbra (3D Separator, COMPASS, and INVEST). 4; C; Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical Ltd., Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corp, Rist Neurovascular, Serenity Medical Inc., Silk Road Medical, StimMed, Synchron, Three Rivers Medical, Viseon Spine Inc. 6; C; HEAT Trial, Penumbra, Q’Apel Medical Inc., Rapid Medical, Rebound Therapeutics Corp., Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, W.L. Gore and Associates. T. Andersson: 2; C; Neuravi/Cerenovus, Ablynx, Amnis Therapeutics, Medtronic, Rapid Medical, Stryker. 4; C; Rapid Medical, Ceroflo. 6; C; DSMB for EXCELLENT Registry, SPERO Study, Solonda Study. D. Haussen: 2; C; Stryker, Vesalio, Cerenovus, Chiesi USA, Brainomix, Poseydon Medical. 4; C; Viz.ai. 6; C; Jacobs Insitute. A. Yoo: 1; C; Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, Q’Apel, NIH, Interline Endowment, Microvention, Stryker, CNX. 2; C; MiVI, eLum, Three Rivers, Shape Medical, Corindus. 4; C; InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc., Scientia, RisT, BlinkTBI, Corindus. R. Hanel: 1; C; NIH, Interline Endowment, Microvention, Stryker, CNX. 2; C; Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, Q’Apel, MiVI, eLum, Three Rivers, Shape Medical, Corindus. 4; C; InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc., Scientia, RisT, BlinkTBI, Corindus. O. Zaidat: 1; C; Stryker, Genentech, Medtronic Neurovascular. 2; C; NIH, StrokeNet, Penumbra, Medtronic Neurovascular, Codman, Stryker. 4; C; Galaxy Therapeutics, LLC. 6; C; Codman, Stryker, Penumbra, Medtronic Neurovascular. W. Hacke: 1; C; Boehringer Ingelheim. 2; C; Cerenovus, Phenox, Angels. T. Jovin: 2; C; Cerenovus, Stryker Neurovascular. 4; C; Anaconda, Blockade Medical, Route 92, Corindus, FreeOx Biotech, Viz.ai, Silk Road. J. Fiehler: 1; C; German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions und Förderbank, Medtronic, Microvention, Philips, Stryker. 2; C; Acandis, Boehringer Ingelheim, Cerenovus, Covidien, Evasc, Neurovascular, MDClinicals, Medtronic, Medina, Microvention, Penumbra, Route92, Stryker, Transverse Medical. S. De Meyer: None. D. Liebeskind: 2; C; Genentech, Cerenovus, Medtronic, Stryker, Rapid Medical. V. Inoa: None. W. Humphries: None. K. Woodward: 2; C; Penumbra. P. Jabbour: 2; C; Medtronic, Cerenovus, Microvention. O. Francois: None. E. Levy: 1; C; CONFIDENCE Study (MicroVention), STRATIS Study—Sub I (Medtronic). 2; C; Medtronic SWIFT Prime and SWIFT Direct Trials, Claret Medical, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, Rebound, StimMed, Stryker, NeXtGen Biologics, MEDX, Cognition Medical, Endostream Medical. 4; C; NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical. 6; C; Medtronic. H. Bozorgchami: 2; C; Neuravi/Cerenovus, Stryker. S. Boor: None. J. Cohen: None. S. Dashti: 2; C; Cerenovus. M. Taqi: 2; C; Stryker, Rapid Medical, Balt USA, Medtronic. R. Budzik: 2; C; Stryker Neurovascular, Medtronic, Cerenovus. C. Schirmer: 1; C; Penumbra. 4; C; Neurotechnology Investors. M. Hussain: 2; C; Cerenovus. L. Estrade: None. R. De Leacy: 2; C; Imperative Care, Cerenovus, Siemens Healthineers, Stryker Neurovascular, Cerenovus, Penumbra. 4; C; Synchron, Endostream, Q’Apel Medical, Spartan Micro, Vastrax. A. Puri: 1; C; Medtronic Neurovascular, Stryker Neurovascular, Cerenovus, NIH. 2; C; Medtronic Neurovascular, Stryker Neurovascular, Cerenovus, Microvention, Agile Medical, Merit Medical, Perfuze Medical, Corindus, Q’Apel, Arsenal, Imperative Care. 4; C; InNeuroCo Inc., Galaxy Therapeutics, Agile Medical, Perfuze Medical, NTI. R. Chitale: 1; C; NIH, Leducq Foundation, 4C Medical, 4Tech, Abbott Vascular, Ablative Solutions, Absorption Systems, Advanced NanoTherapies, Aerwave Medical Inc., Alivas, Amgen Inc., Asahi Medical, Aurios Medical, Avantec Vascular, BD Bioscences, Biosensors, Biotronik, Biotyx Medical, Bolt Medical Inc., Boston Scientific, Canon Inc., Cardiac Implants LLC, Cardiawave, CardioMech, Cardionomic, CeloNova BioSciences Inc., Cerus Endovascular Inc., Chansu Vascular Technologies LLC, Children’s National Medical Center, Concept Medical, Cook Medical, Cooper Health, Cormaze Technologies GmbH, CRL/AccelLab, CroíValve, CSI, DexCom Inc., Edwards Lifesciences, Elucid Bioimaging, eLum Technologies Inc., Emboline Inc., Endotronix, Envision, Filterlex, Imperative Care Inc., Innovative Cardiovascular Solutions LLC, Intact Vascular Inc., Interface Biologics, InterShunt Technologies Inc., Invatin Technologies, Lahav CRO, LimFlow, L & J Biosciences, Lutonix, Lyra Therapeutics Inc., Mayo Clinic, Maywell, MD Start, MedAlliance, Medanex Clinic, Medtronic plc, Mercator Limited, MicroPort, MicroVention, Neovasc Inc., Nephronyx Ltd., Nova Vascular, Nyra Medical, Occultech, Olympus Therapeutics, OhioHealth, OrbusNeich, Ossio, Phenox Inc., Pi-Cardia, Polares Medical, PolyVascular, Profusa Inc., ProKidney LLC, Protembis, Pulse Biosciences Inc., Qool Therapeutics, Recombinetics, ReCor Medical Inc., Regencor Inc., Renata Medical, Restore Medical Ltd., Ripple Therapeutics, Rush University, Sanofi SA, Shockwave Medical, Sahajanand Medical Technologies Limited, SoundPipe, Spartan Micro, SpectraWAVE Inc., Surmodics Inc., Terumo Corporation, Jacobs Institute, Transmural Systems LLC, Transverse Medical Inc., TruLeaf Medical, University of California, San Francisco, University of Pennsylvania Medical Center, Vascudyne Inc., Vesper, Vetex Medical, WhiteSwell, WL Gore and Associates Inc., Xeltis. 6; C; Abbott Vascular, Boston Scientific, CeloNova BioSciences Inc., OrbusNeich, Terumo Corporation, W. L. Gore and Associates Inc., Edwards Lifesciences, Cook Medical, CSI, ReCor Medical, Sino Medical Sciences Technology Inc., Surmodics Inc., Bard BD, Medtronic plc, Xeltis. C. Brekenfeld: None. R. Nogueira: 2; C; Stryker Neurovascular, Cerenovus, Medtronic, Phenox, RapidPulse, Anaconda, Perfuze, Genentech, Biogen, Prolong Pharmaceuticals, Imperative Care, Brainomix, Viz-AI, Corindus Vascular Robotics, Vesalio, Ceretrieve, Astrocyte, Cerebrotech. 4; C; Brainomix, Viz-AI, Corindus Vascular Robotics, Vesalio, Ceretrieve, Astrocyte, Cerebrotech.

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