Percutaneous closure of patent foramen ovale without echocardiographic guidance.

ABSTRACT

BACKGROUND: A percutaneous patent foramen ovale (PFO) closure procedure includes transesophageal or intracardiac echocardiographic guidance at many centers. We investigated the feasibility and complications of the PFO closure without echocardiography. METHODS AND RESULTS: A total of 420 consecutive patients (185 women and 235 men, mean age 51 +/- 12 years) underwent percutaneous PFO closure without echocardiographic guidance using 7 different devices. Of these, 106 patients (25%) had an associated atrial septal aneurysm. The implantation was successful in 418 patients (99%). There were 12 procedural complications (3%), including embolization of the device or of parts of it with successful percutaneous removal in 5 cases, pericardial tamponade requiring pericardiocentesis in 1 patient, air embolism with transient symptoms in 3 patients, and vascular access problems in 3 patients. In none of the cases, echocardiography had to be summoned during the case or its lack was associated with acute or subsequent problems. The fluoroscopy time and procedure time were 5.4 +/- 2.7 and 25 +/- 17 minutes, respectively. Transthoracic contrast echocardiography, 24 hours after device implantation, detected a residual shunt in 19% of the patients. CONCLUSIONS: Percutaneous PFO closure with fluoroscopic guidance only is feasible and has low complication rates, especially with Amplatzer PFO Occluders. The added time and cost of echocardiography during the procedure is not warranted.