Transcatheter patch closure of an atrial septal defect of sinus venosus type using the immediate release patch.

Following promising preclinical studies, we report our first clinical experience with transcatheter closure of an atrial septal defect of sinus venosus type in a 65-year-old patient using the Immediate Release Patch.

Closure of interatrial defects by immediate-release patch.

The Immediate-Release Patch is the newest version of the Transcatheter Patch, which is a bioabsorbable device for the closure of cardiac defects. Closure of 12 atrial septal defects and 1 fenestration was attempted using this device. Of the 13 devices used, 12 were implanted successfully (including that for the fenestration), whereas 1 device moved from the original position and was retrieved percutaneously. No other major adverse events occurred. After a median follow-up period of 11 months, trivial (≤ 2-mm) residual shunts remained in two patients, and a significant residual defect (7 mm) remained in 1 patient. The major advantages of this device include its wirelessness, its bioabsorbablity, potential application for defects up to 30 mm using only three sizes, its easier retrieval, and its ability to occlude defects with a deficient rim and some ostium primum and sinus venosus type defects. In contrast to the metal devices, it is bulkier and has a different application method requiring operator familiarity, and it sometimes leaves residual shunts.

Transcatheter patch occlusion of the left atrial appendage using surgical adhesives in high-risk patients with atrial fibrillation.

OBJECTIVES: The efficacy of left atrial appendage (LAA) occlusion using the Transcatheter Patch (TP) (Custom Medical Devices, Athens, Greece) in conjunction with surgical adhesives was assessed. BACKGROUND: The TP is a bioabsorbable device that can be adjusted for the shape and size of the LAA without the risk of perforation. It is attached by a surgical adhesive and is released in 45 min. METHODS: Occlusion of the LAA was performed in 20 high-risk patients, 59 to 89 years of age, with atrial fibrillation. A 2-stage polyethylene glycol surgical adhesive was applied to the distal half of the device. Activation of the adhesive was achieved by direct injection of alkaline solution. Fluoroscopy and transesophageal echocardiography only were used for device placement in 17 patients. In 3 patients, angiography was used as well. Follow-up transesophageal echocardiography was performed upon discharge. RESULTS: The procedure was successful in 17 cases. In the 3 patients in whom angiography was performed, the patch did not attach and was retrieved. In 1 case, the patch was placed beyond the mouth of the appendage, resulting in a residual opening. There was further improvement of the occlusion rate on the follow-up transesophageal echocardiography. There was 1 complication related to the procedure, namely, thrombus was released from the long sheath in the left atrium upon withdrawal and required treatment to be dissolved. No recurrent strokes were reported. CONCLUSIONS: Occlusion of the LAA by the TP is feasible and effective in most patients with atrial fibrillation at high risk for embolic stroke. Angiography before placement probably affects patch adhesion and is contraindicated.

Transcatheter patch occlusion of perimembranous ventricular septal defects.

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.

Transcatheter patch occlusion of experimental atrial septal defects.

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.

Transcatheter patch correction of secundum atrial septal defects.

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.

Buttoned Device Occlusion of Patent Ductus Arteriosus.

Buttoned device, consisting of a square-shaped occluder and a rhomboid-shaped counter-occluder can be implanted across patent ductus arteriosus (PDA) via relatively small sheaths. In a large multi-institutional study, successful device implantation was achieved in 98% of patients. Decrease in the pulmonary-to-systemic flow ratio occurred. Effective occlusion was demonstrated in 88% of patients. PDAs could be occluded irrespective of their shape (conical, tubular, or short), length (short or long), or diameter (small or large). During follow-up for 1 to 60 months, 3% of patients required reintervention to treat residual shunts with (1%) or without (2%) hemolysis. There was gradual reduction and disappearance of the residual shunt during follow-up. Despite these encouraging results, patients with residual shunts are at risk for developing bacterial endocarditis. Therefore, the device was modified by incorporating a folding plug over the button loop, which resulted in complete occlusion of PDA at implantation.