Publications by authors named "Marcos García Aguado"

25 Publications

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Aspirin Therapy on Prophylactic Anticoagulation for Patients Hospitalized With COVID-19: A Propensity Score-Matched Cohort Analysis of the HOPE-COVID-19 Registry.

J Am Heart Assoc 2022 Jun 22:e024530. Epub 2022 Jun 22.

Hospital Clinico San Carlos Madrid Spain.

Background COVID-19 is an infectious illness, featured by an increased risk of thromboembolism. However, no standard antithrombotic therapy is currently recommended for patients hospitalized with COVID-19. The aim of this study was to evaluate safety and efficacy of additional therapy with aspirin over prophylactic anticoagulation (PAC) in patients hospitalized with COVID-19 and its impact on survival. Methods and Results A total of 8168 patients hospitalized for COVID-19 were enrolled in a multicenter-international prospective registry (HOPE COVID-19). Clinical data and in-hospital complications, including mortality, were recorded. Study population included patients treated with PAC or with PAC and aspirin. A comparison of clinical outcomes between patients treated with PAC versus PAC and aspirin was performed using an adjusted analysis with propensity score matching. Of 7824 patients with complete data, 360 (4.6%) received PAC and aspirin and 2949 (37.6%) PAC. Propensity-score matching yielded 298 patients from each group. In the propensity score-matched population, cumulative incidence of in-hospital mortality was lower in patients treated with PAC and aspirin versus PAC (15% versus 21%, Log Rank =0.01). At multivariable analysis in propensity matched population of patients with COVID-19, including age, sex, hypertension, diabetes, kidney failure, and invasive ventilation, aspirin treatment was associated with lower risk of in-hospital mortality (hazard ratio [HR], 0.62; [95% CI 0.42-0.92], =0.018). Conclusions Combination PAC and aspirin was associated with lower mortality risk among patients hospitalized with COVID-19 in a propensity score matched population compared to PAC alone.
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http://dx.doi.org/10.1161/JAHA.121.024530DOI Listing
June 2022

Chronic Oral Anticoagulation Therapy and Prognosis of Patients Admitted to Hospital for COVID-19: Insights from the HOPE COVID-19 Registry.

Int J Clin Pract 2022 26;2022:7325060. Epub 2022 May 26.

Hospital Clínico San Carlos Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Background: Most evidence regarding anticoagulation and COVID-19 refers to the hospitalization setting, but the role of oral anticoagulation (OAC) before hospital admission has not been well explored. We compared clinical outcomes and short-term prognosis between patients with and without prior OAC therapy who were hospitalized for COVID-19.

Methods: Analysis of the whole cohort of the HOPE COVID-19 Registry which included patients discharged (deceased or alive) after hospital admission for COVID-19 in 9 countries. All-cause mortality was the primary endpoint. Study outcomes were compared after adjusting variables using propensity score matching (PSM) analyses.

Results: 7698 patients were suitable for the present analysis (675 (8.8%) on OAC at admission: 427 (5.6%) on VKAs and 248 (3.2%) on DOACs). After PSM, 1276 patients were analyzed (638 with OAC; 638 without OAC), without significant differences regarding the risk of thromboembolic events (OR 1.11, 95% CI 0.59-2.08). The risk of clinically relevant bleeding (OR 3.04, 95% CI 1.92-4.83), as well as the risk of mortality (HR 1.22, 95% CI 1.01-1.47; log-rank value = 0.041), was significantly increased in previous OAC users. Amongst patients on prior OAC only, there were no differences in the risk of clinically relevant bleeding, thromboembolic events, or mortality when comparing previous VKA or DOAC users, after PSM.

Conclusion: Hospitalized COVID-19 patients on prior OAC therapy had a higher risk of mortality and worse clinical outcomes compared to patients without prior OAC therapy, even after adjusting for comorbidities using a PSM. There were no differences in clinical outcomes in patients previously taking VKAs or DOACs. This trial is registered with NCT04334291/EUPAS34399.
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http://dx.doi.org/10.1155/2022/7325060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9158796PMC
June 2022

Thalassaemia is paradoxically associated with a reduced risk of in-hospital complications and mortality in COVID-19: Data from an international registry.

J Cell Mol Med 2022 05 30;26(9):2520-2528. Epub 2022 Mar 30.

Policlinico Umberto I, Rome, Italy.

Although numerous patient-specific co-factors have been shown to be associated with worse outcomes in COVID-19, the prognostic value of thalassaemic syndromes in COVID-19 patients remains poorly understood. We studied the outcomes of 137 COVID-19 patients with a history of transfusion-dependent thalassaemia (TDT) and transfusion independent thalassaemia (TIT) extracted from a large international cohort and compared them with the outcomes from a matched cohort of COVID-19 patients with no history of thalassaemia. The mean age of thalassaemia patients included in our study was 41 ± 16 years (48.9% male). Almost 81% of these patients suffered from TDT requiring blood transfusions on a regular basis. 38.7% of patients were blood group O. Cardiac iron overload was documented in 6.8% of study patients, whereas liver iron overload was documented in 35% of study patients. 40% of thalassaemia patients had a history of splenectomy. 27.7% of study patients required hospitalization due to COVID-19 infection. Amongst the hospitalized patients, one patient died (0.7%) and one patient required intubation. Continuous positive airway pressure (CPAP) was required in almost 5% of study patients. After adjustment for age-, sex- and other known risk factors (cardiac disease, kidney disease and pulmonary disease), the rate of in-hospital complications (supplemental oxygen use, admission to an intensive care unit for CPAP therapy or intubation) and all-cause mortality was significantly lower in the thalassaemia group compared to the matched cohort with no history of thalassaemia. Amongst thalassaemia patients in general, the TIT group exhibited a higher rate of hospitalization compared to the TDT group (p = 0.001). In addition, the rate of complications such as acute kidney injury and need for supplemental oxygen was significantly higher in the TIT group compared to the TDT group. In the multivariable logistic regression analysis, age and history of heart or kidney disease were all found to be independent risk factors for increased in-hospital, all-cause mortality, whereas the presence of thalassaemia (either TDT or TIT) was found to be independently associated with reduced all-cause mortality. The presence of thalassaemia in COVID-19 patients was independently associated with lower in-hospital, all-cause mortality and few in-hospital complications in our study. The pathophysiology of this is unclear and needs to be studied in vitro and in animal models.
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http://dx.doi.org/10.1111/jcmm.17026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9077285PMC
May 2022

Prevalence and 30-Day Mortality in Hospitalized Patients With Covid-19 and Prior Lung Diseases.

Arch Bronconeumol 2021 Apr 16;57:13-20. Epub 2020 Dec 16.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Introduction: Patients with pre-existing respiratory diseases in the setting of COVID-19 may have a greater risk of severe complications and even death.

Methods: A retrospective, multicenter, cohort study with 5847 COVID-19 patients admitted to hospitals. Patients were separated in two groups, with/without previous lung disease. Evaluation of factors associated with survival and secondary composite end-point such as ICU admission and respiratory support, were explored.

Results: 1,271 patients (22%) had a previous lung disease, mostly COPD. All-cause mortality occurred in 376 patients with lung disease (29.5%) and in 819 patients without (17.9%) ( < 0.001). Kaplan-Meier curves showed that patients with lung diseases had a worse 30-day survival (HR = 1.78; 95%C.I. 1.58-2.01;  < 0.001) and COPD had almost 40% mortality. Multivariable Cox regression showed that prior lung disease remained a risk factor for mortality (HR, 1.21; 95%C.I. 1.02-1.44;  = 0.02). Variables independently associated with all-cause mortality risk in patients with lung diseases were oxygen saturation less than 92% on admission (HR, 4.35; 95% CI 3.08-6.15) and elevated D-dimer (HR, 1.84; 95% CI 1.27-2.67). Age younger than 60 years (HR 0.37; 95% CI 0.21-0.65) was associated with decreased risk of death.

Conclusions: Previous lung disease is a risk factor for mortality in patients with COVID-19. Older age, male gender, home oxygen therapy, and respiratory failure on admission were associated with an increased mortality. Efforts must be done to identify respiratory patients to set measures to improve their clinical outcomes.
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http://dx.doi.org/10.1016/j.arbres.2020.11.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744014PMC
April 2021

Antiplatelet therapy and outcome in COVID-19: the Health Outcome Predictive Evaluation Registry.

Heart 2022 01 5;108(2):130-136. Epub 2021 Oct 5.

Department of Cardiology, San Carlos, University Hospital, Madrid, Spain.

Background: Standard therapy for COVID-19 is continuously evolving. Autopsy studies showed high prevalence of platelet-fibrin-rich microthrombi in several organs. The aim of the study was therefore to evaluate the safety and efficacy of antiplatelet therapy (APT) in hospitalised patients with COVID-19 and its impact on survival.

Methods: 7824 consecutive patients with COVID-19 were enrolled in a multicentre international prospective registry (Health Outcome Predictive Evaluation-COVID-19 Registry). Clinical data and in-hospital complications were recorded. Data on APT, including aspirin and other antiplatelet drugs, were obtained for each patient.

Results: During hospitalisation, 730 (9%) patients received single APT (93%, n=680) or dual APT (7%, n=50). Patients treated with APT were older (74±12 years vs 63±17 years, p<0.01), more frequently male (68% vs 57%, p<0.01) and had higher prevalence of diabetes (39% vs 16%, p<0.01). Patients treated with APT showed no differences in terms of in-hospital mortality (18% vs 19%, p=0.64), need for invasive ventilation (8.7% vs 8.5%, p=0.88), embolic events (2.9% vs 2.5% p=0.34) and bleeding (2.1% vs 2.4%, p=0.43), but had shorter duration of mechanical ventilation (8±5 days vs 11±7 days, p=0.01); however, when comparing patients with APT versus no APT and no anticoagulation therapy, APT was associated with lower mortality rates (log-rank p<0.01, relative risk 0.79, 95% CI 0.70 to 0.94). On multivariable analysis, in-hospital APT was associated with lower mortality risk (relative risk 0.39, 95% CI 0.32 to 0.48, p<0.01).

Conclusions: APT during hospitalisation for COVID-19 could be associated with lower mortality risk and shorter duration of mechanical ventilation, without increased risk of bleeding.

Trial Registration Number: NCT04334291.
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http://dx.doi.org/10.1136/heartjnl-2021-319552DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8494537PMC
January 2022

Impact of smoking on COVID-19 outcomes: a HOPE Registry subanalysis.

BMJ Nutr Prev Health 2021 17;4(1):285-292. Epub 2021 Jun 17.

Pneumology, Hospital Clínico Universitario, Incliva. Universidad de Valencia, Valencia, Spain.

Background: Smoking has been associated with poorer outcomes in relation to COVID-19. Smokers have higher risk of mortality and have a more severe clinical course. There is paucity of data available on this issue, and a definitive link between smoking and COVID-19 prognosis has yet to be established.

Methods: We included 5224 patients with COVID-19 with an available smoking history in a multicentre international registry Health Outcome Predictive Evaluation for COVID-19 (NCT04334291). Patients were included following an in-hospital admission with a COVID-19 diagnosis. We analysed the outcomes of patients with a current or prior history of smoking compared with the non-smoking group. The primary endpoint was all-cause in-hospital death.

Results: Finally, 5224 patients with COVID-19 with available smoking status were analysed. A total of 3983 (67.9%) patients were non-smokers, 934 (15.9%) were former smokers and 307 (5.2%) were active smokers. The median age was 66 years (IQR 52.0-77.0) and 58.6% were male. The most frequent comorbidities were hypertension (48.5%) and dyslipidaemia (33.0%). A relevant lung disease was present in 19.4%. In-hospital complications such sepsis (23.6%) and embolic events (4.3%) occurred more frequently in the smoker group (p<0.001 for both). All cause-death was higher among smokers (active or former smokers) compared with non-smokers (27.6 vs 18.4%, p<0.001). Following a multivariate analysis, current smoking was considered as an independent predictor of mortality (OR 1.77, 95% CI 1.11 to 2.82, p=0.017) and a combined endpoint of severe disease (OR 1.68, 95% CI 1.16 to 2.43, p=0.006).

Conclusion: Smoking has a negative prognostic impact on patients hospitalised with COVID-19.
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http://dx.doi.org/10.1136/bmjnph-2021-000269DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214987PMC
June 2021

Gender Differences in the Presentation and Outcomes of Hospitalized Patients With COVID-19.

J Hosp Med 2021 06;16(6):349-352

Hospital Clínico San Carlos, Madrid, Spain.

Gender-related differences in COVID-19 clinical presentation, disease progression, and mortality have not been adequately explored. We analyzed the clinical profile, presentation, treatments, and outcomes of patients according to gender in the HOPE-COVID-19 International Registry. Among 2,798 enrolled patients, 1,111 were women (39.7%). Male patients had a higher prevalence of cardiovascular risk factors and more comorbidities at baseline. After propensity score matching, 876 men and 876 women were selected. Male patients more often reported fever, whereas female patients more often reported vomiting, diarrhea, and hyposmia/anosmia. Laboratory tests in men presented alterations consistent with a more severe COVID-19 infection (eg, significantly higher C-reactive protein, troponin, transaminases, lymphocytopenia, thrombocytopenia, and ferritin). Systemic inflammatory response syndrome, bilateral pneumonia, respiratory insufficiency, and renal failure were significantly more frequent in men. Men more often required pronation, corticosteroids, and tocilizumab administration. A significantly higher 30-day mortality was observed in men vs women (23.4% vs 19.2%; P = .039). Trial Numbers: NCT04334291/EUPAS34399.
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http://dx.doi.org/10.12788/jhm.3594DOI Listing
June 2021

Anticoagulation Therapy in Patients With Coronavirus Disease 2019: Results From a Multicenter International Prospective Registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019 [HOPE-COVID19]).

Crit Care Med 2021 06;49(6):e624-e633

Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Objectives: No standard therapy, including anticoagulation regimens, is currently recommended for coronavirus disease 2019. Aim of this study was to evaluate the efficacy of anticoagulation in coronavirus disease 2019 hospitalized patients and its impact on survival.

Design: Multicenter international prospective registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019).

Setting: Hospitalized patients with coronavirus disease 2019.

Patients: Five thousand eight hundred thirty-eight consecutive coronavirus disease 2019 patients.

Interventions: Anticoagulation therapy, including prophylactic and therapeutic regimens, was obtained for each patient.

Measurements And Main Results: Five thousand four hundred eighty patients (94%) did not receive any anticoagulation before hospitalization. Two-thousand six-hundred one patients (44%) during hospitalization received anticoagulation therapy and it was not associated with better survival rate (81% vs 81%; p = 0.94) but with higher risk of bleeding (2.7% vs 1.8%; p = 0.03). Among patients admitted with respiratory failure (49%, n = 2,859, including 391 and 583 patients requiring invasive and noninvasive ventilation, respectively), anticoagulation started during hospitalization was associated with lower mortality rates (32% vs 42%; p < 0.01) and nonsignificant higher risk of bleeding (3.4% vs 2.7%; p = 0.3). Anticoagulation therapy was associated with lower mortality rates in patients treated with invasive ventilation (53% vs 64%; p = 0.05) without increased rates of bleeding (9% vs 8%; p = 0.88) but not in those with noninvasive ventilation (35% vs 38%; p = 0.40). At multivariate Cox' analysis mortality relative risk with anticoagulation was 0.58 (95% CI, 0.49-0.67) in patients admitted with respiratory failure, 0.50 (95% CI, 0.49-0.67) in those requiring invasive ventilation, 0.72 (95% CI, 0.51-1.01) in noninvasive ventilation.

Conclusions: Anticoagulation therapy in general population with coronavirus disease 2019 was not associated with better survival rates but with higher bleeding risk. Better results were observed in patients admitted with respiratory failure and requiring invasive ventilation.
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http://dx.doi.org/10.1097/CCM.0000000000005010DOI Listing
June 2021

Renin-angiotensin system inhibitors effect before and during hospitalization in COVID-19 outcomes: Final analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry.

Am Heart J 2021 07 15;237:104-115. Epub 2021 Apr 15.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Background: The use of Renin-Angiotensin system inhibitors (RASi) in patients with coronavirus disease 2019 (COVID-19) has been questioned because both share a target receptor site.

Methods: HOPE-COVID-19 (NCT04334291) is an international investigator-initiated registry. Patients are eligible when discharged after an in-hospital stay with COVID-19, dead or alive. Here, we analyze the impact of previous and continued in-hospital treatment with RASi in all-cause mortality and the development of in-stay complications.

Results: We included 6503 patients, over 18 years, from Spain and Italy with data on their RASi status. Of those, 36.8% were receiving any RASi before admission. RASi patients were older, more frequently male, with more comorbidities and frailer. Their probability of death and ICU admission was higher. However, after adjustment, these differences disappeared. Regarding RASi in-hospital use, those who continued the treatment were younger, with balanced comorbidities but with less severe COVID19. Raw mortality and secondary events were less frequent in RASi. After adjustment, patients receiving RASi still presented significantly better outcomes, with less mortality, ICU admissions, respiratory insufficiency, need for mechanical ventilation or prone, sepsis, SIRS and renal failure (p<0.05 for all). However, we did not find differences regarding the hospital use of RASi and the development of heart failure.

Conclusion: RASi historic use, at admission, is not related to an adjusted worse prognosis in hospitalized COVID-19 patients, although it points out a high-risk population. In this setting, the in-hospital prescription of RASi is associated with improved survival and fewer short-term complications.
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http://dx.doi.org/10.1016/j.ahj.2021.04.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047303PMC
July 2021

[Atrial fibrillation in patients with COVID-19. Usefulness of the CHADS-VASc score: an analysis of the international HOPE COVID-19 registry].

Rev Esp Cardiol 2021 Jul 2;74(7):608-615. Epub 2021 Mar 2.

Servicio de Cardiología, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, España.

Introduction And Objectives: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2. Atrial fibrillation (AF) is common in acute situations, where it is associated with more complications and higher mortality.

Methods: Analysis of the international HOPE registry (NCT04334291). The objective was to assess the prognostic information of AF in COVID-19 patients. A multivariate analysis and propensity score matching were performed to assess the relationship between AF and mortality. We also evaluated the impact on mortality and embolic events of the CHADS-VASc score in these patients.

Results: Among 6217 patients enrolled in the HOPE registry, 250 had AF (4.5%). AF patients had a higher prevalence of cardiovascular risk factors and comorbidities. After propensity score matching, these differences were attenuated. Despite this, patients with AF had a higher incidence of in-hospital complications such as heart failure (19.3% vs 11.6%,  = .021) and respiratory insufficiency (75.9% vs 62.3%,  = .002), as well as a higher 60-day mortality rate (43.4% vs 30.9%,  = .005). On multivariate analysis, AF was independently associated with higher 60-day mortality (hazard ratio, 1.234; 95%CI, 1.003-1.519). CHADS-VASc score acceptably predicts 60-day mortality in COVID-19 patients (area ROC, 0.748; 95%CI, 0.733-0.764), but not its embolic risk (area ROC, 0.411; 95%CI, 0.147-0.675).

Conclusions: AF in COVID-19 patients is associated with a higher number of complications and 60-day mortality. The CHADS-VASc score may be a good risk marker in COVID patients but does not predict their embolic risk.
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http://dx.doi.org/10.1016/j.recesp.2020.12.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923850PMC
July 2021

COVID-19 anosmia and gustatory symptoms as a prognosis factor: a subanalysis of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry.

Infection 2021 Aug 1;49(4):677-684. Epub 2021 Mar 1.

Hospital Clínico San Carlos, Madrid, Spain.

Olfactory and gustatory dysfunctions (OGD) are a frequent symptom of coronavirus disease 2019 (COVID-19). It has been proposed that the neuroinvasive potential of the novel SARS-CoV-2 could be due to olfactory bulb invasion, conversely studies suggest it could be a good prognostic factor. The aim of the current study was to investigate the prognosis value of OGD in COVID-19. These symptoms were recorded on admission from a cohort study of 5868 patients with confirmed or highly suspected COVID-19 infection included in the multicenter international HOPE Registry (NCT04334291). There was statistical relation in multivariate analysis for OGD in gender, more frequent in female 12.41% vs 8.67% in male, related to age, more frequent under 65 years, presence of hypertension, dyslipidemia, diabetes, smoke, renal insufficiency, lung, heart, cancer and neurological disease. We did not find statistical differences in pregnant (p = 0.505), patient suffering cognitive (p = 0.484), liver (p = 0.1) or immune disease (p = 0.32). There was inverse relation (protective) between OGD and prone positioning (0.005) and death (< 0.0001), but no with ICU (0.165) or mechanical ventilation (0.292). On univariable logistic regression, OGD was found to be inversely related to death in COVID-19 patients. The odds ratio was 0.26 (0.15-0.44) (p < 0.001) and Z was - 5.05. The presence of anosmia is fundamental in the diagnosis of SARS.CoV-2 infection, but also could be important in classifying patients and in therapeutic decisions. Even more knowing that it is an early symptom of the disease. Knowing that other situations as being Afro-American or Latino-American, hypertension, renal insufficiency, or increase of C-reactive protein (CRP) imply a worse prognosis we can make a clinical score to estimate the vital prognosis of the patient. The exact pathogenesis of SARS-CoV-2 that causes olfactory and gustative disorders remains unknown but seems related to the prognosis. This point is fundamental, insomuch as could be a plausible way to find a treatment.
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http://dx.doi.org/10.1007/s15010-021-01587-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917537PMC
August 2021

Atrial fibrillation in patients with COVID-19. Usefulness of the CHADS-VASc score: an analysis of the international HOPE COVID-19 registry.

Rev Esp Cardiol (Engl Ed) 2021 Jul 13;74(7):608-615. Epub 2021 Jan 13.

Servicio de Cardiología, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Introduction And Objectives: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2. Atrial fibrillation (AF) is common in acute situations, where it is associated with more complications and higher mortality.

Methods: Analysis of the international HOPE registry (NCT04334291). The objective was to assess the prognostic information of AF in COVID-19 patients. A multivariate analysis and propensity score matching were performed to assess the relationship between AF and mortality. We also evaluated the impact on mortality and embolic events of the CHADS-VASc score in these patients.

Results: Among 6217 patients enrolled in the HOPE registry, 250 had AF (4.5%). AF patients had a higher prevalence of cardiovascular risk factors and comorbidities. After propensity score matching, these differences were attenuated. Despite this, patients with AF had a higher incidence of in-hospital complications such as heart failure (19.3% vs 11.6%, P=.021) and respiratory insufficiency (75.9% vs 62.3%, P=.002), as well as a higher 60-day mortality rate (43.4% vs 30.9%, P=.005). On multivariate analysis, AF was independently associated with higher 60-day mortality (hazard ratio, 1.234; 95%CI, 1.003-1.519). CHADS-VASc score acceptably predicts 60-day mortality in COVID-19 patients (area ROC, 0.748; 95%CI, 0.733-0.764), but not its embolic risk (area ROC, 0.411; 95%CI, 0.147-0.675).

Conclusions: AF in COVID-19 patients is associated with a higher number of complications and 60-day mortality. The CHADS-VASc score may be a good risk marker in COVID patients but does not predict their embolic risk.
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http://dx.doi.org/10.1016/j.rec.2020.12.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836821PMC
July 2021

Clinical presentation, therapeutic approach, and outcome of young patients admitted for COVID-19, with respect to the elderly counterpart.

Clin Exp Med 2021 May 8;21(2):249-268. Epub 2021 Feb 8.

Hospital Clinico San Carlos, Madrid, Spain.

There is limited information on the presenting characteristics, prognosis, and therapeutic approaches of young patients hospitalized for coronavirus disease 2019 (COVID-19). We sought to investigate the baseline characteristics, in-hospital treatment, and outcomes of a wide cohort < 65 years admitted for COVID-19. Using the international multicenter HOPE-COVID-19 registry, we evaluated the baseline characteristics, clinical presentation, therapeutic approach, and prognosis of patients < 65 years discharged (deceased or alive) after hospital admission for COVID-19, also compared with the elderly counterpart. Of the included 5746 patients, 2676 were < 65 and 3070 ≥ 65 years. All risk factors and several parameters suggestive of worse clinical presentation augmented through increasing age classes. In-hospital mortality rates were 6.8% and 32.1% in the younger and older cohort, respectively (p < 0.001). Among young patients, mortality, access to ICU and treatment with IMVwere positively correlated with age. Contrariwise, over 65 years of age this trend was broken so that only the association between age and mortality was persistent, while the rates of access to ICU and IMV started to decline. Younger patients also recognized specific predictors of case fatality, such as obesity and gender. Age negatively impacts on mortality, access to ICU and treatment with IMV in patients < 65 years. In elderly patients only case fatality rate keeps augmenting in a stepwise manner through increasing age categories, while therapeutic approaches become more conservative. Besides age, obesity, gender, history of cancer, and severe dyspnea, tachypnea, chest X-ray bilateral abnormalities, abnormal level of creatinine and leucocyte among admission parameters seem to play a central role in the outcome of patients younger than 65 years.
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http://dx.doi.org/10.1007/s10238-021-00684-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868661PMC
May 2021

Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis.

Front Endocrinol (Lausanne) 2020 30;11:599255. Epub 2020 Nov 30.

Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Dysnatremia is associated with increased mortality in patients with community-acquired pneumonia. SARS-COV2 (Severe-acute-respiratory syndrome caused by Coronavirus-type 2) pneumonia can be fatal. The aim of this study was to ascertain whether admittance dysnatremia is associated with mortality, sepsis, or intensive therapy (IT) in patients hospitalized with SARS-COV2 pneumonia. This is a retrospective study of the HOPE-COVID-19 registry, with data collected from January 1 through April 31, 2020. We selected all hospitalized adult patients with RT-PCR-confirmed SARS-COV2 pneumonia and a registered admission serum sodium level (SNa). Patients were classified as hyponatremic (SNa <135 mmol/L), eunatremic (SNa 135-145 mmol/L), or hypernatremic (SNa >145 mmol/L). Multivariable analyses were performed to elucidate independent relationships of admission hyponatremia and hypernatremia, with mortality, sepsis, or IT during hospitalization. Four thousand six hundred sixty-four patients were analyzed, median age 66 (52-77), 58% males. Death occurred in 988 (21.2%) patients, sepsis was diagnosed in 551 (12%) and IT in 838 (18.4%). Hyponatremia was present in 957/4,664 (20.5%) patients, and hypernatremia in 174/4,664 (3.7%). Both hyponatremia and hypernatremia were associated with mortality and sepsis. Only hyponatremia was associated with IT. In conclusion, hyponatremia and hypernatremia at admission are factors independently associated with mortality and sepsis in patients hospitalized with SARS-COV2 pneumonia.

Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04334291, NCT04334291.
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http://dx.doi.org/10.3389/fendo.2020.599255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734292PMC
January 2021

Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19.

Age Ageing 2021 02;50(2):326-334

Unidad de Gestión Clínica Área del Corazón, Instituto de Investigación Biomédica de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria, Universidad de Málaga (UMA), Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Málaga, Spain.

Background: the coronavirus disease 2019 (COVID-19) is characterized by poor outcomes and mortality, particularly in older patients.

Methods: post hoc analysis of the international, multicentre, 'real-world' HOPE COVID-19 registry. All patients aged ≥65 years hospitalised for COVID-19 were selected. Epidemiological, clinical, analytical and outcome data were obtained. A comparative study between two age subgroups, 65-74 and ≥75 years, was performed. The primary endpoint was all cause in-hospital mortality.

Results: about, 1,520 patients aged ≥65 years (60.3% male, median age of 76 [IQR 71-83] years) were included. Comorbidities such as hypertension (69.2%), dyslipidaemia (48.6%), cardiovascular diseases (any chronic heart disease in 38.4% and cerebrovascular disease in 12.5%), and chronic lung disease (25.3%) were prevalent, and 49.6% were on ACEI/ARBs. Patients aged 75 years and older suffered more in-hospital complications (respiratory failure, heart failure, renal failure, sepsis) and a significantly higher mortality (18.4 vs. 48.2%, P < 0.001), but fewer admissions to intensive care units (11.2 vs. 4.8%). In the overall cohort, multivariable analysis demonstrated age ≥75 (OR 3.54), chronic kidney disease (OR 3.36), dementia (OR 8.06), peripheral oxygen saturation at admission <92% (OR 5.85), severe lymphopenia (<500/mm3) (OR 3.36) and qSOFA (Quick Sequential Organ Failure Assessment Score) >1 (OR 8.31) to be independent predictors of mortality.

Conclusion: patients aged ≥65 years hospitalised for COVID-19 had high rates of in-hospital complications and mortality, especially among patients 75 years or older. Age ≥75 years, dementia, peripheral oxygen saturation <92%, severe lymphopenia and qSOFA scale >1 were independent predictors of mortality in this population.
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http://dx.doi.org/10.1093/ageing/afaa258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717146PMC
February 2021

Left Ventricular Ejection Fraction Recovery in Patients with Heart Failure and Reduced Ejection Fraction Treated with Sacubitril/Valsartan.

Cardiology 2020 15;145(5):275-282. Epub 2020 Jan 15.

Servicio de Cardiología, Hospital Universitario Gregorio Marañón, Madrid, Spain.

Background: A significant number of heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF) experience ventricular function recovery during follow-up. We studied the variables associated with LVEF recovery in patients treated with sacubitril/valsartan (SV) in clinical practice.

Methods: We analyzed data from a prospective and multicenter registry including 249 HF outpatients with reduced LVEF who started SV between October 2016 and March 2017. The patients were classified into 2 groups according to LVEF at the end of follow-up (>35%: group R, or ≤35%: group NR).

Results: After a mean follow-up of 7 ± 0.1 months, 62 patients (24.8%) had LVEF >35%. They were older (71.3 ± 10.8 vs. 67.5 ± 12.1 years, p = 0.025), and suffered more often from hypertension (83.9 vs. 73.8%, p = 0.096) and higher blood pressure before and after SV (both, p < 0.01). They took more often high doses of beta-blockers (30.6 vs. 27.8%, p = 0.002), with a smaller proportion undergoing cardiac resynchronization therapy (14.8 vs. 29.0%, p = 0.028) and fewer implanted cardioverter defibrillators (ICD; 32.8 vs. 67.9%, p < 0.001), this being the only predictive variable of NR in the multivariate analysis (OR 0.26, 95% CI 0.13-0.47, p < 0.0001). At the end of follow-up, the mean LVEF in group R was 41.9 ± 8.1% (vs. 26.3 ± 4.7% in group NR, p < 0.001), with an improvement compared with the initial LVEF of 14.6 ± 10.8% (vs. 0.8 ± 4.5% in group NR, p < 0.0001). Functional class improved in both groups, mainly in group R (p = 0.035), with fewer visits to the emergency department (11.5 vs. 21.6%, p = 0.07).

Conclusions: In patients with LVEF ≤35% treated with SV, not carrying an ICD was independently associated with LVEF recovery, which was related to greater improvement in functional class.
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http://dx.doi.org/10.1159/000505148DOI Listing
September 2020

Sacubitril/Valsartan is useful and safe in elderly people with heart failure and reduced ejection fraction. Data from a real-word cohort.

Rev Esp Geriatr Gerontol 2020 Mar - Apr;55(2):65-69. Epub 2019 Dec 28.

Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Madrid, Spain; Universidad Complutense, Universidad Europea, Madrid, Spain.

Background: HF elderly patients are underrepresented in Sacubitril/Valsartan HF trials, and the effect of S/V in real-life patients with advanced age is unknown. The aim of this study was to evaluate the use and safety of S/V in a real-word cohort of elderly patients.

Methods: We performed a prospective registry of patients who started S/V in clinical practice. We compared baseline characteristics, adverse events during follow-up and causes of S/V withdrawal according to age.

Results: A total of 427 patients started treatment with S/V: 222 (52.0%)<70 years old, 140 (32.8%) between 70 and 79 and 65 (15.2%)≥80. During a mean follow-up of 7.0±0.1months S/V was well tolerated, with no age-related differences in adverse events (26.8%, 25.9%, 23.1% respectively; p=0.83). Symptomatic hypotension tended to be more frequent in the elderly (19.8%, 25.6%, 33.3% respectively; p=0.17). The withdrawal of S/V was more frequent in younger patients (14.4%, 10.0%, 4.6% respectively; p=0.05) and related to poor prognosis (HR 13.51, 95% CI 3.22-56.13, p<0.001).

Conclusions: Sacubitril/Valsartan is useful and safe in elderly people with HF-rEF in real-life clinical practice, and withdrawal is associated to poor prognosis. The doses achieved are lower in elderly people.
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http://dx.doi.org/10.1016/j.regg.2019.10.002DOI Listing
May 2021

Sex Influence on the Efficacy and Safety of Sacubitril/Valsartan.

Cardiology 2019;142(2):73-78. Epub 2019 Apr 18.

Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Madrid, Spain,

Background: Women are underrepresented in sacubitril/valsartan (SV) clinical trials. The aim of this study was to assess sex-specific differences in efficacy, tolerability, and safety of SV in real-world heart failure with reduced ejection fraction (HFrEF) patients.

Methods: A prospective registry in 10 centers including all patients who started SV during the last 6 months was analyzed in this study.

Results: A total of 427 patients were included, 126 (29.5%) were women. There were no substantial differences in HFrEF treatment before SV initiation, although fewer women than men carried an implantable cardioverter defibrillator (57 [45.2%] vs. 173 [58.1%], p = 0.02). SV starting dose was 24/26 mg b.i.d. in 206 patients (48.2%), 49/51 mg b.i.d. in 184 (43.1%), and 97/103 mg b.i.d. in 34 (8.2%), without relevant differences associated to sex. There were no losses during a mean follow-up of 7.0 ± 0.1 months. The proportion of patients who discontinued the drug (16 [12.7%] women vs. 33 [11.0%] men, p = 0.66) or presented SV-related adverse effects (31 [24.6%] women vs. 79 [26.5%] men, p = 0.72) was also similar in both sexes. However, female sex was an independent predictor of functional class improvement in the multivariate analysis (odds ratio 2.33, 95% confidence interval: 1.24-4.38, p = 0.04).

Conclusions: SV in women with HFrEF has a similar tolerability as in men. Females seem to have a more frequent functional class improvement than males.
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http://dx.doi.org/10.1159/000498984DOI Listing
December 2019

Sacubitril/Valsartan in Daily Clinical Practice: Data From a Prospective Registry.

J Cardiovasc Pharmacol 2019 02;73(2):118-124

Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Madrid, Spain.

Sacubitril/valsartan (SV) is a new therapy in heart failure with reduced ejection fraction. Our aim was to determine the efficacy and safety of this drug daily clinical practice. We performed a multicenter registry in 10 hospitals. All patients who started SV from October 2016 to March 2017 on an outpatient basis were included. A total of 427 patients started treatment with SV. Mean follow-up was 7.0 ± 0.1 months. Forty-nine patients (11.5%) discontinued SV, and 12 (2.8%) died. SV discontinuation was associated with higher cardiovascular (hazard ratio 13.22, 95% confidence interval, 6.71-15.73, P < 0.001) and all-cause mortality (hazard ratio 13.51, 95% confidence interval 3.22-56.13, P < 0.001). Symptomatic hypotension occurred in 71 patients (16.6%). Baseline N-terminal pro-B-type natriuretic peptide levels, functional class, and left ventricular ejection fraction improved at the end of follow-up in patients who continued with SV (all P values ≤0.001). This improvement was not significant in patients with SV discontinuation. SV has a good tolerability in patients from daily clinical practice. SV withdrawal in patients with heart failure and reduced ejection fraction was independently associated with increased all-cause mortality. Patients who continued with SV presented an improvement in functional class left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide levels.
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http://dx.doi.org/10.1097/FJC.0000000000000641DOI Listing
February 2019

Clinical Profile of a Nonselected Population Treated With Sacubitril/Valsartan Is Different From PARADIGM-HF Trial.

J Cardiovasc Pharmacol 2018 08;72(2):112-116

Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Madrid, Spain.

Our aim is to describe the characteristics of the patients receiving sacubitril/valsartan (SV) in daily clinical practice. This is a prospective registry in 10 hospitals including all patients who started SV in everyday clinical practice. From October 2016 to March 2017, 427 patients started treatment with SV. The mean age was 68.1 ± 12.4 years, and 30.5% were women (22.0% in PARADIGM-HF, P < 0.001). Comparing our cohort with patients included in PARADIGM-HF, baseline treatment was different, with a lower ratio of angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (2.7 vs. 3.5, P < 0.001), and a higher proportion of patients with implantable cardioverter defibrillator (53.8% vs. 15%, P < 0.001), and cardiac resynchronization therapy (25.8% vs. 5%, P < 0.001). Treatment with mineralocorticoid receptor antagonists was more frequent (76.7% vs. 60.0%, P < 0.001), and the use of beta-blockers was similar (94.6% vs. 93.0%, P = 0.43). We observed more patients in functional class III-IV (30.4 vs. 24.8, P = 0.015), higher levels of Nt pro-BNP [3421 (904-4161) vs. 1631 (885-3154) pg/mL] and worse renal function (creatinine level 1.3 ± 0.7 vs. 1.1 ± 0.3 mg/dL, P < 0.001). In real life, patients receiving SV have a higher risk profile than in the pivotal trial, poorer functional class, higher levels of natriuretic peptides, and worse renal function.
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http://dx.doi.org/10.1097/FJC.0000000000000603DOI Listing
August 2018

The Importance of Family-genetic Screening: The Phenotype Caused by the p.L3778F Ryanodine Receptor Mutation is Likely Less Severe Than Previously Thought.

Rev Esp Cardiol (Engl Ed) 2016 Jul 16;69(7):702-4. Epub 2016 May 16.

Unidad de Cardiopatías Familiares, Servicio de Cardiología, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.rec.2016.04.007DOI Listing
July 2016

Delayed myocardial perforation following pacemaker implantation.

Int J Cardiol 2004 Jan;93(1):89-91

Myocardial perforation is a rare complication following pacemaker implantation that may cause cardiac tamponade. If it does occur, it is usually at the time of lead insertion. This condition requires urgent recognition since the prompt drainage of the pericardial fluid may be lifesaving. We present a case report of myocardial perforation complicated by cardiac tamponade 4 days after pacemaker lead insertion that was repaired surgically.
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http://dx.doi.org/10.1016/s0167-5273(03)00129-3DOI Listing
January 2004
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