Transcatheter closure of patent foramen ovale with the Spider patent foramen ovale occluder: a prospective, single-center trial.

Background Transcatheter closure of patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulation therapy to prevent paradoxical embolic events in patients with PFO. Several different devices have been used for transcatheter PFO closure. The aim of the present study was to evaluate the safety and feasibility for closure of PFO with a new PFO occluder, the Spider (TM) PFO occluder. Methods The device was implanted in the PFO patients under fluoroscopy and transthoracic echocardiography (TTE) using a 10 French delivery sheath employing a femoral vein approach. Aspirin was administered at 100 mg/d for six months after occlusion. The clinical and echocardiographic follow-up of patients were performed at the 24th hour, 1st month, 3rd month, 6th month, and 12th month after occlusion, and yearly thereafter. Results The device was implanted successfully in all 55 patients. No major complications occurred during the perioperative period, such as thromboembolism, occluder dislodgement, infection or myocardial infarction. No residual shunt of the atrial level was shown by transesophageal echocardiography, and no latent arrhythmia or cerebral vessel events occurred in any cases during follow-up ((35 +/- 9) months, range 6-51 months). Conclusion Transcatheter closure of a PFO with the Spider (TM) PFO occluder is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. However, randomized trials comparing this device with other devices and therapies have to be performed. Chin Med J 2010;123(7):834-837