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- Title
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?
- Authors
Mijangos-Vázquez, Roberto; García-Montes, Antonio J.; Zabal, Carlos; Soto-López, Elena M.; Guarner-Lans, Verónica; Mijangos-Vázquez, Roberto; García-Montes, Antonio J; Soto-López, Elena M; Guarner-Lans, Verónica
- Abstract
<bold>Objectives: </bold>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.<bold>Background: </bold>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 resultsPatients 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.<bold>Conclusions: </bold>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.
- Subjects
MEXICO; ATRIAL septal defects; CONGENITAL heart disease; POLYVINYL alcohol; CARDIOLOGY; PEDIATRIC cardiology; EQUIPMENT &; supplies; COMPARATIVE studies; DOPPLER echocardiography; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; POLYTEF; PROSTHETICS; COMPLICATIONS of prosthesis; RESEARCH; SURGICAL complications; TIME; TRANSESOPHAGEAL echocardiography; POLYSTYRENE; EVALUATION research; TREATMENT effectiveness; DISEASE incidence; RETROSPECTIVE studies; DIAGNOSIS
- Publication
Cardiology in the Young, 2018, Vol 28, Issue 5, p709
- ISSN
1047-9511
- Publication type
journal article
- DOI
10.1017/S1047951118000100