Outcome of Percutaneous Patent Foramen Ovale Closure with the Premere Occluder ? A Single Center Experience

Introduction: Percutaneous closure of patent foramen ovale (PFO) has become a widely used procedure in patients with suspected paradoxical embolism. Despite being generally safe and effective, the minimally invasive intervention has been associated with several serious complications such as air embolism, cardiac perforation, device embolization, device thrombus formation and puncture site problems. Unlike the conventionally used devices originally designed for closure of atrial septum defects, the novel Premere PFO Closure System (St. Jude Medical, St. Paul, MN, USA) was exclusively designed for PFO occlusion. We therefore aimed to evaluate the safety and efficacy of the novel Premere PFO Closure System in patients with PFO and a previous transient ischemic attack (TIA) or stroke. Methods: 67 patients (mean age 47 ± 29 years) who underwent PFO closure with the novel Premere device were analyzed retrospectively. Indications for PFO closure were prior stroke (n=42), transient ischemic attack (n=20), or other related clinical events such as peripheral embolism (n=5). PFO was documented in all patients by transthoracic and transesophageal echocardiography. Procedural success was confirmed by fluoroscopy with contrast injection through the guiding catheter. Mid-term safety and efficacy was evaluated by clinical follow-up, including echocardiography (TTE/TEE) scheduled at 6 months after PFO closure. Results: Follow-up data was available in 64 patients (95.5%). Device implantation was successful in all patients without any periprocedural complications. At clinical follow-up after a median of 189 ± 135 days, one patient (1.6%) presented with device thrombus, which resolved under oral anticoagulation without further complications. Another was diagnosed with new onset of atrial fibrillation. One patient each had experienced a recurrent stroke and a transient ischemic attack. While in the former case no residual shunt could be detected, the later was likely related to device malposition. At echocardiographic follow-up, significant residual shunt was noted in 6 patients (9.4%). Conclusion: In our series we demonstrate that percutaneous PFO closure using the dedicated Premere occluder is safe and effective. Type and rate of complications are in line with other studies assessing this closure device.