Author + information
- Aimee K. Armstrong, MD∗∗ (, )
- David T. Balzer, MD†,
- Allison K. Cabalka, MD‡,
- Robert G. Gray, MD§,
- Alexander J. Javois, MD‖,
- John W. Moore, MD¶,
- Jonathan J. Rome, MD#,
- Daniel R. Turner, MD∗∗,
- Thomas M. Zellers, MD†† and
- Jacqueline Kreutzer, MD‡‡
- ∗Department of Pediatrics and Communicable Diseases, Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Michigan
- †Department of Pediatrics, Division of Pediatric Cardiology, St. Louis Children’s Hospital, St. Louis, Missouri
- ‡Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota
- §Department of Pediatric Cardiology, University of Utah, Salt Lake City, Utah
- ‖Department of Pediatrics, Division of Pediatric Cardiology, Hope Children’s Hospital, Oak Lawn, Illinois
- ¶Division of Cardiology, Department of Pediatrics, Rady Children’s Hospital, San Diego, California
- #Division of Cardiology, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- ∗∗Division of Cardiology, Carman and Ann Adams Department of Pediatrics, Children’s Hospital of Michigan, Detroit, Michigan
- ††Division of Cardiology, Department of Pediatrics, Children’s Medical Center, Dallas, Texas
- ‡‡Division of Pediatric Cardiology, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh, Pittsburgh, Pennsylvania
- ↵∗Reprint requests and correspondence:
Dr. Aimee K. Armstrong, University of Michigan C.S. Mott Children’s Hospital, Floor 11, 1540 East Hospital Drive, Ann Arbor, Michigan 48109-4204.
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)
- congenital heart disease
- pulmonary regurgitation
- right ventricular outflow tract conduit
- transcatheter heart valve
This study was sponsored by Medtronic, Inc. (Minneapolis, Minnesota). Dr. Armstrong has received a research grant from Edwards Lifesciences. Drs. Balzer and Kreutzer are proctors for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 19, 2014.
- Accepted August 28, 2014.