作者
Aimee K Armstrong, David T Balzer, Allison K Cabalka, Robert G Gray, Alexander J Javois, John W Moore, Jonathan J Rome, Daniel R Turner, Thomas M Zellers, Jacqueline Kreutzer
发表日期
2014/11
期刊
JACC: Cardiovascular Interventions
卷号
7
期号
11
页码范围
1254-1262
出版商
American College of Cardiology Foundation
简介
Objectives
This study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to the historical results established in the initial 5-center Investigational Device Exemption trial.
Background
TPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device.
Methods
Patients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient ≤30 mm Hg, pulmonary regurgitation less than moderate as measured by …
学术搜索中的文章
AK Armstrong, DT Balzer, AK Cabalka, RG Gray… - JACC: Cardiovascular Interventions, 2014