PMID- 25453718 OWN - NLM STAT- MEDLINE DCOM- 20150804 LR - 20220408 IS - 1875-2128 (Electronic) IS - 1875-2128 (Linking) VI - 107 IP - 11 DP - 2014 Nov TI - Melody (R) transcatheter pulmonary valve implantation: results from a French registry. PG - 607-14 LID - S1875-2136(14)00259-9 [pii] LID - 10.1016/j.acvd.2014.10.001 [doi] AB - 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 pediatrique et congenitale. 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. CI - Copyright (c) 2014 Elsevier Masson SAS. All rights reserved. FAU - Fraisse, Alain AU - Fraisse A AD - Cardiologie Pediatrique, hopital de la Timone-Enfants, 13385 Marseille, France. FAU - Aldebert, Philippe AU - Aldebert P AD - Cardiologie Pediatrique, hopital de la Timone-Enfants, 13385 Marseille, France. FAU - Malekzadeh-Milani, Sophie AU - Malekzadeh-Milani S AD - Pediatric Cardiology, unite medico-chirurgicale de cardiologie congenitale et pediatrique, centre de reference malformations cardiaques congenitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hopitaux de Paris, 149, rue de Sevres, 75015 Paris cedex, France; Unit for adults with congenital heart defects, centre de reference malformations cardiaques congenitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hopitaux de Paris, 75015 Paris, France. FAU - Thambo, Jean-Benoit AU - Thambo JB AD - Unit for children and adults with congenital heart defects, hospital Bordeaux, 33604 Bordeaux, France. FAU - Piechaud, Jean-Francois AU - Piechaud JF AD - Institut hospitalier Jacques-Cartier, 91300 Massy, France. FAU - Aucoururier, Pascaline AU - Aucoururier P AD - Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hopitaux de Paris, 75015 Paris, France. FAU - Chatelier, Gilles AU - Chatelier G AD - Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hopitaux de Paris, 75015 Paris, France. FAU - Bonnet, Damien AU - Bonnet D AD - Pediatric Cardiology, unite medico-chirurgicale de cardiologie congenitale et pediatrique, centre de reference malformations cardiaques congenitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hopitaux de Paris, 149, rue de Sevres, 75015 Paris cedex, France; Universite Paris-Descartes, Sorbonne Paris-Cite, 75008 Paris, France. FAU - Iserin, Laurence AU - Iserin L AD - Unit for adults with congenital heart defects, centre de reference malformations cardiaques congenitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hopitaux de Paris, 75015 Paris, France. FAU - Bonello, Beatrice AU - Bonello B AD - Cardiologie Pediatrique, hopital de la Timone-Enfants, 13385 Marseille, France. FAU - Assaidi, Anass AU - Assaidi A AD - Cardiologie Pediatrique, hopital de la Timone-Enfants, 13385 Marseille, France. FAU - Kammache, Issam AU - Kammache I AD - Cardiologie Pediatrique, hopital de la Timone-Enfants, 13385 Marseille, France. FAU - Boudjemline, Younes AU - Boudjemline Y AD - Pediatric Cardiology, unite medico-chirurgicale de cardiologie congenitale et pediatrique, centre de reference malformations cardiaques congenitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hopitaux de Paris, 149, rue de Sevres, 75015 Paris cedex, France; Unit for adults with congenital heart defects, centre de reference malformations cardiaques congenitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hopitaux de Paris, 75015 Paris, France; Universite Paris-Descartes, Sorbonne Paris-Cite, 75008 Paris, France. Electronic address: younes.boudjemline@nck.aphp.fr. LA - eng SI - ClinicalTrials.gov/NCT01250327 PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20141106 PL - Netherlands TA - Arch Cardiovasc Dis JT - Archives of cardiovascular diseases JID - 101465655 SB - IM MH - Adolescent MH - Adult MH - Aged MH - Cardiac Catheterization/adverse effects/*instrumentation/methods/mortality MH - Child MH - Female MH - France MH - Health Care Surveys MH - Heart Defects, Congenital/mortality/*surgery MH - *Heart Valve Prosthesis MH - Heart Valve Prosthesis Implantation/adverse effects/*instrumentation/methods/mortality MH - Humans MH - Kaplan-Meier Estimate MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Predictive Value of Tests MH - Prospective Studies MH - Prosthesis Design MH - Prosthesis Failure MH - Pulmonary Valve/physiopathology/*surgery MH - Pulmonary Valve Insufficiency/diagnosis/etiology/mortality/physiopathology/*therapy MH - Pulmonary Valve Stenosis/diagnosis/etiology/mortality/physiopathology/*therapy MH - Recovery of Function MH - Registries MH - Risk Factors MH - Time Factors MH - Treatment Outcome MH - Ventricular Function, Right MH - Young Adult OTO - NOTNLM OT - Cardiac catheterization OT - Catheterisme interventionnel OT - Implantation de valve pulmonaire OT - Pulmonary valve implantation OT - Trans-catheter OT - Transcatheter EDAT- 2014/12/03 06:00 MHDA- 2015/08/05 06:00 CRDT- 2014/12/03 06:00 PHST- 2014/07/02 00:00 [received] PHST- 2014/10/03 00:00 [revised] PHST- 2014/10/03 00:00 [accepted] PHST- 2014/12/03 06:00 [entrez] PHST- 2014/12/03 06:00 [pubmed] PHST- 2015/08/05 06:00 [medline] AID - S1875-2136(14)00259-9 [pii] AID - 10.1016/j.acvd.2014.10.001 [doi] PST - ppublish SO - Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.