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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

Roberto Mijangos-Vázquez*
Affiliation:
Pediatric Interventional Cardiology Department, Pediatric Specialties Hospital, Tuxtla Gutiérrez, Chiapas, México
Antonio J. García-Montes
Affiliation:
Pediatric Interventional Cardiology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
Elena M. Soto-López
Affiliation:
Aorta Clinic, Immunology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
Verónica Guarner-Lans
Affiliation:
Physiology Department, National Institute of Cardiology “Ignacio Chávez”, Mexico City, Mexico
Carlos Zabal
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: dr.rmijangos@gmail.com

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.

Type
Original Articles
Copyright
© Cambridge University Press 2018 

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References

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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?
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