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Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience – has the perforation of Ivalon’s membrane been solved?

Published online by Cambridge University Press:  27 February 2018

Mijangos-Vázquez Roberto Open the ORCID record for Mijangos-Vázquez Roberto [Opens in a new window] ,
García-Montes Antonio J. ,
Soto-López Elena M. ,
Guarner-Lans Verónica  and
Zabal Carlos
Mijangos-Vázquez Roberto*
Affiliation:
Pediatric Interventional Cardiology Department, Pediatric Specialties Hospital, Tuxtla Gutiérrez, Chiapas, México
García-Montes Antonio J.
Affiliation:
Pediatric Interventional Cardiology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
Soto-López Elena M.
Affiliation:
Aorta Clinic, Immunology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
Guarner-Lans Verónica
Affiliation:
Physiology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
Zabal Carlos
Affiliation:
Pediatric Interventional Cardiology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
*
Author for correspondence: M.-V. Roberto, Pediatric Interventional Cardiology Department, Pediatric Specialties Hospital, Blvd. SS Juan Pablo II y Blvd. Antonio Pariente Algarín S/N, CP. 29070, Tuxtla Gutiérrez, Chiapas. Tel: +52 961 6170700; E-mail: [email protected]
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Abstract

Objectives

The objective of this study was to demonstrate the safety and feasibility of using the new Cardia Ultrasept II™ device with interposed Goretex patch referring to the perforation of polyvinyl alcohol membrane.

Background

Great advances have been made in the development of devices for closure of atrial septal defect. The Cardia Ultrasept II™ with interposed Goretex patch is the modified last generation of Cardia devices, having the advantage of a super-low profile within the atria and an integral locking delivery-retrieval mechanism that ensures safe deployment. In addition, with the interposition of the Goretex, it has been possible to abolish perforation of Ivalon’s membrane as a complication.

Methods and results

Patients with ostium secundum atrial septal defect with surrounding rims with a minimum length of 5 mm and who underwent atrial septal defect closure with the new Ultrasept II™ with Goretex patch were included from two paediatric cardiac centres. Primary end point was to determine perforation of the Goretex membrane at follow-up; secondary end point included right ventricular diastolic diameter. In total, 30 patients underwent atrial septal defect closure at a median age of 6 (1–29) years. At follow-up for 6 (range, 1–15) months, freedom from perforations was 100%. A continuous decrease in right ventricular diastolic diameter was found with an initial median of 30 (25–49) mm and after catheterisation of 27.5 (18–33) mm, p=0.01, and Z-score of 2.6 (1.7–3.6) versus 1.9 (1–2.9) after procedure, p=0.01.

Conclusions

The new modified generation of the Ultrasept II™ device with interposed Goretex patch is a good alternative to achieve atrial septal defect closure safely and feasibly with no membrane perforation at follow-up.

Keywords

Atrial septal defectCardia Ultrasept IICHDMexico
Type
Original Articles
Information
Cardiology in the Young , Volume 28 , Issue 5 , May 2018 , pp. 709 - 714
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Copyright
© Cambridge University Press 2018 

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References

1. Du, ZD, Hijazi, ZM, Kleinman, CS, Silverman, NH, Larntz, K, The Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol 2002; 39: 1836–1844.CrossRefGoogle ScholarPubMed
2. Visconti, KJ, Bichell, DP, Jonas, RA, Newburger, JW, Bellinger, DC. Developmental outcome after surgical versus interventional closure of secundum atrial septal defect in children. Circulation 1999; 100 (Suppl): II145–II150.Google Scholar
3. King, TD, Thompson, SL, Steiner, C, et al. Secundum atrial septal defect: non operative closure during cardiac catheterization. J Am Med Assoc 1976; 235: 2506–2509.CrossRefGoogle Scholar
4. Schraeder, R, Fassbender, D, Strasser, RH. PFO-star for closure of patent foramen ovale in patients with presumed paradoxical embolism. In: PS Rao, MJ Kern (eds) Catheter Based Devices for the Treatment of Non-Coronary Cardiovascular Disease in Adults and Children. Lippincott Williams & Wilkins, Philadelphia, PA, USA, 2003: 103–109.Google Scholar
5. Turner, DR, Forbes, TJ. Cardia devices. In: Hijazi Z, Feldman T, Abdullah Al-Qbandi MH, et al (eds). Transcatheter Closure of ASDs and PFOs: A Comprehensive Assessment. Cardiotext, Minneapolis, MN, 2010: 407–416.Google Scholar
6. Huang, Y, Kong, JF, Venkatraman, SS. Biomaterials and design in occlusion devices for cardiac defects: a review. Acta Biomaterialia 2014; 10: 1088–1101.Google Scholar
7. Aubry, P, Brochet, E, Halna du Fretay, X, et al. Early malfunction of polyvinyl alcohol membrane-covered atrial septal defect closure devices. Circ Cardiovasc Intrerv 2014; 7: 721–722.Google Scholar
8. Bhattacharyya, S, Ilsley, CD, Baltabaeva, A. Disintegration of polyvinyl alcohol membrane covering atrial septal defect closure device. Eur Heart J 2015: 1153.Google ScholarPubMed
9. Ramoglu, MG, Ucar, T, Tutar, E. Early malfunction of polyvinyl alcohol membrane of septal occluder. Cathet Cardiovasc Intervent 2016; 87: E151–E153.Google Scholar
10. Labombarda, F, Roule, V, Beygui, F. Delayed spontaneous perforation of polyvinyl alcohol membrane – covered atrial septal defect closure devices. Catheter Cardiovasc Interv 2016; 89: E141–E144.Google Scholar
11. Chamie, F, Maia, J, Giuliano, LC. Device-in-device: a transcatheter alternative to surgical explantation of a failing atrial septal defect intracardiac prosthesis. Catheter Cardiovasc Interv 2016; 88: 239–243.Google Scholar
12. Feltes, TF, Bacha, E, Beekman, RH, et al. Indications for cardiac catheterization and intervention in pediatric cardiac disease: a scientific statement from the American Heart Association. Circulation 2011; 123: 2607–2652.Google Scholar
13. Butera, G, Biondi-Zoccai, G, Sangiorgi, G, et al. Percutaneous versus surgical closure of secundum atrial septal defects: a systematic review and meta-analysis of currently available clinical evidence. Euro Intervention 2011; 7: 377–385.Google Scholar
14. 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: 300–306.Google Scholar
15. Chessa, M, Carminati, M, Butera, G, et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol 2002; 39: 1061–1065.Google Scholar