Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience.
Int J Cardiol
; 327: 68-73, 2021 03 15.
Article
em En
| MEDLINE
| ID: mdl-33220363
ABSTRACT
BACKGROUND:
This perspective, observational study evaluated safety and efficacy of the GORE® Cardioform ASD Occluder (WL Gore & Associates, Flagstaff, AZ), compliant and potentially innovative prosthesis recently approved for closure of ostium secundum atrial septal defects (ASD).METHODS:
Between January and June 2020, 43 unselected patients with -significant ASD were submitted to trans-catheter closure with GORE® Cardioform ASD Occluder at two high-volume Italian Pediatric Cardiology centers. Primary endpoints were procedural success and safety. Secondary endpoints were closure rate and clinical safety at 1-month follow-up.RESULTS:
Patients' age and weight were 8.2 ± 3.9 years (range 3-21, median 9.9) and 29.6 ± 15.3 kg (range 16-57, median 33.3), respectively. ASD diameter was 16.6 ± 4.5 mm (median 10), resulting in QP/QS of 1.7 ± 0.7 (median 1.6). Seventeen pts. (39.5%) were considered "surgical" candidates due to challenging septum morphology, ASD rim deficiency or ASD diameter/patient weight ratio ≥ 1.2. Device placement was successfully achieved in all but one patient (97.7%), in whom it embolized early after deployment, resulting in rescue surgical repair. No cross-over with different devices was recorded. Median procedure and fluoroscopy times were 40 and 6.8 min, respectively. Major adverse events were recorded in 7.0% (3 pts). Complete closure rate was 78.5% at discharge, rising to 92.9% (39/42 pts) at 1 month evaluation, without cardiac or extra-cardiac adverse events. "Challenging" procedures were more time-consuming but as effective and safe as the "simple" ones.CONCLUSIONS:
The GORE® Cardioform ASD Occluder device was highly effective and versatile in closure of ASDs with different anatomy and size, even in challenging settings.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Dispositivo para Oclusão Septal
/
Comunicação Interatrial
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adolescent
/
Adult
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Child
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Child, preschool
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Humans
Idioma:
En
Revista:
Int J Cardiol
Ano de publicação:
2021
Tipo de documento:
Article