@article{9450534c00c74072a231c09ae37070df,
title = "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",
abstract = "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.",
keywords = "Cardiac devices, Device evaluation, Real world evidence",
author = "Dhruva, {Sanket S.} and Guoqian Jiang and Doshi, {Amit A.} and Friedman, {Daniel J.} and Eric Brandt and Jiajing Chen and Akar, {Joseph G.} and Ross, {Joseph S.} and Ervin, {Keondae R.} and Farr, {Kimberly Collison} and Shah, {Nilay D.} and Paul Coplan and Noseworthy, {Peter A.} and Shumin Zhang and Thomas Forsyth and Schulz, {Wade L.} and Yue Yu and Drozda, {Joseph P.}",
note = "Funding Information: Funding Funding for this publication was made possible, in part, by the Food and Drug Administration through grant 1U01FD006292-01. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the US Government. We also acknowledge the analytic assistance of H. Patrick Young, Yale School of Medicine. Funding Information: Competing interests SD receives research funding from the National Heart, Lung, and Blood Institute (NHLBI, K12HL138046) of the National Institutes of Health (NIH), from the Medical Device Innovation Consortium as part of the National Evaluation System for health Technology Coordinating Center (NESTcc), Food and Drug Administration (FDA), Greenwall Foundation, and Arnold Ventures. DJF has received educational grants from Boston Scientific, Medtronic, and Abbott; research grants from the American Heart Association, National Cardiovascular Data Registry, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; consulting fees from Abbott and AtriCure. JGA has received consulting fees from Biosense Webster. JSR received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Medical Device Innovation Consortium as part of NESTcc, from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. NDS has received research support through Mayo Clinic from the Food and Drug Administration to establish the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938), from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative, from the Agency for Healthcare Research and Quality (U19HS024075, R01HS025164, R01HS025402, R03HS025517), from the National Heart, Lung, and Blood Institute of the National Institutes of Health (R56HL130496, R01HL131535), from the National Science Foundation, and from the Patient Centered Outcomes Research Institute to develop a Clinical Data Research Network. PC is an employee of Johnson & Johnson; the manufacturer of the ThermoCool catheters, and Biosense Webster, is a Johnson & Johnson company. However, this study was a feasibility study to evaluate the suitability of the databases to conduct a study and no evaluation of the safety and effectiveness of any medical device was conducted in the study. PAN receives research funding from National Institutes of Health (NIH, including the NHLBI and the National Institute on Aging [NIA]), Agency for Healthcare Research and Quality (AHRQ), FDA, and the American Heart Association (AHA). He is a study investigator in an ablation trial sponsored by Medtronic. PAN and Mayo Clinic are involved in potential equity/royalty relationship with AliveCor. SZ is an employee of Johnson & Johnson; the manufacturer of the ThermoCool cathetersand Biosense Webster, is a Johnson & Johnson company. WLS was an investigator for a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; is a technical consultant to Hugo Health, a personal health information platform, and cofounder of Refactor Health, an AI-augmented data management platform for healthcare; is a consultant for Interpace Diagnostics Group, a molecular diagnostics company. In the past 36 months, JPD has received research support from Medtronic and Johnson & Johnson. His non-dependent son is an employee of Boston Scientific. Funding Information: Acknowledgements This project was supported by a research grant from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for Health Technology (NEST), an initiative funded by the U.S. Food and Drug Administration (FDA). Its contents are solely the responsibility of the authors and do not necessarily represent the official views nor the endorsements of the Department of Health and Human Services or the FDA. While MDIC provided feedback on project conception and design, the organisation played no role in collection, management, analysis and interpretation of the data, nor preparation, review and approval of the manuscript. The research team, not the funder, made the decision to submit the manuscript for publication. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2021",
month = dec,
day = "1",
doi = "10.1136/bmjsit-2021-000089",
language = "English (US)",
volume = "3",
journal = "BMJ Surgery, Interventions, and Health Technologies",
issn = "2631-4940",
publisher = "BMJ Publishing Group",
number = "1",
}