Irvine, CA – February 1, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, revealed findings from a company-funded study of real-world data. Titled “Real-world Data Affirms Safety and Effectiveness of Low/Zero Fluoroscopy Atrial Fibrillation Ablation,” the study was presented as a late-breaker at the 29th Annual International AF Symposium. The results support the use of workflows to reduce radiation exposure during catheter ablation for the treatment of paroxysmal atrial fibrillation (AFib) while maintaining safety, efficacy, and long-term patient outcomes comparable to traditional procedures.1
“Cardiac ablation procedures for the treatment of AFib usually require fluoroscopy to guide intracardiac catheters, which can result in considerable radiation exposure for patients, operators, and support medical staff,” explained Jose Osorio, MD, FHRS, President of Heart Rhythm Clinical and Research Solutions, the lead author of the study.ii “Our study shows that adopting workflows that integrate a 3D electro-anatomical mapping system with intracardiac echocardiography can support reducing or eliminating fluoroscopy exposure during catheter ablation procedures while providing electrophysiologists and patients the confidence of uncompromised safety.”
Biosense Webster’s zero fluoroscopy workflow is the first and only such workflow available in a radiofrequency (RF) cardiac ablation device. The company received approval for this workflow from the U.S. Food and Drug Administration last year, and it is available for cardiac ablation for several products in the company’s portfolio, including the THERMOCOOL SMARTTOUCH™ SF catheter. This the most commonly used ablation catheter in the world for RF ablation and is fully integrated with the CARTO™ 3 System. The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy.
“As Biosense Webster advances innovation for the treatment of AFib, we are thinking not only about new modalities of ablation, such as pulsed field ablation, but also how to make procedures safer, more effective and efficient. This includes zero fluoroscopy workflows, enabled by our CARTO™ 3 Navigation System, which allows clinicians to reduce or eliminate radiation exposure for themselves and their patients while maintaining excellent clinical outcomes,” said Jasmina Brooks, President, Biosense Webster. “The results of this real-world evidence demonstrate that a zero fluoroscopy workflow can enhance patient care while also making procedures safer and more comfortable for medical staff by removing the need to wear heavy protective gear for hours each day.”
AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide.2,3 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.4 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.5 Catheter ablation is a safe and effective procedure when drugs don’t work to help restore the heart’s incorrect electrical signals, which causes an abnormal heart rhythm.6
About the Study
In the study, real-world data from 16 sites participating in the REAL AF Registry – an observational, prospective, multicenter registry that assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness with low/zero fluoroscopy workflows and RF technologies in paroxysmal AFib patients – were analyzed. The primary endpoint of the analysis was incidence of procedure – or device-related primary adverse events (PAEs) within seven to ninety days of the ablation procedure; the secondary endpoint was the rate of acute pulmonary vein (PV) isolation.1 Study success was defined by meeting both safety and acute effectiveness performance goals.1 Low/zero fluoroscopy safety was evaluated further by a secondary analysis of data from electronic health records from 45 hospitals within the Mercy Health integrated hospital network, comparing PAEs between procedures with low fluoroscopy (two minutes or fewer) versus conventional fluoroscopy (three minutes or longer).1
Results from the analysis reaffirmed the safety and effectiveness of low/zero fluoroscopy procedures.1 Among 208 patients included in the Real AF Registry cohort, a total of three PAEs were reported.1 These included one pseudoaneurysm, one PV stenosis and one hematoma.1 Acute PV isolation was achieved by 100% of patients in the cohort, and both safety and effectiveness endpoints were achieved.1 Among 299 patients in the MH cohort, secondary PAE rates were low and similar between groups, with a PAE rate of 0.8% observed among patients who underwent low fluoroscopy procedures and 0.3% among patients who had procedures utilizing conventional fluoroscopy.1
About Biosense Webster
Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding data presented at the 29th Annual International AF Symposium. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. None of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Important Information: For product details such as indications, contraindications, warnings and precautions please consult the IFU. Johnson & Johnson MedTech bears no responsibility for the accuracy, legality or content of the external site.
The THERMOCOOL SMARTTOUCH® SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal AFib and for drug refractory recurrent symptomatic persistent AF (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.
i. Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii. Heart Rhythm Clinical and Research Solutions, LLC has received research funding from Biosense Webster Inc. for REAL AF registry conduct and for supporting medical writing and statistical analysis of study related publications under the direction of the authors. Dr. Jose Osorio and the authors were not compensated for their effort in the publications.
© Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_THER_303884
1 Osorio J, Oza S, Sackett M, Sellers M, D’Souza B. Real-world Data Affirms Safety and Effectiveness of Low/Zero Fluoroscopy Atrial Fibrillation Ablation [abstract]. In: AF Symposium.; February 2-4; Boston.
2 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221.
3 Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20.
4 Staerk, et al. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ 2018;361:k1453 5.
5 Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. doi: 10.1093/europace/euaa298.
6 Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072