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Melody ® transcatheter pulmonary valve implantation: results from a French registry.
Arch Cardiovasc Dis. 2014 Nov; 107(11):607-14.AC

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.

Authors+Show Affiliations

Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.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.Unit for children and adults with congenital heart defects, hospital Bordeaux, 33604 Bordeaux, France.Institut hospitalier Jacques-Cartier, 91300 Massy, France.Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.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.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.Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.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.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

25453718

Citation

Fraisse, Alain, et al. "Melody ® Transcatheter Pulmonary Valve Implantation: Results From a French Registry." Archives of Cardiovascular Diseases, vol. 107, no. 11, 2014, pp. 607-14.
Fraisse A, Aldebert P, Malekzadeh-Milani S, et al. Melody ® transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014;107(11):607-14.
Fraisse, A., Aldebert, P., Malekzadeh-Milani, S., Thambo, J. B., Piéchaud, J. F., Aucoururier, P., Chatelier, G., Bonnet, D., Iserin, L., Bonello, B., Assaidi, A., Kammache, I., & Boudjemline, Y. (2014). Melody ® transcatheter pulmonary valve implantation: results from a French registry. Archives of Cardiovascular Diseases, 107(11), 607-14. https://doi.org/10.1016/j.acvd.2014.10.001
Fraisse A, et al. Melody ® Transcatheter Pulmonary Valve Implantation: Results From a French Registry. Arch Cardiovasc Dis. 2014;107(11):607-14. PubMed PMID: 25453718.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Melody ® transcatheter pulmonary valve implantation: results from a French registry. AU - Fraisse,Alain, AU - Aldebert,Philippe, AU - Malekzadeh-Milani,Sophie, AU - Thambo,Jean-Benoit, AU - Piéchaud,Jean-François, AU - Aucoururier,Pascaline, AU - Chatelier,Gilles, AU - Bonnet,Damien, AU - Iserin,Laurence, AU - Bonello,Béatrice, AU - Assaidi,Anass, AU - Kammache,Issam, AU - Boudjemline,Younes, Y1 - 2014/11/06/ PY - 2014/07/02/received PY - 2014/10/03/revised PY - 2014/10/03/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2015/8/5/medline KW - Cardiac catheterization KW - Cathétérisme interventionnel KW - Implantation de valve pulmonaire KW - Pulmonary valve implantation KW - Trans-cathéter KW - Transcatheter SP - 607 EP - 14 JF - Archives of cardiovascular diseases JO - Arch Cardiovasc Dis VL - 107 IS - 11 N2 - 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. SN - 1875-2128 UR - https://www.unboundmedicine.com/medline/citation/25453718/Melody_®_transcatheter_pulmonary_valve_implantation:_results_from_a_French_registry_ DB - PRIME DP - Unbound Medicine ER -