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?

Autor: Roberto Mijangos-Vázquez, Carlos Zabal, Verónica Guarner-Lans, Antonio J. García-Montes, Elena M. Soto-López
Rok vydání: 2018
Předmět:
Adult
Male
medicine.medical_specialty
Time Factors
Adolescent
Septal Occluder Device
Perforation (oil well)
Diastole
02 engineering and technology
030204 cardiovascular system & hematology
Prosthesis Design
Heart Septal Defects
Atrial

Young Adult
03 medical and health sciences
Postoperative Complications
0302 clinical medicine
Humans
Medicine
Child
Mexico
Polytetrafluoroethylene
Retrospective Studies
Ostium secundum atrial septal defect
End point
business.industry
Incidence
Follow up studies
Infant
General Medicine
Atrial septal defect closure
021001 nanoscience & nanotechnology
Echocardiography
Doppler
Color

Prosthesis Failure
Surgery
GoreTex patch
Treatment Outcome
Child
Preschool

Pediatrics
Perinatology and Child Health

Female
Polyvinyls
0210 nano-technology
Cardiology and Cardiovascular Medicine
business
Echocardiography
Transesophageal

Follow-Up Studies
Zdroj: Cardiology in the Young. 28:709-714
ISSN: 1467-1107
1047-9511
Popis: ObjectivesThe 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.BackgroundGreat 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.ConclusionsThe 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.
Databáze: OpenAIRE