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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

Publication ,  Journal Article
Dhruva, SS; Jiang, G; Doshi, AA; Friedman, DJ; Brandt, E; Chen, J; Akar, JG; Ross, JS; Ervin, KR; Farr, KC; Shah, ND; Coplan, P; Zhang, S ...
Published in: BMJ Surgery, Interventions, and Health Technologies
December 1, 2021

Objectives To 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. Design Retrospective cohort. Setting Three health systems in the USA. Participants Patients receiving ablation with the two ablation catheters of interest at any of the three health systems. Main outcome measures Feasibility 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. Results Overall, 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. Conclusions It 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.

Duke Scholars

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Published In

BMJ Surgery, Interventions, and Health Technologies

DOI

EISSN

2631-4940

Publication Date

December 1, 2021

Volume

3

Issue

1
 

Citation

APA
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ICMJE
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Dhruva, S. S., Jiang, G., Doshi, A. A., Friedman, D. J., Brandt, E., Chen, J., … Drozda, J. P. (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. BMJ Surgery, Interventions, and Health Technologies, 3(1). https://doi.org/10.1136/bmjsit-2021-000089
Dhruva, S. S., G. Jiang, A. A. Doshi, D. J. Friedman, E. Brandt, J. Chen, J. G. Akar, et al. “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, and Health Technologies 3, no. 1 (December 1, 2021). https://doi.org/10.1136/bmjsit-2021-000089.
Dhruva SS, Jiang G, Doshi AA, Friedman DJ, Brandt E, Chen J, et al. 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, and Health Technologies. 2021 Dec 1;3(1).
Dhruva, S. S., et al. “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, and Health Technologies, vol. 3, no. 1, Dec. 2021. Scopus, doi:10.1136/bmjsit-2021-000089.
Dhruva SS, Jiang G, Doshi AA, Friedman DJ, Brandt E, Chen J, Akar JG, Ross JS, Ervin KR, Farr KC, 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, and Health Technologies. 2021 Dec 1;3(1).

Published In

BMJ Surgery, Interventions, and Health Technologies

DOI

EISSN

2631-4940

Publication Date

December 1, 2021

Volume

3

Issue

1