Pulsed-field ablation (PFA) is a new non-thermal ablative approach for treating paroxysmal and persistent atrial fibrillation (AF). It provides an alternative to the conventional thermal techniques of radiofrequency ablation and cryoablation. PFA is currently performed with the Farapulse PFA system (Boston Scientific, USA), which recently received CE marking in Europe. In this study, we describe the current evidence on the efficacy, safety, and cost-effectiveness of this new technology.

The Early Awareness and Alert System of the Agencia de Evaluación de Tecnologías Sanitarias-at the Instituto de Salud Carlos III- identified this new ablation approach in June 2021. An early technology assessment was conducted by reviewing relevant literature published to November 2021. The literature was identified by searching PubMed, Embase, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Library.

Seven relevant publications were identified, including three open-label trials for paroxysmal AF and one for persistent AF. Three studies comparing PFA with conventional thermal ablation techniques were also included. The safety results showed a lower incidence of complications (esophageal injury, pulmonary venous stenosis, pericardial effusion, and aortic injury) after PFA relative to conventional techniques. In terms of efficacy, PFA resulted in lower rates of AF recurrence in the medium and long term, compared with conventional techniques, and there were no differences in the lengths or success rates of the procedures. No cost-effectiveness studies were identified. Seven ongoing trials were identified, but no results have been published.

The current evidence for PFA in the treatment of AF showed good safety and promising efficacy. However, there is a lack of information on its effect on quality of life and the risk of death, disabling stroke, or cardiac arrest. Early evaluation of new and emerging technologies makes it possible to gather the minimum information necessary to support decisions on their inclusion in the healthcare system. In this case, based on current evidence, the widespread use of PFA is not recommended, except under a rigorous research protocol.