One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study

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, 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

Abstract

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).

Keywords: congenital heart disease; pulmonary regurgitation; right ventricular outflow tract conduit; transcatheter heart valve.

Copyright © 2014. Published by Elsevier Inc.

Source: PubMed

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