Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus

Daisuke Kobayashi, Morris M. Salem, Thomas J. Forbes, Brent M. Gordon, Brian D. Soriano, Vasiliki V Dimas, Bryan H. Goldstein, Carl Owada, Alexander Javois, John Bass, Thomas K. Jones, Darren P. Berman, Matthew J. Gillespie, John W. Moore, Daniel S. Levi

Research output: Contribution to journalArticle

Abstract

Objectives: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. Background: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. Methods: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. Results: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events. Conclusions: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.

Original languageEnglish (US)
JournalCatheterization and Cardiovascular Interventions
DOIs
StateAccepted/In press - Jan 1 2018

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Pediculus
Patent Ductus Arteriosus
Multicenter Studies
Equipment and Supplies
United States Food and Drug Administration
Germany
Echocardiography
Angiography
Clinical Trials
Prospective Studies
Safety
Mortality

Keywords

  • coil
  • occluder device
  • patent ductus arteriosus

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus. / Kobayashi, Daisuke; Salem, Morris M.; Forbes, Thomas J.; Gordon, Brent M.; Soriano, Brian D.; Dimas, Vasiliki V; Goldstein, Bryan H.; Owada, Carl; Javois, Alexander; Bass, John; Jones, Thomas K.; Berman, Darren P.; Gillespie, Matthew J.; Moore, John W.; Levi, Daniel S.

In: Catheterization and Cardiovascular Interventions, 01.01.2018.

Research output: Contribution to journalArticle

Kobayashi, D, Salem, MM, Forbes, TJ, Gordon, BM, Soriano, BD, Dimas, VV, Goldstein, BH, Owada, C, Javois, A, Bass, J, Jones, TK, Berman, DP, Gillespie, MJ, Moore, JW & Levi, DS 2018, 'Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus', Catheterization and Cardiovascular Interventions. https://doi.org/10.1002/ccd.27995
Kobayashi, Daisuke ; Salem, Morris M. ; Forbes, Thomas J. ; Gordon, Brent M. ; Soriano, Brian D. ; Dimas, Vasiliki V ; Goldstein, Bryan H. ; Owada, Carl ; Javois, Alexander ; Bass, John ; Jones, Thomas K. ; Berman, Darren P. ; Gillespie, Matthew J. ; Moore, John W. ; Levi, Daniel S. / Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus. In: Catheterization and Cardiovascular Interventions. 2018.
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abstract = "Objectives: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. Background: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. Methods: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. Results: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8{\%}) had successful device implantation. After 12 months, 98.7{\%} (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4{\%} (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4{\%}. There were no mortalities and no serious device-related adverse events. Conclusions: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.",
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AU - Salem, Morris M.

AU - Forbes, Thomas J.

AU - Gordon, Brent M.

AU - Soriano, Brian D.

AU - Dimas, Vasiliki V

AU - Goldstein, Bryan H.

AU - Owada, Carl

AU - Javois, Alexander

AU - Bass, John

AU - Jones, Thomas K.

AU - Berman, Darren P.

AU - Gillespie, Matthew J.

AU - Moore, John W.

AU - Levi, Daniel S.

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N2 - Objectives: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. Background: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. Methods: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. Results: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events. Conclusions: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.

AB - Objectives: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. Background: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. Methods: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported. Results: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events. Conclusions: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials.

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