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

For The Pivotal And Continuing Access Studies Of The Nit Occlud Pda Investigators

Research output: Contribution to journalArticle

16 Scopus citations

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. Investigatorreported 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.

Original languageEnglish (US)
Pages (from-to)1430-1436
Number of pages7
JournalJACC: Cardiovascular Interventions
Volume7
Issue number12
DOIs
StatePublished - 2014

Keywords

  • Coil
  • Occluder device
  • Patent ductus arteriosus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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