Abstract 1696: Safety and Feasibility of Percutaneous Closure of Patent Foramen Ovale Without Intra-Procedural Echocardiography in 825 Patients
Background: Percutaneous closure of patent foramen ovale (PFO) is generally performed using intra-procedural guidance by transesophageal (TEE) or intracardiac (ICE) echocardiography. While TEE requires sedation or general anesthesia, ICE is costly and adds risk. Both imaging modalities lengthen the procedure.
Methods: A total of 825 consecutive patients (51±13 years; 58% male) underwent percutaneous PFO closure solely under fluoroscopic guidance, without intra-procedural echocardiography, using 8 different devices, according to historical availability (83% Amplatzer PFO Occluders). Indications were paradoxical embolism in 698 patients (95% cerebral, 5% other locations), an embolic event with concurrent etiologies in 47, diving in 51, migraine headaches in 13, and others in 16. An atrial septal aneurysm (ASA) was associated with the PFO in 242 patients (29%).
Results: Device implantation failed in 2 patients (0.2%). There were 18 procedural complications (2.2%), including embolization of the device or parts of it with successful percutaneous removal in 5 (0.6%) patients, air embolism with transient symptoms in 4 (0.5%), pericardial tamponade requiring pericardiocentesis in 1 (0.1%), a TIA with visual symptoms in 1 (0.1%), and vascular access site problems in 7 patients (0.9%, with simultaneous coronary angiography in 5). For Amplatzer PFO Occluders, device success was 100%, and complication rate 0.9%. None of the complications had long-term sequelae. Total procedure time, including incidental coronary angiography in 591 patients (72%), and ad hoc PCI in 41 (5%), was 45±25 min. Total fluoroscopy time was 9±8 min. Patients with small devices (<30 mm; n=701) had less procedural complications (1.4% vs. 6.6%; p=0.0003). Patients with an associated ASA (n=242; 29%) had similar device success (99.6% vs. 99.8%; p=0.52) and complication rates (2.1% vs. 2.2%; p=0.88). Contrast TEE at 6 months showed complete occlusion in 88% of patients (90% with Amplatzer PFO Occluders), whereas a minimal, moderate, or large residual shunt persisted in 7%, 3%, and 2%, respectively.
Conclusions: This study confirms the safety and feasibility of percutaneous PFO closure without intra-procedural echocardiographic guidance in a large cohort of consecutive patients.