Article (Scientific journals)
Retrievable patent ductus arteriosus plug for interventional, transvenous occlusion of the patent ductus arteriosus : Evaluation in lambs and preliminary clinical results.
Grabitz, R. G.; Schrader, R.; Sigler, M. et al.
1997In Investigative Radiology, 32 (9), p. 523-8
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Keywords :
Adolescent; Adult; Aged; Animals; Animals, Newborn; Aortography; Ductus Arteriosus, Patent/pathology/radiography/therapy; Embolization, Therapeutic/instrumentation/methods; Female; Follow-Up Studies; Humans; Male; Microscopy, Electron, Scanning; Middle Aged; Polyvinyls/therapeutic use; Sheep; Treatment Outcome
Abstract :
[en] RATIONALE AND OBJECTIVES: The clinically most widely used devices (Porstmann-plug, Rashkind-umbrella, Botallooccluder) have inherent specific limitations (eg, transarterial approach, residual shunts, limited retrieval). The authors assess practicability, efficacy, and tissue reaction of the new retrievable transvenous plug device for the occlusion of the persistent patent ductus arteriosus (PDA). METHODS: A foam plug (polyvinyl alcohol) is mounted on a titanium core pin where, at both ends, small legs (titanium nickel alloy) with titanium heads are anchored, to ensure safe fixation in the ductus. The device is introduced transvenously through a long sheath (Mullins sheath) and held by a modified biopsy forceps allowing complete retrieval until final release. A common lamb model of large PDAs (n = 11) was used to test for practicability and the histomorphologic outcome. Clinical results were obtained from a consecutive series of 16 patients (aged 13 to 71 years). RESULTS: In all lambs, placement of the plug within the PDA was possible. Histopathology (follow-up 10 to 215 days; mean 112 days) revealed an adequate ingrowing of the device and no pathologic foreign body reaction. The diameter of the human PDAs ranged from 3 to 7 mm (mean 5 mm). The size of the sheath used for introducing the plug (diameter 8 to 16 mm) ranged from 8 to 16 French. Fourteen of 16 PDAs were closed immediately after or on day 1 after implantation, 1 was closed after the 12-month follow-up, and 1 needed an additional plug after 30 months for definitive closure. CONCLUSIONS: The device demonstrated practicability and biocompatibility in our experimental lamb model and effectively closed the PDA in a consecutive series of 16 patients. A greater number of patients and a longer follow-up period are necessary for the definitive clinical assessment of the new device.
Disciplines :
Pediatrics
Cardiovascular & respiratory systems
Author, co-author :
Grabitz, R. G.;  Rheinisch - Westfälische Technische Hochschule Aachen - RWTH > Pediatric Cardiology
Schrader, R.;  Cardioangio Centre Bethanien, Hospital Bethanien, Frankfurt, Germany
Sigler, M.;  Rheinisch - Westfälische Technische Hochschule Aachen - RWTH > Pediatric Cardiology
SEGHAYE, Marie-Christine ;  Rheinisch - Westfälische Technische Hochschule Aachen - RWTH > Pediatric Cardiology
Dzionsko, C.;  Rheinisch - Westfälische Technische Hochschule Aachen - RWTH > Pediatric Cardiology
Handt, S.;  Rheinisch - Westfälische Technische Hochschule Aachen - RWTH > Pathology
Schneidt, B.;  ID Medizintechnik, Gelnhausen, Germany
Von Bernuth, G.;  Rheinisch - Westfälische Technische Hochschule Aachen - RWTH > Pediatric Cardiology
Language :
English
Title :
Retrievable patent ductus arteriosus plug for interventional, transvenous occlusion of the patent ductus arteriosus : Evaluation in lambs and preliminary clinical results.
Publication date :
September 1997
Journal title :
Investigative Radiology
ISSN :
0020-9996
eISSN :
1536-0210
Publisher :
Lippincott Williams & Wilkins, Hagerstown, United States - Maryland
Volume :
32
Issue :
9
Pages :
523-8
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 07 February 2014

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