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Cumulative incidence of organ support and treatment limitations. a Combined mechanical ventilation (MV) and non-invasive ventilation. b Mechanical ventilation (MV). c Vasoactive drugs. d Non-invasive ventilation (NIV). e Treatment limitations. f Renal replacement therapy (RRT)

Cumulative incidence of organ support and treatment limitations. a Combined mechanical ventilation (MV) and non-invasive ventilation. b Mechanical ventilation (MV). c Vasoactive drugs. d Non-invasive ventilation (NIV). e Treatment limitations. f Renal replacement therapy (RRT)

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Background The COVID-19 pandemic has led highly developed healthcare systems to the brink of collapse due to the large numbers of patients being admitted into hospitals. One of the potential prognostic indicators in patients with COVID-19 is frailty. The degree of frailty could be used to assist both the triage into intensive care, and decisions re...

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... in vulnerable and 6 days (IQR 3.0-13) in frail patients (p < 0.001). Table 2 shows models revealing the association between frailty and outcome even after controlling for comorbidities and disease severity and treatment strategies. Frailty was associated with increased use of treatment limitations and reduction in respiratory support as shown in Fig. 2 (cumulative incidences in Additional file 9). The use of treatment limitations was significantly higher in frail patients compared to fit patients and vulnerable patients (20-day cumulative incidence was 26% (95% CI 23-29) for fit patients, 40% (33-47) for vulnerable patients and 43% (95% CI 37-48) for frail patients (p < 0.001). The ...

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Background: The COVID-19 pandemic has led highly developed healthcare systems to the brink of collapse due to the large numbers of patients being admitted into hospitals. One of the potential prognostic indicators in patients with COVID-19 is frailty. The degree of frailty could be used to assist both the triage into intensive care, and decisions...
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Background: The COVID-19 pandemic has led highly developed healthcare systems to the brink of collapse due to the large numbers of patients being admitted into hospitals. One of the potential prognostic indicators in patients with COVID-19 is frailty. The degree of frailty could be used to assist both the triage into intensive care, and decisions r...

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... The COVID-19 pandemic exposed all HCPs to the new situations. Physicians had to perform rationing and triage patients without enough information about this new diagnosis with a poor prognosis [42][43][44]. The hospitals were overloaded, and the nursing staff had less time for patient care, which could lead to poor quality of care. ...
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Background: Providing palliative care at the end of life (EOL) in intensive care units (ICUs) seems to be modified during the COVID-19 pandemic with potential burden of moral distress to health care providers (HCPs). We seek to assess the practice of EOL care during the COVID-19 pandemic in ICUs in the Czech Republic focusing on the level of moral distress and its possible modifiable factors. Methods: Between 16 June 2021 and 16 September 2021, a national, cross-sectional study in intensive care units (ICUs) in Czech Republic was performed. All physicians and nurses working in ICUs during the COVID-19 pandemic were included in the study. For questionnaire development ACADEMY and CHERRIES guide and checklist were used. A multivariate logistic regression model was used to analyse possible modifiable factors of moral distress. Results: In total, 313 HCPs (14.5% out of all HCPs who opened the questionnaire) fully completed the survey. Results showed that 51.8% (n = 162) of respondents were exposed to moral distress during the COVID-19 pandemic. 63.1% (n = 113) of nurses and 71.6% of (n = 96) physicians had experience with the perception of inappropriate care. If inappropriate care was perceived, a higher chance for the occurrence of moral distress for HCPs (OR, 1.854; CI, 1.057-3.252; p = 0.0312) was found. When patients died with dignity, the chance for moral distress was lower (OR, 0.235; CI, 0.128-0.430; p < 0.001). The three most often reported differences in palliative care practice during pandemic were health system congestion, personnel factors, and characteristics of COVID-19 infection. Conclusions: HCPs working at ICUs experienced significant moral distress during the COVID-19 pandemic in the Czech Republic. The major sources were perceiving inappropriate care and dying of patients without dignity. Improvement of the decision-making process and communication at the end of life could lead to a better ethical and safety climate. Trial registration: NCT04910243 .
... Due to multimorbidity and frailty, critically ill elderly patients have a particularly poor prognosis [13]. Similar analyses among patients with COVID-19 confirmed that increasing age and degree of frailty are related to worse outcomes in this population [14]. Compared to NIV, endotracheal intubation and IMV are associated with more discomfort and a higher risk of complications, e.g., ventilator-associated pneumonia. ...
... The COVIP study aims to assess outcomes and factors associated with the outcomes in the population of elderly ICU patients with COVID-19. It is a part of the Very old Intensive Care Patients (VIP) research network, which includes critical care physicians and researchers from around the world and is focused on investigating the management and outcomes of VIPs [14,17]. Patients included in this substudy were recruited in 156 centres from 15 countries between March 2020 and April 2021. ...
... Additionally, we revealed an association between an increasing degree of frailty and the risk of NIV failure. This is consistent with previous studies describing the impact of frailty on outcomes in elderly patients admitted to the ICU [14,19]. ...
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Background Noninvasive ventilation (NIV) is a promising alternative to invasive mechanical ventilation (IMV) with a particular importance amidst the shortage of intensive care unit (ICU) beds during the COVID-19 pandemic. We aimed to evaluate the use of NIV in Europe and factors associated with outcomes of patients treated with NIV. Methods This is a substudy of COVIP study—an international prospective observational study enrolling patients aged ≥ 70 years with confirmed COVID-19 treated in ICU. We enrolled patients in 156 ICUs across 15 European countries between March 2020 and April 2021.The primary endpoint was 30-day mortality. Results Cohort included 3074 patients, most of whom were male (2197/3074, 71.4%) at the mean age of 75.7 years (SD 4.6). NIV frequency was 25.7% and varied from 1.1 to 62.0% between participating countries. Primary NIV failure, defined as need for endotracheal intubation or death within 30 days since ICU admission, occurred in 470/629 (74.7%) of patients. Factors associated with increased NIV failure risk were higher Sequential Organ Failure Assessment (SOFA) score (OR 3.73, 95% CI 2.36–5.90) and Clinical Frailty Scale (CFS) on admission (OR 1.46, 95% CI 1.06–2.00). Patients initially treated with NIV (n = 630) lived for 1.36 fewer days (95% CI − 2.27 to − 0.46 days) compared to primary IMV group (n = 1876). Conclusions Frequency of NIV use varies across European countries. Higher severity of illness and more severe frailty were associated with a risk of NIV failure among critically ill older adults with COVID-19. Primary IMV was associated with better outcomes than primary NIV. Clinical Trial Registration NCT04321265 , registered 19 March 2020, https://clinicaltrials.gov .
... Considering that social research cannot be independent of social changes, the two important concepts mentioned above have become a universal phenomenon in today's world life. In other words, the speed of social change and the current COVID 19 pandemic are similar in terms of affecting human behavior all over the world [8,22,23,24]. When the literature on the subject is examined, it is possible to come across studies that reveal the effects of the mentioned social events on various social groups [13,25]. ...
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Background and Study Aim: The social change brought about by the pandemic process all over the world has led to the restructuring of human behavior and daily life practices. This process has brought with it some social-psychological problems (such as alienation and social anhedonia) for social segments. For this reason, the aim of the research is to examine the alienation and social anhedonia levels of the students studying at the faculty of sport sciences during the pandemic process. Material and Methods: The sample of the research consists of students studying at the faculties of sport sciences of different universities in Turkey. A total of 423 students (271 males, 152 females) participated in the study. Due to the normal distribution of the data, the t-test, one of the parametric tests, was performed for paired groups, and the relationship between Social Anhedonia Scale and Alienation Scale sub-dimensions was tested with Pearson correlation analysis. Statistical analyzes were performed with the “Statistical Package for the Social Sciences” commercial software (SPSS for Windows, version 26.0, SPSS). The significance level was determined as p<0.05 in the analyzes, and skewness and kurtosis values were considered for the normality analysis. Results: According to the results obtained, it can be said that the pandemic process negatively affected the social anhedonia and alienation levels of male students studying at the faculty of sport sciences compared to female students. Again, it is seen that the level of alienation of the students who do sports at the professional level is higher than the students who do sports at the amateur level. Similarly, it is seen that the students of the faculty of sport sciences dealing with team sports have higher levels of social isolation, which is one of the sub-dimensions of the alienation scale, compared to the students who are engaged in individual sports. Finally, there is a negative and low-level significant relationship between social anhedonia and alienation scale sub-dimensions (p<0.05; r=-0.187; r=-0.164; r=-132). Conclusion: As a result, it can be said that the pandemic process has had similar negative effects on the students studying in the faculties of sport sciences, as in other social segments.
... Furthermore, patients ≥70 years old have six times more likely to die than patients < 70 years old [6]. Even in short time followup, the mortality rate of geriatric patients with COVID-19 in ICU is relatively high, reaching up to 80% in several studies [24][25][26]. A comparison using Indonesian Task Force big data showed that although the most common age group admitted to the hospital in the COVID-19 pandemic was 31-45 years old, the elderly population experienced the most mortality rate (> 60 years old) with roughly 18% [27]. ...
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Background With the more advanced science in the field of medicine and disease management, the population of geriatric intensive care patients is increasing. The COVID-19 pandemic has impacted healthcare management around the globe, especially on critically-ill elderly patients. We aim to analyse the relationship between underlying illnesses, including COVID-19, and the survival rate of elderly patients who are treated in the intensive care setting. Methods We conducted a prospective cohort study at 14 teaching hospitals for Anaesthesiology and Intensive Therapy Education in Indonesia. We selected all subjects with 60 years of age or older in the period between February to May 2021. Variables recorded included subject characteristics, comorbidities, and COVID-19 status. Subjects were followed for 30-day mortality as an outcome. We analysed the data using Kaplan-Meier survival analysis. Results We recruited 982 elderly patients, and 728 subjects were in the final analysis (60.7% male; 68.0 ± 6.6 years old). The 30-day mortality was 38.6%. The top five comorbidities are hypertension (21.1%), diabetes (16.2%), moderate or severe renal disease (10.6%), congestive heart failure (9.2%), and cerebrovascular disease (9.1%). Subjects with Charlson’s Comorbidity Index Score > 5 experienced 66% death. Subjects with COVID-19 who died were 57.4%. Subjects with comorbidities and COVID-19 had lower survival time than subjects without those conditions (p < 0.005). Based on linear correlation analysis, the more comorbidities the geriatric patients in the ICU had, the higher chance of mortality in 30 days (p < 0.005, R coefficient 0.22). Conclusion Approximately one in four elderly intensive care patients die, and the number is increasing with comorbidities and COVID-19 status.
... Frail patients are more vulnerable to adverse outcomes (e.g., mortality, disability), particularly in critical illness (1). Recently, frailty has been proposed as a significant risk factor for shortterm mortality in critically ill patients with the COVID-19 (1)(2)(3). ...
... For instance, the association between frailty and mortality has been inconsistent across studies (4,5). Also, we have little Leandro Utino Taniguchi, PhD [1][2][3] Thiago Junqueira Avelino-Silva, PhD 4,5 Murilo Bacchini Dias, MD 4 Wilson Jacob-Filho, PhD 4 information about the effect of frailty on the long-term survival (i.e., follow-up period longer than 90 d) of COVID-19 patients admitted to ICUs. Additionally, data from developing countries and younger patients are underrepresented in the context of patients admitted to the ICU with COVID-19 (2). ...
... Also, we have little Leandro Utino Taniguchi, PhD [1][2][3] Thiago Junqueira Avelino-Silva, PhD 4,5 Murilo Bacchini Dias, MD 4 Wilson Jacob-Filho, PhD 4 information about the effect of frailty on the long-term survival (i.e., follow-up period longer than 90 d) of COVID-19 patients admitted to ICUs. Additionally, data from developing countries and younger patients are underrepresented in the context of patients admitted to the ICU with COVID-19 (2). Furthermore, the association between frailty and ICU resource use is discordant between recent reports (2,3,6,7). ...
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OBJECTIVES:. Few studies have explored the effect of frailty on the long-term survival of COVID-19 patients after ICU admission. Furthermore, the Clinical Frailty Scale (CFS) validity in critical care patients remains debated. We investigated the association between frailty and 6-month survival in critically ill COVID-19 patients. We also explored whether ICU resource utilization varied according to frailty status and examined the concurrent validity of the CFS in this setting. DESIGN:. Ancillary study of a longitudinal prospective cohort. SETTING:. University hospital in São Paulo. PATIENTS:. Patients with severe COVID-19 admitted to ICU. INTERVENTIONS:. None. MEASUREMENTS AND MAIN RESULTS:. We assessed baseline frailty using the CFS (1–9; frail ≥ 5) and used validated procedures to compute a Frailty Index (0–1; frail > 0.25). We used Cox models to estimate associations of frailty status with 6-month survival after ICU admission and area under the receiver operating characteristic curves (AUCs) to estimate CFS’s accuracy in identifying frailty according to Frailty Index. We included 1,028 patients (mean age, 66 yr; male, 61%). Overall, 224 (22%) patients were frail (CFS ≥ 5), and 608 (59%) died over the 6-month follow-up. Frailty was independently associated with lower 6-month survival and further stratified mortality in patients with similar age and Sequential Organ Failure Assessment scores. We additionally verified that the CFS was highly accurate in identifying frailty as defined by the Frailty Index (AUC, 0.91; 95% CI, 0.89–0.93). Although treatment modalities did not diverge according to frailty status, higher CFS scores were associated with withholding organ support due to refractory organ failure. CONCLUSIONS:. One in five COVID-19 patients admitted to the ICU was frail. CFS scores greater than or equal to 5 were associated with lower long-term survival and decisions on withholding further escalation of invasive support for multiple organ failure in the ICU. Clinicians should consider frailty alongside sociodemographic and clinical measures to have a fuller picture of COVID-19 prognosis in critical care.
... Respiratory failure with or without shock led to high mortality. In ICU admitted patients, up to 30-50% of the patients did not survive the first month [1][2][3]. Thus, early and reliable identification of complex disease courses is of pivotal importance in COVID-19 (Additional file 1). ...
... This lack of evidence is especially true in the particularly vulnerable population of very old intensive care unit patients. Yet, this subgroup has been disproportionally affected by the need for ICU admissions and a high mortality [3,10,11]. ...
... This investigation aimed to understand which factors can predict mortality in elderly COVID-19 patients to help detect these patients early (the COVIP study, COVID-19 in very old intensive care patients). As in the previous VIP studies [3,12,13], national coordinators recruited the intensive care units (ICUs), coordinated national and local ethical permissions, and supervised patient recruitment at the national level. Ethical approval was mandatory for study participation. ...
... In our study, age, comorbidities and functional autonomy were also associated with in-hospital mortality, which is congruent with other geriatric cohort studies of patients hospitalized for COVID-19 (40,41). Contrary to several studies (40,42), frailty was not significantly associated with in-hospital mortality in our cohort, but we found a trend (CFS 5-9, OR = 1.28 [95% CI 0.75-2.18]). One explanation could be the great proportion of frail patients included in our study (64% in the unmatched cohort and 59% in the matched cohort). ...
Article
Background Few data are available on the prognosis of older patients who received corticosteroids for COVID-19. We aimed to compare the in-hospital mortality of geriatric patients hospitalized for COVID-19 who received corticosteroids or not. Methods We conducted a multicentric retrospective cohort study in 15 acute COVID-19 geriatric wards in the Paris area from March to April 2020 and November 2020 to May 2021. We included all consecutive patients aged 70 years and older who were hospitalized with confirmed COVID-19 in these wards. Propensity score and multivariate analyses were used. Results Of the 1579 patients included (535 received corticosteroids), the median age was 86 (interquartile range 81-91)years, 56% of patients were female, the median Charlson Comorbidity Index (CCI) was 2.6 (interquartile range 1-4), and 64% of patients were frail (Clinical Frailty Score 5-9). The propensity score analysis paired 984 patients (492 with and without corticosteroids). The in-hospital mortality was 32.3% in the matched cohort. On multivariate analysis, the probability of in-hospital mortality was increased with corticosteroids use (odds ratio [OR]=2.61 [95% confidence interval (CI) 1.63-4.20]). Other factors associated with in-hospital mortality were age (OR=1.04[1.01-1.07], CCI (OR=1.18[1.07-1.29], activities of daily living (OR=0.85[0.75-0.95], oxygen saturation <90% on room air (OR=2.15[1.45-3.17], C-reactive protein level (OR=2.06[1.69-2.51] and lowest lymphocyte count (OR=0.49[0.38-0.63]). Among the 535 patients who received corticosteroids, 68.3% had at least one corticosteroid side effect, including delirium(32.9%), secondary infections(32.7%) and decompensated diabetes(14.4%). Conclusions In this multicentric matched-cohort study of geriatric patients hospitalized for COVID-19, the use of corticosteroids was significantly associated with in-hospital mortality.
... In our ageing society, there are increasing possibilities for medical treatment, especially in critical care, and growing numbers of frail pre-ICU patients are being ad-Bertschi/Waskowski/Schilling/Donatsch/ Schefold/Pfortmueller Gerontology 2 DOI: 10.1159/000523674 mitted to intensive care units (ICUs) [1,2]. Frailty in the general population has a high prevalence and affects 7-11% of persons aged 65 years and older and 25-40% of those aged 80 years and over [3][4][5]. Nonetheless, it is frequently overlooked since medical consultations often assess specific health or organ problems rather than assessing the global health and functional state of a patient [6]. Therefore, pre-ICU frailty should be assessed before or during the early period after admitting a patient to an ICU, in order to evaluate the extent to which burdensome intensive care treatments might be beneficial for the individual patient [7,8]. ...
... The current mostly used and validated tool for critically ill patients is the CFS. The current literature indicates that frailty assessment is of prognostic value [5]. ...
... A further limitation to this review is that due to the global COVID-19 pandemic many ICUs experienced considerable limitations in available resources and the utility of frailty as a triage tool may have been hampered due to the "new disease COVID-19." However, a recently published large multicentre study revealed that frailty assessment by the CFS is also reliable for patients with COVID-19 [5]. For many studies, no stratification has been performed on how frailty was assessed or the cut-off value used for the CFS across studies. ...
Article
Introduction: As new treatments have become established, more frail pre-ICU patients are being admitted to intensive care units (ICUs); this is creating new challenges to provide adequate care and to ensure that resources are allocated in an ethical and economical manner. This systematic review evaluates the current standard for assessing frailty on the ICU, including methods of assessment, time point of measurements, and cut-offs. Methods: A systematic search was conducted on MEDLINE, Clinical Trials, Cochrane Library, and Embase. Randomized and non-randomized controlled studies were included that evaluated diagnostic tools and ICU outcomes for frailty. Exclusion criteria were the following: studies without baseline assessment of frailty on ICU admission, studies in paediatric patients or pregnant women, and studies that targeted very narrow populations of ICU patients. Eligible articles were included until January 31, 2021. Methodological quality was assessed using the Newcastle-Ottawa Scale. No meta-analysis was performed, due to heterogeneity. Results: N = 57 articles (253,376 patients) were included using 19 different methods to assess frailty or a surrogate. Frailty on ICU admission was most frequently detected using the Clinical Frailty Scale (CFS) (n = 35, 60.3%), the Frailty Index (n = 5, 8.6%), and Fried's frailty phenotype (n = 6, 10.3%). N = 22 (37.9%) studies assessed functional status. Cut-offs, time points, and manner of baseline assessment of frailty on ICU admission varied widely. Frailty on ICU admission was associated with short- and long-term mortality, functional and cognitive impairment, increased health care dependency, and impaired quality of life post-ICU discharge. Conclusions: Frailty assessment on the ICU is heterogeneous with respect to methods, cut-offs, and time points. The CFS may best reflect frailty in the ICU. Frailty assessments should be harmonized and performed routinely in the critically ill.
... For the same age category, the overall mortality was lower than that reported by a smaller regional Turkish cohort (80.5%) [19], but slightly higher than in most Western European published studies: 55% in an Italian cohort [9], 62.5% and 66.8% in French cohorts [25,26], and 72% in a German study [27]. The COVIP study observed a mortality at 30 days (not general in-hospital mortality) of 41% in patients aged 70 or older, which increased to 48% at 90 days, and was 67% in frail patients [28]. Raw comparisons are difficult to make, as different age cut-offs are used in COVID-19-related articles: 60-years, 65-years, 70-years, 75-years, 80-years, and 85-years [4,10,19,21,25,[28][29][30][31]. ...
... The COVIP study observed a mortality at 30 days (not general in-hospital mortality) of 41% in patients aged 70 or older, which increased to 48% at 90 days, and was 67% in frail patients [28]. Raw comparisons are difficult to make, as different age cut-offs are used in COVID-19-related articles: 60-years, 65-years, 70-years, 75-years, 80-years, and 85-years [4,10,19,21,25,[28][29][30][31]. ...
... However, the ethical controversy regarding ICU admission for the elderly is ongoing, as age alone might not be an appropriate predictor for hospital outcomes [36,37]. The assessment of individual benefit-risk balance and the degree of frailty, rather than age or comorbidities alone, are better predictors of COVID-19 outcomes [28,38]. ...
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Background: During the COVID-19 pandemic, resource allocation became a major problem in globally overwhelmed ICUs. The main goal of this study was to describe the clinical characteristics of the very elderly patients (aged ≥ 80 years) with COVID-19 admitted in Romanian ICUs. The study objectives were to evaluate and determine the factors associated with ICU mortality. Methods: We designed a national, multicentric, observational platform with prospective enrolment. This study included patients aged ≥ 80 years admitted in Romanian ICUs with SARS-CoV-2 infection from March 2020 to December 2021. Results: We included 1666 patients with a median age of 83 years and 78% ICU mortality. Male sex, dyspnoea, lower Glasgow Coma Scale and lower SpO2 at ICU admission, the need for mechanical ventilation (MV), and corticosteroid use were independently associated with mortality. A total of 886/1666 (53%) elderly patients underwent invasive mechanical ventilation, with a mortality of 97%. The age impact on mortality was confirmed by a 1:1 propensity matching with less elderly ICU patients. Conclusion: In extremely elderly patients with COVID-19 admitted in the ICU, mortality is high, particularly when requiring MV. Therapy should be directed towards the optimization of less invasive ventilatory methods and the use of MV and corticosteroids only in highly selected patients.
... Critically ill intensive care patients with severe coronavirus disease 2019 (COVID-19) suffer from mortality rates up to 50%. [1][2][3] Early in the pandemic, pre-existing chronic heart failure (CHF) was reported as a major risk factor for adverse outcomes in hospitalized patients. 4 COVID-19 itself is associated with both systolic and diastolic left ventricular dysfunction, pulmonary hypertension, and right ventricular dysfunctioneven in patients without known pre-existing CHF 5 and in asymptomatic patients. ...
... Older patients, in whom there is a high prevalence of CHF, 3,7,8 are particularly vulnerable. They have been disproportionally affected by the pandemic with an increased need for intensive care and a high mortality. ...
... They have been disproportionally affected by the pandemic with an increased need for intensive care and a high mortality. 3,9,10 Co-morbidities such as frailty and limitations in daily life activity 3,7 further contribute to a worse prognosis and may enhance the effect of CHF on prognosis. Older patients are thus important to study in this setting. ...
Article
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Aims: Chronic heart failure (CHF) is a major risk factor for mortality in coronavirus disease 2019 (COVID-19). This prospective international multicentre study investigates the role of pre-existing CHF on clinical outcomes of critically ill old (≥70 years) intensive care patients with COVID-19. Methods and results: Patients with pre-existing CHF were subclassified as having ischaemic or non-ischaemic cardiac disease; patients with a documented ejection fraction (EF) were subclassified according to heart failure EF: reduced (HFrEF, n = 132), mild (HFmrEF, n = 91), or preserved (HFpEF, n = 103). Associations of heart failure characteristics with the 30 day mortality were analysed in univariate and multivariate logistic regression analyses. Pre-existing CHF was reported in 566 of 3917 patients (14%). Patients with CHF were older, frailer, and had significantly higher SOFA scores on admission. CHF patients showed significantly higher crude 30 day mortality [60% vs. 48%, P < 0.001; odds ratio 1.87, 95% confidence interval (CI) 1.5-2.3] and 3 month mortality (69% vs. 56%, P < 0.001). After multivariate adjustment for confounders (SOFA, age, sex, and frailty), no independent association of CHF with mortality remained [adjusted odds ratio (aOR) 1.2, 95% CI 0.5-1.5; P = 0.137]. More patients suffered from pre-existing ischaemic than from non-ischaemic disease [233 vs. 328 patients (n = 5 unknown aetiology)]. There were no differences in baseline characteristics between ischaemic and non-ischaemic disease or between HFrEF, HFmrEF, and HFpEF. Crude 30 day mortality was significantly higher in HFrEF compared with HFpEF (64% vs. 48%, P = 0.042). EF as a continuous variable was not independently associated with 30 day mortality (aOR 0.98, 95% CI 0.9-1.0; P = 0.128). Conclusions: In critically ill older COVID-19 patients, pre-existing CHF was not independently associated with 30 day mortality. Trial registration number: NCT04321265.