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Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: A Multicenter Pediatric Heart Network Scholar Study.
JACC Cardiovasc Interv. 2018 08 27; 11(16):1642-1650.JC

Abstract

OBJECTIVES

This study sought to determine the safety and feasibility of transcatheter pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right ventricular outflow tracts (nRVOT), and to identify factors associated with successful TPVR.

BACKGROUND

The Melody valve is Food and Drug Administration-approved for TPVR within right ventricle-to-pulmonary artery conduits and bioprosthetic pulmonary valves. However, most patients needing pulmonary valve replacement have nRVOT and TPVR has been adapted for this indication.

METHODS

In this multicenter retrospective study of all patients presenting for nRVOT TPVR, we collected pre-procedural magnetic resonance imaging, echocardiography, and catheterization data, and evaluated procedural and early outcomes.

RESULTS

Of 229 patients (age 21 ± 15 years from 11 centers), 132 (58%) had successful TPVR. In the remaining 97, TPVR was not performed, most often because of prohibitively large nRVOT (n = 67) or compression of the aortic root or coronary arteries (n = 18). There were no deaths and 5 (4%) serious complications, including pre-stent embolization requiring surgery in 4 patients, and arrhythmia in 1. Higher pre-catheterization echocardiographic RVOT gradient was associated with TPVR success (p = 0.001) and larger center volume approached significance (p = 0.08). Magnetic resonance imaging anterior-posterior and lateral RVOT diameters were smaller in implanted versus nonimplanted patients (18.0 ± 3.6 mm vs. 20.1 ± 3.5 mm; p = 0.005; 18.4 ± 4.3 mm vs. 21.5 ± 3.8 mm; p = 0.002).

CONCLUSIONS

TPVR in the nRVOT was feasible and safe. However, nearly half the patients presenting for catheterization did not undergo TPV implantation, mainly because of prohibitively large nRVOT size. Improved understanding of magnetic resonance imaging data and availability of larger devices may improve the success rate for nRVOT TPVR.

Authors+Show Affiliations

Division of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah. Electronic address: mary.hunt.martin@hsc.utah.edu.Division of Cardiology, Department of Pediatrics, University of California San Francisco, San Francisco, California.Division of Cardiology, Department of Pediatrics, Lucile Packard Children's Hospital at Stanford, Palo Alto, California; Department of Cardiothoracic Surgery, Lucile Packard Children's Hospital at Stanford, Palo Alto, California.Division of Cardiology, Department of Pediatrics, Cincinnati Children's Hospital, Cincinnati, Ohio.Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.The Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.Division of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri.Division of Cardiology, Department of Pediatrics, University of California Los Angeles, Los Angeles, California.Division of Cardiology, Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio.Division of Cardiology, Department of Pediatrics, Lucile Packard Children's Hospital at Stanford, Palo Alto, California.Division of Cardiology, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.Division of Cardiology, Department of Pediatrics, C.S. Mott Children's Hospital, Ann Arbor, Michigan.Department of Statistics, University of Utah, Salt Lake City, Utah.Division of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.Division of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

30077685

Citation

Martin, Mary Hunt, et al. "Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: a Multicenter Pediatric Heart Network Scholar Study." JACC. Cardiovascular Interventions, vol. 11, no. 16, 2018, pp. 1642-1650.
Martin MH, Meadows J, McElhinney DB, et al. Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: A Multicenter Pediatric Heart Network Scholar Study. JACC Cardiovasc Interv. 2018;11(16):1642-1650.
Martin, M. H., Meadows, J., McElhinney, D. B., Goldstein, B. H., Bergersen, L., Qureshi, A. M., Shahanavaz, S., Aboulhosn, J., Berman, D., Peng, L., Gillespie, M., Armstrong, A., Weng, C., Minich, L. L., & Gray, R. G. (2018). Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: A Multicenter Pediatric Heart Network Scholar Study. JACC. Cardiovascular Interventions, 11(16), 1642-1650. https://doi.org/10.1016/j.jcin.2018.05.051
Martin MH, et al. Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: a Multicenter Pediatric Heart Network Scholar Study. JACC Cardiovasc Interv. 2018 08 27;11(16):1642-1650. PubMed PMID: 30077685.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: A Multicenter Pediatric Heart Network Scholar Study. AU - Martin,Mary Hunt, AU - Meadows,Jeffery, AU - McElhinney,Doff B, AU - Goldstein,Bryan H, AU - Bergersen,Lisa, AU - Qureshi,Athar M, AU - Shahanavaz,Shabana, AU - Aboulhosn,Jamil, AU - Berman,Darren, AU - Peng,Lynn, AU - Gillespie,Matthew, AU - Armstrong,Aimee, AU - Weng,Cindy, AU - Minich,L LuAnn, AU - Gray,Robert G, Y1 - 2018/08/01/ PY - 2018/03/22/received PY - 2018/05/07/revised PY - 2018/05/15/accepted PY - 2018/8/6/pubmed PY - 2019/11/21/medline PY - 2018/8/6/entrez KW - Melody valve KW - native right ventricular outflow tract KW - percutaneous valve KW - pulmonary insufficiency KW - pulmonary valve KW - transcatheter SP - 1642 EP - 1650 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 11 IS - 16 N2 - OBJECTIVES: This study sought to determine the safety and feasibility of transcatheter pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right ventricular outflow tracts (nRVOT), and to identify factors associated with successful TPVR. BACKGROUND: The Melody valve is Food and Drug Administration-approved for TPVR within right ventricle-to-pulmonary artery conduits and bioprosthetic pulmonary valves. However, most patients needing pulmonary valve replacement have nRVOT and TPVR has been adapted for this indication. METHODS: In this multicenter retrospective study of all patients presenting for nRVOT TPVR, we collected pre-procedural magnetic resonance imaging, echocardiography, and catheterization data, and evaluated procedural and early outcomes. RESULTS: Of 229 patients (age 21 ± 15 years from 11 centers), 132 (58%) had successful TPVR. In the remaining 97, TPVR was not performed, most often because of prohibitively large nRVOT (n = 67) or compression of the aortic root or coronary arteries (n = 18). There were no deaths and 5 (4%) serious complications, including pre-stent embolization requiring surgery in 4 patients, and arrhythmia in 1. Higher pre-catheterization echocardiographic RVOT gradient was associated with TPVR success (p = 0.001) and larger center volume approached significance (p = 0.08). Magnetic resonance imaging anterior-posterior and lateral RVOT diameters were smaller in implanted versus nonimplanted patients (18.0 ± 3.6 mm vs. 20.1 ± 3.5 mm; p = 0.005; 18.4 ± 4.3 mm vs. 21.5 ± 3.8 mm; p = 0.002). CONCLUSIONS: TPVR in the nRVOT was feasible and safe. However, nearly half the patients presenting for catheterization did not undergo TPV implantation, mainly because of prohibitively large nRVOT size. Improved understanding of magnetic resonance imaging data and availability of larger devices may improve the success rate for nRVOT TPVR. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/30077685/Safety_and_Feasibility_of_Melody_Transcatheter_Pulmonary_Valve_Replacement_in_the_Native_Right_Ventricular_Outflow_Tract:_A_Multicenter_Pediatric_Heart_Network_Scholar_Study_ DB - PRIME DP - Unbound Medicine ER -