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      Utilização de prótese bioabsorvível para oclusão de defeitos do septo atrial: um passo em direção ao futuro Translated title: Use of bioabsorbable device to close atrial septal defects: one step towards the future

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          Abstract

          INTRODUÇÃO: Apesar do sucesso das intervenções por cateter nos defeitos congênitos em geral, a possibilidade de se dispor de um dispositivo percutaneamente implantável e que desapareça sem deixar vestígios é altamente desejável. Neste estudo apresentamos a experiência inicial dos autores com uma nova prótese parcialmente bioabsorvível. MÉTODO: Foram selecionados pacientes portadores de forame oval patente (FOP) com pelo menos um evento embólico prévio, sem defeitos associados, passíveis de correção cirúrgica. O diagnóstico foi feito por meio de ecocardiograma transesofágico (ETE) e teste de bolhas. Durante o procedimento as próteses foram escolhidas de acordo com as medidas de comprimento e abertura do FOP, ao ETE. O seguimento foi realizado por meio de avaliação clínica e ecocardiograma transtorácico com um mês e três meses e ETE aos seis meses após o implante. Os pacientes utilizaram a associação de ácido acetilsalicílico e clopidogrel por três meses e ácido acetilsalicílico isolado nos três meses subsequentes. A profilaxia antimicrobiana para endocardite infecciosa foi mantida por seis meses. RESULTADOS: Foram tratados 9 pacientes (5 do sexo masculino e 4 do sexo feminino), entre fevereiro e agosto de 2010. A média de idade foi de 43,4 ± 13,5 anos e de peso, de 71,4 ± 16,3 kg. A pressão pulmonar foi normal em todos os casos. O comprimento dos túneis variou de 6 mm a 11 mm e a abertura, de 2 mm a 3 mm. A média de variação de abertura não-provocadaprovocada foi de 2,1 ± 0,8 mm. O implante foi possível em todos os casos. Utilizamos 13 dispositivos nos 9 pacientes e um deles necessitou um segundo dispositivo implantado em um orifício adicional. Não houve complicações significativas nem óbitos. CONCLUSÃO: O uso da prótese BioSTAR TM mostrou-se seguro e eficaz, constituindo excelente alternativa para o fechamento do FOP simples.

          Translated abstract

          BACKGROUND: Despite the overall high success rate of per-cutaneous intervention in congenital defects, the possibility of having a percutaneous bioabsorbable implantable device is extremely desirable. The initial experience of the authors with a new partially bioabsorbable prosthesis is reported in this study. METHOD: Patients with patent foramen ovale (PFO), with at least one previous embolic event, without additional surgical defects were selected. Diagnosis was made by transesophageal echocardiography (TEE) and the bubble test. Devices were chosen according to length and opening of PFO at the TEE. Patients were followed-up by transthoracic echocardiogram at 1 and 3 months and TEE at 6 months post implantation. Patients received a combination of acetylsalicylic acid and clopidogrel for 3 months and acetylsalicylic acid for another 3 months. Patients were maintained on antimicrobial prophylaxis for infectious endocarditis for 6 months. RESULTS: Nine patients (5 male and 4 female) were treated from February to August 2010. Mean age was 43.4 ± 13.5 years and mean weight was 71.4 ± 16.3 kg. Pulmonary arterial pressure was normal in all of the patients. PFO tunnel lengths ranged from 6-11 mm and the opening ranged from 2-3 mm. Mean range from rest to stretched PFO opening was 2.1 ± 0.8 mm. Prosthesis implantation was possible in all of the cases. Thirteen devices were used in 9 patients, and one of them required a second device for an additional orifice. No major complications or procedure-related deaths were observed. CONCLUSION: The use of the BioSTAR TM device was safe and effective. It is an excellent alternative for PFO closure.

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          Most cited references17

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          Dissolution of tungsten coils does not produce systemic toxicity, but leads to elevated levels of tungsten in the serum and recanalization of the previously occluded vessel.

          To evaluate the failure of mechanically detachable spirals produced from tungsten (MDS, Balt, Montmorency, France) and the toxicity of elevated levels of tungsten in the serum subsequent to their implantation. We reviewed findings in 21 patients in whom tungsten coils had been used to occlude pathologic vessels, aneurysms and fistulas between 1996 and 1999. We achieved clinical follow-up, and measured renal and hepatic function, in 14 of the 21 patients. Decreased radiopacity of the coils was observed in 9 of 13 patients who had follow-up fluoroscopy during repeat cardiac catheterization. Repeat angiography of the vessel occluded by the coil was performed in 7 patients, 5 of whom showed recanalization. Levels of tungsten in the serum were analyzed 6 to 35 months after implantation of coils in 8 patients. The mean concentration was 6.43 micrograms/l, with a range from 2 to 14.4 micrograms/l, normal values being less than 0.2 microgram/l. Tungsten coils may dissolve over time and lead to markedly elevated levels of tungsten in the serum, with recanalization of previously occluded vessels. Despite lack of clinical and laboratory data in patients with elevated levels of tungsten in the serum, our study suggests that the clinical use of mechanically detachable coils produced from tungsten should no longer be recommended.
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            Biological response to Bard Clamshell Septal Occluders in the canine heart.

            The Clamshell Septal Occluder has been used to close various congenital heart defects. The purpose of this study was to evaluate the long-term biological response to this device after placement in the canine heart. Previous in vivo studies with device placement were limited to 60 days. An atrial septal defect was created in dogs by blade septostomy followed by balloon dilation. Both old and new (redesigned) devices were placed. Angiographic follow-up was performed at 1, 3, and 6 months and 1 and 2 years after device placement with groups of dogs euthanitized at the same intervals. Gross and microscopic assessment was done on the explanted devices. The implants were covered at least 50% by neointima at 1 month and covered completely by 3 months. There was no thrombus formation. Areas of focal hemorrhage were evident at 1 month and were not present at 3 months. The fibrous capsule that covered the device became more densely organized and neovascularized by 2 years. A focal foreign body reaction at the device-tissue interface persisted for 2 years. There were no arm fractures with either the old or new devices in these dogs. The Bard Clamshell Septal Occluder is well tolerated in the canine heart for at least 2 years and elicits a normal healing process.
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              New horizon of bioabsorbable stent.

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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                rbci
                Revista Brasileira de Cardiologia Invasiva
                Rev. Bras. Cardiol. Invasiva
                Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista - SBHCI (São Paulo )
                2179-8397
                2010
                : 18
                : 4
                : 448-455
                Affiliations
                [1 ] Universidade do Estado do Rio de Janeiro Brazil
                [2 ] MS Brasil
                [3 ] INTERCAT Brasil
                Article
                S2179-83972010000400016
                10.1590/S2179-83972010000400016
                256338d6-a9ed-4827-ae92-0d2b7e23f1fc

                http://creativecommons.org/licenses/by/4.0/

                History
                Product

                SciELO Brazil

                Self URI (journal page): http://www.scielo.br/scielo.php?script=sci_serial&pid=2179-8397&lng=en
                Categories
                CARDIAC & CARDIOVASCULAR SYSTEMS

                Cardiovascular Medicine
                Foramen ovale, patent,Heart catheterization,Prostheses and implants,Forame oval patente,Cateterismo cardíaco,Próteses e implantes

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