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Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure

Multicenter clinical experience

Ceraflex™- vs. Amplatzer™-Occluder zum Verschluss eines Vorhofseptumdefekts vom Sekundumtyp

Klinische Multizenterstudie

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Abstract

Aim

The Ceraflex atrial septal defect occluder is an alternative device to the Amplatzer septal occluder with some structural innovations including flexible connection, increased flexibility, and minimized amount of implant material. We evaluated the efficiency and safety of the Ceraflex septal occluder device in percutaneous closure of secundum atrial septal defects.

Patients and methods

This was a prospective, nonrandomized, multicenter study of patients undergoing transcatheter closure for an atrial septal defect with the Ceraflex and the Amplatzer septal occluder devices. A clinical evaluation and follow-up transthoracic echocardiography were performed at 1, 6, and 12 months.

Results

Between 2010 and 2014, 125 patients underwent atrial septal defect closure with the Ceraflex septal occluder (n = 58) and the Amplatzer septal occluder (n = 67) under transesophageal echocardiography guidance. Patient characteristics, the stretched size of the defect, device size, and fluoroscopy time were similar between the groups. The immediate and follow-up complete occlusion rates for both groups were 100%. There was no device embolization, procedure-related stroke, or pericardial effusion.

Conclusions

The Ceraflex septal occluder is a safe and efficient device for closure of secundum atrial septal defects with no procedural complications. The Ceraflex has similar outcomes when compared with the Amplatzer septal occluder device. The advantage of the Ceraflex septal occluder device is that it can be deployed without the tension of the delivery catheter.

Zusammenfassung

Ziel

Der Ceraflex™-Occluder zum Verschluss eines Vorhofseptumdefekts stellt ein alternatives System zum Amplatzer™-Occluder dar, das mit einigen strukturellen Innovationen einschließlich einer flexiblen Verbindung, erhöhten Flexibilität und Minimierung der Menge implantierten Materials einhergeht. Untersucht wurde die Wirksamkeit und Sicherheit des Ceraflex™-Occluders bei perkutanem Verschluss von Vorhofseptumdefekten vom Sekundumtyp.

Methoden

Es handelte sich um eine prospektive, nichtrandomisierte Multizenterstudie an Patienten mit Verschluss eines Vorhofseptumdefekts mittels eines Katheters, und zwar dem Ceraflex™- oder dem Amplatzer™-Occluder. Nach 1, 6 und 12 Monaten erfolgten bei den Patienten mit Vorhofseptumdefekt eine klinische Untersuchung und eine transthorakale Nachsorgeechokardiographie.

Ergebnisse

Zwischen 2010 und 2014 wurde bei 125 Patienten der Verschluss eines Vorhofseptumdefekts mit dem Ceraflex™-Occluder (n = 58) bzw. dem Amplatzer™-Occluder (n = 67) unter transösophagealer Steuerung durchgeführt. Patientenmerkmale, Defektgröße unter Dehnung, Größe des Occluders und Durchleuchtungsdauer waren in beiden Gruppen ähnlich. Die vollständige Verschlussrate lag unmittelbar nach dem Eingriff und im Verlauf für beide Gruppen bei 100%. Es gab keine Occluderembolie, interventionsbedingten Schlaganfälle oder Perikardergüsse.

Schlussfolgerungen

Der Ceraflex™-Occluder ist ein sicheres und wirksames System zum Verschluss eines Vorhofseptumdefekts vom Sekundumtyp ohne interventionsbedingte Komplikationen. Für den Ceraflex™-Occluder liegen ähnliche Ergebnisse vor wie für den Amplatzer™-Occluder. Der Vorteil des Ceraflec™-Occluders liegt darin, dass er eingesetzt wird, ohne dass der Platzierungskatheter Zug daran ausübt.

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Fig. 1
Fig. 2

Abbreviations

ASD:

Atrial septal defect

ASO:

Amplatzer septal occluder

CSO:

Ceraflex septal occluder

PET:

Polyethylene terephthalate

TEE:

Transesophageal echocardiography

TTE:

Transthoracic echocardiography

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Compliance with ethical guidelines

Conflict of interest. M.A. Astarcioglu, M. Kalcik, T. Sen, A.C. Aykan, T. Gokdeniz, O.M. Gursoy, S. Karakoyun, S. Kulahcioglu, S. Gunduz, C. Kilit, M. Oylumlu, and B. Amasyali state that there are no conflicts of interest. The accompanying manuscript does not include studies on humans or animals.

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Authors and Affiliations

  1. Department of Cardiology, Evliya Celebi Training and Research Hospital, Kutahya, Turkey

    M.A. Astarcioglu MD & T. Sen

  2. Department of Cardiology, Koşuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey

    M. Kalcik, O.M. Gursoy, S. Kulahcioglu & S. Gunduz

  3. Department of Cardiology, Ahi Evran Training and Research Hospital, Trabzon, Turkey

    A.C. Aykan

  4. Department of Cardiology, Kars Kafkas Medical Faculty, Kars, Turkey

    T. Gokdeniz & S. Karakoyun

  5. Department of Cardiology, Dumlupinar University, Kutahya, Turkey

    C. Kilit, M. Oylumlu & B. Amasyali

Authors
  1. M.A. Astarcioglu MD
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  2. M. Kalcik
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  3. T. Sen
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  4. A.C. Aykan
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  5. T. Gokdeniz
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  6. O.M. Gursoy
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  7. S. Karakoyun
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  8. S. Kulahcioglu
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  9. S. Gunduz
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  10. C. Kilit
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  11. M. Oylumlu
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  12. B. Amasyali
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Corresponding author

Correspondence to M.A. Astarcioglu MD.

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Astarcioglu, M., Kalcik, M., Sen, T. et al. Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure. Herz 40 (Suppl 2), 146–150 (2015). https://doi.org/10.1007/s00059-014-4192-0

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  • DOI: https://doi.org/10.1007/s00059-014-4192-0

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