Abstract
Background
The ThermoCool STSF catheter is used for ablation of ischemic ventricular tachycardia (VT) in routine clinical practice, although outcomes have not been studied and the catheter does not have Food and Drug Administration (FDA) approval for this indication. We used real-world health system data to evaluate its safety and effectiveness for this indication.
Methods
Among patients undergoing ischemic VT ablation with the ThermoCool STSF catheter pooled across two health systems (Mercy Health and Mayo Clinic), the primary safety composite outcome of death, thromboembolic events, and procedural complications within 7 days was compared to a performance goal of 15%, which is twice the expected proportion of the primary composite safety outcome based on prior studies. The exploratory effectiveness outcome of rehospitalization for VT or heart failure or repeat VT ablation at up to 1 year was averaged across health systems among patients treated with the ThermoCool STSF vs. ST catheters.
Results
Seventy total patients received ablation for ischemic VT using the ThermoCool STSF catheter. The primary safety composite outcome occurred in 3/70 (4.3%; 90% CI, 1.2–10.7%) patients, meeting the pre-specified performance goal, p = 0.0045. At 1 year, the effectiveness outcome risk difference (STSF-ST) at Mercy was − 0.4% (90% CI: − 25.2%, 24.3%) and at Mayo Clinic was 12.6% (90% CI: − 13.0%, 38.4%); the average risk difference across both institutions was 5.8% (90% CI: − 12.0, 23.7).
Conclusions
The ThermoCool STSF catheter was safe and appeared effective for ischemic VT ablation, supporting continued use of the catheter and informing possible FDA label expansion. Health system data hold promise for real-world safety and effectiveness evaluation of cardiovascular devices.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Cronin EM, Bogun FM, Maury P, et al. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Heart Rhythm. 2020;17(1):e2–154.
Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace. 2018;20(FI_3):f392-f400.
Chen CF, Gao XF, Liu MJ, ** CL, Xu YZ. Safety and efficacy of the ThermoCool SmartTouch SurroundFlow catheter for atrial fibrillation ablation: a meta-analysis. Clin Cardiol. 2020;43(3):267–74.
21st Century Cures Act, PL 114–255(December 13, 2016).
Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices. https://www.fda.gov/media/99447/download. Published August 31, 2017. Accessed December 19, 2022.
Food & Drug Administration. Premarket approval (PMA). https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma. Accessed December 19, 2022.
Selzman KA, Patel H, Cavanaugh K. Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad. J Interv Card Electrophysiol. 2019;56(2):173–182.
Dhruva SS, Jiang G, Doshi AA, 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 Surg Interv Health Technol. 2021;3(1): e000089.
Jiang G, Dhruva SS, Chen J, et al. Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: a fit-for-purpose informatics analysis report. J Am Med Inform Assoc. 2021;28(10):2241–50.
Dhruva SS, Zhang S, Chen J, et al. Safety and effectiveness of a catheter with contact force and 6-hole irrigation for ablation of persistent atrial fibrillation in routine clinical practice. JAMA Netw Open. 2022;5(8): e2227134.
European Network of Centres for Pharmacoepidemiology and Pharmacovigiliance. http://www.encepp.eu/index.shtml. Accessed December 19, 2022.
Marchlinski FE, Haffajee CI, Beshai JF, et al. Long-term success of irrigated radiofrequency catheter ablation of sustained ventricular tachycardia: post-approval THERMOCOOL VT trial. J Am Coll Cardiol. 2016;67(6):674–83.
Lu N, Xu Y, Yue LQ. Some considerations on design and analysis plan on a nonrandomized comparative study using propensity score methodology for medical device premarket evaluation. Stat Biopharm Res 2020;12(2):155–63.
Ding WY, Pearman CM, Bonnett L, et al. Complication rates following ventricular tachycardia ablation in ischaemic and non-ischaemic cardiomyopathies: a systematic review. J Interv Card Electrophysiol. 2022;63(1):59–67.
Palaniswamy C, Kolte D, Harikrishnan P, et al. Catheter ablation of postinfarction ventricular tachycardia: ten-year trends in utilization, in-hospital complications, and in-hospital mortality in the United States. Heart Rhythm. 2014;11(11):2056–63.
Selzman KA, Fellman M, Farb A, de Del CS, Zuckerman B. New technology in electrophysiology: FDA process and perspective. J Interv Card Electrophysiol. 2016;47(1):11–8.
Bohnen M, Stevenson WG, Tedrow UB, et al. Incidence and predictors of major complications from contemporary catheter ablation to treat cardiac arrhythmias. Heart Rhythm. 2011;8(11):1661–6.
Dhruva SS, Zeitler EP, Canos D, et al. Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION). J Interv Card Electrophysiol. 2022.
Guandalini GS, Liang JJ, Marchlinski FE. Ventricular tachycardia ablation: past, present, and future perspectives. JACC Clin Electrophysiol. 2019;5(12):1363–83.
Food and Drug Administration. Examples of real-world evidence (RWE) used in medical device regulatory decisions. https://www.fda.gov/media/146258/download. Accessed December 19, 2022.
Dhruva SS, Shah ND, Ross JS. Mandatory Registration and results reporting of real-world evidence studies of FDA-regulated medical products. Mayo Clin Proc. 2020;95(12):2609–11.
Reddy VY, Reynolds MR, Neuzil P, et al. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007;357(26):2657–65.
Acknowledgements
The research team, not the funder, made the decision to submit the manuscript for publication. 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 thank Eric Brandt and Sunthosh Parvathaneni, MD, FHRS for their support of this study.
Funding
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 organization played no role in collection, management, analysis and interpretation of the data. Funding for this publication was made possible, in part, by the FDA through grant 1U01FD006292-01.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Ethical approval
This study was deemed exempt from institutional review board review at Mercy Health and was deemed minimal risk research with a waiver of informed consent at Mayo Clinic.
Conflict of interest
Dr. Dhruva reports research funding from the Medical Device Innovation Consortium (MDIC), Arnold Ventures, National Institute for Health Care Management, and Department of Veterans Affairs. Drs. Zhang, Cafri, and Coplan are employees of Johnson & Johnson; the manufacturer of the ThermoCool catheters is Biosense Webster, which is part of the Johnson & Johnson Family of Companies. Dr. Noseworthy receives research funding from National Institutes of Health (NIH), including the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Aging, Agency for Healthcare Research and Quality (AHRQ), FDA, and the American Heart Association. He is a study investigator in an ablation trial sponsored by Medtronic. Dr. Noseworthy and Mayo Clinic are involved in potential equity/royalty relationship with AliveCor. Dr. Herrin receives support from the Centers for Medicare and Medicaid Services to develop quality measures; research support from NIH (1R01CA217889-01A1, 1UM1CA233033-01, and 1UG3AT010669-01), Patient-Centered Outcomes Research Institute, and AHRQ (R01 HS022882-02); and support from Delta Airlines. Dr. Ross receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), MDIC, AHRQ (R01HS022882), NHLBI of the NIH (R01HS025164, R01HL144644), and 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 at Yale; in addition, Dr. Ross is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. In the past 36 months, Dr. Drozda has received research support from MDIC, Medtronic, and Johnson & Johnson. His non-dependent son is an employee of Boston Scientific. The remaining authors have nothing to disclose.
Additional information
Publisher's note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
This publication is dedicated to the memory of Jia**g Chen, PhD.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Dhruva, S.S., Zhang, S., Chen, J. et al. Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia. J Interv Card Electrophysiol 66, 1817–1825 (2023). https://doi.org/10.1007/s10840-023-01496-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10840-023-01496-x