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Background: Early percutaneous coronary intervention (PCI) is recommended for ST-segment elevation myocardial infarction (STEMI) treatment. Delays in time-to-PCI, kept within guideline recommendations, have seldom been investigated. Objectives: The purpose of this study was to investigate the consequences of delay, due to system factors or hospital distance, for the time between last patient distress call and PCI. Methods: Registry-based cohort study including times of first call to medical services, admission and PCI for patients admitted with STEMI in Copenhagen, Denmark (2014-2018). The main combined outcome included death, recurrent myocardial infarction, or heart failure estimated at 30 days and 1 year from event. Outcomes according to time from call to PCI (system delay) and door-to-balloon time were standardized to the STEMI population using multivariate logistic regression. Results: In total, 1,822 STEMI patients (73.5% male, median age 63.3 years [Q1-Q3: 54.6-72.9 years]) called the emergency services ≤72 hours before PCI (1,735, ≤12 hours). The combined endpoint of 1-year cumulative incidence was 13.9% (166/1,196) for patients treated within 120 minutes of the call and 21.2% (89/420) for patients treated later. Standardized 30-day outcomes were 7.33% (95% CI: 5.41%-9.63%) for patients treated <60 minutes, and 11.1% (95% CI: 8.39%-14.2%) for patients treated >120 minutes. Conclusions: The risk of recurrent myocardial infarction, death, and heart failure following PCI treatment of STEMI increases rapidly when delay exceeds 1 hour. This indicates a particular advantage of minimizing time from first contact to PCI.
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BACKGROUND: The post-cardiac arrest syndrome (PCAS) after out-of-hospital cardiac arrest (OHCA) is characterized by a series of pathological events, including inflammation. In the randomized "STERoid for OHCA" (STEROHCA) trial, prehospital high-dose glucocorticoid decreased interleukin (IL) 6 and C-reactive protein levels following resuscitated OHCA. The aim of this predefined sub-study was to assess the inflammatory response the first three days of admission. METHODS: The STEROHCA trial enrolled 137 OHCA patients randomized to either a single prehospital injection of methylprednisolone 250 mg or placebo. Inflammatory markers, including pro- and anti-inflammatory cytokines, were analyzed in plasma samples, from 0-, 24-, 48-, and 72 h post-admission. Mixed-model analyses were applied using log-transformed data to assess group differences. RESULTS: The 137 patients included in this sub-study had a median age of 67 years (57 to 74), and the 180-day survival rates were 75% (n = 51/68) and 64% (n = 44/69) in the glucocorticoid and placebo group, respectively. A total of 130 (95%) patients had at least one plasma sample available. The anti-inflammatory cytokine IL-10 was increased at hospital admission in the glucocorticoid group (ratio 2.74 (1.49-5.05), p = 0.006), but the intervention showed the strongest effect after 24 h, decreasing pro-inflammatory levels of IL-6 (ratio 0.06 (0.03-0.10), p < 0.001), IL-8 (ratio 0.53 (0.38-0.75), p < 0.001), macrophage chemokine protein-1 (MCP-1, ratio 0.02 (0.13-0.31), p < 0.001), macrophage inflammatory protein-1-beta (MIP-1b, ratio 0.28 (0.18-0.45), p < 0.001), and tumor necrosis factor-α (TNF-α, ratio 0.6 (0.4-0.8), p = 0.01). CONCLUSION: Administering high-dose glucocorticoid treatment promptly after resuscitation from OHCA influenced the inflammatory response with a reduction in several systemic proinflammatory cytokines after 24 h. TRIAL REGISTRATION: EudraCT number: 2020-000855-11; submitted March 30, 2020. URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT04624776.
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OBJECTIVES: Call-takers face a complex situation when assessing medical problems in emergency medical services calls. Patients with myocardial infarction experiencing atypical symptoms risk misinterpretation. We examined development in call-takers' decision-making process in telephone consultations with patients having imminent myocardial infarction. METHODS: Recording of 38 calls among 19 patients (two per patient) who contacted Copenhagen Emergency Medical Services (Denmark) at least twice within one week before myocardial infarction diagnosis. The penultimate and last call were compared using qualitative content analysis. RESULTS: Call-takers' assessment of the condition changed from unclear symptom picture and dismissal of heart disease in penultimate call to severe condition, not heart-related, and possible heart disease in last call. Call-takers recommended watchful waiting in the penultimate call. Both calls involved response negotiation, while caution regarding misinterpretation was only seen in the penultimate call. CONCLUSION: Call-takers used different decision-making approaches when the caller's symptom descriptions appeared unclear and not corresponding with the medical understanding of severe conditions. Call-takers did not negotiate the condition's assessment but engaged in discussions about the response choice. PRACTICE IMPLICATIONS: A protocol to negotiate response choice with callers having unclear clinical conditions should be developed. Clarifying watchful waiting as a recommendation may assist call-takers' decision-making.
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BACKGROUND: Strategies to reach out-of-hospital cardiac arrests (called cardiac arrest) in residential areas and reduce disparities in care and outcomes are warranted. This study investigated incidences of cardiac arrests in public housing areas. METHODS: This register-based cohort study included cardiac arrest patients from Amsterdam (the Netherlands) from 2016 to 2021, Copenhagen (Denmark) from 2016 to 2021, and Vienna (Austria) from 2018 to 2021. Using Poisson regression adjusted for spatial correlation and city, we compared cardiac arrest incidence rates (number per square kilometer per year and number per 100â 000 inhabitants per year) in public housing and other residential areas and examined the proportion of cardiac arrests within public housing and adjacent areas (100-m radius). RESULTS: Overall, 9152 patients were included of which 3038 (33.2%) cardiac arrests occurred in public housing areas and 2685 (29.3%) in adjacent areas. In Amsterdam, 635/1801 (35.3%) cardiac arrests occurred in public housing areas; in Copenhagen, 1036/3077 (33.7%); and in Vienna, 1367/4274 (32.0%). Public housing areas covered 42.4 (12.6%) of 336.7 km2 and 1â 024â 470 (24.6%) of 4â 164â 700 inhabitants. Across the capitals, we observed a lower probability of 30-day survival in public housing versus other residential areas (244/2803 [8.7%] versus 783/5532 [14.2%]). The incidence rates and rate ratio of cardiac arrest in public housing versus other residential areas were incidence rate, 16.5 versus 4.1 n/km2 per year; rate ratio, 3.46 (95% CI, 3.31-3.62) and incidence rate, 56.1 versus 36.8 n/100â 000 inhabitants per year; rate ratio, 1.48 (95% CI, 1.42-1.55). The incidence rates and rate ratios in public housing versus other residential areas were consistent across the 3 capitals. CONCLUSIONS: Across 3 European capitals, one-third of cardiac arrests occurred in public housing areas, with an additional third in adjacent areas. Public housing areas exhibited consistently higher cardiac arrest incidences per square kilometer and 100â 000 inhabitants and lower survival than other residential areas. Public housing areas could be a key target to improve cardiac arrest survival in countries with a public housing sector.
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Parada Cardíaca Extra-Hospitalar , Habitação Popular , Sistema de Registros , Humanos , Parada Cardíaca Extra-Hospitalar/mortalidade , Parada Cardíaca Extra-Hospitalar/epidemiologia , Parada Cardíaca Extra-Hospitalar/diagnóstico , Parada Cardíaca Extra-Hospitalar/terapia , Incidência , Masculino , Feminino , Idoso , Dinamarca/epidemiologia , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Fatores de Tempo , Áustria/epidemiologia , Idoso de 80 Anos ou mais , Fatores de Risco , Medição de Risco , Disparidades em Assistência à Saúde/tendênciasRESUMO
This study used demographic data in a novel prediction model to identify areas with high risk of out-of-hospital cardiac arrest (OHCA) in order to target prehospital preparedness. We combined data from the nationwide Danish Cardiac Arrest Registry with geographical- and demographic data on a hectare level. Hectares were classified in a hierarchy according to characteristics and pooled to square kilometers (km2). Historical OHCA incidence of each hectare group was supplemented with a predicted annual risk of at least 1 OHCA to ensure future applicability. We recorded 19,090 valid OHCAs during 2016 to 2019. The mean annual OHCA rate was highest in residential areas with no point of public interest and 100 to 1000 residents per hectare (9.7/year/km2) followed by pedestrian streets with multiple shops (5.8/year/km2), areas with no point of public interest and 50 to 100 residents (5.5/year/km2), and malls with a mean annual incidence per km2 of 4.6. Other high incidence areas were public transport stations, schools and areas without a point of public interest and 10 to 50 residents. These areas combined constitute 1496 km2 annually corresponding to 3.4% of the total area of Denmark and account for 65% of the OHCA incidence. Our prediction model confirms these areas to be of high risk and outperforms simple previous incidence in identifying future risk-sites. Two thirds of out-of-hospital cardiac arrests were identified in only 3.4% of the area of Denmark. This area was easily identified as having multiple residents or having airports, malls, pedestrian shopping streets or schools. This result has important implications for targeted intervention such as automatic defibrillators available to the public. Further, demographic information should be considered when implementing such interventions.
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Parada Cardíaca Extra-Hospitalar , Humanos , Parada Cardíaca Extra-Hospitalar/epidemiologia , Masculino , Feminino , Dinamarca/epidemiologia , Idoso , Pessoa de Meia-Idade , Incidência , Sistema de Registros , Adulto , Previsões , Idoso de 80 Anos ou maisRESUMO
OBJECTIVE: Patients with sleep apnea (SA) are at increased cardiovascular risk. However, little is known about the risk of out-of-hospital cardiac arrest (OHCA) in patients with SA. Therefore, we studied the relation between SA patients who did and did not receive continuous positive airway pressure (CPAP) therapy with OHCA in the general population. METHODS: Using nationwide databases, we conducted a nested case-control study with OHCA-cases of presumed cardiac causes and age/sex/OHCA-date matched non-OHCA-controls from the general population. Conditional logistic regression models with adjustments for well-known OHCA risk factors were performed to generate odds ratio (OR) of OHCA comparing patients with SA receiving and not receiving CPAP therapy with individuals without SA. RESULTS: We identified 46,578 OHCA-cases and 232,890 matched non-OHCA-controls [mean: 71 years, 68.8% men]. Compared to subjects without SA, having SA without CPAP therapy was associated with increased odds of OHCA after controlling for relevant confounders (OR:1.20, 95%-Cl:1.06-1.36), while having SA with CPAP therapy was not associated with OHCA (OR:1.04, 95%-Cl:0.93-1.36). Regardless of CPAP therapy, age and sex did not significantly influence our findings. Our findings were confirmed in: (I) patients with neither ischemic heart disease nor heart failure (untreated SA, OR:1.24, 95%-CI:1.04-1.47; SA with CPAP, OR:1.08, 95%-CI:0.93-1.25); and (II) in patients without cardiovascular disease (untreated SA, OR:1.33, 95%-CI:1.07-1.65; SA with CPAP, OR:1.14, 95%-CI:0.94-1.39). CONCLUSION: SA not treated with CPAP was associated with OHCA, while no increased risk of OHCA was found for SA patients treated with CPAP.
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Pressão Positiva Contínua nas Vias Aéreas , Parada Cardíaca Extra-Hospitalar , Humanos , Parada Cardíaca Extra-Hospitalar/terapia , Parada Cardíaca Extra-Hospitalar/epidemiologia , Masculino , Pressão Positiva Contínua nas Vias Aéreas/métodos , Pressão Positiva Contínua nas Vias Aéreas/estatística & dados numéricos , Feminino , Idoso , Estudos de Casos e Controles , Pessoa de Meia-Idade , Síndromes da Apneia do Sono/complicações , Síndromes da Apneia do Sono/terapia , Síndromes da Apneia do Sono/epidemiologia , Fatores de Risco , Reanimação Cardiopulmonar/métodos , Reanimação Cardiopulmonar/estatística & dados numéricos , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Defibrillation is essential for achieving return of spontaneous circulation (ROSC) following out-of-hospital cardiac arrest (OHCA) with shockable rhythms. This study aimed to investigate if the type of defibrillator used was associated with ROSC in OHCA. METHODS AND RESULTS: This study included adult patients with OHCA from the Danish Cardiac Arrest Registry from 2016 to 2021 with at least 1 defibrillation by the emergency medical services. We used multivariable logistic regression and a difference-in-difference analysis, including all patients with or without emergency medical services shock to assess the causal inference of using the different defibrillator models (LIFEPAK or ZOLL) for OHCA defibrillation. Among 6516 patients, 77% were male, the median age (quartile 1; quartile 3) was 70 (59; 79), and 57% achieved ROSC. In total, 5514 patients (85%) were defibrillated using LIFEPAK (ROSC: 56%) and 1002 patients (15%) were defibrillated using ZOLL (ROSC: 63%). Patients defibrillated using ZOLL had an increased adjusted odds ratio (aOR) for ROSC compared with LIFEPAK (aOR, 1.22 [95% CI, 1.04-1.43]). There was no significant difference in 30-day mortality (aOR, 1.11 [95% CI, 0.95-1.30]). Patients without emergency medical services defibrillation, but treated by ZOLL-equipped emergency medical services, had a nonsignificant aOR for ROSC compared with LIFEPAK (aOR, 1.10 [95% CI, 0.99-1.23]) and the difference-in-difference analysis was not statistically significant (OR, 1.10 [95% CI, 0.91-1.34]). CONCLUSIONS: Defibrillation using ZOLL X Series was associated with increased odds for ROSC compared with defibrillation using LIFEPAK 15 for patients with OHCA. However, a difference-in-difference analysis suggested that other factors may be responsible for the observed association.
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Reanimação Cardiopulmonar , Serviços Médicos de Emergência , Parada Cardíaca Extra-Hospitalar , Adulto , Humanos , Masculino , Feminino , Estudos de Coortes , Reanimação Cardiopulmonar/métodos , Serviços Médicos de Emergência/métodos , Sistema de RegistrosRESUMO
BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is a frequent and lethal condition with a yearly incidence of approximately 5000 in Denmark. Thirty-day survival is associated with the patient's prodromal complaints prior to cardiac arrest. This paper examines the odds of 30-day survival dependent on the reported prodromal complaints among OHCAs witnessed by the emergency medical services (EMS). METHODS: EMS-witnessed OHCAs in the Capital Region of Denmark from 2016-2018 were included. Calls to the emergency number 1-1-2 and the medical helpline for out-of-hours were analyzed according to the Danish Index; data regarding the OHCA was collected from the Danish Cardiac Arrest Registry. We performed multiple logistic regression to calculate the odds ratio (OR) of 30-day survival with adjustment for sex and age. RESULTS: We identified 311 eligible OHCAs of which 79 (25.4%) survived. The most commonly reported complaints were dyspnea (n = 209, OR 0.79 [95% CI 0.46: 1.36]) and 'feeling generally unwell' (n = 185, OR 1.07 [95% CI 0.63: 1.81]). Chest pain (OR 9.16 [95% CI 5.09:16.9]) and heart palpitations (OR 3.15 [95% CI 1.07:9.46]) had the highest ORs, indicating favorable odds for 30-day survival, while unresponsiveness (OR 0.22 [95% CI 0.11:0.43]) and blue skin or lips (OR 0.30, 95% CI 0.09, 0.81) had the lowest, indicating lesser odds of 30-day survival. CONCLUSION: Experiencing chest pain or heart palpitations prior to EMS-witnessed OHCA was associated with higher 30-day survival. Conversely, complaints of unresponsiveness or having blue skin or lips implied reduced odds of 30-day survival.
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Reanimação Cardiopulmonar , Serviços Médicos de Emergência , Parada Cardíaca Extra-Hospitalar , Humanos , Parada Cardíaca Extra-Hospitalar/terapia , Sistema de Registros , Arritmias Cardíacas , Dor no Peito/diagnóstico , Dor no Peito/etiologiaRESUMO
BACKGROUND: Patients with out-of-hospital cardiac arrest (OHCA) in rural areas experience longer emergency response times and have lower survival rates compared with patients in urban areas. Volunteer responders might improve care and outcomes for patients with OHCA specifically in rural areas. Therefore, we investigated volunteer responder interventions based on the degree of urbanization. METHODS AND RESULTS: We included 1310 OHCAs from 3 different regions in Denmark where volunteer responders had arrived at the OHCA location. The location was classified as urban, suburban, or rural according to the Eurostat Degree of Urbanization Tool. A logistic regression model was used to examine associations between the degree of urbanization and volunteer responder arrival before emergency medical services, cardiopulmonary resuscitation, or defibrillation. We found the odds for volunteer responder arrival before emergency medical services more than doubled in rural areas (odds ratio [OR], 2.60 [95% CI, 1.91-3.53]) and suburban areas (OR, 2.05 [95% CI, 1.56-2.69]) compared with urban areas. In OHCA cases where volunteer responders arrived first, odds for bystander cardiopulmonary resuscitation was tripled in rural areas (OR, 3.83 [95% CI, 1.64-8.93]) and doubled in suburban areas (OR, 2.27 [95% CI, 1.17-4.41]) compared with urban areas. Bystander defibrillation was more common in suburban areas (OR, 1.53 [95% CI, 1.02-2.31]), where almost 1 out of 4 patients received bystander defibrillation, compared with urban areas. CONCLUSIONS: Volunteer responders are significantly more likely to arrive before emergency medical services in rural and suburban areas than in urban areas. Patients with OHCA received more cardiopulmonary resuscitation in rural and suburban areas and more defibrillation in suburban areas than in urban areas.
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Reanimação Cardiopulmonar , Serviços Médicos de Emergência , Parada Cardíaca Extra-Hospitalar , Humanos , Parada Cardíaca Extra-Hospitalar/epidemiologia , Parada Cardíaca Extra-Hospitalar/terapia , Reanimação Cardiopulmonar/métodos , Urbanização , Razão de ChancesRESUMO
INTRODUCTION: Most cardiac arrest survivors are classified with mild to moderate cognitive impairment; roughly, 50% experience long-term neurocognitive impairment. Postarrest challenges complicate participation in society and are associated with social issues such as failure to resume social activities and impaired return to work. The effectiveness of rehabilitation interventions for out-of-hospital cardiac arrest survivors are sparsely described, but the body of evidence describes high probabilities of survivors not returning to work, returning to jobs with modified job descriptions, returning to part-time employment, and often in combination with extensive unmet rehabilitation needs. Hence, there is a need to develop and test a pragmatic individual targeted intervention to facilitate return to work (RTW) in survivors of OHCA. The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. METHODS AND ANALYSIS: The ROCK trial is a two-arm parallel group multicentre investigator-initiated pragmatic randomized controlled superiority trial with primary endpoint measured 12 months after the cardiac arrest. Adult survivors who were part of the labour force prior to the OCHA and had at least 2 years until they are qualified to receive retirement state pensions are eligible for inclusion. Survivors will be randomized 1:1 to usual care group or usual care plus a comprehensive tailored rehabilitation intervention focusing on supporting RTW. After comprehensive assessment of individual rehabilitation needs, the intervention is ongoingly coordinated within a multidisciplinary rehabilitation team, and the intervention can be delivered for up until 12 months. Data for the primary outcome will be obtained from the national register on social transfer payments. The primary outcome will be analysed using logistic regression assessing RTW status at 12 months adjusting for the intervention and age at OHCA, sex, marital status, and occupation prior to OHCA. DISCUSSION: The ROCK trial is the first RCT to investigate the effectiveness of a rehabilitation intervention focusing on return to work after cardiac arrest. TRIAL REGISTRATION: ClinicalTrials.gov NCT05173740. Registered on May 2018.
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Parada Cardíaca Extra-Hospitalar , Retorno ao Trabalho , Adulto , Humanos , Emprego , Estudos Multicêntricos como Assunto , Parada Cardíaca Extra-Hospitalar/diagnóstico , Parada Cardíaca Extra-Hospitalar/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reabilitação Vocacional/métodos , Sobreviventes/psicologiaRESUMO
BACKGROUND: Following resuscitated out-of-hospital cardiac arrest (OHCA), inflammatory markers are significantly elevated and associated with hemodynamic instability and organ dysfunction. Vasopressor support is recommended to maintain a mean arterial pressure (MAP) above 65 mmHg. Glucocorticoids have anti-inflammatory effects and may lower the need for vasopressors. This study aimed to assess the hemodynamic effects of prehospital high-dose glucocorticoid treatment in resuscitated comatose OHCA patients. METHODS: The STEROHCA trial was a randomized, placebo-controlled, phase 2 trial comparing one prehospital injection of methylprednisolone 250 mg with placebo immediately after resuscitated OHCA. In this sub-study, we included patients who remained comatose at admission and survived until intensive care unit (ICU) admission. The primary outcome was cumulated norepinephrine use from ICU admission until 48 h reported as mcg/kg/min. Secondary outcomes included hemodynamic status characterized by MAP, heart rate, vasoactive-inotropic score (VIS), and the VIS/MAP-ratio as well as cardiac function assessed by pulmonary artery catheter measurements. Linear mixed-model analyses were performed to evaluate mean differences between treatment groups at all follow-up times. RESULTS: A total of 114 comatose OHCA patients were included (glucocorticoid: n = 56, placebo: n = 58) in the sub-study. There were no differences in outcomes at ICU admission. From the time of ICU admission up to 48 h post-admission, patients in the glucocorticoid group cumulated a lower norepinephrine use (mean difference - 0.04 mcg/kg/min, 95% CI - 0.07 to - 0.01, p = 0.02). Moreover, after 12-24 h post-admission, the glucocorticoid group demonstrated a higher MAP with mean differences ranging from 6 to 7 mmHg (95% CIs from 1 to 12), a lower VIS (mean differences from - 4.2 to - 3.8, 95% CIs from - 8.1 to 0.3), and a lower VIS/MAP ratio (mean differences from - 0.10 to - 0.07, 95% CIs from - 0.16 to - 0.01), while there were no major differences in heart rate (mean differences from - 4 to - 3, 95% CIs from - 11 to 3). These treatment differences between groups were also present 30-48 h post-admission but to a smaller extent and with increased statistical uncertainty. No differences were found in pulmonary artery catheter measurements between groups. CONCLUSIONS: Prehospital treatment with high-dose glucocorticoid was associated with reduced norepinephrine use in resuscitated OHCA patients. TRIAL REGISTRATION: EudraCT number: 2020-000855-11; submitted March 30, 2020. URL: https://www. CLINICALTRIALS: gov ; Unique Identifier: NCT04624776.
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Serviços Médicos de Emergência , Parada Cardíaca Extra-Hospitalar , Humanos , Glucocorticoides/farmacologia , Glucocorticoides/uso terapêutico , Coma/tratamento farmacológico , Parada Cardíaca Extra-Hospitalar/complicações , Parada Cardíaca Extra-Hospitalar/tratamento farmacológico , Hemodinâmica , Norepinefrina/uso terapêuticoRESUMO
Although recommended in the European Resuscitation Council (ERC) and European Society of Intensive Care Medicine (ESICM) Guidelines, a framework for delivering post-cardiac arrest care in a systematic manner in dedicated high-volume cardiac arrest centers is lacking in the existing literature. To our knowledge, the Copenhagen Framework is the only established framework of its kind. The framework comprises management of out-of-hospital cardiac arrest (OHCA) survivors, and follow-up, and rehabilitation. The framework also incorporates research projects on cardiac arrest survivors and their close family members. The overall aim of this paper is to describe a framework made in order to bridge the gaps between international recommendations and delivering high-quality post-resuscitation clinical care, improving the continuity of care for OHCA survivors, access to post-CA rehabilitation, a seamless transition to everyday life, and ultimately patient outcomes in the future.
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AIM: Conflicting results have been reported regarding the association between fluoroquinolones (FQs) and the risk of out-of-hospital cardiac arrest (OHCA). In particular, it has not become clear whether OHCA in FQ users is related to the inherent comorbidities or whether there is a direct pro-arrhythmic effect of FQs. Therefore, we studied the relation between FQs and OHCA in the general population. METHODS: Through Danish nationwide registries, we conducted a nested case-control study with OHCA cases of presumed cardiac causes and age/sex/OHCA date-matched non-OHCA controls from the general population. Conditional logistic regression models with adjustments for well-known risk factors of OHCA were employed to estimate the OR with 95% CI of OHCA comparing FQs with amoxicillin. RESULTS: The study population consisted of 46 578 OHCA cases (mean: 71 years (SD: 14.40), 68.8% men) and 232 890 matched controls. FQ was used by 276 cases and 328 controls and conferred no increase in the odds of OHCA compared with amoxicillin use after controlling for the relevant confounders (OR: 0.91 (95% CI: 0.71 to 1.16)). The OR of OHCA associated with FQ use did not vary significantly by age (OR≤65: 0.96 (95% CI: 0.53 to 1.74), OR>65: 0.88 (95% CI: 0.67 to 1.16), p value interaction=0.7818), sex (ORmen: 0.96 (95% CI: 0.70 to 1.31), ORwomen: 0.80 (95% CI: 0.53 to 1.20), p value interaction=0.9698) and pre-existing cardiovascular disease (ORabsent: 1.02 (95% CI: 0.57 to 1.82), ORpresent: 0.98 (95% CI: 0.75 to 1.28), p value interaction=0.3884), including heart failure (ORabsent: 0.93 (95% CI: 0.72 to 1.22), ORpresent: 1.11 (95% CI: 0.61 to 2.02), p value interaction=0.7083) and ischaemic heart disease (ORabsent: 0.85 (95% CI: 0.64 to 1.12), ORpresent: 1.38 (95% CI: 0.86 to 2.21), p value interaction=0.6230). CONCLUSION: Our findings do not support an association between FQ exposure and OHCA in the general population. This lack of association was consistent in men and women, in all age categories, and in the presence or absence of cardiovascular disease.
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Fluoroquinolonas , Parada Cardíaca Extra-Hospitalar , Masculino , Humanos , Feminino , Estudos de Casos e Controles , Fluoroquinolonas/efeitos adversos , Parada Cardíaca Extra-Hospitalar/induzido quimicamente , Parada Cardíaca Extra-Hospitalar/diagnóstico , Parada Cardíaca Extra-Hospitalar/epidemiologia , Fatores de Risco , AmoxicilinaRESUMO
BACKGROUND: Inflammation in ST-segment elevation myocardial infarction (STEMI) is an important contributor to both acute myocardial ischemia and reperfusion injury after primary percutaneous coronary intervention (PCI). Methylprednisolone is a glucocorticoid with potent anti-inflammatory properties with an acute effect and is used as an effective and safe treatment of a wide range of acute diseases. The trial aims to investigate the cardioprotective effects of pulse-dose methylprednisolone administered in the pre-hospital setting in patients with STEMI transferred for primary PCI. METHODS: This trial is a randomized, blinded, placebo-controlled prospective clinical phase II trial. Inclusion will continue until 378 patients with STEMI have been evaluated for the primary endpoint. Patients will be randomized 1:1 to a bolus of 250 mg methylprednisolone intravenous or matching placebo over a period of 5 min in the pre-hospital setting. All patients with STEMI transferred for primary PCI at Rigshospitalet, Copenhagen University Hospital, Denmark, will be screened for eligibility. The main eligibility criteria are age ≥ 18 years, acute onset of chest pain with < 12 h duration, STEMI on electrocardiogram, no known allergy to glucocorticoids or no previous coronary artery bypass grafting, previous acute myocardial infarction in assumed culprit, or a history with previous maniac/psychotic episodes. Primary outcome is final infarct size measured by late gadolinium enhancement on cardiac magnetic resonance (CMR) 3 months after STEMI. Secondary outcomes comprise key CMR efficacy parameters, clinical endpoints at 3 months, the peak of cardiac biomarkers, and safety. DISCUSSION: We hypothesize that pulse-dose methylprednisolone administrated in the pre-hospital setting decreases inflammation and thus reduces final infarct size in patients with STEMI treated with primary PCI. TRIAL REGISTRATION: EU-CT number: 2022-500762-10-00; Submitted May 5, 2022. CLINICALTRIALS: gov Identifier: NCT05462730; Submitted July 7, 2022, first posted July 18, 2022.