Early single clinical experience with the new Figulla ASD Occluder for transcatheter closure of atrial septal defect in adults

Background. Recently, the Occlutech Figulla ASD Occluder (FSO) has been introduced for transcatheter closure of atrial septal defects. This device can be used for transcatheter closure of small as well as large atrial septal defects. Aims. To evaluate the feasibility and short-term results of transcatheter closure of secundum type atrial septal defects using the FSO device in adult patients. Methods. Seventy-four consecutive adult patients were referred for transcatheter closure of secundum large atrial septal defects ("stretched" diameter > 20 mm and/or invasive pulmonary/systemic flow [Qp/Qs] ratio > 1.5) using the FSO device. Results. The FSO device was successfully implanted in 68 patients (mean +/- SD [range] age: 31.8 +/- 12.3 [17-64] years; weight: 71.5 +/- 18.4 [49-98] kg). All patients had right atrial and ventricular volume overload with a mean Qp/Qs ratio of 2.5 +/- 0.6 (range 1.5-3.8). Mean atrial septal defect diameter was 22.3 +/- 4.8 (range 12-33) mm and the size of the implanted FSO was 24.1 +/- 4.9 (range 12-36) mm. Two patients had trivial (jet width <1 mm in diameter) residual shunts and one patient had a small (1-2 mm) residual shunt. There were no moderate or severe residual shunts. No device embolization or other serious complication occurred during either the procedure or the follow-up. Conclusion. The present study found that transcatheter closure of isolated secundum atrial septal defects using the novel design of the FSO device was safe, effective, and had an excellent outcome during the 6 month follow-up period. (C) 2011 Elsevier Masson SAS. All rights reserved.