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  • Title: Melody ® transcatheter pulmonary valve implantation: results from a French registry.
    Author: Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piéchaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y.
    Journal: Arch Cardiovasc Dis; 2014 Nov; 107(11):607-14. PubMed ID: 25453718.
    Abstract:
    BACKGROUND: Percutaneous implantation of pulmonary valves has recently been introduced into clinical practice. AIM: To analyse data of patients treated in France between April 2008 and December 2010. METHODS: Prospective, observational, multi-centric survey by means of a database registry of the Filiale de cardiologie pédiatrique et congénitale. RESULTS: Sixty-four patients were included, with a median (range) age of 21.4 (10.5-77.3) years. The majority (60.9%) of the patients were New York Heart Association (NYHA) class II. The most common congenital heart disease was tetralogy of Fallot with or without pulmonary atresia (50%). Indication for valve implantation was stenosis in 21.9%, regurgitation in 10.9% and association of stenosis and regurgitation in 67.2%. Implantation was successful in all patients. Pre-stenting was performed in 96.9% of cases. Median (range) procedure time was 92.5 (25-250) minutes. No significant regurgitation was recorded after the procedure, and the trans-pulmonary gradient was significantly reduced. Early minor complications occurred in five cases (7.8%). Three patients died during a median follow-up of 4.6 (0.2-5.2) years, two from infectious endocarditis and one from end-stage cardiac failure. Surgical reintervention was required in three patients. Follow-up with magnetic resonance imaging demonstrated significant improvements in right ventricular volumes and pulmonary regurgitation in mixed and regurgitant lesions. CONCLUSIONS: Transcatheter pulmonary valve implantation is highly feasible and mid-term follow-up demonstrates sustained improvement of right ventricular function. Late endocarditis is of concern, therefore longer follow-up in more patients is urgently needed to better assess long-term outcome. CLINICAL TRIAL REGISTRATION: NCT01250327.
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