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Objectives: This study was designed to evaluate the safety, procedural success, and short-term effectiveness of the Melody transcatheter pulmonary valve (Medtronic, Inc., Minneapolis, Minnesota) in patients with dysfunctional right ventricular outflow tract conduits. Background: Conduit dysfunction has recently been treated with transcatheter pulmonary valve placement. There have been no prospective, multicenter trials evaluating this technology. Methods: Standardized entry criteria, implantation, and follow-up protocols were used. Nonimplanting core laboratories were used to evaluate results. Results: Between January 2007 and September 2007, 34 patients underwent catheterization for intended Melody valve implantation at 3 centers. Mean age was 19.4 ± 7.7 years. Initial conduit Doppler mean gradient was 28.8 ± 10.1 mm Hg, and 94% of patients had moderate or severe pulmonary regurgitation (PR). Implantation was successful in 29 of 30 attempts and not attempted in 4 patients. Procedural complications included conduit rupture requiring urgent surgery and device removal (n = 1), wide-complex tachycardia (n = 1), and distal pulmonary artery guidewire perforation (n = 1). Peak systolic conduit gradient fell acutely from 37.2 ± 16.3 mm Hg to 17.3 ± 7.3 mm Hg, and no patient had more than mild PR. There were no deaths or further device explants. At 6-month follow-up, conduit Doppler mean gradient was 22.4 ± 8.1 mm Hg, and PR fraction by magnetic resonance imaging was significantly improved (3.3 ± 3.6% vs. 27.6 ± 13.3%, p < 0.0001). Stent fracture occurred in 8 of 29 implants; 3 of these were treated with a second Melody valve for recurrent stenosis later in follow-up. Conclusions: Implantation of the Melody valve for right ventricular outflow tract conduit dysfunction can be performed by experienced operators at multiple centers, appears safe, and has encouraging acute and short-term outcomes. [Copyright &y& Elsevier]

Objectives: This study was designed to report a novel indication for percutaneous pulmonary valve implantation in patients with previous right ventricular outflow tract (RVOT) patch. Background: Current indications for percutaneous pulmonary valve implantation are limited to patients who had pulmonary valve stenosis and/or regurgitation in a right ventricle-to-pulmonary artery conduit. Percutaneous pulmonary valve implantation has not been previously reported in patients with severe pulmonary valve regurgitation following repair of tetralogy of Fallot (TOF) using RVOT patch. Methods: After assessment of the RVOT patch in multiple projections, a catheter was placed in a distal pulmonary artery branch. In patients with an RVOT patch, sizing of the narrowest diameter of the RVOT patch by manual inflation of a sizing balloon was performed; a stent was placed into the RVOT patch at the level of the narrowest area to anchor the stent and to create an artificial conduit to place the Melody valve. The percutaneous valve was then implanted. Results: Seven females and 6 males with a mean age of 14.3 years and mean body weight 45 kg had successful percutaneous implantation of the Melody valve. Four patients had previous repair of TOF using RVOT patch. All patients were discharged within 2 days after the procedure without complications. After a mean of 4 months follow-up all patients were alive and well. Transthoracic echocardiography showed competent pulmonary valve. Chest X-ray showed no stent migration or fracture. Conclusions: Percutaneous pulmonary valve implantation can be performed in patients with pulmonary valve regurgitation, including those with previous RVOT patch using pre-stenting techniques, with satisfactory results. [Copyright &y& Elsevier]