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1.
N Engl J Med ; 389(26): 2446-2456, 2023 Dec 28.
Artículo en Inglés | MEDLINE | ID: mdl-37952133

RESUMEN

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).


Asunto(s)
Anemia , Transfusión Sanguínea , Infarto del Miocardio , Humanos , Anemia/sangre , Anemia/etiología , Anemia/terapia , Transfusión Sanguínea/métodos , Transfusión de Eritrocitos/efectos adversos , Transfusión de Eritrocitos/métodos , Hemoglobinas/análisis , Infarto del Miocardio/sangre , Infarto del Miocardio/complicaciones , Infarto del Miocardio/mortalidad , Infarto del Miocardio/terapia , Recurrencia
2.
Clin Infect Dis ; 2024 Mar 11.
Artículo en Inglés | MEDLINE | ID: mdl-38466039

RESUMEN

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.

3.
J Nucl Cardiol ; 34: 101786, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38472038

RESUMEN

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.


Asunto(s)
Infecciones Cardiovasculares , Endocarditis , Humanos , Tomografía Computarizada por Tomografía de Emisión de Positrones , Fluorodesoxiglucosa F18 , Consenso , Tomografía Computarizada por Rayos X , Imagen Multimodal , Endocarditis/diagnóstico por imagen , Tomografía Computarizada de Emisión de Fotón Único
4.
Circulation ; 145(2): 97-106, 2022 01 11.
Artículo en Inglés | MEDLINE | ID: mdl-34743530

RESUMEN

BACKGROUND: Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. The DAPT Study (Dual Antiplatelet Therapy) found that longer-duration DAPT decreased ischemic events at the expense of greater bleeding, but subsequent evolution in stent technology and clinical practice may attenuate the benefit of prolonged DAPT in a contemporary population. We evaluated whether the DAPT Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention and estimated the treatment effect of extended-duration antiplatelet therapy after percutaneous coronary intervention in this more contemporary cohort. METHODS: We compared the characteristics of drug-eluting stent-treated patients randomly assigned in the DAPT Study to a sample of more contemporary drug-eluting stent-treated patients in the National Cardiovascular Data Registry CathPCI Registry from July 2016 to June 2017. After linking trial and registry data, we used inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary real-world treatment effect of 30 versus 12 months of DAPT after coronary stent procedures. RESULTS: The US drug-eluting stent-treated trial cohort included 8864 DAPT Study patients, and the registry cohort included 568 540 patients. Compared with the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd-generation drug-eluting stents. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40 [95% CI, -0.99% to 0.15%]), major adverse cardiac and cerebrovascular events (reweighted treatment effect, -0.52 [95% CI, -2.62% to 1.03%]), or myocardial infarction (reweighted treatment effect, -0.97% [95% CI, -2.75% to 0.18%]), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect, 2.42% [95% CI, 0.79% to 3.91%]). CONCLUSIONS: The differences between the patients and devices used in contemporary clinical practice compared with the DAPT Study were associated with the attenuation of benefits and greater harms attributable to prolonged DAPT duration. These findings limit the applicability of the average treatment effects from the DAPT Study in modern clinical practice.


Asunto(s)
Terapia Antiplaquetaria Doble/métodos , Anciano , Femenino , Humanos , Masculino
5.
J Card Fail ; 2023 Nov 10.
Artículo en Inglés | MEDLINE | ID: mdl-37951494

RESUMEN

BACKGROUND: Female sex is frequently cited as a risk factor for anthracycline cardiotoxicity based on pediatric data, but the role of sex in the development of cardiotoxicity has not been clearly established in adults. OBJECTIVES: To assess the effect of female sex on the development of incident heart failure (HF) in adult patients treated with anthracyclines. METHODS: This was a retrospective cohort study of 1525 adult patients with no prior history of HF or cardiomyopathy who were treated with anthracyclines between 1992 and 2019. The primary outcome was new HF within 5 years of the first dose of anthracyclines. The effect of sex was assessed using Cox proportional hazards and competing risk models. RESULTS: Over a median (IQR) follow-up of 1.02 (0.30-3.01) years, 4.78% of patients developed HF (44 men and 29 women). Female sex was not associated with the primary outcome in a multivariable Cox proportional hazards model (HR 0.87; 95% CI 0.53-1.43; P = 0.58). Similar results were observed in a multivariable model accounting for the competing risk of death (HR 0.94; 95% CI 0.39-2.25; P = 0.88). Age, coronary artery disease and hematopoietic stem cell transplant were associated with the primary outcome in a multivariable Cox proportional hazards model. Age and body mass index were associated with the primary outcome in a multivariable competing risk model. CONCLUSIONS: In this large, single-center, retrospective cohort study, female sex was not associated with incident HF in adult patients treated with anthracyclines. CONDENSED ABSTRACT: Female sex is frequently cited as a risk factor for anthracycline cardiotoxicity based on pediatric data, but the role of sex in the development of cardiotoxicity has not been clearly established in adults. In this retrospective cohort study, we assessed the effect of female sex on the development of incident heart failure in adult patients treated with anthracyclines. Using Cox proportional hazards and competing risk regression models, we found that there was no association between female sex and heart failure after treatment with anthracyclines.

6.
Pacing Clin Electrophysiol ; 46(3): 242-250, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36530151

RESUMEN

AIMS: Frailty is associated with increased morbidity and mortality in patients undergoing left atrial appendage closure (LAAC). This study aimed to compare the performance of two claims-based frailty measures in predicting adverse outcomes following LAAC. METHODS: We identified patients 66 years and older who underwent LAAC between October 1, 2016, and December 31, 2019, in Medicare fee-for-service claims. Frailty was assessed using the previously validated Hospital Frailty Risk Score (HFRS) and Kim Claims-based Frailty Index (CFI). Patients were identified as frail based on HFRS ≥5 and CFI ≥0.25. RESULTS: Of the 21,787 patients who underwent LAAC, frailty was identified in 45.6% by HFRS and 15.4% by CFI. There was modest agreement between the two frailty measures (kappa 0.25, Pearson's correlation 0.62). After adjusting for age, sex, and comorbidities, frailty was associated with higher risk of 30-day mortality, 1-year mortality, 30-day readmission, long hospital stay, and reduced days at home (p < .01 for all) regardless of the frailty measure used. The addition of frailty to standard comorbidities significantly improved model performance to predict 1-year mortality, long hospital stay, and reduced days at home (Delong p-value < .001). CONCLUSION: Despite significant variation in frailty detection and modest agreement between the two frailty measures, frailty status remained highly predictive of mortality, readmissions, long hospital stay, and reduced days at home among patients undergoing LAAC. Measuring frailty in clinical practice, regardless of the method used, may provide prognostic information useful for patients being considered for LAAC, and may inform shared decision-making in this population.


Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Procedimientos Quirúrgicos Cardíacos , Fragilidad , Accidente Cerebrovascular , Humanos , Anciano , Estados Unidos/epidemiología , Recién Nacido , Apéndice Atrial/cirugía , Medicare , Procedimientos Quirúrgicos Cardíacos/métodos , Comorbilidad , Fibrilación Atrial/complicaciones , Accidente Cerebrovascular/etiología
7.
Anesth Analg ; 137(3): 618-628, 2023 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-36719955

RESUMEN

BACKGROUND: The recommendation for transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in patients 65 to 80 years of age is equivocal, leaving patients with a difficult decision. We evaluated whether TAVR compared to SAVR is associated with reduced odds for loss of independent living in patients ≤65, 66 to 79, and ≥80 years of age. Further, we explored mechanisms of the association of TAVR and adverse discharge. METHODS: Adult patients undergoing TAVR or SAVR within a large academic medical system who lived independently before the procedure were included. A multivariable logistic regression model, adjusting for a priori defined confounders including patient demographics, preoperative comorbidities, and a risk score for adverse discharge after cardiac surgery, was used to assess the primary association. We tested the interaction of patient age with the association between aortic valve replacement (AVR) procedure and loss of independent living. We further assessed whether the primary association was mediated (ie, percentage of the association that can be attributed to the mediator) by the procedural duration as prespecified mediator. RESULTS: A total of 1751 patients (age median [quartiles; min-max], 76 [67, 84; 23-100]; sex, 56% female) were included. A total of 27% (222/812) of these patients undergoing SAVR and 20% (188/939) undergoing TAVR lost the ability to live independently. In our cohort, TAVR was associated with reduced odds for loss of independent living compared to SAVR (adjusted odds ratio [OR adj ] 0.19 [95% confidence interval {CI}, 0.14-0.26]; P < .001). This association was attenuated in patients ≤65 years of age (OR adj 0.63 [0.26-1.56]; P = .32) and between 66 and 79 years of age (OR adj 0.23 [0.15-0.35]; P < .001), and magnified in patients ≥80 years of age (OR adj 0.16 [0.10-0.25]; P < .001; P -for-interaction = .004). Among those >65 years of age, a shorter procedural duration mediated 50% (95% CI, 28-76; P < .001) of the beneficial association of TAVR and independent living. CONCLUSIONS: Patients >65 years of age undergoing TAVR compared to SAVR had reduced odds for loss of independent living. This association was partly mediated by shorter procedural duration. No association between AVR approach and the primary end point was found in patients ≤65 years of age.


Asunto(s)
Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Masculino , Válvula Aórtica/cirugía , Estudios Retrospectivos , Vida Independiente , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Factores de Riesgo
8.
Curr Opin Cardiol ; 37(5): 389-393, 2022 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-35913366

RESUMEN

PURPOSE OF REVIEW: Ultrasound enhancing agents (UEAs), microbubbles which are composed of lipid or albumin shells containing high molecular weight gases with nonlinear acoustic properties in the ultrasound field, are important components of the diagnostic armamentarium in echocardiography. This review highlights the substantial value of UEAs in delineating endocardial border definition and influencing downstream decision-making in cardiovascular ultrasound. RECENT FINDINGS: In this article, we review recent updates to the clinical applications of UEAs, special circumstances regarding use, the impact of use on downstream testing and cost-effectiveness, and recommended approaches for optimizing workflow in the echocardiography laboratory with UEAs. SUMMARY: In multiple studies, UEAs have been identified as a useful tool in echocardiography, improving study accuracy and reader confidence, while reducing downstream testing and procedures and resulting in significant changes in clinical management. Despite their proven efficacy and cost-effectiveness, recent studies have suggested utilization remains low, in part due to perceived concerns and workflow issues that impair uptake. With an increasingly broader list of indications for echocardiography, UEAs will continue to play an important role in the diagnosis and management of patients with cardiovascular and noncardiovascular diseases.


Asunto(s)
Medios de Contraste , Ecocardiografía , Ecocardiografía/métodos , Humanos , Microburbujas , Ultrasonografía
9.
BMC Med Educ ; 22(1): 863, 2022 Dec 13.
Artículo en Inglés | MEDLINE | ID: mdl-36514029

RESUMEN

BACKGROUND: In response to COVID-19 pandemic state restrictions, our institution deferred elective procedures from 3/15/2020 to 6/13/2020, and removed cardiology fellows from the echocardiography rotation to staff clinical services. We assessed the impact of the COVID-19 pandemic on fellow education and echocardiography volumes. METHODS: Our institutional database was used to examine volumes of transthoracic (TTE), stress (SE), and transesophageal echocardiograms (TEE) from 7/1/2018 to 10/10/2020. Study volumes were compared in three intervals: pre-pandemic (7/1/2018- 3/14/2020), pandemic (3/15/2020-6/13/2020), and pandemic recovery (6/14/2020-10/10/2020). We examined weekly number of TTEs performed or interpreted by cardiology fellows during the study period, and compared these to the two previous academic years. RESULTS: Weekly TTE volume declined by 54% during the pandemic, and increased by 99% during pandemic recovery, (p < 0.05). SE and TEE revealed similar trends. A strong correlation between weekly TTE volume and inpatient admissions was observed during the study period (rs=0.67, p < 0.05). Weekly fellow TTE scans declined by 78% during the pandemic, with a 380% increase during pandemic recovery (p < 0.05). Weekly fellow TTE interpretations declined by 56% during the pandemic, with a 76% increase during pandemic recovery (p < 0.05). CONCLUSION: COVID restrictions between 3/15/2020- 6/14/2020 coincided with a marked decline in TTE, SE, and TEE volumes, with an increase similar to near pre-pandemic volumes during the pandemic recovery period. A similar decline with the onset of COVID restrictions, and increase to pre-restriction volumes thereafter was observed with fellow scans and interpretations, but total academic year fellow training volumes remained depressed. With the ongoing COVID-19 pandemic and rise of multiple variants, training programs may need to adjust fellows' clinical responsibilities so as to support achievement of echocardiography training certification.


Asunto(s)
COVID-19 , Cardiología , Internado y Residencia , Humanos , Pandemias , COVID-19/epidemiología , Ecocardiografía , Cardiología/educación
10.
Circulation ; 142(3): 203-213, 2020 07 21.
Artículo en Inglés | MEDLINE | ID: mdl-32436390

RESUMEN

BACKGROUND: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. METHODS: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). RESULTS: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial's primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65-1.09]; P=0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66-1.11]; P=0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes (Pnoninferiority<0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate, 60.5%), the trial's primary end point was 12.9% for TAVR and 13.1% for SAVR using trial data (hazard ratio, 1.08 [95% CI, 0.79-1.48]; P=0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73-1.41]; P=0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims (Pnoninferiority<0.001 for both). Rates of procedural secondary outcomes (eg, aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than nonprocedural outcomes (eg, stroke, bleeding, cardiogenic shock). CONCLUSIONS: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.


Asunto(s)
Medicare/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Femenino , Encuestas de Atención de la Salud , Humanos , Incidencia , Masculino , Evaluación de Resultado en la Atención de Salud , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estados Unidos/epidemiología
11.
Eur Heart J ; 40(27): 2231-2239, 2019 07 14.
Artículo en Inglés | MEDLINE | ID: mdl-30977798

RESUMEN

AIMS: We sought to identify the prevalence and related outcomes of frail individuals undergoing transcatheter mitral valve repair and transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Patients aged 65 and older were included in the study if they had at least one procedural code for transcatheter mitral valve repair or TAVR between 1 January 2016 and 31 December 2016 in the Centers for Medicare and Medicaid Services Medicare Provider and Review database. The Hospital Frailty Risk Score, an International Classification of Diseases, Tenth Revision (ICD-10) claims-based score, was used to identify frailty and the primary outcome was all-cause 1-year mortality. A total of 3746 (11.6%) patients underwent transcatheter mitral valve repair and 28 531 (88.4%) underwent TAVR. In the transcatheter mitral valve repair and TAVR populations, respectively, there were 1903 (50.8%) and 14 938 (52.4%) patients defined as low risk for frailty (score <5), 1476 (39.4%) and 11 268 (39.5%) defined as intermediate risk (score 5-15), and 367 (9.8%) and 2325 (8.1%) defined as high risk (score >15). One-year mortality was 12.8% in low-risk patients, 29.7% in intermediate-risk patients, and 40.9% in high-risk patients undergoing transcatheter mitral valve repair (log rank P < 0.001). In patients undergoing TAVR, 1-year mortality rates were 7.6% in low-risk patients, 17.6% in intermediate-risk patients, and 30.1% in high-risk patients (log rank P < 0.001). CONCLUSIONS: This study successfully identified individuals at greater risk of short- and long-term mortality after undergoing transcatheter valve therapies in an elderly population in the USA using the ICD-10 claims-based Hospital Frailty Risk Score.


Asunto(s)
Válvula Aórtica/cirugía , Fragilidad/complicaciones , Enfermedades de las Válvulas Cardíacas/complicaciones , Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Válvula Mitral/cirugía , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Humanos , Masculino , Medicare , Reemplazo de la Válvula Aórtica Transcatéter , Resultado del Tratamiento , Estados Unidos
12.
Am Heart J ; 212: 64-71, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30953936

RESUMEN

BACKGROUND: Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes. METHODS AND RESULTS: Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The concordance between baseline and outcomes data collected within nontrial data sets and trial information, including adjudicated end point events, will be assessed. We will compare the study results obtained using these alternative data sources to those derived using trial-ascertained variables and end points using trial-adjudicated end points and covariates. CONCLUSIONS: Linkage of trials to registries and claims data represents an opportunity to use alternative data sources in place of and as adjuncts to randomized clinical trial data but requires further validation. The results of this research will help determine how these data sources can be used to improve our present and future understanding of new medical treatments.


Asunto(s)
Terapia Antiplaquetaria Doble/métodos , Registros Electrónicos de Salud/provisión & distribución , Isquemia Miocárdica/terapia , Revascularización Miocárdica/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Sistema de Registros , Anciano de 80 o más Años , Bases de Datos Factuales , Femenino , Humanos , Masculino , Reproducibilidad de los Resultados
13.
Crit Care Med ; 47(3): e214-e221, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30585830

RESUMEN

OBJECTIVES: Increasing age is a well-recognized risk factor for in-hospital mortality in patients receiving extracorporeal membrane oxygenation for cardiogenic shock, but the shape of this relationship is unknown. In addition, the impact of age on hospital length of stay, patterns of patient disposition, and costs has been incompletely characterized. DESIGN: Retrospective analysis of the National Inpatient Sample. SETTING: U.S. nonfederal hospitals, years 2004-2016. PATIENTS: Adults with cardiogenic shock treated with extracorporeal membrane oxygenation (3,094; weighted national estimate: 15,415). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The mean age of extracorporeal membrane oxygenation recipients was 54.8 ± 15.4 years (range, 18-90 yr). Crude in-hospital mortality was 57.7%. Median time-to-death was 8 days (interquartile range, 3-17 d). A linear relationship between age and in-hospital mortality was observed with a 14% increase in the adjusted odds of in-hospital mortality for every 10-year increase in age (adjusted odds ratio, 1.14; 95% CI, 1.08-1.21; p < 0.0001). Thirty-four percent of patients were discharged alive at a median time of 30 days (interquartile range, 19-48 d). The median length of stay and total hospitalization costs were 14 days (interquartile range, [5-29 d]) and $134,573 ($71,782-$239,439), respectively, both of which differed significantly by age group (length of stay range from 17 d [18-49 yr] to 9 d [80-90 yr]; p < 0.0001 and cost range $147,548 [18-49 yr] to $105,350 [80-90 yr]; p < 0.0001). CONCLUSIONS: Age is linearly associated with increasing in-hospital mortality in individuals receiving extracorporeal membrane oxygenation for cardiogenic shock without evidence of a threshold effect. Median time-to-death is approximately 1 week. One third of patients are discharged from the hospital alive, but the median time-to-discharge is 1 month. Median length of stay ranges from 9 to 17 days depending on age. Hospitalization costs exceed $100,000 in all age groups.


Asunto(s)
Oxigenación por Membrana Extracorpórea , Costos de Hospital/estadística & datos numéricos , Tiempo de Internación/estadística & datos numéricos , Choque Cardiogénico/terapia , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Oxigenación por Membrana Extracorpórea/economía , Oxigenación por Membrana Extracorpórea/mortalidad , Oxigenación por Membrana Extracorpórea/estadística & datos numéricos , Femenino , Mortalidad Hospitalaria , Humanos , Tiempo de Internación/economía , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Choque Cardiogénico/economía , Choque Cardiogénico/mortalidad , Estados Unidos , Adulto Joven
14.
Ann Intern Med ; 168(9): 631-639, 2018 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-29582086

RESUMEN

Background: Readmission rates after hospitalizations for heart failure (HF), acute myocardial infarction (AMI), and pneumonia among Medicare beneficiaries are used to assess quality and determine reimbursement. Whether these measures reflect readmission rates for other conditions or insurance groups is unknown. Objective: To investigate whether hospital-level 30-day readmission measures for publicly reported conditions (HF, AMI, and pneumonia) among Medicare patients reflect those for Medicare patients hospitalized for unreported conditions or non-Medicare patients hospitalized with HF, AMI, or pneumonia. Design: Cross-sectional. Setting: Population-based. Participants: Hospitals in the all-payer Nationwide Readmissions Database in 2013 and 2014. Measurements: Hospital-level 30-day all-cause risk-standardized excess readmission ratios (ERRs) were compared for 3 groups of patients: Medicare beneficiaries admitted for HF, AMI, or pneumonia (Medicare reported group); Medicare beneficiaries admitted for other conditions (Medicare unreported group); and non-Medicare beneficiaries admitted for HF, AMI, or pneumonia (non-Medicare group). Results: Within-hospital differences in ERRs varied widely among groups. Medicare reported ratios differed from Medicare unreported ratios by more than 0.1 for 29% of hospitals and from non-Medicare ratios by more than 0.1 for 46% of hospitals. Among hospitals with higher readmission ratios, ERRs for the Medicare reported group tended to overestimate ERRs for the non-Medicare group but underestimate those for the Medicare unreported group. Limitation: Medicare groups and risk adjustment differed slightly from those used by the Centers for Medicare & Medicaid Services. Conclusion: Hospital ERRs, as estimated by Medicare to determine financial penalties, have poor agreement with corresponding measures for populations and conditions not tied to financial penalties. Current publicly reported measures may not be good surrogates for overall hospital quality related to 30-day readmissions. Primary Funding Source: Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology.


Asunto(s)
Economía Hospitalaria/estadística & datos numéricos , Hospitales/estadística & datos numéricos , Reembolso de Seguro de Salud , Readmisión del Paciente/economía , Readmisión del Paciente/estadística & datos numéricos , Estudios Transversales , Insuficiencia Cardíaca/terapia , Hospitales/normas , Humanos , Medicare/economía , Infarto del Miocardio/terapia , Neumonía/terapia , Mejoramiento de la Calidad , Estados Unidos
15.
Catheter Cardiovasc Interv ; 91(5): 832-839, 2018 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-28766924

RESUMEN

OBJECTIVES: Factors associated with performing urgent coronary angiography (UCA) in patients with out-of-hospital cardiac arrest (OHCA) were identified. BACKGROUND: Current guidelines for resuscitated OHCA patients recommend UCA if there is ST-elevation on post-arrest electrocardiogram or high suspicion of acute myocardial infarction. Some have advocated for UCA in all OHCA regardless of suspected etiology. The reasons for variations in performing UCA are not well understood. METHODS: A retrospective analysis of subjects presenting with resuscitated OHCA to a single academic medical center from 12/15/2007 to 8/31/2014 was conducted. Demographic and clinical characteristics of patients undergoing UCA, defined as angiography within 6 hr of presentation, were compared with those not undergoing UCA. Logistic regression was used to determine predictors of UCA. RESULTS: A total of 323 resuscitated OHCA patients (mean age, 64 years; women, 35%) were included in the analysis; 107 (33.1%) underwent coronary angiography during their hospitalization and 66 (20.4%) underwent UCA. Multivariable adjusted factors associated with UCA were ST-elevation [odds ratio (OR) 14.66, 95% confidence interval (CI) 6.28-34.24, P < 0.001], initial shockable rhythm (OR 3.69, 95% CI 1.52-8.97, P = 0.004), and history of coronary artery disease (CAD) (OR 3.37, 95% CI 1.43-7.95, P = 0.005). Higher age (OR 0.71 per decade, 95% CI 0.55-0.92, P = 0.01) and obvious non-cardiac cause of arrest (OR 0.08, 95% CI 0.02-0.38, P = 0.001) were negatively associated with UCA. CONCLUSIONS: In resuscitated out-of-hospital cardiac arrest patients, ST-elevation, shockable rhythm, and history of CAD were associated with performing urgent coronary angiography; older patients and those with obvious non-cardiac causes of arrest were negatively associated.


Asunto(s)
Toma de Decisiones Clínicas , Angiografía Coronaria , Paro Cardíaco Extrahospitalario/diagnóstico por imagen , Selección de Paciente , Centros Médicos Académicos , Anciano , Anciano de 80 o más Años , Boston , Reanimación Cardiopulmonar , Electrocardiografía , Femenino , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Paro Cardíaco Extrahospitalario/etiología , Paro Cardíaco Extrahospitalario/fisiopatología , Paro Cardíaco Extrahospitalario/terapia , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo
18.
Europace ; 16(10): 1508-14, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-24906607

RESUMEN

AIMS: To determine the incidence and predictors of atrial fibrillation (AF) and its impact on survival in patients with other forms of supraventricular arrhythmias (SVAs) including atrial flutter (AFL), atrial tachycardia (AT), atrioventricular reentrant (AVRT), and AV nodal reentrant tachycardia (AVNRT). We hypothesized that SVA may increase risk of AF and concomitant AF may influence long-term survival. METHODS AND RESULTS: All patients who underwent catheter ablation for SVA from 2000 to 2010 were included in this study. The patients were identified retrospectively and the vital status determined prospectively. Observed survival in the study cohort was compared with survival rates in the age- and sex-matched general population. The study group included 1573 patients (mean age 50.5 ± 18 years, 47% female) with AVNRT (38.5%), AFL (29.6%), AVRT (22.6%) and AT (9.3%). The patients were followed for a mean of 35 months (median 23 months). Atrial fibrillation was documented in 424 patients (27%) with a higher incidence in males (35 vs. 18%). Atrial fibrillation was present in 19.6% of patients before the ablation and developed in 9.07% after ablation. Atrial fibrillation commonly occurred in patients with AFL (57.5%), AT (27.4%), AVRT (13.5%), and AVNRT (9.7%). Older age, prolonged PR interval, dilated left atrium, low left ventricular ejection fraction and presence of AFL were independent predictors for concomitant AF. Long-term survival was worse in the presence of AF. CONCLUSION: The incidence of AF is high in patients with other forms of SVA. The most common association is between AFL and AF. Long-term survival is decreased in those who have concomitant AF, although AF did not emerge as an independent predictor of mortality when adjusted for other covariates.


Asunto(s)
Fibrilación Atrial/epidemiología , Fibrilación Atrial/etiología , Aleteo Atrial/complicaciones , Aleteo Atrial/cirugía , Ablación por Catéter , Comorbilidad , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Tasa de Supervivencia , Taquicardia por Reentrada en el Nodo Atrioventricular/complicaciones , Taquicardia por Reentrada en el Nodo Atrioventricular/cirugía , Taquicardia Supraventricular/complicaciones , Taquicardia Supraventricular/cirugía
19.
Echo Res Pract ; 11(1): 3, 2024 Feb 07.
Artículo en Inglés | MEDLINE | ID: mdl-38321564

RESUMEN

BACKGROUND: Ultrasound enhancing agents (UEAs) are an invaluable adjunct to stress and transthoracic echocardiography (STE) to improve left ventricular visualization. Despite multiple single center studies evaluating UEA use, investigation into the rates, sources of variation, and outcomes of UEA use on a national level in the United States (US) has been limited by lack of validation of UEA codes for claims analyses. METHODS: We conducted a retrospective cross-sectional study, 2019-2022, using linked multicenter electronic medical record (EMR) data from > 30 health systems linked to all-payor claims data representing > 90% of the US population. Individuals receiving STE in both EMR and claims data on the same day during the study window were included. UEA receipt as identified by presence of a Current Procedural Terminology (CPT) or National Drug Code (NDC) for UEA use within 1-day of the index STE event. We evaluated the performance of claims to identify UEA use, using EMR data as the gold standard, stratified by inpatient and outpatient status. RESULTS: Amongst 54,525 individuals receiving STE in both EMR and claims data, 12,853 (23.6%) had a UEA claim in EMR, 10,461 (19.2%) had a UEA claim in claims, and 9140 (16.8%) had a UEA claim in both within the 1-day window. The sensitivity, specificity, accuracy, positive, and negative predictive values for UEA claims were 71.1%, 96.8%, 90.8%, 87.4%. and 91.6% respectively. However, amongst inpatients, the sensitivity of UEA claims was substantially lower (6.8%) compared to outpatients (79.7%). CONCLUSIONS: While the overall accuracy of claims to identify UEA use was high, there was substantial under-capture of UEA use by claims amongst inpatients. These results call into question published rates of UEA use amongst inpatients in studies using administrative claims, and highlight ongoing need to improve inpatient coding for UEA use.

20.
J Am Heart Assoc ; 13(8): e034029, 2024 Apr 16.
Artículo en Inglés | MEDLINE | ID: mdl-38567667

RESUMEN

BACKGROUND: Normalization of echocardiographic chamber measurements for body surface area may result in misclassification of individuals with obesity or sarcopenia. Normalization for alternative measures of body size may be preferable, but there remains a dearth of information on their normative values and association with cardiovascular function metrics. METHODS AND RESULTS: A total of 3032 individuals underwent comprehensive 2-dimensional echocardiography at Exam 6 in MESA (Multi-Ethnic Study of Atherosclerosis). In the subgroup of 608 individuals free of cardiopulmonary disease (69.5±7.0 years, 46% male, 48% White, 17% Chinese, 15% Black, 21% Hispanic), normative values were derived for left and right cardiac chamber measurements across a variety of ratiometric (body surface area, body mass index, height) and allometric (height1.6, height2.7) scaling parameters. Normative upper and lower reference values were provided for each scaling parameter stratified across age groups, sex, and race or ethnicity. Among scaling parameters, body surface area and height were associated with the least variability across race and ethnicity categories and height2.7 was associated with the least variability across sex categories. CONCLUSIONS: In this diverse cohort of community-dwelling older adults, we provide normative values for common echocardiographic parameters across a variety of indexation methods.


Asunto(s)
Aterosclerosis , Ventrículos Cardíacos , Humanos , Masculino , Anciano , Femenino , Valores de Referencia , Ecocardiografía/métodos , Etnicidad , Aterosclerosis/diagnóstico por imagen
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