Objective: To investigate the safety and efficacy of patent foramen ovale (PFO) closure with Left-disk-coated PFO occluder.
Methods: The device was implanted in patients with PFO under the guidance of fluoroscopy and transthoracal echocardiography using a 10-12 French delivery sheath via femoral vein approach. Aspirin (100 mg/d for 6 months) was administered post procedure. Patients were followed clinically and echocardiographically at 24 hours, 1 month, 3 months, 6 months, and 12 months after device implantation and yearly thereafter.
Results: Permanent device implantation failed in one patient (4%) and succeed in the remaining 24 patients (96%). There were no major in-hospital-adverse events or complications (thromboembolism, occluder dislodgement, infection or myocardial infarction). Seven patients developed transient atrial premature beats or atrial tachycardia during implantation and stopped without medication post procedure. Follow-up [(25 + or - 12) months] results showed that all occluders were in position and there were no residual shunt, arrhythmia and cerebral vessel events post procedure.
Conclusion: Left-disk-coated PFO occluder is safe and effective for PFO closure.
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