New data from three late-breaking clinical trials supports pulsed field ablation as treatment option for atrial fibrillation 

NEW ORLEANS, LA, May 20, 2023 – Today, the Heart Rhythm Society (HRS) announced the findings of three new studies demonstrating the safety and efficacy of pulsed field ablation (PFA), a non-thermal ablation treatment for patients with atrial fibrillation (AF). The studies were presented as late-breaking clinical science during Heart Rhythm 2023.

Atrial fibrillation is the most common type of arrhythmia, and by 2050, up to 16 million Americans are projected to have AF¹. Given the prevalence of AF, researchers are continuously evaluating the latest approaches to deliver patient care safely and effectively. Today, the standard approaches to AF treatment have been medication, cardioversion, and catheter ablation. An emerging treatment option that uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death, PFA has become an alternative solution to conventional thermal ablation technologies.

The findings of the following studies contribute to the growing body of evidence supporting PFA as a treatment option for patients with AF.

• Long-term Clinical Outcomes of Pulsed Field Ablation to Treat Patients with Paroxysmal Atrial Fibrillation: This study combines three of the first-in-human studies with a follow-up of 49±7 months to examine the success of PFA in preventing recurrent arrhythmias. The study found 73% of patients remain free from AF/atrial flutter at the five-year mark. In a landmark analysis (excluding patients with AF recurrence <1 year), late on-set recurrence occurred in 11%. Aside from previously noted acute procedural complications, there were no noted delayed adverse effects of PFA.   
  
  "Early in-human data suggests PFA offers improved safety and at least comparable, if not improved, efficacy in comparison to traditional thermal modalities," said Daniel Musikantow, MD, Icahn School of Medicine at Mount Sinai. "This analysis demonstrates no late-adverse effects and encouraging long-term outcomes, especially with the use of the optimized wave form."
   
• Influence of Atrial Arrhythmia Burden on Quality of Life in Patients Undergoing Pulsed Field Ablation: A sub-study of the PULSED AF trial: This sub-study analyzed AF burden among patients following PFA procedure using post-ablation monitoring methods similar to other reported trials. The authors collected 12,264 hours of Holter recordings in 300 patients. In the paroxysmal and persistent cohorts, AF burden was <10% in 87% and 82% of patients respectively. Overall, 83% of paroxysmal atrial fibrillation (PAF) and 75% of persistent atrial fibrillation (PsAF) patients experienced ≤1 week of atrial arrhythmia recurrence on trans-telephonic monitoring.  
  
  "This sub-study of the PULSED AF trial set out to further validate the trial’s outcomes using additional post-ablation monitoring methods. These results show a predictable outcome following pulsed field ablation and were in line with other studies that used different monitoring methods," said Atul Verma, MD, McGill University Health Centre. "As we look to evolve patient care, we are encouraged that this procedure may be able to improve quality of life for those undergoing ablation treatment for AF."
   
• Late Breaking Clinical Trials and Science - Ablation: Updates and Registries: European Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation - Lessons from the multicenter EU-PORIA Registry: The multi-center EU-PORIA registry sought to determine real-world safety, efficacy, and learning curve characteristics for the pentaspline, multielectrode PFA catheter across 7 European high volume AF ablation centers. A total of 1233 patients were treated by 42 operators with different AF ablation experience and different primary ablation modality backgrounds. The findings demonstrate a favorable single procedure success rate along with short procedure times in a real-world all-comer AF patient population.   
  
  "These findings add to our understanding of how PFA will work as a treatment option for patients outside of controlled clinical studies and gave us new insight into how the new system is adopted and used by different operators across centers," said Boris Schmidt, MD, Cardioangiologisches Centrum Bethanien, Frankfurt, Germany. "We look forward to future randomized multi-center trials to further compare PFA-guided ablation to thermal ablation modalities."
   

The trials will be presented at respective late-breaking clinical trial sessions on Friday, May 19, and Saturday, May 20.

¹ Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001;285:2370-2370. doi:10.1001/jama.285.18.2370

Session Details

"Late Breaking Clinical Trials and Science - Ablation: Updates and Registries: Long-term Clinical Outcomes of Pulsed Field Ablation to Treat Patients with Paroxysmal Atrial Fibrillation" [Friday, May 19, 2023 at 11:00 am CT]

"Late Breaking Clinical Trials and Science - Ablation: Updates and Registries: Influence of Atrial Arrhythmia Burden on Quality of Life in Patients Undergoing Pulsed Field Ablation: A sub-study of the PULSED AF trial" [Friday, May 19, 2023 at 11:00 am CT]

"Late Breaking Clinical Trials and Science - Ablation: Updates and Registries: EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation - Lessons from the multicenter EU-PORIA Registry" [Saturday, May 20, 2023 at 9:30 am CT]

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About the Heart Rhythm Society

The Heart Rhythm Society (HRS) is a 501(c)(3) international nonprofit organization and the preeminent leader in science, education, and advocacy for cardiac arrhythmia professionals and patients. HRS continues to be the primary information resource on heart rhythm disorders with a mission to improve the care of patients by promoting research, education, and optimal health care policies and standards, and a mission to eliminate death and suffering due to heart rhythm disorders. Incorporated in 1979 and based in Washington, D.C., it has a membership of more than 8,000 heart rhythm professionals from 94 countries. For more information, visit www.HRSonline.org.

About Heart Rhythm 2023

The Heart Rhythm Society's annual Heart Rhythm meeting convenes 7,000+ of the world’s finest clinicians, scientists, researchers, and innovators in the field of cardiac pacing and electrophysiology. More than 1,500 international experts in the field will serve as faculty and presenters for the 200+ educational sessions, forums, symposia, and ceremonies, while 120+ exhibitors will showcase innovative products and services. For more information, visit www.HeartRhythm.com.