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Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits.
JACC Cardiovasc Interv. 2018 03 26; 11(6):554-564.JC

Abstract

OBJECTIVES

This study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter.

BACKGROUND

The Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits.

METHODS

The study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes.

RESULTS

A total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year).

CONCLUSIONS

In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.

Authors+Show Affiliations

Division of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri. Electronic address: shahanavaz_s@uustl.edu.Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.Ahmanson/UCLA Adult Congenital Heart Disease Center, David Geffen School of Medicine at UCLA, Los Angeles, California.Department of Paediatric Cardiology, Centre de Référence Malformations Cardiaques Congénitales Complexes-M3C, Necker Hospital for Sick Children, Assistance Publique des Hôpitaux de Paris, Paris, France.Division of Pediatric Cardiology, Lucille Packard Children's Hospital at Stanford University, Palo Alto, California.Division of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.Department of Pediatrics, Children's Healthcare of Atlanta, Stanford University, Palo Alto, California.Division of Pediatric Cardiology, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington.Department of Pediatrics, Yale University, New Haven, Connecticut.Division of Pediatric Cardiology, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington.Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.Ahmanson/UCLA Adult Congenital Heart Disease Center, David Geffen School of Medicine at UCLA, Los Angeles, California.Division of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.Division of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri; Division of Cardiology, Department of Pediatrics, Rush University Medical College, Chicago, Illinois.Division of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri.Division of Pediatric Cardiology, Lucille Packard Children's Hospital at Stanford University, Palo Alto, California; Department of Pediatrics, Lucile Packard Children's Hospital Heart Center, Stanford University School of Medicine, Palo Alto, California; Department of Cardiothoracic Surgery, Lucile Packard Children's Hospital Heart Center, Stanford University School of Medicine, Palo Alto, California.

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

29566801

Citation

Shahanavaz, Shabana, et al. "Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits." JACC. Cardiovascular Interventions, vol. 11, no. 6, 2018, pp. 554-564.
Shahanavaz S, Qureshi AM, Levi DS, et al. Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits. JACC Cardiovasc Interv. 2018;11(6):554-564.
Shahanavaz, S., Qureshi, A. M., Levi, D. S., Boudjemline, Y., Peng, L. F., Martin, M. H., Bauser-Heaton, H., Keeshan, B., Asnes, J. D., Jones, T. K., Justino, H., Aboulhosn, J. A., Gray, R. G., Nguyen, H., Balzer, D. T., & McElhinney, D. B. (2018). Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits. JACC. Cardiovascular Interventions, 11(6), 554-564. https://doi.org/10.1016/j.jcin.2018.01.239
Shahanavaz S, et al. Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits. JACC Cardiovasc Interv. 2018 03 26;11(6):554-564. PubMed PMID: 29566801.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits. AU - Shahanavaz,Shabana, AU - Qureshi,Athar M, AU - Levi,Daniel S, AU - Boudjemline,Younes, AU - Peng,Lynn F, AU - Martin,Mary Hunt, AU - Bauser-Heaton,Holly, AU - Keeshan,Britton, AU - Asnes,Jeremy D, AU - Jones,Thomas K, AU - Justino,Henri, AU - Aboulhosn,Jamil A, AU - Gray,Robert G, AU - Nguyen,Hoang, AU - Balzer,David T, AU - McElhinney,Doff B, PY - 2017/11/28/received PY - 2017/12/23/revised PY - 2018/01/02/accepted PY - 2018/3/24/entrez PY - 2018/3/24/pubmed PY - 2019/5/7/medline KW - allograft KW - bovine jugular vein conduit KW - percutaneous valve KW - pulmonary artery KW - stent KW - tetralogy of Fallot SP - 554 EP - 564 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 11 IS - 6 N2 - OBJECTIVES: This study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter. BACKGROUND: The Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits. METHODS: The study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes. RESULTS: A total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year). CONCLUSIONS: In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/29566801/Transcatheter_Pulmonary_Valve_Replacement_With_the_Melody_Valve_in_Small_Diameter_Expandable_Right_Ventricular_Outflow_Tract_Conduits_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(18)30346-7 DB - PRIME DP - Unbound Medicine ER -