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. 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.

• Authors: John W Moore, Jessica Greene, Salvadore Palomares, Alexander Javois, Carl Y Owada, John P Cheatham, Mark H Hoyer, Thomas K Jones, Daniel S Levi, Pivotal and Continuing Access Studies of the Nit Occlud PDA Investigators
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 7 Issue 12 Pg. 1430-6 (Dec 2014) ISSN: 1876-7605 [Electronic] United States
• PMID: 25523534 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Alloys
• nitinol

Topics

• Adolescent
• Alloys
• Cardiac Catheterization (adverse effects, instrumentation)
• Child
• Child, Preschool
• Ductus Arteriosus, Patent (diagnosis, therapy)
• Female
• Humans
• Infant
• Male
• Prospective Studies
• Prosthesis Design
• Risk Factors
• Time Factors
• Treatment Outcome
• United States
• Young Adult