Brian H Morray1, Thomas K Jones1, James Y Coe2, Roland Gitter3, Jose Zunzunegui Martinez4, Daniel R Turner5, Robert G Gray6, Te-Hsin Lung7, Darren P Berman8, Daniel S Levi9. 1. Division of Pediatric Cardiology, Seattle Children's Hospital, Seattle, Washington. 2. Division of Pediatric Cardiology, University of Alberta, Edmonton, Alberta, Canada. 3. Department of Pediatric Cardiology, Kepler University Clinic, Linz, Austria. 4. Pediatric Catheterization Lab, Gregorio Marañon Hospital, Madrid, Spain. 5. Carman and Ann Adams Department of Pediatrics, Division of Cardiology, Children's Hospital of Michigan, Detroit, Michigan. 6. Department of Pediatrics, Division of Cardiology, University of Utah, Salt Lake City, Utah. 7. Coronary and Structural Heart Clinical Department, Medtronic, Santa Rosa, California. 8. The Heart Center, Nationwide Children's Hospital, Columbus, Ohio. 9. Department of Pediatric Cardiology, Mattel Children's Hospital at UCLA, Los Angeles, California.
Abstract
OBJECTIVES: This study describes procedural and 1-year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. BACKGROUND: The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm. METHODS: This is a prospective, non-randomized, multicenter study of the procedural and short-term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis. RESULTS: During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P < 0.001). There were three cases of confined conduit tears successfully treated with covered stents or the valve itself. Repeat catheterization was performed in one patient for early re-obstruction that was successfully treated with balloon valvuloplasty. At recent follow-up, there were no cases of more than mild valve regurgitation and the mean pulmonary valve gradient by echocardiogram remained reduced relative to pre-TPVR implant measurements (33.5 mmHg vs. 15.2 mmHg). There were no cases of valve stent fracture or endocarditis reported at the 1-year follow-up. CONCLUSIONS: Our analysis of TPVR with the PB1016 valve in RVOT conduits showed it to be safe and effective and can be performed in a wide range of conduit sizes with preserved valve function. ClinicalTrials.gov Identifier: NCT02347189.
OBJECTIVES: This study describes procedural and 1-year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. BACKGROUND: The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm. METHODS: This is a prospective, non-randomized, multicenter study of the procedural and short-term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis. RESULTS: During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P < 0.001). There were three cases of confined conduit tears successfully treated with covered stents or the valve itself. Repeat catheterization was performed in one patient for early re-obstruction that was successfully treated with balloon valvuloplasty. At recent follow-up, there were no cases of more than mild valve regurgitation and the mean pulmonary valve gradient by echocardiogram remained reduced relative to pre-TPVR implant measurements (33.5 mmHg vs. 15.2 mmHg). There were no cases of valve stent fracture or endocarditis reported at the 1-year follow-up. CONCLUSIONS: Our analysis of TPVR with the PB1016 valve in RVOT conduits showed it to be safe and effective and can be performed in a wide range of conduit sizes with preserved valve function. ClinicalTrials.gov Identifier: NCT02347189.