Showing papers by "Leslee J. Shaw published in 2018"

Effects of Statins on Coronary Atherosclerotic Plaques: The PARADIGM Study

Abstract: OBJECTIVES:This study sought to describe the impact of statins on individual coronary atherosclerotic plaques. BACKGROUND:Although statins reduce the risk of major adverse cardiovascular events, their long-term effects on coronary atherosclerosis remain unclear. METHODS:We performed a prospective, multinational study consisting of a registry of consecutive patients without history of coronary artery disease who underwent serial coronary computed tomography angiography at an interscan interval of ≥2 years. Atherosclerotic plaques were quantitatively analyzed for percent diameter stenosis (%DS), percent atheroma volume (PAV), plaque composition, and presence of high-risk plaque (HRP), defined by the presence of ≥2 features of low-attenuation plaque, positive arterial remodeling, or spotty calcifications. RESULTS:Among 1,255 patients (60 ± 9 years of age; 57% men), 1,079 coronary artery lesions were evaluated in statin-naive patients (n = 474), and 2,496 coronary artery lesions were evaluated in statin-taking patients (n = 781). Compared with lesions in statin-naive patients, those in statin-taking patients displayed a slower rate of overall PAV progression (1.76 ± 2.40% per year vs. 2.04 ± 2.37% per year, respectively; p = 0.002) but more rapid progression of calcified PAV (1.27 ± 1.54% per year vs. 0.98 ± 1.27% per year, respectively; p 50% DS were not different (1.0% vs. 1.4%, respectively; p > 0.05). Statins were associated with a 21% reduction in annualized total PAV progression above the median and 35% reduction in HRP development. CONCLUSIONS:Statins were associated with slower progression of overall coronary atherosclerosis volume, with increased plaque calcification and reduction of high-risk plaque features. Statins did not affect the progression of percentage of stenosis severity of coronary artery lesions but induced phenotypic plaque transformation. (Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging [PARADIGM]; NCT02803411).

Sex differences in calcified plaque and long-term cardiovascular mortality: observations from the CAC Consortium.

Abstract: Author(s): Shaw, Leslee J; Min, James K; Nasir, Khurram; Xie, Joe X; Berman, Daniel S; Miedema, Michael D; Whelton, Seamus P; Dardari, Zeina A; Rozanski, Alan; Rumberger, John; Bairey Merz, C Noel; Al-Mallah, Mouaz H; Budoff, Matthew J; Blaha, Michael J | Abstract: AimsPathologic evidence supports unique sex-specific mechanisms as precursors for acute cardiovascular (CV) events. Current evidence on long-term CV risk among women when compared with men based on measures of coronary artery calcium (CAC) remains incomplete.Methods and resultsA total of 63 215 asymptomatic women and men were enrolled in the multicentre, CAC Consortium with median follow-up of 12.6 years. Pooled cohort equation (PCE) risk scores and risk factor data were collected with the Agatston score and other CAC measures (number of lesions and vessels, lesion size, volume, and plaque density). Cox proportional hazard models were employed to estimate CV mortality (n = 919). Sex interactions were calculated. Women and men had average PCE risk scores of 5.8% and 9.1% (P l 0.001). Within CAC subgroups, women had fewer calcified lesions (P l 0.0001) and vessels (P = 0.017), greater lesion size (P l 0.0001), and higher plaque density (P = 0.013) when compared with men. For women and men without CAC, long-term CV mortality was similar (P = 0.67), whereas detectable CAC was associated with 1.3-higher hazard for CV death among women when compared with men (P l 0001). Cardiovascular mortality was higher among women with more extensive, numerous, or larger CAC lesions. The relative hazard for cardiovascular disease (CVD) mortality for women and men was 8.2 vs. 5.1 for multivessel CAC, 8.6 vs. 5.9 for ≥5 CAC lesions, and 8.5 vs. 4.4 for a lesion size ≥15 mm3, respectively. Additional explorations revealed that women with larger sized and more numerous CAC lesions had 2.2-fold higher CVD mortality (P l 0.0001) as compared to men. Moreover, CAC density was not predictive of CV mortality in women (P = 0.51) but was for men (P l 0.001), when controlling for CAC volume and cardiac risk factors.ConclusionOur overall findings support that measures beyond the Agatston score provide important clues to sex differences in atherosclerotic plaque and may further refine risk detection and focus preventive strategies of care.

Quantification of Coronary Atherosclerosis in the Assessment of Coronary Artery Disease

Abstract: Background: Diagnosis of coronary artery disease and management strategies have relied solely on the presence of diameter stenosis ≥50%. We assessed whether direct quantification of plaque burden (...

Natural History of Diabetic Coronary Atherosclerosis by Quantitative Measurement of Serial Coronary Computed Tomographic Angiography: Results of the PARADIGM Study

Abstract: Objectives This study aimed to determine the rate and extent of plaque progression (PP), changes in plaque features, and clinical predictors of PP in patients with diabetes mellitus (DM). Background The natural history of coronary PP in patients with DM is not well established. Methods A total of 1,602 patients (age 61.3 ± 9.0 years; 60.3% men; median scan interval 3.8 years) who underwent serial coronary computed tomography angiography over a period of at least 24 months were enrolled and analyzed from the PARADIGM (Progression of Atherosclerotic Plaque Determined by Computed Tomographic Angiography Imaging) trial. Study endpoints were changes in plaque features in diabetics with PP and risk factors for PP by serial coronary computed tomography angiography between patients with and without DM. PP was defined if plaque volume at follow-up minus plaque volume at baseline was >0. Results DM was an independent risk factor for PP (84.6%; 276 of 326 patients with PP) in multivariate analysis (odds ratio [OR]: 1.526; 95% confidence interval [CI]: 1.100 to 2.118; p = 0.011). Independent risk factors for PP in patients with DM were male sex (OR: 1.485; 95% CI: 1.003 to 2.199; p = 0.048) and mean plaque burden at baseline ≥75% (OR: 3.121; 95% CI: 1.701 to 5.725; p ≤0.001). After propensity matching, percent changes in overall plaque volume (30.3 ± 36.9% in patients without DM and 36.0 ± 29.7% in those with DM; p = 0.032) and necrotic core volume (−7.0 ± 35.8% in patients without DM and 21.5 ± 90.5% in those with DM; p = 0.007) were significantly greater in those with DM. The frequency of spotty calcification, positive remodeling, and burden of low-attenuation plaque were significantly greater in patients with DM. Conclusions People with DM experience greater PP, particularly significantly greater progression in adverse plaque, than those without DM. Male sex and mean plaque burden >75% at baseline were identified as independent risk factors for PP.

High-Sensitivity Troponin I Levels and Coronary Artery Disease Severity, Progression, and Long-Term Outcomes.

Abstract: Background The associations between high‐sensitivity troponin I (hsTnI) levels and coronary artery disease (CAD) severity and progression remain unclear. We investigated whether there is an association between hsTnI and angiographic severity and progression of CAD and whether the predictive value of hsTnI level for incident cardiovascular outcomes is independent of CAD severity. Methods and Results In 3087 patients (aged 63±12 years, 64% men) undergoing cardiac catheterization without evidence of acute myocardial infarction, the severity of CAD was calculated by the number of major coronary arteries with ≥50% stenosis and the Gensini score. CAD progression was assessed in a subset of 717 patients who had undergone ≥2 coronary angiograms >3 months before enrollment. Patients were followed up for incident all‐cause mortality and incident cardiovascular events. Of the total population, 11% had normal angiograms, 23% had nonobstructive CAD, 20% had 1‐vessel CAD, 20% had 2‐vessel CAD, and 26% had 3‐vessel CAD. After adjusting for age, sex, race, body mass index, smoking, hypertension, diabetes mellitus history, and renal function, hsTnI levels were independently associated with the severity of CAD measured by the Gensini score (log 2 s=0.31; 95% confidence interval, 0.18–0.44; P P =0.001). hsTnI level was also a significant predictor of incident death, cardiovascular death, myocardial infarction, revascularization, and cardiac hospitalizations, independent of the aforementioned covariates and CAD severity. Conclusions Higher hsTnI levels are associated with the underlying burden of coronary atherosclerosis, more rapid progression of CAD, and higher risk of all‐cause mortality and incident cardiovascular events. Whether more aggressive treatment aimed at reducing hsTnI levels can modulate disease progression requires further investigation.

Race/Ethnicity and the Prognostic Implications of Coronary Artery Calcium for All-Cause and Cardiovascular Disease Mortality: The Coronary Artery Calcium Consortium.

Abstract: Background Coronary artery calcium (CAC) predicts cardiovascular disease (CVD) events; however, less is known about how its prognostic implications vary by race/ethnicity. Methods and Results A tot...

Comparison of the Association Between High-Sensitivity Troponin I and Adverse Cardiovascular Outcomes in Patients With Versus Without Chronic Kidney Disease.

Abstract: It is unknown whether the association of high-sensitivity troponin I (hs-TnI) with adverse cardiovascular outcomes varies by the presence of chronic kidney disease (CKD). We examined the association of hs-TnI with adverse cardiovascular outcomes in those with and without CKD in 4,107 (mean age, 64 years; 63% men; 20% black) patients from the Emory Cardiovascular Biobank who underwent coronary angiography. CKD (n = 1,073) was defined as estimated glomerular filtration rate 30 mg/g at baseline. Cox regression was used to compute hazard ratios (HR) for the association between hs-TnI levels (per doubling of hs-TnI: log2[hs-TnI] + 1) and death, cardiovascular death, and major adverse cardiac events (MACE), separately. Hs-TnI was a stronger predictor of death (CKD: HR 1.23, 95% confidence interval [CI] 1.15 to 1.31; no CKD: HR 1.11, 95% CI 1.05 to 1.17, p-interaction = 0.023), cardiovascular death (CKD: HR 1.24, 95% CI 1.14 to 1.34; no CKD: HR 1.15, 95% CI 1.07 to 1.22, p-interaction = 0.12), and MACE (CKD: HR 1.18, 95% CI 1.11 to 1.25; no CKD: HR 1.11, 95% CI 1.06 to 1.16, p-interaction = 0.095) in CKD compared with non-CKD. The association between hs-TnI and death in patients with CKD was stronger for patients without obstructive coronary artery disease (no obstructive coronary artery disease: HR 1.60, 95% CI 1.27 to 2.01; obstructive coronary artery disease: HR 1.19, 95% CI 1.11 to 1.27, p-interaction = 0.041). In conclusion, hs-TnI is a stronger predictor of adverse cardiovascular events in patients who have CKD than those without, even in the absence of obstructive coronary artery disease. Hs-TnI may identify CKD patients who are high risk for adverse cardiovascular outcomes in whom aggressive risk factor modification strategies are warranted.

Is There an Age When Myocardial Perfusion Imaging May No Longer Be Prognostically Useful

Abstract: Background: Heart disease continues to be the leading cause of death, and the prevalence of coronary artery disease is expected to increase as the population ages. It is important to understand the...

Progress in Cardiovascular Imaging

Abstract: We once again present an overview of the progress in cardiovascular imaging as seen through the pages of JACC: Cardiovascular Imaging . Your Journal continues to witness some of the most important advances in cardiovascular imaging and we have tried to showcase as many of the best papers as possible

Prognostic value of vasodilator response using rubidium-82 positron emission tomography myocardial perfusion imaging in patients with coronary artery disease

Abstract: Prognostic value of positron emission tomography (PET) myocardial perfusion imaging (MPI) is well established. There is paucity of data on how the prognostic value of PET relates to the hemodynamic response to vasodilator stress. We hypothesize that inadequate hemodynamic response will affect the prognostic value of PET MPI. Using a multicenter rubidium (Rb)-82 PET registry, 3406 patients who underwent a clinically indicated rest/stress PET MPI with a vasodilator agent were analyzed. Patients were categorized as, “responders” [increase in heart rate ≥ 10 beats per minute (bpm) and decrease in systolic blood pressure (SBP) ≥10 mmHg], “partial responders” (either a change in HR or SBP), and “non-responders” (no change in HR or SBP). Primary outcome was all-cause death (ACD), and secondary outcome was cardiac death (CD). Ischemic burden was measured using summed stress score (SSS) and % left ventricular (LV) ischemia. After a median follow-up of 1.68 years (interquartile range = 1.17- 2.55), there were 7.9% (n = 270) ACD and 2.6% (n = 54) CD. Responders with a normal PET MPI had an annualized event rate (AER) of 1.22% (SSS of 0–3) and 1.58% (% LV ischemia = 0). Partial and non-responders had higher AER with worsening levels of ischemic burden. In the presence of severe SSS ≥12 and LV ischemia of ≥10%, partial responders had an AER of 10.79% and 10.36%, compared to non-responders with an AER of 19.4% and 12.43%, respectively. Patient classification was improved when SSS was added to a model containing clinical variables (NRI: 42%, p < 0.001) and responder category was added (NRI: 61%, p < 0.001). The model including clinical variables, SSS and hemodynamic response has good discrimination ability (Harrell C statistics: 0.77 [0.74–0.80]). Hemodynamic response during a vasodilator Rb-82 PET MPI is predictive of ACD. Partial and non-responders may require additional risk stratification leading to altered patient management.

Errors in Electronic Health Record-Based Data Query of Statin Prescriptions in Patients With Coronary Artery Disease in a Large, Academic, Multispecialty Clinic Practice.

Abstract: Background With the recent implementation of the Medicare Quality Payment Program, providers face increasing accountability for delivering high‐quality care. Such pay‐for‐performance programs aim to leverage systematic data captured by electronic health record (EHR) systems to measure performance; however, the fidelity of EHR query for assessing performance has not been validated compared with manual chart review. We sought to determine whether our institution9s methodology of EHR query could accurately identify cases in which providers failed to prescribe statins for eligible patients with coronary artery disease. Methods and Results A total of 9459 patients with coronary artery disease were seen at least twice at the Emory Clinic between July 2014 and June 2015, of whom 1338 (14.1%, 95% confidence interval 13.5–14.9%) had no statin prescription or exemption per EHR query. A total of 120 patient cases were randomly selected and reviewed by 2 physicians for further adjudication. Of the 120 cases initially classified as statin prescription failures, only 21 (17.5%; 95% confidence interval, 11.7–25.3%) represented true failure following physician review. Conclusions Sole reliance on EHR data query to measure quality metrics may lead to significant errors in assessing provider performance. Institutions should be cognizant of these potential sources of error, provide support to medical providers, and form collaborative data management teams to promote and improve meaningful use of EHRs. We propose actionable steps to improve the accuracy of EHR data query that require hypothesis testing and prospective validation in future studies.

Patient Selection Criteria for Diagnostic Imaging for Ischemic Heart Disease: Desperately in Need of Revision.

Abstract: ![Figure][1] ![Figure][1] Over the past decade, the field of noninvasive imaging for ischemic heart disease (IHD) has been transformed by an increasing amount of high-quality evidence to support newer imaging technology, such as coronary computed tomography (CT) angiography, and to

Ensuring safety and protecting patients from unnecessary harm.

Abstract: Radiation safety is an essential element of high-quality imaging practice, a core domain on a par with timely, equitable, and effective use of a diagnostic procedure. Technological innovation in cardiovascular imaging has been dramatic,with constantly improving techniques replacing older approaches; the result is a field in constant evolution whereby the tools available to the practising clinician are innumerable. For imaging procedures, such as nuclear, invasive angiography, and computed tomographic (CT) imaging that expose patients to ionizing radiation, the impact of technological innovation and the ensuing increased utilization patterns broaden exposure levels across our adult populations. The progressive efforts toward technological innovation create conflict between greater population exposure and the need for intensifying dose reduction practices, thus creating a fundamental need for tracking radiation safety on a population level. Within the imaging community, patient safety initiatives have focused on two approaches, namely the development of novel dose reduction strategies and eliminating inappropriate or unnecessary use of cardiovascular imaging procedures. As the clinical effectiveness evidence has evolved dramatically in the field of cardiovascular imaging, technological innovation has also evolved, with novel approaches introduced to improve safety and replace outdated modes of imaging associated with higher radiation exposure levels. Positron emission tomography (PET) is a great example of a perfusion imaging modality using radioisotopes with effective doses generally lower than that of single photon emission computed tomography (SPECT). For the field of cardiovascular CT imaging, technological innovation on radiation dose reduction strategies has successfully led to markedly lower, patient-specific effective doses. To date, the widespread implementation of dose reduction strategies and the aggregate evaluation of safety on a population level has yet to be fully evaluated. In this issue of the European Heart Journal, the results from the PROTECTION VI (Prospective Multicenter Registry on RadiaTion Dose Estimates of Cardiac CT AngIOgraphy IN Daily Practice in 2017) trial are published. This group of investigators have been at the forefront of cutting-edge research in radiation use in CT and, now, with the PROTECTION VI trial, focus on the importance of implementation of radiation dose reduction techniques at the population level and propose a new safety threshold for CT. This trial reports on patient safety data from 60 imaging centres worldwide, including 32 countries; with the reported results on a par with the recently published International Atomic Energy Agency-sponsored Nuclear Cardiology Protocols Cross-Sectional Study (INCAPS) of SPECT imaging. When compared with a worldwide survey of SPECT where the median effective dose was 10.4 mSv, marked reductions in radiation doses were observed for CT imaging around the world. In fact, from the PROTECTION VI trial, the median dose–length product was reduced 78% over the past decade, such that now the median effective dose for CT is 5.1 mSv; half that reported for SPECT imaging. Importantly, the range of exposures to ionizing radiation between the different modalities is unnecessarily wide. This observation of improved population safety from the PROTECTION VI trial should prompt a shift in healthcare policies to limit higher exposures and provide broader support for imaging techniques capable of aggressive reduction in doses, such as is achievable with CT or PET imaging. In the field of cardiovascular imaging, radiation scientists have been hard at work providing numerous techniques for radiation dose reduction, but the evidence as to how commonly these practices are implemented is limited. At the core of the PROTECTION VI trial is a focus on implementation science or the assimilation of evidence-based standards into everyday clinical imaging. Based on the observed marked reduction in radiation exposure with CT over the past decade from the PROTECTION VI trial, it appears that the novel dose reduction techniques available to the practising imager can be easily implemented and benefit patients worldwide. However, this investigative group also devised a metric for radiological risk management, the dose

Appropriate use of noninvasive ischemia testing to guide revascularization decision making following acute ST elevation myocardial infarction in Latin American countries: Results from an expert panel meeting of the International Atomic Energy Agency.

Abstract: Across Latin American and Caribbean countries, cardiovascular disease and especially ischemic heart disease is currently the main cause of death both in men and in women. For most Latin American and Caribbean countries, public and community health efforts aim to define care strategies which are both clinically and cost effective and promote primary and secondary prevention, resulting in improved patient outcomes. The optimal approach to deal with acute events such as ST-elevation myocardial infarction (STEMI) is a matter of controversy; however, there is an expanding role for assessing residual ischemic burden in STEMI patients following primary percutaneous coronary intervention. Although randomized clinical trials have established the value of staged fractional flow reserve-guided revascularization, the use of noninvasive functional imaging modalities may play a similar role at a much lower cost. For LAC, available stress imaging techniques could be applied to define residual ischemia in the non-infarct related artery and to target revascularization in a staged procedure after primary percutaneous coronary intervention The use of nuclear cardiac imaging, supported by its relatively wide availability, moderate cost, and robust quantitative capabilities, may serve to guide effective care and to reduce subsequent cardiac events in patients with coronary artery disease. This noninvasive approach may avert potential safety issues with repeat and lengthy invasive procedures, and serve as a baseline for subsequent follow-up stress testing following the index STEMI event. This consensus document was devised from an expert panel meeting of the International Atomic Energy Agency, highlighting available evidence with a focus on the utility of stress myocardial perfusion imaging in post-STEMI patients. The document could serve as guidance to the prudent and appropriate use of nuclear imaging for targeting therapeutic management and avoiding unnecessary invasive procedures within Latin American and Caribbean countries, where resources could be scarce.

Uso adecuado de las pruebas no invasivas de isquemia para guiar la toma de decisión sobre revascularización tras un infarto agudo de miocardio con elevación del segmento ST en países iberoamericanos: Resultados de la reunión de un panel de expertos de la International Atomic Energy Agency

Abstract: Resumen En los paises iberoamericanos y caribenos las cardiopatias, y en especial las cardiopatias isquemicas, constituyen la causa principal de muerte tanto en varones como en mujeres. En muchos de estos paises los esfuerzos sobre salud publica y comunitaria tratan de definir las estrategias de cuidados que sean efectivas desde los puntos de vista clinico y de costes, promuevan la prevencion primaria y secundaria, y redunden en la mejora de los resultados de los pacientes. El enfoque optimo para el tratamiento de episodios agudos tales como el infarto de miocardio con elevacion del segmento ST (IAMCEST) es una cuestion controvertida; sin embargo, el papel de la valoracion de la carga isquemica residual en los pacientes de IAMCEST tras una intervencion coronaria percutanea primaria se encuentra en expansion. Aunque los ensayos clinicos aleatorizados han establecido el valor de la revascularizacion guiada por la reserva de flujo fraccional escalonada, el uso de tecnicas de imagen funcionales no invasivas puede jugar un papel similar a mucho menor coste. Para los pacientes iberoamericanos y caribenos, podrian aplicarse las tecnicas disponibles de imagenes de estres para definir la isquemia residual en la arteria no infartada y orientar la revascularizacion en un procedimiento escalonado tras una intervencion coronaria percutanea primaria. El uso de imagen cardiaca nuclear, respaldado por su disponibilidad relativamente amplia, coste moderado y capacidades cuantitativas solidas, puede servir de guia a una atencion efectiva y reducir los episodios cardiacos subsiguientes en pacientes con cardiopatia coronaria. Esta tecnica no invasiva puede evitar las cuestiones de seguridad potenciales de los procedimientos invasivos prolongados y repetidos, y servir de referencia para las pruebas subsiguientes de estres tras el episodio de IAMCEST inicial. Este documento de consenso fue disenado por la reunion del panel de expertos de la International Atomic Energy Agency y destaca la evidencia disponible centrada en la utilidad de la imagen de perfusion miocardica de estres en pacientes post-IAMCEST. El documento podria servir como guia para el uso prudente y adecuado de la imagen nuclear orientada a la gestion terapeutica, a fin de evitar los procedimientos invasivos innecesarios en los paises iberoamericanos y caribenos, en los que los recursos podrian ser escasos.