Hostname: page-component-cd9895bd7-fscjk Total loading time: 0 Render date: 2024-12-27T07:18:18.319Z Has data issue: false hasContentIssue false
  • English
  • Français

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: drserdar1980@gmail.com
Get access Rights & Permissions [Opens in a new window]

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 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Masura, J, Walsh, KP, Thanopoulous, B, et al. Catheter closure of moderate- to large-sized patent ductus arteriosus using the new Amplatzer duct occluder: immediate and short-term results. J Am Coll Cardiol 1998; 31: 878–882.CrossRefGoogle ScholarPubMed
Atiq, M, Aslam, N,Kazmi, KA. Transcatheter closure of small-to-large patent ductus arteriosus with different devices: queries and challenges. J Invasive Cardiol 2007; 19: 295–298.Google ScholarPubMed
Cambier, PA, Kirby, WC, Wortham, DC, Moore, JW. Percutaneous closure of the small (less than 2.5 mm) patent ductus arteriosus using coil embolization. Am J Cardiol 1992; 69: 815–816.CrossRefGoogle ScholarPubMed
Moore, JW, George, L, Kirkpatrick, SE, et al. Percutaneous closure of the small patent ductus arteriosus using occluding spring coils. J Am Coll Cardiol 1994; 23: 759–765.CrossRefGoogle ScholarPubMed
Celebi, A, Demir, IH, Saritas, T, et al. Cardi-O-Fix duct occluder versus Amplatzer duct occluder for closure of patent ductus arteriosus. Catheter Cardiovasc Interv 2013; 82: 961–967.CrossRefGoogle ScholarPubMed
Sungur, M, Karakurt, C, Ozbarlas, N,Baspinar, O. Closure of patent ductus arteriosus in children, small infants, and premature babies with Amplatzer duct occluder II additional sizes: multicenter study. Catheter Cardiovasc Interv 2013; 82: 245–252.CrossRefGoogle ScholarPubMed
Bilici, M, Demir, F, Akin, A, Ture, M, Balik, H,Kuyumcu, M. Transcatheter closure of patent ductus arteriosus in children with the occlutech duct occluder. Pediatr Cardiol 2017; 38: 1598–1605.CrossRefGoogle ScholarPubMed
Bilkis, AA, Alwi, M, Hasri, S, et al. The Amplatzer duct occluder: experience in 209 patients. J Am Coll Cardiol 2001; 37: 258–261.CrossRefGoogle ScholarPubMed
Al-Ata, J, Arfi, AM, Hussain, A, Kouatli, AA,Jalal, MO. The efficacy and safety of the Amplatzer ductal occluder in young children and infants. Cardiol Young 2005; 15: 279–285.CrossRefGoogle ScholarPubMed
Masura, J, Tittel, P, Gavora, P,Podnar, T. Long-term outcome of transcatheter patent ductus arteriosus closure using Amplatzer duct occluders. Am Heart J 2006; 151: 755 e757–755 e710.CrossRefGoogle ScholarPubMed
Moore, JW, Levi, DS, Moore, SD, Schneider, DJ,Berdjis, F. Interventional treatment of patent ductus arteriosus in 2004. Catheter Cardiovasc Interv 2005; 64: 91–101.CrossRefGoogle ScholarPubMed
Galal, MO, Hussain, A,Arfi, AM. Do we still need the surgeon to close the persistently patent arterial duct? Cardiol Young 2006; 16: 522–536.CrossRefGoogle ScholarPubMed
Bass, JL,Wilson, N. Transcatheter occlusion of the patent ductus arteriosus in infants: experimental testing of a new Amplatzer device. Catheter Cardiovasc Interv 2014; 83: 250–255.CrossRefGoogle ScholarPubMed
Garay, FJ, Aguirre, D, Cardenas, L, Springmuller, D,Heusser, F. Use of the Amplatzer vascular plug II device to occlude different types of patent ductus arteriosus in pediatric patients. J Interv Cardiol 2015; 28: 198–204.CrossRefGoogle ScholarPubMed
Sudhakar, P, Jose, J,George, OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J 2018; 70: 308–315.Google Scholar
Baruteau, AE, Hascoet, S, Baruteau, J, et al. Transcatheter closure of patent ductus arteriosus: past, present and future. Arch Cardiovasc Dis 2014; 107: 122–132.CrossRefGoogle ScholarPubMed
Lam, JY, Lopushinsky, SR, Ma, IWY, Dicke, F, Brindle, ME. Treatment options for pediatric patent ductus arteriosus: systematic review and meta-analysis. Chest 2015; 148: 784–793.CrossRefGoogle ScholarPubMed
Yuko-Jowi, CA, Okello, CA,Mutai, L. Complementary techniques of percutaneous closure of ductus arteriosus using detachable cook coils and Amplatzer devices. East Afr Med J 2013; 90: 214–221.Google ScholarPubMed
Arora, R. Transcatheter closure of patent ductus arteriosus. Expert Rev Cardiovasc Ther 2005; 3: 865–874.CrossRefGoogle ScholarPubMed
Liddy, S, Oslizlok, P, Walsh, KP. Comparison of the results of transcatheter closure of patent ductus arteriosus with newer Amplatzer devices. Catheter Cardiovasc Interv 2013; 82: 253–259.CrossRefGoogle ScholarPubMed
Saliba, Z, El-rassi, I, Helou, D, et al. Development of catheter-based treatment of patent ductus arteriosus: a medium-sized centre experience. Arch Cardiovasc Dis 2009; 102: 111–118.CrossRefGoogle ScholarPubMed
Backes, CH, Kennedy, KF, Locke, M, et al. Transcatheter occlusion of the patent ductus arteriosus in 747 infants <6 kg: insights from the NCDR IMPACT registry. JACC Cardiovasc Interv 2017; 10: 1729–1737.CrossRefGoogle ScholarPubMed
Santoro, G, Giordano, M, Gaio, G, et al. Transcatheter closure of arterial duct in infants < 6 kg: Amplatzer duct occluder type I vs Amplatzer duct occluder II additional sizes. Pediatr Cardiol 2018; 39: 627–632.CrossRefGoogle ScholarPubMed
Backes, CH, Rivera, BK, Bridge, JA, et al. Percutaneous patent ductus arteriosus (PDA) closure during infancy: a meta-analysis. Pediatrics 2017; 139: e20162927.CrossRefGoogle ScholarPubMed
Masri, S, El Rassi, I, Arabi, M, Tabbakh, A, Bitar, F. Percutaneous closure of patent ductus arteriosus in children using Amplatzer duct occluder II: relationship between PDA type and risk of device protrusion into the descending aorta. Catheter Cardiovasc Interv 2015; 86: E66–72.CrossRefGoogle ScholarPubMed
Buys, DG, Greig, C, Brown, SC. ASD and PDA closure with CeraTM and CeraFlexTM devices. SA Heart 2016; 13: 6–10.Google Scholar

Epçaçan et al. supplementary material

Epçaçan et al. supplementary material 1

Download Epçaçan et al. supplementary material(Video)
Video 5.2 MB

Epçaçan et al. supplementary material

Epçaçan et al. supplementary material 2

Download Epçaçan et al. supplementary material(Video)
Video 1.2 MB

Epçaçan et al. supplementary material

Epçaçan et al. supplementary material 3

Download Epçaçan et al. supplementary material(Video)
Video 5.9 MB