Abstract 11028: Meta-Analysis of Transcatheter Closure Versus Medical Therapy for Patent Foramen Ovale in Prevention of Recurrent Neurological Events After Presumed Paradoxical Embolism
Background: There is significant controversy surrounding the optimal strategy for treatment of cryptogenic stroke or transient ischemic attack (TIA) and coexistent patent foramen ovale (PFO). We performed a meta-analysis of existing observational studies to compare the rate of recurrent neurological events (RNE) between transcatheter closure and medical management of patients presenting with cryptogenic stroke or TIA and concomitant PFO.
Methods: We conducted a Medline search using standard search terms to determine eligible observational studies, and we also searched cross-references at the end of each included study.
Results: In the transcatheter closure arm, the incidence rate (95% confidence interval) of RNE was 0.7 (0.5-0.9) events per 100 person-years, which was significantly less compared to 4.4 (3.2 - 5.6) events per 100 person-years in the medical management arm (Figure1). Comparison of the anticoagulation and antiplatelet therapy subgroups of the medical arm yielded a significantly lower risk of RNE within patients treated with anticoagulants. Device related complications were encountered at the rate of 2.8 (2.4 - 3.4) events per 100 person years, with atrial arrhythmias being the most frequent complication. The risk of recurrent thromboembolism did not appear to be related to the presence of residual shunting in the follow-up period. The largest clinical experience was available from the Amplatzer Device with variable closure, RNE and complication rates.
Conclusions: There is a significant reduction in the rate of RNE with transcatheter PFO closure in patients presenting with cryptogenic stroke or TIA as compared to medical therapy alone. Further randomized controlled trials are needed to conclusively verify this finding.
- © 2011 by American Heart Association, Inc.