2018
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICD
2009
Association of Physician Certification and Outcomes Among Patients Receiving an Implantable Cardioverter-Defibrillator
Curtis JP, Luebbert JJ, Wang Y, Rathore SS, Chen J, Heidenreich PA, Hammill SC, Lampert RI, Krumholz HM. Association of Physician Certification and Outcomes Among Patients Receiving an Implantable Cardioverter-Defibrillator. JAMA 2009, 301: 1661-1670. PMID: 19383957, PMCID: PMC2805129, DOI: 10.1001/jama.2009.547.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCardiac ElectrophysiologyCertificationClinical CompetenceDefibrillators, ImplantableFemaleHumansIntraoperative ComplicationsLogistic ModelsMaleMedicineMiddle AgedOutcome and Process Assessment, Health CarePhysiciansPostoperative ComplicationsProsthesis ImplantationRegistriesRetrospective StudiesSpecializationTreatment OutcomeUnited StatesConceptsCRT-D devicesThoracic surgeonsICD implantationPhysician certificationImplantable cardioverter-defibrillator (ICD) proceduresRetrospective cohort studyCardiac resynchronization therapyPatients meeting criteriaRisk of complicationsProcedural complication rateImplantable cardioverter defibrillatorHierarchical logistic regression modelsLogistic regression modelsCohort studyComplication rateICD RegistryResynchronization therapyProcedural complicationsIndependent associationPhysician specialtyCardioverter defibrillatorHigh riskPatientsMeeting criteriaNonelectrophysiologists
2008
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons
Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith S, Jacobs A, Adams C, Anderson J, Buller C, Creager M, Ettinger S, Faxon D, Halperin J, Hiratzka L, Hunt S, Krumholz H, Kushner F, Lytle B, Nishimura R, Ornato J, Page R, Riegel B, Tarkington L, Yancy C. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Heart Rhythm 2008, 5: e1-e62. PMID: 18534360, DOI: 10.1016/j.hrthm.2008.04.014.Peer-Reviewed Original ResearchACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. Circulation 2008, 117: e350-e408. PMID: 18483207, DOI: 10.1161/circualtionaha.108.189742.Peer-Reviewed Original ResearchACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons
Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Journal Of The American College Of Cardiology 2008, 51: e1-e62. PMID: 18498951, DOI: 10.1016/j.jacc.2008.02.032.Peer-Reviewed Original Research