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1.
JAMA Netw Open ; 7(3): e240809, 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38446482

RESUMO

Importance: The MOSCA-FRAIL randomized clinical trial compared invasive and conservative treatment strategies in patients with frailty with non-ST-segment elevation myocardial infarction (NSTEMI). It showed no differences in the number of days alive and out of the hospital at 1 year. Objective: To assess the outcomes of the MOSCA-FRAIL trial during extended follow-up. Design, Setting, and Participants: The MOSCA-FRAIL randomized clinical trial was conducted at 13 hospitals in Spain between July 7, 2017, and January 9, 2021, and included 167 adults (aged ≥70 years) with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. In this preplanned secondary analysis, follow-up was extended to January 31, 2023. Data analysis was performed from April 5 to 29, 2023, using the intention-to-treat principle. Interventions: Patients were randomized to a routine invasive (coronary angiography and revascularization if feasible [n = 84]) or a conservative (medical treatment with coronary angiography only if recurrent ischemia [n = 83]) strategy. Main outcomes and measures: The primary end point was the difference in restricted mean survival time (RMST). Secondary end points included readmissions for any cause, considering recurrent readmissions. Results: Among the 167 patients included in the analysis, the mean (SD) age was 86 (5) years; 79 (47.3%) were men and 88 (52.7%) were women. A total of 93 deaths and 367 readmissions accrued. The RMST for all-cause death over the entire follow-up was 3.13 (95% CI, 2.72-3.60) years in the invasive and 3.06 (95% CI, 2.84-3.32) years in the conservative treatment groups. The RMST analysis showed inconclusive differences in survival time (invasive minus conservative difference, 28 [95% CI, -188 to 230] days). Patients under invasive treatment tended to have shorter survival in the first year (-28 [95% CI, -63 to 7] days), which improved after the first year (192 [95% CI, 90-230] days). Kaplan-Meier mortality curves intersected, displaying higher mortality to 1 year in the invasive group that shifted to a late benefit (landmark analysis hazard ratio, 0.58 [95% CI, 0.33-0.99]; P = .045). Early harm was more evident in the subgroup with a Clinical Frailty Scale score greater than 4. No differences were found for the secondary end points. Conclusions and Relevance: In this extended follow-up of a randomized clinical trial of patients with frailty and NSTEMI, an invasive treatment strategy did not improve outcomes at a median follow-up of 1113 (IQR, 443-1441) days. However, a differential distribution of deaths was observed, with early harm followed by later benefit. The phenomenon of depletion of susceptible patients may be responsible for this behavior. Trial registration: ClinicalTrials.gov Identifier: NCT03208153.


Assuntos
Fragilidade , Infarto do Miocárdio sem Supradesnível do Segmento ST , Infarto do Miocárdio com Supradesnível do Segmento ST , Feminino , Humanos , Masculino , Tratamento Conservador , Angiografia Coronária , Análise de Dados , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
Eur J Heart Fail ; 25(8): 1439-1443, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37323111

RESUMO

AIM: Patients with heart failure with reduced ejection fraction (HFrEF) have not been shown to benefit from statins. We hypothesized that, by limiting disease progression in stable HFrEF of ischaemic etiology, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab could reduce circulating troponin levels, a surrogate biomarker of myocyte injury and atherosclerosis progression. METHODS AND RESULTS: The EVO-HF multicentre prospective randomized trial compared evolocumab (420 mg/month administered subcutaneously) plus guideline-directed medical therapy (GDMT; n = 17) versus GDMT alone (n = 22) for 1 year in patients with stable coronary artery disease and left ventricular ejection fraction (LVEF) <40%, ischaemic aetiology, New York Heart Association class II, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥400 pg/ml, high-sensitivity troponin T (hs-TnT) >10 pg/ml, low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dl. The primary endpoint was change in hs-TnT concentration. Secondary endpoints included NT-proBNP, interleukin-1 receptor-like 1 (ST2), high-sensitivity C-reactive protein (hs-CRP), LDL, low-density lipoprotein receptor (LDLR), high-density lipoprotein cholesterol (HDL-C), and PCSK9 levels at 1 year. Patients were mainly Caucasian (71.8%), male (79.5%), relatively young (mean age 68.1 ± 9.4 years), with a mean LVEF of 30.4 ± 6.5%, and managed with contemporary treatments. No significant changes in hs-TnT levels were observed in any group at 1 year. NT-proBNP and ST2 levels decreased in the GDMT plus evolocumab group (p = 0.045 and p = 0.008, respectively), without changes in hs-CRP, HDL-C, or LDLR. Total and LDL-C decreased in both groups, significantly higher in the intervention group (p = 0.003), and PCSK9 levels increased in the intervention group. CONCLUSIONS: This prospective randomized pilot trial, although with the limitation of the small sample size, does not support the benefit of evolocumab in reducing troponin levels in patients with elevated LDL-C levels, history of coronary artery disease, and stable HFrEF.


Assuntos
Doença da Artéria Coronariana , Insuficiência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Insuficiência Cardíaca/tratamento farmacológico , Pró-Proteína Convertase 9 , Volume Sistólico , LDL-Colesterol , Proteína C-Reativa , Proteína 1 Semelhante a Receptor de Interleucina-1 , Estudos Prospectivos , Função Ventricular Esquerda , Biomarcadores , Troponina , Fragmentos de Peptídeos , Peptídeo Natriurético Encefálico
3.
JAMA Intern Med ; 183(5): 407-415, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36877502

RESUMO

Importance: To our knowledge, no randomized clinical trial has compared the invasive and conservative strategies in frail, older patients with non-ST-segment elevation acute myocardial infarction (NSTEMI). Objective: To compare outcomes of invasive and conservative strategies in frail, older patients with NSTEMI at 1 year. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted at 13 Spanish hospitals between July 7, 2017, and January 9, 2021, and included 167 older adult (≥70 years) patients with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. Data analysis was performed from April 2022 to June 2022. Interventions: Patients were randomized to routine invasive (coronary angiography and revascularization if feasible; n = 84) or conservative (medical treatment with coronary angiography for recurrent ischemia; n = 83) strategy. Main Outcomes and Measures: The primary end point was the number of days alive and out of the hospital (DAOH) from discharge to 1 year. The coprimary end point was the composite of cardiac death, reinfarction, or postdischarge revascularization. Results: The study was prematurely stopped due to the COVID-19 pandemic when 95% of the calculated sample size had been enrolled. Among the 167 patients included, the mean (SD) age was 86 (5) years, and mean (SD) Clinical Frailty Scale score was 5 (1). While not statistically different, DAOH were about 1 month (28 days; 95% CI, -7 to 62) greater for patients managed conservatively (312 days; 95% CI, 289 to 335) vs patients managed invasively (284 days; 95% CI, 255 to 311; P = .12). A sensitivity analysis stratified by sex did not show differences. In addition, we found no differences in all-cause mortality (hazard ratio, 1.45; 95% CI, 0.74-2.85; P = .28). There was a 28-day shorter survival in the invasive vs conservatively managed group (95% CI, -63 to 7 days; restricted mean survival time analysis). Noncardiac reasons accounted for 56% of the readmissions. There were no differences in the number of readmissions or days spent in the hospital after discharge between groups. Neither were there differences in the coprimary end point of ischemic cardiac events (subdistribution hazard ratio, 0.92; 95% CI, 0.54-1.57; P = .78). Conclusions and Relevance: In this randomized clinical trial of NSTEMI in frail older patients, there was no benefit to a routine invasive strategy in DAOH during the first year. Based on these findings, a policy of medical management and watchful observation is recommended for older patients with frailty and NSTEMI. Trial Registration: ClinicalTrials.gov Identifier: NCT03208153.


Assuntos
COVID-19 , Fragilidade , Infarto do Miocárdio , Infarto do Miocárdio sem Supradesnível do Segmento ST , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Idoso , Idoso de 80 Anos ou mais , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Infarto do Miocárdio/mortalidade , Tratamento Conservador , Assistência ao Convalescente , Pandemias , Angina Instável/terapia , Alta do Paciente , Angiografia Coronária
4.
Am J Cardiol ; 168: 55-63, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35058053

RESUMO

We systematically categorized the longer-term (≥3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 ± 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised in-segment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p <0.03 for all) were each independently associated with abnormal BVS endothelium-dependent vasomotor function. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Idoso , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/patologia , Desenho de Prótese , Tomografia de Coerência Óptica , Resultado do Tratamento
7.
Cardiol J ; 28(4): 566-578, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34031866

RESUMO

BACKGROUND: To date, there is little information regarding management of patients with infective endocarditis (IE) that did not undergo an indicated surgery. Therefore, we aimed to evaluate prognosis of these patients treated with a long-term antibiotic treatment strategy, including oral long term suppressive antibiotic treatment in five referral centres with a multidisciplinary endocarditis team. METHODS: This retrospective, multicenter study retrieved individual patient-level data from five referral centres in Spain. Among a total of 1797, 32 consecutive patients with IE were examined (median age 72 years; 78% males) who had not undergone an indicated surgery, but received long-term antibiotic treatment (LTAT) and were followed by a multidisciplinary endocarditis team, between 2011 and 2019. Primary outcomes were infection relapse and mortality during follow-up. RESULTS: Among 32 patients, 21 had IE associated with prostheses. Of the latter, 8 had an ascending aorta prosthetic graft. In 24 patients, a switch to long-term oral suppressive antibiotic treatment (LOSAT) was considered. The median duration of LOSAT was 277 days. Four patients experienced a relapse during follow-up. One patient died within 60 days, and 12 patients died between 60 days and 3 years. However, only 4 deaths were related to IE. CONCLUSIONS: The present study results suggest that a LTAT strategy, including LOSAT, might be considered for patients with IE that cannot undergo an indicated surgery. After hospitalization, they should be followed by a multidisciplinary endocarditis team.


Assuntos
Endocardite Bacteriana , Endocardite , Idoso , Antibacterianos/uso terapêutico , Endocardite/diagnóstico , Endocardite/tratamento farmacológico , Endocardite/cirurgia , Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/tratamento farmacológico , Endocardite Bacteriana/cirurgia , Feminino , Humanos , Masculino , Prognóstico , Estudos Retrospectivos
8.
Rev. esp. cardiol. (Ed. impr.) ; 73(9): 734-740, sept. 2020. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-197858

RESUMO

INTRODUCCIÓN Y OBJETIVOS: En endocarditis infecciosa (EI), la decisión quirúrgica es difícil. Un alto porcentaje de pacientes con indicación quirúrgica no son intervenidos. El objetivo fue evaluar el pronóstico a corto y largo plazo de los pacientes con indicación quirúrgica, comparando los que se sometieron a cirugía con los que no lo hicieron. MÉTODOS: Se incluyeron 271 pacientes con EI izquierda e indicación quirúrgica tratados en el centro desde 2003 a 2018. Ochenta y tres pacientes (31%) no fueron finalmente operados. El objetivo primario fue la mortalidad a 60 días y el secundario desde el día 61 a los 3 años de seguimiento. Se realizó regresión de Cox multivariable y emparejamiento por puntuación de propensión. RESULTADOS: A los 60 días, 40 (21,3%) pacientes operados y 53 (63,9%) pacientes no intervenidos fallecieron (p <0,001). El riesgo de mortalidad a 60 días fue superior en los pacientes no intervenidos (HR = 3,59; IC95%, 2,16-5,96; p <0,001). La ausencia de diagnóstico microbiológico, la insuficiencia cardiaca, el shock y el bloqueo auriculoventricular fueron otros predictores independientes del objetivo primario. Del día 61 a los 3 años del seguimiento no hubo diferencias significativas del riesgo de muerte entre el grupo operado y los no intervenidos (HR = 1,89; IC95%, 0,68-5,19; p = 0,220). Las variables independientes asociadas con el objetivo secundario fueron los antecedentes de EI, diabetes mellitus y el índice de Charlson. Los resultados fueron consistentes tras el emparejamiento por puntuación de propensión. CONCLUSIONES: Dos tercios de los pacientes con indicación quirúrgica no intervenidos fallecieron antes de 60 días. Entre los supervivientes, la mortalidad a largo plazo depende más de factores relacionados con comorbilidad previa que del tratamiento recibido durante el ingreso


INTRODUCTION AND OBJECTIVES: In infective endocarditis (IE), decisions on surgical interventions are challenging and a high percentage of patients with surgical indication do not undergo these procedures. This study aimed to evaluate the short- and long-term prognosis of patients with surgical indication, comparing those who underwent surgery with those who did not. METHODS: We included 271 patients with left-sided IE treated at our institution from 2003 to 2018 and with an indication for surgery. There were 83 (31%) surgery-indicated not undergoing surgery patients with left-sided infective endocarditis (SINUS-LSIE). The primary outcome was all-cause death by day 60 and the secondary outcome was all-cause death from day 61 to 3 years of follow-up. Multivariable Cox regression and propensity score matching were used for the analysis. RESULTS: At the 60-day follow-up, 40 (21.3%) surgically-treated patients and 53 (63.9%) SINUS-LSIE patients died (P <.001). Risk of 60-day mortality was higher in SINUS-LSIE patients (HR, 3.59; 95%CI, 2.16-5.96; P <.001). Other independent predictors of the primary endpoint were unknown etiology, heart failure, atrioventricular block, and shock. From day 61 to the 3-year follow-up, there were no significant differences in the risk of death between surgically-treated and SINUS-LSIE patients (HR, 1.89; 95%CI, 0.68-5.19; P=.220). Results were consistent after propensity score matching. Independent variables associated with the secondary endpoint were previous IE, diabetes mellitus, and Charlson index. CONCLUSIONS: Two-thirds of SINUS-LSIE patients died within 60 days. Among survivors, the long-term mortality depends more on host conditions than on the treatment received during admission


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Endocardite Bacteriana/mortalidade , Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Infecções Relacionadas à Prótese/mortalidade , Endocardite Bacteriana/complicações , Efeitos Adversos de Longa Duração/epidemiologia , Prognóstico , Recusa do Paciente ao Tratamento/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Estudos Prospectivos
9.
Rev Esp Cardiol (Engl Ed) ; 73(9): 734-740, 2020 Sep.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31767290

RESUMO

INTRODUCTION AND OBJECTIVES: In infective endocarditis (IE), decisions on surgical interventions are challenging and a high percentage of patients with surgical indication do not undergo these procedures. This study aimed to evaluate the short- and long-term prognosis of patients with surgical indication, comparing those who underwent surgery with those who did not. METHODS: We included 271 patients with left-sided IE treated at our institution from 2003 to 2018 and with an indication for surgery. There were 83 (31%) surgery-indicated not undergoing surgery patients with left-sided infective endocarditis (SINUS-LSIE). The primary outcome was all-cause death by day 60 and the secondary outcome was all-cause death from day 61 to 3 years of follow-up. Multivariable Cox regression and propensity score matching were used for the analysis. RESULTS: At the 60-day follow-up, 40 (21.3%) surgically-treated patients and 53 (63.9%) SINUS-LSIE patients died (P <.001). Risk of 60-day mortality was higher in SINUS-LSIE patients (HR, 3.59; 95%CI, 2.16-5.96; P <.001). Other independent predictors of the primary endpoint were unknown etiology, heart failure, atrioventricular block, and shock. From day 61 to the 3-year follow-up, there were no significant differences in the risk of death between surgically-treated and SINUS-LSIE patients (HR, 1.89; 95%CI, 0.68-5.19; P=.220). Results were consistent after propensity score matching. Independent variables associated with the secondary endpoint were previous IE, diabetes mellitus, and Charlson index. CONCLUSIONS: Two-thirds of SINUS-LSIE patients died within 60 days. Among survivors, the long-term mortality depends more on host conditions than on the treatment received during admission.


Assuntos
Endocardite Bacteriana , Endocardite , Endocardite/cirurgia , Endocardite Bacteriana/cirurgia , Mortalidade Hospitalar , Hospitalização , Humanos , Prognóstico , Estudos Retrospectivos , Sobreviventes
10.
Cardiology ; 143(1): 14-21, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31390616

RESUMO

BACKGROUND: Statins are recommended for secondary prevention. Our aims were to describe the proportion of very elderly patients receiving statins after non-ST segment elevation acute coronary syndrome (NST-ACS) and to determine the prognostic implications of statins use. METHODS: This prospective registry was performed in 44 hospitals that included patients ≥80 years discharged after a NST-ACS from April 2016 to September 2016. RESULTS: We included 523 patients, the mean age was 84.2 ± 4.0 years and 200 patients (38.2%) were women. Previous statin treatment was recorded in 282 patients (53.4%), and 135 (32.5%) had LDL cholesterol levels >2.6 mmol/L. Mean LDL cholesterol levels during admission were 2.3 ± 0.9 mmol/L. Statins were prescribed at discharge to 474 patients (90.6%). Compared with patients discharged on statins, those that did not receive statins were more often frail (22 [47.8%] vs. 114 [24.4%], p < 0.01) and underwent an invasive approach less frequently (30 [61.2%] vs. 374 [78.9%], p = 0.01). During a 6-month follow-up, 50 patients died (9.5%). There was a nonsignificant trend to higher mortality in patients not treated with statins (6 [15%] vs. 44 [9.6%], p = 0.30), but statins were not independently associated with lower mortality (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.30-2.11, p = 0.65), nor with a reduction in the combined endpoint mortality/hospitalizations (HR 0.89; 95% CI 0.52-1.55, p = 0.69). CONCLUSIONS: Although most octogenarians presenting a NST-ACS are already on statins before the episode, their LDL cholesterol is frequently >2.6 mmol/L. Octogenarians who do not receive statins have a high-risk profile, with significant frailty and comorbidity.


Assuntos
Síndrome Coronariana Aguda/mortalidade , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Síndrome Coronariana Aguda/terapia , Idoso de 80 Anos ou mais , LDL-Colesterol/sangue , Comorbidade , Feminino , Seguimentos , Idoso Fragilizado , Humanos , Masculino , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Alta do Paciente , Prognóstico , Estudos Prospectivos , Sistema de Registros , Espanha/epidemiologia
11.
Rev. esp. cardiol. (Ed. impr.) ; 72(2): 154-159, feb. 2019. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-182547

RESUMO

Introducción y objetivos: Aunque las guías de práctica clínica recomiendan una estrategia invasiva para el infarto agudo de miocardio sin elevación del segmento ST (IAMSEST), en la práctica clínica esta estrategia se infrautiliza en ancianos frágiles. Además estos enfermos habitualmente quedan excluidos de los ensayos clínicos, por lo que la evidencia es escasa. Nuestra hipótesis es que una estrategia invasiva para el anciano con fragilidad y IAMSEST mejorará el pronóstico. Métodos: Se trata de un estudio prospectivo, multicéntrico y aleatorizado que compara una estrategia invasiva frente a una conservadora en ancianos frágiles con IAMSEST. Los criterios de inclusión son: IAMSEST, edad ≥ 70 años y fragilidad definida por al menos 4 criterios de la escala Clinical Frailty Scale. Se aleatorizará a los participantes a una estrategia invasiva (coronariografía y revascularización si se considera anatómicamente indicada) o conservadora (tratamiento médico y coronariografía solo en caso de inestabilidad clínica persistente). El objetivo principal será el número de días vivo fuera del hospital durante el primer año. El objetivo coprincipal será el tiempo hasta la presentación de muerte cardiovascular, reinfarto agudo de miocardio o revascularización tras el alta. El tamaño de la muestra estimado es de 178 pacientes (89 por grupo), asumiendo un incremento del 20% en la proporción de días vivo fuera del hospital con la estrategia invasiva. Resultados: Los resultados del estudio aportarán información novedosa para el tratamiento del anciano frágil con IAMSEST. Conclusiones: Nuestra hipótesis es que una estrategia invasiva mejorará el pronóstico de los pacientes ancianos frágiles con IAMSEST. Si esta hipótesis se confirmara, la situación de fragilidad no debería disuadir al cardiólogo de indicar un tratamiento invasivo. Ensayo registrado en ClinicalTrials.gov (Identificador: NCT03208153)


Introduction and objectives: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI. Methods: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a category ≥ 4 in the Clinical Frailty Scale. Participants will be randomized to an invasive (coronary angiogram and revascularization if anatomically amenable) or conservative (medical treatment and coronary angiogram only if persistent clinical instability) strategy. The primary endpoint will be the number of days alive out of hospital during the first year. The coprimary endpoint will be the time until the first cardiac event (cardiac death, reinfarction or postdischarge revascularization). We estimate a sample size of 178 patients (89 per arm), considering an increase of 20% in the proportion of days alive out of hospital with the invasive management. Results: The results of this study will add important knowledge to inform the management of frail elderly patients hospitalized with NSTEMI. Conclusions: We hypothesize that the invasive strategy will improve outcomes in frail elderly patients with NSTEMI. If this is confirmed, frailty status should not dissuade physicians from implementing an invasive management strategy. Clinical trial registration: URL: http://www.clinicaltrials.gov .Identifier: NCT03208153


Assuntos
Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Fragilidade/complicações , Angiografia Coronária/estatística & dados numéricos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Idoso Fragilizado/estatística & dados numéricos , Revascularização Miocárdica/estatística & dados numéricos
12.
J Atr Fibrillation ; 12(2): 2225, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-32002114

RESUMO

BACKGROUND: The diagnostic yield of 24-hour ECG Holter monitoring (24H) is currently overcome by alternative ECG monitoring techniquesand it needs to be optimized. The recognition of inter-atrial block (IAB) has emerged as a reliable indicator of patients at risk of atrial fibrillation relapses, and its role enhancing the yield of 24H is yet to be determined. We hypothesized that a presumably low yield of 24H may be ameliorated by means of incorporating the assessment for IAB. METHODS: We retrospectively analyzed 1017 consecutive 24H registers performed in a Multidisciplinary Integrated Health Care Institution, in which a restrictive definition of diagnostic 24H findings was used. A univariate and multivariate regression analysis served to determine the variables associated with a higher 24H's yield, including the requesting medical specialty, type of indication and a number of clinical, echocardiographic and ECG variables, including IAB. RESULTS: The mean age of our population was 62 ± 17 years (55% males). The majority of 24H were indicated from the Cardiology department (48%). The overall yield was 12.8%, higher for the assessment of the integrity of the electrical conduction system (26.1%) and poorer for the assessment of syncope (3.2%) and cryptogenic stroke (4.6%). The variables associated with higher diagnostic performance were indication from Cardiology (p < 0.001), IAB (p = 0.004), structural heart disease (p = 0.008) and chronic renal failure (p = 0.009). Patients ≤ 50 years old only retrieved a 7% yield. In the multivariate analysis, indication from Cardiology and IAB remained significant predictors of higher 24H's yield. In a secondary analysis including echocardiographic data, only identification of IAB remained statistically significant. CONCLUSIONS: The recognition of IAB and the type of indication are major determinants of a higher 24H's diagnostic yield and may help to optimize the selection of candidates.

13.
Rev Esp Cardiol (Engl Ed) ; 72(2): 154-159, 2019 Feb.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29525724

RESUMO

INTRODUCTION AND OBJECTIVES: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI. METHODS: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a category ≥ 4 in the Clinical Frailty Scale. Participants will be randomized to an invasive (coronary angiogram and revascularization if anatomically amenable) or conservative (medical treatment and coronary angiogram only if persistent clinical instability) strategy. The primary endpoint will be the number of days alive out of hospital during the first year. The coprimary endpoint will be the time until the first cardiac event (cardiac death, reinfarction or postdischarge revascularization). We estimate a sample size of 178 patients (89 per arm), considering an increase of 20% in the proportion of days alive out of hospital with the invasive management. RESULTS: The results of this study will add important knowledge to inform the management of frail elderly patients hospitalized with NSTEMI. CONCLUSIONS: We hypothesize that the invasive strategy will improve outcomes in frail elderly patients with NSTEMI. If this is confirmed, frailty status should not dissuade physicians from implementing an invasive management strategy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.Identifier: NCT03208153.


Assuntos
Tratamento Conservador , Idoso Fragilizado , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Idoso , Angiografia Coronária , Humanos , Estudos Multicêntricos como Assunto , Revascularização Miocárdica , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamanho da Amostra , Resultado do Tratamento
14.
Thromb Haemost ; 118(3): 581-590, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29536466

RESUMO

BACKGROUND: Bleeding risk scores have shown a limited predictive ability in elderly patients with acute coronary syndromes (ACS). No study explored the role of a comprehensive geriatric assessment to predict in-hospital bleeding in this clinical setting. METHODS: The prospective multicentre LONGEVO-SCA registry included 532 unselected patients with non-ST segment elevation ACS (NSTEACS) aged 80 years or older. Comorbidity (Charlson index), frailty (FRAIL scale), disability (Barthel index and Lawton-Brody index), cognitive status (Pfeiffer test) and nutritional risk (mini nutritional assessment-short form test) were assessed during hospitalization. CRUSADE score was prospectively calculated for each patient. In-hospital major bleeding was defined by the CRUSADE classification. The association between geriatric syndromes and in-hospital major bleeding was assessed by logistic regression method and the area under the receiver operating characteristic curves (AUC). RESULTS: Mean age was 84.3 years (SD 4.1), 61.7% male. Most patients had increased troponin levels (84%). Mean CRUSADE bleeding score was 41 (SD 13). A total of 416 patients (78%) underwent an invasive strategy, and major bleeding was observed in 37 cases (7%). The ability of the CRUSADE score for predicting major bleeding was modest (AUC 0.64). From all aging-related variables, only comorbidity (Charlson index) was independently associated with major bleeding (per point, odds ratio: 1.23, p = 0.021). The addition of comorbidity to CRUSADE score slightly improved the ability for predicting major bleeding (AUC: 0.68). CONCLUSION: Comorbidity was associated with major bleeding in very elderly patients with NSTEACS. The contribution of frailty, disability or nutritional risk for predicting in-hospital major bleeding was marginal.


Assuntos
Síndrome Coronariana Aguda/diagnóstico , Avaliação Geriátrica/métodos , Hemorragia/diagnóstico , Síndrome Coronariana Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Comorbidade , Feminino , Idoso Fragilizado , Hemorragia/epidemiologia , Humanos , Pacientes Internados , Masculino , Estudos Prospectivos , Sistema de Registros , Medição de Risco , Troponina/sangue
15.
EBioMedicine ; 7: 248-54, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27322478

RESUMO

BACKGROUND: The present study evaluates the safety and efficacy of the Adipose Graft Transposition Procedure (AGTP) as a biological regenerative innovation for patients with a chronic myocardial scar. METHODS: This prospective, randomized single-center controlled study included 10 patients with established chronic transmural myocardial scars. Candidates for myocardial revascularization were randomly allocated into two treatment groups. In the control arm (n=5), the revascularizable area was treated with CABG and the non-revascularizable area was left untouched. Patients in the AGTP-treated arm (n=5) were treated with CABG and the non-revascularizable area was covered by a biological adipose graft. The primary endpoint was the appearance of adverse effects derived from the procedure including hospital admissions and death, and 24-hour Holter monitoring arrhythmias at baseline, 1week, and 3 and 12months. Secondary endpoints of efficacy were assessed by cardiac MRI. FINDINGS: No differences in safety were observed between groups in terms of clinical or arrhythmic events. On follow-up MRI testing, participants in the AGTP-treated arm showed a borderline smaller left ventricular end systolic volume (LVESV; p=0.09) and necrosis ratio (p=0.06) at 3months but not at 12months. The AGTP-treated patient with the largest necrotic area and most dilated chambers experienced a noted improvement in necrotic mass size (-10.8%), and ventricular volumes (LVEDV: -55.2mL and LVESV: -37.8mL at one year follow-up) after inferior AGTP. INTERPRETATION: Our results indicate that AGTP is safe and may be efficacious in selected patients. Further studies are needed to assess its clinical value. (ClinicalTrials.org NCT01473433, AdiFlap Trial).


Assuntos
Tecido Adiposo/transplante , Cicatriz/terapia , Ponte de Artéria Coronária/métodos , Infarto do Miocárdio/cirurgia , Idoso , Volume Cardíaco , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Regeneração , Transplante Autólogo , Resultado do Tratamento
16.
Cardiovasc Pathol ; 25(4): 275-279, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27131516

RESUMO

The preferred management of a cardiac mass remains controversial, but it often includes open-chest surgical excision to obtain an adequate tissue sample for histological workup. We herein report a less invasive approach in which an accurate and timely cytological diagnosis of pericardial angiosarcoma was reached by studying a CT-guided fine-needle aspiration cell block. The cell block showed proliferation of atypical cells with occasional mitotic figures, vasoformative features, and immunoreactivity to WT1, vimentin, CD31, CD34, ERG, and Ki67. Recourse to fine-needle aspiration and cell block study is a valuable diagnostic approach to be considered when a cardiac mass is percutaneously accessible.


Assuntos
Neoplasias Cardíacas/diagnóstico , Hemangiossarcoma/diagnóstico , Pericárdio/patologia , Radiografia Intervencionista/métodos , Biomarcadores Tumorais/análise , Biópsia por Agulha Fina , Evolução Fatal , Feminino , Neoplasias Cardíacas/patologia , Humanos , Imuno-Histoquímica , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X
18.
Biomarkers ; 21(3): 225-32, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26767401

RESUMO

CONTEXT: Prognostic value of ST2 levels and dynamics has not been investigated in acute heart failure (AHF) using prospective real-life measurements. OBJECTIVE: The objective of this study is to investigate the prognostic value of ST2 in AHF. METHODS: ST2 levels were determined at admission (n = 182) and discharge (n = 85). Primary endpoint was the composite of all-cause death and HF rehospitalisation at one year. RESULTS: Discharge ST2 (HR 2.42 [95% CI 1.46-4], p = 0.001) and ΔST2 (HR 2.32 [95% CI 1.21-4.57], p = 0.01) but not admission ST2, remained independently prognostic for the primary endpoint after comprehensive multivariable adjustment. ST2 significantly improved prognosis stratification on top of clinical variables and NTproBNP. CONCLUSIONS: Routine clinical use of discharge ST2 and ST2 dynamics provide independent prognostic information.


Assuntos
Biomarcadores/sangue , Insuficiência Cardíaca/sangue , Proteína 1 Semelhante a Receptor de Interleucina-1/sangue , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Idoso , Feminino , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Prognóstico , Fatores de Risco
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