Cost-effectiveness analysis of patent foramen ovale closure with Amplatzer plus medical therapy compared to medical therapy in patients with a history of stroke in France.

BACKGROUND:A patent foramen ovale (PFO) is formed when the ovale foramen does not close spontaneously or re-opens leaving the right and left atrium connected. The present study was conducted to analyze the cost-effectiveness of PFO closure with Amplatzer device plus medical therapy (MT) compared to MT alone in the French reimbursement system for PFO patients with a prior history of stroke, using the RESPECT study data. METHODS:A multi-state Markov model was used. The analysis was conducted from a collective perspective over a 10-year time horizon with 4% discount applied for costs and health effects. The simulated population included adult patients with PFO. Sub-group analysis was limited to patients with atrial septal aneurysm and/or a large-shunt. Clinical inputs were derived from the RESPECT study and literature. Costs associated with the device, drugs, and management were sourced from literature and national databases. The outcomes of analyses included life-years (LYs), quality-adjusted LYs (QALYs), incremental cost-effectiveness ratio (ICER), and number of recurrent strokes avoided. Scenario and sensitivity analyses were conducted to assess the robustness of the results. RESULTS:The use of Amplatzer plus MT provided additional QALYs (0.16) at an incremental cost of 7301€, generating an ICER of 46,288€/QALY for Amplatzer vs. MT alone. In the sub-group analysis, Amplatzer plus MT provided additional QALYs (0.20) at an incremental cost of 5818€, generating an ICER of 28,624€/QALY for Amplatzer plus MT vs. MT alone. Amplatzer plus MT led to lower number of recurrent strokes in comparison to MT alone in both populations. Scenario and sensitivity analyses confirmed the robustness of the results. CONCLUSION:Amplatzer plus MT represents a cost-effective treatment option and is associated with lower stroke recurrence compared to MT alone for PFO patients with a prior history of stroke.