Propensity-Score Matched Comparison of the Cera PFO Occluder With the Amplatzer PFO Occluder for Percutaneous Closure of Patent Foramen Ovale Without Echocardiographic Guidance.

Background: Percutaneous patent foramen ovale (PFO) closure has become a routine procedure and was proven to be safe and feasible. In a recently published pooled analysis of randomized trials, percutaneous PFO closure was shown to more effectively reduce recurrent stroke when compared with medical therapy in patients with cryptogenic strokes. However, procedural safety and closure rate are device dependent.

Methods: We performed a propensity-score matched comparison of 28 patients undergoing percutaneous PFO closure using the Cera PFO occluder (CPO) with 28 patients who received the Amplatzer PFO occluder (APO). The main endpoints were procedural complications and closure rate at 6 months verified by transesophageal echocardiography.

Results: The implantation procedure using the CPO was successful and without complications in all cases. After propensity-score matching, there was no significant difference between groups for the primary endpoint of residual shunt at 6 months (7% in the CPO group vs 4% in the APO group; log-rank test P=.15).

Conclusions: With regard to procedural safety and closure rate at 6 months, the performance of the CPO is comparable with the APO in this small patient cohort.