Long-term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three-year pilot study in Yucatan miniswine.

AIMS: Peripheral arteries are constantly exposed to deformation (elongation, twisting, shortening, compression) making bioresorbable scaffolds (BRS) a potentially attractive therapeutic alternative to metallic stents. We conducted a long-term pilot preclinical study of a novel sirolimus-eluting BRS in peripheral arteries. METHODS AND RESULTS: Fourteen BRS were deployed in iliofemoral arteries of seven healthy Yucatan miniswine and examined with imaging, pharmacokinetic, histopathologic, and polymer degradation techniques at 0, 30, 90, 180 days, 1, 2, and 3.3 years. Angiographic late luminal loss remained unchanged at 30 and 180 days but significantly decreased from 1 to 3.3 years. optical coherence tomography (OCT) showed late increase in lumen area (1 year: 14.70 ± 3.58 mm2 , 2 years 22.04 ± 3.81 mm2 , and 3.3 years 23.45 ± 7.07 mm2 ; p < .05) primarily due to scaffold area enlargement between 1 and 3.3 years, while there was no difference in the percent area stenosis at all time points. Histologic evidence of scaffold degradation was observed starting at 2 years, with minimal inflammatory reaction. At 3.3 years, BRS struts were rarely discernible by OCT, confirmed by a nearly complete polymer degradation by molecular weight analysis. CONCLUSIONS: In this pilot study, novel sirolimus-eluting BRS showed promising acute and chronic performance in the iliofemoral arteries of Yucatan miniswine.

Striving to meet targets for ideal treatment of acute myocardial infarction in Brazil: Data from the Midwest region.

OBJECTIVES: To evaluate the systematic chain of care for patients with acute ST-elevation myocardial infarction (STEMI) referred for primary angioplasty in a capital city in Midwestern Brazil. BACKGROUND: Acute myocardial infarction is recognized as an important cause of morbidity and mortality and as a public health problem worldwide. Early specialized care is crucial for a good prognosis. METHODS: All STEMI patients receiving care through the public health system at two tertiary care centers from March 2012 to June 2014 were retrospectively analyzed. Symptom onset-to-balloon time and door-to-balloon time were analyzed and compared with current guideline recommendations. RESULTS: A total of 835 patients were included. Median symptom onset-to-balloon time was 32 h. A total of 783 (94%) patients had had symptoms for more than 12 h and 507 (61%) for more than 24 h. Only 51 (6%) patients arrived within 12 h of symptom onset and were treated with primary angioplasty. Among these patients, median door-to-balloon time was 37 min, in accordance with guideline recommendations. CONCLUSION: Treatment of STEMI through the public health system in a capital city in Midwestern Brazil falls short of the recommended guidelines due to failure in the initial links of the chain of care. This potentially reversible failure has an important impact on patient outcomes and on health care burden.

Modular aortic valve prosthesis for transcatheter aortic valve implantation: a novel concept with a new implantation method.

Transcatheter aortic valve implantation (TAVI) is a relatively new medical intervention. Research on dedicated TAVI devices is an exciting and dynamic field to be explored by professionals involved in technological innovation. The authors describe in this article the first engineering concept and part of the US Patent of a new valve prosthesis. Divided into two pieces to be separately implanted using a single catheter by means of an innovative technique, this device aims at reducing prosthesis and delivery catheter profile. Miniaturization of the valve and delivery system is probably the best solution to reduce the morbidity and mortality that derive from vascular complications associated with TAVI.

Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry.

OBJECTIVE: To compare the 1-year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among "real-world" patients from the multi-center Brazilian TAVI registry. BACKGROUND: Vascular access still remains a major challenge for TAVI via transfemoral approach. Vascular access through complete percutaneous approaches or through open surgical vascular techniques seems to be acutely similar. However, the long-term outcomes of both techniques remain poorly described. METHODS: The study population comprised all patients treated via transfemoral route in the Brazilian TAVI registry, a "real-world", nation-based, multi-center study. Patients were divided according to the initial vascular access approach (percutaneous vs. surgical) and clinically followed-up for 1 year. The primary endpoint was the incidence of combined adverse events all-cause mortality, life-threatening bleeding, and/or major vascular complication at 1 year. RESULTS: A total of 402 patients from 18 centers comprised the study population (percutaneous approach in 182 patients; surgical cutdown approach 220 patients). The incidence of combined adverse events was not different in the percutaneous and the surgical groups at 30 days (17.6% vs. 16.3%; P = 0.8) and at 1 year (primary endpoint) (30.9% vs. 28.8%; P = 0.8). Also, the study groups overall were comparable regarding the incidence of each individual safety adverse events at 30 days and at 1 year. CONCLUSION: Total percutaneous techniques or surgical cutdown and closure may provide similar safety and effectiveness during the first year of follow-up in patients undergoing transfemoral TAVI.

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.

Left ventricular guidewire pacing for transcatheter aortic valve implantation.

Previous reports prove the safety and efficacy of cardiac pacing employing a guidewire in the left ventricle as unipolar pacing electrode. We describe the use of left ventricular guidewire pacing as an alternative to conventional transvenous temporary right ventricular pacing in the context of transcatheter aortic valve implantation.

Percutaneous left atrial appendage closure: beyond the classic indications.

Percutaneous left atrial appendage closure (LAAC) has proven to be an effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). International guidelines traditionally recommend LAAC for NVAF patients at high thromboembolic risk and contraindication to or at high risk for OAC. However, there are many other clinical situations in which this procedure may also be beneficial. This paper discusses the potential role of LAAC in specific haemorrhagic diseases (cerebral amyloid angiopathy, age-related macular degeneration, hereditary haemorrhagic telangiectasia, and Moyamoya disease), after left atrial appendage (LAA) electrical isolation, in cases of persistent thrombus inside the LAA, in end-stage renal disease and in special groups of patients for whom low compliance and persistence to OAC may be anticipated.

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Mitral stenosis and percutaneous mitral valvuloplasty (part 1).

Although the incidence and severity of rheumatic mitral stenosis have declined in developed countries, the disease is still highly prevalent in many of the poorer and most densely populated areas of the globe, remaining a major public health issue and reflecting the socioeconomic status of the region. In the last 30 years, mitral stenosis therapy has undergone a reorientation with the introduction of percutaneous mitral valvuloplasty. This manuscript is an updated review of percutaneous dilation of mitral stenosis in its different aspects, encompassing traditional techniques, technical innovations, the most significant case loads worldwide, an analysis of the procedure as well as immediate and late outcomes.

Double device left atrial appendage closure.

AIMS: Percutaneous left atrial appendage (LAA) occlusion is an alternative to oral anticoagulation for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). Due to the great anatomic variability of the LAA, complete closure may not always be obtained with a single device. We report cases in which adequate closure of the LAA was achieved with implantation of two devices. METHODS AND RESULTS: Five out of 223 consecutive patients who underwent LAA occlusion without guidance with transoesophageal echocardiography (TOE) had a second device implanted to treat significant residual leaks or uncovered parts of the LAA after first device implantation. All procedures were successful, with no complications. Two patients received two AMPLATZER Cardiac Plugs (ACP); one patient received one ACP and one AMPLATZER Vascular Plug; one patient received one AMPLATZER Septal Occluder (ASO) and one ACP prototype; and one patient received two ASOs. TOE performed at least four months after the procedure showed complete closure of the LAA in all patients, without thrombus formation on the devices. After 14 patient-years there were no strokes, peripheral thromboemboli, or device embolisations. CONCLUSIONS: When necessary, the implantation of two devices to achieve complete LAA occlusion in patients with NVAF is feasible and leads to favourable results during follow-up. Potentially, this technical innovation may widen LAA occlusion indications by permitting occlusion of LAAs with large ostia or complex anatomy.

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.