Interest growing in fluoroscopy-free workflows during RF ablation
Paul Zei, MD, director of the comprehensive atrial fibrillation (AFib) program at Brigham and Women’s Hospital, explained key findings from the late-breaking REAL-AF Registry at HRS 2024, the annual meeting of the Heart Rhythm Society. This registry study evaluated the short- and long-term outcomes of radiofrequency ablation (RF) in treating both paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PsAF), revealing significant advancements in procedural techniques and patient safety.
Chief among these was data showing more than 70% of electrophysiologists involved in the registry used a zero-fluoro workflow.
Zei presented the long-term and short-term outcomes for our first 2,500 patients that were treated within this registry. He took time at HRS to speak with Cardiovascular Business about the implications of the registry.
High adoption of zero-fluoroscopy techniques
One of the most notable findings from the registry is the widespread adoption of zero-fluoroscopy techniques, which were used in 71% of the procedures. Even in the remaining 29% of procedures, fluoroscopy time averaged less than two minutes per case, showing significant progress at lowering and eliminating the used of angiographic X-ray imaging in the EP lab.
He said this has been enabled by advancements in EP electro-mapping systems that are much more precise, accurate and show changes on the overhead screen in real-time. Additionally, most EP operators now use intra-cardiac echo (ICE) to visualize the procedure, so fluoro is not required.
One of the big benefits of the ongoing registry is that it helps collect data on new aspects of procedures. That rigorous data collection and analysis led to a significant milestone with a new FDA indication for the Biosense Webster Carto 3 mapping system specifically to enable zero-fluoroscopy procedures. This is the first indication of its kind for any mapping system in the U.S.
"This is a win-win for both industry and physicians. It provides a faster, more efficient pathway for evaluating and adopting new medical innovations," Zei explained.
Efficacy and safety outcomes in the REAL-AF Registry
The study reported a one-year clinical freedom from all atrial arrhythmias at just under 82% for all comers. The complication rate stood at 1.9%, underscoring the safety of these advanced techniques. "We employed best practices such as high-power, short-duration ablation and high-frequency, low tidal volume ventilation protocols," Zei noted. "These innovations have contributed to shorter procedure times and better outcomes."
He said most of the findings point to what should be considered best practices in RF ablation. These include high power, short duration ablation, low or zero fluoro and using a mapping system ICE. He said these were the main drivers for high rates of freedom from all atrial arrhythmias and the low complication rate.
REAL-AF is a living document
"This is part of what we call a learning health network, where we've gathered like-minded physician centers who perform high-volume procedures for AFib ablation using RF and are interested in continual learning. We collect the data, we generate evidence and we look for best practices and then reincorporate that into the network and try to improve our outcomes with this scaffolding infrastructure," Zei explained.
The idea is the registry will be a "living document" that is constantly updated, helping show how new technologies and techniques may impact outcomes as they become common among operators.
"This is not a static study," Zei emphasized. "It is a living document that we can update as new technologies and techniques emerge."
This adaptability allows for the continuous incorporation of new data and practices, ensuring that the registry remains at the forefront of AF treatment advancements.
Future directions for the registry with PFA
Looking ahead, the REAL-AF Registry is poised to look at new technologies such as pulsed field ablation (PFA). As more centers adopt PFA, the registry will incorporate these data to continue refining AF ablation techniques.
"Our goal is to continuously improve the safety and efficacy of AFib treatments, benefiting patients, physicians, and the broader medical community," Zei said.
what are they doing with fluoroscopy or if they're doing RF still, what are they doing with high power, short duration like I'm talking about? So all these little sort of sub-questions then get asked and then reincorporated into the evidence.
Acknowledgments to partners for helping advance AFib care
Zei expressed gratitude to his co-investigators, co-founders, and Biosense Webster for their crucial support. "This collaborative effort has made significant strides in advancing our understanding and treatment of atrial fibrillation," he said.
He said the REAL-AF Registry's findings mark a significant step forward in the field of electrophysiology, showcasing the potential for innovative, data-driven approaches to revolutionize patient care.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com