OBJECTIVES : Some people have an opening in the partition between the anterior ventricles, a patent foramen ovale (PFO). Such an opening is relatively common and most individuals will never notice any ailments. However, in some individuals, a PFO can lead to an ischemic stroke. In patients with a previous ischemic stroke and a PFO, secondary prevention is currently pharmacological management with either platelet inhibitor or anticoagulation. New evidence suggests that catheter based PFO closure may be a more effective treatment alternative.

The objective is to assess the cost effectiveness of PFO closure vs the two modes of pharmacological treatment.

METHODS : We developed a Markov model, health states were based on the Modified Ranking Scale (mRS). We included the events new ischaemic strokes and major bleeding. Efficacy estimates were collected from a systematic review. Baseline rate of ischaemic strokes, transitions between mRS states and cost allocated in states were based on 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 11.24 QALY vs 9.79 in the antiplatelet arm, a gain of 1.44 QALY. The cost of PFO closure was more than neutralised by the reduced cost of functional decline following stroke events, resulting in cost savings of NOK 755 339.

Results were similar for the anticoagulation comparison, but health gains and potential savings were smaller. PSA indicate a high certainty (vs antiplatelet therapy and anticoagulation, respectively 98% and 80% cost effective).

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 other published evaluations.