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Transcatheter Closure versus Medical Therapy of Patent Foramen Ovale and Presumed Paradoxical Thromboemboli: A Systematic Review

Paul Khairy, MD, MSc; Clare P. O'Donnell, MB, ChB; and Michael J. Landzberg, MD
[+] Article, Author, and Disclosure Information

From the Boston Adult Congenital Heart Service, Brigham and Women's Hospital and Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts.

Grant Support: In part by a fellowship award from Canadian Institutes of Health Research (Dr. Khairy).

Potential Financial Conflicts of Interest: Dr. Landzberg has participated in research trials involving numerous transcatheter devices, as well as medical therapies. On occasion, expenses related to these trials have been covered by individual pharmaceutical or manufacturing companies.

Requests for Single Reprints: Michael J. Landzberg, MD, Boston Adult Congenital Heart Service, Department of Cardiology, Children's Hospital Boston, 300 Longwood Avenue, Boston, MA 02115; e-mail, michael.landzberg@cardio.chboston.org.

Current Author Addresses: Drs. Khairy, O'Donnell, and Landzberg: Boston Adult Congenital Heart Service, Department of Cardiology, Children's Hospital Boston, 300 Longwood Avenue, Boston, MA 02115.

Ann Intern Med. 2003;139(9):753-760. doi:10.7326/0003-4819-139-9-200311040-00010
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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.


Grahic Jump Location
Figure 2.
Incidence of recurrent events by patient age per study for medical therapy and transcatheter closure of patent foramen ovale.

Solid lines are regression lines; the dotted line marks the zero level. TIA = transient ischemic attack.

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Figure 3.
Six-month rates of complete patent foramen ovale closure in studies of transcatheter device intervention.

The solid line is a regression line; the dotted line marks the zero level. TIA = transient ischemic attack.

Grahic Jump Location




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