Sacubitril/Valsartan Versus Enalapril in Chronic Chagas Cardiomyopathy: Rationale and Design of the PARACHUTE-HF Trial.

Chronic Chagas cardiomyopathy (CCC) has unique pathogenic and clinical features with worse prognosis than other causes of heart failure (HF), despite the fact that patients with CCC are often younger and have fewer comorbidities. Patients with CCC were not adequately represented in any of the landmark HF studies that support current treatment guidelines. PARACHUTE-HF (Prevention And Reduction of Adverse outcomes in Chagasic Heart failUre Trial Evaluation) is an active-controlled, randomized, phase IV trial designed to evaluate the effect of sacubitril/valsartan 200 mg twice daily vs enalapril 10 mg twice daily added to standard of care treatment for HF. The study aims to enroll approximately 900 patients with CCC and reduced ejection fraction at around 100 sites in Latin America. The primary outcome is a hierarchical composite of time from randomization to cardiovascular death, first HF hospitalization, or relative change from baseline to week 12 in NT-proBNP levels. PARACHUTE-HF will provide new data on the treatment of this high-risk population. (Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC [PARACHUTE-HF]; NCT04023227).

More Hospital Complications in Women after Cabg Even for Reduced Surgical Times: Call to Action for Equity in Quality Improvement. / Mais Complicações em Mulheres após Revascularização do Miocárdio Mesmo com Tempos Cirúrgicos Reduzidos: Atenção por Equidade e Melhoria da Qualidade.

BACKGROUND: Analyses of extensive registries indicate adverse outcomes for women undergoing coronary artery bypass grafting (CABG) surgery, while randomized studies often lack representativeness. OBJECTIVE: To compare adjusted hospital outcomes between men and women undergoing CABG. METHODS: From July 2017 to June 2019, 3991 patients underwent primary isolated CABG, both electively and urgently, in 5 hospitals in the state of São Paulo, Brazil. To mitigate demographic differences between men and women, populations were adjusted using propensity score matching (PSM). The outcomes considered for analysis were those used by the STS Adult Database. The analyses were performed using R software, with a significance set at p<0.05. RESULTS: After PSM (1:1), each group included 1089 patients. Regarding intraoperative variables, men exhibited longer cardiopulmonary bypass (CPB) time (p<0.001), surgical time (p<0.001), a higher number of distal anastomoses (p<0.001), and increased use of arterial grafts. Regarding outcomes, women had a higher incidence of deep sternal wound infection (p=0.006), prolonged Intensive Care Unit stay (p=0.002), increased need for an intra-aortic balloon pump (p=0.04), higher blood transfusion rates (p<0.001), higher 30-day hospital readmission rates after surgery (p=0.002) and higher mortality rate (p=0.03). CONCLUSIONS: Although men had longer CPB times, a greater number of arterial grafts, and a greater number of distal anastomoses, immediate results after CABG were poorer in women.

FUNDAMENTO: Análises em grandes registros apontam desfechos desfavoráveis para mulheres submetidas à cirurgia de revascularização do miocárdio (CRM), enquanto estudos randomizados sofrem com a falta de representatividade. OBJETIVO: Comparar os resultados hospitalares ajustados entre homens e mulheres submetidos à CRM. MÉTODOS: Entre julho de 2017 e junho de 2019, 3991 pacientes foram submetidos à CRM primária isolada, tanto de forma eletiva como de urgência, em 5 hospitais de estado de São Paulo, Brasil. Para equilibrar as diferenças entre homens e mulheres, as populações foram ajustadas utilizando o Propensity Score Matching. Os desfechos considerados para análise foram os utilizados pelo STS Adult Database. As análises foram conduzidas no software R, considerando significância valores de p < 0,05. RESULTADOS: Após o Propensity Score Matching (1:1), cada grupo incluiu 1089 pacientes. Em relação às variáveis intraoperatórias os homens apresentaram maior tempo de CEC (p<0,001), tempo cirúrgico (p<0,001), número de anastomoses distais (p<0,001) e uso de enxertos arteriais. Em relação aos desfechos as mulheres apresentaram maior incidência de infecção de ferida profunda (p=0,006), tempo prolongado na Unidade de Terapia Intensiva (p=0,002), maior necessidade do uso de balão intraórtico (p=0,04), maior taxa de transfusão sanguínea (p<0,001), maior readmissão hospitalar em até 30 dias após a cirurgia (p=0,002) e maior taxa de óbitos (p=0,03). CONCLUSÕES: Apesar dos homens terem apresentado um maior tempo de CEC, maior número de enxertos arteriais e maior número de anastomoses distais, os resultados imediatos após CRM foram piores em mulheres.

Lipid Control and Medical Costs Among Patients With and Without Established Atherosclerotic Cardiovascular Disease Followed in a Brazilian Private Healthcare System.

Background: There is limited real-world data of lipid control and healthcare costs among patients with and without Atherosclerotic Cardiovascular Disease (ASCVD) in Latin America. Methods: A retrospective cohort study including patients with LDL-cholesterol (LDL-C) assessment from 2015 to 2017 was performed in a health insurance database. Patient characteristics, comorbidities and laboratory data were collected, and International Classification of Diseases (ICD) codes were used to identify a subcohort of patients with ASCVD (secondary prevention) and assess the proportion of these patients with LDL-C controlled. Lipid control among patients without ASCVD (primary prevention) and healthcare costs in one year in the overall population were also assessed. Results: From the 17,434 patients selected, 5,208 (29.8%) had ASCVD. The mean age of these patients in secondary prevention was 68.9 (±12.3) years and 47.8% were male patients. LDL-C < 70 mg/dL was identified in 19.1% of the ASCVD population and only 4.1% had an LDL-C < 50 mg/dL. LDL control was worse in women compared to men (13.1% vs. 25.7%; P < 0.01). The average cost in one year was 3,591 American dollars (USD) per patient in primary prevention compared to 8,210 dollars per year for patients in secondary prevention (P < 0.01). While outpatient costs accounted for 59.8% of the total cost in the primary prevention group, the main cost of the secondary prevention population was related to hospital costs (54.1%). Conclusion: Despite the favorable evidence for intensive cholesterol reduction, the evaluation of large real-world database with more than 17,000 individuals showed that the targets of guideline recommendations have not yet been adequately incorporated into clinical practice. Average annual cost per patient in secondary prevention is more than twice compared to primary prevention. Hospital expenses account for most of the cost in the secondary prevention group, while outpatient costs predominate in primary prevention.

Exposure to Glycolysis-Enhancing Drugs and Risk of Parkinson's Disease: A Meta-Analysis.

Background: Impaired glucose and energy metabolism has been suggested as a pathogenic mechanism underlying Parkinson's disease (PD). In recent cohorts, phosphoglycerate kinase 1 activators (PGK1a) have been associated with a lower incidence of PD when compared with other antiprostatic agents that do not activate PGK1. Objective: We aimed to perform a systematic review and meta-analysis comparing the incidence of PD in patients taking PGK1a versus tamsulosin. Methods: We searched PubMed, Embase, and Cochrane Library for studies comparing PGK1a vs. tamsulosin in adults and elderly. The primary outcome was the incidence of PD. We computed hazard ratios (HR) for binary endpoints, with 95% confidence intervals (CIs). Statistical analysis was performed using Review Manager 5.4 and R (version 4.3.1). Results: A total of 678,433 participants from four cohort studies were included, of whom 287,080 (42.3%) received PGK1a. Mean age ranged from 62 to 74.7 years and nearly all patients were male. Patients taking PGK1a had a lower incidence of PD (PGK1a 1.04% vs. tamsulosin 1.31%; HR 0.80; 95% CI 0.71-0.90; p < 0.01). This result remained consistent in a sensitivity analysis excluding patients of age 60 years old or younger (PGK1a 1.21% vs. tamsulosin 1.42%; HR 0.82; 95% CI 0.71-0.95; p < 0.01). Conclusions: Glycolysis-enhancing drugs are associated with a lower incidence of PD when compared with tamsulosin in adults and elderly individuals with prostatic disease in use of alpha-blockers. Our findings support the notion of glycolysis as a potential neuroprotective mechanism in PD. Future investigations with randomized controlled trials are needed.

It has been suggested that impairment in glucose and energy metabolism is one of the mechanisms underlying the development of Parkinson's disease. In recent studies, medications traditionally prescribed for prostate diseases, called phosphoglycerate kinase 1 activators (PGK1a), have been associated with a lower incidence of Parkinson's disease when compared to other medications for the same purpose that do not activate the same energetic pathway. Therefore, we thoroughly reviewed the literature and combined the results of studies that compared both medications (PGK1a versus another medication  that  does not activate this energetic pathway, called tamsulosin), evaluating the incidence of Parkinson's disease in both groups. We included a total of 678,433 individuals, of whom 42.3% received PGK1a and 57.7% received tamsulosin. In our analysis, patients taking PGK1a had a lower incidence of Parkinson's disease when compared to the other group, even when we excluded patients younger than 60 years of age. As a result, our findings support the notion that the increase of energy metabolism is a potential neuroprotective mechanism in Parkinson's disease and future investigations are needed.

Immune mechanisms and predictive biomarkers related to neoadjuvant immunotherapy response in stage III melanoma.

The treatment for stage III melanoma has advanced significantly, nevertheless, a substantial proportion of patients experience relapse. Neoadjuvant immune checkpoint blockade has emerged as a promising approach, allowing early micrometastatic disease treatment, reduction of tumor burden before surgery, and enhanced tumor-specific T-cell responses. However, not all patients respond to treatment, highlighting the need for understanding immune mechanisms behind failure and identification of predictive markers. Here we performed a robust evaluation of systemic and tumoral immune profiles in a well-defined cohort of advanced melanoma patients treated with immune checkpoint inhibitors. Elevated CTACK and CXCL9 chemokines pre-treatment suggested their potential as predictive tools for treatment response. Furthermore, CD95 expression in CD8+ T lymphocytes surfaced as a favorable prognostic indicator, while PD-1, CD161, and PD-L2 exhibited correlations with worst outcomes. These findings shed light on the intricate interplay between immune markers and melanoma response to neoadjuvant immune checkpoint therapy, offering insights into personalized treatment strategies.

Age, Renal Failure and Transfusion are Risk Predictors of Prolonged Hospital Stay after Coronary Artery Bypass Grafting Surgery. / Idade, Insuficiência Renal e Transfusão são Preditores de Risco de Longa Permanência Hospitalar após Cirurgia de Revascularização do Miocárdio.

BACKGROUND: Identifying risk factors in cardiovascular surgery assists in predictability, resulting in optimization of outcomes and cost reduction. OBJECTIVE: This study aimed to identify preoperative and intraoperative risk predictors for prolonged hospitalization after coronary artery bypass grafting (CABG) surgery in the state of São Paulo, Brazil. METHODS: A cross-sectional analysis using data from the REPLICCAR II database, a prospective, consecutive, multicenter registry that included CABG surgeries performed between August 2017 and July 2019. The primary outcome was a prolonged hospital stay (PHS), defined as a postoperative period exceeding 14 days. Univariate and multivariate logistic regression analyses were performed to identify the predictors with significance set at p <0.05. RESULTS: The median age was 63 (57-70) years and 26.55% of patients were female. Among the 3703 patients analyzed, 228 (6.16%) had a PHS after CABG, with a median hospital stay of 17 (16-20) days. Predictors of PHS after CABG included age >60 years (OR 2.05; 95% CI 1.43-2.87; p<0.001); renal failure (OR 1.73; 95% CI 1.29-2.32; p <0.001) and intraoperative red blood cell transfusion (OR 1.32; 95% CI 1.07-2.06; p=0.01). CONCLUSION: Age >60 years, renal failure, and intraoperative red blood cell transfusion were independent predictors of PHS after CABG. The identification of these variables can help in multiprofessional strategic planning aimed to enhance results and resource utilization in the state of São Paulo.

FUNDAMENTO: A identificação de fatores de riscos na cirurgia cardiovascular auxilia na previsibilidade resultando na otimização de desfechos e redução de custos. OBJETIVO: Identificação dos preditores de risco pré e intraoperatórios para internação prolongada após cirurgia de revascularização do miocárdio (CRM) no Estado de São Paulo. MÉTODOS: Análise transversal no banco de dados REPLICCAR II, registro prospectivo, consecutivo, multicêntrico que incluiu cirurgias de revascularização miocárdica realizadas entre agosto de 2017 e julho de 2019. O desfecho principal foi o tempo de internação prolongado, definida como período de pós-operatório superior a 14 (quatorze) dias. Para a identificação dos preditores foram realizadas análises de regressão logística uni- e multivariada. Os valores de p menores de 0,05 foram considerados significativos. RESULTADOS: A mediana de idade foi de 63 (57-70) anos e 26,55% eram do sexo feminino. Dos 3703 pacientes analisados, 228 (6,16%) apresentaram longa permanência hospitalar (LPH) após a CRM e a mediana da internação foi de 17 (16-20) dias. Foram preditores da LPH após a CRM: idade >60 anos (OR 2,05; IC95% 1,43 - 2,87; p<0,001); insuficiência renal (OR 1,73; IC95% 1,29 - 2,32; p<0,001) e transfusão de hemácias no intraoperatório (OR 1,32; IC 1,07 - 2,06; p=0,01). CONCLUSÃO: Nesta análise, a idade > 60 anos, insuficiência renal e a transfusão de hemácias no intraoperatório foram preditores independentes de LPH após a CRM. A identificação destas variáveis pode ajudar no planejamento estratégico multiprofissional visando melhoria de resultados e otimização de recursos no estado de São Paulo.

Reasons and Expectations for Seeking Spiritual Treatment in Brazilian Spiritist Centers: A Qualitative Study.

The objective of this study is to identify the main motivations and expectations for seeking spiritual treatment (ST) in  spiritist centers. This is a qualitative study developed at two spiritist centers in the state of Mato Grosso, Brazil. ST was considered as the set of activities that use magnetic current as the main treatment method. We observed that most of the participants first sought treatments from health professionals and that, after insufficient results, they went in search of ST. Their treatments take place simultaneously and, for the participants, they complement each other. The motivations that led the participants to ST ranged from physical reasons to mental health complaints and even family conflicts. One possibility for investing in this type of treatment is due to the participants' desire for a more comprehensive approach, and not as a mere solution to the problem that directly afflicts them.

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.

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.

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.

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.

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. Trial Registration: ClinicalTrials.gov Identifier: NCT04062461.

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.

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.