Boston Scientific Corporation (NYSE: BSX) today welcomed guidance1 supporting the use of pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) from the National Institute for Health and Care Excellence (NICE), which provides evidence-based recommendations to improve health and social care in the National Health Service (NHS) in England and Wales. NICE reviewed the safety and efficacy evidence of PFA, including the Boston Scientific FARAPULSE™ Pulsed Field Ablation (PFA) System.2
AF is the most common sustained cardiac arrhythmia, estimated to effect approximately 2% of adults in the UK,3 and is thought to have risen significantly over the past decade (up to 50%).4 The often asymptomatic condition can go untreated and increases the risk of stroke, heart failure and all-cause mortality,5 placing a significant burden on the NHS. As the population ages, the prevalence of AF is expected to rise considerably, underscoring the importance of innovative and effective treatment options.
A study published in BMJ Open6 highlights that the FARAPULSE PFA System is not only clinically effective but also a cost-saving option for the NHS compared to standard cryoablation. The study, which scrutinised various parameters including procedure costs and complication rates, found that over a 12-month period, the total average cost per patient for PFA was -3% (-£343) less than those who received treatment with cryoablation.
“AF is estimated to directly cost the NHS between £1.4- £2.5 billion annually.7 With poorer AF outcomes for those from lower socioeconomic and different minority groups,8 PFA can improve health equity which is a priority for the NHS. Compared to some other ablation energy sources (i.e., cryoablation), patients treated with PFA have a lower residual burden of atrial fibrillation which is well-known and linked to improved quality of life and lower health care utilisation,” said Angelo Auricchio, M.D., Ph. D., chief medical officer, Rhythm Management, Boston Scientific, Europe, Middle East and Africa (EMEA). “The FARAPULSE PFA System can help enable the NHS to achieve its shift from treatment to prevention under its 10-year Health Plan by addressing the risk of stroke and other complications.”
Boston Scientific’s FARAPULSE™ PFA System became the first commercialised cardiac PFA technology in Europe after receiving CE mark in 2021. It delivers controlled pulses of electric fields to ablate cardiac tissue, offering a promising alternative to traditional thermal ablation methods.
“The shorter procedure time of pulsed field ablation can help reduce waiting lists while addressing the significantly higher stroke and heart failure risk associated with atrial fibrillation,” said Trudie Lobban, MBE, CEO and Founder, Arrhythmia Alliance, a coalition of patients and medical groups that
promotes timely and effective diagnosis and treatment of arrhythmias. “It is a win-win situation for both patients and the NHS – saving time, saving costs and importantly saving lives.”
NICE advised that PFA can be used as an option to treat AF, provided that standard arrangements are in place for clinical governance, consent, and audit. NICE guidance is available here.
