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Arch Cardiovasc Dis · Nov 2014
Multicenter Study Observational StudyMelody ® transcatheter pulmonary valve implantation: results from a French registry.
- Alain Fraisse, Philippe Aldebert, Sophie Malekzadeh-Milani, Jean-Benoit Thambo, Jean-François Piéchaud, Pascaline Aucoururier, Gilles Chatelier, Damien Bonnet, Laurence Iserin, Béatrice Bonello, Anass Assaidi, Issam Kammache, and Younes Boudjemline.
- Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
- Arch Cardiovasc Dis. 2014 Nov 1;107(11):607-14.
BackgroundPercutaneous implantation of pulmonary valves has recently been introduced into clinical practice.AimTo analyse data of patients treated in France between April 2008 and December 2010.MethodsProspective, observational, multi-centric survey by means of a database registry of the Filiale de cardiologie pédiatrique et congénitale.ResultsSixty-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.ConclusionsTranscatheter 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 RegistrationNCT01250327.Copyright © 2014 Elsevier Masson SAS. All rights reserved.
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