RESUMO
BACKGROUND: Delayed hypothermia, initiated after hospital arrival, several hours after cardiac arrest with 8-10 hours to reach the target temperature, is likely to have limited impact on overall survival. However, the effect of ultrafast hypothermia, i.e., delivered intra-arrest or immediately after return of spontaneous circulation (ROSC), on functional neurologic outcome after out-of-hospital cardiac arrest (OHCA) is unclear. In two prior trials, prehospital trans-nasal evaporative intra-arrest cooling was safe, feasible and reduced time to target temperature compared to delayed cooling. Both studies showed trends towards improved neurologic recovery in patients with shockable rhythms. The aim of the PRINCESS2-study is to assess whether cooling, initiated either intra-arrest or immediately after ROSC, followed by in-hospital hypothermia, significantly increases survival with complete neurologic recovery as compared to standard normothermia care, in OHCA patients with shockable rhythms. METHODS/DESIGN: In this investigator-initiated, randomized, controlled trial, the emergency medical services (EMS) will randomize patients at the scene of cardiac arrest to either trans-nasal cooling within 20 minutes from EMS arrival with subsequent hypothermia at 33°C for 24 hours after hospital admission (intervention), or to standard of care with no prehospital or in-hospital cooling (control). Fever (>37,7°C) will be avoided for the first 72 hours in both groups. All patients will receive post resuscitation care and withdrawal of life support procedures according to current guidelines. Primary outcome is survival with complete neurologic recovery at 90 days, defined as modified Rankin scale (mRS) 0-1. Key secondary outcomes include survival to hospital discharge, survival at 90 days and mRS 0-3 at 90 days. In total, 1022 patients are required to detect an absolute difference of 9% (from 45 to 54%) in survival with neurologic recovery (80% power and one-sided α=0,025, ß=0,2) and assuming 2,5% lost to follow-up. Recruitment starts in Q1 2024 and we expect maximum enrolment to be achieved during Q4 2024 at 20-25 European and US sites. DISCUSSION: This trial will assess the impact of ultrafast hypothermia applied on the scene of cardiac arrest, as compared to normothermia, on 90-day survival with complete neurologic recovery in OHCA patients with initial shockable rhythm. TRIAL REGISTRATION: NCT06025123.
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Serviços Médicos de Emergência , Hipotermia Induzida , Parada Cardíaca Extra-Hospitalar , Recuperação de Função Fisiológica , Humanos , Parada Cardíaca Extra-Hospitalar/terapia , Parada Cardíaca Extra-Hospitalar/mortalidade , Hipotermia Induzida/métodos , Serviços Médicos de Emergência/métodos , Reanimação Cardiopulmonar/métodos , Masculino , Feminino , Fatores de Tempo , Retorno da Circulação Espontânea , Cardioversão Elétrica/métodosRESUMO
BACKGROUND: Cardiac arrest is a major public health issue in Europe. Cardiac arrest seems to be associated with a large socioeconomic burden in terms of resource utilization and health care costs. The aim of this study is the analysis of the economic burden of cardiac arrest in Spain and a cost-effectiveness analysis of the key intervention identified, especially in relation to neurological outcome at discharge. METHODS: The data comes from the information provided by 115 intensive care and cardiology units from Spain, including information on the care of patients with out-of-hospital cardiac arrest who had a return of spontaneous circulation. The information reported by theses 115 units was collected by a nationwide survey conducted between March and September 2020. Along with number of patients (2631), we also collect information about the structure of the units, temperature management, and prognostication assessments. In this study we analyze the potential association of several factors with neurological outcome at discharge, and the cost associated with the different factors. The cost-effectiveness of using servo-control for temperature management is analyzed by means of a decision model, based on the results of the survey and data collected in the literature, for a one-year and a lifetime time horizon. RESULTS: A total of 109 cardiology units provided results on neurological outcome at discharge as evaluated with the cerebral performance category (CPC). The most relevant factor associated with neurological outcome at discharge was 'servo-control use', showing a 12.8% decrease in patients with unfavorable neurological outcomes (i.e., CPC3-4 vs. CPC1-2). The total cost per patient (2020 Euros) was 73,502. Only "servo-control use" was associated with an increased mean total cost per hospital. Patients treated with servo-control for temperature management gained in the short term (1 year) an average of 0.039 QALYs over those who were treated with other methods at an increased cost of 70.8, leading to an incremental cost-effectiveness ratio of 1,808 euros. For a lifetime time horizon, the use of servo-control is both more effective and less costly than the alternative. CONCLUSIONS: Our results suggest the implementation of servo-control techniques in all the units that are involved in managing the cardiac arrest patient from admission until discharge from hospital to minimize the neurological damage to patients and to reduce costs to the health and social security system.
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Parada Cardíaca , Parada Cardíaca Extra-Hospitalar , Humanos , Espanha , Análise Custo-Benefício , Estresse Financeiro , Parada Cardíaca/terapia , Custos de Cuidados de Saúde , Parada Cardíaca Extra-Hospitalar/terapiaRESUMO
OBJECTIVES: The aim of this study was to describe the procedural and early outcomes of patients with mechanical mitral valve prosthesis (MVP) undergoing transcatheter aortic valve replacement (TAVR) with a novel self-expandable retrievable device. BACKGROUND: TAVR in patients with prior MVP may have an increased risk of complications related to device positioning and interference between both prosthetic valves. METHODS: An observational study was conducted, including eight patients with severe symptomatic aortic stenosis and prior mechanical MVP who underwent TAVR with the novel device AllegraTM (Biosensors). No transesophageal monitoring was used. RESULTS: The mean age of the study population was 75 years. The mean distance between MVP and aortic annulus was 3.8 mm. Procedural success was achieved in all patients with no major intraprocedural, in-hospital, or follow-up complications. CONCLUSIONS: TAVR with Allegra TAVI system in patients with prior MVP offers good procedural and clinical outcomes.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Desenho de Prótese , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Próteses Valvulares Cardíacas/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
AIMS: Age, sex, and cardiovascular disease have been linked to thromboembolic complications and poorer outcomes in COVID-19. We hypothesize that CHADS2 and CHA2DS2-VASc scores may predict thromboembolic events and mortality in COVID-19. METHODS AND RESULTS: COVID-19 hospitalized patients with confirmed SARS-CoV-2 infection from 1 March to 20 April 2020 who completed at least 1-month follow-up or died were studied. CHADS2 and CHA2DS2-VASc scores were calculated. Given the worse prognosis of male patients in COVID-19, a modified CHA2DS2-VASc score (CHA2DS2-VASc-M) in which 1 point was given to male instead of female was also calculated. The associations of these scores with laboratory results, thromboembolic events, and death were analysed. A total of 3042 patients (mean age 62.3 ± 20.3 years, 54.9% male) were studied and 115 (3.8%) and 626 (20.6%) presented a definite thromboembolic event or died, respectively, during the study period [median follow 59 (50-66) days]. Higher score values were associated with more marked abnormalities of inflammatory and cardiac biomarkers. Mortality was significantly higher with increasing scores for CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M (P < 0.001 for trend). The CHA2DS2-VASc-M showed the best predictive value for mortality [area under the receiver operating characteristic curve (AUC) 0.820, P < 0.001 for comparisons]. All scores had poor predictive value for thromboembolic events (AUC 0.497, 0.490, and 0.541, respectively). CONCLUSION: The CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M scores are significantly associated with all-cause mortality but not with thromboembolism in COVID-19 patients. They are simple scoring systems in everyday use that may facilitate initial 'quick' prognostic stratification in COVID-19.
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Fibrilação Atrial , COVID-19 , Acidente Vascular Cerebral , Tromboembolia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , SARS-CoV-2 , Tromboembolia/diagnóstico , Tromboembolia/epidemiologiaRESUMO
BACKGROUND: Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018. METHODS: ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years. RESULTS: Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA2DS2-VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label. CONCLUSION: Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label. TRIAL REGISTRATION: NCT02944019; Date of registration: October 24, 2016.
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Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Padrões de Prática Médica , Piridinas/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Tiazóis/administração & dosagem , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Rotulagem de Medicamentos , Uso de Medicamentos , Europa (Continente)/epidemiologia , Inibidores do Fator Xa/efeitos adversos , Feminino , Fidelidade a Diretrizes , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Vigilância de Produtos Comercializados , Piridinas/efeitos adversos , Sistema de Registros , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Tiazóis/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: We aimed to assess the impact of eplerenone on cardiovascular (CV) outcomes in STEMI without known heart failure, when initiated within 24 h of symptom onset. METHODS AND RESULTS: In this randomized, placebo-controlled, double-blind trial, we assigned 1012 patients with acute STEMI and without a history of heart failure to receive either eplerenone (25-50 mg once daily) or placebo in addition to standard therapy. The primary endpoint was the composite of CV mortality, re-hospitalization, or, extended initial hospital stay, due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40%, or elevated BNP/NT-proBNP at 1 month or more after randomization. BNP elevation was defined as BNP levels or values above 200 pg/mL or NT-proBNP values above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or above 1800 pg/mL (patients older than 75). After a mean follow-up of 10.5 months, the primary endpoint occurred in 92 patients (18.2%) in the eplerenone group and in 149 patients (29.4%) in the placebo group [adjusted hazard ratio (HR), 0.58; 95% confidence interval (CI), 0.45-0.76; P < 0.0001]. The primary endpoint was driven by a high BNP/NT-proBNP level (adjusted HR, 0.60; 95% CI, 0.45-0.79; P < 0.0003). Adverse event rates were similar in both groups. Serum potassium levels exceeded 5.5 mmol/L in 5.6 vs. 3.2% (P = 0.09) and were below 3.5 mmol/L in 1.4 vs. 5.6% of patients (P = 0.0002), in the eplerenone and placebo groups, respectively. CONCLUSION: The addition of eplerenone during the acute phase of STEMI was safe and well tolerated. It reduced the primary endpoint over a mean 13 months follow-up mostly because of significantly lower BNP/NT-proBNP levels. Additional studies are needed to clarify the role of early use of MRAs in STEMI patients without heart failure. CLINICAL TRIAL REGISTRATION: NCT01176968.
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Antagonistas de Receptores de Mineralocorticoides/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Espironolactona/análogos & derivados , Método Duplo-Cego , Eplerenona , Feminino , Insuficiência Cardíaca/prevenção & controle , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Espironolactona/administração & dosagem , Resultado do TratamentoRESUMO
BACKGROUND: To assess long-term effectiveness and safety of edoxaban in Europe. METHODS AND RESULTS: ETNA-AF-Europe, a prospective, multinational, multi-centre, post-authorisation, observational study was conducted in agreement with the European Medicines Agency. The primary and secondary objectives assessed real-world safety (including bleeding and deaths) and effectiveness (including stroke, systemic embolic events and clinical edoxaban use), respectively. Median (interquartile range) age of the 13,164 patients was 75.0 (68.0-80.0) years; CHA2DS2-VASc and HAS-BLED scores were 3.0 (2.0-4.0) and 2.0 (1.0-2.0), respectively. Follow-up duration was 3.98 (3.21-4.05) years. Patients on edoxaban 30 mg (n = 3042) at baseline were older (80.0 vs 73.0 years), more likely assessed as frail by investigators (27.0% vs 6.6%) and had more comorbidities than those on edoxaban 60 mg (n = 9617; missing dosing information for n = 505). Annualised event rates of all-cause and cardiovascular death in the overall population, edoxaban 60 mg and edoxaban 30 mg groups were 4.1%, 2.8% and 8.4%, and 1.0%, 0.7% and 2.0%, respectively. Annualised rates of stroke were relatively constant throughout the follow-up, transient ischaemic attack and systemic embolism were < 1% in the overall population. Rates of any major and major gastrointestinal bleeding were low, with slightly higher rates for edoxaban 30 vs 60 mg group. Intracranial haemorrhage was uncommon (0.2%). CONCLUSIONS: In European patients with AF, long-term therapy with edoxaban is associated with low and relatively constant annualised rates of stroke and major bleeding. Differences in outcomes between the two approved doses are attributable to differences in clinical characteristics.
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Fibrilação Atrial , Inibidores do Fator Xa , Piridinas , Tiazóis , Humanos , Tiazóis/efeitos adversos , Tiazóis/uso terapêutico , Tiazóis/administração & dosagem , Piridinas/efeitos adversos , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Idoso , Fibrilação Atrial/tratamento farmacológico , Masculino , Feminino , Europa (Continente)/epidemiologia , Estudos Prospectivos , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/uso terapêutico , Idoso de 80 Anos ou mais , Resultado do Tratamento , Seguimentos , Fatores de Tempo , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/epidemiologia , Hemorragia/induzido quimicamente , Hemorragia/epidemiologiaRESUMO
BACKGROUND: It is recommended that comatose survivors of out-of-hospital cardiac arrest should be cooled to 32° to 34°C for 12 to 24 hours. However, the optimal level of cooling is unknown. The aim of this pilot study was to obtain initial data on the effect of different levels of hypothermia. We hypothesized that deeper temperatures will be associated with better survival and neurological outcome. METHODS AND RESULTS: Patients were eligible if they had a witnessed out-of-hospital cardiac arrest from March 2008 to August 2011. Target temperature was randomly assigned to 32°C or 34°C. Enrollment was stratified on the basis of the initial rhythm as shockable or asystole. The target temperature was maintained during 24 hours followed by 12 to 24 hours of controlled rewarming. The primary outcome was survival free from severe dependence (Barthel Index score ≥60 points) at 6 months. Thirty-six patients were enrolled in the trial (26 shockable rhythm, 10 asystole), with 18 assigned to 34°C and 18 to 32°C. Eight of 18 patients in the 32°C group (44.4%) met the primary end point compared with 2 of 18 in the 34°C group (11.1%) (log-rank P=0.12). All patients whose initial rhythm was asystole died before 6 months in both groups. Eight of 13 patients with initial shockable rhythm assigned to 32°C (61.5%) were alive free from severe dependence at 6 months compared with 2 of 13 (15.4%) assigned to 34°C (log-rank P=0.029). The incidence of complications was similar in both groups except for the incidence of clinical seizures, which was lower (1 versus 11; P=0.0002) in patients assigned to 32°C compared with 34°C. On the contrary, there was a trend toward a higher incidence of bradycardia (7 versus 2; P=0.054) in patients assigned to 32°C. Although potassium levels decreased to a greater extent in patients assigned to 32°C, the incidence of hypokalemia was similar in both groups. CONCLUSIONS: The findings of this pilot trial suggest that a lower cooling level may be associated with a better outcome in patients surviving out-of-hospital cardiac arrest secondary to a shockable rhythm. The benefits observed here merit further investigation in a larger trial in out-of-hospital cardiac arrest patients with different presenting rhythms. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01155622.
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Temperatura Corporal , Coma/terapia , Parada Cardíaca/terapia , Hipotermia Induzida/métodos , Parada Cardíaca Extra-Hospitalar/terapia , Idoso , Coma/mortalidade , Cardioversão Elétrica/mortalidade , Feminino , Parada Cardíaca/mortalidade , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/mortalidade , Projetos Piloto , Recuperação de Função Fisiológica , Fatores de Risco , Sobreviventes/estatística & dados numéricosRESUMO
AIMS: We explored the effect of treatment with ivabradine, a pure heart rate-slowing agent, on recurrent hospitalizations for worsening heart failure (HF) in the SHIFT trial. METHODS AND RESULTS: SHIFT was a double-blind clinical trial in which 6505 patients with moderate-to-severe HF and left ventricular systolic dysfunction, all of whom had been hospitalized for HF during the preceding year, were randomized to ivabradine or to placebo on a background of guideline-recommended HF therapy (including maximized ß-blockade). In total, 1186 patients experienced at least one additional HF hospitalization during the study, 472 suffered at least two, and 218 suffered at least 3. Patients with additional HF hospitalizations had more severe disease than those without. Ivabradine was associated with fewer total HF hospitalizations [902 vs. 1211 events with placebo; incidence rate ratio, 0.75, 95% confidence interval (CI), 0.65-0.87, P = 0.0002] during the 22.9-month median follow-up. Ivabradine-treated patients evidenced lower risk for a second or third additional HF hospitalization [hazard ratio (HR): 0.66, 95% CI, 0.55-0.79, P < 0.001 and HR: 0.71, 95% CI, 0.54-0.93, P = 0.012, respectively]. Similar observations were made for all-cause and cardiovascular hospitalizations. CONCLUSION: Treatment with ivabradine, on a background of guidelines-based HF therapy, is associated with a substantial reduction in the likelihood of recurrent hospitalizations for worsening HF. This benefit can be expected to improve the quality of life and to substantially reduce health-care costs.
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Benzazepinas/uso terapêutico , Cardiotônicos/uso terapêutico , Insuficiência Cardíaca Sistólica/tratamento farmacológico , Doença Crônica , Método Duplo-Cego , Feminino , Insuficiência Cardíaca Sistólica/mortalidade , Hospitalização/estatística & dados numéricos , Humanos , Ivabradina , Masculino , Pessoa de Meia-Idade , Prevenção Secundária , Resultado do TratamentoRESUMO
BACKGROUND: Little is known about the incidence of influenza among admissions to the cardiac intensive care unit (C-ICU), accuracy of clinical suspicion, and influenza vaccination uptake. We evaluated the incidence of influenza at C-ICU admission during the influenza season, potential underdiagnosis, and vaccination uptake. METHODS: Prospective study at five C-ICUs during the 2017-2020 influenza seasons. A nasopharyngeal swab was collected at admission from patients who consented (n = 788). Testing was with Xpert®XpressFlu/RSV. RESULTS: Influenza was detected in 43 patients (5.5%) (40 FluA; 3 FluB) and clinically suspected in 27 (62.8%). Compared to patients without influenza, patients with influenza more frequently had heart failure (37.2% vs 22.8%, P = 0.031), previous contact with relatives with influenza-like illnesses (23.3% vs 12.5%, P = 0.042), antimicrobial use (67.4% vs 23.2%, P <0.01), and need for mechanical ventilation (25.6% vs 14.5%, P = 0.048). Patients received oseltamivir promptly. We found no differences in mortality (11.6% vs 5.2%, P = 0.076). Patients with influenza more frequently had myocarditis (9.3% vs 0.9%, P <0.01) and pericarditis (7.0% vs 0.8%, P = 0.01). Overall, 43.0% of patients (339/788) were vaccinated (51.9% of those with a clear indication [303/584]). CONCLUSION: Influenza seems to be a frequently underdiagnosed underlying condition in admissions to the C-ICU. Influenza should be screened for at C-ICU admission during influenza epidemics.
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Influenza Humana , Humanos , Influenza Humana/diagnóstico , Influenza Humana/tratamento farmacológico , Influenza Humana/epidemiologia , Estudos Prospectivos , Estações do Ano , Espanha/epidemiologia , Unidades de Terapia IntensivaRESUMO
Despite the efforts made to improve the care of cardiogenic shock (CS) patients, including the development of mechanical circulatory support (MCS), the prognosis of these patients continues to be poor. In this context, CS code initiatives arise, based on providing adequate, rapid, and quality care to these patients. In this multidisciplinary document we try to justify the need to implement the SC code, defining its structure/organization, activation criteria, patient flow according to care level, and quality indicators. Our specific purposes are: a) to present the peculiarities of this condition and the lessons of infarction code and previous experiences in CS; b) to detail the structure of the teams, their logistics and the bases for the management of these patients, the choice of the type of MCS, and the moment of its implantation, and c) to address challenges to SC code implementation, including the uniqueness of the pediatric SC code. There is an urgent need to develop protocolized, multidisciplinary, and centralized care in hospitals with a large volume and experience that will minimize inequity in access to the MCS and improve the survival of these patients. Only institutional and structural support from the different administrations will allow optimizing care for CS.
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Oxigenação por Membrana Extracorpórea , Coração Auxiliar , Humanos , Criança , Choque Cardiogênico/terapia , Balão Intra-Aórtico , Resultado do TratamentoRESUMO
Aims: Many historical and recent reports showed that post-infarction ventricular septal rupture (VSR) represents a life-threatening condition and the strategy to optimally manage it remains undefined. Therefore, disparate treatment policies among different centres with variable results are often described. We analysed data from European centres to capture the current clinical practice in VSR management. Methods and results: Thirty-nine centres belonging to eight European countries participated in a survey, filling a digital form of 38 questions from April to October 2022, to collect information about all the aspects of VSR treatment. Most centres encounter 1-5 VSR cases/year. Surgery remains the treatment of choice over percutaneous closure (71.8% vs. 28.2%). A delayed repair represents the preferred approach (87.2%). Haemodynamic conditions influence the management in almost all centres, although some try to achieve patients stabilization and delayed surgery even in cardiogenic shock. Although 33.3% of centres do not perform coronarography in unstable patients, revascularization approaches are widely variable. Most centres adopt mechanical circulatory support (MCS), mostly extracorporeal membrane oxygenation, especially pre-operatively to stabilize patients and achieve delayed repair. Post-operatively, such MCS are more often adopted in patients with ventricular dysfunction. Conclusion: In real-life, delayed surgery, regardless of the haemodynamic conditions, is the preferred strategy for VSR management in Europe. Extracorporeal membrane oxygenation is becoming the most frequently adopted MCS as bridge-to-operation. This survey provides a useful background to develop dedicated, prospective studies to strengthen the current evidence on VSR treatment and to help improving its currently unsatisfactory outcomes.
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Risk factors associated with in-hospital mortality in young patients with ST-segment elevation myocardial infarction are poorly described. In addition, it is increasingly recognized that these risk factors might differ from those of older patients. The dataset herein presented describes the association between different variables and in-hospital mortality in patients <55 years old with ST-segment elevation myocardial infarction. This data supplements the manuscript "Sex Related Differences in the Treatment of ST-Segment Elevation Acute Myocardial Infarction in Patients Aged <55 Years" (Lorente-Ros et al.) Data for this data in brief article were obtained from a prospective database of patients <55 years old with confirmed ST-segment elevation myocardial infarction admitted to a tertiary care hospital during an 11-year period. The data were collected via review of the clinical charts. The dataset describes the relative risk and 95% confidence interval of in-hospital mortality for each variable, including cardiovascular risk factors, angiographic findings, treatment received, and complications developed. Patients in this dataset represent a unique population, given that it only includes confirmed ST-segment elevation myocardial infarction while excluding other types of acute coronary syndrome, the patient's young age, and the reflection of contemporary up-to-date practices. This dataset will be valuable to further build on knowledge on the prognostic markers of acute myocardial infarction in a younger patient population.
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Gender-related differences after ST-segment elevation myocardial infarction (STEMI) have been reported, but studies have generally focused on high-risk groups and results are inconsistent. This study aims to determine gender-related differences in the treatment of STEMI and in-hospital mortality in a contemporary cohort of young patients. We included patients aged <55 years admitted to the Acute Cardiac Care Unit with STEMI during an 11-year period. We retrospectively reviewed the clinical charts to register information on demographics, clinical and laboratory data, angiography, treatment received, complications, and in-hospital mortality. A total of 812 patients were included (712 men and 100 women). There were no gender-related differences in age or prevalence of cardiovascular risk factors. Women, as compared with men, had higher incidence of nonobstructive angiography (14.0% vs 2.4%) and coronary tortuosity (4.0% vs 0.8%), and lower incidence of multivessel disease (35.0% vs 49.6%) (p <0.05). Less frequently than men, women received percutaneous transluminal coronary angioplasty (94.0% vs 98.2%), and stent placement (82.0% vs 93.8%), inotropic agents (2.0% vs 8.3%), hypothermia after cardiac arrest (25.0% vs 84.0%), and mechanical ventilation (4.0% vs 11.0%) (p <0.05). These differences were not explained by the different angiographic findings. In-hospital mortality was 2.0% and 3.4%, in women and men, respectively (adjusted odds ratio 0.712, 95% confidence interval 0.164 to 3.093, p = 0.650). In conclusion, women aged <55 years with STEMI were held to different treatment standards than men.
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Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Fatores Sexuais , Resultado do TratamentoRESUMO
Heavily calcified coronary lesions increase the complexity of percutaneous coronary interventions (PCI) and represent a challenge for interventional cardiologists. They are an important cause of stent underexpansion and poor clinical outcome. Nowadays, there are different dedicated devices which enhance the chances of success. Rotational atherectomy is the first-line modality which permits to cross balloons or stents through severe calcified lesions. However, when circumferential deep calcium plaques exist may not be enough to achieve adequate expansion of these devices. In these cases, the complementary use of intracoronary lithotripsy ("RotaTripsy") can be an effective approach that further modifies the calcified plaque and enables optimal stent implantation. We present the first case series undergoing PCI using "RotaTripsy" technique.
Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana , Litotripsia , Intervenção Coronária Percutânea , Calcificação Vascular , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapiaRESUMO
AIMS: Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. METHODS AND RESULTS: The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P < 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P < 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P < 0.0001) and cardiovascular death (Wald χ2: 100.38; P < 0.0001). CONCLUSION: Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively.
Assuntos
Fibrilação Atrial , Isquemia Encefálica , Embolia , Insuficiência Cardíaca , Acidente Vascular Cerebral , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Inibidores do Fator Xa , Isquemia Encefálica/prevenção & controle , Anticoagulantes/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Hemorragia/induzido quimicamente , Insuficiência Cardíaca/tratamento farmacológicoRESUMO
INTRODUCTION AND OBJECTIVES: Myocardial dysfunction contributes to early mortality (24-72 hours) among survivors of a cardiac arrest (CA). The benefits of mechanical support in refractory shock should be balanced against the patient's potential for neurological recovery. To date, these early treatment decisions have been taken based on limited information leading mainly to undertreatment. Therefore, there is a need for early, reliable, accessible, and simple tools that offer information on the possibilities of neurological improvement. METHODS: We collected data from bispectral index (BIS) and suppression ratio (SR) monitoring of adult comatose survivors of CA managed with targeted temperature management (TTM). Neurological status was assessed according to the Cerebral Performance Category (CPC) scale. RESULTS: We included 340 patients. At the first full neurological evaluation, 211 patients (62.1%) achieved good outcome or CPC 1-2. Mean BIS values were significantly higher and median SR lower in patients with CPC 1-2. An average BIS> 26 during first 12 hours of TTM predicted good outcome with 89.5% sensitivity and 75.8% specificity (AUC of 0.869), while average SR values> 24 during the first 12 hours of TTM predicted poor outcome (CPC 3-5) with 91.5% sensitivity and 81.8% specificity (AUC, 0.906). Hourly BIS and SR values exhibited good predictive performance (AUC> 0.85), as soon as hour 2 for SR and hour 4 for BIS. CONCLUSIONS: BIS/SR are associated with patients' potential for neurological recovery after CA. This finding could help to create awareness of the possibility of a better outcome in patients who might otherwise be wrongly considered as nonviable and to establish personalized treatment escalation plans.
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Parada Cardíaca , Hipotermia Induzida , Parada Cardíaca Extra-Hospitalar , Adulto , Humanos , Prognóstico , Hipotermia Induzida/efeitos adversosRESUMO
BACKGROUND: Ventricular septal rupture (VSR) following acute myocardial infarction (AMI) is a dangerous condition. Surgical VSR closure is the definitive therapy, but there is controversy regarding the surgical timing and the bridging therapy between diagnosis and intervention. The objective of this study is to analyze the ideal time of surgical repair and to establish the contribution of mechanical circulatory support (MCS) devices on the prognosis. METHODS: We designed an observational, retrospective, multicenter study, selecting all consecutive patients with post-AMI VSR between January 1, 2008 and December 31, 2018, with non-exclusion criteria. The main objective of this study was to analyze the optimal timing for surgical repair of post-AMI VSR. Secondary endpoints were to determine which factors could influence mortality in the patients of the surgical group. RESULTS: A total of 141 patients were included. We identified lower mortality rates with an odds ratio of 0.3 (0.1-0.9) in patients operated on from day 4 compared with the surgical mortality in the first 24 hours after VSR diagnosis. The use of MCS was more frequent in patients treated with surgery, particularly for intra-aortic balloon pump (IABP; 79.6% vs. 37.8%, p < 0.001), but also for veno-arterial extracorporeal membrane oxygenation (VA-ECMO; 18.2% vs. 6.4%, p = 0.134). Total mortality was 91.5% for conservative management and 52.3% with surgical repair (p < 0.001). CONCLUSIONS: In our study, we observed that the lowest mortality rates in patients with surgical repair of post-AMI VSR were observed in patients operated on from day 4 after diagnosis of VSR, compared to earlier interventions.
Assuntos
Infarto do Miocárdio , Ruptura do Septo Ventricular , Doença Aguda , Humanos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Estudos Retrospectivos , Choque Cardiogênico/terapia , Resultado do Tratamento , Ruptura do Septo Ventricular/diagnóstico , Ruptura do Septo Ventricular/etiologia , Ruptura do Septo Ventricular/cirurgiaRESUMO
AIMS AND OBJECTIVES: Statins have been proposed as potentially useful agents for modulating the host response in COVID-19. However, solid evidence-based recommendations are still lacking. Our aim was to study the association between statin use and clinical outcomes in a large cohort of hospitalized patients with SARS-CoV-2 infection, as well as the specific consequences of chronic treatment withdrawal during hospital admission. MATERIAL AND METHODS: Retrospective observational study including 2191 hospitalized patients with confirmed SARS-CoV-2 infection. RESULTS: Mean age was 68.0±17.8 years and 597 (27.3%) patients died during follow-up. A total of 827 patients (37.7% of the whole sample), received chronic treatment with statins. Even though they underwent more frequent admissions in critical care units, chronic treatment with statins was not independently associated with all-cause mortality [HR 0.95 (0.72-1.25)]. During the whole hospital admission, 371 patients (16.9%) received at least one dose of statin. Although these patients had a significantly worse clinical profile, both treatment with statins during admission [HR 1.03 (0.78-1.35)] and withdrawal of chronic statin treatment [HR 1.01 (0.78-1.30)] showed a neutral effect in mortality. However, patients treated with statins presented more frequently hepatic cytolysis, rhabdomyolysis and thrombotic/hemorrhagic events. CONCLUSIONS: In this large cohort of hospitalized COVID-19 patients, statins were not independently associated with all-cause mortality during follow-up. Clinically relevant statin-associated adverse effects should be carefully monitored during hospital admission.