Transcatheter closure of atrial septal defects using the Cardio-Seal implant

Objective-To review the outcomes of transcatheter closure of atrial septal defects using the Cardio-Seal implant. Design-A prospective interventional study Setting-Tertiary referral centre. Patients-The first 50 patients (median age 9.7 years) who underwent attempt ed percutaneous occlusion. Interventions-Procedures were done under general anaesthesia and transoesop hageal guidance between December 1996 and July 1998. Main outcome measures-Success of deployment, complications, and assessment of right ventricular end diastolic diameter, septal wall motion? and occlus ion status by echocardiography. Results-The median balloon stretched diameter was 14 mm. Multiple atrial se ptal defects were present in 11 patients (22%) and a deficient atrial rim ( < 4 mm) in 19 (38%). In four patients (8%), a second device was implanted a fter removal of an initially malpositioned first implant. There were no sig nificant immediate complications. Ail patients except one were discharged w ithin 24 hours. At the latest follow up (mean 9.9 months) a small shunt was present in 23 patients (46%), although right ventricular end diastolic dim ensions (mean (SD)) corrected for age decreased from 137 (29)% to 105 (17)% of normal, and septal motion abnormalities normalised in all but one patie nt. No predictors for a residual shunt were identified. Supporting arm frac tures were detected in seven patients (14 %) and protrusion of one arm thro ugh the defect in 16 (32%), the latter being more common in those with smal ler anterosuperior rims. No untoward effects resulted from arm fractures or protrusion. There were no complications during follow up, although five pa tients (10%) experienced transient headaches. Conclusions-The implantation of the Cardio-Seal device corrects the haemody namic disturbances secondary to the right ventricular volume overload, with good early outcome.