One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study.
JACC Cardiovasc Interv
; 7(11): 1254-62, 2014 Nov.
Article
em En
| MEDLINE
| ID: mdl-25459038
ABSTRACT
OBJECTIVES:
This study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to the historical results established in the initial 5-center Investigational Device Exemption trial.BACKGROUND:
TPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device.METHODS:
Patients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient ≤30 mm Hg, pulmonary regurgitation less than moderate as measured by echocardiography, and freedom from conduit reintervention and reoperation.RESULTS:
Cardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year.CONCLUSIONS:
This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692).Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Valva Pulmonar
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Insuficiência da Valva Pulmonar
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Estenose da Valva Pulmonar
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Próteses Valvulares Cardíacas
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Cateterismo Cardíaco
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Implante de Prótese de Valva Cardíaca
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Cardiopatias Congênitas
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Procedimentos Cirúrgicos Cardíacos
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
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Observational_studies
Limite:
Adolescent
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Adult
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Child
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Female
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Humans
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Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
JACC Cardiovasc Interv
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2014
Tipo de documento:
Article