Patent foramen ovale closure in patients over versus under 60 years old: a systematic review and meta-analysis

Abstract Background Recent evidence from randomized trials support patent foramen ovale (PFO) closure in patients with cryptogenic stroke. However, the majority of trials excluded older age individuals, and namely patients over 60 years old. Thus, current guidelines support the intervention in patients under 60, with no recommendation on older individuals. Purpose The aim of this meta-analysis is to analyze available evidence, comparing PFO closure in younger and older individuals. Methods A systematic search in medical literature databases was conducted. After selecting all appropriate trials according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a random effect meta-analysis was performed. Results A total of 6 studies and 2,744 patients were included in this analysis, of which 721 were over 60 years of age and 2,023 were under 60 years. Technical success was similar between the two cohorts Risk Ratio (RR): 1.00; 95% Confidence Interval (CI): 0.99-1.00, with also no difference noted in periprocedural complications (RR: 1.17; 95%CI: 0.72-1.92). At a mean of 5.3 years follow-up, there was a significantly higher risk of all-cause mortality (RR: 6.34; 95%CI: 2.55-15.77), as well as the composite of ischemic stroke and transient ischemic attack (TIA) (RR: 2.48; 95%CI: 1.22-5.05) in patients over 60 years old undergoing PFO closure. Significant differences were also independently noted in stroke (RR: 3.69; 95%CI: 1.88-7.24) and TIA (RR: 2.77; 95%CI: 1.77-4.35) events in older, compared to younger, individuals. Notably, a trend towards increase of new-onset atrial fibrillation in older patients, but no statistical significance, was found (RR: 2.01; 95%CI: 1.00-4.02). Conclusions Despite PFO closure in older patients has similar technical success and periprocedural complications to the currently indicated patient phenotype, the meta-analysis of available studies hints towards a potential increase of all-cause mortality and cerebrovascular events. More evidence from randomized trials is needed, in order to identify potential differences between these distinct patient groups and identify those individuals older than 60 years that would ultimately benefit from the procedure.