ArticleClinical drug investigation2026
Budget Impact Analysis of Pulsed Field Versus Cryoballoon and Laser Procedures for Atrial Fibrillation in Italy.
Article in Clinical drug investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
BACKGROUND AND
objectivesAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with a higher prevalence due to the ageing of the population. Traditional ablation techniques, such as cryoballoon ablation (CB) and laser ablation (LA), are widely used but may be associated with longer procedure times and a risk of collateral tissue injury. Pulsed field ablation (PFA) is an emerging non-thermal technology that uses electroporation, with early evidence suggesting a favourable safety profile and improved procedural efficiency. This study assessed the budget impact of the introduction of PFA within the Italian National Health Service (NHS) compared with current CB and LA practice, estimating short-term differences in healthcare costs to support resource allocation decisions.
methodsA 5-year budget impact model compared two scenarios: current clinical practice (CB and LA) and a progressive uptake of PFA, increasing from 20% in 2025 to 67.2% in 2029. The analysis included direct medical costs: device acquisition, staff time, procedural resources, complications and repeat interventions. The population and treatment assumptions were based on national and regional data from Italy. The analysis was conducted from the perspective of the NHS. A deterministic sensitivity analysis was performed to assess the robustness of the results.
resultsThe introduction of PFA resulted in cumulative cost savings of €11.7 million over 5 years. In the current scenario, costs increased from €36.2 million to €38.1 million. In contrast, costs in the PFA scenario decreased from €35.8 million to €33.2 million. The main savings came from reduced staff and procedural costs (€7.6 million), fewer recurrences (€5.9 million) and lower costs related to complication (€1.5 million). Sensitivity analysis confirmed the robustness of the results, with device cost, CB pricing and procedure time identified as the most influential parameters.
conclusionsOur study suggests that the progressive integration of PFA into routine AF care within the Italian NHS could generate meaningful cost savings while maintaining clinical outcomes.
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