New bioabsorbable septal repair implant for percutaneous closure of a patent foramen ovale: Short-term results of a single-centre experience

Background: Permanent implants for closure of a patent foramen ovale (PFO) have a number of possible disadvantages including erosions, thrombus formation, and allergic reactions. The incidence of adverse events may be lower using a bioabsorbable device. Objective. To evaluate the short-term safety and efficacy of a new bioabsorbable closure device. Methods: All 35 consecutive patients (21 female, mean age 47.9 ± 10.8 years), who underwent a percutaneous PFO closure between November 2007 and July 2008, were included. All complications were reported. The efficacy was based on the residual shunting the day after implant and at 1 month follow-up and was graded as minimal, moderate, or severe, using contrast transthoracic echocardiography with the Valsalva manoeuvre. Results: The only in-hospital complication was a surgical device retrieval from the femoral vein. Four patients developed a minimal inguinal haematoma. One day after closure, residual shunting was present in 56% of the patients (minimal 27%, moderate 23% and severe 6%). At 1 month follow-up (n = 33), one patient developed a transient neurological deficit and three patients suffered from paroxysmal atrial fibrillation. A residual shunt at 1 month was present in 45% of the patients (minimal 30%, moderate 12%, and severe 3%). Conclusions: Percutaneous PFO cloture using the bioabsorbable closure device seems to be safe. However, a high rate of residual shunting is present at 1 month follow-up. Long term follow-up data are necessary to evaluate the efficacy and safety of this device.