Pediatric and Congenital Heart Disease
Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke
Article first published online: 12 OCT 2006
Copyright © 2006 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions
Volume 68, Issue 5, pages 741–746, November 2006
How to Cite
Thanopoulos, B. D., Dardas, P. D., Karanasios, E. and Mezilis, N. (2006), Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke. Cathet. Cardiovasc. Intervent., 68: 741–746. doi: 10.1002/ccd.20868
- Issue published online: 25 OCT 2006
- Article first published online: 12 OCT 2006
- Manuscript Accepted: 1 JUN 2006
- Manuscript Received: 23 MAR 2006
- patent foramen ovale;
- cryptogenic stroke;
- device closure
Objectives: The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS). Background: There are no controlled data to support the therapeutic value of PFO closure with a device compared to medical treatment in patients with CS. Methods: We performed a nonrandomized, prospective, patient preference case series comparing the recurrence rate in 92 patients with PFO and CS who were treated either with antiplatelet agents (44 patients) or underwent catheter closure (48 patients) using the Amplatzer PFO occluder (APFOO). All patients completed a 2-year follow-up. Results: PFO closure group. Immediate complete closure (CC) was observed in 44/48 (91%) patients. Four (9%) patients had a minimal residual shunt immediately after the procedure. One patient developed hemopericardium that was successfully managed by pericardiocentesis. No other complication was observed. Follow-up. PFO closure group. Contrast bubble study at 6-month follow-up confirmed CC in all 48 patients. No complications were observed. Antiplatelet therapy group. Three (6%) and 6 (13%) patients had a major and minor hemorrhagic event, respectively. The average incidence of embolic events/year was 0 and 14.75% for the PFO closure group and the antiplatelet therapy group, respectively (P < 0.001). Conclusions: PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy. © 2006 Wiley-Liss, Inc.