BACKGROUND: Despite the overall high success rate of per-cutaneous intervention in congenital defects, the possibility of having a percutaneous bioabsorbable implantable device is extremely desirable. The initial experience of the authors with a new partially bioabsorbable prosthesis is reported in this study. METHOD: Patients with patent foramen ovale (PFO), with at least one previous embolic event, without additional surgical defects were selected. Diagnosis was made by transesophageal echocardiography (TEE) and the bubble test. Devices were chosen according to length and opening of PFO at the TEE. Patients were followed-up by transthoracic echocardiogram at 1 and 3 months and TEE at 6 months post implantation. Patients received a combination of acetylsalicylic acid and clopidogrel for 3 months and acetylsalicylic acid for another 3 months. Patients were maintained on antimicrobial prophylaxis for infectious endocarditis for 6 months. RESULTS: Nine patients (5 male and 4 female) were treated from February to August 2010. Mean age was 43.4 ± 13.5 years and mean weight was 71.4 ± 16.3 kg. Pulmonary arterial pressure was normal in all of the patients. PFO tunnel lengths ranged from 6-11 mm and the opening ranged from 2-3 mm. Mean range from rest to stretched PFO opening was 2.1 ± 0.8 mm. Prosthesis implantation was possible in all of the cases. Thirteen devices were used in 9 patients, and one of them required a second device for an additional orifice. No major complications or procedure-related deaths were observed. CONCLUSION: The use of the BioSTAR TM device was safe and effective. It is an excellent alternative for PFO closure.
Foramen ovale, patent; Heart catheterization; Prostheses and implants
