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 THERMOCOOL ST CATHETER FOR ABLATION OF PERSISTENT ATRIAL FIBRILLATION USING REAL-WORLD DATA
Dhruva S, Zhang S, Chen J, Noseworthy P, Doshi A, Agboola K, Herrin J, Jiang G, Yu Y, Cafri G, Farr K, Ervin K, Ross J, Coplan P, Drozda J. SAFETY AND EFFECTIVENESS OF THERMOCOOL ST CATHETER FOR ABLATION OF PERSISTENT ATRIAL FIBRILLATION USING REAL-WORLD DATA. Journal Of The American College Of Cardiology 2022, 79: 73. DOI: 10.1016/s0735-1097(22)01064-6.Peer-Reviewed Original ResearchSAFETY AND EFFECTIVENESS OF THERMOCOOL STSF CATHETER FOR ABLATION OF 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, Ervin K, Ross J, Coplan P, Drozda J. SAFETY AND EFFECTIVENESS OF THERMOCOOL STSF CATHETER FOR ABLATION OF ISCHEMIC VENTRICULAR TACHYCARDIA. Journal Of The American College Of Cardiology 2022, 79: 116. DOI: 10.1016/s0735-1097(22)01107-x.Peer-Reviewed Original ResearchRenewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
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
2020
Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology
Akar JG, Hummel JP, Yao X, Sangaralingham L, Dhruva S, Dong J, Ward R, Shah ND, Ross J, Noseworthy PA. Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology. BMJ Surgery Interventions & Health Technologies 2020, 2: e000058. PMID: 35047796, PMCID: PMC8647613, DOI: 10.1136/bmjsit-2020-000058.Peer-Reviewed Original ResearchContact force-sensing catheterForce-sensing catheterAcute care useAtrial fibrillation ablationCatheter-related complicationsFibrillation ablationCare useAtrial fibrillationStroke/transient ischemic attackTransient ischemic attackRetrospective cohort analysisEmergency department visitsInverse probability treatment weightsOptumLabs Data WarehouseCatheter complicationsIschemic attackBaseline characteristicsComplication rateDepartment visitsAtrioesophageal fistulaEsophageal injuryCohort analysisContact force monitoringClinical practiceCatheter