2020
Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures
Resnic F, Majithia A, Dhruva S, Ssemaganda H, Robbins S, Marinac-Dabic D, Hewitt K, Ohno-Machado L, Reynolds M, Matheny M. Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006105. PMID: 32283971, PMCID: PMC7360169, DOI: 10.1161/circoutcomes.119.006105.Peer-Reviewed Original ResearchConceptsICD RegistryLead failureActive surveillanceNational Cardiovascular Data Registry ICD RegistryImplantable Cardioverter-Defibrillator RegistryPrimary safety end pointPropensity-matched survival analysisRate of freedomSafety end pointLead failure rateLong-term safetySignificant patient harmDefibrillator lead failureEarly lead failureMonitoring of safetyComparator patientsContemporary ICDLead survivalMeaningful differencesOutcome ascertainmentFailure rateNew ICDPatient harmPatientsSurvival analysis
2007
Rare adverse event monitoring of medical devices with the use of an automated surveillance tool.
Matheny M, Arora N, Ohno-Machado L, Resnic F. Rare adverse event monitoring of medical devices with the use of an automated surveillance tool. AMIA Annual Symposium Proceedings 2007, 2007: 518-22. PMID: 18693890, PMCID: PMC2655807.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryCardiac CatheterizationConfounding Factors, EpidemiologicElectronic Data ProcessingEquipment FailureEquipment SafetyFemaleFemoral ArteryHemorrhageHemostatic TechniquesHumansMaleProduct Surveillance, PostmarketingProstheses and ImplantsRegistriesRetroperitoneal SpaceStatistics as Topic
2005
Monitoring Device Safety in Interventional Cardiology
Matheny M, Ohno-Machado L, Resnic F. Monitoring Device Safety in Interventional Cardiology. Journal Of The American Medical Informatics Association 2005, 13: 180-187. PMID: 16357356, PMCID: PMC1447549, DOI: 10.1197/jamia.m1908.Peer-Reviewed Original ResearchMeSH KeywordsBayes TheoremCardiologyComputer SystemsDatabases, FactualEquipment FailureEquipment SafetyHospital MortalityHumansLogistic ModelsProduct Surveillance, PostmarketingSoftwareStatistics as TopicStents