New PFO device for closure of patent foramen ovale in patients who had a history of cryptogenic stroke; a report of 14 cases.

OBJECTIVE

The Cocoon PFO Occluder is a device for percutaneous closure of inter-atrial communications. Its self-centering characteristics make it attractive for closure of patent foramen ovales (PFOs) with or without atrial septal aneurysms. The goal of this study is to report the immediate and follow-up results of the first 14 patients in implanted with the Cocoon PFO Occluder.

MATERIAL AND METHOD

This is a retrospective report of immediate and short-term clinical and echocardiographic outcome of patients who underwent transcatheter closure of PFO because of paradoxical embolism. Procedural success was defined as successful deployment of the device and effective occlusion (no, or trivial, shunt after device placement). All patients had a transesophageal echocardiography (TEE) with saline contrast injection at baseline and clinical follow-up at 6 months.

RESULTS

Between September 2012 and March 2014, 14 patients had successfully undergone transcatheter closure of PFO using Cocoon device. During follow-up none of the patients had a recurrence of stroke after device closure. No residual shunt was observed in any patients at follow-up.

CONCLUSION

Transcatheter closure of PFO with the Cocoon PFO device is safe and effective and can be used for preventing recurrent strokes in patients who present with cryptogenic stroke and PFO.