John W Moore1, Jessica Greene2, Salvadore Palomares2, Alexander Javois3, Carl Y Owada4, John P Cheatham5, Mark H Hoyer6, Thomas K Jones7, Daniel S Levi8. 1. Division of Cardiology, Rady Children's Hospital, University of California, San Diego School of Medicine, San Diego, California. Electronic address: jmoore@rchsd.org. 2. PFM Medical, Inc., Carlsbad, California. 3. Division of Cardiology, Advocate Children's Hospital, University of Illinois School of Medicine, Park Ridge, Illinois. 4. Division of Cardiology, Children's Hospital Central California, Fresno, California. 5. Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus, Ohio. 6. Division of Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana. 7. Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington. 8. Division of Cardiology, Mattel Children's Hospital UCLA, David Geffen School of Medicine, University of California, Los Angeles, California.
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.
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.
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