BioSTAR Evaluation STudy (BEST)

Mullen, Michael; Hildick‐Smith, David; Giovanni, Joseph V. De; Duke, Chris; Hillis, W S; Morrison, W.L.; Jux, Christian

doi:10.1161/circulationaha.106.664672

Cited by 130 publications

(19 citation statements)

References 34 publications

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“…The Bio-STAR implant has been available in Europe for patent oval foramen and atrial septal defect closure since 2006, and used in North America primarily for patent oval foramen closure for recurrent stroke prevention [22][23][24]. There is a limited pediatric experience and few studies assessing efficacy in secundum atrial septal defect closure [25].…”

Section: Discussionmentioning

confidence: 99%

A biodegradable device (BioSTAR™) for atrial septal defect closure in children

Morgan

Lee

Chaturvedi

et al. 2010

Cathet Cardio Intervent

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Section: Discussionmentioning

confidence: 99%

A biodegradable device (BioSTAR™) for atrial septal defect closure in children

Morgan

Lee

Chaturvedi

et al. 2010

Cathet Cardio Intervent

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“…33 As próteses são fabricadas a partir de matriz acelular de colágeno intestinal de porcos montado sobre uma prótese Starflex ® MP35N de duplo disco. O remodelamento é gradual e ocorre em um período de 24 meses, durante o qual o colágeno é absorvido e substituído por tecido próprio do paciente.…”

Section: Tratamento Percutâneo Das Comunicações Interatriaisunclassified

Oclusão percutânea de comunicação interatrial pelo sistema único de saúde: uma opção economicamente viável

Filho¹,

Mânica²,

Cardoso³

2010

Rev. Bras. Cardiol. Invasiva

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A comunicação interatrial (CIA) é uma das malformações congênitas mais frequentes, representando aproximadamente 5% a 10% de todos os defeitos cardíacos congêni-tos. O tipo mais comum é a CIA ostium secundum (CIA OS), que representa cerca de 75% dessas malformações. Quando descoberta tardiamente ou na ausência de tratamento, além da alteração no exame clínico, pode existir insuficiên-cia cardíaca, arritmias cardíacas, insuficiência mitral, sobrecarga ventricular direita e hipertensão pulmonar. Em casos avançados com hipertensão pulmonar grave e reversão do shunt interatrial (direita para esquerda) instala-se a cianose, o que indica doença cardiopulmonar grave e mortalidade aumentada. Nas últimas décadas, com o aprimoramento das técnicas e dos dispositivos percutâneos, as possibilidades de tratamento dos defeitos congênitos por via percutânea têm crescido vertiginosamente. Vários estudos já demonstraram os excelentes resultados imediatos e a longo prazo da atriosseptoplastia percutânea. Além de proporcionar maior conforto ao paciente, menores taxas de complicações, menor tempo de recuperação intra e extra-hospitalar e eficácia similar à da atriosseptoplastia cirúrgica, em países desenvolvidos, é comprovadamente a opção mais econômica. Não há dúvidas de que, em futuro próximo, a relação custoefetividade desse procedimento será observada também em países em desenvolvimento como o Brasil, em que o custo da prótese, ainda hoje, é o principal obstáculo para a padronização desse procedimento, e em que os valores pagos pelos procedimentos cirúrgicos continuam muito defasados. DESCRITORES:Comunicação interatrial. Cardiopatias congênitas. Próteses e implantes. ABSTRACT Percutaneous Closure of Atrial Septal Defects by the Brazilian Health System: an Economically Feasible OptionAtrial septal defect (ASD) is one of the most frequent congenital malformations, representing 5% to 10% of all congenital heart defects. The most common type is the ostium secundum ASD (OS ASD), and represents 75% of these malformations. When diagnosed late or left untreated, in addition to abnormalities in the clinical examination, there may be heart failure, cardiac arrhythmias, mitral insufficiency, right ventricular overload and pulmonary hypertension. In advanced cases with severe pulmonary hypertension and interatrial shunt reversal (right to left), there is cyanosis, which indicates severe cardiopulmonary disease and increased mortality. In the last decades, with the improvement of percutaneous techniques and devices, the possibility of percutaneous treatment of congenital defects has increased dramatically. Several studies have shown excellent early and long-term results of percutaneous atrial septoplasty. In addition to providing greater comfort for patients, lower complication rates, less in-hospital and extra-hospital recovery time and efficacy similar to that of surgical atrial septoplasty in developed countries, it is definitely the most economic option. There is no doubt that in the near future, the cost-effectiveness ratio of this proc...

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“…Some efforts have been made to develop biodegradable occlusion devices for the closure of ASDs, such as the BioSTAR, BioDisk, and Double BioDisk devices [13,14,15,16,17,18]. The BioSTAR device was the first septal defect occluder to use an absorbable matrix as a barrier membrane, which opened a new era of absorbable occluders.…”

Section: Discussionmentioning

confidence: 99%

A Novel-Design Poly-<smlcap>L</smlcap>-Lactic Acid Biodegradable Device for Closure of Atrial Septal Defect: Long-Term Results in Swine

Xie¹,

Wang²,

Zhang³

et al. 2016

Cardiology

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Objectives: The aim of this study is to evaluate the long-term effectiveness and safety of a self-expandable, double-disk biodegradable device made of poly-L-lactic acid (PLLA) for closure of atrial septal defects (ASDs) in swine. Methods: ASDs were created by transseptal needle puncture followed by balloon dilatation in 20 piglets. The experimental group comprised 18 animals, while the remaining 2 animals were used as controls. Effectiveness and safety were evaluated by rectal temperature, leukocyte count, chest radiography, electrocardiogram, transthoracic echocardiography (TTE), intracardiac echocardiography (ICE), and histologic studies. Animals were followed up at 1, 3, 6, and 12 months. Results: An ASD model was successfully created in 19 animals; 1 piglet died during the procedure. The ASD diameters that were created ranged from 5 to 6.4 mm. Devices were successfully implanted in 17 animals. No animal died during the follow-up studies. Rectal temperatures and electrocardiograms were normal at follow-up, while leukocyte counts transiently increased from 1 to 6 months. Radiography, TTE, ICE, and macroscopic studies demonstrated that PLLA occluders were positioned well, with no shifting, mural thrombus formation, or atrioventricular valve insufficiency. Histologic evaluations showed that PLLA devices were partially degraded in the follow-up study. Conclusions: ASD closure with the novel PLLA biodegradable device is safe and effective. Longer-term studies are needed to evaluate long-term biodegradability.

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BioSTAR Evaluation STudy (BEST)

Cited by 130 publications

References 34 publications

A biodegradable device (BioSTAR™) for atrial septal defect closure in children

A biodegradable device (BioSTAR™) for atrial septal defect closure in children

Oclusão percutânea de comunicação interatrial pelo sistema único de saúde: uma opção economicamente viável

A Novel-Design Poly-<smlcap>L</smlcap>-Lactic Acid Biodegradable Device for Closure of Atrial Septal Defect: Long-Term Results in Swine

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