Gender-related differences on short- and long-term outcomes of patients undergoing transcatheter aortic valve implantation

OBJECTIVES: This study aimed to compare gender-related differences in outcomes of patients undergoing TAVI over a long-term follow-up period.BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been considered the standard therapy for patients with inoperable or high-risk symptomatic aortic stenosis. The influence of gender-related differences in outcomes of patients undergoing TAVI is currently on debate.METHODS: From January 2008 to January 2015, 819 patients (49% men) underwent TAVI and were included in a multicenter Brazilian registry. Patients were followed-up and clinical outcomes were evaluated according to the updated Valve Academic Research Consortium-2 criteria. RESULTS: Mean follow-up was 497 ± 478 days. Compared with women, men had a lower rate of major or life-threatening bleeding (12.0% vs. 20.6%; HR = 0.57 [95CI% 0.40-0.81]; P = 0.001), and major vascular complications (6% vs. 11.7%; HR = 0.50 [95CI% 0.31-0.82]; P = 0.004). At 30 days, all-cause mortality was lower in men than in women (6.5% vs. 11.5%; P = 0.013), however, cumulative all-cause mortality was similar between groups (25.9% vs. 29.7%, men and women, respectively, HR = 0.92 [95CI% 0.71-1.19]; P = 0.52) over the entire follow-up period. By adjusted Cox regression model, renal function, diabetes, peripheral artery disease, and chronic obstructive pulmonary disease (COPD) remained independently predictors of all-cause mortality...

Predictors and impact of myocardial injury after transcatheter aortic valve replacement: a multicenter registry.

BACKGROUND: Cardiac biomarker release signifying myocardial injury post-transcatheter aortic valve replacement (TAVR) is common, yet its clinical impact within a large TAVR cohort receiving differing types of valve and procedural approaches is unknown. OBJECTIVES: This study sought to determine the incidence, clinical impact, and factors associated with cardiac biomarker elevation post TAVR. METHODS: This multicenter study included 1,131 consecutive patients undergoing TAVR with balloon-expandable (58%) or self-expandable (42%) valves. Transfemoral and transapical (TA) approaches were selected in 73.1% and 20.3% of patients, respectively. Creatine kinase-myocardial band (CK-MB) measurements were obtained at baseline and at several time points within the initial 72 h post TAVR. Echocardiography was performed at baseline and at 6- to 12-month follow-up. RESULTS: Overall, 66% of the TAVR population demonstrated some degree of myocardial injury as determined by a rise in CK-MB levels (peak value: 1.6-fold [interquartile range (IQR): 0.9 to 2.8-fold]). A TA approach and major procedural complications were independently associated with higher peak of CK-MB levels (p < 0.01 for all), which translated into impaired systolic left ventricular function at 6 to 12 months post TAVR (p < 0.01). A greater rise in CK-MB levels independently associated with an increased 30-day, late (median of 21 [IQR: 8 to 36] months) overall and cardiovascular mortality (p < 0.001 for all). Any increase in CK-MB levels was associated with poorer clinical outcomes, and there was a stepwise rise in late mortality according to the various degrees of CK-MB increase after TAVR (p < 0.001). CONCLUSIONS: Some degree of myocardial injury was detected in two-thirds of patients post TAVR, especially in those undergoing TA-TAVR or presenting with major procedural complications. A greater rise in CK-MB levels associated with greater acute and late mortality, imparting a negative impact on left ventricular function.

Aterectomia rotacional em artérias com calcificação extrema ou falha em dilatação prévia: aspectos técnicos e evolução tardia após intervenção coronária percutânea / Rotational atherectomy in arteries with extreme calcification or previous failed dilation: technical aspects and late outcomes after percutaneous coronary intervention

A aterectomia rotacional com incorporação de novas estratégias ablativas tem sido proposta para o preparo de lesões extremamente calcificadas. Entretanto, pouco se conhece a respeito da adoçãodessas novas estratégias na prática contemporânea e sobre a evolução tardia dos pacientes submetidos aesse tratamento. Objetivamos avaliar os aspectos técnicos da aterectomia e a evolução tardia dos pacientesquanto à ocorrência de eventos cardiovasculares adversos maiores (ECAM). Métodos: Estudo retrospectivo e unicêntrico, incluindo todos os pacientes submetidos à aterectomiarotacional como parte do tratamento de lesões coronárias com calcificação extrema ou falha de dilataçãoem procedimento prévio, no período de julho de 2012 a novembro de 2014. Foram definidos como ECAM: óbito, infarto agudo do miocárdio com onda Q ou nova revascularização do vaso-alvo.Resultados: Foram submetidos à aterectomia 29 pacientes com idade média de 69,5 ± 7,6 anos. A médiada relação oliva/vaso foi de 0,54 ± 0,07; a velocidade de rotação inicial adotada foi de 161.000 ± 13.928 e a taxa de utilização de cutting balloon pós-aterectomia foi de 45,1%. Sucesso angiográfico foi obtido em todos os procedimentos. Na evolução tardia, a mediana de tempo de seguimento foi de 13,2 meses (intervalo interquartil: 4,0 a 17,4 meses). Foram registrados um óbito por causa não cardíaca e duas novas revascularizações do vaso-alvo. A média do tempo de sobrevivência livre de ECAM foi de 29,7 ± 2,1 meses.Conclusões: A aterectomia rotacional contemporânea incorporou estratégias menos agressivas de ablação,com elevada taxa de sucesso imediato e baixa ocorrência de ECAM na evolução tardia...

Rotational atherectomy with new ablative strategies have been proposed for the treatment of extremely calcified lesions prior to stent implantation. Nevertheless, few data are available about the adoption of these new strategies in contemporary practice and about late outcomes of patients undergoing this therapy. Methods: From July 2012 to November 2014, a retrospective single center registry was conducted, including all patients undergoing rotational atherectomy as part of the treatment of coronary arteries with heavy calcification or previous failed dilation. We evaluated technical aspects of atherectomy and late outcomes of patients for the occurrence of major adverse cardiovascular events (MACE), defined as death, Q-wave myocardial infarction or repeat target vessel revascularization.Results: Twenty-nine patients with a mean age of 69.5 ± 7.6 years, underwent atherectomy. The averageburr-to-artery ratio was 0.54 ± 0.07, the initial rotational speed was 161.000 ± 13.928 and the rate of cuttingballoon utilization after atherectomy was 45.1%. Angiographic success was achieved in all procedures. The median follow-up time was 13.2 months (IQ: 4.0-17.4) and there were three events: 1 death of non cardiac cause and 2 new target vessel revascularizations. The mean MACE-free survival time was 29.7 ± 2.1 months. Conclusions: Contemporary rotational atherectomy incorporates less aggressive strategies of ablation with high rates of acute success and low occurrence of major adverse cardiovascular events during late follow-up...

Late cardiac death in patients undergoing transcatheter aortic valve replacement: incidence and predictors of advanced heart failure and sudden cardiac death.

BACKGROUND: Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR. METHODS: The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2. RESULTS: At a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006). CONCLUSIONS: Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.

Late cardiac death in patients undergoing transcatheter aortic valve replacement

BACKGROUND Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valvereplacement (TAVR).OBJECTIVES The purpose of this study was to assess the incidence and predictors of cardiac death from advancedheart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR.METHODS The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable(43%) valves. Causes of death were defined according to the Valve Academic Research Consortium–2.RESULTS At a mean follow-up of 22 18 months, 155 patients had died due to advanced HF (15.2% of total deaths,46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baselinecomorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction #40%, lowermean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p 160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p » 0.006).CONCLUSIONS Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR.Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future.

Tendências da Utilização da Via de Acesso Transradial em Mais de Uma Década: A Experiência do InCor / Trends in the Use of the Transradial Approach in More Than a Decade: The InCor's Experience

Introdução: A utilização da via radial para a realização de cateterismo cardíaco diagnóstico e intervenção coronária percutânea varia entre os diversos centros de hemodinâmica. Descrevemos as tendências do uso dessa via de acesso ao longo dos últimos 14 anos num serviço terciário. Métodos: Foram identificados procedimentos coronarianos consecutivos realizados de 1999 a 2013, em um único centro, em pacientes com idade ≥ 35 anos. Dados como idade, sexo, fonte provedora de recursos (Sistema de Saúde Público ou Saúde Suplementar/Privado) e complexidade do procedimento (diagnóstico ou terapêutico) foram retrospectivamente analisados. Resultados: Foram incluídos 103.253 procedimentos, dos quais o Sistema Único de Saúde (SUS) foi o provedor de recursos em 77% dos casos. A média de idades dos pacientes foi 62,2 ± 11,3 e 58,8% eram do sexo masculino. A via radial foi utilizada em 6.402 (6,2%) dos procedimentos, apresentando ascensão significativa ao longo do tempo, mais evidente quando analisada comparativamente nos seis períodos de experiência do serviço: 0,2%, 0,6%, 3,1%, 2,1%, 6,9% e 24,4%, respectivamente (p < 0,01). Porcentuais ainda maiores do uso da via radial foram encontrados, restringindo-se aos procedimentos realizados pelo SUS e quando apenas os cateterismos cardíacos diagnósticos foram contabilizados. Houve também mudança no perfil da via de acesso, ainda que de menor monta, no setor de Saúde Suplementar/Privado. Conclusões: Demonstramos a progressiva modificação do perfil de utilização das vias de acesso para a realização de cateterismo cardíaco diagnóstico e intervenção coronária percutânea de um centro de grande porte ao longo do tempo. Esses dados são condizentes...

Background: The use of the radial approach for diagnostic cardiac catheterization and percutaneous coronary interventions varies among different interventional cardiology centers in the world. We describe the trends in the use of this approach over the past 14 years at a tertiary hospital. Methods: Consecutive coronary procedures performed from 1999 to 2013 at a single center, in patients aged ≥ 35 years were identified. Age, gender, resource provider (Public or Private Healthcare System) and the complexity of the procedure (diagnostic or therapeutic) were retrospectively analyzed. Results: 103,253 procedures were included. The Brazilian Public Healthcare Service (SUS - Sistema Único de Saúde) was the resource provider in 77% of the cases. Mean age of patients was 62.2 ± 11.3 years and 58% were male. The radial approach was used in 6,402 (6.2%) procedures, showing a significant rise over time, which was more evident when analyzed comparatively for the six timepoints of service experience: 0.2%; 0.6%; 3.1%; 2.1%; 6.9%, and 24.4% respectively (p < 0.01). Even larger percentages of radial approach were observed when only the procedures performed by the SUS and diagnostic cardiac catheterizations were taken into account. There were also changes in the profile of vascular access, even though smaller, in the Private Healthcare System. Conclusions: We demonstrated progressive changes in the profile of the use of access routes for diagnostic cardiac catheterization and percutaneous coronary interventions at a large center over time. These data are consistent with the global trend and are significantly robust, especially when the last sextile is analyzed...

Remoção Precoce do Introdutor Arterial Após Intervenção Coronária Percutânea por Via Femoral: Estudo de Segurança e Eficácia / Early Removal of the Arterial Sheath After Percutaneous Coronary Intervention Using the Femoral Approach: Safety and Efficacy Study

Introdução: Avaliamos a segurança e eficácia do uso de protamina, guiada pelo tempo de coagulação ativado, para a remoção imediata do introdutor arterial femoral em pacientes submetidos à intervenção coronária percutânea com heparina não fracionada, com o objetivo de propor um algoritmo para a prática clínica. Métodos: Estudo prospectivo, com pacientes consecutivos, com angina estável ou com síndrome coronariana aguda de baixo ou moderado risco. Comparamos os pacientes com a retirada precoce do introdutor arterial àqueles nos quais o introdutor foi retirado de acordo com o protocolo convencional. A decisão pela remoção precoce ou convencional do introdutor foi deixada a critério do operador. Resultados: O grupo de remoção precoce (n = 149) apresentou menor tempo de manuseio do sítio de punção que o grupo de remoção convencional (58,3 ± 21,4 minutos vs. 355 ± 62,9 minutos; p < 0,01), principalmente devido à redução do tempo até a retirada do introdutor (42,3 ± 21,1 minutos vs. 338,6 ± 61,5 minutos; p < 0,01), sem impacto sobre a duração da compressão femoral (16,0 ± 3,6 minutos vs. 16,4 ± 5,1 minutos; p = 0,49). Não houve trombose hospitalar de stent e nem diferença significativa na incidência de eventos vasculares ou hemorrágicos. A incidência de outras hemorragias, que levaram à hospitalização prolongada, foi menor no grupo de remoção precoce (1,3% vs. 5,1%; p = 0,05). Conclusões: O uso seletivo de uma abordagem, para a remoção imediata do introdutor femoral guiada pelo tempo de coagulação ativado e a administração de protamina, é seguro e eficaz em pacientes submetidos à intervenção coronária...

Introduction: We evaluated the safety and efficacy of protamine administration, guided by activated clotting time, for the immediate femoral arterial sheath removal in patients undergoing percutaneous coronary intervention with unfractionated heparin in order to propose an algorithm for clinical practice. Methods: Prospective study with consecutive patients with stable angina or low-to-moderate risk acute coronary syndrome. We compared patients with an early removal of the arterial sheath to those whose sheath removal was based on a standard protocol. Results: The early removal group (n = 149) had lower access manipulation time than the conventional group (58.3 ± 21.4 minutes vs. 355.0 ± 62.9 minutes; p < 0.01), mainly due to a reduced time to sheath removal (42.3 ± 21.1 minutes vs. 338.6 ± 61.5 minutes; p < 0.01), with no impact on the duration of femoral compression (16.0 ± 3.6 minutes vs. 16.4 ± 5.1 minutes; p = 0.49). There was no stent thrombosis during hospitalization and no significant differences in the incidence of major vascular or bleeding events. The incidence of other bleeding events leading to a prolonged in-hospital length of stay was lower in the early removal group (1.3% vs. 5.1%; p = 0.05). Conclusions: The selective use of an approach for immediate femoral sheath removal, based on activated clotting time guidance and protamine administration, is a safe and effective option in patients undergoing percutaneous coronary intervention by femoral access...

Dissecção Espontânea de Artéria Coronária: Abordagem Terapêutica e Desfechos de Uma Série Consecutiva de Casos / Spontaneous Coronary Artery Dissection: Therapeutic Approach and Outcomes of a Consecutive Series of Cases

Introdução: A dissecção espontânea de artéria coronária é causa rara de síndrome coronariana aguda e, em mais de 70% das vezes, o diagnóstico é feito por meio de necrópsia. O tratamento ideal ainda é incerto, sendo a intervenção coronária percutânea, a cirurgia de revascularização miocárdica e o tratamento clínico as opções terapêuticas. O objetivo deste trabalho foi avaliar as características clínicas, o tratamento e a evolução de uma série de casos de dissecção espontânea de artéria coronária. Métodos: Estudo retrospectivo, unicêntrico, baseado em análise de banco de dados de um serviço de alta complexidade em cardiologia. Resultados: Identificamos 25 pacientes com dissecção espontânea de artéria coronária, dos quais 56% eram do sexo feminino, com idade de 48,8 ± 10 anos. Apenas 24% não apresentaram fator de risco para aterosclerose e, em 92% dos casos, o quadro clínico foi de síndrome coronária aguda. A artéria descendente anterior foi o vaso mais acometido (48%) e houve apenas um caso envolvendo múltiplos vasos. A estratégia conservadora foi realizada em 56%, a intervenção coronária percutânea em 40% e a revascularização miocárdica em 4%. A taxa livre de eventos hospitalares e tardios foi de 92 e 84,2%, respectivamente. Conclusões: A dissecção espontânea de artéria coronária foi predominante em mulheres jovens, com pelo menos um fator de risco para doença arterial coronariana. A escolha de diferentes estratégias terapêuticas confirma a natureza ainda controversa da abordagem ideal da dissecção espontânea de artéria coronária. Acreditamos que o tratamento ideal ainda seja o individualizado.

Background: Spontaneous coronary artery dissection is a rare cause of acute coronary syndrome and diagnosis is made by necropsy in more than 70% of the cases. Optimal treatment is still uncertain, and the treatment options are percutaneous coronary intervention, coronary artery bypass surgery and medical therapy. The objective of this study was to evaluate the clinical characteristics, treatment modalities and outcome of a series of cases with spontaneous coronary artery dissection. Methods: Retrospective, single-center study, based on the analysis of the database at a high-complexity cardiology service. Results: We identified 25 patients with spontaneous coronary artery dissection, 56% were female, with a mean age of 48.8 ± 10 years. Only 24% had no risk factor for atherosclerosis and in 92% of the cases, the clinical presentation was of acute coronary syndrome. The left anterior descending artery was the most commonly affected vessel (48,1%) and there was only one case involving multiple vessels. The conservative approach was used in 56%, percutaneous coronary intervention in 40% and coronary artery bypass grafting in 4%. The in-hospital and late event-free survival was 92% and 84.2%, respectively. Conclusions: Spontaneous coronary artery dissection predominated in young women, with at least one risk factor for coronary artery disease. The choice of different therapeutic strategies confirms the still controversial nature of the optimal approach for spontaneous coronary artery dissection. We believe that individualized therapy is still the optimal modality.

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.

Effect of implementing an acute myocardial infarction guideline on quality indicators.

OBJECTIVE: To evaluate the compliance rates to quality of care indicators along the implementation of an acute myocardial infarction clinical practice guideline. METHODS: A clinical guideline for acute myocardial infarction was introduced on March 1st, 2005. Patients admitted for acute myocardial infarction from March 1st, 2005 to December 31st, 2012 (n=1,431) were compared to patients admitted for acute myocardial infarction before the implementation of the protocol (n=306). Compliance rates to quality of care indicators (ASA prescription on hospital admission and discharge, betablockers on discharge and door-to-balloon time) as well as the length of hospital stay and in-hospital mortality were compared before and after the implementation of the clinical guideline. RESULTS: The rates of ASA prescription on admission, on discharge and of betablockers were higher after guideline implementation: 99.6% versus 95.8% (p<0.001); 99.1% versus 95.8% (p<0.001); and 95.9% versus 81.7% (p<0.001), respectively. ASA prescription rate increased over time, reaching 100% from 2009 to 2012. Door-to-balloon time after versus before implementation was of 86(32) minutes versus 93(51) (p=0.20). The length of hospital stay after the implementation versus before was of 6(6) days versus 6(4) days (p=0.34). In-hospital mortality was 7.6% (before the implementation), 8.7% between 2005 and 2008, and 5.3% between 2009 and 2012, (p=0.04). CONCLUSION: The implementation of an acute myocardial infarction clinical practice guideline was associated with an increase in compliance to quality of care indicators.

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.

Efeito da implementação de um protocolo assistencial de infarto agudo do miocárdio sobre os indicadores de qualidade / Effect of implementing an acute myocardial infarction guideline on quality indicators

OBJETIVO: Avaliar a adesão aos indicadores de qualidade assistencial ao longo da implementação de um protocolo assistencial de infarto agudo do miocárdio. MÉTODOS: Em 1º de março de 2005 foi implementado o protocolo assistencial de infarto agudo do miocárdio. Foram selecionados pacientes admitidos de 1ºde março de 2005 a 31 de dezembro de 2012 (n=1.431). Para comparação, utilizamos os dados de pacientes admitidos por infarto na fase pré-protocolo (n=306). Comparamos a taxa de adesão aos indicadores (taxa de prescrição de AAS na admissão hospitalar e na alta hospitalar, betabloqueador na alta e tempo porta-balão) entre as fases pré e pós-implementação do protocolo, além de tempo de permanência hospitalar e mortalidade intra-hospitalar nas diferentes fases. RESULTADOS: As taxas de prescrição de AAS na admissão e na alta hospitalar, e de betabloqueador foram maiores na fase pós versus a pré-implementação do protocolo: 99,6% versus 95,8% (p<0,001); 99,1% versus 95,8% (p<0,001) e 95,9% versus 81,7% (p<0,001), respectivamente. A taxa de prescrição de AAS aumentou ao longo da implementação do protocolo, atingindo 100% de 2009 a 2012. O tempo porta-balão pós versus pré foi de 86(32) minutos versus 93(51), respectivamente (p=0,20). O tempo de permanência hospitalar foi semelhante na fase pré versus pós-protocolo: 6(6) dias versus 6(4) dias (p=0,34). A mortalidade intra-hospitalar foi de 7,6% no pré-protocolo, 8,7% entre 2005 e 2008 e 5,3% entre 2009 e 2012 (p=0,04). CONCLUSÃO: A implementação do protocolo assistencial refletiu-se na maior adesão aos indicadores de qualidade.

OBJECTIVE: To evaluate the compliance rates to quality of care indicators along the implementation of an acute myocardial infarction clinical practice guideline. METHODS: A clinical guideline for acute myocardial infarction was introduced on March 1st, 2005. Patients admitted for acute myocardial infarction from March 1st, 2005 to December 31st, 2012 (n=1,431) were compared to patients admitted for acute myocardial infarction before the implementation of the protocol (n=306). Compliance rates to quality of care indicators (ASA prescription on hospital admission and discharge, betablockers on discharge and door-to-balloon time) as well as the length of hospital stay and in-hospital mortality were compared before and after the implementation of the clinical guideline. RESULTS: The rates of ASA prescription on admission, on discharge and of betablockers were higher after guideline implementation: 99.6% versus 95.8% (p<0.001); 99.1% versus 95.8% (p<0.001); and 95.9% versus 81.7% (p<0.001), respectively. ASA prescription rate increased over time, reaching 100% from 2009 to 2012. Door-to-balloon time after versus before implementation was of 86(32) minutes versus 93(51) (p=0.20). The length of hospital stay after the implementation versus before was of 6(6) days versus 6(4) days (p=0.34). In-hospital mortality was 7.6% (before the implementation), 8.7% between 2005 and 2008, and 5.3% between 2009 and 2012, (p=0.04). CONCLUSION: The implementation of an acute myocardial infarction clinical practice guideline was associated with an increase in compliance to quality of care indicators.

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry.

OBJECTIVES: This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND: Very little data exist on CO following TAVI. METHODS: This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS: Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS: Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Injeção de trombina guiada por ultrassom no tratamento de pseudoaneurisma da artéria femoral após procedimento percutâneo em pacientes com síndrome coronária aguda / Ultrasound-guided thrombin injection in the treatment of femoral artery pseudoaneurysm after percutaneous procedures in patients with acute coronary syndrome

INTRODUÇÃO: A injeção de trombina guiada por ultrassom (IT) é uma opção para o tratamento de pseudoaneurisma da artéria femoral. No entanto, o resultado dessa técnica em pacientes com síndrome coronária aguda (SCA) pode ser comprometido pelo uso de medicações antitrombóticas. Também, o extravasamento de trombina para a circulação sistêmica pode causar aumento de eventos tromboembólicos. MÉTODOS: Foram selecionados todos os pacientes admitidos com SCA que apresentaram pseudoaneurisma da artéria femoral após procedimento percutâneo, tratados com IT, entre janeiro de 2007 e julho de 2011. Características clínicas e laboratoriais, resultado do tratamento e complicações foram avaliados. RESULTADOS: Analisamos 23 pacientes, com idade de 67,1 ± 14,2 anos, 60,9% eram do sexo feminino, com índice de massa corporal de 28,4 ± 4,7 kg/m², e 52,2% eram diabéticos. À apresentação, 87% tinham SCA sem supradesnivelamento do segmento ST e o restante, infarto do miocárdio com supradesnivelamento do segmento ST. Entre os pacientes avaliados, 70% foram submetidos a intervenção coronária percutânea. Todos os pacientes estavam em uso de ácido acetilsalicílico, 78,3% utilizaram inibidores da P2Y12 e 39,1%, inibidores da glicoproteína IIb/IIIa. A IT foi eficaz em ocluir o pseudoaneurisma em 100% dos casos (96,7% após a primeira injeção), sem embolia distal, infecção local ou necessidade de correção cirúrgica em nenhum caso. Não houve infarto, acidente vascular cerebral ou revascularização não-programada. Houve um óbito por choque cardiogênico, 22 dias após a IT, no segundo dia após cirurgia eletiva de revascularização miocárdica. CONCLUSÕES: O tratamento de pseudoaneurisma da artéria femoral com IT é um método seguro e eficaz em pacientes com SCA.

BACKGROUND: Ultrasound-guided thrombin injection (TI) is an option for the treatment of femoral artery pseudoaneurysm. Nevertheless, the result of this technique in patients with acute coronary syndrome (ACS) may be compromised by the use of antithrombotic drugs. In addition, thrombin extravasation to systemic circulation could potentially cause an increase in thromboembolic events. METHODS: Patients admitted with ACS who developed femoral artery pseudoaneurysm after a percutaneous procedure and treated by TI between January 2007 and July 2011 were included. Clinical and laboratory characteristics, treatment results and complications were evaluated. RESULTS: We evaluated 23 patients with mean age of 67.1 ± 14.2 years, 60.9% were women, with body mass index of 28.4 ± 4.7 kg/m² and 52.2% were diabetics. At presentation, 87% had non-ST elevation ACS and the remaining had ST elevation myocardial infarction. Of the evaluated patients, 70% were submitted to percutaneous coronary intervention. All patients were receiving aspirin, 78.3% used P2Y12 inhibitors and 39.1% used glycoprotein IIb/IIIa inhibitors. TI was successful in occluding the pseudoaneurysm in 100% of cases (96.7% after the first injection), without distal embolization, local infection or need of surgical correction. There were no cases of myocardial infarction, stroke or unscheduled revascularization. There was one death due to cardiogenic shock 22 days after TI, on the second post-operative day after an elective coronary artery bypass graft surgery. CONCLUSIONS: Treatment of femoral artery pseudoaneurysm by TI is a safe and effective procedure in patients with ACS.

Valvuloplastia aórtica por cateter balão na estenose aórtica degenerativa: impacto terapêutico em pacientes em condição clínica in extremis / Balloon aortic valvuloplasty in degenerative aortic stenosis: therapeutic impact on patients in extremis

INTRODUÇÃO: A valvuloplastia aórtica por cateter balão (VAB) é utilizada como estratégia paliativa em pacientes inelegíveis tanto para troca valvar cirúrgica quanto para implante valvar aórtico transcateter, ou como ponte para essas modalidades de tratamento. Não se sabe o impacto terapêutico da VAB quando realizada como medida de salvamento para pacientes em condições clínicas extremas (in extremis). MÉTODOS: Foram analisados pacientes com estenose aórtica grave de etiologia degenerativa submetidos à VAB entre julho de 2008 e janeiro de 2013. Os pacientes foram divididos entre o grupo in extremis (definido pela presença de duas ou mais das seguintes disfunções orgânicas: ventilação mecânica, instabilidade hemodinâmica, terapia renal dialítica, coagulopatia ou disfunção hepática graves) e o grupo controle, que incluiu os demais pacientes. RESULTADOS: Um total de 19 pacientes realizaram VAB no período. A condição clínica in extremis esteve presente em 42,1%. Os pacientes do grupo in extremis tiveram EUROSCORE II mais elevado (41,1 ± 24,7 vs. 15,9 ± 14,0; P = 0,01) e fração de ejeção do VE mais baixa que o grupo controle (33,9 ± 17,3% vs. 49,0 ± 12,5%; P = 0,04). Nenhum paciente do grupo in extremis sobreviveu ao período intra-hospitalar, enquanto que, no grupo controle, a mortalidade foi de 27,3% (P < 0,01). CONCLUSÕES: Para o tratamento de pacientes com estenose aórtica grave de etiologia degenerativa, a VAB tem resultado desfavorável quando indicada para pacientes com duas ou mais disfunções orgânicas, ou seja, em condição clínica in extremis.

BACKGROUND: Balloon aortic valvuloplasty (BAV) is used as a palliative strategy in patients who are not eligible for valve replacement surgery, transcatheter aortic valve implantation, or as a bridge to these treatment modalities. The impact of BAV as a salvage procedure for patients in extreme clinical conditions (in extremis) is unknown. METHODS: Patients with severe degenerative aortic stenosis undergoing BAV between July 2008 and January 2013 were evaluated. Patients were divided into the in-extremis group (defined by the presence of two or more of the following organ dysfunctions: mechanical ventilation, hemodynamic instability, dialysis, coagulopathy or severe hepatic dysfunction) and the control group, which included the remaining patients. RESULTS: A total of 19 patients underwent BAV. The clinical condition in-extremis was present in 42.1% of them. Patients from the in-extremis group had a higher EUROSCORE II (41.1 ± 24.7 vs. 15.9 ± 14.0; P = 0.001) and LV ejection fraction lower than the control group (33.9 ± 17.3% vs. 49.0 ± 12.5; P = 0.04). None of the patients in the in-extremis group survived past the hospitalization period, whereas the control group mortality was 27.3% (P < 0.01). CONCLUSIONS: BAV has an unfavorable result in patients with severe degenerative aortic stenosis with two or more organ dysfunctions, that is, patients in extremis.

Influência da localização das lesões nos desfechos clínicos tardios após intervenção coronária percutânea em enxertos de veia safena / Influence of lesion location on late clinical outcomes after percutaneous coronary intervention in saphenous vein grafts

INTRODUÇÃO: A evolução tardia de pacientes submetidos à intervenção coronária percutânea em enxertos de veia safena (ICP-Saf) é pouco discutida na literatura, havendo, inclusive, controvérsias sobre a influência da localização da estenose (em posição aorto-ostial ou no corpo do enxerto). MÉTODOS: Registro unicêntrico, que incluiu pacientes submetidos à ICP-Saf, entre os anos de 2006 e 2011. A lesão aorto-ostial foi definida como aquela localizada nos primeiros 8 mm do enxerto; as lesões de corpo foram as localizadas nas porções remanescentes. Foram excluídas as intervenções que abordaram somente a anastomose distal ou o leito coronário nativo. Foram avaliadas as taxas de eventos cardíacos adversos maiores (ECAM), óbito, infarto agudo do miocárdio (IAM) ou revascularização do vaso-alvo (RVA) entre os grupos. RESULTADOS: Foram avaliados 195 pacientes, sendo 69 no Grupo Óstio e 126 no Grupo Corpo. A média de idade da população total foi de 69,6 ± 10,2 anos, 41% dela era diabética, e 65,1% apresentaram síndromes coronárias agudas, sendo a maioria tratada com stents convencionais (82,5%). Não houve diferença entre os grupos na maioria das características estudadas. No seguimento tardio, a taxa de RVA (50,8% vs. 22%; P = 0,03) foi maior no Grupo Óstio. As taxas de ECAM (67,7% vs. 63,3%; P = 0,33), morte (31,7% vs. 35,6%; P = 0,95) e IAM (55% vs. 42%; P = 0,64) foram semelhantes entre os grupos. CONCLUSÕES: Essa população compôs um subgrupo de risco elevado, com alta mortalidade tardia, independentemente da localização da lesão no enxerto. Em pacientes tratados predominantemente com stents não farmacológicos, lesões aorto-ostiais apresentaram maior taxa de reintervenção em relação às lesões de corpo.

BACKGROUND: Little is known about the late clinical outcomes of patients undergoing saphenous vein graft percutaneous coronary intervention (SVG-PCI), and there are controversies regarding the role of lesion location (aorto-ostial or graft body). METHODS: Single-center registry including patients undergoing SVG-PCI between 2006 and 2011. Aorto-ostial lesion was defined as a lesion within the first 8 mm of the graft; graft body lesion was defined as a lesion located in the remaining portions of the graft. Interventions approaching only the distal anastomosis or the native coronary bed were excluded. We evaluated the rates of major adverse cardiac events (MACE), death, myocardial infarction (MI), and target vessel revascularization (TVR) between the groups. RESULTS: One hundred and ninety-five patients were evaluated, 69 in the Aorto-Ostial Group and 126 in the Graft Body Group. Mean age was 69.6 ± 10.2 years, 41% were diabetic, 65.1% had acute coronary syndromes and most of them were treated with bare metal stents (82.5%). There was no statistical difference between groups for most of the characteristics evaluated. In the late follow-up, the TVR rate (50.8% vs. 22%; P = 0.03) was greater in the Aorto-Ostial Group. The MACE rate (67.7% vs. 63.3%; P = 0.33), death (31.7% vs. 35.6%; P = 0.95) and MI (55% vs. 42%; P = 0.64) were similar between the two groups. CONCLUSIONS: This population included a high-risk subgroup, with high late mortality rates, regardless of the location of the lesion in the graft. In patients treated predominantly by bare-metal stents, aorto-ostial lesions had a higher reintervention rate when compared to graft body lesions.