2023
Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia
Dhruva S, Zhang S, Chen J, Noseworthy P, Doshi A, Agboola K, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Mbwana M, Ross J, Coplan P, Drozda J. Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia. Journal Of Interventional Cardiac Electrophysiology 2023, 66: 1817-1825. PMID: 36738387, DOI: 10.1007/s10840-023-01496-x.Peer-Reviewed Original ResearchConceptsIschemic ventricular tachycardiaVentricular tachycardiaHealth system dataVT ablationSTSF catheterComposite outcomeHealth systemRisk differencePre-specified performance goalComposite safety outcomeReal-world safetyRoutine clinical practiceDrug Administration approvalAverage risk differenceThromboembolic eventsTotal patientsHeart failureProcedural complicationsMethodsAmong patientsAdministration approvalMayo ClinicSafety outcomesEffectiveness outcomesClinical practiceCatheter
2022
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
Dhruva SS, Zhang S, Chen J, Noseworthy PA, Doshi AA, Agboola KM, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin KR, Ross JS, Coplan PM, Drozda JP. Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice. JAMA Network Open 2022, 5: e2227134. PMID: 35976649, PMCID: PMC9386540, DOI: 10.1001/jamanetworkopen.2022.27134.Peer-Reviewed Original ResearchConceptsPersistent AF ablationRoutine clinical practiceMercy HealthAF ablationMayo ClinicSafety outcomesClinical practiceCatheter groupCohort studyCatheter ablationPersistent AFParoxysmal atrial fibrillation ablationThermocool SmartTouch catheterComposite of deathPrimary safety outcomeAtrial fibrillation ablationPersistent atrial fibrillationElectronic health record dataHealth system dataHealth record dataHealth care systemSmartTouch catheterThromboembolic eventsFibrillation ablationProcedural complications
2021
Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center
Dhruva SS, Jiang G, Doshi AA, Friedman DJ, Brandt E, Chen J, Akar JG, Ross JS, Ervin KR, Farr K, Shah ND, Coplan P, Noseworthy PA, Zhang S, Forsyth T, Schulz WL, Yu Y, Drozda JP. Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center. BMJ Surgery Interventions & Health Technologies 2021, 3: e000089. PMID: 35047806, PMCID: PMC8749235, DOI: 10.1136/bmjsit-2021-000089.Peer-Reviewed Original ResearchPositive predictive valuePersistent atrial fibrillationIschemic ventricular tachycardiaAblation catheterHealth systemAtrial fibrillationVentricular tachycardiaCardiac ablation catheterAcute heart failureDuration of patientsHealth system dataCardiac tamponadeIschemic strokeRetrospective cohortHeart failureClinical outcomesEndpoint ascertainmentPredictive valueCatheterChart validationCoordinating CenterTachycardiaPatientsFibrillationParticipant population