Author + information
- Received November 28, 2017
- Revision received December 23, 2017
- Accepted January 2, 2018
- Published online March 19, 2018.
- Shabana Shahanavaz, MBBSa,∗ (, )
- Athar M. Qureshi, MDb,
- Daniel S. Levi, MDc,
- Younes Boudjemline, MDd,
- Lynn F. Peng, MDe,
- Mary Hunt Martin, MDf,
- Holly Bauser-Heaton, MD, PhDg,
- Britton Keeshan, MD, MPHh,
- Jeremy D. Asnes, MDi,
- Thomas K. Jones, MDh,
- Henri Justino, MDb,
- Jamil A. Aboulhosn, MDc,
- Robert G. Gray, MDf,
- Hoang Nguyen, MDa,j,
- David T. Balzer, MDa and
- Doff B. McElhinney, MDe,k,l
- aDivision of Cardiology, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, Missouri
- bLillie Frank Abercrombie Section of Cardiology, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas
- cAhmanson/UCLA Adult Congenital Heart Disease Center, David Geffen School of Medicine at UCLA, Los Angeles, California
- dDepartment of Paediatric Cardiology, Centre de Référence Malformations Cardiaques Congénitales Complexes—M3C, Necker Hospital for Sick Children, Assistance Publique des Hôpitaux de Paris, Paris, France
- eDivision of Pediatric Cardiology, Lucille Packard Children's Hospital at Stanford University, Palo Alto, California
- fDivision of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City, Utah
- gDepartment of Pediatrics, Children's Healthcare of Atlanta, Stanford University, Palo Alto, California
- hDivision of Pediatric Cardiology, Seattle Children’s Hospital, University of Washington School of Medicine, Seattle, Washington
- iDepartment of Pediatrics, Yale University, New Haven, Connecticut
- jDivision of Cardiology, Department of Pediatrics, Rush University Medical College, Chicago, Illinois
- kDepartment of Pediatrics, Lucile Packard Children's Hospital Heart Center, Stanford University School of Medicine, Palo Alto, California
- lDepartment of Cardiothoracic Surgery, Lucile Packard Children's Hospital Heart Center, Stanford University School of Medicine, Palo Alto, California
- ↵∗Address for correspondence:
Dr. Shabana Shahanavaz, Washington University School of Medicine, One Children’s Place; Campus Box 8116-NWT, St Louis, Missouri 63110.
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.
Dr. Levi has served as a consultant for Edwards Lifesciences and Medtronic. Dr. Asnes has served as a proctor for Edwards Lifesciences. Dr. Jones has received research grant support and served as a consultant for Medtronic. Dr. Justino has served as a consultant for Medtronic, Edwards Lifesciences, and Abbott; on the clinical trial executive committee for Janssen Pharmaceuticals; and on the scientific advisory board for PediaStent. Drs. Boudgemline and Balzer have served as a proctor for Medtronic. Dr. McElhinney has served as a proctor and consultant for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 28, 2017.
- Revision received December 23, 2017.
- Accepted January 2, 2018.
- 2018 American College of Cardiology Foundation