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One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study.
JACC Cardiovasc Interv. 2014 Nov; 7(11):1254-62.JC

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).

Authors+Show Affiliations

Department of Pediatrics and Communicable Diseases, Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Michigan. Electronic address: aimeearm@med.umich.edu.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.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25459038

Citation

Armstrong, Aimee K., et al. "One-year Follow-up of the Melody Transcatheter Pulmonary Valve Multicenter Post-approval Study." JACC. Cardiovascular Interventions, vol. 7, no. 11, 2014, pp. 1254-62.
Armstrong AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014;7(11):1254-62.
Armstrong, A. K., Balzer, D. T., Cabalka, A. K., Gray, R. G., Javois, A. J., Moore, J. W., Rome, J. J., Turner, D. R., Zellers, T. M., & Kreutzer, J. (2014). One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC. Cardiovascular Interventions, 7(11), 1254-62. https://doi.org/10.1016/j.jcin.2014.08.002
Armstrong AK, et al. One-year Follow-up of the Melody Transcatheter Pulmonary Valve Multicenter Post-approval Study. JACC Cardiovasc Interv. 2014;7(11):1254-62. PubMed PMID: 25459038.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2014/11/17/ PY - 2014/08/19/received PY - 2014/08/28/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2015/8/5/medline KW - congenital heart disease KW - pulmonary regurgitation KW - right ventricular outflow tract conduit KW - transcatheter heart valve SP - 1254 EP - 62 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 7 IS - 11 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. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692). SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/25459038/One_year_follow_up_of_the_Melody_transcatheter_pulmonary_valve_multicenter_post_approval_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(14)01230-8 DB - PRIME DP - Unbound Medicine ER -