Abstract 3049: Long Term Results of Transcatheter Patch Occlusion of Atrial Septal Defects: Benefits and Problems of a Frameless Bioabsorbable Device
We examined the hypothesis that a bioabsorbable and frameless device like the Transcatheter Patch (TP) could influence the long term effectiveness and safety of atrial septal defect (ASD) occlusion following already known early implantation results. The TP is made by polyurethane which is absorbed and replaced by connective tissue and endothelium as seen in animal histopathology. The implantation and follow-up records of 86 successfully implanted patients with the TP records were reviewed. The patients were followed non-invasively for a mean time of 4.25 yrs (1–9 yrs). The TP was sized by planimetry on implantation, one month, six months, one year and on latest follow-up, by echocardiography on apical 4-chamber view. The patch sizes and occlusion rates were correlated. Eighty six ASDs with a mean diameter of 25 mm (12–35 mm) were implanted with the TP in different centers; the TP was released in 48 hrs in 76 patients (fibrin mediated adhesion) and in less than 24 hrs in 10 ( use of surgical adhesives). Most of ASDs were secundum except for two sinus venosus and one ostium primum. The patch size decreased to 68% of the original size in one month, 43% in six months and 36% at one year with additional decrease later on. The effective occlusions (full occlusions and trivial shunts) were 92% on implantation and 96.5% on latest follow-up. There were no serious device related complications on follow-up. There were three re-interventions for additional defects or residual shunts. In conclusion bioabsorption of the TP is actually improving the effectiveness of ASD occlusion on follow-up; the long term safety of the method is excellent lacking the rare serious complications of metal devices.