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BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).
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BACKGROUND: Despite significant advances in surgical techniques and perioperative care, people undertaking cardiac surgery due to cardiovascular disease are more prone to the development of postoperative adverse events. Statins (5-hydroxy-3-methylglutaryl-co-enzyme A (HMG-CoA) reductase inhibitors) are well-known for their anti-inflammatory and antioxidant effects and are established for primary and secondary prevention of coronary artery disease. In addition, statins are thought to have clinical benefits in perioperative outcomes in people undergoing cardiac surgery. This review is an update of a review that was first published in 2012 and updated in 2015. OBJECTIVES: To evaluate the benefits and harms of preoperative statin therapy in adults undergoing cardiac surgery compared to standard of care or placebo. SEARCH METHODS: We performed a search of the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 9, 2023), Ovid MEDLINE (1980 to 14 September 2023), and Ovid Embase (1980 to 2023 (week 36)). We applied no language restrictions. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) comparing any statin treatment before cardiac surgery, for any given duration and dose, versus no preoperative statin therapy (standard of care) or placebo. We excluded trials without a registered trial protocol and trials without approval by an institutional ethics committee. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. Primary outcomes were short-term mortality and major adverse cardiovascular events. Secondary outcomes were myocardial infarction, atrial fibrillation, stroke, renal failure, length of intensive care unit (ICU) stay, length of hospital stay and adverse effects related to statin therapy. We reported effect measures as risk ratios (RRs) or mean differences (MDs) with corresponding 95% confidence intervals (CIs). We used the RoB 1 tool to assess the risk of bias in included trials, and GRADE to assess the certainty of the evidence. MAIN RESULTS: We identified eight RCTs (five new to this review) including 5592 participants. Pooled analysis showed that statin treatment before surgery may result in little to no difference in the risk of postoperative short-term mortality (RR 1.36, 95% CI 0.72 to 2.59; I2 = 0%; 6 RCTs, 5260 participants; low-certainty evidence; note 2 RCTs reported 0 events in both groups so RR calculated from 4 RCTs with 5143 participants). We are very uncertain about the effect of statins on major adverse cardiovascular events (RR 0.93, 95% CI 0.77 to 1.13; 1 RCT, 2406 participants; very low-certainty evidence). Statins probably result in little to no difference in myocardial infarction (RR 0.88, 95% CI 0.73 to 1.06; I2 = 0%; 5 RCTs, 4645 participants; moderate-certainty evidence), may result in little to no difference in atrial fibrillation (RR 0.87, 95% CI 0.72 to 1.05; I2 = 60%; 8 RCTs, 5592 participants; low-certainty evidence), and may result in little to no difference in stroke (RR 1.47, 95% CI 0.90 to 2.40; I2 = 0%; 4 RCTs, 5143 participants; low-certainty evidence). We are very uncertain about the effect of statins on renal failure (RR 1.04, 95% CI 0.80 to 1.34; I2 = 57%; 4 RCTs, 4728 participants; very low-certainty evidence). Additionally, statins probably result in little to no difference in length of ICU stay (MD 1.40 hours, 95% CI -1.62 to 4.41; I2 = 43%; 3 RCTs, 4528 participants; moderate-certainty evidence) and overall hospital stay (MD -0.31 days, 95% CI -0.64 to 0.03; I2 = 84%; 5 RCTs, 4788 participants; moderate-certainty evidence). No study had any individual risk of bias domain classified as high. However, two studies were at high risk of bias overall given the classification of unclear risk of bias in three domains. AUTHORS' CONCLUSIONS: In this updated Cochrane review, we found no evidence that statin use in the perioperative period of elective cardiac surgery was associated with any clinical benefit or worsening, when compared with placebo or standard of care. Compared with placebo or standard of care, statin use probably results in little to no difference in MIs, length of ICU stay and overall hospital stay; and may make little to no difference to mortality, atrial fibrillation and stroke. We are very uncertain about the effects of statins on major harmful cardiac events and renal failure. The certainty of the evidence validating this finding varied from moderate to very low, depending on the outcome. Future trials should focus on assessing the impact of statin therapy on mortality and major adverse cardiovascular events.
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Procedimentos Cirúrgicos Cardíacos , Inibidores de Hidroximetilglutaril-CoA Redutases , Complicações Pós-Operatórias , Cuidados Pré-Operatórios , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/mortalidade , Cuidados Pré-Operatórios/métodos , Complicações Pós-Operatórias/prevenção & controle , Infarto do Miocárdio/prevenção & controle , Tempo de Internação , Adulto , Viés , Acidente Vascular Cerebral/prevenção & controleRESUMO
AIM: Patients with a lymphoma diagnosis undergo non-gated chest computed tomography (CT) scans as part of cancer diagnosis or staging. Although coronary artery calcification (CAC) is traditionally evaluated on dedicated cardiac CT, CAC can also be detected on standard chest CT. This exploratory study aimed to determine the prognostic value of CAC detected on non-gated chest CT and to report its use on clinical practice. METHOD: Consecutive patients with a lymphoma diagnosis who performed non-contrasted non-gated chest CT for cancer diagnosis or staging were included and retrospectively evaluated. Coronary artery calcification was evaluated by quantitative (Agatston score) and qualitative (visual) assessment. RESULTS: Fifty-seven patients were included in this study (mean age 61±15 years; 58% male). Coronary artery calcification was identified in 22 patients (39%), most of them with multi-vessel involvement. Coronary artery calcification was qualitatively classified as mild, moderate and severe in 11%, 19% and 9% patients, respectively. This study suggested that moderate or severe CAC was an independent predictor of all-cause mortality (odds ratio 3, 95% confidence interval 2-11; p=0.04) after adjusting for cardiovascular risk factors and lymphoma staging. Regarding quantitative evaluation, a higher CAC score was also associated with higher mortality. While significant CAC was identified in 22 patients, it was only reported in four patients. CONCLUSIONS: The preliminary findings of this hypothesis-generating study support the investigation of CAC identified by chest CT for diagnosis/staging of cancer as a risk modifier in the global risk assessment of patients with lymphoma. The unrecognition and underreporting of this finding may represent a wasted opportunity to detect subclinical coronary atherosclerosis in these patients and may help in guiding preventive cardiology care.
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Doença da Artéria Coronariana , Linfoma , Estadiamento de Neoplasias , Tomografia Computadorizada por Raios X , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco/métodos , Linfoma/diagnóstico , Linfoma/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/diagnóstico por imagem , Idoso , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/diagnóstico , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Taxa de Sobrevida/tendências , Fatores de Risco de Doenças CardíacasRESUMO
BACKGROUND: Falls are always a concern regarding the balance of risk/benefit in patients with atrial fibrillation treated with anticoagulants. In this analysis, we aimed to evaluate the outcomes of patients that had a fall/head injury reported in the RE-LY clinical trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) and to explore the safety of dabigatran (a nonvitamin K antagonist oral anticoagulant). METHODS: We performed a post hoc retrospective analysis of intracranial hemorrhage and major bleeding outcomes in the RE-LY trial with 18 113 individuals with atrial fibrillation, according to the status occurrence of falls (or head injury) reported as adverse events. Multivariate Cox regression models were used to provide adjusted hazard ratio (HR) and 95% CI. RESULTS: In the study, 974 falls or head injury events were reported among 716 patients (4%). These patients were older and had more frequently comorbidities such as diabetes, previous stroke, or coronary artery disease. Patients with fall had a higher risk of major bleeding (HR, 2.41 [95% CI, 1.90-3.05]), intracranial hemorrhage (HR, 1.69 [95% CI, 1.35-2.13]), and mortality (HR, 3.91 [95% CI, 2.51-6.10]) compared to those who did not have reported falls or head injury. Among patients who had falls, those allocated to dabigatran showed a lower intracranial hemorrhage risk (HR, 0.42 [95% CI, 0.18-0.98]) compared with warfarin. CONCLUSIONS: In this population, the risk of falls is important and confers a worse prognosis, increasing intracranial hemorrhage, and major bleeding. Patients who fell and were under dabigatran was associated with lower intracranial hemorrhage risk than those anticoagulated with warfarin, but the analysis was merely exploratory.
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Fibrilação Atrial , Traumatismos Craniocerebrais , Acidente Vascular Cerebral , Humanos , Varfarina/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Dabigatrana/efeitos adversos , Acidentes por Quedas , Estudos Retrospectivos , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/complicações , Hemorragia/induzido quimicamente , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/complicações , Traumatismos Craniocerebrais/complicações , Traumatismos Craniocerebrais/tratamento farmacológicoRESUMO
INTRODUCTION: Scar-related ventricular tachycardia (VT) usually results from an underlying reentrant circuit facilitated by anatomical and functional barriers. The later are sensitive to the direction of ventricular activation wavefronts. We aim to evaluate the impact of different ventricular activation wavefronts on the functional electrophysiological properties of myocardial tissue. METHODS: Patients with ischemic heart disease referred for VT ablation underwent high-density mapping using Carto®3 (Biosense Webster). Maps were generated during sinus rhythm, right and left ventricular pacing, and analyzed using a new late potential map software, which allows to assess local conduction velocities and facilitates the delineation of intra-scar conduction corridors (ISCC); and for all stable VTs. RESULTS: In 16 patients, 31 high-resolution substrate maps from different ventricular activation wavefronts and 7 VT activation maps were obtained. Local abnormal ventricular activities (LAVAs) were found in VT isthmus, but also in noncritical areas. The VT isthmus was localized in areas of LAVAs overlapping surface between the different activation wavefronts. The deceleration zone location differed depending on activation wavefronts. Sixty-six percent of ISCCs were similarly identified in all activating wavefronts, but the one acting as VT isthmus was simultaneously identified in all activation wavefronts in all cases. CONCLUSION: Functional based substrate mapping may improve the specificity to localize the most arrhythmogenic regions within the scar, making the use of different activation wavefronts unnecessary in most cases.
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Ablação por Cateter , Taquicardia Ventricular , Humanos , Cicatriz/diagnóstico , Cicatriz/etiologia , Técnicas Eletrofisiológicas Cardíacas , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/etiologia , Taquicardia Ventricular/cirurgia , Arritmias Cardíacas/cirurgia , Frequência Cardíaca , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodosRESUMO
BACKGROUND: Visual assessment of the percentage diameter stenosis (%DSVE ) of lesions is essential in coronary angiography (CAG) interpretation. We have previously developed an artificial intelligence (AI) model capable of accurate CAG segmentation. We aim to compare operators' %DSVE in angiography versus AI-segmented images. METHODS: Quantitative coronary analysis (QCA) %DS (%DSQCA ) was previously performed in our published validation dataset. Operators were asked to estimate %DSVE of lesions in angiography versus AI-segmented images in separate sessions and differences were assessed using angiography %DSQCA as reference. RESULTS: A total of 123 lesions were included. %DSVE was significantly higher in both the angiography (77% ± 20% vs. 56% ± 13%, p < 0.001) and segmentation groups (59% ± 20% vs. 56% ± 13%, p < 0.001), with a much smaller absolute %DS difference in the latter. For lesions with %DSQCA of 50%-70% (60% ± 5%), an even higher discrepancy was found (angiography: 83% ± 13% vs. 60% ± 5%, p < 0.001; segmentation: 63% ± 15% vs. 60% ± 5%, p < 0.001). Similar, less pronounced, findings were observed for %DSQCA < 50% lesions, but not %DSQCA > 70% lesions. Agreement between %DSQCA /%DSVE across %DSQCA strata (<50%, 50%-70%, >70%) was approximately twice in the segmentation group (60.4% vs. 30.1%; p < 0.001). %DSVE inter-operator differences were smaller with segmentation. CONCLUSION: %DSVE was much less discrepant with segmentation versus angiography. Overestimation of %DSQCA < 70% lesions with angiography was especially common. Segmentation may reduce %DSVE overestimation and thus unwarranted revascularization.
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BACKGROUND: Renal denervation (RDN) has emerged in recent years as a possible treatment for hypertension. The first sham-controlled trial showed a small magnitude and non-significant in the blood pressure (BP) lowering effect, also due to a substantial decrease of BP in sham arm. Considering this, we aimed to quantify the magnitude of BP decrease within the sham arm of Randomized Controlled Trials (RCT) with RDN in patients with hypertension. METHODS: Electronic databases were searched since inception until January 2022 for randomized sham-controlled trials which assessed the efficacy in lowering BP of the sham intervention for catheter-based RDN in adult patients with hypertension. The outcomes were change in ambulatory/office systolic and diastolic BP. RESULTS: A total of 9 RCT were included in the analysis enrolling a total of 674 patients. Sham intervention showed a decrease in all evaluated outcomes. Office systolic BP had a reduction of -5.52 mmHg [95%CI -7.91, -3.13] and office diastolic BP of -2.13 mmHg [95%CI -3.08, -1.17]. Sham procedure for RDN also showed a reduction of -3.41 mmHg [95%CI -5.08, -1.75] in ambulatory systolic BP and - 2.44 mmHg [95%CI -3.31, -1.57] in ambulatory diastolic BP. CONCLUSION: Despite recent data indicating that RDN might be an effective treatment for patients with resistant hypertension when compared to a sham intervention, our results indicate that the sham intervention for RDN also has a significant effect on lowering Office and Ambulatory (24-h) Blood Pressure in adult patients with hypertension. This highlights that BP itself might be sensitive to placebo-like effect and also brings further difficulties in establishing the BP lowering efficacy of invasive interventions due to the magnitude of the sham effect.
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Hipertensão , Adulto , Humanos , Hipertensão/diagnóstico , Hipertensão/cirurgia , Hipertensão/tratamento farmacológico , Rim , Pressão Sanguínea , Resultado do Tratamento , Simpatectomia/efeitos adversos , Simpatectomia/métodos , Anti-Hipertensivos/uso terapêutico , Monitorização Ambulatorial da Pressão ArterialRESUMO
BACKGROUND: Coronary artery calcium (CAC) evaluated on dedicated cardiac computed tomography (CT) is an independent predictor of cardiovascular events. This study aimed to evaluate the correlation between CAC detected on non-gated standard chest CT and coronary lesions on coronary angiography (CAG) and determine its impact on prognosis. METHODS: Consecutive patients who underwent CAG due to acute coronary syndrome and had prior non-contrasted non-gated chest CT were included and retrospectively evaluated. Coronary artery calcium was evaluated by quantitative (Agatston score) and qualitative (visual assessment) assessment. RESULTS: A total of 114 patients were included in this study. The mean time difference between chest CT and CAG was 23 months. Coronary artery calcium was visually classified as mild, moderate, and severe in 31%, 33%, and 16% of patients, respectively. Moderate or severe CAC was an independent predictor of significant lesions on CAG (OR 22; 95% CI 8-61; p<0.001) and all-cause mortality (OR 4; 95% CI 2-9; p=0.001). Quantitative CAC evaluation accurately predicted significant lesions on CAG (AUC 0.81; p<0.001). While significant CAC was identified in 80% of chest CTs, formal reporting was 25%. CONCLUSION: Coronary artery calcium evaluation with chest CT was feasible and strongly associated with severity of coronary disease on CAG and mortality. Although the identification of CAC on chest CT represents a unique opportunity for cardiovascular risk stratification for preventive care, CAC underreporting is frequent.
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Doença da Artéria Coronariana , Calcificação Vascular , Humanos , Cálcio , Vasos Coronários/diagnóstico por imagem , Estudos Retrospectivos , Fatores de Risco , Calcificação Vascular/diagnóstico por imagem , Doença da Artéria Coronariana/complicações , Tomografia Computadorizada por Raios X , Angiografia Coronária/métodos , Valor Preditivo dos TestesRESUMO
BACKGROUND: Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis. METHODS: We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed. RESULTS: A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03). CONCLUSIONS: Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.).
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Anti-Inflamatórios/administração & dosagem , Colchicina/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Idoso , Angina Pectoris/epidemiologia , Anti-Inflamatórios/efeitos adversos , Biomarcadores/sangue , Proteína C-Reativa/análise , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Colchicina/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Incidência , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Modelos de Riscos Proporcionais , Recidiva , Acidente Vascular Cerebral/epidemiologiaRESUMO
BACKGROUND: Automated systems for substrate mapping in the context of ventricular tachycardia (VT) ablation may annotate far-field rather than near-field signals, rendering the resulting maps hard to interpret. Additionally, quantitative assessment of local conduction velocity (LCV) remains an unmet need in clinical practice. We evaluate whether a new late potential map (LPM) algorithm can provide an automatic and reliable annotation and localized bipolar voltage measurement of ventricular electrograms (EGMs) and if LCV analysis allows recognizing intrascar conduction corridors acting as VT isthmuses. METHODS: In 16 patients referred for scar-related VT ablation, 8 VT activation maps and 29 high-resolution substrate maps from different activation wavefronts were obtained. In offline analysis, the LPM algorithm was compared to manually annotated substrate maps. Locations of the VT isthmuses were compared with the corresponding substrate maps in regard to LCV. RESULTS: The LPM algorithm had an overall/local abnormal ventricular activity (LAVA) annotation accuracy of 94.5%/81.1%, which compares to 83.7%/23.9% for the previous wavefront algorithm. The resultant maps presented a spatial concordance of 88.1% in delineating regions displaying LAVA. LAVA median localized bipolar voltage was 0.22 mV, but voltage amplitude assessment had modest accuracy in distinguishing LAVA from other abnormal EGMs (area under the curve: 0.676; p < .001). LCV analysis in high-density substrate maps identified a median of two intrascar conduction corridors per patient (interquartile range: 2-3), including the one acting as VT isthmus in all cases. CONCLUSION: The new LPM algorithm and LCV analysis may enhance substrate characterization in scar-related VT.
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Ablação por Cateter , Taquicardia Ventricular , Algoritmos , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Cicatriz/diagnóstico , Cicatriz/etiologia , Frequência Cardíaca , Humanos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/cirurgiaRESUMO
INTRODUCTION: The summary of product characteristics of vaccines administered intramuscularly, including the vaccine for coronavirus SARS-CoV-2 (COVID-19) and Influenza, warned for risks of bleeding in patients treated with oral anticoagulants. We aimed to estimate the incidence of major bleeding events in this setting and to compare these risks against other vaccination routes. METHODS: This systematic review included all prospective and retrospective studies enrolling anticoagulated patients that received intramuscular vaccination, published until December 2020 in CENTRAL, MEDLINE and EMBASE. The outcomes of interest were major bleeding and haematoma related with vaccination. The incidence of the outcomes was estimated through a random-effects meta-analysis using the Freeman-Turkey transformation. The results are expressed in percentages, with 95%-confidence intervals (95%CI), limited between 0 and 100%. When studies compared intramuscular vaccination vs. other route, the data were compared and pooled using random-effects meta-analysis. Risk ratios (RR) with 95%CI were reported. RESULTS: Overall 16 studies with 642 patients were included. No major bleeding event was reported. The pooled incidence of haematomas following vaccination (mostly against Influenza) in patients treated with oral anticoagulants (mostly warfarin; no data with DOACs / NOACs) was 0.46% (95%CI 0-1.53%). Three studies evaluated the intramuscular vs. subcutaneous route of vaccination. Intramuscular vaccines did not increase the risk of haematoma (RR 0.53, 95%CI 0.10-2.82) compared with subcutaneous route. CONCLUSIONS: Intramuscular vaccination in anticoagulated patients is safe with very low incidence of haematomas and the best available evidence suggests that using the intramuscular route does not increase the risk of haematomas compared with the subcutaneous route.
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BACKGROUND: Some patients with chronic coronary syndromes undergo invasive procedures but the efficacy of such interventions remains to be robustly established by randomised sham-controlled trials (RCTs). PURPOSE: To determine the sham effect in patients with chronic coronary syndromes enrolled in RCTs by performing a systematic review and meta-analysis. METHODS: In April 2022, we performed a literature search for published patient-blind RCTs (CENTRAL, MEDLINE®, PsycINFO, and reference lists) with sham procedures, reporting the pre-post effects in the invasive sham arm among patients with Canadian cardiovascular society (CCS) angina or angina equivalents. RESULTS: 16 RCTs were included with 546 patients in the sham arm. Pooled results showed that sham interventions were associated with: improvement of 7% (95% CI 2-11%; I2 = 0%) in exercise time; decrease of 0.78 (95% CI - 1.10 to - 0.47; I2 = 75%) in CCS angina class; decrease of 53% (95% CI 24-71%; I2 = 96%) and 25% (95% CI 20-29%; I2 = 0%) in anginal episodes and nitroglycerine (NTG) use, respectively. Pooled results also showed an improvement in the physical functioning, angina frequency, treatment satisfaction, and disease perception domains of the Seattle Angina Questionnaire (SAQ). CONCLUSION: Sham interventions in patients with chronic coronary syndromes were associated with a significant decrease in anginal episodes, NTG use, and CCS angina class and increased SAQ quality of life and exercise time. These results highlight the need for previous non sham-controlled trials to be interpreted with caution, and the importance of new invasive interventions to be evaluated versus a sham procedure.
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Angina Pectoris , Doença da Artéria Coronariana , Ensaios Clínicos Controlados Aleatórios como Assunto , Angina Pectoris/diagnóstico , Angina Pectoris/terapia , Canadá , Doença da Artéria Coronariana/terapia , Humanos , Placebos , Qualidade de Vida , SíndromeRESUMO
TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) is carried out in various clinical settings, with an increasing importance, and sedation usually is required to perform it. Several sedative agents are available, and the authors aimed to compare the cardiovascular and respiratory safety of the strategies used for sedation in TEE through a systematic review with network meta-analysis (NMA). The MEDLINE, CENTRAL, EMBASE, and PsycInfo databases were searched in December 2020 for randomized clinical trials (RCTs) comparing sedation strategies for patients undergoing TEE. The authors assessed variations in systolic blood pressure (SBP), heart rate (HR), and peripheral oxygen saturation (SpO2), along with the incidences of hypotension, bradycardia, and desaturation. A random-effect meta-analysis was performed. Nine RCTs (N = 881 patients) with 20 active arms (5 dexmedetomidine; 4 propofol; 4 midazolam; 3 midazolam + opioid; 2 ketamine + propofol; 1 midazolam + ondansetron; 1 midazolam + metoclopramide) and 1 placebo arm were included. Dexmedetomidine was associated with decreases in SBP (mean difference [MD] = -18.78 mmHg; 95% CI [-26.27 to -11.28]) and HR (MD = -11.15 beats/min; 95% CI [-16.15 to -6.15]). Dexmedetomidine significantly reduced the HR compared with ketamine + propofol (-16.90 beats/min; 95% CI: -33.21 to -0.58]) and midazolam + opioid (-24.15 beats/min; 95% CI: -42.67 to -5.63). Midazolam was found to reduce SBP (-12.09 mmHg; 95% CI: -20.43 to -3.74) and was shown to reduce SpO2 compared with the placebo (-1.00%; 95% CI -1.74 to -0.26). Based on the NMA, the drugs with a higher likelihood of decreasing both SBP and HR were dexmedetomidine and midazolam. All of the drugs led to a small decrease (only statistically significant for midazolam) in SpO2, with the systematic use of supplemental O2 in some trials. The risks of hypotension, bradycardia, or desaturation were not significantly different among the evaluated drugs.
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Dexmedetomidina , Hipotensão , Ketamina , Propofol , Analgésicos Opioides , Bradicardia/induzido quimicamente , Ecocardiografia Transesofagiana/efeitos adversos , Humanos , Hipnóticos e Sedativos/efeitos adversos , Hipotensão/induzido quimicamente , Hipotensão/prevenção & controle , Metoclopramida , Midazolam/efeitos adversos , Metanálise em Rede , OndansetronRESUMO
PURPOSE OF REVIEW: Hypertension represents the most important cardiovascular risk factor, affecting over 4.06 billion adults worldwide. In this review, we will discuss potential barriers and their solutions to improve prevention, detection, and management of hypertension. RECENT FINDINGS: The prevalence of hypertension has been increasing in low- and middle-income countries, requiring new strategies to improve its recognition and proper management. The World Heart Federation (WHF) developed a roadmap for hypertension, advising health system policies and clinical practices as part of its commitment to improving global cardiovascular health. The World Health Organization (WHO) has published in 2021 practical guidelines for the pharmacological treatment of hypertension in adults. Identifying potential roadblocks and solutions deserves high priority to improve the detection, management, and control of hypertension.
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Hipertensão , Adulto , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , PrevalênciaRESUMO
AIMS: The impact of opioids in acute heart failure (AHF) is unclear. This systematic review with meta-analysis aimed to evaluate the mortality risk associated with opioid use in AHF. METHODS AND RESULTS: An electronic search was performed in MEDLINE, CENTRAL, Web of Science Core Collection, and SCIELO (December 2019) for randomized controlled trials and observational studies evaluating the impact of opioids in in-hospital and 30-day mortality in patients with AHF. Data were screened, extracted, and appraised by 2 independent reviewers. A random-effects meta-analysis to estimate the pooled odds ratios (OR) with 95% confidence intervals (CI) was performed and heterogeneity was evaluated using the I2 statistics. Six observational retrospective studies with 151,735 participants were included. Pooled results showed a statistical significant association between morphine and in-hospital mortality (OR 1.78; 95% CI 1.01-3.13; I2 = 92%; 6 studies) and 30-day mortality (OR 1.56; 95% CI 1.14-2.15; I2 = 0; 2 studies). Both outcomes were rated as having a serious risk of bias and had a very low Grading of Recommendation, Assessment, Development, and Evaluation evidence. CONCLUSIONS: Opioids seem to be associated with an increased risk of short-term mortality in AHF patients; however, the confidence in the estimated effect is very low, which highlights the need of further research to evaluate this question.
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Insuficiência Cardíaca/mortalidade , Mortalidade Hospitalar , Antagonistas de Entorpecentes/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Estudos Observacionais como Assunto , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: Nationwide hospital admissions data series have contributed to a reliable assessment of the changing epidemiology of infective endocarditis, even though conclusions are not uniform. We sought to use a recent populational series to describe the temporal trends on the incidence of infective endocarditis, its clinical characteristics and outcome results, in Portugal. METHODS: A nationwide retrospective temporal trend study on the incidence and clinical characterization of patients hospitalized with infective endocarditis, between 2010 and 2018. RESULTS: 7574 patients were hospitalized with infective endocarditis from 2010 to 2018 in Portuguese public hospitals. The average length of hospitalization was 29.3 ± 28.7 days, predominantly men (56.9%), and 47.1% had between 60 and 79 years old. The most frequent infectious agents involved were Staphylococcus (16.4%) and Streptococcus (13.6%). During hospitalization, 12.4% of patients underwent heart valve surgery and 20% of the total cohort died. After a 1-year post-discharge follow-up, 13.2% of the total initial cohort had had heart valve surgery and 21.2% in total died. The annual incidence of infective endocarditis was 8.31 per 100,000 habitants, being higher in men (9.96 per 100,000 in males versus 6.82 in females, p < 0.001) and increased with age, peaking at patients 80 years old or older (40.62 per 100,000). In-hospital mortality rate significantly increased during the analyzed period, the strongest independent predictors being ischemic or hemorrhagic stroke, sepsis, and acute renal failure. Younger age and cardiac surgery had a protective effect towards a fatal outcome. CONCLUSIONS: In Portugal, between 2010 and 2018, the incidence of infective endocarditis presented a general growth trend with a deceleration in the most recent years. Also, a significant rate of in-hospital complications, a mildly lower than expected stable surgical rate and a still high and growing mortality rate were noted.
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Endocardite Bacteriana/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Endocardite Bacteriana/microbiologia , Endocardite Bacteriana/mortalidade , Endocardite Bacteriana/terapia , Feminino , Hospitalização/tendências , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Portugal , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Adulto JovemRESUMO
BACKGROUND: Cavotricuspid isthmus (CTI) ablation in typical atrial flutter (AFL) restores sinus rhythm in 95% of patients, which may lead to the discontinuation of oral anticoagulation during follow-up. Therefore, we aimed to systematically review the clinical impact of oral anticoagulation in the incidence of thromboembolic events (TE) after typical AFL ablation. METHODS: We searched for controlled studies evaluating the impact of anticoagulation in the incidence of TE in patients submitted to AFL ablation in MEDLINE, CENTRAL, PsycINFO database (June/2021). The primary outcome was TE events (ischemic stroke or systemic embolism). A meta-analysis was performed deriving risk ratios (RR) and 95% confidence intervals (CI). Statistical heterogeneity was measured through I2 metric. The confidence in the evidence was appraised with Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. RESULTS: Eight observational studies with 4870 patients were included. TE events were not significantly reduced (RR 1.18, 95% CI 0.59-2.36; n = 4870; GRADE very low). A meta-regression showed that for each 10% increase in the prevalence of previous AF in the studied population, anticoagulation reduced TE risk in 32%. There were no significant differences regarding bleeding events (RR 2.16, 95% CI 0.43-10.97, I2 = 0%; GRADE low), but there was a lower all-cause mortality (RR 0.24, 95% CI 0.17-0.32, GRADE low). CONCLUSION: The best available evidence lacks robustness and the data did not definitely associate anticoagulation after typical AFL ablation with reduced TE.
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Anticoagulantes/administração & dosagem , Flutter Atrial/cirurgia , Ablação por Cateter , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia/prevenção & controle , Administração Oral , HumanosRESUMO
BACKGROUND: Cardiac resynchronization therapy demonstrated benefits in heart failure. However, only 60-70% are responders and only 22% are super-responders. MultiPoint pacing (MPP) improves structural remodeling, but data in responder patients is scarce. METHODS: A prospective, randomized study of the efficacy of MPP was conducted in patients who were CRT responders after 6 months of bi-ventricular (BiV) therapy. At 6 months, responder patients (LV end-systolic volume [LVESV] reduction ≥15%) were randomized to either continued BiV therapy or to MPP programmed with wide anatomical separation ≥30 mm, and followed until 12 months. Efficacy was determined by 6-12 month changes in LVESV and LV ejection fraction (LVEF). Evaluations of super-responder rate (LVESV reduction ≥30%) and quality of life (NYHA, EQ-5D, MLHFQ) were also performed. RESULTS: From February 2017 to February 2019, 73 CRTs with Quartet LV leads were implanted (42.9% female, 65.7 ± 10.8 years old, 79.5% dilated cardiomyopathy). At 6 months, 74.2% responded to BiV and were randomized to BiV (n = 25) or MPP (n = 24). MPP versus BiV delivered greater LVESV improvement (8.3% decrease in MPP vs. 10.3% increase in BiV patients, p = .047), greater increase in LVEF (7.7% vs. 1.8%, p = .008), and higher 0-12 month super-responder rate (86.4% vs. 56.0%, p = .027). More MPP vs. BiV patients experienced an improvement in NYHA (84.6% vs. 50.0%, p = .047) and EQ-5D (94.4% vs. 54.0%, p = .006). CONCLUSIONS: MPP with wide anatomical spacing in CRT responder patients resulted in improved LV reverse remodeling with higher rates of super-responders, and better quality of life metrics.
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Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca/métodos , Insuficiência Cardíaca/terapia , Implantação de Prótese/métodos , Idoso , Feminino , Humanos , Masculino , Estudos Prospectivos , Qualidade de Vida , Volume Sistólico , Remodelação VentricularRESUMO
OBJECTIVE: Pulmonary embolism (PE) is a common complication of SARS-CoV-2 infection. Several diagnostic prediction rules based on pretest probability and D-dimer have been validated in non-COVID patients, but it remains unclear if they can be safely applied in COVID-19 patients. We aimed to compare the diagnostic accuracy of the standard approach based on Wells and Geneva scores combined with a standard D-dimer cut-off of 500 ng/mL with three alternative strategies (age-adjusted, YEARS and PEGeD algorithms) in COVID-19 patients. METHODS: This retrospective study included all COVID-19 patients admitted to the Emergency Department (ED) who underwent computed tomography pulmonary angiography (CTPA) due to PE suspicion. The diagnostic prediction rules for PE were compared between patients with and without PE. RESULTS: We included 300 patients and PE was confirmed in 15%. No differences were found regarding comorbidities, traditional risk factors for PE and signs and symptoms between patients with and without PE. Wells and Geneva scores showed no predictive value for PE occurrence, whether a standard or an age-adjusted cut-off was considered. YEARS and PEGeD algorithms were associated with increased specificity (19% CTPA reduction) but raising non-diagnosed PE. Despite elevated in all patients, those with PE had higher D-dimer levels. However, incrementing thresholds to select patients for CTPA was also associated with a substantial decrease in sensitivity. CONCLUSION: None of the diagnostic prediction rules are reliable predictors of PE in COVID-19. Our data favour the use of a D-dimer threshold of 500 ng/mL, considering that higher thresholds increase specificity but limits this strategy as a screening test.
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COVID-19/complicações , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/virologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Algoritmos , COVID-19/sangue , COVID-19/diagnóstico por imagem , Angiografia por Tomografia Computadorizada , Serviço Hospitalar de Emergência , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Portugal , Valor Preditivo dos Testes , Embolia Pulmonar/sangue , Estudos RetrospectivosRESUMO
AIMS: The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether time-to-treatment initiation (TTI) influences the beneficial impact of colchicine. METHODS AND RESULTS: In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (<3, 4-7 and >8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo [hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32-0.84], in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53-1.75) or > Day 8 (HR = 0.82, 95% CI 0.61-1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05). CONCLUSION: Patients benefit from early, in-hospital initiation of colchicine after MI. TRIAL REGISTRATION: COLCOT ClinicalTrials.gov number, NCT02551094.