TY - JOUR
T1 - Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract
T2 - 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. Lu Ann
AU - Gray, Robert G.
N1 - Funding Information:
Funded by the National Heart Lung Blood Institute Pediatric Heart Network Scholar Award, Bethesda, Maryland. Dr. McElhinney is a proctor for Medtronic. Dr. Goldstein is a proctor for Edwards Lifesciences and a consultant for Medtronic. Dr. Bergersen is a consultant for 480 Biomedical Inc. Dr. Qureshi is a consultant to W.L. Gore. Dr. Shahanavaz is a proctor for Edwards Lifesciences and a consultant for Medtronic. Dr. Aboulhosn is a co-PI at UCLA for the Medtronic Harmony valve trial. Dr. Berman is a proctor for Edwards Lifesciences. Dr. Gillespie is a consultant and proctor for Medtronic. Dr. Armstrong is a proctor/consultant for Abbott, B. Braun Interventional Systems Inc., and Edwards Lifesciences; and has received research grants from Abbott, Edwards Lifesciences, Medtronic, and Siemens Medical Solutions USA Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/8/27
Y1 - 2018/8/27
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.
AB - 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.
KW - Melody valve
KW - native right ventricular outflow tract
KW - percutaneous valve
KW - pulmonary insufficiency
KW - pulmonary valve
KW - transcatheter
UR - http://www.scopus.com/inward/record.url?scp=85053853932&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2018.05.051
DO - 10.1016/j.jcin.2018.05.051
M3 - Article
C2 - 30077685
AN - SCOPUS:85053853932
SN - 1936-8798
VL - 11
SP - 1642
EP - 1650
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 16
ER -