The objective of this study was to determine the feasibility of device closure of patent foramen ovale (PFO) for presumed paradoxical emboli without echocardiographic guidance or balloon sizing and the clinical outcome after device closure. Closure of the PFO has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli. At present, most centers perform device closure with transesophageal echocardiographic guidance and balloon sizing of the defect. Between May 1998 and April 2002, 92 consecutive patients underwent device closure for a PFO using fluoroscopic monitoring only. Procedural success and major complications were recorded. Follow-up outcomes were recurrence rate and residual atrial shunting on transthoracic echocardiography. All patients (mean age, 45 +/- 13 years; 52% male) had successful device deployment using either the CardioSeal (n = 78) and Amplatzer (n = 14) PFO occluders with no major complications. Mean procedure time and fluoroscopy time was 27 +/- 13 and 6 +/- 4 min, respectively. One patient had a residual shunt on echocardiography at 1 year. Cumulative event-free survival for recurrence of paradoxical embolus at 1 year was 97.3% +/- 1.8%. This study provides a basis for device closure of PFO becoming a safe, day-case procedure, resulting in a low rate of residual shunting and recurrent thromboembolic events.
Copyright 2004 Wiley-Liss, Inc.