OBJECTIVES: Closure of a patent foramen ovale (PFO) has been shown to reduce the risk of recurrent stroke in selected patients.^1-3 The aim of this study was to evaluate the cost-effectiveness of PFO closure using an occluder comprised of expanded polytetrafluoroethylene (ePFTE)/nitinol wire frame (Device A) versus a nitinol mesh/polyester occluder (Device B) in the United Kingdom National Health Service (NHS).

METHODS: A Markov model with seven healthcare states was developed to simulate the clinical pathways and costs over 5 years in the NHS. Clinical parameters were derived from a match-adjusted indirect treatment comparison study of the device randomised controlled trials with other clinical inputs obtained from the published literature. Costing information was gathered from national tariffs and data gaps filled with information from the published literature. Uncertainty was also tested using deterministic and probabilistic sensitivity analyses.

RESULTS: Over the five-year horizon, 1,000 patients were run through the modelling analysis, with total costs for Device A at £7,814,058 and total Quality- adjusted life year (QALY) gained at 4,068. Total costs for Device B were £8,222,038 and total QALYs gained at 4,043. Device A demonstrated a total cost saving of £407,980 over a 5-year time horizon and a probability of being 82% cost-effective in the probabilistic sensitivity analysis across a willingness-to-pay threshold of £20,000/QALY. Savings with Device A were driven by a decreased stroke rate and resultant reduced healthcare resource utilisation.

CONCLUSIONS: In this cost-effectiveness evaluation, Device A was dominant (cost-saving and more effective) compared to Device B. It was also highly cost-effective across the national UK willingness-to-pay threshold of £20,000/QALY. These findings underscore the potential of Device A as a cost-effective option for PFO closure in the UK NHS, providing crucial insights for clinical decision-making and healthcare resource allocation.