Patent foramen ovale treatment strategy: an Italian large prospective study.

Aim: There is still controversy regarding the benefit of percutaneous closure of patent foramen ovale (PFO) among patients with cryptogenic stroke. Here we aimed to evaluate the factors associated with treatment choice and predictors of adverse events in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO.

Methods: Of 418 consecutive patients with PFO and cryptogenic stroke or TIA, 262 underwent percutaneous PFO closure, whereas 156 were medically treated. Multivariable logistic regression models were developed to evaluate factors influencing the treatment strategy and predictors of outcome, a composite of stroke, TIA or all-cause mortality.

Results: Patients with large interatrial right-to-left shunt were more likely treated with percutaneous closure [odds ratio (OR) = 4.79, 95% confidence interval (2.73-8.42); P < 0.0001], whereas those with multiple cerebrovascular accident (CVA) risk factors were more likely treated medically [OR = 0.15 (0.03-0.60); P = 0.023]. Age greater than 55 years [OR = 2.70 (1.05-6.88); P = 0.04], previous CVAs [OR = 2.49 (1.03-6.02); P = 0.02] and atrial septal aneurism [ASA, OR = 2.64 (1.09-6.39); P = 0.02], but not percutaneous closure of PFO [OR = 1.10 (0.44-2.74); P = 0.81], were independent predictors of outcome.

Conclusion: Among patients with cryptogenic stroke and PFO, the presence of large interatrial right-to-left shunt and multiple CVA risk factors influenced the treatment choice. Older age, multiple previous CVAs and ASA, but not PFO closure, independently predicted the composite outcome of cryptogenic stroke, TIA or all-cause mortality.