دورية أكاديمية
Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot.
| العنوان: | Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot. |
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| المؤلفون: | Mao J; Population Health Sciences, Weill Cornell Medical College, New York, New York, USA jim2012@med.cornell.edu., Ansari SA; Radiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Siddiqui AH; Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.; Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA., Sedrakyan A; Population Health Sciences, Weill Cornell Medical College, New York, New York, USA., Marinac-Dabic D; US Food and Drug Administration, Silver Spring, Maryland, USA., Sheldon M; US Food and Drug Administration, Silver Spring, Maryland, USA., Claffey M; Clinical Research, Cerenovus a JnJ MedTech company, Galway, Ireland., Hall AM; Medtronic, Irvine, California, USA., Sancheti H; Medtronic, Irvine, California, USA., Kim T; Medtronic, Irvine, California, USA., Nguyen N; Clinical Research Department, Penumbra Inc, Alameda, California, USA., Liebeskind DS; Department of Neurology, University of California, Los Angeles, California, USA. |
| المصدر: | Journal of neurointerventional surgery [J Neurointerv Surg] 2024 Jun 11. Date of Electronic Publication: 2024 Jun 11. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 101517079 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1759-8486 (Electronic) Linking ISSN: 17598478 NLM ISO Abbreviation: J Neurointerv Surg Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : BMJ Publishing Group, c2009- |
| مستخلص: | 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. Competing Interests: 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. (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.) |
| فهرسة مساهمة: | Keywords: Device; Intervention; Stroke |
| تواريخ الأحداث: | Date Created: 20240611 Latest Revision: 20240611 |
| رمز التحديث: | 20240612 |
| DOI: | 10.1136/jnis-2024-021741 |
| PMID: | 38862209 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1759-8486 |
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| DOI: | 10.1136/jnis-2024-021741 |