A Novel System for Transcatheter Closure of Patent Foramen Ovale: Clinical and Echocardiographic Outcome Comparison With Other Contemporary Devices

Background: Effective closure performance for patent foramen ovale (PFO) has been suggested to be one of the factors that plays a relevant role in future clinical outcomes after stroke or transient ischemic attack. Methods: Between January 2009 and June 2012, all consecutive patients undergoing transcatheter PFO closure in our institution using the Amplatzer PFO Occluder (APO) (St Jude Medical, St Paul, MN), BioSTAR (NMT Medical Inc, Boston, MA), GORE HELEX (HELEX) (W.L. Gore & Associates, Newark, DE), and GORE Septal Occluder (GSO) (W.L. Gore & Associates) were included. Closure performance was assessed using transesophageal echocardiography 4 months after the index procedure. Results: One hundred ninety-three patients were included in the study. Patient distribution was as follows: (1) 48 GSO (24.8%); (2) 34 HELEX (17.6%); (3) 74 APO (38.3%); and (4) 37 BioSTAR (19.1%). No complications occurred during device implantation. During clinical follow-up (20.8 +/- 13.2 months), 2 (1.1%) patients had a stroke, 3 (1.7%) patients had a peripheral embolism, and 8 (4.7%) patients presented with a documented atrial arrhythmia. There were no significant differences in clinical outcomes among the devices. Transesophageal echocardiography follow-up revealed higher closure rates with GSO (92.6%) and BioSTAR (93.7%) compared with HELEX (74.2%; P = 0.031 and P = 0.034, respectively) and APO (76.4%; P = 0.036 and P = 0.041, respectively). Conclusions: The GSO and BioSTAR showed better closure rates than HELEX and APO at 4 months. PFO closure is a safe procedure with a low rate of clinical events at follow-up.