Results of the combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.
JACC Cardiovasc Interv
; 7(12): 1430-6, 2014 Dec.
Article
en En
| MEDLINE
| ID: mdl-25523534
ABSTRACT
OBJECTIVES:
This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC).BACKGROUND:
The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system.METHODS:
Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total).RESULTS:
The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%).CONCLUSIONS:
Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Cateterismo Cardíaco
/
Conducto Arterioso Permeable
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Límite:
Adolescent
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Adult
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
País/Región como asunto:
America do norte
Idioma:
En
Revista:
JACC Cardiovasc Interv
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2014
Tipo del documento:
Article