Transcatheter pulmonary valve replacement with the Melody valve resulted in 5-year freedom from reintervention and explantation of 76% and 92%, respectively, with rare primary valve failure.
Does transcatheter pulmonary valve replacement with the Melody valve provide durable long-term clinical and hemodynamic outcomes in patients with right ventricular outflow tract conduit obstruction or regurgitation?
Transcatheter pulmonary valve replacement with the Melody valve provides durable hemodynamic and clinical outcomes up to 7 years, with stent fracture being the main cause of reintervention.
BACKGROUND: Studies of transcatheter pulmonary valve (TPV) replacement with the Melody valve have demonstrated good short-term outcomes, but there are no published long-term follow-up data. METHODS AND RESULTS: The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median age, 19 years) with right ventricular outflow tract conduit obstruction or regurgitation. The 148 patients who received and were discharged with a TPV were followed up annually according to a standardized protocol. During a median follow-up of 4.5 years (range, 0.4-7 years), 32 patients underwent right ventricular outflow tract reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis and 1 with pulmonary regurgitation), or right ventricular dysfunction (n=2). Eleven patients had the TPV explanted as an initial or second reintervention. Five-year freedom from reintervention and explantation was 76±4% and 92±3%, respectively. A conduit prestent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention. In the 113 patients who were alive and reintervention free, the follow-up gradient (median, 4.5 years after implantation) was unchanged from early post-TPV replacement, and all but 1 patient had mild or less pulmonary regurgitation. Almost all patients were in New York Heart Association class I or II. More severely impaired baseline spirometry was associated with a lower likelihood of improvement in exercise function after TPV replacement. CONCLUSIONS: TPV replacement with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was uncommon once prestenting became more widely adopted. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.
Cheatham et al. (Wed,) conducted a other in Right ventricular outflow tract conduit obstruction or regurgitation (n=171). Transcatheter pulmonary valve replacement with the Melody valve was evaluated on Five-year freedom from reintervention and explantation. Transcatheter pulmonary valve replacement with the Melody valve resulted in 5-year freedom from reintervention and explantation of 76% and 92%, respectively, with rare primary valve failure.