Pulmonary Artery Stents-Still "Off Label"

In this issue of Korean Circulation Journal, Ko et al. report on the effectiveness and safety of percutaneous implantation of pulmonary arterial stents in congenital heart disease between 1999 and 2010 in one institute. Since Dr. Mullins recognized the potential for stents to treat pulmonary arterial stenosis effectively which were compared to the surgical methods, many reports about these experiences have been reported. Most of the studies demonstrated the effectiveness of pulmonary arterial stenting by increasing pulmonary artery size, reducing pressure gradients, decreasing right ventricular pressure and improving the disparity in pulmonary arterial blood flow. However, there are few reports with long-term follow-up data in a large population of patients, especially no multicenter, randomized controlled studies as Ko et al. noted. Therefore, in spite of the efforts of many doctors, the use of stents to treat pulmonary arterial stenosis is still considered “off label”-i.e., not approved by the Food and Drug Administration, even though the investigational device exemption (IDE) was obtained by Dr. Mullins’ efforts. Recently, Law et al. reported a long-term follow-up study including Dr. Mullins’ very first human implantation of stents in the pulmonary artery. They confirmed that intravascular stents maintained their safety and efficacy over 15-20 years in relieving branch pulmonary artery stenosis. However, the follow-up of this study also has limitations, that is, 18 of 68 patients were lost to follow-up less than 5 years after stent implantation. Current issues in pulmonary arterial stent implantation includEditorial