Effectiveness of the Fiocruz recombinant ChadOx1-nCoV19 against variants of SARS-CoV-2 in the Municipality of Botucatu-SP.

Introduction: As the COVID-19 pandemic progresses, rapidly emerging variants of concern raise fears that currently licensed vaccines may have reduced effectiveness against these new strains. In the municipality of Botucatu, São Paulo State, Brazil, a mass vaccination campaign using ChadOx1-nCoV19 was initiated on 16th of May 2021, targeting people 18-60 years old. Two vaccine doses were offered 12 weeks apart, with the second delivered on 8th of August, 2021. This setting offered a unique opportunity to assess the effectiveness of two ChadOx1-nCoV19 doses in a real-life setting. Materials and methods: Data on testing, hospitalization, symptoms, demographics, and vaccination were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu. A test-negative study design was employed; whereby the odds of being vaccinated among cases vs controls were calculated to estimate vaccine effectiveness (VE; 1-OR). All individuals aged 18-60 who received a PCR test after the 16th of May and were unvaccinated prior to this date were included in the analysis until the study ended in mid-November 2021. Results: 77,683 citizens of Botucatu aged 18-60 received the first dose, and 74,051 received a second ChadOx1-nCoV19 dose 12 weeks later for a vaccination coverage of 84.2 and 80.2%, respectively. Of 7.958 eligible PCR tests, 2.109 were positive and 5.849 negative. The VE against any symptomatic infection was estimated at 39.2%, 21 days after dose 1, and 74.5%, 14 days after dose 2. There were no COVID-19-related hospitalizations or deaths among the 74,051 fully vaccinated individuals. The VE against severe disease was estimated at 70.8 and 100% after doses 1 and 2, respectively. 90.5% of all lineages sequenced between doses 1 and 2 (16th of May-7th of August) were of the Gamma variant, while 83.0% were of the Delta variant during the second period after dose 2 (8th of August-18th of November). Discussion: This observational study found the effectiveness of ChadOx1-nCoV19 to be 74.5% against COVID-19 disease of any severity, comparable to the efficacy observed in clinical trials (81.3% after dose 2), despite the dominance of the Gamma and Delta VoCs. No COVID-19-related hospitalizations or deaths in fully vaccinated individuals were reported.

Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil.

INTRODUCTION: Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18-60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. METHODS: The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. RESULTS AND DISCUSSION: A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.

Renal denervation in patients with heart failure secondary to Chagas' disease: A pilot randomized controlled trial.

INTRODUCTION: Chagas disease is one of the most relevant endemic parasitic diseases in Latin America, affecting approximately 6 million people. Overt Chagas heart disease is an ominous condition, occurring in 20-30% of infected individuals, which has besides the persistent myocarditis a peculiar intracardiac ganglionic neuronal depletion and dysautonomy. This study aims to evaluate the safety and feasibility of renal denervation for patients with advanced symptomatic Chagas cardiomyopathy. METHODS: Open-label prospective pilot study that randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio). The primary endpoint was the incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function. RESULTS: A total of 17 patients were allocated for renal denervation (n = 11) or conservative treatment (n = 6). Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7 ± 4.9%). For patients randomized to renal denervation, the procedure was performed successfully and uneventfully. After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6). After 9 months, clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups. CONCLUSIONS: This pilot study suggests that renal denervation is safe and feasible in patients with Chagas cardiomyopathy, warranting future studies to better evaluate the clinical efficacy of the interventional strategy in improving the prognosis of this high-risk population.

Preliminary Results of a Combined Score Based on sIL2-Rα and TIM-3 Levels Assayed Early After Hematopoietic Transplantation.

Assays of cytokines in the plasma at the onset of graft-vs. -host disease (GVHD) can predict disease severity and treatment-related mortality (TRM); however, the optimal time during which cytokines should be tested and the specific panel of cytokines with the highest predictive ability remain unknown. We chose a predefined time point, 18 days after hematopoietic stem cell transplantation (HSCT), to measure the levels of six cytokines in the plasma: soluble interleukin-2 receptor alpha (sIL2-Rα), T-cell immunoglobulin domain and mucin domain-3 (TIM-3), suppression of tumorigenicity-2 (ST-2), intercellular adhesion molecule (ICAM-1), interferon-gamma (IFN-γ), and interleukin-6 (IL-6). The study included 95 patients, who underwent allogeneic hematopoietic transplantation at our institution. Plasma levels of sIL2-Rα and TIM-3, measured as continuous data, had predictive value for overall survival (sIL2-Rα, p = 0.002; TIM-3, p = 0.0007), while TRM could be predicted by sIL2-Rα (p = 0.0005), IFN-gamma (p = 0.01), and IL-6 (p = 0.0001). No cytokine was associated with the risk of relapse. Patients were categorized into groups, according to cytokine thresholds determined by receiver operating characteristic curve analysis (sIL2-Rα ≤ or > 8,100 pg/ml; TIM-3 ≤ or > 950 pg/ml) and multivariate analysis was conducted. High levels of both TIM-3 and sIL2-Rα were significant predictors of poor survival [TIM-3 > 950 pg/ml: hazard ratio (HR) = 6.214 (95% CI 1.939-19.910), p = 0.002 and sIL2-Rα > 8.100 pg/ml: HR = 2.644 (95% CI 1.308-5.347), p = 0.006]. Using these cutoff thresholds, we constructed a composite scoring system that could distinguish three different groups of patients with varying rates of TRM: high risk, 41.7%; intermediate risk, 10.8%; and low risk, 7.1% (Gray's test: p = 0.001). If confirmed in a validation cohort, this composite scoring system could be used to guide the modulation of post-transplant immune suppressive therapy.

Left Main Ostial Compression in a Patient with Pulmonary Hypertension: Dynamic Findings by IVUS.

BACKGROUND: Pulmonary artery dilatation is a common feature among patients with severe pulmonary hypertension. Left main coronary artery extrinsic compression by an enlarged pulmonary artery is a rare complication and a potential cause for chest pain and sudden cardiac death in patients with pulmonary hypertension. This situation is very rare and few reports have described it. Currently, the appropriate management of these patients remains unknown. CASE REPORT: In the present report we describe the case of a 39-year-old woman who presented with a 2-year history of cardiac symptoms related to exercise. The patient underwent a 64-slice multidetector computed tomography (MDCT) coronary angiography, which showed left main coronary artery (LMCA) compression by a markedly enlarged pulmonary artery trunk (44 mm), without intraluminal stenosis or coronary artery calcium, as determined by the Agatston score. This compression was considered to be the cause of the cardiac symptoms. To confirm and plan the treatment, the patient underwent cardiac catheterization that confirmed the diagnosis of pulmonary hypertension and LMCA critical obstruction. Taking into account the paucity of information regarding the best management in these cases, the treatment decision was shared among a "heart team" that chose percutaneous coronary intervention with stent placement. An intra-vascular ultrasound was performed during the procedure, which showed a dynamic compression of the left main coronary artery. The intervention was successfully executed without any adverse events. CONCLUSIONS: This case illustrates dynamic compression of the LMCA by IVUS, visually demonstrating the mechanism of the intermittent symptoms of myocardial ischemia in this kind of patient. It also shows that percutaneous stenting technique may be an appropriate treatment for this unusual situation.

Does Ad Hoc Coronary Intervention Reduce Radiation Exposure? – Analysis of 568 Patients / Intervenção Coronariana Ad Hoc Reduz a Exposição Radiológica? - Análise em 568 Pacientes

Background:Advantages and disadvantages of ad hoc percutaneous coronary intervention have been described. However little is known about the radiation exposure of that procedure as compared with the staged intervention.Objective:To compare the radiation dose of the ad hoc percutaneous coronary intervention with that of the staged procedureMethods:The dose-area product and total Kerma were measured, and the doses of the diagnostic and therapeutic procedures were added. In addition, total fluoroscopic time and number of acquisitions were evaluated.Results:A total of 568 consecutive patients were treated with ad hoc percutaneous coronary intervention (n = 320) or staged percutaneous coronary intervention (n = 248). On admission, the ad hoc group had less hypertension (74.1% vs 81.9%; p = 0.035), dyslipidemia (57.8% vs. 67.7%; p = 0.02) and three-vessel disease (38.8% vs. 50.4%; p = 0.015). The ad hoc group was exposed to significantly lower radiation doses, even after baseline characteristic adjustment between both groups. The ad hoc group was exposed to a total dose-area product of 119.7 ± 70.7 Gycm2, while the staged group, to 139.2 ± 75.3 Gycm2 (p < 0.001).Conclusion:Ad hoc percutaneous coronary intervention reduced radiation exposure as compared with diagnostic and therapeutic procedures performed at two separate times.

Fundamento:Uma série de vantagens e desvantagens tem sido descrita para a intervenção coronária percutânea ad hoc, como a realizada ao mesmo tempo que o cateterismo diagnóstico, porém pouco se sabe sobre a exposição radiológica desse procedimento, comparado com a intervenção estadiada, ou seja, em dois momentos.Objetivo:Comparar a dose de radiação utilizada na angioplastia ad hoc com a angioplastia estadiada.Métodos:O produto de dose por área e o Kerma total foram mensurados, somando-se ambas as fases de diagnóstico e terapêutica. Além disso, foram computados o tempo total de fluoroscopia e o número de filmagens.Resultados:Um total de 568 pacientes consecutivos foram tratados com intervenção coronária percutânea ad hoc (n = 320) ou estadiada (n = 248). À admissão, o grupo do ad hoc apresentava menos hipertensão (74,1% vs. 81,9%; p = 0,035), dislipidemia (57,8% vs. 67,7%; p = 0,02) e doença triarterial (38,8% vs. 50,4%; p = 0,015). O grupo ad hoc foi exposto a doses significativamente menores de radiação, mesmo após ajuste para as diferenças basais entre os grupos. O grupo ad hoc foi exposto a uma dose de produto de dose por área total de 119,7 ± 70,7 Gycm2 enquanto que os pacientes estadiados foram expostos a uma dose de 139,2 ± 75,3 Gycm2 (p < 0,001).Conclusão:A intervenção coronária percutânea ad hoc reduziu a exposição radiológica, em comparação com procedimentos diagnósticos e terapêuticos realizados em tempos separados.

Does Ad Hoc Coronary Intervention Reduce Radiation Exposure? - Analysis of 568 Patients.

BACKGROUND: Advantages and disadvantages of ad hoc percutaneous coronary intervention have been described. However little is known about the radiation exposure of that procedure as compared with the staged intervention. OBJECTIVE: To compare the radiation dose of the ad hoc percutaneous coronary intervention with that of the staged procedureMethods:The dose-area product and total Kerma were measured, and the doses of the diagnostic and therapeutic procedures were added. In addition, total fluoroscopic time and number of acquisitions were evaluated. RESULTS: A total of 568 consecutive patients were treated with ad hoc percutaneous coronary intervention (n = 320) or staged percutaneous coronary intervention (n = 248). On admission, the ad hoc group had less hypertension (74.1% vs 81.9%; p = 0.035), dyslipidemia (57.8% vs. 67.7%; p = 0.02) and three-vessel disease (38.8% vs. 50.4%; p = 0.015). The ad hoc group was exposed to significantly lower radiation doses, even after baseline characteristic adjustment between both groups. The ad hoc group was exposed to a total dose-area product of 119.7 ± 70.7 Gycm2, while the staged group, to 139.2 ± 75.3 Gycm2 (p < 0.001). CONCLUSION: Ad hoc percutaneous coronary intervention reduced radiation exposure as compared with diagnostic and therapeutic procedures performed at two separate times.

Segurança e preditores de sucesso da alta hospitalar no mesmo dia apósintervenção coronária percutânea eletiva / Safety and predictors of same day discharge after elective percutaneous coronary intervention

Apesar de a alta hospitalar no mesmo dia (AHMD) após intervenção coronária percutânea(ICP) eletiva não complicada ser adotada mundialmente, ela permanece pouco estudada em nosso meio.Objetivamos, assim, avaliar nossa experiência inicial com a AHMD após ICP eletiva, em relação à suas egurança e aos preditores de sucesso. Métodos: Foram incluídos 161 pacientes consecutivos para AHMD, de único centro, selecionados em ambulatório especializado. Para a identificação dos fatores associados ao sucesso da AHMD, foram ajustados modelos de regressão logística simples e múltipla. Resultados: A AHMD foi realizada com sucesso em 114 pacientes (70,8%), tendo os 47 pacientes restantes permanecido internados (45 com alta na manhã seguinte e 2 pacientes após 2 dias). Nenhum paciente com AHMD apresentou evento cardíaco adverso maior ou complicação vascular importante aos 30 dias e no seguimento mediano de 12 meses. No grupo internação, ocorreu apenas um caso de infarto agudo do miocárdio por oclusão de ramo lateral e dois hematomas > 5 cm relacionados ao sítio de punção. Os preditores de sucesso da AHMD foram: via de acesso radial (OR = 5,92; IC95% 1,73-20,21; p = 0,005), presença de lesões tipo A/B1 (OR = 14,09; IC95% 1,70-116,49; p = 0,01) e volume de contraste (OR = 0,76;IC95% 0,65-0,88; p < 0,001). Conclusões: A AHMD foi segura e pôde ser realizada com sucesso na maioria dos pacientes selecionados para ICP eletiva, sendo seus preditores de sucesso o acesso radial, as lesões menos complexas e um volume menor de contraste...

Background: Although same-day discharge (SDD) after elective uncomplicated percutaneous coronary intervention (PCI) be adopted worldwide, it remains poorly studied in our country. We aim to evaluate our initial experience with SDD after elective PCI, regarding its safety and predictors of success. Methods: A hundred and sixty-one single-center consecutive patients, selected in a specialized out patient clinic, were included for SDD. To identify the factors associated with SDD, single and multiple logistic regression models were adjusted. Results: SDD was successfully performed in 114 patients (70.8%) and the remaining 47 patients remained hospitalized (45 with discharge in the following morning and 2 patients after 2 days). No patient with SDD presented major adverse cardiac events or major vascular complications at 30 days or at a median follow-up of 12 months. In the inpatient group, there was only one case of acute myocardial infarction due to a lateral branch occlusion and two patients with > 5 cm hematoma related to the access site. The SDD predictors were radial access route (OR = 5.92; 95%CI 1.73-20.21; p = 0.005), presence of type A/B1 lesions(OR = 14.09; 95%CI 1.70-116.49%; p = 0.01) and contrast volume (OR = 0.76; 95%CI 0.65-0.88; p < 0.001). Conclusions: SDD was safe and could be successfully performed in most patients selected for elective PCI, and its predictors were the radial access, less complex coronary lesions and a and lower contrast volume...

Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial.

OBJECTIVES: The aim of this study was to evaluate the impact of intravascular ultrasound (IVUS) guidance on the final volume of contrast agent used in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: To date, few approaches have been described to reduce the final dose of contrast agent in PCIs. We hypothesized that IVUS might serve as an alternative imaging tool to angiography in many steps during PCI, thereby reducing the use of iodine contrast. METHODS: A total of 83 patients were randomized to angiography-guided PCI or IVUS-guided PCI; both groups were treated according to a pre-defined meticulous procedural strategy. The primary endpoint was the total volume contrast agent used during PCI. Patients were followed clinically for an average of 4 months. RESULTS: The median total volume of contrast was 64.5 ml (interquartile range [IQR]: 42.8 to 97.0 ml; minimum, 19 ml; maximum, 170 ml) in the angiography-guided group versus 20.0 ml (IQR: 12.5 to 30.0 ml; minimum, 3 ml; maximum, 54 ml) in the IVUS-guided group (p < 0.001). Similarly, the median volume of contrast/creatinine clearance ratio was significantly lower among patients treated with IVUS-guided PCI (1.0 [IQR: 0.6 to 1.9] vs. 0.4 [IQR: 0.2 to 0.6, respectively; p < 0.001). In-hospital and 4-month outcomes were not different between patients randomized to angiography-guided and IVUS-guided PCI. CONCLUSIONS: Thoughtful and extensive use of IVUS as the primary imaging tool to guide PCI is safe and markedly reduces the volume of iodine contrast compared with angiography-alone guidance. The use of IVUS should be considered for patients at high risk of contrast-induced acute kidney injury or volume overload undergoing coronary angioplasty. (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy [MOZART]; NCT01947335).

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...

Denervação simpática renal percutânea / Percutaneous sympathetic renal denervation

A hipertensão arterial sistêmica (HAS) é uma doença de alta prevalência e está comprovadamente relacionada a maior risco de eventos cardiovasculares. Apesar dos grandes avanços no tratamento farmacológico, uma parcela considerável dos pacientes não obtém um controle efetivo da doença, a despeito do uso de múltiplos fármacos e em doses elevadas. A denervação simpática renal percutânea (DSRP) tem se mostrado uma terapia promissora, com elevada segurança e eficácia em estudos preliminares em pacientes com HAS resistente. O papel do sistema nervoso simpático na fisiopatologia da HAS é bem conhecido e constitui o racional para a ablação das fibras simpáticas, por meio da aplicação de radiofrequência por via transluminal nas artérias renais. Nos últimos anos, resultados provenientes de algumas séries de casos, estudos não controlados e um estudo randomizado multicêntrico, com número limitado de pacientes, mostraram queda significativa dos níveis tensionais em curto e médio prazos. Esta revisão teve por objetivo reunir as evidências do uso da DSRP no controle da HAS resistente de maneira crítica, assim como descrever aspectos técnicos do procedimento e perspectivas.

Arterial hypertension is a highly prevalent disease and is associated with increased cardiovascular risk. Despite great advances in drug therapy, a considerable number of patients do not have an effective control of the disease, despite the use of multiple drugs, usually in high doses. Renal sympathetic denervation (RSD) has proved to be a promising therapy, with high safety and efficacy in preliminary studies in patients with resistant hypertension. The role of sympathetic nervous system in the physiopathology of hypertension is well known and is the rationale for the ablation of sympathetic fibers by transluminal delivery of radiofrequency in the renal arteries. In the last few years, results from case series, non-controlled studies and one multicenter randomized trial with a limited number of patients have shown a significant decrease in short and mid-term blood pressure levels. The objective of this review was to gather evidence on the use of RSD in the control of resistant hypertension and describe technical aspects and perspectives of the procedure.

Evolução clínica após intervenção coronária percutânea em indivíduos com transplante renal prévio / Clinical outcome after percutaneous coronary intervention in patients with prior renal transplantation

INTRODUÇÃO: A doença arterial coronária é uma das principais causas de óbito em pacientes com doença renal crônica. Além disso, em decorrência da elevada prevalência de fatores de risco para aterosclerose, muitos desses pacientes necessitam de intervenção coronária percutânea (ICP) mesmo após o transplante renal. O objetivo deste estudo é descrever a evolução tardia de pacientes transplantados renais submetidos a ICP com stent. MÉTODOS: Foram incluídos pacientes transplantados renais, com idade > 18 anos, tratados com ICP. O seguimento foi realizado por análise de prontuários e contato telefônico. O desfecho do estudo foi a incidência de eventos cardíacos adversos maiores (ECAM) durante o seguimento. RESULTADOS: Foram incluídos 29 pacientes. A média de idade foi de 54,8 ± 8 anos, sendo a maioria do sexo masculino (72,4%). A prevalência de hipertensão arterial sistêmica foi de 89,7%, de dislipidemia, de 69%, e de diabetes, de 51,7%. A maior parte apresentava doença multiarterial (biarterial: 44,8%; triarterial: 41,4%). A complexidade das lesões foi elevada, sendo 84,3% dos tipos B2 ou C e 27,5% com lesões em bifurcação. A taxa de sucesso do procedimento foi de 100%. Stents convencionais foram utilizados em 96,6% dos casos. O tempo de seguimento foi de 1.378 ± 977 dias. A mortalidade foi de 25,1%, a taxa de revascularização do vaso-alvo foi de 15,9% e nenhum paciente apresentou infarto não-fatal. A incidência de ECAM durante a evolução foi de 34,5%. CONCLUSÕES: A evolução clínica tardia após ICP em pacientes transplantados renais demonstrou elevada probabilidade de eventos clínicos. No entanto, a população estudada foi uma amostra de alta complexidade clínica e angiográfica.

BACKGROUND: Coronary artery disease is a major cause of death in patients with chronic kidney disease. Moreover, due to the high prevalence of risk factors for atherosclerosis, many of these patients require percutaneous coronary intervention (PCI) even after renal transplantation. The aim of this study is to report the late follow-up of patients with renal transplantation treated with PCI and stenting. METHODS: Patients > 18 years of age, with prior kidney transplantation, and treated with PCI were included. Clinical follow-up was evaluated by medical record analysis and telephone contact. The study endpoint was the incidence of major adverse cardiac events (MACE) during follow-up. RESULTS: Twenty-nine patients were included. Mean age was 54.8 ± 8 years and the majority male (72.4%). The prevalence of hypertension was 89.7%, dyslipidemia 69% and diabetes 51.7%. Most of them had multivessel disease (2-vessel: 44.8%; 3-vessel: 41.4%). Lesion complexity was high, being 84.3% type B2 or C lesions and 27.5% bifurcation lesions. Procedural success rate was 100%. Bare metal stents were used in 96.6% of cases. The follow-up time was 1,378 ± 977 days. The mortality rate was 25.1%, target vessel revascularization rate was 15.9% and none of the patients presented non-fatal infarction. The incidence of MACE during follow-up was 34.5%. CONCLUSIONS: Late follow-up after PCI in renal transplantation patients demonstrated a high probability of clinical events. However, the study population was a sample of high clinical and angiographic complexity.

Experiência inicial com o uso do autopulse em sala de hemodinâmica / Initial experience with autopulse in the catheterization laboratory

Os autores apresentam a experiência inicial do uso de dispositivo mecânico de reanimação AutoPulse®. O dispositivo foi utilizado em caso de parada cardiorrespiratória em sala dehemodinâmica, permitindo a continuidade do procedimentopercutâneo concomitantemente à ressuscitação cardiopulmonar. O dispositivo proporcionou compressões torácicas ininterruptas e efetivas, bem como liberou um médico da equipe paraoutras funções durante o procedimento. Houve dificuldades quanto à rapidez na instalação do dispositivo no momento daemergência e em relação à radiopacidade dos componenteseletrônicos, que impediram algumas projeções angiográficas.O uso de dispositivos mecânicos de compressões torácicasdurante parada cardiorrespiratória é factível, porém ainda nãohá comprovação de seus benefícios em relação à ressuscitaçãocardiopulmonar com compressões manuais.

Evolução hospitalar de pacientes submetidos a assistência circulatória com balão intra-aórtico durante intervenção coronária percutânea de alto risco: registro InCor / In-hospital outcomes of patients submitted to circulatory support with intra-aortic balloon pump during high risk percutaneous coronary intervention: InCor registry

Introdução: O balão intra-aórtico (BIA) é utilizado há décadas como dispositivo de assistência circulatória, sendo recomendado na maioria das diretrizes, apesar da fraca evidência em relação à redução da mortalidade. O objetivo deste estudo foi avaliar o uso do BIA como ferramenta adjunta na intervenção coronária percutânea (ICP). Métodos: Registro unicêntrico que analisou a evolução hospitalar de 134 pacientes consecutivos que utilizaram BIA durante ICP de alto risco ou na vigência de choque cardiogênico. Resultados: A média de idade foi de 64,7 ± 12,5 anos e 67,9 eram do sexo masculino. A população apresentou características de alto risco, com 33,5 de diabéticos, 73,1 tratados na vigência de infarto do miocárdio, 68,6 com padrão triarterial, e fração de ejeção do ventrículo esquerdo de 38,6 ± 16,1. Fluxo TIMI 2/3 foi obtido em 86,4 dos casos, sendo tratada 1,6 ± 0,6 lesão/paciente. Ocorreram 18 (13,4) reinfartos, dos quais 9 (6,7) por trombose do stent, sendo 2 (1,4) pacientes encaminhados para cirurgia de revascularização miocárdica e 16 (11,9), para nova ICP. A mortalidade hospitalar foi de 61,2 e a taxa de eventos cardíacos adversos maiores (ECAM) foi de 67,2. Por análise multivariada, foram preditores de mortalidade: idade > 65 anos, ICP prévia, necessidade de diálise e padrão triarterial. Os preditores de sobrevida foram: função ventricular normal, fluxo TIMI 2/3 ao final do procedimento e permanência do BIA > 72 horas. Conclusões: Os pacientes que utilizaram BIA durante ICP apresentaram perfil clínico de risco muito alto, que se refletiu em elevada taxa de óbito. Fatores clínicos, angiográficos e do procedimento podem identificar variáveis que interferem independentemente na mortalidade.

The intra-aortic balloon pump (IABP) has been used for decades as a circulatory support device, being recommended in most guidelines, despite poor evidence of mortality reduction. The purpose of this study was to evaluate the use of IABP as an adjunct therapy in percutaneous coronary intervention (PCI). METHODS: Single center registry analyzing in-hospital outcomes of 134 consecutive patients submitted to IABP during high risk PCI or in the presence of cardiogenic shock. RESULTS: Mean age was 64.7 + 12.5 years and 67.9% were males. The population presented high-risk features, with 33.5% of diabetic patients, 73.1% treated in the presence of myocardial infarction, 68.6% with three-vessel disease and left ventricular ejection fraction of 38.6 + 16.1%. TIMI 2/3 flow was obtained in 86.4% of the cases and 1.6 + 0.6 lesion/patient was treated. There were 18 (13.4%) reinfarctions, of which 9 (6.7%) were due to stent thrombosis, 2 (1.4%) patients were referred for CABG and 16 (11.9%) for a new PCI. Hospital mortality was 61.2% and the major adverse cardiac events (MACE) rate was 67.2%. By multivariate analysis, predictors of mortality were: age > 65 years, prior PCI, need of dialysis and three-vessel disease. Predictors of survival were: normal ventricular function, TIMI 2/3 flow at the end of the procedure and IABP utilization > 72 hours. CONCLUSIONS: Patients undergoing PCI with IABP support have a very high risk clinical profile, which led to high mortality rates. Clinical, angiographic and procedure-related factors can identify independent variables for mortality.

Comparação das vias radial e femoral nas intervenções coronárias percutâneas: resultados do registro TotalCor / Comparison of radial vs. femoral access in percutaneous coronary interventions: outcomes of the TotalCor registry

Introdução: A intervenção coronária percutânea (ICP) por via radial ainda é pouco utilizada em nosso meio. O objetivo do presente estudo foi avaliar a prevalência e os resultados da ICP por via radial, comparada à via femoral, em uma população do mundo real. Métodos: Registro unicêntrico, com 507 pacientes consecutivos submetidos a ICP pelas vias radial (n = 121) e femoral (n = 386), de acordo com a escolha do operador. Resultados: Os pacientes que utilizaram a via radial (23,9%) eram mais frequentemente do sexo masculino (78,5% vs. 69,9%; P = 0,07) e tabagistas (19,8% vs. 11,7%; P = 0,02), com maior prevalência de lesões uniarteriais (59,5% vs. 46,4%), tipo A/B1 (39% vs. 28,4%) e com função ventricular preservada (87,1% vs. 73%; P < 0,01). Nesse grupo foram utilizados stents de maior diâmetro e menor comprimento. O sucesso do procedimento foi elevado (97,3% vs. 96,3%; P = 0,56) e a incidência de óbito foi baixa, não diferindo entre os grupos (0,8% vs. 0,8%; P = 0,96), assim como as taxas de infarto do miocárdio (2,5% vs. 2,1%; P = 0,73). Não ocorreram revascularizações do vaso-alvo de urgência. Os pacientes tratados pela via radial permaneceram menos tempo internados (1 dia vs. 2 dias; P = 0,02) e não apresentaram complicações vasculares (0 vs. 3,4%; P = 0,045). Conclusões: A utilização da ICP por via radial representa o dobro da média nacional na instituição em que o estudo foi realizado, e a escolha de pacientes para essa técnica trouxe resultados do procedimento equivalentes aos da via femoral, nenhuma complicação vascular, e reduziu à metade o tempo de internação hospitalar.

BACKGROUND: In our country radial access is still underused in percutaneous coronary interventions (PCI). The objective of this study was to evaluate the prevalence and compare radial to femoral vascular access for PCI in a real-world population. METHODS: Single center registry, with 507 consecutive patients undergoing PCI by radial (n = 121) and femoral (n = 386) access, according to the operator's choice. RESULTS: Patients using radial access (23.9%) were more often male (78.5% vs. 69.9%; P = 0.07) and smokers (19.8% vs. 11.7%; P = 0.02), had a higher prevalence of single-vessel disease (59.5% vs. 46.4%), type A/B1 (39% vs. 28.4%) lesions and had preserved ventricular function (87.1% vs. 73%; P < 0.01). Larger diameter and shorter stents were used in this group. Procedure success was high (97.3% vs. 96.3%; P = 0.56), the incidence of death was low and was not different between groups (0.8% vs. 0.8%; P = 0.96), as well as myocardial infarction rates (2.5% vs. 2.1%; P = 0.73). There were no urgent target-vessel revascularizations. Patients treated by the radial approach had a shorter hospitalization period (1 day vs. 2 days; P = 0.02) and did not have vascular complications (0 vs. 3.4%; P = 0.045). CONCLUSIONS: The use of radial access for PCI in our institution is twice the national average and the choice of patients for this technique provided similar results to those obtained by the femoral approach, no vascular complications and halved patients' average stay in hospital.

Desfechos tardios da intervenção coronária percutânea com stent farmacológico em pontes de veia safena: dados do Registro InCor / Late percutaneous coronary intervention outcomes with drug-eluting stent in saphenous vein grafts: data from the InCor Registry

Introdução: A segurança e a eficácia do uso de stent farmacológico para o tratamento de lesões em ponte de veia safena (PVS) ainda é motivo de controvérsia. Este estudo avaliou a evolução tardia de pacientes com lesões em PVS tratados com stent farmacológico. Métodos: Registro unicêntrico que incluiu todos os pacientes submetidos a intervenção em PVS com stent farmacológico (n = 82), sem restrições clínicas ou angiográficas, no período de 2003 a 2009. Foram avaliadas as taxas de eventos cardíacos adversos maiores (ECAM), óbito, infarto agudo do miocárdio (IAM), revascularização do vaso-alvo (RVA) e trombose de stent. Resultados: A média de idade foi de 67,8 + 10,2 anos, a maioria era do sexo masculino (85,4%), 40,2% eram diabéticos e 52,4% eram portadores de angina estável. Foi utilizado 1,45 + 0,5 stent por paciente, empregando-se ostent CypherTM na maioria (61%) dos casos. O diâmetro dos stents foi de 3,22 + 0,39 mm e o comprimento, de 20,1 +7,3 mm. A taxa de sucesso angiográfico foi de 96,3%. No seguimento de 4,1 anos, a taxa de ECAM foi de 28%, com 6% de óbito, 19,5% de IAM e 18,2% de RVA. Nesse período ocorreram dois casos de trombose de stent definitiva ou provável (2,4%). Conclusões: Os resultados demonstraram, em seguimento muito tardio, altas taxas de ECAM em pacientes com lesões de PVS tratados com stent farmacológico, provavelmente pelo aspecto mais agressivo da doença vascular em enxertos venosos.

Background: The safety and efficacy of drug-eluting stents in the treatment of saphenous vein graft (SVG) lesions remains controversial. This study assessed the late follow-up of patients with SVG lesions treated with drug-eluting stents. Methods: Single center registry including patients undergoingSVG interventions using drug-eluting stents (n = 82), without clinical or angiographic exclusion criteria, from 2003 to 2009. The rates of major adverse cardiac events (MACE), death, acute myocardial infarction (AMI), target vessel revascularization (TVR) and stent thrombosis were evaluated. Results: Mean age was 67.8 + 10.2 years, most of them were male (85.4%), 40.2% were diabetic and 52.4% had stable angina. An average of 1.45 + 0.5 stents per patient were implanted and CypherTM was the stent used in most ofthe cases (61%). Stent diameter was 3.22 + 0.39 mm and stent length was 20.1 + 7.3 mm. Angiographic success rate was 96.3%. In the 4.1-year follow-up, the rate of MACE was 28%, death 6%, AMI 19.5% and TVR 18.2%. Therewere two cases of definitive or probable stent thrombosis (2.4%) within the follow-up period. Conclusions: Longtermfollow-up showed high MACE rates in patients with SVG lesions treated with drug-eluting stents, probably due tothe accelerated atherosclerosis that develops within the grafted vein conduits.

Stents convencionais de aço inoxidável vs. cromo-cobalto: imapcto clínico da liga metálica no cenário atual - registro InCor / Stainless steel versus cobalt-chromium bare metal stents: clinical impact of the metal alloy in a real world scenario – InCor registry

Introdução: Há alguns anos estudos demonstraram que stents de cromo-cobalto, com hastes mais finas, reduziram de forma expressiva a reestenose coronária, comparativamente aos stents convencionais de aço inoxidável disponíveis na época. Desde então, stents com hastes < 100 µm e diferentes ligas metálicas estão disponíveis para uso clínico. O objetivo deste estudo foi avaliar a existência de diferenças nos resultados clínicos de pacientes submetidos a intervenção coronária percutânea (ICP) com stents de hastes finas e diferentes ligas metálicas. Métodos: Registro unicêntrico, em que foram comparados os resultados de pacientes submetidos a ICP com stent de aço inoxidável (n = 135) vs. stent de cromo-cobalto (n = 181). O desfecho primário foi a ocorrência de eventos cardíacos adversos maiores (ECAM), definidos pela ocorrência de óbito, infarto agudo do miocárdio (IAM) ou revascularização do vaso-alvo (RVA) no seguimento tardio. Resultados: A média de idade dos pacientes foi de 64 ± 11 anos, com 32,6% de diabéticos e 65,5% com síndrome coronária aguda à admissão, sem diferenças na maioria das características clínicas e angiográficas avaliadas entre os grupos. Na comparação das características do procedimento, a estratégia de implante direto do stent foi mais frequente no grupo cromo-cobalto (30,3% vs. 40,2%; P = 0,04). Ao final de mediana de 500 dias de seguimento, não houve diferenças significativas entre os grupos para a ocorrência de ECAM (15,5% vs. 16,5%; P = 0,6), óbito (4,6% vs. 6,8%; P = 0,29), IAM (2,7% vs. 4,1%; P = 0,41) ou RVA (10,4% vs. 10,1%; P = 0,97). Conclusões: Nessa população do mundo real os stents de cromo-cobalto apresentaram eficácia e segurança semelhantes às dos stents de aço inoxidável, porém com menor necessidade de instrumentação coronária.

Background: Years ago studies demonstrated that the use of cobalt-chromium stents with thinner struts significantly reduced coronary restenosis when compared to conventional stainless steel stents available at the time. Since then, stents with struts < 100 μm and different metal alloys are available for clinicaluse. The objective of this study was to assess differences in the clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) with thin strut stents and differentmetal alloys. Methods: Single center registry comparing the results of patients undergoing PCI with stainless steel stents (n = 135) vs. cobalt-chromium bare metal stents (n = 181).The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined by death, acute myocardial infarction (AMI) or target vessel revascularization (TVR) in thelate follow-up. Results: Mean patient age was 64 ± 11 years, 32.6% were diabetic and 65.5% had acute coronary syndrome at admission, with no differences for most of the clinical andangiographic characteristics assessed between groups. The use of direct stenting was more frequent in the cobalt-chromium group (30.3% vs. 40.2%; P = 0.04). After a median of500 days of follow up, there was no statistically significant difference between groups for the occurrence of MACE (15.5% vs. 16.5%; P = 0.6), death (4.6% vs. 6.8%; P = 0.29),AMI (2.7% vs. 4.1%; P = 0.41) or TVR (10.4% vs. 10.1%; P = 0.97). Conclusions: In this real world population, cobaltchromiumstents had similar efficacy and safety when compared to stainless steel stents, but with less coronary instrumentation.

Evolução clínica de pacientes de alto risco cirúrgico submetidos a intervenção coronária percutânea em tronco da coronária esquerda não-protegido / Clinical outcome in high-surgical-risk patients undergoing percutaneous coronary intervention for unprotected left main coronary artery disease

INTRODUÇÃO: Recentemente, a intervenção coronária percutânea (ICP) em tronco de coronária esquerda (TCE) não-protegido tem se mostrado uma alternativa real à cirurgia de revascularização miocárdica. Os resultados clínicos tardios da ICP nesses pacientes são escassos na literatura, especialmente em nosso meio. Método: Registro de um centro terciário de atenção em cardiologia, que avaliou o seguimento clínico de pacientes com contraindicação à revascularização miocárdica cirúrgica submetidos A ICP em TCE, no período de 2002 a 2009. Nosso objetivo foi avaliar a mortalidade ao final de um ano. Resultados: No total, foram incluídos 77 indivíduos nesta análise, com média de idade de 65,4 +- 13,7 anos, dos quais 59,2 por cento eram do sexo masculino, 25 por cento eram diabéticos e 3,9 por cento eram portadores de insuficiência renal crônica dialítica. Com relação às características angiográficas, 79,6 por cento das lesões eram do tipo B2/C, com envolvimento do óstio em 47,4 por cento e da bifurcação distal em 62,3 por cento. Na maioria dos casos, a indicação de ICP foi emergencial (85,5 por cento) e os stents farmacológicos foram utilizados em 17,5 por cento dos pacientes. Suporte hemodinâmico por meio de balão intra-aórtico foi utilizado em 28,2 por cento da população. Ao final de um ano a probabilidade de sobrevivência...

BACKGROUND: Percutaneous coronary intervention (PCI) in unprotected left main coronary artery (LMCA) disease has proven to be an alternative to coronary artery bypass graft surgery (CABG). However, late clinical results of PCI in these patients are scarce in the literature, especially in our country. METHOD: Data from a tertiary cardiology center registry, which included patients with contraindications to CABG undergoing LMCA PCI, from 2002 to 2009, were analyzed. Our objective was to evaluate the 1-year mortality. RESULTS: A total of 77 subjects were included in this analysis, mean age was 65.4 ± 13.7 years, 59.2% were male, 25% were diabetic, and 3.9% had renal failure requiring dialysis. Regarding the angiographic characteristics, 79.6% of lesions were type B2/C, with involvement of the ostium in 47.4% and distal bifurcation in 62.3%. In most cases PCI was performed as an emergency procedure (85.5%) and drug eluting stents were used in 17.5% of the patients. Hemodynamic support using an intraaortic balloon pump was used in 28.2% of the population. At the end of 1 year the probability of overall survival was 69.7% and almost all of the deaths occurred in the first month of follow-up. CONCLUSION: In this highly selected population with unprotected LMCA disease, including high-surgi

Evaluation of plaque composition by intravascular ultrasound "virtual histology": the impact of dense calcium on the measurement of necrotic tissue.

AIMS: We aimed to evaluate if the co-localisation of calcium and necrosis in intravascular ultrasound virtual histology (IVUS-VH) is due to artefact, and whether this effect can be mathematically estimated. METHODS AND RESULTS: We hypothesised that, in case calcium induces an artefactual coding of necrosis, any addition in calcium content would generate an artificial increment in the necrotic tissue. Stent struts were used to simulate the "added calcium". The change in the amount and in the spatial localisation of necrotic tissue was evaluated before and after stenting (n=17 coronary lesions) by means of a especially developed imaging software. The area of "calcium" increased from a median of 0.04 mm2 at baseline to 0.76 mm2 after stenting (p<0.01). In parallel the median necrotic content increased from 0.19 mm2 to 0.59 mm2 (p<0.01). The "added" calcium strongly predicted a proportional increase in necrosis-coded tissue in the areas surrounding the calcium-like spots (model R2=0.70; p<0.001). CONCLUSIONS: Artificial addition of calcium-like elements to the atherosclerotic plaque led to an increase in necrotic tissue in virtual histology that is probably artefactual. The overestimation of necrotic tissue by calcium strictly followed a linear pattern, indicating that it may be amenable to mathematical correction.