2025
Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry
Faridi K, Freeman J, Wang Y, Pereira L, Zimmerman S, Friedman D, Sharma R, Higgins A, Mortazavi B, Ross J, Krumholz H, Yeh R, Curtis J. Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry. JACC Advances 2025, 4: 102019. PMID: 40712270, PMCID: PMC12311505, DOI: 10.1016/j.jacadv.2025.102019.Peer-Reviewed Original ResearchInternational ClassificationPositive predictive valueClaims dataRegistry dataIncidence rateNational Cardiovascular Data Registry LAAO RegistryGastrointestinal bleedingIntracranial hemorrhageHemorrhagic strokeBleeding eventsIschemic strokePostmarketing surveillanceTranscatheter left atrial appendage occlusionInpatient hospitalizationSurveillance of therapyRevision codesMajor bleeding eventsNegative predictive valueKappa statisticRegistryRegistry patientsModerate agreementEstimates of sensitivityMajor bleedingAppendage occlusion
2024
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketing
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