Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Oclusão do Apêndice Atrial Esquerdo com a Prótese Lambre: Experiência Multicêntrica Inicial no Brasil / Left Atrial Appendage Closure with the LAmbre Device - Initial Multicentre Experience in Brazil

Resumo Fundamento A oclusão do apêndice atrial esquerdo (AAE) tem se mostrado uma alternativa à terapia de anticoagulação oral (ACO) para prevenção de acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não valvar (FANV). Objetivos Descrever os primeiros resultados de uma experiência inicial multicêntrica no Brasil e investigar a viabilidade, a segurança e a eficácia da oclusão do AAE com o novo dispositivo LAmbre. Métodos Coletamos dados do procedimento e do acompanhamento de 51 pacientes consecutivos com FANV, restrições para ACO em longo prazo e com anatomia adequada, submetidos à oclusão do AAE com o dispositivo LAmbre em 18 centros no Brasil. Indicações para o procedimento foram: sangramento importante em pacientes recebendo ACO (47,1%), AVC ou trombo persistente no AAE apesar de ACO adequada (27.5%), sangramento e AVC (17.6%), outras contraindicações clínicas apara ACO (5,9%), e escolha do paciente devido à prática esportiva (1,9%). Resultados Foram estudados 25 homens (49%) e 26 mulheres (51%), com idade média de 76±7,7 anos, escore CHA2DS2-VASc médio de 4,6± 1,7 e escore HAS-BLED médio de 3.4± 1,1. A taxa de sucesso do procedimento foi de 100%. As complicações imediatas relacionadas ao procedimento foram derrame pericárdico em dois pacientes, e embolização do dispositivo em um caso. Não foram observados shunts residuais > 5mm. Shunts < 5mm foram detectados em quatro pacientes por Doppler colorido ao final do procedimento. Após um período médio de acompanhamento de 18 meses ± 12 meses, não foram observados óbito, AVC ou complicações maiores. Conclusão A oclusão do AAE com o dispositivo LAmbre foi segura e eficaz nesta pequena série de casos. Apesar desses resultados iniciais encorajadores, dado o pequeno número de casos, serão necessários mais estudos com um maior período de acompanhamento.

Abstract Background Left atrial appendage (LAA) closure has been an alternative to oral anticoagulation (OAC) for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Objectives To report the first results of an initial multicenter experience in Brazil and to investigate the feasibility, safety, and efficacy of LAA closure with the new LAmbre device. Methods We collected procedural and follow-up data of 51 consecutive patients with non-valvular atrial fibrillation, restrictions for long-term OAC and suitable anatomy that underwent LAA closure with the LAmbre device in 18 centers in Brazil. Procedural indications were significant bleeding under OAC (47.1%), stroke or persistent LAA thrombus despite OAC (27.5%), bleeding plus stroke (17.6%), other clinical contraindications for OAC (5.9%), and patient's choice due to sports practice (1.9%). Results Twenty-five men (49%) and 26 women (51%), with a mean age of 76±7.7 years, mean CHA2DS2-VASc score of 4.6± 1.7 and mean HAS-BLED score of 3.4± 1.1 were studied. Procedural success rate was 100%. Procedure-related immediate complications were pericardial effusion in two patients, and immediate device embolization in one case. No large residual shunts (> 5 mm) were observed, and small shunts (<5mm) were detected in four patients by color Doppler at the end of the procedure. After a mean follow-up of 18 ± 12 months, there were no deaths, strokes nor any other major complications. Conclusion LAA occlusion with the LAmbre device was safe and effective in this small case series. Despite these encouraging initial results, the small number of cases warrants further studies with longer-term follow-up.

A Relação entre Regurgitação Mitral e Implante Transcateter de Válvula Aórtica: um Estudo de Acompanhamento Multi-Institucional / Relationship between Mitral Regurgitation and Transcatheter Aortic Valve Implantation: a Multi-Institutional Follow-up Study

Resumo Fundamento A regurgitação mitral (RM) é prevalente em pacientes submetidos a implante transcateter de válvula aórtica (TAVI). Há algumas controvérsias sobre o impacto prognóstico da RM na sobrevida de pacientes submetidos a TAVI. Objetivo Examinar a relação entre TAVI e RM em uma população de pacientes do Registro Brasileiro de TAVI. Métodos Setecentos e noventa e cinco pacientes do Registro Brasileiro de TAVI foram divididos na linha de base, alta e acompanhamento de acordo com o grau da RM da maneira seguinte: ausente/leve (RMAL) ou moderado/grave (RMMG). Eles foram subsequentemente reagrupados de acordo com as mudanças imediatas e tardias na gravidade da RM após TAVI da maneira seguinte: RM sem mudança, melhora ou piora. Foram analisados os preditores e o impacto prognóstico na linha de base, bem como as mudanças na gravidade da RM. A significância estatística foi estabelecida em p < 0,05. Resultados RMMG basal estava presente em 19,3% dos pacientes e foi um preditor de aumento da mortalidade tardia. Imediatamente após o TAVI, 47,4% dos casos melhoraram para RMAL, previsto por uma pontuação mais alta da Society of Thoracic Surgeons e um grau mais alto de regurgitação aórtica basal. No acompanhamento, 9,2% dos casos de RMAL pioraram para RMMG, enquanto 36,8% dos casos de RMMG melhoraram para RMAL. Fração de ejeção do ventrículo esquerdo (FEVE) mais baixa na linha de base e melhora na FEVE durante o acompanhamento foram preditores de melhora da RM. Piora progressiva da RM no acompanhamento foi um preditor independente de maior mortalidade tardia após TAVI (p = 0,005). Conclusões A RMMG na linha de base é um preditor de mortalidade tardia após TAVI. FEVE mais baixa e melhora na FEVE durante o acompanhamento são preditores de melhora da RM após TAVI. A pior progressiva da gravidade da RM durante o acompanhamento é um preditor independente de mortalidade tardia; isto é um achado raro na literatura.

Abstract Background Mitral regurgitation (MR) is prevalent in patients undergoing transcatheter aortic valve implantation (TAVI). There are some controversies about the prognostic impact of MR in survival of TAVI patients. Objective To examine the relationship between TAVI and MR in a patient population from the Brazilian TAVI Registry. Methods Seven hundred and ninety-five patients from the Brazilian TAVI Registry were divided at baseline, discharge, and follow-up according to their MR grade as follows: absent/mild (AMMR) or moderate/severe (MSMR). They were subsequently regrouped according to their immediate and late changes in MR severity after TAVI as follows: no change, improved, or worsened MR. Predictors and prognostic impact on baseline as well as changes in MR severity were analyzed. Statistical significance was set at p < 0.05. Results Baseline MSMR was present in 19.3% of patients and was a predictor of increased late mortality. Immediately after TAVI, 47.4 % of cases improved to AMMR, predicted by a higher Society of Thoracic Surgeons score and a higher grade of baseline aortic regurgitation. Upon follow-up, 9.2% of cases of AMMR worsened to MSMR, whereas 36.8% of cases of MSMR improved to AMMR. Lower baseline left ventricular ejection fraction (LVEF) and improvement in LVEF at follow-up were predictors of MR improvement. Progressive worsening of MR upon follow-up was an independent predictor of higher late mortality after TAVI (p = 0.005). Conclusions Baseline MSMR predicts late mortality after TAVI. Lower LVEF and improved LVEF at follow-up predict MR improvement after TAVI. Progressive worsening of MR severity at follow-up is an independent predictor of late mortality, which is a rare finding in the literature.

Ondine's curse: myth meets reality.

Ondine's curse is one of the most enchanting mythical tales in the field of Medicine. The nymph Ondine was an immortal water spirit who became human after falling in love for a man, marrying him, and having a baby. In one of the versions of the tale, when she caught her husband sleeping with another woman, she cursed him to remain awake in order to control his own breathing. During the 19th century, the rare syndrome characterized by loss of autonomic breath control, while voluntary respiration remains intact, was cleverly named "Ondine's curse". Nowadays, the term Ondine's curse is usually associated with congenital central hypoventilation syndrome; however, in medical literature, it also designates several respiratory disorders. Here, we present a review of the myth focused on history, arts and medicine.

Permanent Pacing After Transcatheter Aortic Valve Implantation: Incidence, Predictors and Evolution of Left Ventricular Function / Marca-passo Definitivo após Implante Valvar Aórtico Transcateter: Incidência, Preditores e Evolução da Função Ventricular Esquerda

Abstract Background: Transcatheter aortic valve implantation (TAVI) is a well-established procedure; however, atrioventricular block requiring permanent pacemaker implantation (PPI) is a common complication. Objectives: To determine the incidence, predictors and clinical outcomes of PPI after TAVI, focusing on how PPI affects left ventricular ejection fraction (LVEF) after TAVI. Methods: The Brazilian Multicenter TAVI Registry included 819 patients submitted to TAVI due to severe aortic stenosis from 22 centers from January/2008 to January/2015. After exclusions, the predictors of PPI were assessed in 670 patients by use of multivariate regression. Analysis of the ROC curve was used to measure the ability of the predictors; p < 0.05 was the significance level adopted. Results: Within 30 days from TAVI, 135 patients (20.1%) required PPI. Those patients were older (82.5 vs. 81.1 years; p = 0.047) and mainly of the male sex (59.3% vs 45%; p = 0.003). Hospital length of stay was longer in patients submitted to PPI (mean = 15.7 ± 25.7 vs. 11.8 ± 22.9 days; p < 0.001), but PPI affected neither all-cause death (26.7% vs. 25.6%; p = 0.80) nor cardiovascular death (14.1% vs. 14.8%; p = 0.84). By use of multivariate analysis, the previous presence of right bundle-branch block (RBBB) (OR, 6.19; 3.56-10.75; p ≤ 0.001), the use of CoreValve® prosthesis (OR, 3.16; 1.74-5.72; p ≤ 0.001) and baseline transaortic gradient > 50 mm Hg (OR, 1.86; 1.08-3.2; p = 0.025) were predictors of PPI. The estimated risk of PPI ranged from 4%, when none of those predictors was present, to 63%, in the presence of all of them. The model showed good ability to predict the need for PPI: 0.69 (95%CI: 0.64 - 0.74) in the ROC curve. The substudy of 287 echocardiograms during the 1-year follow-up showed worse LVEF course in patients submitted to PPI (p = 0.01). Conclusion: BRD prévio, gradiente aórtico médio > 50 mmHg e CoreValve® são preditores independentes de implante de MPD pós-TAVI. Ocorreu implante de MPD em aproximadamente 20% dos casos de TAVI, o que prolongou a internação hospitalar, mas não afetou a mortalidade. O implante de MPD afetou negativamente a FEVE pós-TAVI.

Resumo Fundamento: O implante valvar aórtico transcateter (TAVI) está bem estabelecido, porém, o bloqueio atrioventricular, com necessidade de marca-passo definitivo (MPD), é complicação frequente. Objetivo: Determinar a incidência, preditores e desfechos clínicos de implante de MPD após TAVI, focando em como a evolução da fração de ejeção do ventrículo esquerdo (FEVE), após o TAVI, é afetada pelo MPD. Métodos: No registro brasileiro foram incluídos 819 pacientes submetidos a TAVI por estenose aórtica severa em 22 centros entre janeiro/2008 e janeiro/2015. Após exclusões, os preditores de implante de MPD foram avaliados em 670 pacientes por regressão multivariada. Análise da curva ROC foi utilizada para medir a habilidade dos preditores; p < 0,05 foi considerado significativo. Resultados: Aos 30 dias, 135 pacientes (20,1%) necessitaram de MPD. Tais pacientes eram mais velhos (82,5 vs. 81,1 anos; p = 0,047) e predominantemente homens (59,3% vs 45%; p = 0,003). A permanência hospitalar foi maior no Grupo MPD (média= 15,7 ± 25,7 vs. 11,8 ± 22,9 dias; p < 0,001), mas o implante não afetou morte por qualquer causa (26,7% vs. 25,6%; p = 0,80) nem morte cardiovascular (14,1% vs. 14,8%; p = 0,84). Por análise multivariada, a presença prévia de bloqueio de ramo direito (BRD) (OR, 6,19; 3,56-10,75; p ≤ 0,001), o uso da prótese CoreValve® (OR, 3,16; 1,74-5,72; p ≤ 0,001) e gradiente transaórtico basal > 50 mmHg (OR, 1,86; 1,08-3,2; p= 0,025) foram preditores de implante de MPD. O risco estimado de implante de MPD foi 4%, quando nenhum dos fatores de risco estava presente, e 63% na presença de todos. O modelo mostrou boa habilidade de prever a necessidade de MPD: 0,69 (IC95%: 0,64 - 0,74) na curva ROC. Subestudo de 287 ecocardiogramas durante o seguimento de 1 ano mostrou pior evolução da FEVE no Grupo MPD (p = 0,01). Conclusão: Em crianças de 6 a 11 anos, circunferência da cintura aumentada está associada à PA elevada, mesmo quando o IMC é normal. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)

Permanent Pacing After Transcatheter Aortic Valve Implantation: Incidence, Predictors and Evolution of Left Ventricular Function.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established procedure; however, atrioventricular block requiring permanent pacemaker implantation (PPI) is a common complication. OBJECTIVES: To determine the incidence, predictors and clinical outcomes of PPI after TAVI, focusing on how PPI affects left ventricular ejection fraction (LVEF) after TAVI. METHODS: The Brazilian Multicenter TAVI Registry included 819 patients submitted to TAVI due to severe aortic stenosis from 22 centers from January/2008 to January/2015. After exclusions, the predictors of PPI were assessed in 670 patients by use of multivariate regression. Analysis of the ROC curve was used to measure the ability of the predictors; p < 0.05 was the significance level adopted. RESULTS: Within 30 days from TAVI, 135 patients (20.1%) required PPI. Those patients were older (82.5 vs. 81.1 years; p = 0.047) and mainly of the male sex (59.3% vs 45%; p = 0.003). Hospital length of stay was longer in patients submitted to PPI (mean = 15.7 ± 25.7 vs. 11.8 ± 22.9 days; p < 0.001), but PPI affected neither all-cause death (26.7% vs. 25.6%; p = 0.80) nor cardiovascular death (14.1% vs. 14.8%; p = 0.84). By use of multivariate analysis, the previous presence of right bundle-branch block (RBBB) (OR, 6.19; 3.56-10.75; p ≤ 0.001), the use of CoreValve® prosthesis (OR, 3.16; 1.74-5.72; p ≤ 0.001) and baseline transaortic gradient > 50 mm Hg (OR, 1.86; 1.08-3.2; p = 0.025) were predictors of PPI. The estimated risk of PPI ranged from 4%, when none of those predictors was present, to 63%, in the presence of all of them. The model showed good ability to predict the need for PPI: 0.69 (95%CI: 0.64 - 0.74) in the ROC curve. The substudy of 287 echocardiograms during the 1-year follow-up showed worse LVEF course in patients submitted to PPI (p = 0.01). CONCLUSION: BRD prévio, gradiente aórtico médio > 50 mmHg e CoreValve® são preditores independentes de implante de MPD pós-TAVI. Ocorreu implante de MPD em aproximadamente 20% dos casos de TAVI, o que prolongou a internação hospitalar, mas não afetou a mortalidade. O implante de MPD afetou negativamente a FEVE pós-TAVI.

First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure / Primeiros Resultados do Registro Brasileiro de Oclusão Percutânea do Apêndice Atrial Esquerdo

Abstract Background: Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). Objective: To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure. Methods: 91 patients with NVAF, high stroke risk (CHA2DS2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016. Results: Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%). Conclusions: In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA2DS2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.

Resumo Fundamento: A oclusão percutânea do apêndice atrial esquerdo (OAAE) é uma alternativa eficaz à anticoagulação oral (ACO) para a prevenção de acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). Objetivo: Apresentar os resultados imediatos e o seguimento tardio de pacientes submetidos a OAAE e incluídos no Registro Brasileiro de Oclusão Percutânea do Apêndice Atrial Esquerdo. Métodos: 91 pacientes com FANV, alto risco de AVC (escore CHA2DS2VASc = 4,5 ± 1,5) e restrição à AO (escore HAS-BLED = 3,6 ± 1,0) foram submetidos a 92 procedimentos de OAAE com as próteses Amplatzer Cardiac Plug e Watchman em 11 centros do Brasil, entre o final de 2010 e a metade de 2016. Resultados: Utilizaram-se 96 próteses no total (1,04 próteses/procedimento, incluindo-se o uso de 1 prótese não-dedicada adicional em um dos casos), obtendo-se sucesso em 97,8% dos procedimentos. Realizaram-se procedimentos associados à OAAE em 8,7% dos pacientes. Observou-se oclusão total do AAE em 93,3% dos casos com sucesso, e nos casos de oclusão incompleta, nenhum leak foi > 2,5 mm. Um paciente necessitou do implante simultâneo de 2 próteses. Houve 7 complicações maiores periprocedimento (5 derrames pericárdicos necessitando pericardiocentese, 1 embolização da prótese não-dedicada e 1 embolia aérea coronariana sem sequelas) e 4 menores. No seguimento de 128,6 pacientes-ano, houve 3 óbitos não relacionados ao procedimento, 2 sangramentos maiores (um deles em um dos casos de insucesso da OAAE), formação de trombo sobre a prótese em 2 casos (tratados com sucesso com reinstituição da ACO por 3 meses), e 2 AVCs (2,2%). Conclusões: Neste registro multicêntrico de mundo real, que incluiu pacientes com FANV e alto risco de sangramento e de eventos tromboembólicos, a OAAE foi eficaz na prevenção de AVC e sangramento quando comparada às taxas de AVC previstas pelos escores CHA2DS2VASc e HASBLED para esta população. O índice de complicações do procedimento foi aceitável, considerando se tratar do início da curva de aprendizado da maioria dos operadores envolvidos.

Oclusão percutânea do apêndice atrial esquerdo com AMPLATZER® Cardiac Plug para prevenção de fenômenos tromboembólicos na fibrilação atrial crônica / Percutaneous occlusion of the left atrial appendage with AMPLATZER® Cardiac Plug for the prevention of thromboembolic events in chronic atrial fibrillation

A fibrilação atrial (FA) aumenta o risco de eventos tromboembólicos por êmbolos origina do sem apêndice atrial esquerdo (AAE). Métodos mecânicos para a oclusão do AAE foram desenvolvidos como alternativa à anticoagulação oral. O objetivo deste trabalho foi apresentar uma experiência inicial com o AMPLATZER® Cardiac Plug. Métodos: Incluímos pacientes com FA permanente ou paroxística, que apresentavam contraindicações ou complicações derivadas da anticoagulação oral. Pacientes com anatomia e medidas do AAE compatíveis com o oclusor, e sem trombos foram selecionados por meio de ecocardiograma transesofágico. Resultados: Foram realizados 14 procedimentos em 13 pacientes (5M:8F), com média de idade de 66,7 anos. Sangramento significativo e acidentes vasculares cerebrais prévios foram encontrados em 69,2% e em 53,8%, respectivamente. A FA era permanente em 84,6% e paroxística no restante da amostra. Os diâmetros médiodo óstio e da zona alvo mediram 23,9 mm e 20,8 mm, respectivamente. AAE bilobulados foram observados em 76,9%. Os procedimentos foram possíveis em todos os casos. Dezesseis dispositivos foram usados em 13 pacientes, numa razão de 1,2:1, e apenas 1 paciente precisou de um segundo dispositivo para oclusão do AAE. O tempo médio de acompanhamento foi de 12,2 meses. Todos os AAE permanecem fechados e sem defeito residual até o momento. Houve apenas um óbito tardio não relacionado ao procedimento. Conclusões: A oclusão do AAE com o dispositivo de AMPLATZER® Cardiac Plug mostrou ser segura e eficaz nesta pequena série de pacientes. Os resultados iniciais são encorajadores e apontam para o fechamento transcateter do AAE como alternativa para a anticoagulação oral em pacientes selecionados...

Atrial fibrillation (AF) increases the risk of thromboembolic events caused by embolioriginating in the left atrial appendage (LAA). Mechanical methods for LAA occlusion have been developed as an alternative to oral anticoagulation. The aim of this study was to present an initial experience with the AMPLATZER® Cardiac Plug. Methods: Patients with permanent or paroxysmal AF and with contraindications or complications of oral anticoagulation were included. Patients with LAA anatomy and measures compatible with the occluder, and without thrombi, were selected through transesophageal echocardiography. Results: A total of 14 procedures were performed in 13 patients (5M:8F), with mean age of 66.7 years. Significant bleeding and previous strokes were found in 69.2% and 53.8%, respectively. AF was permanent in 84.6% and paroxysmal in the remainder. The mean diameters of the ostium and the landing zone were 23.9 mm and 20.8mm, respectively. Bilobulated LAA was observed in 76.9%. Procedures were possible in all cases. Sixteen devices were used in 13 patients, a ratio of 1.2:1, and only one patient required a second device for LAA occlusion. The mean follow-up was 12.2 months. All LAA remain closed, with no residual defect to date. There was only one late death, unrelated to the procedure. Conclusions: LAA occlusion using the AMPLATZER® Cardiac Plug device was shown to be safe and effective in this small series of patients. The initial results are encouraging and indicate the transcatheter closure of the LAA as an alternative to oral anticoagulation therapy in selected patients...

Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation.

BACKGROUND: Transcatheter left atrial appendage (LAA) occlusion has been proven to be an effective treatment for stroke prophylaxis in patients with atrial fibrillation. For this purpose, the Amplatzer cardiac plug (ACP) was introduced. Its second generation, the Amulet, was developed for easier delivery, better coverage, and reduction of complications. AIM: To investigate the safety and efficacy of first generation versus second generation Amplatzer occluders for LAA occlusion. METHODS: Retrospective analysis of prospectively collected data from the LAA occlusion registries of the Bern and Zurich university hospitals. Comparison of the last consecutive 50 ACP cases versus the first consecutive 50 Amulet cases in patients with non-valvular atrial fibrillation. For safety, a periprocedural combined endpoint, which is composed of death, stroke, cardiac tamponade, and bailout by surgery was predefined. For efficacy, the endpoint was procedural success. RESULTS: There were no differences between the two groups in baseline characteristics. The percentage of associated interventions during LAA occlusion was high in (78% with ACP vs. 70% with Amulet p = ns). Procedural success was similar in both groups (98 vs. 94%, p = 0.61). The combined safety endpoint for severe adverse events was reached by a similar rate of patients in both groups (6 vs. 8%, p = 0.7). Overall complication rate was insignificantly higher in the ACP group, which was mainly driven by clinically irrelevant pericardial effusions (24 vs. 14%, p = 0.31). Death, stroke, or tamponade were similar between the groups (0 vs. 2%, 0 vs. 0%, or 6 vs. 6%, p = ns). CONCLUSION: Transcatheter LAA occlusion for stroke prophylaxis in patients with atrial fibrillation can be performed with similarly high success rates with first and second generations of Amplatzer occluders. According to this early experience, the Amulet has failed to improve results of LAA occlusion. The risk for major procedural adverse events is acceptable but has to be taken into account when selecting patients for LAA occlusion, a preventive procedure.

Oclusão percutânea do apêndice atrial esquerdo e do forame oval patente no mesmo procedimento sem necessidade de punção transeptal / Percutaneous occlusion of left atrial appendage and patent foramen ovale in the same procedure avoiding transeptal puncture

A oclusão do apêndice atrial esquerdo tem sido realizada com sucesso para a prevenção de fenômenos embólicos em pacientes com fibrilação atrial, como alternativa à anticoagulação oral. O acesso atrial, através de forame oval ou comunicação interatrial tipo ostium secundum, tem sido evitado em função da crença de que o posicionamento do dispositivo é dificultado pela disposição mais alta do forame no septo interatrial. Neste manuscrito, relatamos um caso em que foram ocluídos, sequencialmente, o apêndice atrial esquerdo e o forame oval sem a necessidade de punção transeptal, que simplificou e tornou mais seguro o procedimento.

Left atrial appendage occlusion has been successfully employed to prevent embolic events in patients with atrial fibrillation as an alternative to oral anticoagulation. Left atrial access through the patent foramen ovale or ostium secundum atrial septal defect has been discouraged due to the fear that entering the septum in a higher position through the foramen would prevent adequate device positioning. In this manuscript we report a case in which the left atrial appendage and the foramen ovale were sequentially occluded avoiding transseptal puncture, making the procedure simpler and faster.

Autologous Transplantation of Bone Marrow Adult Stem Cells for the Treatment of Idiopathic Dilated Cardiomyopathy / Transplante Autólogo de Células-Tronco Adultas para Tratamento da Cardiomiopatia Dilatada Idiopática

Background: Morbimortality in patients with dilated idiopathic cardiomyopathy is high, even under optimal medical treatment. Autologous infusion of bone marrow adult stem cells has shown promising preliminary results in these patients. Objective: Determine the effectiveness of autologous transplantation of bone marrow adult stem cells on systolic and diastolic left ventricular function, and on the degree of mitral regurgitation in patients with dilated idiopathic cardiomyopathy in functional classes NYHA II and III. Methods: We administered 4,54 x 108 ± 0,89 x 108 bone marrow adult stem cells into the coronary arteries of 24 patients with dilated idiopathic cardiomyopathy in functional classes NYHA II and III. Changes in functional class, systolic and diastolic left ventricular function and degree of mitral regurgitation were assessed after 3 months, 6 months and 1 year. Results: During follow-up, six patients (25%) improved functional class and eight (33.3%) kept stable. Left ventricular ejection fraction improved 8.9%, 9.7% e 13.6%, after 3, 6 and 12 months (p = 0.024; 0.017 and 0.018), respectively. There were no significant changes neither in diastolic left ventricular function nor in mitral regurgitation degree. A combined cardiac resynchronization and implantable cardioversion defibrillation was implanted in two patients (8.3%). Four patients (16.6%) had sudden death and four patients died due to terminal cardiac failure. Average survival of these eight patients was 2.6 years. Conclusion: Intracoronary infusion of bone marrow adult stem cells was associated with an improvement or stabilization of functional class and an improvement in left ventricular ejection fraction, suggesting the efficacy of this intervention. There were no significant changes neither in left ventricular diastolic function nor in the degree of mitral regurgitation. .

Fundamento: Pacientes portadores de cardiomiopatia dilatada idiopática apresentam alta morbimortalidade, mesmo em tratamento clínico otimizado. A infusão autóloga de células-tronco adultas da medula óssea mostrou resultados clínicos preliminares promissores nesses pacientes. Objetivo: Determinar a eficácia do transplante autólogo de células-tronco adultas da medula óssea sobre as funções sistólica e diastólica, e o grau de insuficiência mitral em pacientes portadores de cardiomiopatia dilatada idiopática em classes funcionais NYHA II e III. Métodos: Infundiram-se 4,54 x 108 ± 0,89 x 108 células-tronco adultas da medula óssea nas artérias coronárias de 24 pacientes com cardiomiopatia dilatada idiopática em classes funcionais NYHA II e III. Após 3 meses, 6 meses e 1 ano, avaliaram-se as mudanças de classe funcional, das funções ventricular esquerda sistólica e diastólica, e do grau da insuficiência mitral. Resultados: No seguimento, seis (25%) pacientes melhoraram sua classe funcional e oito (33,3%) mantiveram sua classe funcional inicial. A fração de ejeção ventricular esquerda aumentou 8,9%, 9,7% e 13,6%, após 3 e 6 meses e 1 ano (p = 0,024; p = 0,017 e p = 0,018), respectivamente. A função diastólica ventricular esquerda e o grau de insuficiência mitral não demonstraram mudanças significativas. Dois pacientes (8,3%) receberam cardioversor e ressincronizador implantável. Ocorreram quatro (16,6%) mortes súbitas e quatro (16,6%) mortes por insuficiência cardíaca terminal. A sobrevida média desses oitos pacientes foi de 2,6 anos. Conclusão: A infusão intracoronariana de células-tronco adultas da medula óssea em pacientes com cardiomiopatia dilatada idiopática promoveu melhora ...

Autologous transplantation of bone marrow adult stem cells for the treatment of idiopathic dilated cardiomyopathy.

BACKGROUND: Morbimortality in patients with dilated idiopathic cardiomyopathy is high, even under optimal medical treatment. Autologous infusion of bone marrow adult stem cells has shown promising preliminary results in these patients. OBJECTIVE: Determine the effectiveness of autologous transplantation of bone marrow adult stem cells on systolic and diastolic left ventricular function, and on the degree of mitral regurgitation in patients with dilated idiopathic cardiomyopathy in functional classes NYHA II and III. METHODS: We administered 4,54 x 10(8) ± 0,89 x 10(8) bone marrow adult stem cells into the coronary arteries of 24 patients with dilated idiopathic cardiomyopathy in functional classes NYHA II and III. Changes in functional class, systolic and diastolic left ventricular function and degree of mitral regurgitation were assessed after 3 months, 6 months and 1 year. RESULTS: During follow-up, six patients (25%) improved functional class and eight (33.3%) kept stable. Left ventricular ejection fraction improved 8.9%, 9.7% e 13.6%, after 3, 6 and 12 months (p = 0.024; 0.017 and 0.018), respectively. There were no significant changes neither in diastolic left ventricular function nor in mitral regurgitation degree. A combined cardiac resynchronization and implantable cardioversion defibrillation was implanted in two patients (8.3%). Four patients (16.6%) had sudden death and four patients died due to terminal cardiac failure. Average survival of these eight patients was 2.6 years. CONCLUSION: Intracoronary infusion of bone marrow adult stem cells was associated with an improvement or stabilization of functional class and an improvement in left ventricular ejection fraction, suggesting the efficacy of this intervention. There were no significant changes neither in left ventricular diastolic function nor in the degree of mitral regurgitation.

Oclusão do apêndice atrial esquerdo com o Amplatzer Cardiac Plug em pacientes com fibrilação atrial / Left atrial appendage closure with the Amplatzer Cardiac Plug in patients with atrial fibrillation

FUNDAMENTO: A oclusão percutânea do apêndice atrial esquerdo (OAAE) surgiu como alternativa à anticoagulação oral (AO) para prevenção do acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). OBJETIVO: Relatar os resultados imediatos e o seguimento clínico de pacientes submetidos a OAAE com o Amplatzer Cardiac Plug (ACP) em um único centro de referência. MÉTODOS: Oitenta e seis pacientes consecutivos com FANV, contra-indicação à AO e escore CHADS2= 2,6±1,2 foram submetidos a OAAE com implante de ACP. Realizou-se seguimento clínico e ecocardiográfico no mínimo 4 meses após o implante. RESULTADOS: Todos os implantes foram guiados apenas por angiografia. O sucesso do procedimento foi de 99% (1 insucesso por tamponamento cardíaco e consequente suspensão da OAAE). Houve 4 complicações maiores (o tamponamento já referido, 2 AVCs transitórios e uma embolização com retirada percutânea da prótese) e duas menores (um derrame pericárdico sem tamponamento e uma pequena comunicação interatrial evidenciada no seguimento). Houve 1 óbito hospitalar após 6 dias, não relacionado à intervenção. Todos os outros pacientes receberam alta sem AO. Após seguimento de 25,9 pacientes-ano (69 pacientes) não houve AVCs nem embolizações tardias de próteses. O AAE estava completamente ocluído em 97% dos casos. Seis pacientes apresentaram evidência de trombo sobre a prótese, que desapareceram após reinstituição de AO por 3 meses. CONCLUSÃO: OAAE se associa a um alto índice de sucesso, um índice aceitável de complicações e resultados promissores a médio prazo, podendo ser considerada uma alternativa válida à OA na prevenção do AVC em pacientes com FANV.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OA) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To describe the immediate results and short- to medium-term clinical follow-up (FU) of patients that underwent LAAC with Amplatzer Cardiac Plug (ACP) implantation in a single reference center. METHODS: Eighty-six consecutive patients with NVAF, contraindication to OA, and CHADS2 score=2.6±1.2 underwent LAAC with ACP implantation. Clinical and echocardiographic FU was performed at least four months after the procedure. RESULTS: All implants were guided by angiography alone. Procedural success was 99% (one patient suffered a cardiac tamponade requiring pericardiocentesis, and the procedure was waived). There were four major complications (the already mentioned cardiac tamponade, two transient ischemic attacks and one device embolization with percutaneous retrieval) and two minor complications (one pericardial effusion without clinical significance and one non-significant ASD evidenced at FU). There was one in-hospital death after six days, unrelated to the procedure. All other patients were discharged without OA. After 25.9 patient-years of FU (69 patients), there were no strokes and no late device embolization. The LAA was completely closed in 97% of the cases. Six patients showed evidence of thrombus formation on the device, which resolved after three months of OA. CONCLUSION: LAAC is associated with high success, acceptable complication rates, and promising FU results, and may be considered a valuable alternative or complement to OA for stroke prevention in patients with NVAF.

Artéria coronária única / Single coronary artery

Artéria coronária única é uma anomalia coronária congênita extremamente rara. Embora não seja identificada com muita frequência, por apresentar, em geral, pouca repercussão clínica, a anomalia pode ser causa de isquemia miocárdica significativa e morte súbita. Relatamos o caso de uma paciente de 80 anos de idade, atendida em fase aguda de infarto agudo do miocárdio, que teve o diagnóstico de artéria coronária única durante o cateterismo que precedeu a angioplastia coronária primária. Segue-se uma revisão da literatura, abordando a classificação dessa anomalia, sua fisiopatologia, manifestações e significância clínica, e abordagens diagnósticas e terapêuticas.

Single coronary artery is an extremely rare congenital coronary anomaly. Although it is not frequently identified, due to the lack of clinical manifestations, it may cause significantmyocardial ischemia and sudden death. We report the case of an 80-year old woman who had an acute myocardialinfarction and was found to have a single coronary artery during primary coronary angioplasty. A literature review, detailing the classification, pathophysiology, clinical profileand significance, screening and therapeutic approaches of this anomaly is provided.

Obesity and coronary intervention: should we continue to use Body Mass Index as a risk factor?

BACKGROUND: Central anthropometric indexes are better than the body mass index to discriminate elevated coronary risk. However, the Body Mass Index (BMI) is still the most frequently studied anthropometric index on outcomes of patients undergoing percutaneous coronary angioplasty (PCI). OBJECTIVE: To recognize, among several anthropometric indexes of obesity, which one best discriminates MACE (Major Adverse Cardiac Events) after PCI. METHODS: Subjects were 308 patients (mean age 61.92+/-11.06 years, 60.7% of them men) who had undergone successful coronary angioplasties. Six months after the procedure, patients were contacted for clinical follow-up. Major Adverse Cardiac Events included death, acute myocardial infarction, cardiac surgery, reintervention, angina, or evidence of myocardial ischemia on a non-invasive test. Patients were divided into 2 groups: Group 1 (with MACE, n=91, 29.5%), Group 2 (with no MACE, n= 217; 70.45%). For men and women, the anthropometric indexes studied and their respective cut-off points were waist circumference >90/80 cm, Waist-Hip Ratio > 0.90/0.80 cm, Conicity Index > 1.25/1.18, and Body Mass Index > or =30. RESULTS: There were more cases of familial history and previous infarct in Group 2. For men, waist circumference >90 cm (p=0.0498) in multivariate analyses was an independent predictor of MACE. BMI was not related to MACE. In Group 1, the prevalence of an elevated BMI was significantly different compared to the other anthropometric indexes studied (p<0.0001). CONCLUSION: Waist circumference was an independent predictor of MACE in men. Body Mass Index was not related to MACE and was the least frequent anthropometric index in the MACE group.

Obesidade e intervenção coronariana: devemos continuar valorizando o Índice de Massa Corpórea? / Obesity and coronary intervention: should we continue to use Body Mass Index as a risk factor?

FUNDAMENTO: Para discriminar risco coronariano elevado, indicadores de obesidade central são melhores do que o Índice de Massa Corpórea (IMC), que é ainda o índice antropométrico (IA) mais utilizado para seguimento após intervenção coronariana percutânea (ICP). OBJETIVO: Reconhecer, entre os índices antropométricos (IA), os que melhor se correlacionam com ocorrência de desfechos após intervenção coronariana percutânea (ICP). MÉTODOS: Foram considerados 308 pacientes (p), idade média de 61,92±11,06 anos, 60,7 por cento do sexo masculino, submetidos a ICP com stent. Após seis meses, pesquisaram-se os desfechos: óbito, reintervenção por ICP ou cirurgia cardíaca, exame não-invasivo alterado por isquemia ou sintomas anginosos. Os p foram divididos em: Grupo 1 (com desfechos, n=91; 29,5 por cento) e Grupo 2 (sem desfechos, n=217; 70,45 por cento). No sexo masculino e feminino, os IA estudados e seus respectivos pontos de corte foram: circunferência abdominal (CA) > 90/80 cm, relação cintura-quadril (RCQ) > 0,90/0,80cm, índice de conicidade (IC) >1,25/1,18 e índice de massa corpórea (IMC) >30 para ambos os sexos. RESULTADOS: Os grupos diferiram quanto à maior ocorrência de histórico familiar e infarto prévio no Grupo 2. No sexo masculino, CA > 90 cm (p=0,0498) foi, em análise multivariada, preditor independente de desfechos. IMC não foi preditor de eventos. No Grupo 1, a probabilidade de ocorrência de IMC alterada é significativamente menor do que a ocorrência dos outros IA estudados (p<0,0001). CONCLUSÃO: CA anormal comportou-se como preditor independente de ocorrência de desfechos no sexo masculino dessa população pós-ICP. IMC elevado não foi preditor de desfechos e foi o índice antropométrico menos prevalente em pacientes com eventos.

BACKGROUND: Central anthropometric indexes are better than the body mass index to discriminate elevated coronary risk. However, the Body Mass Index (BMI) is still the most frequently studied anthropometric index on outcomes of patients undergoing percutaneous coronary angioplasty (PCI). OBJECTIVE: To recognize, among several anthropometric indexes of obesity, which one best discriminates MACE (Major Adverse Cardiac Events) after PCI. METHODS: Subjects were 308 patients (mean age 61.92±11.06 years, 60.7 percent of them men) who had undergone successful coronary angioplasties. Six months after the procedure, patients were contacted for clinical follow-up. Major Adverse Cardiac Events included death, acute myocardial infarction, cardiac surgery, reintervention, angina, or evidence of myocardial ischemia on a non-invasive test. Patients were divided into 2 groups: Group 1 (with MACE, n=91, 29.5 percent), Group 2 (with no MACE, n= 217; 70.45 percent). For men and women, the anthropometric indexes studied and their respective cut-off points were waist circumference >90/80 cm, Waist-Hip Ratio > 0.90/0.80cm, Conicity Index > 1.25/1.18, and Body Mass Index > 30. RESULTS: There were more cases of familial history and previous infarct in Group 2. For men, waist circumference >90cm (p=0.0498) in multivariate analyses was an independent predictor of MACE. BMI was not related to MACE. In Group 1, the prevalence of an elevated BMI was significantly different compared to the other anthropometric indexes studied (p<0.0001). CONCLUSION: Waist circumference was an independent predictor of MACE in men. Body Mass Index was not related to MACE and was the least frequent anthropometric index in the MACE group.

Valor prognóstico dos critérios de obesidade em pacientes submetidos a intervenção coronária percutânea / Prognostic value of obesity anthropometric indexes in patients undergoing percutaneous coronary interventions

Introdução: Não há critérios de obesidade específicos para a população brasileira. Os pontos de corte preconizados para os sexos feminino e masculino (circunferência abdominal [CA] 80 cm e 90 cm, relação cintura-quadril [RCQ] 0,80 e 0,90, índice de conicidade 1,18 e 1,25, e índice de massa corporal [IMC] 30, respectivamente) necessitam ser validados como fatores prognósticos após intervenção coronária percutânea (ICP). Objetivo: O objetivo deste estudo foi verificar os pontos de corte de índices antropométricos da população estudada e compará-los à literatura, quanto à ocorrência de desfechos pós-ICP. Método: Foram incluídos nesta análise 308 pacientes submetidos a ICP, predominantemente do sexo masculino (60,7%), com idade de 61,9 ± 11,1 anos. Após seis meses, pesquisaram-se os desfechos óbito, infarto agudo do miocárdio, revascularização do vaso-alvo, angina ou prova funcional isquêmica. Os pacientes foram divididos em: Grupo 1 (com desfechos; n = 91) e Grupo 2 (sem desfechos; n = 217). Para obtenção dos pontos de corte, foram construídas curvas receiver operating characteristic (ROC) dos índices antropométricos versus desfechos. Resultados: Nas mulheres, os pontos de corte encontrados foram: CA, 102 cm; RCQ, 0,93; índice de conicidade, 1,18; e IMC, 24,5. Nos homens, os pontos de corte foram: CA, 102 cm; RCQ, 0,94; índice de conicidade, 1,24; e IMC, 24,98. Comparados à literatura, os valores obtidos de CA e RCQ, para ambos os sexos, ganharam em especificidade, mas perderam em sensibilidade, enquanto o contrário foi observado para o IMC. O índice de conicidade coincidiu com os valores da literatura no sexo feminino; no sexo masculino, porém, aumentou a sensibilidade, mas diminuiu a especificidade. O poder discriminatório foi baixo para todos os índices, que não se mostraram preditores de desfechos no médio prazo pós-ICP. Conclusão: Nesta comparação, os pontos de corte dos índices antropométricos que melhor se correlacionam com desfechos...

Background: No evidence supports obesity cutoff points recommended by literature for the Brazilian population. Some female/male known cutoff points are: waist circumference (WC) 80/90cm, waist-to-hip ratio (WHR) 0.80/0.90, conicity index (CI) 1.18/1.25, body mass index (BMI) 30. These cutoff points need to be validated for the Brazilian population as prognostic after percutaneous coronary intervention (PCI). Objective: To verify cutoff points of obesity anthropometric indexes in this population and to compare them to International Diabetes Federation values for Latin America in determining MACE after PCI. Methods: 308 patients (mean age 61.92 ± 11.06 years old, 60.7% men) undergoing successful PCI. Six months after, patients were contacted for clinical follow-up. MACE included death, acute myocardial infarction, cardiac surgery, reintervention or evidence of myocardial ischemia in a non-invasive test. Patients were divided into 2 groups: group 1 (with MACE, n = 91), Group 2 (without MACE, n = 217). In order to obtain cutoff points, ROC curves were plotted based on anthropometric indexes and MACE. Results: The cutoff points obtained for women were: WC 102cm, WHR 0.93, CI 1.18 and BMI 24.53. Compared with IDF values, WC and WHR obtained had more specificity (76.83% X 31.71% and 43.9% X 7.32%), BMI had more sensibility (66.67% X 20.51%). For men, the cutoff points were: WC 102 cm, WHR 0.94, CI 1.24 and BMI 24.98. WC and WHR had more specificity (69.63% X 45.19% and 7.41% X 2.94%). BMI and CI had more sensibility (65.38% X 28.85% and 55.77% X 53.85%). Conclusion: Cutoff points of anthropometric indexes of this population that better correlate with MACE are different than the literature. Our results suggest that, for prognostic information, we need specific anthropometric cutoff points for each population or disease.

Randomized comparison between Inoue balloon and metallic commissurotome in the treatment of rheumatic mitral stenosis: immediate results and 6-month and 3-year follow-up.

The metallic commissurotome (MC) technique is a cheaper alternative to the Inoue balloon (IB) technique for percutaneous mitral valvuloplasty (PMV). There are no randomized trials comparing these techniques with longer follow-up of the patients. The objective of this study was to compare the immediate results and short- and medium-term follow-up of PMV using either the IB or the MC technique. Fifty patients with rheumatic mitral stenosis were randomly assigned to PMV using the IB (n = 27) or the MC (n = 23) technique. There were no significant differences between the groups regarding baseline clinical, echocardiographic, and hemodynamic data. Clinical and echocardiographic follow-up were done 6 months and 3 years after the procedure. The success rate was 100% in the IB group and 91.3% in the MC group (P = 0.15); two patients in the latter group developed mitral regurgitation grade 3/4, requiring elective surgery. The mean final mitral valve area was bigger in the MC group (2.17 +/- 0.13 vs. 2.00 +/- 0.36 cm2; P = 0.04), but after 6-month and 3-year follow-up, this difference was no longer significant (2.06 +/- 0.27 vs. 1.98 +/- 0.38 cm2, P = 0.22, and 1.86 +/- 0.32 vs. 1.87 +/- 0.34 cm2, P = 0.89, respectively). This finding suggests valve stretching as an important mechanism of valve dilation with the MC. Three patients in the MC group and two patients in the IB group (P = 0.65) developed mitral valve restenosis; one of them underwent repeat PMV and the other four, all asymptomatic, were clinically followed. PMV performed either with the IB or the MC technique is effective and provides excellent short- and medium-term outcomes regardless of the technique employed.