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Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.

Melody ® transcatheter pulmonary valve implantation: results from a French registry.

Author information

1
Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
2
Pediatric Cardiology, unité médico-chirurgicale de cardiologie congénitale et pédiatrique, centre de référence malformations cardiaques congénitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hôpitaux de Paris, 149, rue de Sèvres, 75015 Paris cedex, France; Unit for adults with congenital heart defects, centre de référence malformations cardiaques congénitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
3
Unit for children and adults with congenital heart defects, hospital Bordeaux, 33604 Bordeaux, France.
4
Institut hospitalier Jacques-Cartier, 91300 Massy, France.
5
Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
6
Pediatric Cardiology, unité médico-chirurgicale de cardiologie congénitale et pédiatrique, centre de référence malformations cardiaques congénitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hôpitaux de Paris, 149, rue de Sèvres, 75015 Paris cedex, France; Université Paris-Descartes, Sorbonne Paris-Cité, 75008 Paris, France.
7
Unit for adults with congenital heart defects, centre de référence malformations cardiaques congénitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
8
Pediatric Cardiology, unité médico-chirurgicale de cardiologie congénitale et pédiatrique, centre de référence malformations cardiaques congénitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hôpitaux de Paris, 149, rue de Sèvres, 75015 Paris cedex, France; Unit for adults with congenital heart defects, centre de référence malformations cardiaques congénitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France; Université Paris-Descartes, Sorbonne Paris-Cité, 75008 Paris, France. Electronic address: younes.boudjemline@nck.aphp.fr.

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.

KEYWORDS:

Cardiac catheterization; Cathétérisme interventionnel; Implantation de valve pulmonaire; Pulmonary valve implantation; Trans-cathéter; Transcatheter

PMID:
25453718
DOI:
10.1016/j.acvd.2014.10.001
[Indexed for MEDLINE]
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