Abstract
We present our experience with the Cera (CO) and the CeraFlex occluder (CFO) in transcatheter closure of interatrial communications (IAC). Between 2013 and 2016, 201 patients (75 males, 16 with patent foramen ovale), aged 27 ± 19 (5–75) years, underwent percutaneous closure of IAC using CO or CFO in our institution. After transoesophageal imaging, the procedure was aborted in 7 young paediatric (6–13 years old) patients (3 multiple holes, 3 too small septum, 1 leak with 38 mm occlusion balloon). The occluder was removed prior to release in 11 patients (5.7%), while occlusion was successful in 183 patients (94.3%) with 44 CO, 136 CFO, and 3 Cera multifenestrated occluders. There were no deaths, embolizations, or major complications. Small residual shunts were demonstrated in 8 patients immediately after implantation, 4 (8.5%) with CO and 4 (2.9%) with CFO, all disappearing after 3 months. Over 1.8 ± 1.7 year follow-up, all patients improved with 2 asymptomatic, transient pericardial effusions and 5 adults with transient supraventricular arrhythmias, treated medically for 6 months. IAC closure with CO and CFO proved safe with favourable success rates and few, nonserious complications. The CFO flexible rotation feature helped in conforming to various septal anatomies, minimising manoeuvres and possibly post-occlusion leaks.
Similar content being viewed by others
References
Wilkinson JL, Goh TH. Early clinical experience with use of the ‘Amplatzer Septal Occluder’ device for atrial septal defect. Cardiol Young. 1998;8:295–302.
Vasquez AF, Lasala JM. Atrial septal defect closure. Cardiol Clin. 2013;31:385–400.
Fiszer R, Szkutnik M, Chodor B, Bialkowski J. Preliminary experience in the use of CERA occluders for closure of different intracardiac and extracardiac shunts. J Invasive Cardiol. 2014;26:385–8.
Astarcioglu MA, Kalcik M, Sen T, Aykan AC, Gokdeniz T, Gursoy OM, et al. Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure. Multicenter clinical experience. Herz. 2015;40(Suppl 2):146–50.
Zhang D, Zhang Z, Zi Z, Zhang Y, Zeng W, Chu PK. Fabrication of graded TiN coatings on nitinol occluders and effects on in vivo nickel release. Biomed Mater Eng. 2008;18:387–93.
Chan KC, Godman MJ, Walsh K, Wilson N, Redington A, Gibbs JL. Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience. Heart. 1999;82:300–6.
Masura J, Gavora P, Podnar T. Long-term outcome of transcatheter secundum-type atrial septal defect closure using Amplatzer septal occluders. J Am Coll Cardiol. 2005;45:505–7.
Ammar RI, Hegazy RA. Transcatheter closure of secundum ASD using Occlutech Figulla-N device in symptomatic children younger than 2 years of age. J Invasive Cardiol. 2013;25:76–9.
Kaya MG, Akpek M, Celebi A, Saritas T, Meric M, Soylu K, et al. A multicentre, comparative study of Cera septal occluder versus AMPLATZER Septal Occluder in transcatheter closure of secundum atrial septal defects. EuroIntervention. 2014;10:626–31.
Park SJ, Kim NK, Kim JO, Yoo BW, Choi JY, Sul JH. Morphologic Characteristics and Relating Factors to the Need of Technical Modification in Transcatheter Closure of Large Atrial Septal Defect (>/=25 mm). Korean Circ J. 2010;40:191–6.
Cooke JC, Gelman JS, Harper RW: Cobrahead malformation of the Amplatzer septal occluder device: an avoidable compilation of percutaneous ASD closure. Catheter Cardiovasc Interv. 2001;52:83–5 (discussion 6–7).
Hayes N, Rosenthal E. Tulip malformation of the left atrial disc in the Lifetech Cera ASD device: a novel complication of percutaneous ASD closure. Catheter Cardiovasc Interv. 2012;79:675–7.
Baspinar O, Sahin DA, Sulu A. Holy grail deformity of distal disc hubless atrial septal occluders in pediatric hearts. Int Heart J. 2015;56:469–70.
Kilic T, Ural E, Sahin T. Cobrahead deformity in the right atrial disc of a new-generation Occlutech Figulla Flex II atrial septal defect occluder device. Tex Heart Inst J. 2015;42:454–7.
Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv. 2004;63:496–502.
Tchantchaleishvili V, Melvin AL, Ling FS, Knight PA. Late erosion of Amplatzer septal occluder device resulting in cardiac tamponade. Interact Cardiovasc Thorac Surg. 2014;19:1074–6.
Stroker E, Van De Bruaene A, De Meester P, Van Deyck K, Gewillig M, Budts W. Transcatheter device closure of atrial septal defects in patients above age 60. Acta Cardiol. 2013;68:127–32.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
For this type of study, formal consent is not required.
This article does not contain any studies with animals performed by any of the authors.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Rights and permissions
About this article
Cite this article
Apostolopoulou, S.C., Tsoutsinos, A., Laskari, C. et al. Large single centre experience with the Cera™ and CeraFlex™ occluders for closure of interatrial communications: usefulness of the flexible rotation feature. Cardiovasc Interv and Ther 33, 70–76 (2018). https://doi.org/10.1007/s12928-016-0440-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12928-016-0440-y