ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect.
Catheter Cardiovasc Interv
; 95(7): 1285-1295, 2020 06 01.
Article
em En
| MEDLINE
| ID: mdl-31943749
ABSTRACT
OBJECTIVE:
Assess clinical performance of a new device for transcatheter closure of atrial septal defect (ASD).BACKGROUND:
Previously-approved ASD Closure devices have known limitations. Device erosion has been associated with the AMPLATZER® septal occluder in patients with retro-aortic rim deficiency (<5 mm), while defects ≥18 mm are too large for the GORE® CARDIOFORM septal occluder. The GORE® CARDIOFORM ASD occluder (GCA), a hybrid of the approved devices, was designed to expand the eligible ASD population.METHODS:
One-hundred and twenty-five ASD patients were enrolled in a prospective, multicenter registry. Descriptive clinical endpoints included technical implant success, closure success, serious adverse events (SAE), clinically significant new arrhythmia, and wire frame fracture. Procedural outcomes and adverse events were adjudicated by an Echocardiography Core Lab and Independent Data Review Board, respectively.RESULTS:
Median subject age was 12.3 years (range 2.9-84.7), with 72% of patients ≤18 years old. Median ASD stop-flow diameter was 17.0 mm (8.0-30.0), with 43% ≥18 mm. Deficient retro-aortic rim occurred in 57% of subjects, and 30% had both diameter ≥ 18 mm and deficient rim. Technical Implant Success was achieved in 120/125 (96%), though three devices were removed within 24 hr. At the scheduled 6-month evaluation, 112/117 returned for evaluation. All 112 had closure success. SAE occurred in 6/125 (4.8%) and 6/125 (4.8%) had clinically significant new arrhythmia. Wire frame fractures occurred in 37/104 (36%), without any associated clinical sequelae, residual shunt, or device instability.CONCLUSION:
The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cateterismo Cardíaco
/
Dispositivo para Oclusão Septal
/
Comunicação Interatrial
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adolescent
/
Adult
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Aged
/
Aged80
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Child
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Child, preschool
/
Female
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Humans
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Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Assunto da revista:
CARDIOLOGIA
Ano de publicação:
2020
Tipo de documento:
Article