TY - JOUR
T1 - One-year follow-up of the melody transcatheter pulmonary valve multicenter post-approval study
AU - Armstrong, Aimee K.
AU - Balzer, David T.
AU - Cabalka, Allison K.
AU - Gray, Robert G.
AU - Javois, Alexander J.
AU - Moore, John W.
AU - Rome, Jonathan J.
AU - Turner, Daniel R.
AU - Zellers, Thomas M.
AU - Kreutzer, Jacqueline
N1 - Publisher Copyright:
© 2014 By The American College of Cardiology Foundation Published by Elsevier Inc.
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Congenital heart disease
KW - Pulmonary regurgitation
KW - Right ventricular outflow tract conduit
KW - Transcatheter heart valve
UR - http://www.scopus.com/inward/record.url?scp=84922564224&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2014.08.002
DO - 10.1016/j.jcin.2014.08.002
M3 - Article
C2 - 25459038
AN - SCOPUS:84922564224
SN - 1936-8798
VL - 7
SP - 1254
EP - 1262
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 11
ER -