In a 417-patient study by Chessa et al., the Cardio-SEAL/STARFlex was used in 159 patients and the ASO in 258 patients. Thirty-four patients experienced 36 com¬plications. Ten patients underwent elective surgical repair because of device malposition or embolization. Twenty-four patients experienced 25 minor complications, unsatis¬factory device position, or embolization. One patient had peripheral embolization one year after implantation and sudden death occurred in one patient 1.5 years later. The authors of the study concluded that the ASO device became their first choice for closing defects larger than 18 mm. Transcatheter closure of the hole in the atrial septum has evolved successfully over the past 20 years, but appropriate patient selection and expertise for deployment of the seal is crucial.

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