NICE: Pulsed Field Ablation technology to benefit patients with atrial fibrillation in the NHS
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, has issued final guidance recommending pulsed field ablation (PFA) to treat atrial fibrillation (AF)1. NICE reviewed the safety and efficacy evidence of PFA, which included the FARAPULSE™ Pulsed Field Ablation System2 from Boston Scientific. This is the same recommendation as for other ablation modalities and gives physicians the autonomy to choose the best treatment option for their patients.
The guidance is a significant step forward for the treatment of AF, which affects 1.6 million people in England3. AF can impact quality of life, leading to symptoms such as fatigue, shortness of breath, and heart palpitations4. AF is also associated with a five-fold increase in the risk of stroke4 and can lead to heart failure. According to NICE, prevalence of AF is growing in England due to an ageing population and lifestyle factors. In 2024, the south west of England had the highest AF prevalence partially due to having an older population pushing up the regional average (see heat map).
The FARAPULSE PFA System procedure is a quicker procedure than thermal ablation5. PFA is an alternative to traditional thermal treatment modalities (radiofrequency and cryoablation). It relies on pulses of electric fields to specifically disrupt cardiac cell membranes. This new method has several advantages: improved safety profile 6,7,8,9 (minimising the risk of collateral damages) and enhanced efficacy. There is also anecdotal evidence that some patients experienced reduced post-operative discomfort.9
The FARAPULSE PFA System uses precise, targeted energy pulses to silence the areas of the heart causing abnormal electrical signals. The technology, which has been used to treat more than 200,000 patients across 65 countries and is supported by extensive data, offers several benefits, including reduced risk of damage to surrounding heart tissue potentially contributing to shorter recovery time. 6,7,8,9
Improving quality of life
Lucy, a patient at Royal Papworth Hospital, was diagnosed with AF in 2022 after years of unexplained symptoms and multiple misdiagnoses. She underwent PFA, which is a minimally invasive procedure, and was discharged from hospital on the same day. "I was definitely doing less in my life because I just didn’t have the energy to do things,” she said. “Since the operation, my quality of life is 9 out of 10. The ablation procedure enabled me to return to a normal, active lifestyle."
Dr Claire Martin, Consultant Electrophysiologist at Royal Papworth Hospital, who contributed to the NICE guidance said: “As the first centre in the UK to offer PFA to patients with AF, we are delighted that the NICE guidance has been updated to support its use. Heart rhythm management globally is evolving rapidly, and in the last five years, the use of pulsed field ablation to treat atrial fibrillation has risen exponentially, giving the potential for treatment to be offered to more people suffering from this condition, more efficiently and with lower risk.”
“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.”
“AF is estimated to directly cost the NHS between £1.4- £2.5 billion annually10. With poorer AF outcomes for those from lower socioeconomic and different minority groups11, PFA can improve health equity which is a priority for the NHS. Compared to some other ablation energy sources (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 forthcoming 10-year Health Plan by addressing the risk of stroke and other complications.”
Results from a study published last year in BMJ Open found that use of the FARAPULSE PFA System is more affordable for the NHS compared to the standard cryoablation treatment12. Scrutinising various parameters, including procedure costs and complication rates, the study found that over a 12-month period, the total average cost per patient for those undergoing PFA was -3% (-£343) less than those who received treatment with cryoablation.
The FARAPULSE PFA System is currently available in 17 NHS centres across England13.
References
1 https://www.nice.org.uk/guidance/IPG806
2 FARAPULSE - Pulsed Field Ablation System - Boston Scientific
4 Atrial Fibrillation (AF) - Arrhythmia Alliance - UK
5 Reddy VY et al; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671.
6 Reddy VY, Dukkipati SR, Neuzil P, et al. Pulsed field ablation of Paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol 2021;7:614–27.
7 Lemoine MD, Fink T, Mencke C, et al. Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario. Clin Res Cardiol 2023;112:795–806.
8 Schmidt B, Bordignon S, Tohoku S, et al. 5S study: safe and simple single shot pulmonary vein isolation with pulsed field ablation using sedation. Circ Arrhythm Electrophysiol 2022;15:e010817.
9 Calvert P et al. Cost, efficiency, and outcomes of pulsed field ablation vs thermal ablation for atrial fibrillation: A real-world study. Heart Rhythm. 2024 Sep;21(9):1537-1544..
11 Kotalczyka, A (2021), Disparities in atrial fibrillation: a call for holistic care, The Lancet Regional Health – European Heart Journal
12 Duxbury C, Begley D, Heck PM. Pulsed field ablation with the pentaspline catheter compared with cryoablation for the treatment of paroxysmal atrial fibrillation in the UK NHS: a cost-comparison analysis. BMJ Open 2024;14:e079881. doi:10.1136/ bmjopen-2023-079881.
13 Find your Hospital for FARAPULSE PFA