New data from three late-breaking clinical trials has demonstrated the safety and efficacy of pulsed field ablation (PFA) as a viable, non-thermal treatment option for atrial fibrillation (AF) and were presented at the 2023 Heart Rhythm (May 19–21, New Orleans, USA) annual meeting.
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.
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 onset 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 (Icahn School of Medicine at Mount Sinai, New York, USA). “This analysis demonstrates no late-adverse effects and encouraging long-term outcomes, especially with the use of the optimised wave form.”
This sub-study analysed 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 (McGill University Health Centre, Montreal, Canada). “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.”
The multicentre EU-PORIA registry sought to determine real-world safety, efficacy, and learning curve characteristics for the pentaspline, multielectrode PFA catheter across seven European high volume AF ablation centres. A total of 1,233 patients were treated by 42 operators with different AF ablation experience and different primary ablation modality backgrounds. The findings demonstrate a favourable 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 centres,” said Boris Schmidt (Cardioangiologisches Centrum Bethanien, Frankfurt, Germany). “We look forward to future randomised multicentre trials to further compare PFA-guided ablation to thermal ablation modalities.”