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ABSTRACT: Recent studies have proven benefit of SGLT2i drugs in patients with heart failure with reduced ejection fraction (HFrEF), but their safety when combined with angiotensin-neprilysin inhibitor (ARNI) has not been established. The Safety and Efficacy of the Combination of Sacubitril/Valsartan and SGLT2i in HFrEF Patients registry was conducted to address this issue. SECSI registry is a consecutive, observational, retrospective, multicentre study conducted in 3 Heart Failure Units in Spain. It included 144 HFrEF patients who were treated with ARNI and iSGLT2. Data were collected at baseline, month 2, and month 6. The primary endpoint was the estimated glomerular filtration rate (eGFR), after the initiation of ARNI and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Secondary endpoints included potassium levels and functional class (New York Heart Association class). There were 3 prespecified subgroup analyses: Elderly patients (≥70 years), patients with chronic kidney disease (KDIGO classification G3), and the sequence of drug initiation. Mean age was 69.9 ± 10.1 years, and 110 (76.4%) were men. Left ventricular ejection fraction was 32 ± 7.8%, and most patients were symptomatic [123 (87.2%) New York Heart Association II/III/IV]. eGFR decreased at month 2 and this trend was maintained at month 6 [eGFR baseline 68.5 ± 17.3, month 2 62 ± 19.7 and month 6 64.7 ± 8.6 mL/min/1.73 m2 (P < 0.01 for both)]. In prespecified analysis, elder patients and those who simultaneously initiate both treatments showed the steeper decrease in eGFR. To conclude, co-administration of SGLT2i and ARNI in routine care in HFrEF patients produced a slight decrease in eGFR at 6 months of follow-up. This decrease was especially significant in elder patients and those who initiate both drugs simultaneously.
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Aminobutiratos/uso terapêutico , Bloqueadores do Receptor Tipo 1 de Angiotensina II/uso terapêutico , Compostos de Bifenilo/uso terapêutico , Taxa de Filtração Glomerular/efeitos dos fármacos , Insuficiência Cardíaca Sistólica/tratamento farmacológico , Rim/efeitos dos fármacos , Inibidores de Proteases/uso terapêutico , Insuficiência Renal Crônica/tratamento farmacológico , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Valsartana/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Aminobutiratos/efeitos adversos , Bloqueadores do Receptor Tipo 1 de Angiotensina II/efeitos adversos , Compostos de Bifenilo/efeitos adversos , Combinação de Medicamentos , Feminino , Insuficiência Cardíaca Sistólica/diagnóstico , Insuficiência Cardíaca Sistólica/fisiopatologia , Humanos , Rim/fisiopatologia , Masculino , Pessoa de Meia-Idade , Neprilisina/antagonistas & inibidores , Inibidores de Proteases/efeitos adversos , Sistema de Registros , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/fisiopatologia , Estudos Retrospectivos , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Espanha , Volume Sistólico/efeitos dos fármacos , Fatores de Tempo , Resultado do Tratamento , Valsartana/efeitos adversos , Função Ventricular Esquerda/efeitos dos fármacosRESUMO
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as a new threat to healthcare systems. In this setting, heart failure units have faced an enormous challenge: taking care of their patients while at the same time avoiding patients' visits to the hospital. OBJECTIVE: The aim of this study was to evaluate the results of a follow-up protocol established in an advanced heart failure unit at a single center in Spain during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: During March and April 2020, a protocolized approach was implemented in our unit to reduce the number of outpatient visits and hospital admissions throughout the maximum COVID-19 spread period. We compared emergency room (ER) visits, hospital admissions, and mortality with those of January and February 2020. RESULTS: When compared to the preceding months, during the COVID pandemic there was a 56.5% reduction in the ER visits and a 46.9% reduction in hospital admissions, without an increase in mortality (9 patients died in both time periods). A total of 18 patients required a visit to the outpatient clinic for decompensation of heart failure or others. CONCLUSION: Our study suggests that implementing an active-surveillance protocol in acutely decompensated heart failure units during the SARS-CoV-2 pandemic can reduce hospital admissions, ER visits and, potentially, viral transmission, in a cohort of especially vulnerable patients.
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Infecções por Coronavirus/prevenção & controle , Serviço Hospitalar de Emergência/estatística & dados numéricos , Insuficiência Cardíaca/mortalidade , Pacientes Ambulatoriais/estatística & dados numéricos , Pandemias/prevenção & controle , Admissão do Paciente/estatística & dados numéricos , Pneumonia Viral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus , COVID-19 , Protocolos Clínicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância em Saúde Pública , SARS-CoV-2 , Espanha/epidemiologiaRESUMO
OBJECTIVE: Morphological and functional right ventricular (RV) changes during normal pregnancy remain poorly characterized. Similar to left ventricle, RV load and function are expected to change, and establishing reference values for RV during a healthy pregnancy is critical for the evaluation of pregnancy-related heart disease. The aim of the study was to describe RV adaptation in a prospective cohort. METHODS: Serial echocardiographic examinations were performed in second trimester (24 ± 2 weeks), third (32 ± 2 week) trimester, and postpartum (>3 months after delivery). Nulliparous women were evaluated as control group. RV linear dimensions, areas, and function were assessed and compared. RESULTS: Forty-three pregnant women were evaluated and compared with nineteen nulliparous women as control. Function parameters decreased along gestation. RV fractional area fell from second to third trimester (52.01 ± 0.92 vs 48.73 ± 0.97, P < .05), as well as tricuspid annular plane systolic excursion (2.62 ± 0.05 vs 2.41 ± 0.05, P < .05); however, RV longitudinal strain (L) decreased earlier, showing main changes from second trimester (26.17 ± 0.86 vs 22.71 ± 0.57, P < .003, control vs second trimester). S'-wave velocity followed a different pattern without changes during pregnancy. RV diameters significantly increased during pregnancy: basal (3.65 ± 0.06 vs 3.90 ± 0.06, P < .05), mid- (2.70 ± 0.06 vs 3.00 ± 0.07, P < .05), longitudinal (6.90 ± 0.09 vs 7.32 ± 0.11, P < .05), and right ventricle outflow tract proximal diameter (3.20 ± 0.06 vs 3.44 ± 0.06, P < .05). RV areas also suffered early variation during pregnancy. In postpartum evaluation, all these changes were reversed. CONCLUSION: During pregnancy, RV experiments important variations. RV size increases, and its function decreases. Changes in LS were earlier compared with other function measures.
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Ventrículos do Coração , Função Ventricular Direita , Ecocardiografia , Feminino , Ventrículos do Coração/diagnóstico por imagem , Humanos , Gravidez , Estudos Prospectivos , Valores de ReferênciaRESUMO
AIMS: Combination of hypertonic saline solution (HSS) with intravenous loop diuretics has been suggested to improve diuretic response in patients hospitalized for heart failure (HF). The efficacy and safety of this approach in the ambulatory setting remain unexplored. METHODS AND RESULTS: In this multicentre, double-blind, randomized study, we allocated ambulatory patients with worsening heart failure (WHF) to a 1-h infusion of intravenous furosemide (ivFurosemide)-HSS versus ivFurosemide. The primary endpoint was the volume of diuresis at 3 h. Secondary endpoints included 3-h natriuresis and weight variation, 7-day congestion data, kidney function and electrolytes, and 30-day clinical events. Overall, 167 participants (median age: 81 years, 30.5% female) were randomized across 13 sites between December 2020 and March 2023. There were no differences in 3-h diuresis between treatments (ivFurosemide-HSS: 1099 ml vs. ivFurosemide: 1103 ml, p = 0.963), 3-h natriuresis (∆ +2.642 mEq/L, p = 0.559), or 3-h weight (∆ +0.012 kg, p = 0.920). Patients in the ivFurosemide-HSS arm experienced significant weight decrease at 7 days (Δ -0.586 kg, p = 0.048). There were no between-treatment differences in clinical congestion score, biomarkers, inferior vena cava diameter, or the presence of lung ultrasound B-lines. At 30 days, 26.5% of the patients in the ivFurosemide-HSS group versus 33.3% in the ivFurosemide group experienced WHF (hazard ratio 0.76, p = 0.330). The incidence of death from any cause or HF hospitalization was 6% of patients in the ivFurosemide-HSS group and 8.3% of patients in the ivFurosemide group (hazard ratio 0.69, p = 0.521). The incidence of worsening kidney function or metabolic derangements was not significantly different in the two arms. CONCLUSIONS: A single infusion of ivFurosemide-HSS did not improve 3-h diuresis or congestion parameters in patients with ambulatory WHF. This therapy showed an appropriate safety profile.
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Background: Heart Failure (HF) is a growing epidemic with a similar prevalence in men and women. However, women have historically been underrepresented in clinical trials, leading to uneven evidence regarding the benefit of guideline-directed medical therapy (GDMT). This review aims to outline the sex differences in the efficacy of pharmacological and non-pharmacological treatment of HF with reduced ejection fraction (HFrEF). Methods and results: We conducted a systematic review via Medline from inception to 31 January 2022, including all randomized clinical trials published in English including adult patients suffering HFrEF that reported data on the efficacy of each drug. Baseline clinical characteristics, primary outcomes, and sex-specific effects are summarized in tables. The systemic review has been conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. In total, 29 articles were included in the systematic review. We observed that the proportion of women enrolled in clinical trials was generally low, the absence of a prespecified analysis of efficacy by sex was frequent, and the level of quality of evidence on the efficacy of GDMT and implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-) in women was relatively poor. Conclusions: Sex influences the response to treatment of patients suffering from HFrEF. All the results from the landmark randomized clinical trials are based on study populations composed mainly of men. Further studies specifically designed considering sex differences are warranted to elucidate if GDMT and new devices are equally effective in both sexes.
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The optimal duration of anticoagulation in patients with left-ventricular thrombus (LVT) is unclear. In the present study, we aimed to analyze the effect of treatment duration (≤12 months [short-term anticoagulation, (STA)] versus >12 months [long-term anticoagulation, (LTA)]) in the incidence of stroke and other secondary outcomes (acute myocardial infarction, bleeding, and mortality). Multivariate Cox regression was used to determine the association between treatment duration and stroke, adjusted for baseline embolic risk. A total of 98 cases of LVT (age 64.3 ± 12.8 years, female 18 [18%]) were identified. Sixty-one patients (62%) received LTA. Patients receiving LTA were older than those receiving STA (66.5 ± 11.6 vs 60.7 ± 13.9 years, p = 0.029), more often had atrial fibrillation (31% vs 0%, p <0.001), and had a higher CHA2DS2-VASc score (4.3 ± 1.6 vs 3.6 ± 1.6, p = 0.046). Stroke occurred in 2 and 10 patients (3% vs 27%, p <0.001), acute myocardial infarction in 2 and 3 patients (3% vs 8%, p = 0.292), bleeding in 4 and 3 patients (7% vs 8%, p = 0.773), and mortality in 12 and 7 patients (20% vs 19%, p = 0.927) in the LTA and STA groups, respectively. In multivariate analysis, after adjusting for embolic risk, LTA was associated with decreased risk of stroke at 5 years (adjusted hazard ratio 0.16; 95% confidence interval 0.03 to 0.72, p = 0.017). In conclusion, our data suggest that prolonged anticoagulation in patients with LVT may be associated with significantly lower risk of stroke.
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Fibrilação Atrial , Embolia , Infarto do Miocárdio , Acidente Vascular Cerebral , Trombose , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Anticoagulantes/uso terapêutico , Incidência , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Hemorragia/epidemiologia , Trombose/epidemiologia , Trombose/complicações , Embolia/epidemiologia , Infarto do Miocárdio/epidemiologia , Fatores de Risco , Medição de Risco , Estudos RetrospectivosRESUMO
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has emerged as a new threat, not only to Health Care systems but also to citizen's freedom of movement in many developed countries. CASE SUMMARY: We report a suicidal attempt in a destination therapy left ventricular assist device patient, potentially triggered by coronavirus disease 2019 (COVID-19) lockdown, highlighting the importance of regular and long-term psychological support for this vulnerable population. DISCUSSION: The psychological consequences of this pandemic, particularly in chronically ill patients, are yet to be defined.
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AIM: Differences exist in the diagnosis and treatment of acute coronary syndrome (ACS) between men and women. However, recent advancements in the management of ACSs might have attenuated this sex gap. We evaluated the status of ACS management in a multicenter registry in 10 tertiary Spanish hospitals. METHODS: We enrolled 1056 patients in our study, including only those with type 1 myocardial infarctions or unstable angina presumably not related to a secondary cause in an 'all-comers' design. RESULTS: The women enrolled (29%) were older than men (71.0â±â12.8 vs. 64.0â±â12.3, Pâ=â0.001), with a higher prevalence of hypertension (71.0 vs. 56.5%, Pâ<â0.001), insulin-treated diabetes (13.7 vs. 7.9%, Pâ=â0.003), dyslipidemia (62.2 vs. 55.3%, Pâ=â0.038), and chronic kidney disease (16.9 vs. 9.1%, Pâ=â0.001). Women presented more frequently with back or arm pain radiation (57.3 vs. 49.7%, Pâ=â0.025), palpitations (5.9 vs. 2.0%, Pâ=â0.001), or dyspnea (33.0 vs. 19.4%, Pâ=â0.001). ACS without significant coronary stenosis was more prevalent in women (16.8 vs. 8.1%, Pâ=â0.001). There were no differences in percutaneous revascularization rates, but drug-eluting stents were less frequently employed in women (75.4 vs. 67.8%, Pâ=â0.024); women were less often referred to a cardiac rehabilitation program (19.9 vs. 33.9%, Pâ=â0.001). There were no significant differences in in-hospital complications such as thrombosis or bleeding. CONCLUSION: ACS presenting with atypical symptoms and without significant coronary artery stenosis is more frequent in women. Selection of either an invasive procedure or conservative management is not influenced by sex. Cardiac rehabilitation referral on discharge is underused, especially in women.