Occlusion of PFO with a dedicated adjustable device: influence on one year outcome.

Aims: Though the association of patent foramen ovale with cryptogenic stroke in young patients has been known for 20 years, most interventional closure systems are not specifically designed for PFO closure, but instead are adapted from ASD closure systems. We describe the safety, feasibility and efficacy of transcatheter closure of PFO using a dedicated adjustable device specifically designed to overcome some of the pitfalls of PFO occlusion like erosion, left atrial thrombus formation, embolisation, maladaptation to cardiac structures and excessive foreign material deposition. Methods and results: Seventy-two consecutive patients, aged between 20 and 72 years, underwent PFO occlusion using the Premere (R) PFO occluder, for the greater part for presumed paradoxical embolism causing cryptogenic stroke or transient ischaemic attack. Forty patients received the 20 mm, while 32 received the 25 mm device. Implantation was successful in all patients. Residual shunt rate, excluding absolutely trivial shunts, was 2.8% at six months on contrast TEE study. Peri- and postprocedural adverse events with some possibility of a causal link to the procedure occurred in six patients. The postprocedural annual recurrence rate (0.99%) was lower than reported in most other series. Conclusions: PFO occlusion using the dedicated Premere (R) PFO occluder is effective and safe. The residual shunt rate and post-interventional recurrence rate compares favourably to the literature.