Experience in patent foramen ovale closure with the CERA Lifetech occluder in patients with cryptogenic stroke.

INTRODUCTION

Nowadays, percutaneous closure of patent foramen ovale (PFO) in patients after cryptogenic stroke is becoming a dominating strategy. The most commonly used and investigated device is the Amplatzer occluder. However, several other devices have been designed for transcatheter closure of PFO, which are not so well examined.

AIM

To assess the effectiveness and safety of PFO closure with the Lifetech CERA occluder.

MATERIAL AND METHODS

A prospective, single-arm registry of patients with PFO treated with CERA occluder (Lifetech Scientific, Shenzhen, China) implantation was conducted. We assessed peri-procedural and 12-month follow-up. Patients were screened for the residual shunt in transcranial Doppler/transesophageal echocardiography.

RESULTS

Ninety-six patients entered the registry. Most patients were women (76%) and the analyzed group was relatively young (mean age of 42.3 ±13.6 years). Before closure, most patients had a large shunt through the PFO. Procedures of PFO closure were performed under TEE guidance. All procedures were made under local anesthesia and all patients had the PFO successfully closed. No device-related complications were reported in the peri-procedural period or during follow-up. No recurrent neurological ischemic events were reported at 12 months. During follow-up we observed a 9% rate of residual shunts, which were mostly small.

CONCLUSIONS

The study confirmed excellent immediate and 12-month results of CERA occluder implantation in patients with PFO.