Transcatheter ventricular septal defect closure with a new nanoplatinum-coated nitinol device in a Swine model.

OBJECTIVES: To evaluate the feasibility and efficacy of a new nanoplatinum-coated nitinol device for transcatheter ventricular septal defect (VSD) closure in a swine model. BACKGROUND: In spite of its good closure results, the previous version of Amplatzer perimembranous VSD device had a relatively high incidence of complete heart block as compared to surgical closure. This new VSD device is made from meshed nitinol wires, nanoplatinum-coated and filled with polypropylene sheaths to enhance thrombogenicity. With special design, the device has minimal expanding pressure on the nearby tissue. This may reduce the possibility of atrioventricular block after implantation. METHODS: VSD was created in 12 pigs via retrograde aortic approach, by ventricular septal puncture with Brokenbrough needle and ventricular septal balloon dilation, under echocardiographic and fluoroscopic guidance. After imaging study, the device was deployed for VSD closure. RESULTS: The device was successfully deployed to close the created VSD in all 12 animals. Angiographic and echocardiographic studies demonstrated complete closure of the VSD in 11 animals. One animal had residual VSD leakage. Three animals had unstable hemodynamics and died within 12 hours after the procedure. The remaining 9 animals survived in normal condition. The autopsy findings demonstrated complete endothelialization at 8 weeks after implantation. CONCLUSION: Transcatheter VSD closure with the new nanoplatinum-coated nitinol device is feasible and efficacious. The good occlusion results and complete endothelialization after implantation in the swine model potentiates human application.