OBJECTIVES : In patients with a cryptogenic ischaemic stroke, the cause may be patent foramen ovale (PFO), a hole in the heart. To date, standard treatment has been pharmacological prevention of new events. Recent clinical trials have indicated that surgical closure in combination with antiplatelet therapy may be more effective than antiplatelet alone. The objective of this study is to assess the health and cost impact of surgical PFO closure.

METHODS : We created a de novo Markov model, including for sequelae health states defined per scores on the Modified Ranking Scale (mRS), included events were new ischaemic strokes and events of major bleeding. Efficacy estimates were based on a recently published systematic review, indicating an effect on ischaemic strokes of OR= 0.12 (95% CrI 0.04 to 0.27). Baseline rate of ischaemic strokes, transitions between mRS states and cost allocated in states were based on real world data (Norwegian and Swedish national stroke registries). Costing took a broad health care perspective. We analysed patients 45 years old, cost and health effects were discounted by 4%.

RESULTS : PFO closure generated an estimated 11.24 QALY vs 9.79 in the antiplatelet arm, indication a gain of 1.44 QALY. The cost of PFO closure was close to neutralised by the reduced cost of functional decline following stroke events, resulting in an incremental cost of NOK 389 (USD 46). In PSA, PFO had an estimated probability of 100% of being more effective and a probability of 1.2% of being less costly than antiplatelet therapy. Due to the position on the cost effectiveness plane, conclusion was essentially insensitive to assumed threshold.

CONCLUSIONS : PFO closure is very likely to be a cost effective alternative to medical management. Finding are robust against realistic changes in input data and consistent with findings in the published literature.