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Ischemic stroke
Original research
Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot
  1. Jialin Mao1,
  2. Sameer A Ansari2,
  3. Adnan H Siddiqui3,4,
  4. Art Sedrakyan1,
  5. Danica Marinac-Dabic5,
  6. Murray Sheldon5,
  7. Mairsíl Claffey6,
  8. Alicia M Hall7,
  9. Harsh Sancheti7,
  10. Thomas Kim7,
  11. Nam Nguyen8,
  12. David S Liebeskind9
    1. 1Population Health Sciences, Weill Cornell Medical College, New York, New York, USA
    2. 2Radiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
    3. 3Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA
    4. 4Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA
    5. 5US Food and Drug Administration, Silver Spring, Maryland, USA
    6. 6Clinical Research, Cerenovus a JnJ MedTech company, Galway, Ireland
    7. 7Medtronic, Irvine, California, USA
    8. 8Clinical Research Department, Penumbra Inc, Alameda, California, USA
    9. 9Department of Neurology, University of California, Los Angeles, California, USA
    1. Correspondence to Dr Jialin Mao, Population Health Sciences, Weill Cornell Medical College, New York, NY 10021, USA; jim2012{at}med.cornell.edu

    Abstract

    Background Real-world data can be helpful in evaluating endovascular therapy (EVT) in ischemic stroke care. We conducted a pilot study to aggregate data on basilar artery occlusion (BAO) EVT from existing registries in the USA. We evaluated the availability, completeness, quality, and consistency of common data elements (CDEs) across data sources.

    Methods We harmonized patient-level data from five registry data sources and assessed the availability, completeness (defined by the presence in at least four data sources), and consistency of CDEs. We assessed data quality based on seven pre-defined critical domains for BAO EVT investigation: baseline patient and disease characteristics; time metrics; description of intervention; adjunctive devices, revascularization scores, complications; post-intervention National Institutes of Health Stroke Scale scores; discharge disposition; 30-day and 90-day mortality and modified Rankin Scale (mRS) scores.

    Results The aggregated dataset of five registries included 493 BAO procedures between January 2013 and January 2020. In total, 88 CDEs were screened and 35 (40%) elements were considered prevalent. Of these 35 CDEs, the majority were collected for >80% of cases when aggregated. All seven pre-defined domains for BAO device investigation could be fulfilled with harmonized data elements. Most data elements were collected with consistent or compatible definitions across registries. The main challenge was the collection of 90-day outcomes.

    Conclusions This pilot shows the feasibility of aggregating and harmonizing critical CDEs across registries to create a Coordinated Registry Network (CRN). The CRN with partnerships between multiple registries and stakeholders could help improve the breadth and/or depth of real-world data to help answer relevant questions and support clinical and regulatory decisions.

    • Stroke
    • Device
    • Intervention

    Data availability statement

    No data are available. All data used in this study are subject to data use agreements and cannot be shared publicly.

    https://doi.org/10.1136/jnis-2024-021741

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      Data availability statement

      No data are available. All data used in this study are subject to data use agreements and cannot be shared publicly.

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      Footnotes

      • X @JialinMao

      • Contributors JM, SAA, AHS, AS, and DSL conceptualized and designed the study and all authors provided input for the study protocol. SAA, MC, AMH, HS, TK, and NN contributed to data curation and JM performed data harmonization and statistical analysis. JM wrote the first draft of the manuscript and all authors revised the manuscript critically for important intellectual content. All authors gave approval for the final version to be published and DSL is the guarantor.

      • Funding This study is supported by the Office of the Assistant Secretary for Planning and Evaluation Patient-Centered Outcomes Research Trust Fund under Interagency Agreement (#750119PE060048) through the US Food and Drug Administration (FDA) (grant number U01FD006936, PI: AS). JM receives a Career Development Award from the National Heart, Lung, and Blood Institute (K01HL159315) to support her effort.

      • Competing interests DSL was consultant for Imaging Core Lab to Cerenovus, Genentech, Medtronic, Rapid Medical, Stryker. SAA was consultant/DSMB Member to Imperative Care, Microvention, Medtronic, Rapid Medical. AHS received funding from NIH and was consultant for Amnis Therapeutics, Asahi Intecc, Boston Scientific, Canon Medical Systems USA, Cardinal Health 200, Cerebrotech Medical Systems, CerebrovaKP, Cerenovus, Contego Medical, Cordis, Corindus, Endostream Medical, Hyperfine Operations, Imperative Care, InspireMD, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Peijia Medical, Penumbra, Piraeus Medical, Q’Apel Medical, Rapid Medical, Serenity Medical, Shockwave Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Synchron Australia Pty Ltd, VasSol, Vesalio, Viz.ai, WL Gore. AHS also had financial interest related to Adona Medical, Basecamp Vascular SAS, Bend IT Technologies, BlinkTBI, Borvo Medical, Cerebrotech Medical Systems, CerebrovaKP, Code Zero Medical, Cognition Medical, Collavidence, Contego Medical, CVAID, E8, Endostream Medical, Galaxy Therapeutics, Hyperion Surgical, Imperative Care, InspireMD, Instylla, Launch NY, Neurolutions, NeuroRadial Technologies (sold to Medtronic in 2021), Neurovascular Diagnostics, Peijia Medical, PerFlow Medical, Piraeus Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences Corp), Rist Neurovascular (purchased 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Sim & Cure, Spinnaker Medical, StimMed, Synchron, Tulavi Therapeutics, Vastrax, Viseon, Whisper Medical, Willow Medtech.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.