Concordance between vessel-specific and vascular territory coronary functional assessment: A comparison of quantitative flow ratio and myocardial perfusion scintigraphy.

BACKGROUND: Quantitative flow ratio (QFR) and myocardial perfusion scintigraphy (MPS) are utilized for assessing coronary artery disease (CAD) significance. We aimed to analyze their concordance and prognostic impact. AIMS: We aimed to analyze the concordance between QFR and MPS and their risk stratification. METHODS: Patients with invasive coronary angiography and MPS were categorized as concordant if QFR ≤ 0.80 and summed difference score (SDS) ≥ 4 or if QFR > 0.80 and SDS < 4; otherwise, they were discordant. Concordance was classified by coronary territory involvement: total (three territories), partial (two territories), poor (one territory), and total discordance (zero territories). Leaman score assessed coronary atherosclerotic burden. RESULTS: 2010 coronary territories (670 patients) underwent joint QFR and MPS analysis. MPS area under the curve for QFR ≤ 0.80 was 0.637. Concordance rates were total (52.5%), partial (29.1%), poor (15.8%), and total discordance (2.6%). Most concordance occurred in patients without significant CAD or with single-vessel disease (89.5%), particularly without MPS perfusion defects (91.5%). Leaman score (odds ratio [OR]: 0.839, 95% confidence interval [CI]: 0.805-0.875, p < 0.001) and MPS perfusion defect (summed stress score [SSS] ≥ 4) (OR: 0.355, 95% CI: 0.211-0.596, p < 0.001) were independent predictors for discordance. After 1400 days, no significant difference in death/myocardial infarction was observed based on MPS assessment, but Leaman score, functional Leaman score, and average QFR identified higher risk patients. CONCLUSIONS: MPS showed good overall accuracy in assessing QFR significance but substantial discordance existed. Predictors for discordance included higher atherosclerotic burden and MPS perfusion defects (SSS ≥ 4). Leaman score, QFR-based functional Leaman score, and average QFR provided better risk stratification for all-cause death and myocardial infarction than MPS.

B-type natriuretic peptide and N-terminal Pro-B-type natriuretic peptide in severe aortic stenosis: a comprehensive literature review.

B-type natriuretic peptide (BNP) and N-terminal pro-BNP (NT-pro BNP) are cardiac biomarkers that are released in response to increased ventricular and atrial wall stress. Aortic stenosis (AS) leads to hemodynamic changes and left ventricular hypertrophy and may be associated with natriuretic peptide levels. Several studies have shown that increased natriuretic peptide levels are correlated with AS severity and can predict the need for intervention. It can be useful in risk stratification, monitoring follow-up, and predicting cardiovascular outcomes of patients with severe AS. This paper aims to summarize the evidence of the role of BNP and NT-pro BNP in AS, before and after intervention.

The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study.

BACKGROUND: Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Neutrophil Gelatinase-associated Lipocalin (NGAL) is a biomarker of acute kidney injury (AKI) produced early after an ischemic renal insult. Osmotic diuresis and the vasoconstriction of the afferent arteriole promoted by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) generate a concern regarding the possibility of dehydration and consequent AKI. There is no consensus on the maintenance or discontinuation of SGTL2i in patients who will undergo PCI. This study aimed to evaluate the safety of empagliflozin in diabetic patients submitted to elective PCI regarding kidney function. METHODS: SAFE-PCI trial is a prospective, open-label, randomized (1:1), single-center pilot study and a follow-up of 30 days. The SGLT2i empagliflozin 25 mg daily was initiated at least 15 days before PCI in the intervention group and maintained until the end of the follow-up period. Serum NGAL was collected 6 h after PCI and creatinine before PCI, 24 h, and 48 h after the procedure. As per protocol, both groups received optimal medical treatment and standard protocol of nephroprotection. RESULTS: A total of 42 patients were randomized (22 patients in the iSGLT-2 group and 20 patients in the control group). There was no difference between-group baseline data. The primary outcome (NGAL and creatinine values post PCI) did not differ in both groups: the mean NGAL value was 199 ng/dL in the empagliflozin group and 150 ng/dL in the control group (p = 0.249). Although there was an initial increase in creatinine in the SGLT-2i group compared to the control group between baseline creatinine and pre-PCI and 24 h post-PCI creatinine, no difference was detected in creatinine 48 h post-PCI (p = 0.065). The incidence of CI-AKI, determined by KDIGO criteria, in the iSGLT2-group was 13.6% and 10.0% in the control group without statistical difference. CONCLUSION: The present study showed that the use of empagliflozin is safe regarding kidney function during elective PCI in patients with T2D when compared with no use of SGLT2i. Trial registration Our clinical study is registered on ClinicalTrials.gov with the following number: NCT05037695.

Microvascular lung vessels obstructive thromboinflammatory syndrome in patients with COVID-19: Insights from lung intravascular optical coherence tomography.

Background: Microvascular lung vessels obstructive thromboinflammatory syndrome has been proposed as a possible mechanism of respiratory failure in COVID-19 patients. However, it has only been observed in post-mortem studies and has never been documented in vivo, probably because of a lack of CT scan sensitivity in small pulmonary arteries. The aim of the present study was to assess the safety, tolerability, and diagnostic value of optical coherence tomography (OCT) for the assessment of patients with COVID-19 pneumonia for pulmonary microvascular thromboinflammatory syndrome. Methods: The COVID-OCT trial was a multicenter, open-label, prospective, interventional clinical study. Two cohorts of patients were included in the study and underwent pulmonary OCT evaluation. Cohort A consisted of patients with COVID-19 with a negative CT scan for pulmonary thrombosis and elevated thromboinflammatory markers (D-dimer > 10,000 ng/mL or 5,000 < D-dimer < 10,000 ng/mL and one of: C-reactive Protein > 100 mg/dL, IL-6 > 6 pg/mL, or ferritin > 900 ng/L). Cohort B consisted of patients with COVID-19 and a CT scan positive for pulmonary thrombosis. The primary endpoints of the study were: (i) to evaluate the overall safety of OCT investigation in patients with COVID-19 pneumonia, and (ii) to report on the potential value of OCT as a novel diagnostic tool for the diagnosis of microvascular pulmonary thrombosis in COVID-19 patients. Results: A total of 13 patients were enrolled. The mean number of OCT runs performed in each patient was 6.1 ± 2.0, both in ground glass and healthy lung areas, achieving a good evaluation of the distal pulmonary arteries. Overall, OCT runs identified microvascular thrombosis in 8 patients (61.5%): 5 cases of red thrombus, 1 case of white thrombus, and 2 cases of mixed thrombus. In Cohort A, the minimal lumen area was 3.5 ± 4.6 mm2, with stenosis of 60.9 ± 35.9% of the area, and the mean length of thrombus-containing lesions was 5.4 ± 3.0 mm. In Cohort B, the percentage area obstruction was 92.6 ± 2.6, and the mean thrombus-containing lesion length was 14.1 ± 13.9 mm. No peri-procedural complications occurred in any of the 13 patients. Conclusion: OCT appears to be a safe and accurate method of evaluating the distal pulmonary arteries in hospitalized COVID-19 patients. Here, it enabled the first in vivo documentation of distal pulmonary arterial thrombosis in patients with elevated thromboinflammatory markers, even when their CT angiogram was negative for pulmonary thrombosis. Clinical trial registration: ClinicalTrial.gov, identifier NCT04410549.

Offline Assessment of the Quantitative Flow Ratio: Is it Useful in Clinical Practice?

INTRODUCTION: Fractional flow reserve (FFR) has been established as the gold standard in the physiological assessment of coronary obstructions severity. However, the need to insert an intracoronary pressure guidewire is a factor that limits its use. Quantitative flow ratio (QFR) is a method that infers the value of FFR from 3-dimensional quantitative coronary angiography (3D-QCA), eliminating the use of a pressure wire and coronary hyperemia. The present study aims to evaluate the diagnostic accuracy of QFR and 3D-QCA in comparison with FFR for the identification of significant obstructive coronary lesions (FFR ≤.80) and the feasibility to assess QFR in a cohort of patients without dedicated angiographic acquisition. METHODS: Consecutive patients with coronary angiography with moderate obstructive lesions that had previous FFR measurement were evaluated. Validation of QFR was assessed by the area under the curve (AUC) and other statistical tools, using FFR as the reference method. RESULTS: Seventy-five arteries from 69 patients were evaluated. The accuracy of the QFR to detect FFR ≤.80 was 84.0% (95% confidence interval, 75.6-92.4). The correlation and agreement between FFR and QFR were r=0.54 (P<.01) and mean difference was -0.02 ± 0.09 (P=.09), respectively. The AUC of QFR and 3D-QCA identifying stenosis >50% was 0.854 and 0.755, respectively (P=.09). CONCLUSION: QFR demonstrated good accuracy compared with FFR for the assessment of moderate obstructive coronary lesions in an unselected clinical practice population. However, many patients were excluded from the analysis and there was no statistical difference between the receiver operator characteristic curves of the QFR and percent diameter stenosis.

Same-day discharge percutaneous coronary intervention. Where are we? / Intervenção coronária percutânea com alta no mesmo dia. Onde estamos?

With the evolution of percutaneous coronary intervention techniques and their greater safety, the use of radial access, the greater need to optimize resources in health management and the greater demand from patients for an agile service to solve their problems, the discharge on the same day after percutaneous coronary interventions have been gaining ground in the global scenario as a feasible strategy. The objective of this article was to demonstrate that there is already a scientific basis for this, which extends from the financial aspect, and the patient's experience, to the technical details related to the safety of the strategy. A structured protocol based on evidence and on the most recent recommendations from two major medical societies is also proposed. Selecting patients well, training the multidisciplinary team and educating the patient are fundamental parts for the success of the strategy.

Com a evolução das técnicas de intervenção coronária percutânea e sua maior segurança, o uso do acesso radial, a maior necessidade de otimização dos recursos na gestão em saúde e a maior cobrança por parte dos pacientes por um serviço ágil para resolução de seus problemas, a alta no mesmo dia após as intervenções coronárias percutâneas vem ganhando espaço no cenário global como uma estratégia factível. O objetivo deste artigo foi demonstrar que já há base científica para o assunto, a qual se estende desde a aspectos financeiros, à experiência do paciente até à questão técnica relacionada à segurança da estratégia. Propõe-se, ainda, um protocolo estruturado baseado em evidências e nas recomendações mais recentes de duas grandes sociedades médicas. Selecionar bem os pacientes, treinar a equipe multiprofissional e educar o paciente são partes fundamentais para o sucesso da estratégia.

E/e` ratio is superior to speckle tracking for detecting elevated left ventricular end-diastolic pressure in patients with coronary artery disease and preserved ejection fraction.

BACKGROUND: A weak correlation has been reported between left ventricular filling pressures and the traditional echocardiographic tools for the evaluation of diastolic function in patients with coronary artery disease (CAD) and preserved left ventricular ejection fraction (LVEF). On the other hand, studies that compared invasive measurements with speckle tracking echocardiography have shown promising results, but they were not exclusively targeted on this specific population. METHODS AND RESULTS: Immediately before the left heart catheterization, a comprehensive two-dimensional Doppler echocardiography and speckle tracking analysis was prospectively performed in outpatients referred for coronary angiography. Left ventricular end-diastolic pressure (LVEDP) was measured before any contrast exposure. Eighty-one patients with coronary artery disease were studied, and the group with high LVEDP (n = 40) showed increased left atrial volume index (22 ± 6 mL/m2 vs 26 ± 8.26 mL/m2 , P = 0.04), E-wave velocity (65 ± 15 cm/s vs 78 ± 20 cm/s, P = 0.02), E/e` (average) ratio (8.14 ± 2.0 vs 11.54 ± 2.7, P = 0.03), and E/global circumferential strain rate E peak ratio (E/GCSRE ) (39 cm vs 46 cm, P < 0.01). There was a positive correlation between LVEDP and E/e` (ρ = 0.56; P = 0.03), and between LVEDP and E/GCSRE ratio (ρ = 0.43; P < 0.01). The area under the receiver operating characteristics (ROC) curve was 0.83 and 0.73, respectively (P < 0.05). E/e` and E/GCSRE were both independent predictors of elevated LVEDP (P < 0.05), with a higher C-statistic for the model including E/e` (0.89 vs 0.85). CONCLUSION: The E/e` ratio was able to identify elevated LVEDP in CAD patients with preserved LVEF with more accuracy than the E/GCSRE ratio.

Progression and Prognosis of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation / Evolução e Prognóstico da Regurgitação Paravalvar Após Implante de Valva Aórtica Transcateter

Abstract Background: The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) remains uncertain. Objective: To evaluate the impact of PVR on mortality and hospital readmission one year after TAVI. Methods: Between January 2009 and June 2015, a total of 251 patients underwent TAVI with three different prostheses at two cardiology centers. Patients were assessed according to PVR severity after the procedure. Results: PVR was classified as absent/trace or mild in 92.0% (n = 242) and moderate/severe in 7.1% (n = 18). The moderate/severe PVR group showed higher levels of aortic calcification (22% vs. 6%, p = 0.03), higher serum creatinine (1.5 ± 0.7 vs. 1.2 ± 0.4 mg/dL, p = 0.014), lower aortic valve area (0.6 ± 0.1 vs. 0.7 ± 0.2 cm2, p = 0.05), and lower left ventricular ejection fraction (49.2 ± 14.8% vs. 58.8 ± 12.1%, p = 0.009). Patients with moderate/severe PVR had more need for post-dilatation (p = 0.025) and use of larger-diameter balloons (p = 0.043). At one year, all-cause mortality was similar in both groups (16.7% vs. 12%, p = 0.08), as well as rehospitalization (11.1% vs. 7.3%, p = 0.915). PVR grade significantly reduced throughout the first year after the procedure (p < 0.01). The presence of moderate/severe PVR was not associated with higher one-year mortality rates (HR: 0.76, 95% CI: 0.27-2.13, p = 0.864), rehospitalization (HR: 1.08, 95% CI: 0.25-4.69, p=0.915), or composite outcome (HR: 0.77, 95% CI: 0.28-2.13, p = 0.613). Conclusion: In this sample, moderate/severe PVR was not a predictor of long-term mortality or rehospitalization. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)

Resumo Fundamento: O impacto da regurgitação paravalvular (RPV) após implante de valva aórtica transcateter (TAVI) permanece incerto. Objetivo: Analisar o impacto da RPV na mortalidade e re-hospitalização 1 ano após o TAVI. Métodos: Entre janeiro de 2009 e junho de 2015, 251 pacientes foram submetidos ao TAVI em dois centros cardiológicos com 3 diferentes próteses. Os pacientes foram analisados de acordo com a gravidade da RPV pós-procedimento. Resultados: RPV foi classificada como ausente/mínima ou discreta em 92,0% (n=242) dos pacientes e moderada/grave em 7,1% (n = 18). Os pacientes com RPV moderada/importante apresentaram maior grau de calcificação aórtica (22,0% vs. 6,0%; p = 0,03), creatinina sérica (1,53 ± 0,71 vs. 1,18 ± 0,43 mg/dL; p = 0,01), menor área valvar aórtica (0,61 ± 0,12 vs. 0.69 ± 0,17 cm2; p = 0,05) e menor fração de ejeção do ventrículo esquerdo (49,17±14,79% vs. 58,82±12,14%; p = 0,009). Nos pacientes com RPV moderada/importante a necessidade de pós-dilatação foi maior (p = 0,025) e eventualmente com balão de diâmetro maior (p = 0,04). Ao final de 1 ano, a mortalidade por todas as causas foi similar em ambos os grupos (16,7% vs. 12,0%; p = 0,08), assim como re-hospitalização (11,1% vs. 7,3%; p = 0,91). O grau de RPV ao longo do primeiro ano reduziu progressivamente (p < 0,01). A presença de RPV moderada/importante não foi associada a maiores taxas de mortalidade em 1 ano [RR (risco relativo): 0,76; IC (intervalo de confiança) 95%: 0,27-2,13; p = 0,864)], re-hospitalização (RR: 1,08; IC 95%: 0,25-4,69; p = 0,915) ou desfecho combinado (RR: 0,77; IC 95%: 0,28-2,13; p = 0,61). Conclusões: Nesta amostra, a presença de regurgitação paravalvular moderada/importante não foi um preditor de mortalidade ou reinternação a longo prazo. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)

Progression and Prognosis of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation.

BACKGROUND: The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) remains uncertain. OBJECTIVE: To evaluate the impact of PVR on mortality and hospital readmission one year after TAVI. METHODS: Between January 2009 and June 2015, a total of 251 patients underwent TAVI with three different prostheses at two cardiology centers. Patients were assessed according to PVR severity after the procedure. RESULTS: PVR was classified as absent/trace or mild in 92.0% (n = 242) and moderate/severe in 7.1% (n = 18). The moderate/severe PVR group showed higher levels of aortic calcification (22% vs. 6%, p = 0.03), higher serum creatinine (1.5 ± 0.7 vs. 1.2 ± 0.4 mg/dL, p = 0.014), lower aortic valve area (0.6 ± 0.1 vs. 0.7 ± 0.2 cm2, p = 0.05), and lower left ventricular ejection fraction (49.2 ± 14.8% vs. 58.8 ± 12.1%, p = 0.009). Patients with moderate/severe PVR had more need for post-dilatation (p = 0.025) and use of larger-diameter balloons (p = 0.043). At one year, all-cause mortality was similar in both groups (16.7% vs. 12%, p = 0.08), as well as rehospitalization (11.1% vs. 7.3%, p = 0.915). PVR grade significantly reduced throughout the first year after the procedure (p < 0.01). The presence of moderate/severe PVR was not associated with higher one-year mortality rates (HR: 0.76, 95% CI: 0.27-2.13, p = 0.864), rehospitalization (HR: 1.08, 95% CI: 0.25-4.69, p=0.915), or composite outcome (HR: 0.77, 95% CI: 0.28-2.13, p = 0.613). CONCLUSION: In this sample, moderate/severe PVR was not a predictor of long-term mortality or rehospitalization. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0).

Primary Mitral Valve Regurgitation Outcome in Patients With Severe Aortic Stenosis 1 Year After Transcatheter Aortic Valve Implantation: Echocardiographic Evaluation / Evolução da Insuficiência Mitral Primária em Pacientes com Estenose Aórtica Grave 1 Ano Após Implante Transcateter de Valva Aórtica: Avaliação Ecocardiográfica Evolutiva

Abstract Background: Mitral valve regurgitation (MR), present in up to 74% of the patients with severe aortic stenosis (AS), can be a negative prognostic factor when moderate or severe. The outcome of MR after percutaneous transcatheter aortic valve implantation (TAVI) and predictors associated with that outcome have not been well established in the literature. Objective: To assess the outcome of primary MR in patients submitted to TAVI and to identify associated factors. Methods: Observational study of patients with symptomatic severe AS submitted to TAVI from January 2009 to April 2015 at two specialized centers. Echocardiographic outcome was assessed with data collected before and 1 year after TAVI. Results: Of the 91 patients with MR submitted to TAVI and followed up for at least 12 months, 67 (73.6%) had minimum/mild MR before the procedure and 24 (26.4%) had moderate/severe MR. Of those with minimum/mild MR, 62 (92.5%) had no change in the MR grade (p < 0.001), while 5 (7.5%) showed worsening. Of those with moderate/severe MR, 8 (33.3%) maintained the same grade and 16 (66.7%) improved it (p = 0.076). Patients with moderate/severe MR who improved MR grade had lower EuroSCORE II (p = 0.023) and STS morbidity (p = 0.027) scores, as compared to those who maintained the MR grade. Conclusion: MR grades change after TAVI. This study suggests a trend towards improvement in moderate/severe MR after TAVI, which was associated with lower preoperative risk scores.

Resumo Fundamentos: A insuficiência valvar mitral (IM), presente em até 74% dos pacientes com estenose aórtica (EA) grave, pode representar um fator prognóstico negativo quando moderada ou importante. A evolução da IM após implante percutâneo de valva aórtica transcateter (TAVI) e preditores associados a essa evolução não estão bem estabelecidos na literatura. Objetivos: Avaliar a evolução da IM primária em pacientes submetidos ao TAVI e identificar fatores associados a essa evolução. Métodos: Realizou-se um estudo observacional em pacientes com EA grave sintomática, submetidos ao TAVI no período de janeiro de 2009 a abril de 2015 em dois centros especializados. Foram avaliados desfechos ecocardiográficos com dados antes e 1 ano após a intervenção. Resultados: Dos 91 pacientes com IM que realizaram TAVI e tinham acompanhamento de pelo menos 12 meses, 67 (73,6%) apresentavam IM mínima ou discreta antes da realização do procedimento e 24 (26,4%), IM moderada ou grave. Entre os com IM mínima ou discreta, 62 (92,5%) não apresentaram mudança no grau de refluxo (p < 0,001) e 5 (7,5%) tiveram piora. Entre os com IM moderada ou grave, 8 (33,3%) permaneceram na mesma classe e 16 (66,7%) tiveram melhora (p = 0,076). Pacientes com IM moderada ou grave que melhoraram o grau de insuficiência apresentavam menores valores de EuroSCORE II (p = 0,023) e STS morbidade (p = 0,027), quando comparados aos que continuaram na mesma classe. Conclusão: Observou-se mudança significativa no grau de IM após realização de TAVI. Este estudo sugere uma tendência de melhora da IM moderada ou grave após TAVI, o que se associou a escores de risco pré-operatórios menos elevados.

Primary Mitral Valve Regurgitation Outcome in Patients With Severe Aortic Stenosis 1 Year After Transcatheter Aortic Valve Implantation: Echocardiographic Evaluation.

BACKGROUND:: Mitral valve regurgitation (MR), present in up to 74% of the patients with severe aortic stenosis (AS), can be a negative prognostic factor when moderate or severe. The outcome of MR after percutaneous transcatheter aortic valve implantation (TAVI) and predictors associated with that outcome have not been well established in the literature. OBJECTIVE:: To assess the outcome of primary MR in patients submitted to TAVI and to identify associated factors. METHODS:: Observational study of patients with symptomatic severe AS submitted to TAVI from January 2009 to April 2015 at two specialized centers. Echocardiographic outcome was assessed with data collected before and 1 year after TAVI. RESULTS:: Of the 91 patients with MR submitted to TAVI and followed up for at least 12 months, 67 (73.6%) had minimum/mild MR before the procedure and 24 (26.4%) had moderate/severe MR. Of those with minimum/mild MR, 62 (92.5%) had no change in the MR grade (p < 0.001), while 5 (7.5%) showed worsening. Of those with moderate/severe MR, 8 (33.3%) maintained the same grade and 16 (66.7%) improved it (p = 0.076). Patients with moderate/severe MR who improved MR grade had lower EuroSCORE II (p = 0.023) and STS morbidity (p = 0.027) scores, as compared to those who maintained the MR grade. CONCLUSION:: MR grades change after TAVI. This study suggests a trend towards improvement in moderate/severe MR after TAVI, which was associated with lower preoperative risk scores. FUNDAMENTOS:: A insuficiência valvar mitral (IM), presente em até 74% dos pacientes com estenose aórtica (EA) grave, pode representar um fator prognóstico negativo quando moderada ou importante. A evolução da IM após implante percutâneo de valva aórtica transcateter (TAVI) e preditores associados a essa evolução não estão bem estabelecidos na literatura. OBJETIVOS:: Avaliar a evolução da IM primária em pacientes submetidos ao TAVI e identificar fatores associados a essa evolução. MÉTODOS:: Realizou-se um estudo observacional em pacientes com EA grave sintomática, submetidos ao TAVI no período de janeiro de 2009 a abril de 2015 em dois centros especializados. Foram avaliados desfechos ecocardiográficos com dados antes e 1 ano após a intervenção. RESULTADOS:: Dos 91 pacientes com IM que realizaram TAVI e tinham acompanhamento de pelo menos 12 meses, 67 (73,6%) apresentavam IM mínima ou discreta antes da realização do procedimento e 24 (26,4%), IM moderada ou grave. Entre os com IM mínima ou discreta, 62 (92,5%) não apresentaram mudança no grau de refluxo (p < 0,001) e 5 (7,5%) tiveram piora. Entre os com IM moderada ou grave, 8 (33,3%) permaneceram na mesma classe e 16 (66,7%) tiveram melhora (p = 0,076). Pacientes com IM moderada ou grave que melhoraram o grau de insuficiência apresentavam menores valores de EuroSCORE II (p = 0,023) e STS morbidade (p = 0,027), quando comparados aos que continuaram na mesma classe. CONCLUSÃO:: Observou-se mudança significativa no grau de IM após realização de TAVI. Este estudo sugere uma tendência de melhora da IM moderada ou grave após TAVI, o que se associou a escores de risco pré-operatórios menos elevados.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold / Seguimento Muito Tardio de Pacientes após Intervenção Coronária Percutânea com Suporte Vascular Bioabsorvível Eluidor de Everolimus

Abstract Background: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. Objectives: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. Methods: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). Results: All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). Conclusions: In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary.

Resumo Fundamento: Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. Objetivos: Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. Métodos: Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). Resultados: Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos. A média de idade foi 56,8 ± 7,6 anos, sendo 71,4% da população estudada do sexo masculino e 26,5% composta por diabéticos. Considerando a apresentação clínica, a grande maioria (94%) tinha angina estável ou isquemia silenciosa. Obteve-se sucesso do dispositivo em 100% dos casos e do procedimento, em 96%. A taxa de eventos cardiovasculares maiores foi de 4% aos 30 dias, de 8,2% em 1 ano, e de 12,2% em 2 anos, sem mais eventos até 4,6 anos. Houve 2 casos de trombose (1 subaguda e 1 tardia) até o último seguimento. Conclusões: Nesta análise preliminar, o uso do SVB Absorb® mostrou-se seguro e eficaz no seguimento bastante tardio. Faz-se necessário estabelecer o perfil de eficácia e segurança destes dispositivos em cenários de maior complexidade.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

BACKGROUND:: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. OBJECTIVES:: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. METHODS:: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). RESULTS:: All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). CONCLUSIONS:: In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. FUNDAMENTO:: Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. OBJETIVOS:: Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. MÉTODOS:: Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). RESULTADOS:: Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos. A média de idade foi 56,8 ± 7,6 anos, sendo 71,4% da população estudada do sexo masculino e 26,5% composta por diabéticos. Considerando a apresentação clínica, a grande maioria (94%) tinha angina estável ou isquemia silenciosa. Obteve-se sucesso do dispositivo em 100% dos casos e do procedimento, em 96%. A taxa de eventos cardiovasculares maiores foi de 4% aos 30 dias, de 8,2% em 1 ano, e de 12,2% em 2 anos, sem mais eventos até 4,6 anos. Houve 2 casos de trombose (1 subaguda e 1 tardia) até o último seguimento. CONCLUSÕES:: Nesta análise preliminar, o uso do SVB Absorb® mostrou-se seguro e eficaz no seguimento bastante tardio. Faz-se necessário estabelecer o perfil de eficácia e segurança destes dispositivos em cenários de maior complexidade.

Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments / Regurgitação Paravalvar: Análise de Desfechos Clínicos no Tratamento Cirúrgico e Percutâneo

Abstract Background: Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. Objectives: To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. Methods: This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. Results: The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). Conclusion: Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.

Resumo Fundamento: Regurgitação ou escape paravalvar é uma complicação grave e incomum associada ao implante de prótese valvar. Estudos mostram incidência de 3% a 6% com repercussão hemodinâmica. Existem poucos estudos na literatura que comparam as abordagens cirúrgica e percutânea para sua correção. Objetivos: Comparar as abordagens cirúrgica e percutânea de correção da regurgitação paravalvar quanto a desfechos clínicos durante a internação e após 1 ano do procedimento. Métodos: Este é um estudo retrospectivo, descritivo e observacional, que incluiu 35 pacientes com escape paravalvar acompanhados no Instituto Dante Pazzanese de Cardiologia entre janeiro de 2011 e dezembro de 2013 e que necessitaram de correção. Os pacientes foram divididos de acordo com o tratamento estabelecido e acompanhados por um período 1 ano após o procedimento. Resultados: O grupo submetido ao tratamento percutâneo foi considerado como de maior risco para complicações por apresentar pacientes mais idosos, com maior prevalência de diabetes, maior quantidade de cirurgias valvares prévias e menor valor médio de clearance de creatinina. Durante a evolução intra-hospitalar, observou-se grande número de complicações nos dois grupos (74,3% dos casos), sem diferença estatística nos desfechos analisados. Após 1 ano, o grupo percutâneo teve maior número de reintervenções (8,7% vs. 20%, p = 0,57) e mortalidade maior (0% vs. 20%, p = 0,08). Uma alta incidência de escape residual mitral foi verificada após procedimento percutâneo (8,7% vs. 50%, p = 0,08). Conclusão: A cirurgia é o tratamento de escolha da regurgitação paravalvar. A abordagem percutânea pode ser uma alternativa para os pacientes com risco cirúrgico elevado.

Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments.

BACKGROUND: Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. OBJECTIVES: To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. METHODS: This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. RESULTS: The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). CONCLUSION: Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.

Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients.

BACKGROUND: Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy. METHODS: ARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair. RESULTS: Enrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014. CONCLUSIONS: The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01653587.

Randomized comparison of distal and proximal cerebral protection during carotid artery stenting.

OBJECTIVES: This study sought to randomly compare cerebral protection with ANGIOGUARD (Cordis Corporation, Bridgewater, New Jersey) with Mo.Ma (Invatec/Medtronic Vascular Inc, Santa Rosa, California) during carotid artery stenting (CAS), using diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic cerebral lesions. The number, size, and location of lesions were analyzed. BACKGROUND: The choice of the type of cerebral protection during CAS is controversial. METHODS: From July 2008 to July 2011, 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma, distributed by chance, 30 patients for each group. All patients underwent DW-MRI before and after CAS. An independent neuroradiologist blinded to the cerebral protection used analyzed the images. Univariate and multivariate logistic models were fitted to analyze new ischemic lesions. Alternatively, a propensity score approach was used to reduce the bias due to differences between the groups. For the number of lesions, we used Poisson regression models. RESULTS: New ischemic lesions seen on DW-MRI were present in 63.3% of the ANGIOGUARD group versus 66.7% of the Mo.Ma cohort (p = 0.787). The number of ischemic cerebral lesions per patient, when present, was significantly lower in the Mo.Ma group (a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD, p < 0.001). Most lesions were small (<0.5 mm) and localized in the ipsilateral territory. One patient in the ANGIOGUARD group had a minor stroke during CAS (1.66%). CONCLUSIONS: New ischemic lesions seen on DW-MRI were present in both groups in >60%, but the number of lesions per patient was greater in the ANGIOGUARD group. No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts.

Safety and efficacy of biolimus-eluting stent with biodegradable polymer: insights from EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) Registry.

OBJECTIVE: To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients. METHODS: The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer. RESULTS: The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up. CONCLUSION: The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.

Segurança e eficácia dos stents farmacológicos eluidores de biolimus com polímero biodegradável: análise do registro EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) / Safety and efficacy of biolimus-eluting stent with biodegradable polymer: insights from EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) Registry

OBJETIVO: Avaliar a incidência de eventos adversos cardíacos maiores (morte cardíaca, infarto agudo do miocárdio ou necessidade de nova revascularização do vaso-alvo) em 1 ano em pacientes do "mundo real". MÉTODOS: O registro EINSTEIN é um estudo observacional prospectivo, unicêntrico, que incluiu consecutivamente 103 pacientes (152 lesões) tratados com o stent BiomatrixTM, eluidor de biolimus A9 e polímero biodegradável. RESULTADOS: A média das idades foi de 65,0±12,4 anos; o gênero masculino representou 83,5% dos pacientes; e 37,9% deles eram diabéticos. Em 1 ano, eventos adversos cardíacos maiores ocorreram em 11,7% dos pacientes, incluindo 2,9% de morte cardíaca, 4,9% de infarto agudo do miocárdio sem supradesnivelamento do segmento ST e 3,9% de revascularização do vaso-alvo. Trombose de stent esteve presente em apenas 1% (1 paciente) após o seguimento clínico de 1 ano. CONCLUSÃO: O presente registro sugere que os novos stents farmacológicos eluidores de biolimus A9 com polímero biodegradável são seguros e eficazes em pacientes da prática clínica diária, com baixas taxas de eventos adversos cardíacos maiores no longo prazo.

OBJECTIVE: To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients. METHODS: The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer. RESULTS: The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up. CONCLUSION: The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.