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Preliminary results of the CeraflexTM PDA occluder and device behaviour during releasing

Published online by Cambridge University Press:  30 April 2019

Serdar Epçaçan Open the ORCID record for Serdar Epçaçan [Opens in a new window] ,
Mustafa Orhan Bulut ,
İlker Kemal Yücel ,
Naci Ceviz  and
Ahmet Çelebi
Serdar Epçaçan*
Affiliation:
Department of Pediatric Cardiology, University of Health Sciences, Van Training and Research Hospital, Van, Turkey
Mustafa Orhan Bulut
Affiliation:
Department of Pediatric Cardiology, University of Health Sciences, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
İlker Kemal Yücel
Affiliation:
Department of Pediatric Cardiology, University of Health Sciences, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
Naci Ceviz
Affiliation:
Medical Faculty, Department of Pediatric Cardiology, Ataturk University, Erzurum, Turkey
Ahmet Çelebi
Affiliation:
Department of Pediatric Cardiology, University of Health Sciences, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
*
Author for correspondence: Epçaçan Serdar, Department of Pediatric Cardiology, Van Training and Research Hospital, University of Medical Sciences, Van, Turkey. Tel: +90 505 4541484; Fax: +90 432 2121954; E-mail: [email protected]
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Abstract

Introduction:

The CeraFlexTM PDA occluder is a new flexible device with a unique delivery system that may be beneficial with regard to not changing the device position after releasing. We prospectively evaluate the efficacy of the device and also the device behaviour patterns during release.

Methods:

The study included 21 patients. Their median age was 1.2 years (from 6 months to 28 years) and weight was 9.6 kg (from 5.4 to 82 kg). All of the ducts were conical except one atypical ductus. Median ductal diameter at the pulmonary end was 3.8 mm (from 2.2 to 8.2 mm). The ductus was closed using an antegrade approach, but special attention was paid to the patterns of device behaviour during and just after releasing.

Results:

Three different modes of device behaviour were observed during and just after releasing: (1) Neither difficulty nor change of position in 13 patients (62%), (2) a little difficulty in releasing but no change of position in 6 (29%), and (3) change of the device position in 2 (9%). There was no residual shunt on the next day except in one patient, in whom late device embolisation occurred. The device was retrieved and another, bigger device implanted.

Conclusion:

The CeraFlexTM PDA occlude device seems to be safe and efficacious for patent ductus arteriosus closure. Its unique delivery system generally fixes the device in a stable position that does not change after release (91%). Minor difficulty in releasing is not uncommon; however, the major disadvantage is the need for larger sheaths for delivery.

Keywords

Patent ductus arteriosustranscatheter closuredevice
Type
Original Article
Information
Cardiology in the Young , Volume 29 , Issue 4 , April 2019 , pp. 519 - 523
Copyright
© Cambridge University Press 2019 

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