Transcatheter closure of patent foramen ovale was associated with a 1-year recurrent neurologic thromboembolism rate of 0% to 4.9%, compared to 3.8% to 12.0% with medical management.
Systematic Review (n=2,250)
Does transcatheter closure reduce recurrent neurologic thromboembolism compared to medical therapy in patients with patent foramen ovale and presumed paradoxical emboli?
Transcatheter closure of PFO may prevent cryptogenic strokes compared to medical therapy, but definitive conclusions are precluded by limitations in the available observational data, highlighting the need for randomized trials.
BACKGROUND: The optimal strategy to prevent recurrent presumed paradoxical emboli in patients with patent foramen ovale is unknown. PURPOSE: To synthesize the current knowledge about and qualitatively assess the relative benefits of transcatheter closure versus medical therapy for patent foramen ovale. DATA SOURCES: English-language and foreign-language journals listed in the MEDLINE database from January 1985 to July 2003 were systematically searched. Secondary sources were also used. STUDY SELECTION: Secondary prevention studies of transcatheter closure or medical therapy for patent foramen ovale were required to include at least 10 patients followed for more than 1 year and to report recurrent neurologic events. DATA EXTRACTION: Data from published studies were manually extracted and summarized. DATA SYNTHESIS: Ten studies of transcatheter closure (1355 patients) and 6 studies of medical therapy (895 patients) for patent foramen ovale were included. Overall, the 1-year rate of recurrent neurologic thromboembolism with transcatheter intervention was 0% to 4.9%, and the incidence of major and minor complications was 1.5% and 7.9%, respectively. Medical management was associated with a 1-year recurrence rate of 3.8% to 12.0%. However, limitations resulting from uncontrolled data, nonstandardized definitions, vigilance of follow-up, and baseline imbalances preclude definitive conclusions about the superiority of a particular approach. General differences in study samples included older age, greater proportion of men, and higher prevalence of diabetes and smoking among medically treated patients. Patients undergoing treatment with a transcatheter device were more likely to have had multiple thromboembolic events at baseline. CONCLUSION: Transcatheter closure of patent foramen ovale may prevent a substantial proportion of cryptogenic strokes. Randomized clinical trials are needed.
Khairy et al. (Tue,) conducted a systematic review in Patent foramen ovale and presumed paradoxical thromboemboli (n=2,250). Transcatheter closure vs. Medical therapy was evaluated on Recurrent neurologic thromboembolism at 1 year. Transcatheter closure of patent foramen ovale was associated with a 1-year recurrent neurologic thromboembolism rate of 0% to 4.9%, compared to 3.8% to 12.0% with medical management.