Author + information
- Received October 16, 2017
- Revision received February 12, 2018
- Accepted February 22, 2018
- Published online July 16, 2018.
- David A. Igel, PhDa,∗ (, )
- Jon F. Urban, PhDa,
- James P. Kent, BSa,
- Bernard Lim, MD, PhDb,
- K.L. Venkatachalam, MDc,
- Samuel J. Asirvatham, MDd and
- Daniel C. Sigg, MD, PhDa
- aFocusStart LLC, Minneapolis, Minnesota
- bHeart and Vascular Program, Baystate Medical Center, Springfield, Massachusetts
- cCardiovascular Diseases, Department of Medicine, Mayo Clinic, Jacksonville, Florida
- dDivision of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. David A. Igel, FocusStart, LLC, 807 Broadway Street Northeast, Suite 148, Minneapolis, Minnesota 55413.
Objectives This study investigated whether delivering negative charge to catheter tips reduces thromboembolism during catheter ablation.
Background Radiofrequency (RF) ablation prevents atrial fibrillation that can cause stroke or death. However, ablation itself can cause stroke (2%) or silent ischemia (2% to 41%), possibly via particulate debris that embolizes after coagulum adherence to catheter surfaces. Coagulum formation on RF catheters can be prevented by applying negative charge, but it is unknown if charge reduces peripheral thromboembolism.
Methods Paired (Charge ON vs. OFF) endocardial RF ablations were performed in 9 canines using nonirrigated RF catheters. Continuous negative charge was delivered via −100 μA of DC current applied to ablation catheter electrodes. Intracardiac echocardiography was used to navigate the catheter and to monitor coagulum formation. In a subset of 5 canines, microemboli flowing through polyester tubing between the femoral artery and vein (extracorporeal loop) were monitored with bubble counters and inline filter fabric. After each ablation, catheter-tip coagulum and blood particles deposited on the filters were quantified using photography and imaging software (ImageJ, U.S. National Institutes of Health, Bethesda, Maryland).
Results Negative charge significantly decreased the extracorporeal loop median filter area covered by particles (n = 19 pairs) by 10.2 mm2 (p = 0.03), and decreased median filter particles by 349 (p = 0.03). Negative charge also decreased the percentage of the catheter tip surface area covered by coagulum (n = 39 pairs) by 7.2% (p = 0.03).
Conclusions Negative charge delivery to ablation catheter tips during RF ablation can reduce particulate embolization material in an extracorporeal loop, and potentially reduce thromboembolic risk associated with RF ablation.
Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL127758. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. FocusStart also received material support from Boston Scientific. Drs. Igel, Urban, Kent, and Sigg are employees of FocusStart and own equity pertaining to the charge device. Dr. Igel owns equity in FocusStart. Drs. Lim, Venkatachalam, and Asirvatham own intellectual property rights and equity pertaining to the charge technology. Dr. Venkatachalam has served as a consultant for BioSig Technologies. Dr. Asirvatham has received consulting fees from FocusStart, LLC.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received October 16, 2017.
- Revision received February 12, 2018.
- Accepted February 22, 2018.
- 2018 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.