Predictors of bleeding and thrombotic events among patients admitted to the hospital with COVID-19 and elevated D-dimer: insights from the ACTION randomized clinical trial.

Therapeutic anticoagulation showed inconsistent results in hospitalized patients with COVID-19 and selection of the best patients to use this strategy still a challenge balancing the risk of thrombotic and hemorrhagic outcomes. The present post-hoc analysis of the ACTION trial evaluated the variables independently associated with both bleeding events (major bleeding or clinically relevant non-major bleeding) and the composite outcomes thrombotic events (venous thromboembolism, myocardial infarction, stroke, systemic embolism, or major adverse limb events). Variables were assessed one by one with independent logistic regressions and final models were chosen based on Akaike information criteria. The model for bleeding events showed an area under the curve of 0.63 (95% confidence interval [CI] 0.53 to 0.73), while the model for thrombotic events had an area under the curve of 0.72 (95% CI 0.65 to 0.79). Non-invasive respiratory support was associated with thrombotic but not bleeding events, while invasive ventilation was associated with both outcomes (Odds Ratio of 7.03 [95 CI% 1.95 to 25.18] for thrombotic and 3.14 [95% CI 1.11 to 8.84] for bleeding events). Beyond respiratory support, creatinine level (Odds Ratio [OR] 1.01 95% CI 1.00 to 1.02 for every 1.0 mg/dL) and history of coronary disease (OR 3.67; 95% CI 1.32 to 10.29) were also independently associated to the risk of thrombotic events. Non-invasive respiratory support, history of coronary disease, and creatinine level may help to identify hospitalized COVID-19 patients at higher risk of thrombotic complications.ClinicalTrials.gov: NCT04394377.

An adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in familial hypercholesterolemia: A pilot study protocol

BACKGROUND AND AIMS: A healthy diet is one of the pillars of familial hypercholesterolemia (FH) treatment. However, the best dietary pattern and indication for specific supplementation have not been established. Our aim is to conduct a pilot study to assess the effect of an adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in participants with a probable or definitive diagnosis of FH, treated with moderate/high potency statins. METHODS: A national, multicenter, factorial, and parallel placebocontrolled randomized clinical trial with a superiority design and 1:1:1:1 allocation rate will be conducted. The participants will undergo whole exome sequencing and be allocated into four treatment groups: 1) a cardioprotective diet adapted for FH (DICAFH) þ phytosterol placebo þ krill oil placebo; 2) DICA-FH þ phytosterol 2 g/day þ krill oil placebo; 3) DICA-FH þ phytosterol placebo þ krill oil 2 g/day; or 4) DICA-FH þ phytosterol 2 g/day þ krill oil 2 g/day. The primary outcomes will be low-density lipoprotein (LDL)-cholesterol and lipoprotein (a) levels and adherence to treatment after a 120-day follow-up. LDL- and high-density lipoprotein (HDL)-cholesterol subclasses, untargeted lipidomics analysis, adverse events, and protocol implementation components will also be assessed. RESULTS: A total of 58 participants were enrolled between May e August 2023. After the end of the follow-up period, the efficacy and feasibility results of this pilot study will form the basis of the design of a large-scale randomized clinical trial. CONCLUSIONS: This study's overall goal is to recommend dietary treatment strategies in the context of FH.

Correlation between the vascular resistance index and arteriography for assessment of the distal arterial bed in chronic limb threatening ischemia.

Background: Patients with chronic limb threatening ischemia (CLTI) of the lower limbs (LL) undergo arteriography for revascularization surgery planning. Doppler ultrasound (DU) is non-invasive and can provide information about the distal arteries through measurement of the resistance index (RI). Objectives: To correlate the Rutherford Angiographic Classification with the RI for assessment of the distal arterial bed of the LL. Methods: A cross-sectional study, conducted at a public tertiary hospital with 120 patients with LL CLTI, from September 2019 to April 2022. The RI of arteries that were candidates for revascularization was compared with the images of the same arteries obtained using arteriography, using the Rutherford Angiographic Classification of the distal bed. Results: A total of 120 LL were assessed in 120 patients with a mean age of 68.6 years. The sample was 50.0% male and 90.0% of the patients in the sample were classified as Rutherford category five. The RI values found for the arteries of the leg exhibited a statistically significant positive correlation with the Rutherford Classification (anterior tibial, p< 0.01; posterior tibial, p = 0.012 fibular, p = 0.034; and dorsalis pedis, p < 0.001). Conclusions: In this study, RIs for the arteries of the leg measured using Doppler ultrasound exhibited a positive correlation with the Rutherford Classification. This index could be useful for assessment of the distal arterial bed of the lower limbs of patients with chronic limb threatening ischemia.

Vascular resistance index and the immediate hemodynamic success of lower limb distal artery revascularization.

Background: Revascularization surgery is used to attempt to restore blood flow to the foot in patients with critical ischemia (CI) caused by peripheral arterial occlusive disease of the lower limbs (LL). Ultrasonography with Doppler (USD) SAH emerged in recent years as a highly valuable method for planning this surgical intervention. Objectives: To evaluate the relationship between the resistance index (RI), measured with USD, and immediate hemodynamic success of LL revascularization surgery in patients with CI. Methods: The study design was a prospective cohort assessing 46 patients with LL CLI who underwent operations to perform infrainguinal revascularization by angioplasty or bypass from August 2019 to February 2022. All patients underwent preoperative clinical vascular assessment with USD including measurement of the RI of distal LL arteries, LL arteriography, and measurement of the ankle-brachial index (ABI). All patients had their ABI measured again in the immediate postoperative period. Results: Forty-six patients were assessed, 25 (54.3%) of whom were male. Age varied from 32 to 89 years (mean: 67.83). Hemodynamic success was assessed by comparison of preoperative and postoperative ABI, showing that hemodynamic success was achieved in 31 (67.4%) patients after revascularization surgery (ABI increased by 0.15 or more). A positive correlation (p ≤ 0.05) was observed between the RI of the distal revascularized LL artery and immediate hemodynamic success assessed by ABI (lower RI and hemodynamic success). Conclusions: This study observed a positive correlation between the resistance index of the distal artery and immediate hemodynamic success of lower limb revascularizations, as assessed by the ankle-brachial index, so that the lower the RI the greater the hemodynamic success achieved.

Primary results of the brazilian registry of atherothrombotic disease (NEAT).

There is limited contemporary prospective real-world evidence of patients with chronic arterial disease in Latin America. The Network to control atherothrombosis (NEAT) registry is a national prospective observational study of patients with known coronary (CAD) and/or peripheral arterial disease (PAD) in Brazil. A total of 2,005 patients were enrolled among 25 sites from September 2020 to March 2022. Patient characteristics, medications and laboratorial data were collected. Primary objective was to assess the proportion of patients who, at the initial visit, were in accordance with good medical practices (domains) for reducing cardiovascular risk in atherothrombotic disease. From the total of patients enrolled, 2 were excluded since they did not meet eligibility criteria. Among the 2,003 subjects included in the analysis, 55.6% had isolated CAD, 28.7% exclusive PAD and 15.7% had both diagnoses. Overall mean age was 66.3 (± 10.5) years and 65.7% were male patients. Regarding evidence-based therapies (EBTs), 4% were not using any antithrombotic drug and only 1.5% were using vascular dose of rivaroxaban (2.5 mg bid). Only 0.3% of the patients satisfied all the domains of secondary prevention, including prescription of EBTs and targets of body-mass index, blood pressure, LDL-cholesterol, and adherence of lifestyle recommendations. The main barrier for prescription of EBTs was medical judgement. Our findings highlight that the contemporary practice does not reflect a comprehensive approach for secondary prevention and had very low incorporation of new therapies in Brazil. Large-scale populational interventions addressing these gaps are warranted to improve the use of evidence-based therapies and reduce the burden of atherothrombotic disease.ClinicalTrials.gov NCT04677725.

Ureterovaginal fistula: a case report and review of an unexpected contemporary complication secondary to transvaginal ultrasound-guided oocyte retrieval.

Despite the widespread use of transvaginal ultrasound-guided oocyte retrieval in assisted reproductive technology procedures, there is a lack of systematic data on the incidence and nature of its complications. This makes it difficult for healthcare providers to fully understand and manage the risks associated with the procedure, and for patients to make informed decisions about their care. Ureteral injuries and other complications during oocyte retrieval are important to consider and manage appropriately. Early ureterovaginal fistula is a rare but serious complication that can occur after oocyte collection by transvaginal ultrasound. It is important for medical professionals to be aware of this potential complication and to take appropriate measures to prevent and manage it. Minimally invasive treatments for ureterovaginal fistula can be effective in resolving the condition and minimize the risk of further complications. However, early diagnosis and prompt intervention are critical in achieving a successful outcome.

Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial.

Importance: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. Objective: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. Design, Setting, and Participants: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. Intervention: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. Main Outcomes and Measures: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. Results: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). Conclusions and Relevance: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT04062461.

Single and combination immunotherapy with chemotherapy and the risk of AKI in patients with solid cancer.

BACKGROUND AND OBJECTIVES: Acute kidney injury (AKI) has emerged as an important toxicity among patients with advanced cancer treated with immune checkpoint inhibitors. The aim of this study was to describe the incidence, risk factors and mortality of AKI in patients receiving immune checkpoint inhibitors alone or in combination with another form of immunotherapy or chemotherapy. DESIGN, SETTING AND PARTICIPANTS: We included all patients who received immune checkpoint inhibitors alone or in combination with another form of immunotherapy or chemotherapy at AC Camargo Cancer Center from January 2015 to December 2019. AKI was defined as a ≥ 1.5 fold increase in creatinine from baseline within 12 months of immune checkpoint inhibitor initiation. We assessed the association between baseline demographics, comorbidities, medications and risk of AKI using a competing risk model, considering death as a competing event. RESULTS: We included 614 patients in the analysis. The mean age was 58.4 ± 13.5 years, and the mean baseline creatinine was 0.8 ± 0.18 mg/dL. AKI occurred in 144 (23.5%) of the patients. The most frequent AKI etiologies were multifactorial (10.1%), hemodynamic (8.8%) and possibly immunotherapy-related (3.6%). The likelihood of AKI was greater in patients with genitourinary cancer (sHR 2.47 95% CI 1.34-4.55 p < 0.01), with a prior AKI history (sHR 2.1 95% CI 1.30-3.39 p < 0.01) and taking antibiotics (sHR 2.85 95% CI 1.54-5.27 p < 0.01). CONCLUSIONS: In this study, genitourinary cancer, previous AKI and antibiotics use were associated with a higher likelihood of developing AKI.

Multifaceted strategy based on automated text messaging after a recent heart failure admission: the MESSAGE-HF Randomized Clinical Trial

IMPORTANCE: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. OBJECTIVE: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. INTERVENTION: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. MAIN OUTCOMES AND MEASURES: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. RESULTS: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). CONCLUSIONS and relevance: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome.

Cardiovascular Safety of Azithromycin in Patients Hospitalized With COVID-19: A Prespecified Pooled Analysis of the COALITION I and COALITION II Randomized Clinical Trials.

The cardiovascular safety from azithromycin in the treatment of several infectious diseases has been challenged. In this prespecified pooled analysis of 2 multicenter randomized clinical trials, we aimed to assess whether the use of azithromycin might lead to corrected QT (QTc) interval prolongation or clinically relevant ventricular arrhythmias. In the COALITION COVID Brazil I trial, 667 patients admitted with moderate COVID-19 were randomly allocated to hydroxychloroquine, hydroxychloroquine plus azithromycin, or standard of care. In the COALITION COVID Brazil II trial, 447 patients with severe COVID-19 were randomly allocated to hydroxychloroquine alone versus hydroxychloroquine plus azithromycin. The principal end point for the present analysis was the composite of death, resuscitated cardiac arrest, or ventricular arrhythmias. The addition of azithromycin to hydroxychloroquine did not result in any prolongation of the QTc interval (425.8 ± 3.6 ms vs 427.9 ± 3.9 ms, respectively, mean difference -2.1 ms, 95% confidence interval -12.5 to 8.4 ms, p = 0.70). The combination of azithromycin plus hydroxychloroquine compared with hydroxychloroquine alone did not result in increased risk of the primary end point (proportion of patients with events at 15 days 17.2% vs 16.0%, respectively, hazard ratio 1.08, 95% confidence interval 0.78 to 1.49, p = 0.65). In conclusion, in patients hospitalized with COVID-19 already receiving standard-of-care management (including hydroxychloroquine), the addition of azithromycin did not result in the prolongation of the QTc interval or increase in cardiovascular adverse events. Because azithromycin is among the most commonly prescribed antimicrobial agents, our results may inform clinical practice. Clinical Trial Registration: NCT04322123, NCT04321278.

Therapeutic Adherence According to the Morisky Scale in Patients with Hypertension

Abstract Background In view of the high prevalence of hypertension and the importance of adequate drug therapy in the prevention of complications, it is necessary to know the adherence to drug treatment in this population. Objective To verify adherence to antihypertensive drug treatment in Brazilian patients with hypertension using the Morisky-Green Test (MGT), relating it with demographic data. Methods Prospective, observational, multicenter, national registry study, with 2,578 hypertensive patients participating in study I, the Brazilian Cardiovascular Registry of Arterial Hypertension (I-RBH), recruited in the five regions of Brazil. The analyses carried out on the data were descriptive statistics, qui-square tests, ANOVA, and logistic regression, adopting 5% as the significance level for the tests. Results The research shows that 56.13% of patients in the sample were female; 56.71% were elderly (≥ 65 years); 55.86% were White; 52.37% were from the Southeast Region; and 59.74% were non-adherent. Logistic regression showed an independent relationship between patients' age, ethnicity, and region with medication adherence. Conclusion Adherence to treatment is the key to reducing high rates of cardiovascular complications. The study brings a successful outcome in the relationship between the factors ethnicity, age, and region of patients with hypertension and medication adherence. To this end, it is necessary to understand these factors, considering systematic evaluation in the care of patients with hypertension and other chronic non-communicable diseases. This study is a significant contribution to multidisciplinary teams, as it highlights which risk factors interfere with medication adherence, incorporating better strategies in health education.

Relação entre o índice de resistência vascular e o sucesso hemodinâmico de revascularizações distais dos membros inferiores / Vascular resistance index and the immediate hemodynamic success of lower limb distal artery revascularization

Resumo Contexto A cirurgia de revascularização é proposta para restaurar o fluxo sanguíneo para o pé nos casos de isquemia crítica (IC) devido a doença arterial obstrutiva periférica dos membros inferiores (MMII). O uso de ultrassonografia com Doppler (USD) vem despontando nos últimos anos como um método de grande valor para o planejamento cirúrgico dessa intervenção. Objetivos Avaliar a relação entre o índice de resistência (IR), mensurado por meio de USD, e o sucesso hemodinâmico imediato da cirurgia de revascularização dos MMII em pacientes com IC. Métodos O tipo de estudo empregado foi a coorte prospectiva, na qual foram avaliados 46 pacientes portadores de IC dos MMII submetidos à operação de revascularização infrainguinal por angioplastia ou em ponte de agosto de 2019 a fevereiro de 2022. Todos os pacientes foram submetidos à avaliação clínica vascular, à USD com medida do IR das artérias distais dos MMII, à arteriografia dos MMII e à aferição do índice tornozelo-braquial (ITB) no período pré-operatório. No pós-operatório imediato, todos os pacientes foram submetidos à nova aferição do ITB. Resultados Entre os 46 pacientes avaliados, 25 (54,3%) eram do sexo masculino. A idade variou de 32 a 89 anos (média de 67,83). Quanto ao sucesso hemodinâmico, avaliado pela comparação do ITB pré e pós-operatório, constatou-se que 31 (67,4%) pacientes apresentaram sucesso hemodinâmico após cirurgia de revascularização (aumento do ITB em 0,15 ou mais). Foi observada correlação positiva (p ≤ 0,05) entre o IR da artéria distal revascularizada do MMII e o sucesso hemodinâmico imediato avaliado pela aferição do ITB (IR menor e sucesso hemodinâmico). Conclusões Na presente pesquisa foi observada uma correlação positiva entre o índice de resistência arterial distal e o sucesso hemodinâmico nas revascularizações dos membros inferiores, avaliada através do índice tornozelobraquial, de forma que, quanto menor foi o IR, maior o sucesso hemodinâmico obtido.

Abstract Background Revascularization surgery is used to attempt to restore blood flow to the foot in patients with critical ischemia (CI) caused by peripheral arterial occlusive disease of the lower limbs (LL). Ultrasonography with Doppler (USD) SAH emerged in recent years as a highly valuable method for planning this surgical intervention. Objectives To evaluate the relationship between the resistance index (RI), measured with USD, and immediate hemodynamic success of LL revascularization surgery in patients with CI. Methods The study design was a prospective cohort assessing 46 patients with LL CLI who underwent operations to perform infrainguinal revascularization by angioplasty or bypass from August 2019 to February 2022. All patients underwent preoperative clinical vascular assessment with USD including measurement of the RI of distal LL arteries, LL arteriography, and measurement of the ankle-brachial index (ABI). All patients had their ABI measured again in the immediate postoperative period. Results Forty-six patients were assessed, 25 (54.3%) of whom were male. Age varied from 32 to 89 years (mean: 67.83). Hemodynamic success was assessed by comparison of preoperative and postoperative ABI, showing that hemodynamic success was achieved in 31 (67.4%) patients after revascularization surgery (ABI increased by 0.15 or more). A positive correlation (p ≤ 0.05) was observed between the RI of the distal revascularized LL artery and immediate hemodynamic success assessed by ABI (lower RI and hemodynamic success). Conclusions This study observed a positive correlation between the resistance index of the distal artery and immediate hemodynamic success of lower limb revascularizations, as assessed by the ankle-brachial index, so that the lower the RI the greater the hemodynamic success achieved.

Correlação entre o índice de resistência vascular e a arteriografia na avaliação do leito arterial distal na isquemia crítica dos membros inferiores / Correlation between the vascular resistance index and arteriography for assessment of the distal arterial bed in chronic limb threatening ischemia

Resumo Contexto Pacientes com isquemia crítica (IC) dos membros inferiores (MMII) precisam de arteriografia para o planejamento da cirurgia de revascularização. A ultrassonografia Doppler (UD) não é invasiva e, através da aferição do índice de resistência (IR), pode fornecer informações sobre as artérias distais. Objetivos Correlacionar a Classificação Angiográfica de Rutherford com o IR na avaliação do leito arterial distal dos MMII. Métodos Estudo transversal, realizado em hospital público terciário, com 120 pacientes portadores de IC dos MMII, entre setembro de 2019 a abril de 2022. Foi comparado o IR das artérias da perna passíveis de serem receptoras de revascularização com a imagem obtida através da arteriografia dessas artérias em acordo com a Classificação Angiográfica de leito distal de Rutherford. Resultados Foram avaliados 120 MMII em 120 pacientes com idade média de 68,6 anos. A amostra foi composta de 50,0% de pacientes do sexo masculino. Na amostra, 90,0% pacientes encontravam-se na classe cinco de Rutherford. Os valores do IR encontrados para as artérias de perna apresentaram uma correlação positiva, estatisticamente significativa, quando comparados com a Classificação de Rutherford (tibial anterior, p< 0,01; tibial posterior, p = 0,012 e fibular, p = 0,034 e artéria dorsal do pé, p < 0,001). Conclusões Neste estudo, os IRs das artérias da perna obtidos através da ultrassonografia Doppler apresentaram uma correlação positiva quando comparados à classificação de Rutherford. Em pacientes com isquemia crítica, esse índice pode ser útil na avaliação do leito arterial distal dos membros inferiores.

Abstract Background Patients with chronic limb threatening ischemia (CLTI) of the lower limbs (LL) undergo arteriography for revascularization surgery planning. Doppler ultrasound (DU) is non-invasive and can provide information about the distal arteries through measurement of the resistance index (RI). Objectives To correlate the Rutherford Angiographic Classification with the RI for assessment of the distal arterial bed of the LL. Methods A cross-sectional study, conducted at a public tertiary hospital with 120 patients with LL CLTI, from September 2019 to April 2022. The RI of arteries that were candidates for revascularization was compared with the images of the same arteries obtained using arteriography, using the Rutherford Angiographic Classification of the distal bed. Results A total of 120 LL were assessed in 120 patients with a mean age of 68.6 years. The sample was 50.0% male and 90.0% of the patients in the sample were classified as Rutherford category five. The RI values found for the arteries of the leg exhibited a statistically significant positive correlation with the Rutherford Classification (anterior tibial, p< 0.01; posterior tibial, p = 0.012 fibular, p = 0.034; and dorsalis pedis, p < 0.001). Conclusions In this study, RIs for the arteries of the leg measured using Doppler ultrasound exhibited a positive correlation with the Rutherford Classification. This index could be useful for assessment of the distal arterial bed of the lower limbs of patients with chronic limb threatening ischemia.

Resource utilization and costs related to the management of obstructive hypertrophic cardiomyopathy under the Brazilian supplementary healthcare system´s perspective: results from a modified Delphi panel / Utilização de recursos e custos relacionados ao manejo da cardiomiopatia hipertrófica obstrutiva sob a perspectiva do sistema de saúde suplementar brasileiro: resultados de um painel Delphi modificado

Objective: To generate data on the costs associated with the diagnosis and treatment of obstructive ypertrophic cardiomyopathy (HCM) from the perspective of the private health system in Brazil. Methods: A modified Delphi panel including seven different specialists (three clinical cardiologists with experience in obstructive HCM, two hemodynamicists with experience in septal ablation and two cardiac surgeons with expertise in myectomy), from two Brazilian states (São Paulo and Pernambuco), was conducted between August and November 2022. Two rounds of questions about the use of healthcare resources according to the functional class (NYHA I-IV) and a panel in a virtual platform were conducted to obtain the final consensus. Micro-costing defined costs and unit values were determined based on official price lists. Results: The total diagnosis cost per patient was estimated at BRL 11,486.81. The obstructive HCM management costs analysis showed average annual costs per patient of BRL 17,026.74, BRL 19,401.46, BRL 73,310.07, and BRL 94,885.75 for the functional classes NYHA I, NYHA II, NYHA III, and NYHA IV, respectively. The average costs per patient related to procedures in a year were BRL 12,698.53, BRL 13,462.30, BRL 58,841.67, and BRL 75,595.90 for the functional classes NYHA I, II, III, and IV, respectively. Conclusions: The annual costs of HCM management increased according to the functional class, highlighting the need for safe and effective strategies to improve patient's NYHA functional class while promoting a decrease in the need for invasive therapies.

Objetivo: Gerar dados acerca dos custos associados ao diagnóstico e tratamento da cardiomiopatia hipertrófica (CMH) obstrutiva, sob a perspectiva do sistema de saúde privado no Brasil. Métodos: Um painel Delphi modificado incluindo sete especialistas (três cardiologistas clínicos com experiência em CMH obstrutiva, dois hemodinamicistas com experiência em ablação de septo e dois cirurgiões cardíacos com experiência em miectomia) de dois estados brasileiros (São Paulo e Pernambuco) foi conduzido entre agosto e novembro de 2022. Foram realizadas duas rodadas de perguntas acerca da utilização de recursos de acordo com a classe funcional (NYHA I-IV) e uma reunião virtual para obtenção do consenso final. Os custos foram definidos por meio de microcusteio, e os valores unitários foram definidos com base em listas de preço oficiais. Resultados: O custo total do diagnóstico por paciente foi estimado em R$ 11.486,81. A análise de custos de manejo da CMH obstrutiva mostrou custos médios anuais por paciente de R$ 17.026,74, R$ 19.401,46, R$ 73.310,07 e R$ 94.885,75 para as classes funcionais NYHA I, NYHA II, NYHA III e NYHA IV, respectivamente. Os custos médios por paciente relacionados a procedimentos em um ano foram de R$ 12.698,53, R$ 13.462,30, R$ 58.841,67 e R$ 75.595,90 para as classes NYHA I, II, III e IV, respectivamente. Conclusões: Os custos anuais com o manejo da CMH aumentam de acordo com a classe funcional, destacando a necessidade de estratégias seguras e eficazes capazes de melhorar a classe funcional NYHA do paciente, ao mesmo tempo que promove diminuição da necessidade de terapias invasivas.

Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

Local therapy in advanced melanoma after immune checkpoint inhibitors aiming to achieve complete response.

Background and Objectives: New scenarios for local therapy have arisen after starting immune checkpoint inhibitors (ICIs) to treat advanced melanoma (AM). The aim of this study is to examine the role of local therapies with curative intention for patients with AM that have been on ICI. Methods: This was a single institution, retrospective analysis of unresectable stage III or IV melanoma patients on treatment with anti-PD1 ± anti-CTLA-4 who underwent local therapy with curative intention with no other remaining sites of disease (NRD). Results: Of the 170 patients treated with ICI, 19 (11.2%) met the criteria of curative intention. The median time on ICI before local therapy was 16.6 months (range: 0.92-43.2). At the time of the local treatment, the disease was controlled in 16 (84.25%) and progressing in 3 patients (15.75%); 14 patients (73.7%) treated a single lesion and 5 (26.3%) treated 2 to 3 lesions. In a median follow-up of 17 months (range: 1.51-38.2) after the local therapy and 9.8 months after the last ICI cycle (range: 0.56-31), only 2 (10.5%) out of 19 patients relapsed. Conclusions: Patients with AM on treatment with ICI were able to achieve NRD after local treatment and may benefit from long-term disease control without systemic treatment.

In-Hospital Management and Long-term Clinical Outcomes and Adherence in Patients With Acute Decompensated Heart Failure: Primary Results of the First Brazilian Registry of Heart Failure (BREATHE).

BACKGROUND: Heart failure (HF), a common cause of hospitalization, is associated with poor short-term clinical outcomes. Little is known about the long-term prognoses of patients with HF in Latin America. METHODS: BREATHE was the first nationwide prospective observational study in Brazil that included patients hospitalized due to acute heart failure (HF). Patients were included during 2 time periods: February 2011-December 2012 and June 2016-July 2018 SUGGESTION FOR REPHRASING: In-hospital management, 12-month clinical outcomes and adherence to evidence-based therapies were evaluated. RESULTS: A total of 3013 patients were enrolled at 71 centers in Brazil. At hospital admission, 83.8% had clear signs of pulmonary congestion. The main cause of decompensation was poor adherence to HF medications (27.8%). Among patients with reduced ejection fraction, concomitant use of beta-blockers, renin-angiotensin-aldosterone inhibitors and spironolactone decreased from 44.5% at hospital discharge to 35.2% at 3 months. The cumulative incidence of mortality at 12 months was 27.7%, with 24.3% readmission at 90 days and 44.4% at 12 months. CONCLUSIONS: In this large national prospective registry of patients hospitalized with acute HF, rates of mortality and readmission were higher than those reported globally. Poor adherence to evidence-based therapies was common at hospital discharge and at 12 months of follow-up.

In-Hospital Management and Long-term clinical outcomes and adherence in patients with acute decompensated heart failure: primary results of the first brazilian registry of heart failure (BREATHE)

BACKGROUND: Heart failure (HF), a common cause of hospitalization, is associated with poor short-term clinical outcomes. Little is known about the long-term prognosis of patients with HF in Latin America. METHODS: BREATHE was the first nationwide prospective observational study in Brazil that included patients hospitalized due to acute HF. Patients were included during 2 time periods: February 2011-December 2012 and June 2016-July 2018. In-hospital management and 12-month clinical outcomes were assessed, and adherence to evidence-based therapies was evaluated. RESULTS: A total of 3013 patients were enrolled at 71 centers in Brazil. At hospital admission, 83.8% had clear signs of pulmonary congestion. The main cause of decompensation was poor adherence to HF medications (27.8%). Among patients with reduced ejection fraction, concomitant use of beta-blockers, renin-angiotensin-aldosterone inhibitors, and spironolactone numerical decreased from 44.5% at hospital discharge to 35.2% at 3 months. The cumulative incidence of mortality at 12 months was 27.7%, with 24.3% readmission at 90 days and 44.4% at 12 months. CONCLUSIONS: In this large national prospective registry of patients hospitalized with acute HF, rates of mortality and readmission were higher than those reported globally. Poor adherence to evidence-based therapies was common at hospital discharge and 12 months of follow-up.

Desfechos clínicos intra-hospitalar e em até 1 ano de seguimento da Takotsubo no Brasil: Registro Brasileiro de Takotsubo (Takosubo Br-R) / In-hospital clinical outcomes and up to 1 year of follow-up of Takotsubo in Brazil: Brazilian Takotsubo Registry (Takosubo Br-R)

FUNDAMENTO: A evolução clinica intra-hospitalar e pós alta da Cardiomiopatia por Takotsubo (CT) assim como o perfil clinico dos pacientes de maior risco prognóstico não estão bem caracterizados nos grandes registros assim como no Brasil. OBJETIVO: Determinar a taxa de mortalidade intrahospitalar (MIH), as características dos pacientes que apresentaram relação com uma maior mortalidade, e a taxa de reincidência de CT(RCT)e mortalidade ao fim de 1 ano pós alta no Brasil. Delineamento e MÉTODOS: Este é um estudo retrospectivo, observacional,multicêntrico envolvendo 25 centros dispersos geograficamente pelo Brasil. Os critérios de inclusão foram de acordo com International Takotsubo Diagnostic Criteria (InterTAK Diagnostic Criteria). A características clinicas, biomarcadores, ECG, ecocardiograma (ECO), ressonância magnética cardíaca (RMC), foram avaliados durante a fase IH. Também foram avaliados a taxa de MIH, e a taxa de RCT, readmissão por DCV e mortalidade em 30 dias, 6 meses e 1 ano pós-alta. RESULTADOS: 448 pacientes foram admitidos CT, onde foi observado uma taxa de MIH de 7,5%. Na análise univariada do perfil clinico os pacientes do sexo masculino (p=0,009), com idade menos avançada (67±14 vs 73±11; P=0,0179), com choque cardiogênico (p<0,0001), sepsis (P<0,0001), fibrilação atrial (p=0,01) apresentaram significativamente maior MIH e dor toráxica (p<0,0001) com menor MIH. Na análise do ecocardiograma, ECG, RMC e peptídeos natriuréticos e Troponina não foram observados correlações significativas com a MIH. Quanto a terapêutica utilizada, os pacientes que usaram betabloqueador (P<0,0001), IECA/BRA (p<0,001) e AAS (p=0,04), demonstraram uma menor MIH. Os pacientes que utilizaram Dobutamina (p<0,0001), NE (P<0,0001) e e Vasopressina (P < 0,0001) demonstraram maior MIH. Na regressão logística de todas a variáveis significativas, a presença de sepsis (OR:6,8;IC-95%:2,3- 19,4;p=0,0005), uso de vasopressina(OR:7,5;IC95%:1,8-31;p=0,005) definiram maior MIH, enquanto que Betabloqueador(OR:0,23;IC-95%:0,1- 0,7;p=0,009) edortoráxica (OR:0,28;IC-95%:0,1-0,8;p=0,02) demonstraram uma menor associação com MIH. No seguimento pós-alta observamos uma taxa acumulativa de RCT, readmissão por DCV e mortalidade em 30 dias (0,2%;0,4%;0,2%);6 meses (0,6%; 1,2%;0,8%) e 12meses (0,8%;2,4%;0,8%) respectivamente. CONCLUSÃO: O Registro Brasileiro de Takotsubo demonstrou características clinicas e de exames complementares semelhantes aos dos registros internacionais com predomino de dor toráxica com alteração do segmento ST, assim como nos desfechos clínicos intra-hospitalares. A Takotsubo apresenta um prognostico benigno nos 12 meses pós alta, com uma baixa taxa de recorrência, readmissão hospitalar e mortalidade. Palavras-chave: Takotsubo; cardiomiopatia neuroadrenergica.

Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study.

AIMS: Chest pain is a major cause of medical evaluation at emergency department (ED) and demands observation to exclude the diagnosis of acute myocardial infarction (AMI). High-sensitivity cardiac troponin assays used as isolated measure and by 0- and 1-h algorithms are accepted as a rule-in/rule-out strategy, but there is a lack of validation in specific populations. METHODS AND RESULTS: The IN-HOspital Program to systematizE Chest Pain Protocol (IN-HOPE study) is a multicentre study that prospectively included patients admitted to the ED due to suspected symptoms of AMI at 16 sites in Brazil. Medical decisions of all patients followed the standard approach of 0 h/3 h protocol, but, in addition, blood samples were also collected at 0 and 1 h and sent to a central laboratory (core lab) to measure high-sensitivity cardiac troponin T (hs-cTnT). To assess the theoretical performance of 0 h/1 h algorithm, troponin < 12 ng/L with a delta < 3 was considered rule-out while a value ≥ 52 or a delta ≥ 5 was considered a rule-in criterion (the remaining were considered as observation group). The main objective of the study was to assess, in a population managed by the 0 h/3 h protocol, the accuracy of 0 h/1 h algorithm overall and in groups with a higher probability of AMI. All patients were followed up for 30 days, and potential events were adjudicated. In addition to the prospective cohort, a retrospective analysis was performed assessing all patients with hs-cTnT measured during the year of 2021 but not included in the prospective cohort, regardless of the indication of the test. A total of 5.497 patients were included (583 in the prospective and 4.914 in the retrospective analysis). The prospective cohort had a mean age of 57.3 (± 14.8) and 45.6% of females with a mean HEART score of 4.0 ± 2.2. By the core lab analysis, 74.4% would be eligible for a rule-out approach (45.3% of them with a HEART score > 3) while 7.3% would fit the rule-in criteria. In this rule-out group, the negative predictive value for index AMI was 100% (99.1-100) overall and regardless of clinical scores. At 30 days, no death or AMI occurred in the rule-out group of both 0/1 and 0/3 h algorithms while 52.4% of the patients in the rule-in group (0 h/1 h) were considered as AMI by adjudication. In the observation group (grey zone) of 0 h/1 h algorithm, GRACE discriminated the risk of these patients better than HEART score. In the retrospective analysis, 1.091 patients had a troponin value of <5 ng/L and there were no cardiovascular deaths at 30 days in this group. Among all 4.914 patients, the 30-day risk of AMI or cardiovascular death increased according to the level of troponin: 0% in the group < 5 ng/L, 0.6% between 5 and 14 ng/L, 2.2% between 14 and 42 ng/L, 6.3% between 42 and 90 ng/L, and 7.7% in the level ≥ 90 ng/L. CONCLUSION: In this large multicentre study, a 0 h/1 h algorithm had the potential to classify as rule-in or rule-out in almost 80% of the patients. The rule-out protocol had high negative predictive value regardless of clinical risk scores. Categories of levels of hs-cTn T also showed good accuracy in discriminating risk of the patients with a very favourable prognosis for cardiovascular death in the group with value < 5 ng/L. CLINICALTRIALS.GOV: NCT04756362.