Short- and Medium-Term Outcomes After Transcatheter Pulmonary Valve Placement in the Expanded Multicenter US Melody Valve Trial

• DOI: 10.1161/circulationaha.109.921692
• Publication Date: 2010-07-20T04:50:30Z
• Authors: Doff B. McElhinney; William E. Hellen...; Evan M. Zahn; Thomas K. Jones; John P. Cheatham; James E. Lock; Julie A. Vincent
• Keywords: Ventricular outflow tract; Pulmonary valve; Multicenter trial

Background— Transcatheter pulmonary valve placement is an emerging therapy for regurgitation and right ventricular outflow tract obstruction in selected patients. The Melody was recently approved the United States dysfunctional conduits. Methods Results— From January 2007 to August 2009, 136 patients (median age, 19 years) underwent catheterization intended implantation at 5 centers. Implantation attempted 124 patients; other 12, transcatheter not because of risk coronary artery compression (n=6) or clinical protocol contraindications. There 1 death from intracranial hemorrhage after dissection, explanted conduit rupture. median peak gradient 37 mm Hg before 12 immediately implantation. Before implantation, moderate severe 92 (81% with data); no patient had more than mild early during follow-up (≥1 year 65 patients). Freedom diagnosis stent fracture 77.8±4.3% 14 months. dysfunction reintervention 93.5±2.4% year. A higher discharge ( P =0.003) younger age =0.01) were associated shorter freedom dysfunction. Conclusions— In this updated report multicenter US trial, we demonstrated ongoing high rate procedural success encouraging short-term function. All reinterventions series obstruction, highlighting importance selection, adequate relief measures prevent manage fracture. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.