Non-contrast transcatheter aortic valve implantation for patients with aortic stenosis and chronic kidney disease: a pilot study.

Background: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI). Of note, it is associated with a threefold increase in all-cause and cardiac death. We propose a new non-contrast strategy for evaluating and performing the TAVI procedure that can be especially valuable for patients with aortic stenosis (AS) and chronic kidney disease (CKD) to prevent AKI. Methods: Patients with severe symptomatic AS and CKD stage ≥3a were evaluated for TAVI using four non-contrast imaging modalities for procedural planning: transesophageal echocardiogram (TEE), cardiac magnetic resonance, multidetector computed tomography (MDCT), and aortoiliac CO2 angiography. Patients underwent transfemoral (TF) TAVI using the self-expandable Evolut R/Pro, and the procedures were guided by fluoroscopy and TEE. Contrast MDCT and contrast injection at certain checkpoints during the procedure were used in a blinded fashion to guarantee patient safety. Results: A total of 25 patients underwent TF-TAVI with the zero-contrast technique. The mean age was 79.9 ± 6.1 years, 72% in NYHA class III/IV, with a mean STS-PROM of 3.0% ± 1.5%, and creatinine clearance of 49 ± 7 ml/min. The self-expandable Evolut R and Pro were implanted in 80% and 20% of patients, respectively. In 36% of the cases, the transcatheter heart valve (THV) chosen was one size larger than the one by contrast MDCT, but none of these cases presented adverse events. Device success and the combined safety endpoint (at 30 days) both achieved 92%. Pacemaker implantation was needed in 17%. Conclusion: This pilot study demonstrated that the zero-contrast technique for procedural planning and THV implantation was feasible and safe and might become the preferable strategy for a significant population of CKD patients undergoing TAVR. Future studies with a larger number of patients are still needed to confirm such interesting findings.

Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure. / Estratégias Percutâneas em Doenças Estruturais: Foco em Insuficiência Cardíaca Crônica.

BACKGROUND: Central Illustration : Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure Transcatheter devices for monitoring and treating advanced chronic heart failure patients. PA: pulmonary artery; LA: left atrium; AFR: atrial flow regulator; TASS: Transcatheter Atrial Shunt System; VNS: vagus nerve stimulation; BAT: baroreceptor activation therapy; RDN: renal sympathetic denervation; F: approval by the American regulatory agency (FDA); E: approval by the European regulatory agency (CE Mark). BACKGROUND: Innovations in devices during the last decade contributed to enhanced diagnosis and treatment of patients with cardiac insufficiency. These tools progressively adapted to minimally invasive strategies with rapid, widespread use. The present article focuses on actual and future directions of device-related diagnosis and treatment of chronic heart failure.

Occlusion of the perimembranous ventricular septal defect using CERA® devices.

BACKGROUND: High incidence of atrioventricular (AV) block has been the major limitation of percutaneous closure of perimembranous ventricular septal defect (PMVSD). METHODS: Prospective, multicenter, nonrandomized study including 55 patients who were submitted to 56 procedures from March 2010 to November 2010. Inclusion criteria were PMVSD with diameter ≥ 5 mm or if ≤5 mm with hemodynamic significance and age ≥ 1 year. Exclusion criteria were fixed pulmonary arterial hypertension and associated congenital heart disease needing surgical repair. Procedures were performed under general anesthesia and monitored by transthoracic echocardiography (TTE). The device choice was based on left ventricle (LV) angiography and on TTE images. PMVSDs were crossed by retrograde approach. RESULTS: Mean age was 9.3 ± 7.5 years, and mean weight was 29.1 ± 15.9 kg. Thirty-five (63.6%) patients were females. Mean pulmonary arterial mean pressure, mean LV diastolic diameter, and mean Q(p) /Q(s) were 24.0 ± 6.5 mm Hg, 43.0 ± 5.9 mm, and 2.2 ± 0.8, respectively. Associated nonsurgical malformations were present in 9 (16.3%) patients, and PMVSDs were multifenestrated in 16 (46.2%) cases. Mean PMVSDs diameter was 5.8 ± 1.8 mm by angiography and 6.8 ± 2.3 mm by TTE. New rhythm disturbance without clinical significance was observed in 29% of the patients and was reversible in 87.5%. After procedure, trivial residual shunt was present in 5 (8.9%) patients and moderate residual shunt in other 5 (8.9%). At late FU (mean of 298.7 ± 88.9 days), 91% of the patients had no residual shunts. Third-degree AV block and severe aortic regurgitation occurred in one patient each. CONCLUSIONS: In this experience, PMVSD closure with CERA® devices showed to be safe and effective with low incidence of complications at immediate and mid-term FU.

Translation and Validation of the Boston Technical Performance Score in a Developing Country.

INTRODUCTION: The Technical Performance Score (TPS) was developed and subsequently refined at the Boston Children's Hospital. Our objective was to translate and validate its application in a developing country. METHODS: The score was translated into the Portuguese language and approved by the TPS authors. Subsequently, we studied 1,030 surgeries from June 2018 to October 2020. TPS could not be assigned in 58 surgeries, and these were excluded. Surgical risk score was evaluated using Risk Adjustment in Congenital Heart Surgery (or RACHS-1). The impact of TPS on outcomes was studied using multivariable linear and logistic regression adjusting for important perioperative covariates. RESULTS: Median age and weight were 2.2 (interquartile range [IQR] = 0.5-13) years and 10.8 (IQR = 5.6-40) kilograms, respectively. In-hospital mortality was 6.58% (n=64), and postoperative complications occurred in 19.7% (n=192) of the cases. TPS was categorized as 1 in 359 cases (37%), 2 in 464 (47.7%), and 3 in 149 (15.3%). Multivariable analysis identified TPS class 3 as a predictor of longer hospital stay (coefficient: 6.6; standard error: 2.2; P=0.003), higher number of complications (odds ratio [OR]: 1.84; 95% confidence interval [CI]: 1.1-3; P=0.01), and higher mortality (OR: 3.2; 95% CI: 1.4-7; P=0.004). CONCLUSION: TPS translated into the Portuguese language was validated and showed to be able to predict higher mortality, complication rate, and prolonged postoperative hospital stay in a high-volume Latin-American congenital heart surgery program. TPS is generalizable and can be used as an outcome assessment tool in resource diverse settings.

Como eu faço a avaliação pós-intervenções tricúspides: dicas e truques / My approach to assessment after tricuspid interventions: tips and tricks

A regurgitação tricúspide (RT) importante está associada à alta morbidade e mortalidade. Como o tratamento cirúrgico da RT isolada tem sido associado à alta mortalidade, as intervenções transcateter na valva tricúspide (VT) têm sido utilizadas para o seu tratamento, com risco relativamente mais baixo. Há um atraso na intervenção da RT e provavelmente está relacionado a uma compreensão limitada da anatomia da VT e do ventrículo direito, além da subestimação da gravidade da RT. Nesse cenário, faz-se necessário o conhecimento anatômico abrangente da VT, a fisiopatologia envolvida no mecanismo de regurgitação, assim como a sua graduação mais precisa. A VT tem peculiaridades anatômica, histológica e espacial que fazem a sua avalição ser mais complexa, quando comparado à valva mitral, sendo necessário o conhecimento e treinamento nas diversas técnicas ecocardiográficas que serão utilizadas frequentemente em combinação para uma avaliação precisa. Esta revisão descreverá a anatomia da VT, o papel do ecocardiograma no diagnóstico, graduação e fisiopatologia envolvida na RT, as principais opções atuais de tratamento transcateter da RT e a avaliação do resultado após intervenção transcateter por meio de múltiplas modalidades ecocardiográficas.(AU)

Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality. Given that surgical treatment of TR alone has been associated with high mortality, transcatheter interventions in the tricuspid valve (TV) have been used for its treatment, with relatively lower risk. There is a delay in intervention for TR, and this is probably related to a limited understanding of the anatomy of the TV and the right ventricle, in addition to an underestimation of the severity of TR. In this scenario, it is necessary to have comprehensive anatomical knowledge of the TV, the pathophysiology involved in the mechanism of regurgitation, and more accurate grading. The TV has anatomical, histological, and spatial peculiarities that make its assessment more complex when compared to the mitral valve, requiring knowledge and training in the various echocardiographic techniques that will often be used in combination for accurate assessment. This review will describe the anatomy of the TV, the role of echocardiography in the diagnosis, grading, and pathophysiology involved in TR; the main transcatheter treatment options currently available for TR; and the assessment of outcomes after transcatheter intervention by means of multiple echocardiographic modalities.(AU)

Estratégias Percutâneas em Doenças Estruturais: Foco em Insuficiência Cardíaca Crônica / Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure

Resumo As inovações em dispositivos ao longo das últimas décadas proporcionaram uma melhora no diagnóstico e tratamento de pacientes com insuficiência cardíaca. Essas novas ferramentas progressivamente adaptaram-se a estratégias minimamente invasivas e as opções percutâneas multiplicaram-se de forma rápida. No presente artigo revisamos as direções atuais e futuras dos dispositivos utilizados como opções adjuvantes para o diagnóstico e tratamento adjuvante na insuficiência cardíaca crônica, o seu desenvolvimento, mecanismos e estudos mais recentes

Abstract Innovations in devices during the last decade contributed to enhanced diagnosis and treatment of patients with cardiac insufficiency. These tools progressively adapted to minimally invasive strategies with rapid, widespread use. The present article focuses on actual and future directions of device-related diagnosis and treatment of chronic heart failure.

Translation and Validation of the Boston Technical Performance Score in a Developing Country

Abstract Introduction: The Technical Performance Score (TPS) was developed and subsequently refined at the Boston Children's Hospital. Our objective was to translate and validate its application in a developing country. Methods: The score was translated into the Portuguese language and approved by the TPS authors. Subsequently, we studied 1,030 surgeries from June 2018 to October 2020. TPS could not be assigned in 58 surgeries, and these were excluded. Surgical risk score was evaluated using Risk Adjustment in Congenital Heart Surgery (or RACHS-1). The impact of TPS on outcomes was studied using multivariable linear and logistic regression adjusting for important perioperative covariates. Results: Median age and weight were 2.2 (interquartile range [IQR] = 0.5-13) years and 10.8 (IQR = 5.6-40) kilograms, respectively. In-hospital mortality was 6.58% (n=64), and postoperative complications occurred in 19.7% (n=192) of the cases. TPS was categorized as 1 in 359 cases (37%), 2 in 464 (47.7%), and 3 in 149 (15.3%). Multivariable analysis identified TPS class 3 as a predictor of longer hospital stay (coefficient: 6.6; standard error: 2.2; P=0.003), higher number of complications (odds ratio [OR]: 1.84; 95% confidence interval [CI]: 1.1-3; P=0.01), and higher mortality (OR: 3.2; 95% CI: 1.4-7; P=0.004). Conclusion: TPS translated into the Portuguese language was validated and showed to be able to predict higher mortality, complication rate, and prolonged postoperative hospital stay in a high-volume Latin-American congenital heart surgery program. TPS is generalizable and can be used as an outcome assessment tool in resource diverse settings.

Transcatheter closure of secundum atrial septal defects with complex anatomy.

The aim of this study was to evaluate the feasibility, safety and efficacy of transcatheter closure of secundum atrial septal defects (ASD) in patients with complex anatomy. From September 1997 to July 2003, a total of 40 patients (median age, 34 years; 65% female) with complex ASDs, defined as the presence of a large defect (stretched diameter >26 mm) associated with a deficient rim (n=23); multiple defects (n=8); a multi-fenestrated septum (n=5); and defects associated with an aneurysmal septum irrespective of their size (n=4) underwent closure. The Helex device was used in 4 patients and the Amplatzer in the remaining. Two devices were implanted in 2 patients each. Implantation was unsuccessful in 5 patients, with 4 having large defects associated with a deficient anterior rim and a floppy posterior septum. Occlusion was observed in 22 of 35 patients (63%) immediately after implantation and in 31 (89%) at a mean follow-up of 18+/-9 months. No major complications occurred. Right ventricular end-diastolic dimensions (indexed for body surface area) decreased from 135+/-25% before closure to 124+/-15% 24 hours after closure, and to 92+/-12% after 12 months. Two patients with 2 distant defects and 2 patients with large defects remained with shunts (<4 mm) at the latest visit. Transcatheter closure of complex secundum ASDs was feasible, safe and effective; however, large defects associated with a deficient anterior rim and a floppy posterior septum may not be suitable for this approach.

Ecocardiografia transesofágico intraoperatório na avaliação de gradientes residuais após correção cirúrgica das obstruções das vias de saída ventriculares direita e esquerda / Intraoperative transesophageal echocardiography in the evaluation of residual gradients after surgical correction of right and left ventricular outflow tract obstructions

Fundamento: O Ecocardiograma Transesofágico (ETE) intraoperatório tem sido muito utilizado durante as correções das cardiopatias congênitas; entretanto, em obstruções de vias de saída dos ventrículos, as informações são limitadas. Objetivo: Avaliar a confiabilidade do ETE em detectar gradientes residuais em pacientes com obstruções de vias de saída dos ventrículos. Pacientes e Método: Os gradientes sistólicos após circulação extracorpórea ao ETE de 127 pacientes (idade média de 7 anos), sendo 79 com obstrução direita e 48 com obstrução esquerda, foram comparados ao Ecocardiograma Transtorácico (ETT) após cirurgia. Gradientes maiores que 40 mmHg foram considerados de significância hemodinâmica.Resultados: Nas obstruções esquerdas o ETE mostrou gradientes médios maiores que o ETT (30 mmHg vs 24mmHg; p = 0,014). Os gradientes ao ETE foram menores que 40 mmHg em 75% dos pacientes e houve concordância com o ETT em 97%. Nos demais, o gradiente ao ETE foi maior que 40 mmHg e houve concordância com o ETT em 33%. Nas obstruções direitas o ETE mostrou gradientes médios semelhantes ao ETT (28 mmHg vs 25 mmHg; p = 0,21). Os gradientes ao ETE foram menores que 40 mmHg em 88% dos pacientes e houve concordância com o ETT em 91,5%. Nos demais, o gradiente ao ETE foi maior que 40 mmHg e houve concordância com o ETT em 60%. Conclusão: O ETE mostrou-se útil na detecção de gradientes residuais nas vias de saída dos ventrículos nos pacientes estudados. Entretanto, em gradientes maiores que 40 mmHg, o ETE sugere maior severidade das obstruções, particularmente no lado esquerdo.

Background: Despite the large use of intraoperative Transesophageal Echocardiography (TEE) in congenital heart surgery, limited information is available regarding ventricular outflow tract obstruction. Objective: The aim of this study was to assess the reliability of the post-bypass TEE to detect residual gradients in patients with ventricular outflow obstruction. Patients and Methods: Post-bypass TEE peak systolic gradients of 127 patients (mean age of 7 years), being 79 with right ventricular outflow tract obstruction and 48 with left ventricular outflow tract obstruction, were compared with the postoperative TTE. Postoperative lesions were considered of hemodynamic significance when peak systolic gradient was higher than 40 mmHg. Results: In patients with left ventricular outflow tract obstruction TEE showed mean peak systolic gradients higher than TTE (30 mmHg versus 24 mmHg; p= 0,014). In 75%, TEE gradients were lower than 40 mmHg and agreed with TTE in 97%. In the remaining patients, TEE gradients were higher than 40 mmHg and agree with TTE in 33%. In patients with right ventricular outflow tract obstruction TEE mean gradients agreed with TTE (28 mmHg versus 25 mmHg; p= 0.21). In 88%, TEE gradients were lower than 40 mmHg and agreed with TTE in 91.5%. In the remaining patients, TEE gradients were higher than 40 mmHg and agreed with TTE in 60%.Conclusion: TEE showed to be a reliable technique to detect residual ventricular outflow tract obstructions in the majority of patients. However, when considered gradients higher than 40 mmHg, TEE suggested a greater severity of obstructions, particularly on the left side.

Oclusão percutânea do apêndice atrial esquerdo: relato de caso / Percutaneous left atrial appendage occlusion: case report / Oclusión Percutánea del Apéndice Auricular Izquierdo - Relato del Caso

A anticoagulação com varfarina é eficaz na redução do risco de eventos cardioembólicos nos pacientes com fibrilação atrial,entretanto, diversos fatores podem limitar seu uso. A oclusão percutânea do apêndice atrial esquerdo representa um método minimamente invasivo, que pode ter resultados semelhantes aos da varfarina, na prevenção de eventos cardioembólicos em pacientes de maior risco. Relatamos os aspectos do ecocardiograma transesofágico em um paciente com fibrilação atrial permanente, com repetidos episódios tromboembólicos e dificuldade em atingir adequado controle laboratorial com o uso da anticoagulação oral e submetido à oclusão percutânea do apêndice atrial esquerdo.

Anticoagulation with warfarin is effective in reducing the risk of cardioembolic events in patients with atrial fibrillation, however, several factors may limit its use. The percutaneous closure of the left atrial appendage is a minimally invasive method that may have results similar to warfarin in the prevention of cardioembolic events in high risk patients. We describe the transesophageal echocardiographic features in a patient with persistente atrial fibrillation, with repeated thromboembolic episodes and difficulty in achieving adequate laboratory control with the use of oral anticoagulation, submitted to percutaneous occlusion of the left atrial appendage.

La anticoagulación con warfarina es eficaz en la reducción del riesgo de episodios cardioembólicos en los pacientes con fibrilación auricular, y sin embargo, diversos factores pueden limitar su uso. La oclusión percutánea del apéndice auricular izquierdo representa un método mínimamente invasivo, que puede dar resultados semejantes a los de la warfarina, para la prevención de episodios cardioembólicos en pacientes de mayor riesgo. Relatamos los aspectos del ecocardiograma transesofágico en un paciente con fibrilación auricular crónica, con repetidos episodios tromboembólicos y dificultad para conseguir un adecuado control de laboratorio con el uso de la anticoagulación oral y sometido a la oclusión percutánea del apéndice auricular izquierdo

Implante de stent na via de saída de ventrículo direito: alternativa à paliação cirúrgica convencional? / Stenting the right ventricle outflow tract: is it an alternative to palliative surgery?

O uso de stents intravasculares em crianças com cardiopatia congênita é procedimento bem estabelecido, porém a indicação de paliação por meio de procedimentos percutâneos ao invés da cirurgia convencional permanece incerta. Neste relato são apresentados três casos de obstrução crítica de via de saída do ventrículo direito (VSVD), submetidos a ampliação da VSVD com implante de stent. O implante foi realizado com sucesso nos três casos, permitindo restabelecer o fluxo pulmonar para a árvore pulmonar e melhorar a saturação de oxigênio.

The use of intravascular stents in children with congenital heart disease is well established, however the use of palliative percutaneous therapy instead of a conventional surgery remains uncertain. We present three cases of critical right ventricular outflow tract (RVOT) obstruction treated with stenting to expand the RVOT. Stenting was successful in all three cases, reestablishing pulmonary flow into the pulmonary arteries and improving oxygen saturation.

Double balloon pulmonary valvuloplasty: multi-track system versus conventional technique.

OBJECTIVES: To evaluate whether double balloon pulmonary valvuloplasty (DBPV) with the Multi-Track system (MTS) may help to simplify the procedure. BACKGROUND: DBPV is usually required for patients with pulmonary valve stenosis with large annulus. However, it needs two venous accesses and can be technically demanding. METHODS: From 07/03, 20 consecutive patients (19 +/- 10 yrs) with typical pulmonary valve stenosis underwent DBPV using the MTS (G1). The results were compared with those achieved by conventional DBPV performed in a matched historical group of 28 patients (21 +/- 11 yrs; P = NS) (G2). RESULTS: MTS balloons were easily advanced through the skin and inflated across the valve. Similar results were observed in regards to residual gradients (12 +/- 11 vs 14 +/- 10 mm Hg; P = NS) and right ventricular to systemic pressures (0.35 +/- 0.22 vs 0.37 +/- 0.26; P = NS). Procedure and fluoroscopic times were significant lower in G1 (78 +/- 24 vs 126 +/- 28; 15 +/- 12 vs 25 +/- 8 min, respectively; both P < 0.001). There was no major complication. Median follow-up was 1.8 yr for G1 and 5 yr for G2 (P = 0.037). At the last visit, peak instantaneous gradient across the right ventricular outflow tract by echocardiography was a mean 22 +/- 10 mm Hg for G1 and 25 +/- 9 mm Hg for G2 (P = NS). No patient had severe pulmonary insufficiency or required reintervention. CONCLUSIONS: The use of the MTS helped to expedite the procedure providing satisfactory midterm clinical outcomes, similar to those observed with the conventional DBPV technique.

Punção da artéria axilar para intervenções percutâneas em lactentes portadores de cardiopatias congênitas: "à procura de um caminho mais curto e mais seguro" / Axillary artery access for percutaneous interventions in infants with congenital heart disease: \"in search of a shorter and safer pathway"

INTRODUÇÃO: O acesso através da punção da artéria axilar (AAx) tem sido utilizado em adultos com bons resultados, porém seu uso em neonatos e lactentes jovens tem sido pouco relatado. Nosso objetivo foi relatar a experiência inicial com o uso desse acesso em diferentes intervenções nessa faixa etária de pacientes. Método: De janeiro de 2009 a setembro de 2010 foram incluídas 11 crianças submetidas a diferentes procedimentos intervencionistas realizados através de punção da AAx. O procedimento foi realizado com agulha 21 G, sendo utilizados introdutores 4 F ou 5 F pediátricos. Resultados: A média de idade foi de 26 + - 12 dias e o peso médio de 4,2 +- 1,7 kg. Os procedimentos intervencionistas realizados foram: implante de stent no canal arterial (6) valvoplastia aórtica (1) angioplastia aórtica (2), implante de stent em Blalock-Taussig (1), e redilatação do stent do canal arterial (!). A punção da AAx direita foi realizada com sucesso em todos os pacientes e sem dificuldade técnica. Os tempos médios do procedimento...

BACKGROUND: Axillary artery access (AxA) has been used in adults with good results, however, its use in neonates and infants has not been extensively reported. This study was aimed at reporting our initial experience using this access in different cardiac interventions in this age group. METHOD: From January 2009 to September 2010, 11 children were submitted to different cardiac interventions using AxA. The procedure was performed with a 21 G needle followed by the insertion of a 4 F or a 5 F pediatric sheats. RESULTS: Mean age was 26 ± 12 days and mean weight was 4.2 ± 1.7 Kg. The cardiac interventions performed were: stenting of the arterial duct (6), aortic valvoplasty (1), aortic angioplasty (2), stent implantation in a Blalock-Taussig shunt (1) and stent redilation in the arterial duct (1). Right AxA puncture was successfully obtained in all patients without technical difficulties. Mean procedure and fluoroscopy times were 52 ± 15 minutes and 13 ± 4 minutes, respectively. Pneumothorax without hemodynamic involvement was the single complication in one patient. The other patients did not have any abnormalities. There were no ischemic or neurologic complications in the ipsilateral limb. Mean time of Intensive Care Unit (ICU) stay was 48 ± 16 hours. There were no deaths during the interventional procedures and one patient died of sepsis at the ICU 5 days after the procedure. CONCLUSION: In our experience AxA proved to be a safe and effective alternative for different interventional procedures in neonates and infants with congenital heart diseases.

Oclusão percutânea do forame oval patente com prótese PREMEREtm: resultados preliminares da primeira experiência no Brasil / Percutaneous occlusion of patent foramen ovale with the PREMERE TM device: preliminary results of the first experience in Brazil

INTRODUÇÃO: O forame oval parente ocorre em 27 por cento a 30 por cento da população e pode estar associado a eventos embólicos, dentre eles o acidente vascular cerebral criptogênico. A prótese PREMEREtm. especialmente desenvolvida para a correção do forame oval patente, apresenta baixo perfil, reduzida quantidade de metal e âncora no lado esquerdo, com reduzida superfície para minimizar o risco de formação de trombos. Avaliamos os resultados clínicos e ecocardiográficos imediatos e aos três e seis meses pós-implante do dispositivo. Métodos: Entre maio de 2008 e junho de 2009, a prótese foi implantada em 14 pacientes com forame oval patente e que apresentaram eventos embólicos cerebrais prévios, comprovados por tomografia computadorizada e/ou ressonância nuclear magnética de crânio. O diagnóstico ecocardiográfico de forame oval patente foi realizado quando microbolhas...

BACKGROUND: Patent foramen ovale is observed in 27% to 30% of the population and may be associated to embolic events, among them the cryptogenic stroke. The PREMERE TM device, specially developed to correct patent foramen ovale, has a low profile, reduced amount of metal and a left anchor with a small total surface to minimize the risk of thrombus formation. Clinical and echocardiographic results were evaluated immediately after the procedure and 3 and 6 months after device implantation. METHOD: From May 2008 to June 2009, the device was implanted in 14 patients with patent foramen ovale with prior cerebral embolic events, confirmed by computerized tomography and/or cranial magnetic resonance imaging. Echocardiographic patent foramen ovale was diagnosed when microbubbles were detected in the left atrium within three heartbeats after opacification of the right atrium. Patients with patent foramen ovale with interatrial septal aneurysm > 2 cm, those with atrial fibrilation/flutter or with other diseases that might explain the cryptogenic stroke were excluded. RESULTS: Nine (64.3%) patients were male and mean age was 47.2 ± 17.5 years. Successful implantation was achieved in 100% of the cases. Transesophageal echocardiogram immediately after the procedure showed the presence of microbubbles in the left atrium with Valsalva maneuver in 50% of the cases. All of the patients were discharged the following day, receiving acetyl salicylic acid 200 mg/day and clopidogrel 75 mg/day and returned after 3 months for clinical and echocardiographic follow-up. The transesophageal echocardiogram at three months showed a mild residual flow in only 3 (21.4%) patients. These patients had a totally occluded patent foramen ovale at the 6-month follow-up transesophageal echocardiogram. None of the patients had cardiovascular events during the follow-up period. CONCLUSION: The PREMERE TM device proved to be safe and effective in the occlusion of patent foramen ovale. The occlusion rate in this initial experience was high for a follow-up period of 6 months.