Boston Scientific Embraces Guidance from NICE on the Application of Pulsed Field Ablation
In a significant development for the healthcare sector, the National Institute for Health and Care Excellence (NICE) in the UK has endorsed the use of the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of atrial fibrillation (AF). This decision comes in light of growing evidence supporting PFA as a safe and effective non-thermal ablation method, particularly for persistent AF.
Atrial fibrillation, the most common sustained cardiac arrhythmia, affects approximately 2% of adults in the UK and is on the rise. As the population ages, the prevalence of AF is expected to rise considerably, placing a significant burden on the National Health Service (NHS). AF increases the risk of stroke, heart failure, and all-cause mortality, making it crucial to find effective treatment options.
The FARAPULSE PFA System, a commercialised cardiac PFA technology, delivers controlled pulses of electric fields to ablate cardiac tissue, offering a promising alternative to traditional thermal ablation methods. This technology is linked to improved quality of life and lower healthcare utilisation, particularly for those from lower socioeconomic and different minority groups.
Trudie Lobban, MBE, CEO and Founder of Arrhythmia Alliance, emphasised the potential benefits of PFA for both patients and the NHS. She highlighted the shorter procedure time of pulsed field ablation, which can help reduce waiting lists and address the significantly higher stroke and heart failure risk associated with atrial fibrillation.
The use of PFA as a treatment option for AF, as advised by NICE, could help address the rising prevalence of AF and the associated burden on the NHS. Over a 12-month period, the total average cost per patient for PFA was 3% (-343 GBP) less than those who received treatment with cryoablation, according to a study published in BMJ Open. This cost-saving aspect further strengthens the case for the wider adoption of PFA.
The FDA recently expanded its approval of the Farapulse PFA system to include persistent AF treatment, following strong trial data. The ADVANTAGE AF trial, a prospective, single-arm, open-label study completed in early 2025, provided critical evidence supporting the safety and efficacy of PFA in drug-refractory, symptomatic persistent AF patients.
While the evidence supporting PFA is promising, challenges remain in persistent AF ablation overall, including patient heterogeneity and procedural endpoint standardization. Studies call for further research to optimise PFA protocols, integrate advanced mapping technologies, and confirm sustained efficacy.
In conclusion, pulsed field ablation is supported by reputable sources, including NICE and recent influential clinical trials, as a safe and effective treatment advance for persistent atrial fibrillation. Ongoing research and wider clinical use will further define its long-term role and optimisation relative to existing ablation techniques.
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