Is routine ultrasound guidance really necessary for closure of patent foramen ovale using the Amplatzer PFO occluder?
OBJECTIVE
The aim of the study was to evaluate safety, efficacy, and long-term clinical outcome of percutaneous closure of patent foramen ovale (PFO closure) in a low volume center using the Amplatzer PFO occluder without echocardiographic guidance.


BACKGROUND
Most centers perform PFO closure either by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance for optimal device selection. As TEE is poorly tolerated by patients in supine position and ICE is a costly alternative that increases vascular access complications, we wanted to assess the safety and efficacy of PFO closure by fluoroscopic guidance only.


METHODS
Before PFO closure, all patients had a diagnostic contrast-TEE and morphological classification of PFO. All PFO closures were performed using the 25-mm Amplatzer PFO occluder with fluoroscopic guidance only. Intraprocedural echocardiography was replaced by right atrial opacification using contrast angiography. Contrast TEE was done after 6 weeks, contrast TTE after 3, 6, and 12 months postprocedural.


RESULTS
In all 92 patients (52.4 +/- 1.5 years), a 25-mm Amplatzer PFO occluder was implanted in the correct position. Total fluoroscopic time was 8.4 +/- 0.6 minutes and the application of contrast medium was 122.5 +/- 5.8 mL. By contrast-TEE, 12 patients (13 %) showed a small residual shunt (grade 1). During follow-up (2.09 +/- 0.13 years) two patients (2.1%) suffered from a recurrent event (TIA in both cases).


CONCLUSIONS
Percutaneous closure of PFO using the 25-mm Amplatzer PFO occluder guided by fluoroscopy only is a safe and efficacious intervention for nearly all patients.
Fateh-Moghadam
Suzanne
S
Medizinische Klinik mit Schwerpunkt Kardiologie, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum, Humboldt-Universität zu Berlin, Germany. suzanne.fateh-moghadam@charite.de
Steeg
Martin
M
Dietz
Rainer
R
Bocksch
Wolfgang
W
D006328:Cardiac Catheterization; D004452:Echocardiography; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019919:Prosthesis Implantation; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional