Abstract 3050: New Bioabsorbable Septal Repair Implant for Percutaneous Closure of a Patent Foramen Ovale : Short-Term Results of a Single-Centre Experience
Background: The use of permanent implants for closure of a patent foramen ovale (PFO) has a number of disadvantages including erosions, thrombus formation and allergic reactions. These might be absent using the new BioSTAR® (NMT Medical, Boston, USA) closure device because it will be absorbed and replaced with healthy native tissue. We describe the short-term safety and efficacy of this new device.
Methods: All consecutive patients, undergoing a percutaneous PFO closure with the bioabsorbable closure device between November 2007 and May 2008, were included. The efficacy was based on the residual shunting and graded as minimal, moderate or severe, using contrast transthoracic echocardiography (cTTE) with the Valsalva manoeuvre.
Results: Twenty-nine patients (13 women) with a mean age of 49.5±10.9 years were included in the study. Indications for closure were cryptogenic stroke (n=28) and decompression illness (n=1). Closure was performed under general anaesthesia with transoesophageal echocardiographic guidance (n=6) or local anaesthesia with intra-cardiac echocardiographic guidance (n=23). The device diameters were 28 mm (n=26) and 33 mm (n=3). In-hospital complications were a surgical device retrieval from the femoral vein and atrial fibrillation, both in one patient, two patients developed an inguinal haematoma. One day after closure, residual shunting was present in 54 % of the patients (minimal 29%, moderate 18% and severe 7%). At one month follow up (n=22), 1 patient developed a TIA in the presence of a residual shunt, and 1 patient suffered atrial fibrillation. A residual shunt at one month was present in 50 % of the patients (minimal 32 %, moderate 14%, large 5%).
Conclusion: Percutaneous PFO closure using the new bioabsorbable closure device seems to be safe. However, a high rate of residual shunting is present at short-term follow-up. Long-term follow-up data will be necessary to evaluate the residual shunting and safety of this new device. Intracardiac echocardiographic guidance without general anaesthesia is safe en facilitates the procedure.