Percutaneous PFO closure using the Premere device occluder: initial experience.

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Percutaneous closure of patent foramen ovale (PFO) often utilizes devices not specifically designed for this condition.
• Limited data exists on the efficacy of specialized PFO closure systems.

Purpose of the Study:

• To evaluate the initial clinical experience with the Premere PFO closure system.
• To assess the safety and efficacy of the Premere device in patients with cryptogenic stroke.

Main Methods:

• A cohort of 14 consecutive patients with cryptogenic stroke underwent percutaneous PFO closure using the Premere system.
• Device implantation success rates and reasons for failure were recorded.
• Clinical and echocardiographical follow-up was performed to assess outcomes and complications.

Main Results:

• Successful implantation was achieved in 11 out of 14 patients (78.5%).
• A residual shunt was observed in only one patient (9%) at three months post-implantation.
• No device-related complications (thrombosis, fistula) or significant clinical events (stroke, arrhythmia) occurred during follow-up.

Conclusions:

• The Premere device appears to be a safe and reliable option for PFO closure.
• Careful patient selection, excluding those with significant atrial septal aneurysms, is crucial for successful implantation and optimal outcomes.