One-Year Follow-Up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study

被引：102

作者：

Armstrong, Aimee K. ^{[1
]}

Balzer, David T. ^{[2
]}

Cabalka, Allison K. ^{[3
]}

Gray, Robert G. ^{[4
]}

Javois, Alexander J. ^{[5
]}

Moore, John W. ^{[6
]}

Rome, Jonathan J. ^{[7
]}

Turner, Daniel R. ^{[8
]}

Zellers, Thomas M. ^{[9
]}

Kreutzer, Jacqueline ^{[10
]}

机构：

[1] Univ Michigan, Dept Pediat & Communicable Dis, Div Pediat Cardiol, Ann Arbor, MI 48109 USA

[2] St Louis Childrens Hosp, Dept Pediat, Div Pediat Cardiol, St Louis, MO 63110 USA

[3] Mayo Clin, Div Pediat Cardiol, Rochester, MN USA

[4] Univ Utah, Dept Pediat Cardiol, Salt Lake City, UT USA

[5] Hope Childrens Hosp, Dept Pediat, Div Pediat Cardiol, Oak Lawn, IL USA

[6] Rady Childrens Hosp, Dept Pediat, Div Cardiol, San Diego, CA USA

[7] Childrens Hosp Philadelphia, Div Cardiol, Philadelphia, PA 19104 USA

[8] Childrens Hosp Michigan, Carman & Ann Adams Dept Pediat, Div Cardiol, Detroit, MI 48201 USA

[9] Childrens Med Ctr, Dept Pediat, Div Cardiol, Dallas, TX 75235 USA

[10] Univ Pittsburgh, Childrens Hosp Pittsburgh, UPMC, Div Pediat Cardiol, Pittsburgh, PA 15213 USA

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2014年 / 7卷 / 11期

关键词：

congenital heart disease; pulmonary regurgitation; right ventricular outflow tract conduit; transcatheter heart valve; RISK-FACTORS; IMPLANTATION; REPLACEMENT; TETRALOGY; IMPACT;

D O I：

10.1016/j.jcin.2014.08.002

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 echocardiography, and freedom from conduit reintervention and reoperation. RESULTS Cardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year. CONCLUSIONS This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692) (C) 2014 by the American College of Cardiology Foundation.

引用

页码：1254 / 1262

页数：9