Off-label use of duct occluder in transcatheter closure of secundum atrial septal defect with no rim to right pulmonary vein.

Objective: Transcatheter closure is usually contraindicated in secundum atrial septal defect with no rim to right pulmonary vein. The morphology of an atrial septal defect is special in these patients, and the off-label use of a duct occluder might make transcatheter closure possible with the assistance of a personalized heart model. However, the related data are absent. This study was performed to investigate the off-label use of a duct occluder in the transcatheter closure of an atrial septal defect with no right pulmonary vein rim. Methods: Seven consecutive patients with an atrial septal defect (2 male/5 female; 40.1 +/- 15.2 years) with no right pulmonary vein rim were referred for attempted transcatheter closure, and a personalized heart model was produced on the basis of multislice computed tomography images. With the elastic heart model, in vitro trial occlusion was performed with a duct occluder for preoperative evaluation, and the results were compared with postoperative outcomes. Results: A single atrial septal defect was identified in 6 patients, and a double atrial septal defect was identified in another patient (1 atrial septal defect with no right pulmonary vein rim and 1 with sufficient surrounding rims). The size of the atrial septal defect was 13.4 +/- 2.2 mm, and the in vitro balloon-stretched diameter was 20.2 +/- 3.2 mm in the heart model. In vitro trial occlusion was achieved in all patients, and subsequent in vivo transcatheter closure was performed successfully with the duct occluder of the same size (24.3 +/- 3.1 mm). During follow-up (1.57 +/- 0.84 years), mild pericardial effusion was identified in 2 patients and disappeared within 3 months. No other complications occurred. Conclusions: By using a personalized heart model, the off-label use of a duct occluder is feasible and safe in the transcatheter closure of an atrial septal defect with no right pulmonary vein rim. Further research is required to evaluate the long-term outcomes.