Extended Application of Self-Fabricated Covered Stents for Interventions in Adults with Congenital Heart Disease

Abstract

Background: Covered stents are widely used outside of the United States to treat adult patients with congenital heart disease. However, these stents have not been approved by the United States Food and Drug Administration (FDA). We describe our experience with large diameter, self-fabricated covered stents for patients with congenital heart disease. Methods: We retrospectively examined results of adults with congenital heart disease who received a selfdesigned covered stent at our institution. We detailed our method of fabricating the covered stent and modifications in delivery to minimize traction or trauma against the outer covering of the stent. Conclusions: Our self-fabricated covered stents were safe and provided effective gradient reduction or intraluminal continuity to treat individualized lesions related to congenital heart disease. Covered stents increase the therapeutic options for the interventional cardiologist and in some cases may be safer for the patient. There needs to be increased pressure from providers towards the FDA to approve these stents in the United States.