Publications by authors named "Antonio Fernandez-Ortiz"

265 Publications

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

Angioplastia primaria en España. ¿El volumen influye en la mortalidad hospitalaria?

Rev Esp Cardiol (Engl Ed) 2022 Jun 10. Epub 2022 Jun 10.

Fundación Instituto para la Mejora de la Asistencia Sanitaria (IMAS), Madrid, España. Electronic address:

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http://dx.doi.org/10.1016/j.rec.2022.04.014DOI 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

New 3-Dimensional Volumetric Ultrasound Method for Accurate Quantification of Atherosclerotic Plaque Volume.

JACC Cardiovasc Imaging 2022 Jun 16;15(6):1124-1135. Epub 2022 Mar 16.

Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; The Zena and Michael A. Wiener Cardiovascular Institute/Marie-Josée and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai School of Medicine, New York, New York, USA. Electronic address:

Background: Carotid and femoral plaque burden is a recognized biomarker of cardiovascular disease risk. A new electronic-sweep 3-dimensional (3D)-matrix transducer method can improve the functionality and image quality of vascular ultrasound atherosclerosis imaging.

Objectives: This study aimed to validate this method for plaque volume measurement in early and intermediate-advanced plaques in the carotid and femoral territories.

Methods: Plaque volumes were measured ex vivo in pig carotid and femoral artery specimens by 3-dimensional vascular ultrasound (3DVUS) using a 3D-matrix (electronic-sweep) transducer and its associated 3D plaque quantification software, and were compared with gold-standard histology. To test the clinical feasibility and accuracy of the 3D-matrix transducer, an experiment was conducted in intermediate-high risk individuals with carotid and femoral atherosclerosis. The results were compared with those obtained using the previously validated mechanical-sweep 3D transducer and established 2-dimensional (2D)-based plaque quantification software.

Results: In the ex vivo study, the authors assessed 19 atherosclerotic plaques (plaque volume, 0.76 µL-56.30 μL), finding strong agreement between measurements with the 3D-matrix transducer and the histological gold-standard (intraclass correlation coefficient [ICC]: 0.992; [95% CI: 0.978-0.997]). In the clinical analysis of 20 patients (mean age 74.6 ± 4.45 years; 40% men), the authors found 64 (36 carotid and 28 femoral) of 80 scanned territories with atherosclerosis (measured atherosclerotic volume, 10 μL-859 μL). There was strong agreement between measurements made from electronic-sweep and mechanical-sweep 3DVUS transducers (ICC: 0.997 [95% CI: 0.995-0.998]). Agreement was also high between plaque volumes estimated by the 2D and 3D plaque quantification software applications (ICC: 0.999 [95% CI: 0.998-0.999]). Analysis time was significantly shorter with the 3D plaque quantification software than with the 2D multislice approach with a mean time reduction of 46%.

Conclusions: 3DVUS using new matrix transducer technology, together with improved 3D plaque quantification software, simplifies the accurate volume measurement of early (small) and intermediate-advanced plaques located in carotid and femoral arteries.
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http://dx.doi.org/10.1016/j.jcmg.2022.01.005DOI Listing
June 2022

Transcatheter Treatment of Mitral Regurgitation.

J Clin Med 2022 May 22;11(10). Epub 2022 May 22.

Unit of Interventional Cardiology, Department of Cardiology, Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Calle del Prof Martín Lagos, s/n, 28084 Madrid, Spain.

Mitral valve disease, and in particular mitral regurgitation, is a common clinical entity. Until recently, surgical repair and replacement were the only therapeutic options available, leaving many patients untreated mostly due to excessive surgical risk. Over the last number of years, huge strides have been made regarding percutaneous, catheter-based solutions for mitral valve disease. Transcatheter repair procedures have most commonly been used, and in recent years there has been exponential growth in the number of devices available for transcatheter mitral valve replacement. Furthermore, the evolution of these devices has resulted in both smaller delivery systems and a shift towards transeptal access, negating the need for surgical incisions. In line with these advancements, and clinical trials demonstrating promising outcomes in carefully selected cases, recent guidelines have strengthened their recommendations for these devices. It is appropriate, therefore, to now review the current transcatheter repair and replacement devices available and the evidence for their use.
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http://dx.doi.org/10.3390/jcm11102921DOI Listing
May 2022

Thrombus aspiration with FlowTriever in acute pulmonary embolism.

Med Clin (Barc) 2022 May 14. Epub 2022 May 14.

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

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http://dx.doi.org/10.1016/j.medcli.2022.02.022DOI Listing
May 2022

Bone marrow activation in response to metabolic syndrome and early atherosclerosis.

Eur Heart J 2022 05 11;43(19):1809-1828. Epub 2022 Mar 11.

Centro Nacional de Investigaciones Cardiovasculares (CNIC), c/Melchor Fernández Almagro 3, Madrid 28029, Spain.

Aims: Experimental studies suggest that increased bone marrow (BM) activity is involved in the association between cardiovascular risk factors and inflammation in atherosclerosis. However, human data to support this association are sparse. The purpose was to study the association between cardiovascular risk factors, BM activation, and subclinical atherosclerosis.

Methods And Results: Whole body vascular 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging (18F-FDG PET/MRI) was performed in 745 apparently healthy individuals [median age 50.5 (46.8-53.6) years, 83.8% men] from the Progression of Early Subclinical Atherosclerosis (PESA) study. Bone marrow activation (defined as BM 18F-FDG uptake above the median maximal standardized uptake value) was assessed in the lumbar vertebrae (L3-L4). Systemic inflammation was indexed from circulating biomarkers. Early atherosclerosis was evaluated by arterial metabolic activity by 18F-FDG uptake in five vascular territories. Late atherosclerosis was evaluated by fully formed plaques on MRI. Subjects with BM activation were more frequently men (87.6 vs. 80.0%, P = 0.005) and more frequently had metabolic syndrome (MetS) (22.2 vs. 6.7%, P < 0.001). Bone marrow activation was significantly associated with all MetS components. Bone marrow activation was also associated with increased haematopoiesis-characterized by significantly elevated leucocyte (mainly neutrophil and monocytes) and erythrocyte counts-and with markers of systemic inflammation including high-sensitivity C-reactive protein, ferritin, fibrinogen, P-selectin, and vascular cell adhesion molecule-1. The associations between BM activation and MetS (and its components) and increased erythropoiesis were maintained in the subgroup of participants with no systemic inflammation. Bone marrow activation was significantly associated with high arterial metabolic activity (18F-FDG uptake). The co-occurrence of BM activation and arterial 18F-FDG uptake was associated with more advanced atherosclerosis (i.e. plaque presence and burden).

Conclusion: In apparently healthy individuals, BM 18F-FDG uptake is associated with MetS and its components, even in the absence of systemic inflammation, and with elevated counts of circulating leucocytes. Bone marrow activation is associated with early atherosclerosis, characterized by high arterial metabolic activity. Bone marrow activation appears to be an early phenomenon in atherosclerosis development.[Progression of Early Subclinical Atherosclerosis (PESA); NCT01410318].
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http://dx.doi.org/10.1093/eurheartj/ehac102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9113301PMC
May 2022

Correlation of Intraprocedural and Follow Up Parameters for Mitral Regurgitation Grading after Percutaneous Edge-to-Edge Repair.

J Clin Med 2022 Apr 19;11(9). Epub 2022 Apr 19.

Cardiology Department, Instituto Cardiovascular, Hospital Clínico San Carlos, 28040 Madrid, Spain.

Background: There is no consensus on the best intraprocedural parameter to evaluate residual mitral regurgitation (MR) after transcatheter edge-to-edge mitral repair (TEER). Thus, our aim was to evaluate the predictive value of different MR parameters from intraprocedural transesophageal echocardiogram (TEE) for grading in consecutive transthoracic echocardiogram (TTE) during the follow up.

Methods: All the consecutive patients who underwent TEER with MitraClip between 2010 and 2020 in our center were considered. TEE-derived immediate postprocedural MR parameters were reassessed to blindly compare them with follow up MR grading in sequential TTE.

Results: We finally included 88 patients (64.8% males; 76 ± 10 years-old). Significant MR was detected in 14.3% of the cases at 6 months, in similar proportion than at postprocedural at 1 month. Among all the intraprocedural TEE quantitative parameters only additive and maximum VC were associated with significant MR persistence. Moreover, on ROC analysis maximum VC demonstrated an excellent discriminatory power (AUC 0.96; < 0.001) to identify MR ≥ III at 6 months. Thus, a cut-off point of 0.45 cm demonstrated 88% sensitivity and 89% specificity.

Conclusion: Among intraprocedural TEE parameters to evaluate residual MR in TEER, maximum and additive VC were the most reliable to predict persistence of significant insufficiency.
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http://dx.doi.org/10.3390/jcm11092276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9102104PMC
April 2022

Development of atrioventricular and intraventricular conduction disturbances in patients undergoing transcatheter aortic valve replacement with new generation self-expanding valves: A real world multicenter analysis.

Int J Cardiol 2022 Sep 10;362:128-136. Epub 2022 May 10.

Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Universidad Complutense de Madrid, Madrid, Spain. Electronic address:

Background: High degree cardiac conduction disturbances (HDCD) remain a major complication after transcatheter aortic valve replacement (TAVR), especially with self-expandable valves (SEV). Our aim was to investigate peri-procedural and in-hospital modification of atrioventricular and intracardiac conduction associated to new generation SEV implantation, and the development of new HDCD resulting in permanent pacemaker implantation (PPM) in patients undergoing TAVR.

Methods And Results: Three-hundred forty-four consecutive patients with severe aortic stenosis who underwent TAVR with a new generation SEV [Evolut-R/Pro (n = 130), Acurate-neo (n = 79), Portico (n = 75) and Allegra (n = 60)] were included. An analysis of baseline, post-TAVR and pre-discharge ECG and procedural aspects were centrally performed. A significant increase in baseline PR interval (169.6 ± 28.2 ms) and QRS complex width (101.7 ± 25.9 ms) was noted immediately post-TAVR (188.04 ± 34.49; 129.55 ± 30.02 ms), with a partial in-hospital reversal (179.4 ± 30.1; 123.06 ± 30.94 ms), resulting in a net increase at hospital discharge of 12.6 ± 38.8 ms and 21.4 ± 31.6 ms (p < 0.001), respectively. The global incidence of new onset persistent HDCD at hospital discharge was 46.3%, with 17.7% of patients requiring PPM. Independent predictors of new onset HCDC at hospital discharge were valve recapture (OR: 2.8; 95% IC: 1.1-7.2, p = 0.033) and implantation depth ≥ 6 mm (OR: 1.9 05% IC 1.1-3.3, p = 0.015), while higher implantation (<3 mm (OR: 0.3, 95% IC 0.1-0.7, p = 0.014) and use of Acurate-Neo valve (OR: 0.4; 95% IC 0.2-0.8, p = 0.009) were protective factor.

Conclusions: New generation self-expanding aortic valves were associated with a significant increase in PR and QRS interval at hospital discharge leading to a very high rate of HDCD. While valve recapture and implantation depth were independent predictors for the occurrence of HDCD, use of Accurate-Neo valve was a protective factor.
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http://dx.doi.org/10.1016/j.ijcard.2022.05.014DOI Listing
September 2022

Vasospasm-related stent malapposition in acute coronary syndrome.

Rev Esp Cardiol (Engl Ed) 2022 Mar 10. Epub 2022 Mar 10.

Servicio de Cardiología, Hospital Clínico San Carlos, Madrid, Spain.

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http://dx.doi.org/10.1016/j.rec.2022.01.011DOI Listing
March 2022

Unbiased plasma proteomics discovery of biomarkers for improved detection of subclinical atherosclerosis.

EBioMedicine 2022 Feb 10;76:103874. Epub 2022 Feb 10.

Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid 28029, Spain; CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain. Electronic address:

Background: Imaging of subclinical atherosclerosis improves cardiovascular risk prediction on top of traditional risk factors. However, cardiovascular imaging is not universally available. This work aims to identify circulating proteins that could predict subclinical atherosclerosis.

Methods: Hypothesis-free proteomics was used to analyze plasma from 444 subjects from PESA cohort study (222 with extensive atherosclerosis on imaging, and 222 matched controls) at two timepoints (three years apart) for discovery, and from 350 subjects from AWHS cohort study (175 subjects with extensive atherosclerosis on imaging and 175 matched controls) for external validation. A selected three-protein panel was further validated by immunoturbidimetry in the AWHS population and in 2999 subjects from ILERVAS cohort study.

Findings: PIGR, IGHA2, APOA, HPT and HEP2 were associated with subclinical atherosclerosis independently from traditional risk factors at both timepoints in the discovery and validation cohorts. Multivariate analysis rendered a potential three-protein biomarker panel, including IGHA2, APOA and HPT. Immunoturbidimetry confirmed the independent associations of these three proteins with subclinical atherosclerosis in AWHS and ILERVAS. A machine-learning model with these three proteins was able to predict subclinical atherosclerosis in ILERVAS (AUC [95%CI]:0.73 [0.70-0.74], p < 1 × 10), and also in the subpopulation of individuals with low cardiovascular risk according to FHS 10-year score (0.71 [0.69-0.73], p < 1 × 10).

Interpretation: Plasma levels of IGHA2, APOA and HPT are associated with subclinical atherosclerosis independently of traditional risk factors and offers potential to predict this disease. The panel could improve primary prevention strategies in areas where imaging is not available.

Funding: This study was supported by competitive grants from the Spanish Ministry of Science, Innovation and Universities (BIO2015-67580-P, PGC2018-097019-B-I00, PID2019-106814RB-I00 and SAF2016-80843-R), through the Carlos III Institute of Health-Fondo de Investigacion Sanitaria grant PRB3 (IPT17/0019 - ISCIII-SGEFI / ERDF, ProteoRed), CIBERCV and CIBERDEM, the Fundacio MaratoTV3 (grant 122/C/2015) and "la Caixa" Banking Foundation (project HR17-00247). The PESA study is co-funded equally by the Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain, and Banco Santander, Madrid, Spain. The ILERVAS study was funded by the Diputacio de Lleida. The study also receives funding from the Instituto de Salud Carlos III (PI15/02019; PI18/00610; RD16/0009) and the FEDER funds. The CNIC is supported by the Instituto de Salud Carlos III (ISCIII), the Ministerio de Ciencia, Innovacion y Universidades (MCNU) and the Pro CNIC Foundation.
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http://dx.doi.org/10.1016/j.ebiom.2022.103874DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8844841PMC
February 2022

Incidence, clinical impact and predictors of thrombocytopenia after transcatheter aortic valve replacement.

Int J Cardiol 2022 Apr 4;352:21-26. Epub 2022 Feb 4.

Department of Cardiology, Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain. Electronic address:

Background: Thrombocytopenia is a common, yet poorly understood, complication after transcatheter aortic valve replacement (TAVR). Balloon-expandable transcatheter heart valve has been associated with higher incidence of thrombocytopenia, compared with self-expandable valves. The aim of this study was to analyze the incidence, clinical impact and predictors of acquired thrombocytopenia in patients undergoing TAVR.

Methods: We performed an observational study from consecutive patients with severe aortic stenosis undergoing TAVR (n = 679) in a single center. Association and best cut-off point of platelet decrease with early mortality was analyzed. Patients were classified according to postprocedural percentage decrease in platelet count (PDPC), comparing clinical outcomes and analyzing predictors of platelet decrease.

Results: The median PDPC was 37.1 [IQR: 27.4-46.9]. PDPC was associated with early mortality (OR: 2.1, 95%IC: 1.7-2.5 for each 10% decrease, AUC:0.81, 95%CI:0.72-0.89) with an optimal cut-off point of 46%. PDPC≥46% and late nadir (≥4 days) were both independent predictors of early mortality (OR: 6.0 [IQR: 2.4-14.9] and OR: 5.1 [IQR: 2.2-11.6], respectively). The combination of both factors (PDPC≥46% and nadir ≥4 day) was associated with higher 2-year mortality (55.7%) compared to an early significant nadir (PDPC≥46% and nadir <4 day, 28.9%) and non-significant nadir (PDPC<46%, 21.0%), p < 0.001. Independent predictors of PDPC≥46% were baseline platelet count, Portico™, Abbott valve, intraprocedural major vascular complication and residual aortic regurgitation ≥grade 2.

Conclusion: The platelet count decreased almost 40% after TAVR. Late nadir and PDPC≥46% predicted short-term clinical outcomes. Concomitant late and significant platelet decrease was associated with mid-term mortality.
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http://dx.doi.org/10.1016/j.ijcard.2022.01.072DOI Listing
April 2022

The effect of weekends and public holidays on the care of acute coronary syndrome in the Spanish National Health System.

Rev Esp Cardiol (Engl Ed) 2022 Jan 20. Epub 2022 Jan 20.

Fundación Instituto para la Mejora de la Asistencia Sanitaria, Madrid, Spain. Electronic address:

Introduction And Objectives: To analyze whether admission on weekends or public holidays (WHA) influences the management (performance of angioplasty, percutaneous coronary intervention [PCI]) and outcomes (in-hospital mortality) of patients hospitalized for acute coronary syndrome in the Spanish National Health System compared with admission on weekdays.

Methods: Retrospective observational study of patients admitted for ST-segment elevation myocardial infarction (STEMI) or for non-ST-segment elevation acute coronary syndrome (NSTEACS) in hospitals of the Spanish National Health system from 2003 to 2018.

Results: A total of 438 987 episodes of STEMI and 486 565 of NSTEACS were selected, of which 28.8% and 26.1% were WHA, respectively. Risk-adjusted models showed that WHA was a risk factor for in-hospital mortality in STEMI (OR, 1.05; 95%CI,1.03-1.08; P < .001) and in NSTEACS (OR, 1.08; 95%CI, 1.05-1.12; P < .001). The rate of PCI performance in STEMI was more than 2 percentage points higher in patients admitted on weekdays from 2003 to 2011 and was similar or even lower from 2012 to 2018, with no significant changes in NSTEACS. WHA was a statistically significant risk factor for both STEMI and NSTEACS.

Conclusions: WHA can increase the risk of in-hospital death by 5% (STEMI) and 8% (NSTEACS). The persistence of the risk of higher in-hospital mortality, after adjustment for the performance of PCI and other explanatory variables, probably indicates deficiencies in management during the weekend compared with weekdays.
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http://dx.doi.org/10.1016/j.rec.2021.10.022DOI Listing
January 2022

Vascular Injury After Stenting - Insights of Systemic Mechanisms of Vascular Repair.

Circ J 2022 May 2;86(6):966-974. Epub 2021 Dec 2.

Clinico San Carlos University Hospital, IdISSC.

Background: The role of circulating progenitor cells (CPC) in vascular repair following everolimus-eluting stent (EES) implantation is largely unknown. The aim of the study was to investigate the relationship between temporal variation in CPC levels following EES implantation and the degree of peri-procedural vascular damage, and stent healing, as measured by optical coherence tomography (OCT).Methods and Results: CPC populations (CD133+/KDR+/CD45low) included patients with stable coronary artery disease undergoing stent implantation, and were evaluated using a flow cytometry technique both at baseline and at 1 week. OCT evaluation was performed immediately post-implantation to quantify the stent-related injury and at a 9-month follow up to assess the mid-term vascular response. Twenty patients (mean age 66±9 years; 80% male) with EES-treated stenoses (n=24) were included in this study. Vascular injury score was associated with the 1-week increase of CD133+/KDR+/CD45low (β 0.28 [95% CI 0.15; 0.41]; P<0.001) and with maximum neointimal thickness at a 9-month follow up (β 0.008 [95% CI 0.0004; 0.002]; P=0.04). Inverse relationships between numbers of uncoated and apposed struts for the 9-month and the 1-week delta values of CD133+/KDR+/CD45low (β -12.53 [95% CI -22.17; -2.90]; P=0.011), were also found.

Conclusions: The extent of vessel wall injury influences early changes in the levels of CPC and had an effect on mid-term vascular healing after EES implantation. Early CPC mobilisation was associated with mid-term strut coverage.
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http://dx.doi.org/10.1253/circj.CJ-21-0649DOI Listing
May 2022

Sepsis of Patients Infected by SARS-CoV-2: Real-World Experience From the International HOPE-COVID-19-Registry and Validation of HOPE Sepsis Score.

Front Med (Lausanne) 2021 14;8:728102. Epub 2021 Oct 14.

University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.

Patients with sepsis with a concomitant coronavirus (COVID-19) infection are related to a high morbidity and mortality rate. We investigated a large cohort of patients with sepsis with a concomitant COVID-19, and we developed a risk score for the estimation of sepsis risk in COVID-19. We conducted a sub-analysis from the international Health Outcome Predictive Evaluation Registry for COVID-19 (HOPE-COVID-19-Registry, NCT04334291). Out of 5,837 patients with COVID-19, 624 patients were diagnosed with sepsis according to the Sepsis-3 International Consensus. In multivariable analysis, the following risk factors were identified as independent predictors for developing sepsis: current smoking, tachypnoea (>22 breath per minute), hemoptysis, peripheral oxygen saturation (SpO) <92%, blood pressure (BP) (systolic BP <90 mmHg and diastolic BP <60 mmHg), Glasgow Coma Scale (GCS) <15, elevated procalcitonin (PCT), elevated troponin I (TnI), and elevated creatinine >1.5 mg/dl. By assigning odds ratio (OR) weighted points to these variables, the following three risk categories were defined to develop sepsis during admission: low-risk group (probability of sepsis 3.1-11.8%); intermediate-risk group (24.8-53.8%); and high-risk-group (58.3-100%). A score of 1 was assigned to current smoking, tachypnoea, decreased SpO, decreased BP, decreased GCS, elevated PCT, TnI, and creatinine, whereas a score of 2 was assigned to hemoptysis. The HOPE Sepsis Score including nine parameters is useful in identifying high-risk COVID-19 patients to develop sepsis. Sepsis in COVID-19 is associated with a high mortality rate.
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http://dx.doi.org/10.3389/fmed.2021.728102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8603931PMC
October 2021

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

Eur Heart J 2022 03;43(13):1320-1330

Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.

Aim: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes.

Methods And Results: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups.

Conclusion: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome.

Clinical Trial Registration: ClinicalTrials.gov: NCT03321032.
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http://dx.doi.org/10.1093/eurheartj/ehab790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8970998PMC
March 2022

Pre-dilation and Post-dilation in Transcatheter Aortic Valve Replacement: Indications, Benefits and Risks.

Interv Cardiol 2021 Apr 12;16:e28. Epub 2021 Oct 12.

Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC Madrid, Spain.

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with symptomatic severe aortic stenosis. In recent years, an emphasis has been placed on simplification of the procedure. Balloon predilation was initially considered a mandatory step to cross and prepare the stenotic aortic valve, but several studies demonstrated the feasibility of performing TAVR without balloon valvuloplasty. Balloon postdilation of the implanted valve is sometimes required to optimise results, although many patients do not require this step. Contemporary consensus advocates an individualised approach to TAVR procedures and so balloon pre- and post-dilation are performed selectively. This review aims to outline the advantages and disadvantages of balloon pre- and post-dilation and to identify the scenarios in which they are required during TAVR procedures.
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http://dx.doi.org/10.15420/icr.2020.35DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8532006PMC
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

COVID-19 and the impact of arterial hypertension-An analysis of the international HOPE COVID-19 Registry (Italy-Spain-Germany).

Eur J Clin Invest 2021 Nov 19;51(11):e13582. Epub 2021 Aug 19.

University of Mannheim, Mannheim, Germany.

Background: A systematic analysis of concomitant arterial hypertension in COVID-19 patients and the impact of angiotensin-converting-enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARBs) have not been studied in a large multicentre cohort yet. We conducted a subanalysis from the international HOPE Registry (https://hopeprojectmd.com, NCT04334291) comparing COVID-19 in presence and absence of arterial hypertension.

Materials And Methods: Out of 5837 COVID-19 patients, 2850 (48.8%) patients had the diagnosis arterial hypertension. 1978/2813 (70.3%) patients were already treated with ACEI or ARBs. The clinical outcome of the present subanalysis included all-cause mortality over 40 days of follow-up.

Results: Patients with arterial hypertension suffered significantly more from different complications including respiratory insufficiency (60.8% vs 39.5%), heart failure (9.9% vs 3.1%), acute kidney injury (25.3% vs 7.3%), pneumonia (90.6% vs 86%), sepsis (14.7% vs 7.5%), and bleeding events (3.6% vs 1.6%). The mortality rate was 29.6% in patients with concomitant arterial hypertension and 11.3% without arterial hypertension (P < .001). Invasive and non-invasive respiratory supports were significantly more required in presence of arterial hypertension as compared without it. In the multivariate cox regression analysis, while age≥65, benzodiazepine, antidepressant at admission, elevated LDH or creatinine, respiratory insufficiency and sepsis might be a positive independent predictors of mortality, antiviral drugs, interferon treatment, ACEI or ARBs at discharge or oral anticoagulation at discharge might be an independent negative predictor of the mortality.

Conclusions: The mortality rate and in-hospital complications might be increased in COVID-19 patients with a concomitant history of arterial hypertension. The history of ACEI or ARBs treatments does not seem to impact the outcome of these patients.
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http://dx.doi.org/10.1111/eci.13582DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8420356PMC
November 2021

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

Progression of Early Subclinical Atherosclerosis (PESA) Study: JACC Focus Seminar 7/8.

J Am Coll Cardiol 2021 07;78(2):156-179

Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Atherosclerosis starts early in life and progresses silently for decades. Considering atherosclerosis as a "systemic disease" invites the use of noninvasive methodologies to detect disease in various regions before symptoms appear. The PESA-(Progression of Early Subclinical Atherosclerosis) CNIC-SANTANDER study is an ongoing prospective cohort study examining imaging, biological, and behavioral parameters associated with the presence and progression of early subclinical atherosclerosis. Between 2010 and 2014, PESA enrolled 4,184 asymptomatic middle-aged participants who undergo serial 3-yearly follow-up examinations including clinical interviews, lifestyle questionnaires, sampling, and noninvasive imaging assessment of multiterritorial subclinical atherosclerosis (carotids, iliofemorals, aorta, and coronaries). PESA tracks the trajectories of atherosclerosis and associated disorders from early stages to the transition to symptomatic phases. A joint venture between the CNIC and the Santander Bank, PESA is expected to run until at least 2029, and its significant contributions to date are presented in this review paper.
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http://dx.doi.org/10.1016/j.jacc.2021.05.011DOI Listing
July 2021

Outcomes of Nonagenarians With Acute Coronary Syndrome.

J Am Med Dir Assoc 2022 01 29;23(1):81-86.e4. Epub 2021 Jun 29.

Cardiology Department, Cardiovascular Institute (ICCV), Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain. Electronic address:

Objectives: Nonagenarians are a fast-growing age group among cardiovascular patients, but data about their management and prognosis after an acute coronary syndrome (ACS) is scarce. This study aimed to analyze characteristics of nonagenarian patients with ACS and to compare in-hospital and 1-year clinical outcomes between those treated with medical treatment (MT) alone and those receiving percutaneous coronary intervention (PCI).

Design: Multicenter observational study.

Setting And Participants: We included consecutive nonagenarian patients with ACS admitted at 4 academic centers between 2005 and 2018. Only patients with type 1 myocardial infarction were included.

Methods: Standardized definitions of all patient-related variables, clinical diagnoses, and hospital complications and outcomes were used. The primary endpoint was 1-year all-cause mortality. Long-term survival was compared between patients undergoing PCI and those managed with MT alone. Given differences in baseline characteristics could substantially interfere in outcomes, 3 sensitivity analyses were performed to adjust for confounders.

Results: A total of 680 nonagenarians were included (59% females). Of them, 373 (55%) patients presented with non-ST-segment elevation ACS (NSTE-ACS) and 307 (45%) with ST-segment elevation myocardial infarction (STEMI). A coronary angiogram was performed in 115 (31%) of NSTE-ACS and in 182 (60%) of STEMI patients with subsequent PCI in 81 (22%) and 156 (51%), respectively. Overall mortality rates were 17% in-hospital and 39% at 1-year follow-up. PCI was independently associated with a decreased risk of 1-year all-cause death [hazard ratio (HR) 0.57, 95% confidence interval (CI) 0.35, 0.95; P < .05], mainly observed in those patients without disability (HR 0.59, 95% CI 0.37, 0.94; P < .01) and lower Killip class (HR 0.50, 95% CI 0.28, 0.89; P < .001).

Conclusions And Implications: The prognosis of nonagenarians after an ACS was associated with comorbidities and the therapeutic approach. Although PCI appeared to be a safe and effective strategy, it is still necessary to refine the decision-making process in this high-risk population group.
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http://dx.doi.org/10.1016/j.jamda.2021.04.027DOI Listing
January 2022

Long-term outcomes after deferral of revascularization of in-stent restenosis using fractional flow reserve.

Catheter Cardiovasc Interv 2022 02 22;99(3):723-729. Epub 2021 Jun 22.

Hospital Clínico San Carlos IDISSC, Complutense University of Madrid, Madrid, Spain.

Objectives: To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment.

Background: The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment.

Methods: In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months.

Results: Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE.

Conclusions: Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis.
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http://dx.doi.org/10.1002/ccd.29823DOI Listing
February 2022

Triglycerides and Residual Atherosclerotic Risk.

J Am Coll Cardiol 2021 06;77(24):3031-3041

National Center for Cardiovascular Research (CNIC), Madrid, Spain; Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Background: Even when low-density lipoprotein-cholesterol (LDL-C) levels are lower than guideline thresholds, a residual risk of atherosclerosis remains. It is unknown whether triglyceride (TG) levels are associated with subclinical atherosclerosis and vascular inflammation regardless of LDL-C.

Objectives: This study sought to assess the association between serum TG levels and early atherosclerosis and vascular inflammation in apparently healthy individuals.

Methods: An observational, longitudinal, and prospective cohort study, including 3,754 middle-aged individuals with low to moderate cardiovascular risk from the PESA (Progression of Early Subclinical Atherosclerosis) study who were consecutively recruited between June 2010 and February 2014, was conducted. Peripheral atherosclerotic plaques were assessed by 2-dimensional vascular ultrasound, and coronary artery calcification (CAC) was assessed by noncontrast computed tomography, whereas vascular inflammation was assessed by fluorine-18 fluorodeoxyglucose uptake on positron emission tomography.

Results: Atherosclerotic plaques and CAC were observed in 58.0% and 16.8% of participants, respectively, whereas vascular inflammation was evident in 46.7% of evaluated participants. After multivariate adjustment, TG levels ≥150 mg/dl showed an association with subclinical noncoronary atherosclerosis (odds ratio [OR]: 1.35; 95% confidence interval [CI]: 1.08 to 1.68; p = 0.008). This association was significant for groups with high LDL-C (OR: 1.42; 95% CI: 1.11 to 1.80; p = 0.005) and normal LDL-C (OR: 1.85; 95% CI: 1.08 to 3.18; p = 0.008). No association was found between TG level and CAC score. TG levels ≥150 mg/dl were significantly associated with the presence of arterial inflammation (OR: 2.09; 95% CI: 1.29 to 3.40; p = 0.003).

Conclusions: In individuals with low to moderate cardiovascular risk, hypertriglyceridemia was associated with subclinical atherosclerosis and vascular inflammation, even in participants with normal LDL-C levels. (Progression of Early Subclinical Atherosclerosis [PESA]; NCT01410318).
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http://dx.doi.org/10.1016/j.jacc.2021.04.059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8215641PMC
June 2021

Glycated Hemoglobin and Subclinical Atherosclerosis in People Without Diabetes.

J Am Coll Cardiol 2021 06;77(22):2777-2791

Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Background: The metabolic injury caused by protein glycation, monitored as the level of glycated hemoglobin (HbA1c), is not represented in most risk scores (i.e., Systematic Coronary Risk Estimation or atherosclerotic cardiovascular disease risk scale).

Objectives: The purpose of this study was to assess the association between HbA1c and the extent of subclinical atherosclerosis (SA) and to better identify individuals at higher risk of extensive SA using HbA1c on top of key cardiovascular risk factors (CVRFs).

Methods: A cohort of 3,973 middle-aged individuals from the PESA (Progression of Early Subclinical Atherosclerosis) study, with no history of cardiovascular disease and with HbA1c in the nondiabetic range, were assessed for the presence and extent of SA by 2-dimensional vascular ultrasound and noncontrast cardiac computed tomography.

Results: After adjusting for established CVRFs, HbA1c showed an association with the multiterritorial extent of SA (odds ratio: 1.05, 1.27, 1.27, 1.36, 1.80, 1.87, and 2.47 for HbA1c 4.9% to 5.0%, 5.1% to 5.2%, 5.3% to 5.4%, 5.5% to 5.6%, 5.7% to 5.8%, 5.9% to 6.0%, and 6.1% to 6.4%, respectively; reference HbA1c ≤4.8%; p < 0.001). The association was significant in all pre-diabetes groups and even below the pre-diabetes cut-off (HbA1c 5.5% to 5.6% odds ratio: 1.36 [95% confidence interval: 1.03 to 1.80]; p = 0.033). High HbA1c was associated with an increased risk of SA in low-risk individuals (p < 0.001), but not in moderate-risk individuals (p = 0.335). Relative risk estimations using Systematic Coronary Risk Estimation or atherosclerotic cardiovascular disease predictors confirmed that inclusion of HbA1c modified the risk of multiterritorial SA in most risk categories.

Conclusions: Routine use of HbA1c can identify asymptomatic individuals at higher risk of SA on top of traditional CVRFs. Lifestyle interventions and novel antidiabetic medications might be considered to reduce both HbA1c levels and SA in individuals without diabetes.
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http://dx.doi.org/10.1016/j.jacc.2021.03.335DOI 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

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

Catheter Cardiovasc Interv 2021 10 15;98(4):E617-E625. Epub 2021 Apr 15.

Cardiology Department, Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain.

Background: Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip.

Methods: We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included.

Results: Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention.

Conclusions: Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.
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http://dx.doi.org/10.1002/ccd.29703DOI Listing
October 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

Safety of coronary revascularization deferral based on fractional flow reserve and instantaneous wave-free ratio in patients with chronic kidney disease.

Cardiol J 2021 Apr 12. Epub 2021 Apr 12.

Hospital Clínico San Carlos, Profesor Martín Lagos, s/n, 28040 Madrid, Spain.

Background: The safety of revascularization deferral according to pressure wire examination in patients with chronic kidney disease (CKD) has not been fully established.

Methods: From a retrospective cohort of 439 patients in whom revascularization was deferred after physiological assessment, we examined the incidence of patient-oriented composite endpoint (POCE: all-cause death, myocardial infarction [MI] and unplanned revascularization) in patients with CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m²) and without it.

Results: At 4 years of follow-up, the primary endpoint was met by 25.0% of patients with CKD and by 14.4% of patients without CKD (hazard ratio [HR] 1.56, 95% confidence interval [CI] 0.96-2.53, p = 0.071). The incidence of POCE was even higher in patients with an eGFR < 30 mL/min/1.73 m²: 43.8% (HR 3.10, 95% CI 1.08-8.92, p = 0.036). However, no differences were observed in the incidence of MI (4.2% vs. 4.4% in non-CKD), target vessel revascularization (5.8% vs. 5.9%), and target vessel MI (0.8% vs. 4.6%).

Conclusions: Patients with CKD in whom pressure-wire evaluation led to deferral of coronary revascularization develop more POCE in the long term, compared to patients with normal renal function. However, the increase in POCE in patients with CKD was seldom related to deferred vessels, thus suggesting an epiphenomenon of an intrinsically higher cardiovascular risk of CKD patients.
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http://dx.doi.org/10.5603/CJ.a2021.0035DOI Listing
April 2021

Clinical Profile and 30-Day Mortality of Invasively Managed Patients with Suspected Acute Coronary Syndrome During the COVID-19 Outbreak.

Int Heart J 2021 Mar 17;62(2):274-281. Epub 2021 Mar 17.

Department of Cardiology, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC).

The COVID-19 pandemic severely disrupted cardiovascular care during the spring of 2020 in Europe. Our study analyzed the clinical profile, COVID-19 impact, and 30-day prognosis of invasively managed patients with acute coronary syndrome (ACS) compared to a historical cohort.All invasively managed ACS patients from March 1st to April 30th, 2020 were compared to a cohort from the same timeframe of 2019 (n = 316). COVID-19 confirmed cases were defined by a positive SARS-CoV-2 polymerase chain reaction (PCR) test (CoV+). The primary outcome was all-cause 30-day mortality and multivariable predictors of this outcome.A 40.4% reduction in ACS patients was noted (198 cases in 2019 to 118 in 2020), and 11% of 2020 ACS patients were CoV+. Baseline characteristics were similar between groups. There were significantly more in-hospital patients with ACS (15.3% versus 6.1%, P = 0.007), and fewer patients were found to have a culprit lesion (58.5% versus 74.2%, P = 0.004) in 2020 compared to 2019. Thirty-day mortality in 2020 (7%) was not different from that in 2019 (4.2%), P = 0.294, but it was significantly higher in CoV+ patients (23.1%) compared to that in negative SARS-CoV-2 PCR test (CoV-) patients (5%), P = 0.047, in the 2020 group. In the multivariate analysis, CoV+ was an independent mortality predictor (OR = 9.8, 95% CI = 1.48-64.78), along with the left ventricular ejection fraction (LVEF) (OR = 0.91, 95% CI = 0.86-0.97), P = 0.0006.This study found increased 30-day mortality of invasively managed CoV+ ACS patients compared to that of CoV- patients during the 2020 COVID-19 spring outbreak. In the multivariable analysis, a SARS-CoV-2 positive test was independently associated with 30-day mortality. Further investigations of the underlying physiopathological relations between COVID-19 and ACS are warranted.
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http://dx.doi.org/10.1536/ihj.20-574DOI Listing
March 2021
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