PFO closure found to be cost-effective following cryptogenic stroke

Recent studies have shown closing a patent foramen ovale (PFO) in select patients after cryptogenic stroke is associated with a lower risk of recurrent stroke. Now, according to a new analysis in Stroke, PFO occlusion in combination with antiplatelet treatment appears to be cost-effective when compared to medical therapy alone.

Michelle H. Leppert, MD, MBA, from the department of neurology at University of Colorado Denver, and colleagues pooled information from five randomized clinical trials on PFO closure and from national databases. They then used a Markov model to estimate the 15-year costs and outcomes associated with either PFO closure plus medical therapy or medication alone.

Comparing the two strategies, PFO closure was associated with a gain of 0.33 quality-adjusted life years (QALY) and a cost savings of $3,568 over the 15-year span, making it the “dominant” option by improving both areas. The authors found it would take only seven years to satisfy their prespecified willingness-to-pay threshold of $150,000 per QALY for cost-effectiveness.

“PFO closure for cryptogenic strokes in the right setting is cost-effective, producing benefit in QALYs gained and potential cost savings,” Leppert and coauthors wrote. “However, patient selection remains vitally important as marginal declines in treatment effectiveness can dramatically affect cost-effectiveness.”

Transcatheter PFO closure is expensive and associated with some complications, the authors noted, but cutting the risk of recurrent stroke may make the treatment worth it for many of these patients. This is particularly true because the average age of the cryptogenic stroke patients in this meta-analysis was 45, whereas the average age of incident ischemic stroke in the U.S. is 69 to 72 years.

“Younger patients with strokes have the potential to accrue more costs over their lifetime both from disability and lost income,” the researchers wrote. “Hence, therapies that reduce stroke recurrences in this population are vitally important.”

After the 15 years of this analysis, when patients got into their 60s, Leppert and coauthors noted the risk of incident ischemic stroke may trump the risk of recurrent events related to PFOs.

Leppert et al. reiterated that more work is necessary to define the optimum candidates for PFO closure, and to evaluate the procedure in older adults. For now, they said multidisciplinary teams including vascular neurologists and cardiologists should work together to determine when the intervention is a good fit.

“Further work is needed … to more definitively identify, through patient-level meta-analysis, subgroups that may derive more benefit from treatment such as larger PFOs, presence of an atrial septal aneurysm, or a venous hypercoagulability,” the authors wrote.