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AIMS: To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. METHODS AND RESULTS: Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory causes, analysed by the win ratio method. Patients were followed for 12 months. During two influenza seasons, 1801 participants were included at 25 centres in Brazil. The primary outcome was not different between groups, with 12.7% wins in-hospital double-dose vaccine group and 12.3% wins in the standard-dose vaccine group {win ratio: 1.02 [95% confidence interval (CI): 0.79-1.32], P = 0.84}. Results were consistent for the key secondary outcome, a hierarchical composite of cardiovascular death, myocardial infarction and stroke [win ratio: 0.94 (95% CI: 0.66-1.33), P = 0.72]. Time-to-first event analysis for the primary outcome showed results similar to those of the main analysis [hazard ratio 0.97 (95% CI: 0.75-1.24), P = 0.79]. Adverse events were infrequent and did not differ between groups. CONCLUSION: Among patients hospitalized with an ACS, double-dose influenza vaccination before discharge did not reduce cardiopulmonary outcomes compared with standard-dose vaccination in the outpatient setting. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04001504.
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Síndrome Coronario Agudo , Gripe Humana , Infarto del Miocardio , Accidente Cerebrovascular , Humanos , Síndrome Coronario Agudo/terapia , Gripe Humana/prevención & control , Infarto del Miocardio/prevención & control , Vacunación , Accidente Cerebrovascular/prevención & control , Vacunas de Productos Inactivados , Resultado del TratamientoRESUMEN
OBJECTIVE: We aim to examine the effect of benchmarking on quality-of-care metrics in patients presenting with ST-elevation myocardial infarction (STEMI) through the implementation of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ACTION Registry. DESIGN: From January 2005 to December 2017, 712 patients underwent primary percutaneous coronary intervention PCI-499 before NCDR ACTION Registry implementation (prior to 2013) and 213 after implementation. SETTING: STEMI. PARTICIPANTS: 712 patients. INTERVENTION(S): Primary PCI. MAIN OUTCOME MEASURE(S): We examined hospital performance for the quality indicators in processes and outcomes of the management of patients presenting with STEMI. Outcome measures include door-to-balloon time (DBT), antiplatelet therapy and anti-ischemic drugs prescribed at discharge from pre-NCDR ACTION Registry to post-implementation. RESULTS: There was improvement in DBT, decreasing from 94 min in 2012 (before NCDR adoption) to reach a median of 47 min in 2017 (Ptrend < 0.001). The percentage of cases with the optimal DBT of < 90 min increased from 55.8% before to 90.1% after the implementation of the NCDR ACTION Registry (Ptrend < 0.001). The rate of aspirin (90.3-100%, P < 0.001), P2Y12 inhibitor (70.1-78.4%, P = 0.02), beta-blocker (76.8-100%, P < 0.001) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (60.1-99.5%, P < 0.001) prescribed at discharge increased from pre-NCDR ACTION Registry to post-implementation. Adjusted mortality before and after NCDR ACTION Registry implementation showed significant change (from 9.04 to 5.92%; P = 0.027). CONCLUSIONS: The introduction of the ACC NCDR ACTION Registry led to incremental gains in the quality in STEMI management through the benchmarking of process of care and clinical outcomes, achieving reduced DBT, improving guideline-directed medication adherence and increasing patient safety, treatment efficacy and survival.
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Benchmarking/métodos , Mejoramiento de la Calidad/organización & administración , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Infarto del Miocardio con Elevación del ST/cirugía , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , Inhibidores de la Enzima Convertidora de Angiotensina , Brasil , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Intervención Coronaria Percutánea/estadística & datos numéricos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Sistema de Registros , Infarto del Miocardio con Elevación del ST/mortalidad , Factores de TiempoRESUMEN
OBJECTIVES: To evaluate the diagnostic performance of a novel computational algorithm based on three-dimensional intravascular ultrasound (IVUS) imaging in estimating fractional flow reserve (IVUSFR ), compared to gold-standard invasive measurements (FFRINVAS ). BACKGROUND: IVUS provides accurate anatomical evaluation of the lumen and vessel wall and has been validated as a useful tool to guide percutaneous coronary intervention. However, IVUS poorly represents the functional status (i.e., flow-related information) of the imaged vessel. METHODS: Patients with known or suspected stable coronary disease scheduled for elective cardiac catheterization underwent FFRINVAS measurement and IVUS imaging in the same procedure to evaluate intermediate lesions. A processing methodology was applied on IVUS to generate a computational mesh condensing the geometric characteristics of the vessel. Computation of IVUSFR was obtained from patient-level morphological definition of arterial districts and from territory-specific boundary conditions. FFRINVAS measurements were dichotomized at the 0.80 threshold to define hemodynamically significant lesions. RESULTS: A total of 24 patients with 34 vessels were analyzed. IVUSFR significantly correlated (r = 0.79; P < 0.001) and showed good agreement with FFRINVAS , with a mean difference of -0.008 ± 0.067 (P = 0.47). IVUSFR presented an overall accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 91%, 89%, 92%, 80%, and 96%, respectively, to detect significant stenosis. CONCLUSION: The computational processing of IVUSFR is a new method that allows the evaluation of the functional significance of coronary stenosis in an accurate way, enriching the anatomical information of grayscale IVUS.
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Algoritmos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Reserva del Flujo Fraccional Miocárdico , Imagenología Tridimensional , Ultrasonografía Intervencional/métodos , Anciano , Cateterismo Cardíaco , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/fisiopatología , Vasos Coronarios/fisiopatología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.
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Implantes Absorbibles , Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/cirugía , Diabetes Mellitus , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/mortalidad , Femenino , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
In this issue of CCI, Vejpongsa and coworkers showed that TAVR represented 20.4% of all aortic valve replacements performed in elderly patients from 21 US states in the year 2013. Patients treated with SAVR or TAVR largely overlapped in their baseline characteristics, indicating that both modalities concur in everyday life. One out of six patients was readmitted within 30 days, with no significant differences between the TAVR and SAVR in propensity score analysis. One may ask: since the indications of transcatheter and surgical treatments are interchanged for many cases, and the global results look similar, how to finally select the best therapeutic option for an individual case? Would the results be the same if patient-reported outcomes and experiences, such as pain and analgesic use, time to return to routine activities, or quality of life scores were measured? Combining traditional and patient-reported outcomes, in relation to costs, is the optimal approach to assess value in healthcare. Time has come for investigators to adopt value-based healthcare measures as endpoints in registries and clinical trials.
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Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Válvula Aórtica/cirugía , Humanos , Readmisión del Paciente , Calidad de Vida , Resultado del TratamientoRESUMEN
OBJECTIVES: Elevated B-type natriuretic peptide (BNP) levels following acute myocardial infarction (AMI) are associated with adverse outcomes. The role of serial BNP monitoring after AMI has been poorly investigated. We aimed to evaluate the prognostic value of in-hospital serial BNP measurements in AMI patients. METHODS: Patients with AMI (n=1,924) were retrospectively evaluated. We selected patients with at least 2 in-hospital BNP measurements. The association between in-hospital mortality and BNP measurements (earliest, highest follow-up and the variation between measurements) were tested in multivariate models. RESULTS: Serial BNP levels were determined in 176 patients. Compared to the rest of the population, these patients were older and had higher mortality rates. In the adjusted models, only the highest follow-up BNP remained associated with in-hospital death (odds ratio 1.06; 95% confidence interval, CI, 1.01-1.15; p=0.014). Receiver-operating characteristic curve analysis demonstrated that the highest follow-up BNP was the best predictor of in-hospital death (area under the curve=0.75; 95% CI 0.64-0.86). CONCLUSIONS: Serial BNP monitoring was performed in a high-risk subgroup of AMI patients. The highest follow-up BNP was a better predictor of short-term death than the baseline and in-hospital variation values. In AMI patients, a later in-hospital BNP assessment may be more useful than an early measurement.
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Infarto del Miocardio/mortalidad , Péptido Natriurético Encefálico/metabolismo , Anciano , Biomarcadores/metabolismo , Femenino , Mortalidad Hospitalaria , Humanos , Tiempo de Internación , Masculino , Infarto del Miocardio/sangre , Pronóstico , Curva ROC , Estudios RetrospectivosRESUMEN
Purpose: Stroke is the second leading cause of global adult mortality and the primary cause of disability. A rapid assessment by a neurologist for general and reperfusion treatments in ischemic strokes is linked to decreased mortality and disability. Telestroke assessment is a strategy that allows for neurological consultations with experienced professionals, even in remote emergency contexts. No randomized studies have compared face-to-face neurological care outcomes with telestroke care. Whether neurologists in an institution achieve better results remotely than in person is also unknown. This study aimed to compare mortality and other outcomes commonly measured in stroke protocols for stroke patients assessed by a neurologist via face-to-face evaluations and telestroke assessment. Methods: Observational single-center retrospective study from August/2009 to February/2022, enrolling 2,689 patients with ischemic stroke, subarachnoid hemorrhage, and intracerebral hemorrhage. Group 1 (G1) comprised 2,437 patients with in-person neurological assessments, and Telemedicine Group 2 (G2) included 252 patients. Results: The in-person group had higher admission NIHSS scores (G1, 3 (0; 36) vs. G2, 2 (0; 26), p < 0.001). The door-to-groin puncture time was lower in the in-person group than in the telestroke group (G1, 103 (42; 310) vs. G2, 151 (109; 340), p < 0.001). The telestroke group showed superior metrics for door-to-imaging time, symptomatic hemorrhagic transformation rate in ischemic stroke patients treated with intravenous thrombolysis, hospital stay duration, higher rates of intravenous thrombolysis and mechanical thrombectomy, and lower mortality. Symptomatic hemorrhagic transformation rate was smaller in the group evaluated via telestroke (G1, 5.1% vs. G2, 1.1%, p = 0.016). Intravenous thrombolysis and mechanical thrombectomy rates were significantly higher in telestroke group: (G1, 8.6% vs. G2, 18.2%, p < 0.001 and G1, 5.1% vs. G2, 10.4%, p = 0.002, respectively). Mortality was lower in the telestroke group than in the in-person group (G1, 11.1% vs. G2, 6.7%, p = 0.001). The percentage of patients with an mRS score of 0-2 at discharge was similar in both groups when adjusting for NIHSS score and age. Conclusion: The same neurological emergency team may assess stroke patients in-person or by telemedicine, with excellent outcome metrics. This study reaffirms telestroke as a safe tool in acute stroke care.
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Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).
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Síndrome Coronario Agudo , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ticagrelor/uso terapéutico , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/cirugía , Clorhidrato de Prasugrel/uso terapéutico , Intervención Coronaria Percutánea/efectos adversos , Quimioterapia Combinada , Aspirina/uso terapéutico , Hemorragia/inducido químicamente , Resultado del TratamientoRESUMEN
OBJECTIVE: Low platelet reactivity levels are associated with higher risk of bleeding in patients receiving dual antiplatelet therapy relative to patients with optimal platelet blockade. This study set out to evaluate the prevalence of low platelet reactivity in patients with acute myocardial infarction treated with ticagrelor and aspirin. METHODS: Patients admitted with acute myocardial infarction who were already undergoing dual antiplatelet therapy with aspirin and ticagrelor were enrolled. Blood samples were collected 1 hour before and 2 hours after the maintenance dose of ticagrelor to investigate trough and the peak effects of the drug respectively. Platelet reactivity was measured by three methods: Multiplate®, PFA-100® with Innovance® PFA-P2Y cartridge and PFA-100® with Collagen/ADP cartridge. Platelet reactivity was assessed in the presence of peak levels of ticagrelor and defined according to previously validated cut-offs for each method (<19 AUC, >299 seconds and >116 seconds respectively). The level of significance was set at p<0.05. RESULTS: Fifty patients were enrolled (44% with ST-elevation). Median duration of DAPT was 3 days (interquartile range, 2-5 days). On average, peak and trough platelet reactivity were markedly low and did not differ between different methods. Low platelet reactivity was common, but varied according to analytic method (PFA-100®/Innovance®PFA-P2Y: 86%; Multiplate®: 74%; PFA-100®/Collagen/ADP: 48%; p<0.001). CONCLUSION: Low platelet reactivity was very common in patients with acute myocardial infarction submitted to dual antiplatelet therapy with ticagrelor and aspirin. Findings of this study justify the investigation of less intensive platelet inhibition strategies aimed at reducing the risk of bleeding in this population, such as lower dose regimens or monotherapy with P2Y12 inhibitors.
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Aspirina , Infarto del Miocardio , Adenosina Difosfato/uso terapéutico , Aspirina/efectos adversos , Aspirina/uso terapéutico , Hemorragia/inducido químicamente , Humanos , Infarto del Miocardio/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ticagrelor/efectos adversos , Ticagrelor/uso terapéutico , Resultado del TratamientoRESUMEN
Background: Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty. Methods: Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion. Results: A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold). Conclusions: Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.
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A thorough understanding of advanced device algorithms designed to promote intrinsic atrioventricular conduction is mandatory to allow appropriate management of arrhythmias induced by pacing, particularly when other types of tachycardia are involved.
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BACKGROUND: Takotsubo cardiomyopathy (TTC) is characterized by transient left ventricular (LV) dysfunction, electrocardiographic changes that can mimic acute myocardial infarction (MI), and release of myocardial enzymes in the absence of obstructive coronary artery disease (CAD). Conventionally, gross visual assessment of LV angiogram has been used to classify TTC. We aim to compare quantitative assessment of different regions of LV on angiogram and segmental strain on transthoracic echo to determine a better way to classify TTC rather than conventional qualitative visual assessment. METHODS: We conducted a retrospective observational study of 20 patients diagnosed with TTC who had LV angiogram and transthoracic echocardiograms performed on presentation that were suitable for analysis. Twenty LV angiograms were analyzed using Rubo DICOM viewer software. Areas of different LV regions were measured in diastole and systole, and percentage changes in area of these regions were calculated. Percentage changes in area of less than 10% was considered "akinetic." On the other hand, using echocardiograms of these patients, LV regional longitudinal strain (LS) was derived from speckle-tracking analysis. These findings were compared to determine concordance between both modalities. RESULTS: On quantitative analysis of 20 LV angiograms, the area of all the three LV regional (apex, mid ventricle, and base) shortening (>10%) was observed in 16 patients (80%) during systole as compared to diastole. However, only 4 out of 20 patients (20%) were noted to have apical region area change of <10% between diastole and systole. Analysis of LV regional LS patterns of 20 patients showed that 14 patients had abnormal values (> -18%) in all three LV regions: apex, mid ventricle, and base. The apical region was the most severely affected region (mean LS -13.9%), followed by the basal region (mean -14.7%) and the mid ventricular region (mean -15.1%). Comparing the results of both modalities showed that there was 35% (n = 7) concordance in the results noted for base and apical regions of the LV, whereas only 20% (n = 4) concordance was noted in mid ventricular region. CONCLUSION: Contractility (shortening) on LV angiogram is present in a majority of patients in the three LV regions, but contractility assessed by LS is impaired in most of them. The concordance in both quantitative assessment modalities was low. LV angiogram may not be an accurate imaging modality to assess contractility patterns in Takotsubo patients, and echocardiographic LS analysis should be taken as the preferred imaging modality.
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Cardiomiopatía de Takotsubo , Disfunción Ventricular Izquierda , Angiografía , Ecocardiografía , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Miocardio , Cardiomiopatía de Takotsubo/diagnóstico por imagen , Disfunción Ventricular Izquierda/diagnóstico por imagen , Función Ventricular IzquierdaRESUMEN
AIMS: The FINDRISC was created to predict the development of type 2 diabetes mellitus (T2DM). Since T2DM associates with inflammation we evaluated if the FINDRISC could predict either current or incident T2DM, and elevated high sensitivity C-reactive protein (hs-CRP). METHODS: 41,880 people (age 41.9 ± 9.7 years; 31% female) evaluated between 2008 and 2016 were included. First, the cross-sectional association between the FINDRISC with presence of either T2DM or hs-CRP ≥ 2.0 mg/L was tested. After a 5 ± 3 years follow-up we tested the score predictive value for incident T2DM and inflammation in respectively 10,559 individuals without diabetes and in a subset of 2,816 individuals having no elevated hs-CRP at baseline. RESULTS: In the cross sectional analysis the FINDRISC was associated with both T2DM (OR 1.24, 95% CI: 1.23-1.26, P < 0.001) and inflammation (OR 1.10, 95% CI: 1.09-1.11, P < 0.001) per FINDRISC unit, as well as in longitudinal analyses (OR 1.17, 95% CI: 1.14-1.20, P < 0.001; and OR 1.04, 95% CI: 1.02-1.07, P < 0.001; respectively, per FINDRISC unit). The C-statistic for incident T2DM and inflammation was 0.79 (95% CI 0.77-0.82) and 0.55 (95% CI 0.53-0.58), respectively. CONCLUSION: The FINDRISC shows good discrimination for incident T2DM but less for inflammation.
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Diabetes Mellitus Tipo 2/epidemiología , Inflamación/complicaciones , Adulto , Estudios Transversales , Femenino , Finlandia , Humanos , Incidencia , Masculino , Factores de RiesgoRESUMEN
Aim: Traditional percutaneous cardiovascular interventions require close physical proximity between the patients and the healthcare team, posing occupational hazards that range from radiation exposure to interpersonal air contamination. Materials & methods: Prospective single-arm pilot study (n = 10) to investigate robotic-assisted intervention as a strategy to reduce proximity during the procedure. Primary end point: composite of angiographic success, intervention performed with the team positioned >2 meters from the patient for ≥50% procedure duration, and absence of in-hospital death or acute target lesion occlusion. Results: The composite primary end point was achieved in 100% of cases. Conclusion: Robotic-assisted percutaneous intervention provided successful invasive treatment while reducing proximity and shared air space between the care-delivery team and the patient during the procedure. Trial registration number: NCT04379453 (Clinicaltrials.gov).
Lay abstract Minimally invasive therapies for cardiovascular diseases are techniques that limit the size of incisions needed and so lessen wound healing time, but traditionally require close contact between the patients and the healthcare team. This fact poses hazards that range from radiation exposure to the spread of airborne diseases. We developed a small study of ten patients to investigate whether a new method of robotic-assisted stent implantation for the treatment of a heart attack would reduce proximity between the patient and medical staff during the procedure. To evaluate the effectiveness of that strategy, we assessed the success of the procedure (by analyzing the images of the operation), the amount of time the team was positioned more than 2 meters from the patient and the occurrence of complications during the hospitalization. We concluded that this method of robotic-assisted stent implantation after a heart attack provided successful treatment while reducing proximity and shared air space between the care-delivery team and the patient.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Procedimientos Quirúrgicos Robotizados , Mortalidad Hospitalaria , Humanos , Proyectos Piloto , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The impact of simultaneous adverse climate conditions in the risk of myocardial infarction (MI) was not tested before. The aim of the present study was to investigate the impact of the combination of climate and air pollution features in the number of admissions and mortality due to acute myocardial infarction in 39 municipalities of São Paulo from 2012 to 2015. METHODS: Data about MI admissions were obtained from the Brazilian public health system (DataSUS). Daily information on weather were accessed from the Meteorological Database for Teaching and Research. Additionally, daily information on air pollution were obtained from the Environmental Company of the State of São Paulo. A hierarchical cluster analysis was applied for temperature, rainfall patterns, relative air humidity, nitrogen dioxide, particulate matter 2.5 and particulate matter 10. MI admissions and in-hospital mortality were compared among the clusters. RESULTS: Data analysis produced 3 clusters: High temperature variation-Low humidity-high pollution (n=218 days); Intermediate temperature variation/high humidity/intermediate pollution (n=751 days) and low temperature variation/intermediate humidity-low pollution (n=123 days). All environmental variables were significantly different among clusters. The combination of high temperature variation, dry weather and high pollution resulted in a significant 9% increase in hospital admissions for MI [30.5 (IQR 25.0-36.0)]; patients/day; P<0.01). The differences in weather and pollution did not have impact on in-hospital mortality (P=0.88). CONCLUSION: The combination of atmospheric conditions with high temperature variation, lower temperature, dryer weather and increased inhalable particles was associated with a marked increase of hospital admissions due to MI.
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Contaminantes Atmosféricos , Contaminación del Aire , Contaminantes Ambientales , Infarto del Miocardio , Contaminantes Atmosféricos/efectos adversos , Contaminación del Aire/efectos adversos , Contaminación del Aire/análisis , Brasil/epidemiología , Hospitalización , Humanos , Infarto del Miocardio/epidemiología , Material Particulado/efectos adversos , Estaciones del AñoRESUMEN
BACKGROUND: Chronic kidney disease is commonly found in patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) and has marked impact in their prognosis. It has been shown however that TAVR may improve renal function by alleviating the hemodynamic barrier imposed by AS. Nevertheless, the predictors of and clinical consequences of renal function improvement are not well established. Our aim was to assess the predictors of improvement of renal function after TAVR. METHODS: The present work is an analysis of the Brazilian Registry of TAVR, a national non-randomized prospective study with 22 Brazilian centers. Patients with baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) were stratified according to renal function after TAVR: increase >10% in eGFR were classified as TAVR induced renal function improvement (TIRFI); decrease > 10% in eGFR were classified as acute kidney injury (AKI) and stable renal function (neither criteria). RESULTS: A total of 819 consecutive patients with symptomatic severe AS were included. Of these, baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) was present in 577 (70%) patients. Considering variance in renal function between baseline and at discharge after TAVR procedure, TIRFI was seen in 197 (34.1%) patients, AKI in 203 (35.2%), and stable renal function in 177 (30.7%). The independent predictors of TIRFI were: absence of coronary artery disease (OR: 0.69; 95% CI 0.48-0.98; P = 0.039) and lower baseline eGFR (OR: 0.98; 95% CI 0.97-1.00; P = 0.039). There was no significant difference in 30-day and 1-year all-cause mortality between patients with stable renal function or TIRFI. Nonetheless, individuals that had AKI after TAVR presented higher mortality compared with TIRFI and stable renal function groups (29.3% vs. 15.4% vs. 9.5%, respectively; p < 0.001). CONCLUSIONS: TIRFI was frequently found among baseline impaired renal function individuals but was not associated with improved 1-year outcomes.
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Riñón/fisiología , Insuficiencia Renal Crónica/fisiopatología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Femenino , Tasa de Filtración Glomerular/fisiología , Implantación de Prótesis de Válvulas Cardíacas/métodos , Hemodinámica/fisiología , Humanos , Pruebas de Función Renal/métodos , Modelos Logísticos , Masculino , Oportunidad Relativa , Pronóstico , Estudios Prospectivos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/cirugía , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
INTRODUCTION/OBJECTIVES: In patients who have undergone recent percutaneous coronary intervention (PCI), poor adhesion to antiplatelet agents may increase the risk of stent thrombosis and death. We aimed to investigate the adherence to different P2Y12 receptor inhibitors after PCI with drug-eluting stent in stable and unstable patients and to evaluate the factors associated with low adherence. METHOD: In a prospective study conducted between 2014 and 2018, the 8-item Morisky scale was applied at 30 days and 6 months post-PCI to measure P2Y12 receptor inhibitors adherence. Also, we describe the characteristics of patients using different platelet receptor P2Y12 inhibitors. Regression models were used to identify predictors of poor adherence. RESULTS: A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes). Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years, P < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years, P < .01). Patients with low/moderate adherence at 30 days and 6 months represented, respectively, 19.8% and 27.5% of our sample. Current smokers and preexisting cardiovascular disease at presentation were associated with lower adherence at 30 days. CONCLUSIONS: We found substantial rates of moderate and low adherence to P2Y12 receptor inhibitors early after PCI. Current smokers and preexisting cardiovascular disease at presentation were associated with a lower likelihood of adherence. These results highlight the need of monitoring adherence to medical treatment after PCI.
Asunto(s)
Trombosis Coronaria/prevención & control , Stents Liberadores de Fármacos , Cumplimiento de la Medicación , Intervención Coronaria Percutánea/instrumentación , Inhibidores de Agregación Plaquetaria/uso terapéutico , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Anciano , Anciano de 80 o más Años , Comorbilidad , Trombosis Coronaria/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Inhibidores de Agregación Plaquetaria/efectos adversos , Estudios Prospectivos , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Factores de Riesgo , Fumadores , Fumar/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Percutaneous coronary interventions (PCI) is traditionally a manual procedure executed by one or more operators positioned at a close distance from the patient. The ongoing pandemic of coronavirus disease 2019 (COVID-19) has imposed severe restrictions to such an interventional environment. The novel SARS-CoV-2 virus that causes COVID-19 is transmitted mainly through expelled respiratory particles, which are known to travel approximately 3-6 feet away from infected persons. During PCI, that contamination range obligatorily poses the team and the patient to direct air exposure. We herein present a case report with the description of a minimum-contact strategy to reduce interpersonal air exposure during PCI. The approach designed to minimize proximity between the patient and the healthcare team included the performance of robotic-assisted PCI, operated by unscrubbed cardiac interventionalists from a control cockpit located outside the catheterization suite. Also included, was the delineation of the potential zone of respiratory particle spread; a circle measuring 4 meters (13.1 feet) in diameter was traced on the floor of the cath lab with red tape, centered on the patient's mouth and nose. The team was rigorously trained and advised to minimize time spent within the 4-meter perimeter as much as possible during the procedure. Following this strategy, a 60-year-old male with non-ST-elevation myocardial infarction and COVID-19 was treated with successful coronary implantation of two stents in the obtuse marginal branch and one stent in the circumflex artery. The total duration of the procedure was 103 minutes and 22 seconds. During most of the procedure, the 4-meter spread zone was not entered by any personnel. For each individual team member, the proposed strategy was effective in ensuring that they stayed outside of the 4-meter area for the majority of their work time, ranging from 96.9% to 59.7% of their respective participation. This case report illustrates the potential of robotic-assisted percutaneous coronary intervention in reducing physical proximity between the team and the patient during the procedure.
RESUMEN
AIMS: Diagnostic and therapeutic tools have a significant impact on morbidity and mortality associated with acute coronary syndromes (ACS). Data about ACS performance measures are scarce in Brazil, and improving its collection is an objective of the Brazilian Registry in Acute Coronary syndromEs (BRACE). METHODS AND RESULTS: The BRACE is a cross-sectional, observational epidemiological registry of ACS patients. Stratified 'cluster sampling' methodology was adopted to obtain a representative picture of ACS. A performance score (PS) varying from 0 to 100 was developed to compare studied parameters. Performance measures alone and the PS were compared between institutions, and the relationship between the PS and outcomes was evaluated. A total of 1150 patients, median age 63 years, 64% male, from 72 hospitals were included in the registry. The mean PS for the overall population was 65.9% ± 20.1%. Teaching institutions had a significantly higher PS (71.4% ± 16.9%) compared with non-teaching hospitals (63.4% ± 21%; P < 0.001). Overall in-hospital mortality was 5.2%, and the variables that correlated independently with in-hospital mortality included: PS-per point increase (OR = 0.97, 95% CI 0.95-0.98, P < 0.001), age-per year (OR = 1.06, 95% CI 1.03-1.09, P < 0.001), chronic kidney disease (OR = 3.12, 95% CI 1.08-9.00, P = 0.036), and prior angioplasty (OR = 0.25, 95% CI 0.07-0.84, P = 0.025). CONCLUSIONS: In BRACE, the adoption of evidence-based therapies for ACS, as measured by the performance score, was independently associated with lower in-hospital mortality. The use of diagnostic tools and therapeutic approaches for the management of ACS is less than ideal in Brazil, with high variability especially among different regions of the country.
Asunto(s)
Síndrome Coronario Agudo/epidemiología , Sistema de Registros , Brasil/epidemiología , Estudios Transversales , Femenino , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Persona de Mediana Edad , Morbilidad/tendencias , Pronóstico , Estudios Prospectivos , Factores de RiesgoRESUMEN
In December 2019, a series of patients with severe pneumonia were identified in Wuhan, Hubei province, China, who progressed to severe acute respiratory syndrome and acute respiratory distress syndrome. Subsequently, COVID-19 was attributed to a new betacoronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Approximately 20% of patients diagnosed as COVID-19 develop severe forms of the disease, including acute hypoxemic respiratory failure, severe acute respiratory syndrome, acute respiratory distress syndrome and acute renal failure and require intensive care. There is no randomized controlled clinical trial addressing potential therapies for patients with confirmed COVID-19 infection at the time of publishing these treatment recommendations. Therefore, these recommendations are based predominantly on the opinion of experts (level C of recommendation).