ArticleBMJ surgery, interventions, & health technologies2021
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.
Article in BMJ surgery, interventions, & health technologies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
6 citing papers in PubMed, 6 citations in OpenAlex.
- Capacity assessment for EHR-based medical device post-market surveillance for synthetic mid-urethral slings among women with stress urinary incontinence: a NEST consortium study.BMJ surgery, interventions, & health technologies · 2025Article
- Predictive utility of the impedance drop on AF recurrence using digital intraprocedural data linked to electronic health record data.Heart rhythm O2 · 2024Article
- 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 : an international journal of arrhythmias and pacing · 2023Article
- Article
- 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 · 2022Article
- Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker.JAMA cardiology · 2021Observational
Corrections and comments
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Authors and funding
18 authors at 8 institutions in 1 country.
Funding
Abstract
objectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.
designRetrospective cohort.
settingThree health systems in the USA.
participantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.
main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.
resultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.
conclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.
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