Short- and Medium-Term Outcomes Reported for Medtronic's Melody Valve

July 19, 2010—Doff B. McElhinney, MD, et al have published short- and medium-term outcomes after transcatheter pulmonary valve placement with the Melody valve (Medtronic, Inc., Minneapolis, MN). The study was published online ahead of print in Circulation. The Melody valve was recently approved in the United States for placement in dysfunctional right ventricular outflow tract conduits.

In this updated report from the United States multicenter Melody valve trial, the investigators showed an ongoing high rate of procedural success and encouraging short-term valve function. All reinterventions in this series were for right ventricular outflow tract obstruction, highlighting the importance of patient selection, adequate relief of obstruction, and measures to prevent and manage stent fracture, stated the investigators.

As detailed in Circulation, 136 patients (median age, 19 years) underwent catheterization for intended Melody valve implantation at five centers in the United States from January 2007 to August 2009. Implantation was attempted in 124 patients. In the other 12 patients, transcatheter pulmonary valve placement was not attempted because of the risk of coronary artery compression (n = 6) or other clinical or protocol contraindications. There was one death from intracranial hemorrhage after coronary artery dissection, and one valve was explanted after conduit rupture. The median peak right ventricular outflow tract gradient was 37 mm Hg before implantation and 12 mm Hg immediately after implantation.

The investigators reported that before implantation, pulmonary regurgitation was moderate or severe in 92 patients (81% with data); no patient had more than mild pulmonary regurgitation early after implantation or during follow-up (1 year in 65 patients). Freedom from stent fracture was 77.8% ± 4.3% at 14 months. Freedom from Melody valve dysfunction or reintervention was 93.5% ± 2.4% at 1 year. A higher right ventricular outflow tract gradient at discharge (P = .003) and younger age (P = .01) were associated with shorter freedom from dysfunction.