Objective: To study the feasibility, efficacy, and safety of total percutaneous correction of a tetralogy of Fallot variant with dominant pulmonary valve stenosis. Design: Percutaneous correction of a variant of tetralogy of Fallot with dominant pulmonary valve stenosis, on the basis that there are transcatheter methods for the correction of malalignment-type ventricular septal defect (VSD) (transcatheter patch) and valvar pulmonary stenosis (balloon valvoplasty). Patients: Two patients with tetralogy of Fallot, 4 and 7 years old, were admitted for percutaneous correction. Their aortic saturations were 72% and 88%. Both had severe right ventricular outflow obstruction with dominant valvar pulmonary stenosis with total gradients of 120 and 70 mm Hg. Large malalignment subaortic VSDs, 14 and 16 mm in diameter, were present. The first patient had a previous percutaneous correction of a small atrial septal defect and an aortopulmonary collateral. Interventions: Balloon valvoplasty was first performed, followed by balloon test occlusion of the VSD and double balloon patch occlusion. Forty eight hours after implantation the supporting balloons were extracted, releasing the patches. Results: Both patients became acyanotic with oxygen saturations of 96%. There was mild residual infundibular stenosis with 40 and 30 mm Hg gradients. Both VSDs were effectively occluded with only trivial residual shunts. One patient developed mild haemolysis, which resolved spontaneously in a few days. Both patients were doing well at six and 12 months’ follow up visits. Conclusions: Total percutaneous correction of the tetralogy of Fallot variants with dominant pulmonary valve stenosis is feasible and successful. Larger clinical trials are required to further assess effectiveness and safety.

Sixteen surgical candidates for ventricular septal defect correction were brought to the catheterization laboratory for transcatheter patch occlusion. There were 3 cases of nonrestrictive ventricular septal defects, including 2 with malalignment (tetralogy of Fallot). All patients, except those with tetralogy of Fallot who were cyanotic, had large left-right shunts. They were all corrected through the femoral vein. All defects with the exception of 2 were successfully occluded (12 full occlusions, 2 residual shunts). On follow-up, there were no embolizations, aortic insufficiency, or other complications. The method appears effective and relatively safe, and could challenge the current surgical standard of treatment. (c) 2005 by Excerpta Medical Inc.

The efficacy and safety of the transcatheter patch (TP) correction of a secundum atrial septal defect (ASD) was studied acutely and on short-term follow-up in 20 patients, successfully implanted with the device. TPs are made of polyurethane foam and require temporary balloon catheter immobilization on the atrial septum for 48 hours. Eighteen patients were not suitable for disk-device repair. The patient median age and ASD diameter were 37 years and 26 mm, respectively. Eighteen patients had immediate effective ASD occlusion; 2 patients had significant residual shunts. Premature leaks of the supportive balloons were responsible for the residual shunts. One of the patients with residual shunt received a second patch 6 months later with full occlusion. All patients with implants were doing well up to 24 months after implantation. Existing symptoms improved although residual shunts remained; septal anatomy was normalized, with the patched area becoming progressively indistinguishable from the rest of the septum. In conclusion, TP occlusion of secundum ASD is feasible and effective even for defects unsuitable for disk-device repair. The method appears safe acutely and on short-term follow-up, with symptomatic improvement and normalization of septal anatomy.

The effectiveness and safety of transcatheter patch atrial septal defect (ASD) occlusion were studied in 20 piglets. Experimental atrial septal defects were created by foramen ovale dilation. ASDs were corrected by polyurethane patches of two types (flat and sleeve). Specially made balloon catheters supported the patches for periods varying from 1 to 6 days; after this period, the supporting catheters were withdrawn and the patches were released. All transcatheter patches were safely embedded in the atrial septum 48 hr or more after implantation. All defects were fully occluded. One patch became infected. The transcatheter patch experimental ASD occlusion method was found effective and safe, potentially applicable in the occlusion of human ASDs.