OBJECTIVES

In young patients with an unexplained ischaemic stroke, the cause may be patent foramen ovale (PFO), a hole in the heart. Current clinical practice is pharmacological prevention of new events with either antiplatelet or anticoagulation therapy.The objective of this study is to assess the cost effectiveness of PFO closure vs the two modes of pharmacological treatment.

METHODS : We developed a de novo Markov model, including for sequelae health states defined per scores on the Modified Ranking Scale (mRS), mRS0-2, mRS 3, mRS 4 and mRS 5 and death (mRS 6). We included the events new ischaemic strokes and major bleeding. Efficacy estimates were based on a recently published systematic review. Baseline rate of ischaemic strokes, transitions between mRS states and cost allocated in states were based on data from 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 10.97 QALY vs 9.45 in the antiplatelet arm, indication a gain of 1.49 QALY. The cost of PFO closure was close to neutralised by the reduced cost of functional decline following stroke events, resulting in cost savings of NOK 505 330. Results were similar for the anticoagulation comparison, but health gains and potential savings were smaller and the uncertainty around the decision larger.In PSA, PFO had an estimated probability of 100% of being more effective and a probability of 77% 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 three published evaluations.