Procurement of devices for pulsed-field ablation of paroxysmal atrial fibrillation: the experience of the Tuscany region in Italy

Abstract

In this Health Policy article, we describe the experience conducted in Italy in the Tuscany region to implement an appropriate management of the devices available for pulsed-field ablation of paroxysmal atrial fibrillation. For patients who do not respond to pharmacological treatment, ablation techniques have long been a recognized therapeutic standard. Radiofrequency ablation and cryoballoon ablation (both referred to as thermal ablation options) were the first two techniques made available for this therapeutic indication. More recently, pulsed-field ablation has been developed as a means of achieving the same clinical result without any thermal intervention; iIn fact, thermal techniques are more often involved in determining local tissue damages. In 2024, there are already three different devices available to perform pulsed/field ablation, thus minimizing the risk of thermal damage to local tissues. These three devices include Farawave (from Boston), PulseSelect (from Medtronic), and Varipulse (from Johnson & Johnson). 

Our paper reports on the technical characteristics of these three devices and the available clinical evidence on their effectiveness. The clinical studies for Farawave (the first device developed in 2021) are more numerous than those for PulseSelect and Varipulse, whose development is much more recent.

Epidemiological data from the entire region were analysed to determine the total number of the three devices needed by our hospitals on an annual basis. These regional data were interpreted in comparison with the national consumption of these devices.

In conclusion, the main strength of the experience described here is that the principles of HTA have been successfully applied in daily practice. For more than 5 years, this policy has been applied in our Centro Operativo in the management of about 80 devices classified as class IIb, III or active implantable.