Cost effectiveness of percutaneous closure versus medical therapy for cryptogenic stroke in patients with a patent foramen ovale.

In patients with patent foramen ovales (PFOs) and cryptogenic stroke, observational studies have demonstrated reductions in recurrent neurologic events with transcatheter PFO closure compared with medical therapy. Randomized controlled trials and meta-analyses have shown a trend toward benefit with device closure. The cost-effectiveness of PFO closure has not been described. Therefore, a detailed cost analysis was performed using pooled weighted outcome and complication rates from published randomized controlled trials, Medicare cost tables, and wholesale medication prices. Incremental cost per life-year gained and per quality-adjusted life-year (QALY) gained by PFO closure was calculated. The commonly accepted cost-effectiveness threshold of <$50,000/quality-adjusted life-year gained was used. At 2.6 years (the mean duration of randomized controlled trial follow-up), PFO closure was more costly ($16,213, 95% confidence interval [CI] $15,753 to $16,749) per patient, with a cost of $103,607 (95% CI $5,826 to $2,544,750) per life-year gained. The expenditure to prevent 1 combined end point (transient ischemic attack, stroke, and death) at 2.6 years was $1.09 million (95% CI $1.04 million to $1.20 million). Modeling the costs of medical treatment prospectively, PFO closure reached cost-effectiveness (<$50,000/quality-adjusted life-year gained) at 2.6 years (95% CI 1.5 to 44.2). At 30.2 years (95% CI 28.2 to 36.2), the per patient mean cost of medical therapy exceeded that of PFO closure. In conclusion, PFO closure is associated with higher expenditures related to procedural costs; however, this increase may be offset over time by reduced event rates and costs of long-term medical treatment in patients who undergo transcatheter PFO closure. In younger patients typical of cryptogenic stroke, PFO closure may be cost effective in the long term.