Irvine, CA – May 19, 2023 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced data from 16 company-funded Real World Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation Using Novel Contact Force Technologies (REAL AF) Registry studies. The data, led by Jose Osorio, MD, FHRS, President of Heart Rhythm Clinical and Research Solutions, will be presented at Heart Rhythm 2023, the Heart Rhythm Society’s annual meeting, hosted in New Orleans, Louisiana (May 19-21). Three of the abstracts were selected for oral presentation, including one as the recipient of the highest scoring abstract in two categories – Women in EP Award and the Quality Improvement Award.
In addition to being presented at Heart Rhythm 2023, data from the award-winning presentation, “Same-Day Discharge After Catheter Ablation of Atrial Fibrillation in a Multicenter Registry,’’ was simultaneously published in the Journal of American College of Cardiology (JACC) Clinical EP. To review the manuscript, click here.
“Large databanks, like the REAL AF Registry provide critical insights into how we can deliver effective AFib care for all patients, uncover trends, and identify best practices to drive more positive patient outcomes,” said Jose Osorio, MD, FHRS, President of Heart Rhythm Clinical and Research Solutions, the study’s sponsor.ii “As the prevalence of AFib continues to increase around the world and impact people regardless of racial and ethnic backgrounds, more data are needed to help us eliminate disparities in diagnosis, treatment, and outcomes.’’
The REAL AF Registry is an observational, prospective, multicenter registry that assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness in a broad group of patient populations with novel radiofrequency (RF) technologies in paroxysmal and persistent AFib patients.
“At Biosense Webster, we are committed to learning from real-world data and applying these learnings to advance the standard of care in AFib treatment,” said Celine Martin, Company Group Chairman, Cardiovascular & Specialty Solutions Group, Johnson & Johnson MedTech. “Through the REAL AF Registry, evidence has been generated that can be applied to enhance procedural success and help improve outcomes for those experiencing AFib.”
Highlights of REAL AF oral and poster presentations during Heart Rhythm 2023 include:
Impact of Gender on Patient Characteristics and Long-Term Outcomes in a Real-World Registry of Atrial Fibrillation Ablation. Oral Presentation AB-452665-2 / Room 345, May 19, 11:12 a.m. to 11:24 a.m. CT by Dr. Sandeep Goyal
In this study of first-time paroxysmal AFib ablation procedures, a patient’s gender did not impact rate of clinical success, arrhythmia recurrence, or overall safety. Data did show females were older, held a higher CHADS-Vasc score, and experienced a higher percentage of left atrial scarring than men. Men experienced a higher prevalence of sleep apnea, vascular disease, and congestive heart failure in the 12 months post-procedure.
Same-Day Discharge After Catheter Ablation of Atrial Fibrillation in a Multicenter Registry (REAL-AF). Oral Presentation QI-452785-1 / Room 204, May 20, 8:00 a.m. to 8:12 a.m. CT by Dr. Carolina Hoyos-Ochoa
This study was the recipient of the Heart Rhythm 2023 highest scoring abstract award in two categories: Women in EP and Quality Improvement. The study evaluated the safety and efficacy of a previously described same-day discharge (SDD) protocol in a prospective analysis of >2,300 patients. By using a standardized protocol, the investigators identified a high proportion of patients suitable for SDD and also predicted procedural outcomes and patients with an increased risk of complications. Patients selected by the protocol for SDD presented a low rate of procedural complications compared to non-SDD-eligible patients.
Complications Associated With Catheter Ablation of Atrial Fibrillation in Current Practice: Insights From a Large, Real-World Collaboration. Oral Presentation AB-452642-2 / Room 356, May 20, 8:12 a.m. to 8:24 a.m. CT by Dr. Amneet Sandhu
The study compared cases performed between January 2018 and June 2022 by >50 operators in multiple centers and found that major complications were rare in patients undergoing their first AFib catheter ablation procedures. However, patients with a history of congestive heart failure were associated with major complications. Similarly, data showed older age and a history of vascular disease were associated with stroke and vascular complications, respectively.
[Late-breaker] Contemporary Paroxysmal Atrial Fibrillation Ablation Trends From Real World Practice: Insights From the Large Multi-Center Prospective REAL-AF Registry. PO-03-243, Poster Session III / Abstract Pavilion, May 20, 1:30 p.m. to 3:30 p.m. CT by Dr. Jose Osorio
This study aimed to understand contemporary clinical practice patterns and the safety and effectiveness of RF paroxysmal AFib in a real-world US population. At 1-year follow-up, >85% of patients were free of AFib recurrence, and most did not require additional ablation procedures. Only a small proportion of patients (~5%) were still on antiarrhythmic drugs. Overall, the findings align with recent evidence on the safety and efficacy of paroxysmal AFib as first-line therapy and the safety of zero fluoroscopy procedures.
Novel High Density Octa-Spline Mapping Catheters Improved Left Atrial Mapping Efficiencies in Atrial Fibrillation. PO-04-034, Poster Session IV / Abstract Pavilion, May 21, 9:30 a.m. to 11:30 a.m. CT by Alexandru Costea
This study compared mapping efficiencies between the novel OCTARAY™ Mapping Catheter with TRUERef™ Technology and the legacy penta-spline catheter in patients who underwent left atrial mapping and AFib ablation. The novel octa-spline catheter improved left atrial mapping efficiencies leading to significantly shorter mapping and procedure times, and a higher point density per map.
Visit Biosense Webster’s Scientific Session Guide for the full list of Biosense Webster data being presented at Heart Rhythm 2023.
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 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.
- Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
- 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.
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