RESUMO
OBJECTIVES: To evaluate the feasibility, safety, and efficacy of implantation of the new Nit Occlud ASD-R® (NOASD-R) device for percutaneous closure of ostium secundum atrial septal defects (ASD-OS). BACKGROUND: Device catheter implantation has become the method of choice for most patients with ASD-OS. No single device has proven to be ideal for this type of procedure. The NOASD-R has a distinct design that may help to overcome limitations of other devices. METHODS: A prospective, single arm, observational study including all consecutive patients receiving the NOASD-R device for ASD-OS closure between October 2011 and September 2013 was performed. Patient selection, device design, deployment technique, complications, and procedural outcomes were evaluated. RESULTS: Seventy-four patients underwent attempted transcatheter ASD-OS closure using the NOASD-R device. Implantation of the occluder was successful in 73 patients (98.6%). The majority of patients were female (79.5%) with a median age of 17.2 years (range: 2-74). A 2-D transthoracic color-Doppler echocardiogram (TTE) obtained at the 3 or 6 month follow-up visit showed complete occlusion of the ASD-OS in 72/73 patients (98.6%). At a mean follow-up interval of 11.4 ± 6.8 months there have been no episodes of late device embolization, cardiac perforation or erosion, endocarditis, thromboembolism, wire fracture, embolic neurologic events, or death. CONCLUSIONS: We report the first worldwide clinical experience using the NOASD-R device for ASD-OS closure. The procedure was feasible, with a high rate of successful implantations, and safe. High ASD-OS closure rates and no complications were encountered during short-term follow-up. © 2014 Wiley Periodicals, Inc.
Assuntos
Cateterismo Cardíaco/métodos , Comunicação Interatrial/cirurgia , Dispositivo para Oclusão Septal , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Ecocardiografia Doppler em Cores , Ecocardiografia Transesofagiana , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Seguimentos , Comunicação Interatrial/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
Objectives: To evaluate the feasibility, safety, and efficacy of implantation of the newNit Occlud ASD-RVR (NOASD-R) device for percutaneous closure of ostium secundumatrial septal defects (ASD-OS). Background: Device catheter implantation has becomethe method of choice for most patients with ASD-OS. No single device has proven tobe ideal for this type of procedure. The NOASD-R has a distinct design that may helpto overcome limitations of other devices. Methods: A prospective, single arm, observationalstudy including all consecutive patients receiving the NOASD-R device forASD-OS closure between October 2011 and September 2013 was performed. Patientselection, device design, deployment technique, complications, and procedural outcomeswere evaluated. Results: Seventy-four patients underwent attempted transcatheterASD-OS closure using the NOASD-R device. Implantation of the occluder wassuccessful in 73 patients (98.6%). The majority of patients were female (79.5%) with amedian age of 17.2 years (range: 274). A 2-D transthoracic color-Doppler echocardiogram(TTE) obtained at the 3 or 6 month follow-up visit showed complete occlusion ofthe ASD-OS in 72/73 patients (98.6%). At a mean follow-up interval of 11.466.8 monthsthere have been no episodes of late device embolization, cardiac perforation or erosion,endocarditis, thromboembolism, wire fracture, embolic neurologic events, ordeath. Conclusions: We report the first worldwide clinical experience using theNOASD-R device for ASD-OS closure. The procedure was feasible, with a high rate ofsuccessful implantations, and safe. High ASD-OS closure rates and no complicationswere encountered during short-term follow-up.