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

15 Citations (Scopus)

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

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Pediculus
Patent Ductus Arteriosus
Multicenter Studies
Equipment and Supplies
Safety
Benchmarking
Germany
Incidence

Keywords

  • Coil
  • Occluder device
  • Patent ductus arteriosus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

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.

In: JACC: Cardiovascular Interventions, Vol. 7, No. 12, 2014, p. 1430-1436.

Research output: Contribution to journalArticle

@article{f2906eaedf964d509a406746dd429b7d,
title = "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",
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.",
keywords = "Coil, Occluder device, Patent ductus arteriosus",
author = "{For The Pivotal And Continuing Access Studies Of The Nit Occlud Pda Investigators} and Moore, {John W.} and Jessica Greene and Salvadore Palomares and Alexander Javois and Owada, {Carl Y.} and Cheatham, {John P.} and Mark Hoyer and Jones, {Thomas K.} and Levi, {Daniel S.}",
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AU - Moore, John W.

AU - Greene, Jessica

AU - Palomares, Salvadore

AU - Javois, Alexander

AU - Owada, Carl Y.

AU - Cheatham, John P.

AU - Hoyer, Mark

AU - Jones, Thomas K.

AU - Levi, Daniel S.

PY - 2014

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N2 - 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.

AB - 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.

KW - Coil

KW - Occluder device

KW - Patent ductus arteriosus

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