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BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.
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Cateterismo Periférico , Diseño de Equipo , Hemorragia , Técnicas Hemostáticas , Punciones , Arteria Radial , Humanos , Estudios Prospectivos , Masculino , Femenino , Anciano , Técnicas Hemostáticas/instrumentación , Técnicas Hemostáticas/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento , Cateterismo Periférico/efectos adversos , Factores de Tiempo , Hemorragia/prevención & control , Hemorragia/etiología , Quitosano , Hemostáticos/administración & dosificación , Hemostáticos/efectos adversos , Factores de Riesgo , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Vendajes , Trombosis/etiología , Trombosis/prevención & controlRESUMEN
INTRODUCTION: Beta-aminopropionitrile (BAPN) administration is a chemically induced model for preclinical aortic pathologies research. Angiotensin II (AngII) has been widely used to promotes aortic dissections in mice. Here, we provide insight on a modified aortic dissection model in rats. The effect of smooth muscle cell (SMC) relaxation with vasodilators is studied in this model. METHODS: Forty Sprague-Dawley rats were divided in 4 groups: control, isosorbide dinitrate (ISDN, 30 mg/kg/day) in the drinking water, BAPN (0.02%) in the food, BAPN + ISDN (same doses). Thoracic and abdominal aortic diameters were evaluated through transthoracic ultrasound echography. After 6 weeks, all rats were infused with AngII (1 mg/kg/day) subcutaneously. Survival and type of aortic events were numbered. Histological and histochemical analyses of aorta were performed. RESULTS: Initial telesystolic ascending aorta diameters were equal in all groups and became significantly larger in the BAPN + ISDN group compared to the BAPN group (control: 3.37 ± 0.17 mm, ISDN: 3.49 ± 0.16 mm, BAPN: 3.53 ± 0.13 mm, BAPN + ISDN: 3.61 ± 0.16 mm, analysis of variance p < 0.0001). BAPN followed by AngII infusion showed a significant lower survival rate (p = 0.029) and produced a large panel of aortic events. Association of ISDN and BAPN significantly reduces survival (p = 0.001) and provides more aortic events compared to BAPN alone (p = 0.031). In both BAPN-treated groups, orcein staining revealed split and dissected elastic fibers in the media, alcian blue staining showed mucoid degeneration of the aortic wall, and Perls-diaminobenzidine staining revealed an accumulation of Fe2+. CONCLUSION: SMC relaxation with ISDN increases aortic dilatation, worsens aortic prognosis, and reproduces human histological findings in a low-dose BAPN/AngII-induced aortic dissection model in rats.
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Aminopropionitrilo , Disección Aórtica , Humanos , Ratas , Ratones , Animales , Aminopropionitrilo/toxicidad , Angiotensina II , Ratas Sprague-Dawley , Dilatación , Disección Aórtica/inducido químicamente , Disección Aórtica/diagnóstico por imagen , Modelos Animales de Enfermedad , Miocitos del Músculo LisoRESUMEN
Aims: The aims of the present study were to describe the proportion of patients eligible for the COMPASS trial within the Reduction of Atherothrombosis for Continued Health (REACH) registry, the reasons for ineligibility, and to put in perspective the characteristics and outcomes of trial-eligible patients from the REACH registry compared with those of patients enrolled in the reference aspirin arm of the COMPASS trial. Methods and results: The COMPASS selection and exclusion criteria were applied to REACH patients with either coronary artery disease (CAD) or peripheral artery disease (PAD). We used the COMPASS primary composite outcome of cardiovascular (CV) death, myocardial infarction (MI), or stroke. In REACH, 31 873 patients had CAD or PAD and detailed information allowing evaluation of eligibility. Among these, 9518 (29.9%) patients had exclusion criteria and an additional 5480 patients (17.2%) did not fulfil the inclusion criteria and thus were not eligible. The 'COMPASS-Eligible' population therefore comprised 52.9% of the evaluable REACH patients (n = 16 875). The main reasons for exclusion were high-bleeding risk (51.8%), anticoagulant use (44.8%), requirement for dual antiplatelet therapy within 1 year of an ACS or PCI with stent, (25.9%), history of ischaemic stroke <1 year (12.4%), and severe renal failure (2.2%). Eligibility was highest among patients with PAD alone (68.4%). COMPASS-Eligible patients from REACH experienced higher annualized primary outcome event rates than patients actually enrolled in the reference aspirin arm of COMPASS (4.2% vs. 2.9% per year, P < 0.001). Conclusion: COMPASS-Eligible patients represent a substantial fraction of stable CAD/PAD patients encountered in routine clinical practice in the large international REACH registry suggesting good external applicability. COMPASS-Eligible patients experienced a higher rate of the primary outcome compared with COMPASS participants in the aspirin alone treatment arm.
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Ensayos Clínicos Fase III como Asunto , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Selección de Paciente , Enfermedad Arterial Periférica/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Sistema de Registros , Trombosis/prevención & control , Anciano , Aspirina/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Femenino , Fibrinolíticos/uso terapéutico , Humanos , Masculino , Rivaroxabán/uso terapéuticoRESUMEN
Transcatheter aortic valve implantation (TAVI) has established as a gold standard in the treatment of elderly patients with severe aortic stenosis. Vascular access marks the first step in a TAVI procedure where the transfemoral access is preferred. Therefore, vascular complications are one of the main concerns of operators. With the increasing number of TAVIs performed, the focus is on the prevention and management of vascular complications. Illustrated by a clinical case, this article attempts to review the main vascular complications, their management and how to prevent them.
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BACKGROUND: The optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) in patients with nonvalvular atrial fibrillation (AF) remains uncertain. OBJECTIVES: In this study, the authors sought to compare the efficacy and safety of various antithrombotic strategies after LAAO. METHODS: We searched the Medline, Cochrane, EMBASE, LILACS, and ClinicalTrials.gov databases for studies reporting outcomes after LAAO, stratified by antithrombotic therapy prescribed at postprocedural discharge. Direct oral anticoagulants (DOACs), vitamin K antagonists (VKAs), single antiplatelet therapy (SAPT), dual antiplatelet therapy (DAPT), DOAC plus SAPT, VKA plus SAPT, and no antithrombotic therapy were analyzed. We performed a frequentist random effects model network meta-analysis to estimate the OR and 95% CI for each comparison. P-scores provided a ranking of treatments. RESULTS: Forty-one studies comprising 12,451 patients with nonvalvular AF were included. DAPT, DOAC, DOAC plus SAPT, and VKA were significantly superior to no therapy to prevent device-related thrombosis. DOAC was associated with lower all-cause mortality than VKA (OR: 0.39; 95% CI: 0.17-0.89; P = 0.03). Compared with SAPT, DAPT was associated with fewer thromboembolic events (OR: 0.50; 95% CI: 0.29-0.88; P = 0.02), without a difference in major bleeding. In the analysis of P-scores, DOAC monotherapy was the strategy most likely to have lower thromboembolic events and major bleeding. CONCLUSIONS: In this network meta-analysis comparing initial antithrombotic therapies after LAAO, monotherapy with DOAC had the highest likelihood of lower thromboembolic events and major bleeding. DAPT was associated with a lower incidence of thromboembolic events compared with SAPT and may be a preferred option in patients unable to tolerate anticoagulation.
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Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Tromboembolia , Humanos , Inhibidores de Agregación Plaquetaria , Fibrinolíticos/uso terapéutico , Apéndice Atrial/cirugía , Metaanálisis en Red , Anticoagulantes , Hemorragia/etiología , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Tromboembolia/epidemiología , Tromboembolia/etiología , Tromboembolia/prevención & control , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: Psychoactive drugs, including illicit drugs, are associated with an increased rate of cardiovascular events. The prevalence and outcome of patients using these drugs at the time of admission to an intensive cardiac care unit is unknown. AIM: To assess the prevalence of psychoactive drugs detected in consecutive patients hospitalized in an intensive cardiac care unit for an acute cardiovascular event. METHODS: This is a nationwide prospective multicentre study, involving 39 centres throughout France, including all consecutive patients hospitalized in an intensive cardiac care unit within 2weeks. Psychoactive drug use will be assessed systematically by urine drug assay within 2hours of intensive cardiac care unit admission, to detect illicit (cannabinoids, cocaine, amphetamines, ecstasy, heroin and other opioids) and non-illicit (barbiturates, benzodiazepines, tricyclic antidepressants, methadone and buprenorphine) psychoactive drugs. Smoking will be investigated systematically by exhaled carbon monoxide measurement, and alcohol consumption using a standardized questionnaire. In-hospital major adverse events, including death, resuscitated cardiac arrest and cardiogenic shock, will be recorded. After discharge, all-cause death and major adverse cardiovascular events will be recorded systematically and adjudicated at 12months of follow-up. RESULTS: The primary outcome will be the prevalence of psychoactive drugs detected by systematic screening among all patients hospitalized in an intensive cardiac care unit. The in-hospital major adverse events will be analysed according to the presence or absence of detected psychoactive drugs. Subgroup analysis stratified by initial clinical presentation and type of psychoactive drug will be performed. CONCLUSIONS: This is the first prospective multicentre study to assess the prevalence of psychoactive drugs detected by systematic screening in consecutive patients hospitalized for acute cardiovascular events.
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Cardiólogos , Cardiología , Enfermedades Cardiovasculares , Humanos , Prevalencia , Estudios Prospectivos , Psicotrópicos/efectos adversos , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiologíaRESUMEN
BACKGROUND: The evolution of patients hospitalized with coronavirus disease 2019 (COVID-19) is still hard to predict, even after several months of dealing with the pandemic. AIMS: To develop and validate a score to predict outcomes in patients hospitalized with COVID-19. METHODS: All consecutive adults hospitalized for COVID-19 from February to April 2020 were included in a nationwide observational study. Primary composite outcome was transfer to an intensive care unit from an emergency department or conventional ward, or in-hospital death. A score that estimates the risk of experiencing the primary outcome was constructed from a derivation cohort using stacked LASSO (Least Absolute Shrinkage and Selection Operator), and was tested in a validation cohort. RESULTS: Among 2873 patients analysed (57.9% men; 66.6±17.0 years), the primary outcome occurred in 838 (29.2%) patients: 551 (19.2%) were transferred to an intensive care unit; and 287 (10.0%) died in-hospital without transfer to an intensive care unit. Using stacked LASSO, we identified 11 variables independently associated with the primary outcome in multivariable analysis in the derivation cohort (n=2313), including demographics (sex), triage vitals (body temperature, dyspnoea, respiratory rate, fraction of inspired oxygen, blood oxygen saturation) and biological variables (pH, platelets, C-reactive protein, aspartate aminotransferase, estimated glomerular filtration rate). The Critical COVID-19 France (CCF) risk score was then developed, and displayed accurate calibration and discrimination in the derivation cohort, with C-statistics of 0.78 (95% confidence interval 0.75-0.80). The CCF risk score performed significantly better (i.e. higher C-statistics) than the usual critical care risk scores. CONCLUSIONS: The CCF risk score was built using data collected routinely at hospital admission to predict outcomes in patients with COVID-19. This score holds promise to improve early triage of patients and allocation of healthcare resources.
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COVID-19 , Adulto , Masculino , Humanos , Femenino , COVID-19/diagnóstico , COVID-19/terapia , SARS-CoV-2 , Mortalidad Hospitalaria , Hospitalización , Aprendizaje Automático , Hospitales , Estudios RetrospectivosRESUMEN
Left Bundle Branch Block (LBBB) is a frequently encountered electrical abnormality in patients with chronic (more than 3 months after myocardial infarction, or evidence of coronary artery disease with ischemia) coronary syndromes (CCS), but its prognostic significance remains unclear. We aimed to describe the prevalence, incidence and five-year outcomes of LBBB in outpatients with CCS using the CLARIFY registry. Main outcome was a composite of CV death, MI or stroke. Secondary outcomes included all cause death, hospitalization for heart failure (HF) and permanent pacemaker implantation. Among 23.544 patients with available information regarding LBBB status at baseline, 1.041 (4.4%) had LBBB at baseline and 1.015 (4.5%) patients developed a new LBBB during 5-year follow-up. In multivariate analysis, LBBB at baseline was not associated with the composite outcome of CV death, MI or stroke (HR 1.06, 95% CI [0.86 - 1.31], pâ¯=â¯0.67) or the risk of all-cause death (HR 1.07, 95% CI [0.87 - 1.32], pâ¯=â¯0.52) but was significantly associated with a higher risk of hospitalization for HF (HR 1.50, 95% CI [1.21 - 1.88], p < 0.001) and permanent pacemaker implantation (HR 2.11, 95% CI [1.45 - 3.07], p < 0.001). The main factors associated with new-onset LBBB were male sex (HR 0.8 [0.66-0.98], pâ¯=â¯0.028) history of atrial fibrillation (HR 1.29, 95% CI [1.01 - 1.64], pâ¯=â¯0.04), CABG (HR 1.27, [1.08 - 1.51], pâ¯=â¯0.004) and MI (HR 1.19, 95% CI [1.01 - 1.40], pâ¯=â¯0.034). In conclusion, in a contemporary registry of outpatients with CCS, the prevalence of LBBB was 4.4% and the additional 5-years incidence 6.2%. LBBB, in itself, was not associated with a higher risk of major adverse cardiovascular events or all cause mortality. It was however an independent predictor of risk of hospitalization for heart failure and permanent pacemaker implantation.
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Bloqueo de Rama/epidemiología , Enfermedad Coronaria/complicaciones , Anciano , Bloqueo de Rama/mortalidad , Bloqueo de Rama/terapia , Causas de Muerte , Enfermedad Crónica , Enfermedad Coronaria/mortalidad , Enfermedad Coronaria/terapia , Electrocardiografía , Femenino , Francia/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Incidencia , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Marcapaso Artificial , Prevalencia , Pronóstico , Estudios Prospectivos , Sistema de Registros , Accidente Cerebrovascular/epidemiología , SíndromeRESUMEN
BACKGROUND: The COMPASS trial showed a reduction of ischemic events with low-dose rivaroxaban and aspirin in chronic coronary syndromes (CCS) compared with aspirin alone, at the expense of increased bleeding. HYPOTHESIS: The CHA2 DS2 VaSc Score, REACH Recurrent Ischemic (RIS), and REACH Bleeding Risk Score (BRS) could identify patients with a favorable trade-off between ischemic and bleeding events, among COMPASS-eligible patients. METHODS: We identified the COMPASS-eligible population within the CLARIFY registry (>30.000 patients with CCS). High-bleeding risk patients (REACH BRS > 10) were excluded, as in the COMPASS trial. Patients were categorized as low (0-1) or high (≥ 2) CHA2 DS2 VaSc; low (0-12) or intermediate (13-19) REACH RIS, and low (0-6) or intermediate (7-10) REACH BRS. Ischemic outcome was the composite of cardiovascular death, myocardial infarction or stroke. Bleeding was defined as serious bleeding (haemorrhagic stroke, hospitalization for bleeding, transfusion). RESULTS: The COMPASS-eligible population comprised 5.142 patients with ischemic and bleeding outcome of 2.3 (2.1-2.5) and 0.5 (0.4-0.6) per 100 patient-years, respectively. Patients with intermediate REACH RIS (n = 1934 [37.6%]) had the higher ischemic risk (3.0 [2.6-3.4]) with similar bleeding risk (0.5 [0.4-0.7]) as the overall population. Patients with low CHA2 DS2 VaSc (n = 229 [4.4%]) had a very low ischemic risk (0.6 [0.3-1.3]) with similar bleeding risk (0.5 [0.2-1.1]). CONCLUSIONS: Intermediate REACH RIS identified potential optimal candidates for adjunction of low-dose rivaroxaban while patients with low CHA2 DS2 VaSc score .appears unlikely to benefit from the COMPASS regimen. None of the three risk scores predicted the occurrence of serious bleeding.
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Enfermedad de la Arteria Coronaria/epidemiología , Sistema de Registros , Medición de Riesgo/métodos , Anciano , Enfermedad Crónica , Comorbilidad , Enfermedad de la Arteria Coronaria/diagnóstico , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Suiza/epidemiología , Síndrome , Factores de TiempoRESUMEN
BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to a public health crisis. Only limited data are available on the characteristics and outcomes of patients hospitalized for COVID-19 in France. AIMS: To investigate the characteristics, cardiovascular complications and outcomes of patients hospitalized for COVID-19 in France. METHODS: The Critical COVID-19 France (CCF) study is a French nationwide study including all consecutive adults with a diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infection hospitalized in 24 centres between 26 February and 20 April 2020. Patients admitted directly to intensive care were excluded. Clinical, biological and imaging parameters were systematically collected at hospital admission. The primary outcome was in-hospital death. RESULTS: Of 2878 patients included (mean±SD age 66.6±17.0 years, 57.8% men), 360 (12.5%) died in the hospital setting, of which 7 (20.7%) were transferred to intensive care before death. The majority of patients had at least one (72.6%) or two (41.6%) cardiovascular risk factors, mostly hypertension (50.8%), obesity (30.3%), dyslipidaemia (28.0%) and diabetes (23.7%). In multivariable analysis, older age (hazard ratio [HR] 1.05, 95% confidence interval [CI] 1.03-1.06; P<0.001), male sex (HR 1.69, 95% CI 1.11-2.57; P=0.01), diabetes (HR 1.72, 95% CI 1.12-2.63; P=0.01), chronic kidney failure (HR 1.57, 95% CI 1.02-2.41; P=0.04), elevated troponin (HR 1.66, 95% CI 1.11-2.49; P=0.01), elevated B-type natriuretic peptide or N-terminal pro-B-type natriuretic peptide (HR 1.69, 95% CI 1.0004-2.86; P=0.049) and quick Sequential Organ Failure Assessment score ≥2 (HR 1.71, 95% CI 1.12-2.60; P=0.01) were independently associated with in-hospital death. CONCLUSIONS: In this large nationwide cohort of patients hospitalized for COVID-19 in France, cardiovascular comorbidities and risk factors were associated with a substantial morbi-mortality burden.
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COVID-19/epidemiología , Enfermedades Cardiovasculares/epidemiología , Pacientes Internos/estadística & datos numéricos , Pandemias , SARS-CoV-2 , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/terapia , Comorbilidad , Diabetes Mellitus/epidemiología , Dislipidemias/epidemiología , Femenino , Francia/epidemiología , Mortalidad Hospitalaria , Humanos , Hipertensión/epidemiología , Unidades de Cuidados Intensivos/estadística & datos numéricos , Fallo Renal Crónico/epidemiología , Masculino , Persona de Mediana Edad , Obesidad/epidemiología , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Although cardiovascular comorbidities seem to be strongly associated with worse outcomes in patients with coronavirus disease 2019 (COVID-19), data regarding patients with preexisting heart failure are limited. AIMS: To investigate the incidence, characteristics and clinical outcomes of patients with COVID-19 with a history of heart failure with preserved or reduced ejection fraction. METHODS: We performed an observational multicentre study including all patients hospitalized for COVID-19 across 24 centres in France from 26 February to 20 April 2020. The primary endpoint was a composite of in-hospital death or need for orotracheal intubation. RESULTS: Overall, 2809 patients (mean age 66.4±16.9years) were included. Three hundred and seventeen patients (11.2%) had a history of heart failure; among them, 49.2% had heart failure with reduced ejection fraction and 50.8% had heart failure with preserved ejection fraction. COVID-19 severity at admission, defined by a quick sequential organ failure assessment score>1, was similar in patients with versus without a history of heart failure. Before and after adjustment for age, male sex, cardiovascular comorbidities and quick sequential organ failure assessment score, history of heart failure was associated with the primary endpoint (hazard ratio [HR]: 1.41, 95% confidence interval [CI]: 1.06-1.90; P=0.02). This result seemed to be mainly driven by a history of heart failure with preserved ejection fraction (HR: 1.61, 95% CI: 1.13-2.27; P=0.01) rather than heart failure with reduced ejection fraction (HR: 1.19, 95% CI: 0.79-1.81; P=0.41). CONCLUSIONS: History of heart failure in patients with COVID-19 was associated with a higher risk of in-hospital death or orotracheal intubation. These findings suggest that patients with a history of heart failure, particularly heart failure with preserved ejection fraction, should be considered at high risk of clinical deterioration.
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COVID-19/epidemiología , Insuficiencia Cardíaca/epidemiología , Sistema de Registros/estadística & datos numéricos , SARS-CoV-2 , Anciano , COVID-19/sangre , Comorbilidad , Factores de Confusión Epidemiológicos , Femenino , Francia/epidemiología , Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/fisiopatología , Mortalidad Hospitalaria , Humanos , Incidencia , Intubación Intratraqueal/estadística & datos numéricos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Utilización de Procedimientos y Técnicas , Estudios Retrospectivos , Factores de Riesgo , Volumen Sistólico , Resultado del TratamientoRESUMEN
BACKGROUND: Coronavirus disease-2019 (COVID-19) is an infectious disease appeared in China in December 2019 and, since then, has spread worldwide at a rapid pace. CASE SUMMARY: A patient with COVID-19 was hospitalized in our institution for a diabetic foot ulcer and presented afterwards a pulmonary oedema and concomitant anterior ST-segment elevation myocardial infarction. We report here on the initial presentation, coronary care and intervention, and clinical course of this patient. DISCUSSION: Emergent percutaneous coronary intervention is feasible and safe in COVID-19 patients but requires a multidisciplinary effort involving caregivers from infectious disease, intensive care, and cardiology teams.
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OBJECTIVES: We assess the proportion, baseline characteristics, and outcomes of a cohort of very high bleeding risk (HBR) patients discharged with no antithrombotic therapy after left atrial appendage closure (LAAC). BACKGROUND: The optimal antithrombotic therapy after LAAC remains controversial. However, a substantial proportion of patients have HBR and are contraindicated to any antithrombotic therapy. Data regarding the feasibility and safety of such a strategy are scarce. METHODS: All patients who underwent LAAC at our institution between October 2013 and December 2018 were included. Clinical, procedural, and imaging data were collected prospectively, and patients receiving no antithrombotic therapy were compared with those receiving at least 1 agent. RESULTS: A total of 152 patients were included. At discharge, 72 (47.3%) received single-antiplatelet therapy (SAPT), 57 (37.5%) received dual-antiplatelet therapy (DAPT), and 22 (14.5%) received no antithrombotic therapy (NATT). One patient received a combination of aspirin and vitamin K antagonist. There were no differences regarding baseline characteristics between NATT patients and the others. At a median follow-up of 16 months, 25 patients died. There were no differences between NATT patients and others regarding all-cause mortality (9.1% vs 18.8%, respectively; P=.07) or ischemic stroke (0.0% vs 4.2%, respectively; P=.20). There were 4 episodes of major bleeding, but none occurred in the NATT group, and no device-related thrombosis was seen on computed tomography scan performed within 12 weeks after LAAC. CONCLUSIONS: In highly selected patients at very HBR, discontinuation of any antithrombotic therapy after LAAC appears safe and feasible.
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Apéndice Atrial , Fibrilación Atrial , Hemorragia , Accidente Cerebrovascular , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Resultado del TratamientoRESUMEN
BACKGROUND: The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial found clinical benefit of low-dose rivaroxaban plus aspirin, but at the expense of increased bleeding risk in patients with stable vascular disease. OBJECTIVES: This study evaluated the balance of ischemic and bleeding risks according to the presence of ≥1 enrichment criteria in "COMPASS-eligible" patients. METHODS: Key COMPASS selection criteria were applied to identify a COMPASS-eligible population (n = 16,875) from the REACH (REduction of Atherothrombosis for Continued Health) Registry of stable atherothrombotic patients. Ischemic outcome was the composite of cardiovascular death, myocardial infarction, or stroke. Bleeding outcome was serious bleeding (hemorrhagic stroke, hospitalization for bleeding, transfusion). RESULTS: Patients were categorized according to the enrichment criteria: age >65 years (81.5%), diabetes (41.0%), moderate renal failure (40.2%), peripheral artery disease (33.7%), current smoker (13.8%), heart failure (13.3%), ischemic stroke (11.1%), and asymptomatic carotid stenosis (8.7%). Each criterion was associated with a consistent increase in ischemic and bleeding events, but no individual subgroup derived a more favorable trade-off. Patients with multiple criteria had a dramatic increase in ischemic risk (7.0% [95% confidence interval (CI): 5.6% to 8.7%], 12.5% [95% CI: 11.1% to 14.1%], 16.6% [95% CI: 14.7% to 18.6%], and 21.8% [95% CI: 19.9% to 23.9%] with 1, 2, 3, and ≥4 enrichment criteria, respectively), but a more modest absolute increase in bleeding risk (1.5% [95% CI: 0.9% to 2.1%], 1.8% [95% CI: 1.3% to 2.2%], 2.0% [95% CI: 1.5% to 2.6%], 3.2% [95% CI: 2.6% to 3.9%]). CONCLUSIONS: In a population of stable vascular patients at high risk of atherothrombotic events, the subset with multiple enrichment criteria had a greater absolute increase in ischemic than in bleeding risk and may be good candidates for low-dose rivaroxaban in addition to aspirin.
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Inhibidores del Factor Xa/uso terapéutico , Hemorragia/inducido químicamente , Isquemia/prevención & control , Sistema de Registros , Rivaroxabán/uso terapéutico , Anciano , Aspirina/uso terapéutico , Femenino , Fibrinolíticos/uso terapéutico , Humanos , Masculino , Isquemia Miocárdica/prevención & control , Estudios Prospectivos , Medición de RiesgoRESUMEN
BACKGROUND: Performance of tricuspid annuloplasty (TA) in patients undergoing mitral valve surgery is recommended based on the degree of tricuspid regurgitation and tricuspid annulus size, but is often underused. AIM: To evaluate the impact of combined TA on in-hospital outcome in patients undergoing mitral valve replacement (MVR). METHODS: We selected all consecutive patients who underwent MVR for native valve disease. Clinical, echocardiographic and in-hospital complications were obtained from chart review. RESULTS: We identified 287 patients (mean age 62±17 years; 44% men). Combined TA was performed in 165 patients (57%), who had more rheumatic disease (71% vs. 24%; P<0.0001) and mitral stenosis (55% vs. 22%; P<0.0001), but less endocarditis (4% vs. 31%; P<0.0001), were more often in atrial fibrillation (54% vs. 22%; P<0.0001), were more severely symptomatic (80% vs. 57%; P<0.0001), presented with a higher systolic pulmonary artery pressure (SPAP) (53±16 vs. 45±15mmHg; P=0.0002) and were less likely to have required emergency surgery (17% vs. 38%; P<0.0001). Despite this higher risk profile, in-hospital mortality was slightly lower (5% vs. 13%; P=0.02) and complication rates were similar (redo surgery 22% vs. 16% [P=0.18] and tamponade 20% vs. 15% [P=0.15]). After adjustment for age, sex, functional class, SPAP, emergency surgery and concomitant coronary artery bypass graft or aortic valve replacement surgery, combined TA was not associated with an increased rate of in-hospital death (P=0.08) or major complications (P=0.89). CONCLUSIONS: In a consecutive series of patients who underwent MVR, TA did not seem to have a negative impact on immediate outcome. Hence, additional performance of TA at the time of MVR should not be declined on the basis of an increased surgical risk.