Percutaneous device closure of patent foramen ovale using the premere occlusion device: Initial experience, procedural, and intermediate-term results

Background: Percutaneous device closure is a therapeutic option in patients with presumed stroke complicating paradoxical emboli. Newer devices with lower profiles and potentially reduced thrombogenicity have emerged, such as the Premere PFO occlusion device (St Jude Medical, Inc.); there are limited data on the efficacy and procedural experience with this device. Methods: We evaluated our initial experience with the Premere device in a contemporary patient cohort, comparing the procedural and intermediate follow-up characteristics with the currently utilized Amplatzer PFO occluder. Results: Both devices were similarly effective in terms of immediate procedural success and defect closure. Procedures using the Premere device tended to be longer and required larger vascular access-sheath sizes; there were also significantly more adverse events in the Premere group (4/29) compared to the Amplatzer group (0/42; P=.02), including 1 retroperitoneal bleed, 2 hematomas, and 1 myocardial infarction. Conclusions: While the Amplatzer device may offer advantages in terms of safety and procedural simplicity, this in part reflects the early procedural experience with this new device. The Premere and Amplatzer PFO occlusion devices are similarly effective in achieving PFO closure when applied to appropriate anatomy and should be considered complementary when performing such procedures.