Publications by authors named "Véronique L Roger"

333 Publications

Epidemiology of Heart Failure: A Contemporary Perspective.

Circ Res 2021 May 13;128(10):1421-1434. Epub 2021 May 13.

Department of Quantitative Health Sciences and Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Now at Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health. Véronique L Roger, MD, MPH is now at Chief, Epidemiology and Community Health Branch National Heart, Lung and Blood Institute, National Institutes of Health.

Designated as an emerging epidemic in 1997, heart failure (HF) remains a major clinical and public health problem. This review focuses on the most recent studies identified by searching the Medline database for publications with the subject headings HF, epidemiology, prevalence, incidence, trends between 2010 and present. Publications relevant to epidemiology and population sciences were retained for discussion in this review after reviewing abstracts for relevance to these topics. Studies of the epidemiology of HF over the past decade have improved our understanding of the HF syndrome and of its complexity. Data suggest that the incidence of HF is mostly flat or declining but that the burden of mortality and hospitalization remains mostly unabated despite significant ongoing efforts to treat and manage HF. The evolution of the case mix of HF continues to be characterized by an increasing proportion of cases with preserved ejection fraction, for which established effective treatments are mostly lacking. Major disparities in the occurrence, presentation, and outcome of HF persist particularly among younger Black men and women. These disturbing trends reflect the complexity of the HF syndrome, the insufficient mechanistic understanding of its various manifestations and presentations and the challenges of its management as a chronic disease, often integrated within a context of aging and multimorbidity. Emerging risk factors including omics science offer the promise of discovering new mechanistic pathways that lead to HF. Holistic management approaches must recognize HF as a syndemic and foster the implementation of multidisciplinary approaches to address major contributors to the persisting burden of HF including multimorbidity, aging, and social determinants of health.
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http://dx.doi.org/10.1161/CIRCRESAHA.121.318172DOI Listing
May 2021

Biomarkers and indoor air quality: A translational research review.

J Clin Transl Sci 2020 Sep 4;5(1):e39. Epub 2020 Sep 4.

Well Living Lab, Inc., Mayo Clinic, Rochester, MN 55902, USA.

Introduction: Air pollution is linked to mortality and morbidity. Since humans spend nearly all their time indoors, improving indoor air quality (IAQ) is a compelling approach to mitigate air pollutant exposure. To assess interventions, relying on clinical outcomes may require prolonged follow-up, which hinders feasibility. Thus, identifying biomarkers that respond to changes in IAQ may be useful to assess the effectiveness of interventions.

Methods: We conducted a narrative review by searching several databases to identify studies published over the last decade that measured the response of blood, urine, and/or salivary biomarkers to variations (natural and intervention-induced) of changes in indoor air pollutant exposure.

Results: Numerous studies reported on associations between IAQ exposures and biomarkers with heterogeneity across study designs and methods. This review summarizes the responses of 113 biomarkers described in 30 articles. The biomarkers which most frequently responded to variations in indoor air pollutant exposures were high sensitivity C-reactive protein (hsCRP), von Willebrand Factor (vWF), 8-hydroxy-2'-deoxyguanosine (8-OHdG), and 1-hydroxypyrene (1-OHP).

Conclusions: This review will guide the selection of biomarkers for translational studies evaluating the impact of indoor air pollutants on human health.
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http://dx.doi.org/10.1017/cts.2020.532DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057458PMC
September 2020

Collaborative Cohort of Cohorts for COVID-19 Research (C4R) Study: Study Design.

medRxiv 2021 Mar 20. Epub 2021 Mar 20.

The Collaborative Cohort of Cohorts for COVID-19 Research (C4R) is a national prospective study of adults at risk for coronavirus disease 2019 (COVID-19) comprising 14 established United States (US) prospective cohort studies. For decades, C4R cohorts have collected extensive data on clinical and subclinical diseases and their risk factors, including behavior, cognition, biomarkers, and social determinants of health. C4R will link this pre-COVID phenotyping to information on SARS-CoV-2 infection and acute and post-acute COVID-related illness. C4R is largely population-based, has an age range of 18-108 years, and broadly reflects the racial, ethnic, socioeconomic, and geographic diversity of the US. C4R is ascertaining severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 illness using standardized questionnaires, ascertainment of COVID-related hospitalizations and deaths, and a SARS-CoV-2 serosurvey via dried blood spots. Master protocols leverage existing robust retention rates for telephone and in-person examinations, and high-quality events surveillance. Extensive pre-pandemic data minimize referral, survival, and recall bias. Data are being harmonized with research-quality phenotyping unmatched by clinical and survey-based studies; these will be pooled and shared widely to expedite collaboration and scientific findings. This unique resource will allow evaluation of risk and resilience factors for COVID-19 severity and outcomes, including post-acute sequelae, and assessment of the social and behavioral impact of the pandemic on long-term trajectories of health and aging.
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http://dx.doi.org/10.1101/2021.03.19.21253986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7987050PMC
March 2021

Natural Language Processing and Machine Learning for Identifying Incident Stroke From Electronic Health Records: Algorithm Development and Validation.

J Med Internet Res 2021 Mar 8;23(3):e22951. Epub 2021 Mar 8.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States.

Background: Stroke is an important clinical outcome in cardiovascular research. However, the ascertainment of incident stroke is typically accomplished via time-consuming manual chart abstraction. Current phenotyping efforts using electronic health records for stroke focus on case ascertainment rather than incident disease, which requires knowledge of the temporal sequence of events.

Objective: The aim of this study was to develop a machine learning-based phenotyping algorithm for incident stroke ascertainment based on diagnosis codes, procedure codes, and clinical concepts extracted from clinical notes using natural language processing.

Methods: The algorithm was trained and validated using an existing epidemiology cohort consisting of 4914 patients with atrial fibrillation (AF) with manually curated incident stroke events. Various combinations of feature sets and machine learning classifiers were compared. Using a heuristic rule based on the composition of concepts and codes, we further detected the stroke subtype (ischemic stroke/transient ischemic attack or hemorrhagic stroke) of each identified stroke. The algorithm was further validated using a cohort (n=150) stratified sampled from a population in Olmsted County, Minnesota (N=74,314).

Results: Among the 4914 patients with AF, 740 had validated incident stroke events. The best-performing stroke phenotyping algorithm used clinical concepts, diagnosis codes, and procedure codes as features in a random forest classifier. Among patients with stroke codes in the general population sample, the best-performing model achieved a positive predictive value of 86% (43/50; 95% CI 0.74-0.93) and a negative predictive value of 96% (96/100). For subtype identification, we achieved an accuracy of 83% in the AF cohort and 80% in the general population sample.

Conclusions: We developed and validated a machine learning-based algorithm that performed well for identifying incident stroke and for determining type of stroke. The algorithm also performed well on a sample from a general population, further demonstrating its generalizability and potential for adoption by other institutions.
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http://dx.doi.org/10.2196/22951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985804PMC
March 2021

Improved Incidence of Cardiovascular Disease in Patients with Incident Rheumatoid Arthritis in the 2000s: a Population-Based Cohort Study.

J Rheumatol 2021 Feb 15. Epub 2021 Feb 15.

Division of Rheumatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota; Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota; Department of Cardiovascular Disease, Division of Circulatory Failure, Mayo Clinic, Rochester, Minnesota Division of Medical statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. Funding: This work was supported by a grant from the National Institutes of Health, NIAMS (R01 AR46849) and NHLBI (HL120859). Research reported in this publication was supported by the National Institute of Aging of the National Institutes of Health under Award Number R01AG034676. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Address correspondence to Elena Myasoedova, MD, PhD. Mayo Clinic College of Medicine and Science, Division of Rheumatology, 200 1st St. SW, Rochester, MN 55905. Email:

Objective: To assess trends in incidence of cardiovascular disease (CVD) and mortality following incident CVD events in patients with rheumatoid arthritis (RA) onset in 1980- 2009 versus non-RA subjects.

Methods: We studied Olmsted County, Minnesota residents with incident RA (age ≥ 18 years, 1987 ACR criteria met in 1980-2009) and non-RA subjects from the same source population with similar age, sex and calendar year of index. All subjects were followed until death, migration, or 12/31/2016. Incident CVD events included myocardial infarction and stroke. Patients with CVD before RA incidence/index date were excluded. Cox models were used to compare incident CVD events by decade, adjusting for age, sex and CVD risk factors.

Results: The study included 905 patients with RA and 904 non-RA subjects. Cumulative incidence of any CVD event was lower in patients with incident RA in 2000s versus 1980s. Hazard Ratio [HR] for any incident CVD 2000s versus 1980s: 0.53; 95% confidence interval (CI): 0.31-0.93. The strength of association attenuated after adjustment for anti-rheumatic medication use: HR 0.64, 95%CI 0.34-1.22. Patients with RA in 2000s had no excess in CVD over non-RA subjects (HR: 0.71, 95%CI:0.42-1.19). Risk of death after a CVD event was somewhat lower in patients with RA after 1980s: HR: 0.54, 95%CI:0.33-0.90 in 1990s and HR: 0.68, 95%CI:0.33-1.41 in 2000s versus 1980s.

Conclusion: Incidence of major CVD events in RA has declined in recent decades. The gap in CVD occurrence between RA patients and the general population is closing. Mortality after CVD events in RA may be improving.
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http://dx.doi.org/10.3899/jrheum.200842DOI Listing
February 2021

Rurality, Death, and Healthcare Utilization in Heart Failure in the Community.

J Am Heart Assoc 2021 Feb 3;10(4):e018026. Epub 2021 Feb 3.

Department of Health Sciences Research Mayo Clinic Rochester MN.

Background Prior reports indicate that living in a rural area may be associated with worse health outcomes. However, data on rurality and heart failure (HF) outcomes are scarce. Methods and Results Residents from 6 southeastern Minnesota counties with a first-ever code for HF ( [], code 428, and [] code I50) between January 1, 2013 and December 31, 2016, were identified. Resident address was classified according to the rural-urban commuting area codes. Rurality was defined as living in a nonmetropolitan area. Cox regression was used to analyze the association between living in a rural versus urban area and death; Andersen-Gill models were used for hospitalization and emergency department visits. Among 6003 patients with HF (mean age 74 years, 48% women), 43% lived in a rural area. Rural patients were older and had a lower educational attainment and less comorbidity compared with patients living in urban areas (<0.001). After a mean (SD) follow-up of 2.8 (1.7) years, 2440 deaths, 20 506 emergency department visits, and 11 311 hospitalizations occurred. After adjustment, rurality was independently associated with an increased risk of death (hazard ratio [HR], 1.18; 95% CI, 1.09-1.29) and a reduced risk of emergency department visits (HR, 0.89; 95% CI, 0.82-0.97) and hospitalizations (HR, 0.78; 95% CI, 0.73-0.84). Conclusions Among patients with HF, living in a rural area is associated with an increased risk of death and fewer emergency department visits and hospitalizations. Further study to identify and address the mechanisms through which rural residence influences mortality and healthcare utilization in HF is needed in order to reduce disparities in rural health.
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http://dx.doi.org/10.1161/JAHA.120.018026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955348PMC
February 2021

Accelerated aging: A marker for social factors resulting in cardiovascular events?

SSM Popul Health 2021 Mar 12;13:100733. Epub 2021 Jan 12.

University of Massachusetts Medical School, Department of Population and Quantitative Health Sciences, USA.

Background: Medicine and public health are shifting away from a purely "personal responsibility" model of cardiovascular disease (CVD) prevention towards a societal view targeting social and environmental conditions and how these result in disease. Given the strong association between social conditions and CVD outcomes, we hypothesize that accelerated aging, measuring earlier health decline associated with chronological aging through a combination of biomarkers, may be a marker for the association between social conditions and CVD.

Methods: We used data from the Coronary Artery Risk Development in Young Adults study (CARDIA). Accelerated aging was defined as the difference between biological and chronological age. Biological age was derived as a combination of 7 biomarkers (total cholesterol, HDL, glucose, BMI, CRP, FEV1/h, MAP), representing the physiological effect of "wear and tear" usually associated with chronological aging. We studied accelerated aging measured in 2005-06 as a mediator of the association between social factors measured in 2000-01 and 1) any incident CVD event; 2) stroke; and 3) all-cause mortality occurring from 2007 through 18.

Results: Among 2978 middle-aged participants, mean (SD) accelerated aging was 3.6 (11.6) years, i.e., the CARDIA cohort appeared to be, on average, 3 years older than its chronological age. Accelerated aging partially mediated the association between social factors and CVD (N=219), stroke (N=36), and mortality (N=59). Accelerated aging mediated 41% of the total effects of racial discrimination on stroke after adjustment for covariates. Accelerated aging also mediated other relationships but to lesser degrees.

Conclusion: We provide new evidence that accelerated aging based on easily measurable biomarkers may be a viable marker to partially explain how social factors can lead to cardiovascular outcomes and death.
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http://dx.doi.org/10.1016/j.ssmph.2021.100733DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7823205PMC
March 2021

Bi-directional association between depression and HF: An electronic health records-based cohort study.

J Comorb 2020 Jan-Dec;10:2235042X20984059. Epub 2020 Dec 24.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

Objective: To determine whether a bi-directional relationship exists between depression and HF within a single population of individuals receiving primary care services, using longitudinal electronic health records (EHRs).

Methods: This retrospective cohort study utilized EHRs for adults who received primary care services within a large healthcare system in 2006. Validated EHR-based algorithms identified 10,649 people with depression (depression cohort) and 5,911 people with HF (HF cohort) between January 1, 2006 and December 31, 2018. Each person with depression or HF was matched 1:1 with an unaffected referent on age, sex, and outpatient service use. Each cohort (with their matched referents) was followed up electronically to identify newly diagnosed HF (in the depression cohort) and depression (in the HF cohort) that occurred after the index diagnosis of depression or HF, respectively. The risks of these outcomes were compared (vs. referents) using marginal Cox proportional hazard models adjusted for 16 comorbid chronic conditions.

Results: 2,024 occurrences of newly diagnosed HF were observed in the depression cohort and 944 occurrences of newly diagnosed depression were observed in the HF cohort over approximately 4-6 years of follow-up. People with depression had significantly increased risk for developing newly diagnosed HF (HR 2.08, 95% CI 1.89-2.28) and people with HF had a significantly increased risk of newly diagnosed depression (HR 1.34, 95% CI 1.17-1.54) after adjusting for all 16 comorbid chronic conditions.

Conclusion: These results provide evidence of a bi-directional relationship between depression and HF independently of age, sex, and multimorbidity from chronic illnesses.
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http://dx.doi.org/10.1177/2235042X20984059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768856PMC
December 2020

Achieving Optimal Population Cardiovascular Health Requires an Interdisciplinary Team and a Learning Healthcare System: A Scientific Statement From the American Heart Association.

Circulation 2021 Jan 3;143(2):e9-e18. Epub 2020 Dec 3.

Population cardiovascular health, or improving cardiovascular health among patients and the population at large, requires a redoubling of primordial and primary prevention efforts as declines in cardiovascular disease mortality have decelerated over the past decade. Great potential exists for healthcare systems-based approaches to aid in reversing these trends. A learning healthcare system, in which population cardiovascular health metrics are measured, evaluated, intervened on, and re-evaluated, can serve as a model for developing the evidence base for developing, deploying, and disseminating interventions. This scientific statement on optimizing population cardiovascular health summarizes the current evidence for such an approach; reviews contemporary sources for relevant performance and clinical metrics; highlights the role of implementation science strategies; and advocates for an interdisciplinary team approach to enhance the impact of this work.
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http://dx.doi.org/10.1161/CIR.0000000000000913DOI Listing
January 2021

Racial differences in the association of accelerated aging with future cardiovascular events and all-cause mortality: the coronary artery risk development in young adults study, 2007-2018.

Ethn Health 2020 Nov 21:1-13. Epub 2020 Nov 21.

Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.

Objective: Variability of Cardiovascular disease (CVD) risk, including racial difference, is not fully accounted for by the variability of traditional CVD risk factors. We used a multiple biomarker model as a framework to explore known racial differences in CVD burden.

Design: We measured associations between accelerated aging (AccA) measured by a combination of biomarkers, and cardiovascular morbidity and all-cause mortality using data from the Coronary Artery Risk Development in Young Adults study (CARDIA). AccA was defined as the difference between biological age, calculated using biomarkers with the Klemera and Doubal method, and chronological age. Using logistic regression, we assessed overall and race-specific associations between AccA, CVD, and all-cause mortality.

Results: Among our cohort of 2959 Black or White middle-aged adults, after adjustment, a one-year increase in AccA was associated with increased odds of CVD (Odds Ratio (OR) = 1.04; 95% CI: 1.02, 1.06), stroke (OR = 1.12; 95% CI: 1.07, 1.17), and all-cause mortality (OR = 1.05; 95% CI: 1.02, 1.08). We did not find significant overall racial differences, but we did find race by sex differences where Black men differed markedly from White men in the strength of association with CVD (OR = 1.06, 95% CI: 1.01, 1.12).

Conclusions: We provide evidence that AccA is associated with future CVD.
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http://dx.doi.org/10.1080/13557858.2020.1839021DOI Listing
November 2020

Evaluation of claims-based computable phenotypes to identify heart failure patients with preserved ejection fraction.

Pharmacol Res Perspect 2020 12;8(6):e00676

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

The purpose of this analysis was to develop and validate computable phenotypes for heart failure (HF) with preserved ejection fraction (HFpEF) using claims-type measures using the Rochester Epidemiology Project. This retrospective study utilized an existing cohort of Olmsted County, Minnesota residents aged ≥ 20 years diagnosed with HF between 2007 and 2015. The gold standard definition of HFpEF included meeting the validated Framingham criteria for HF and having an LVEF ≥ 50%. Computable phenotypes of claims-type data elements (including ICD-9/ICD-10 diagnostic codes and lab test codes) both individually and in combinations were assessed via sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the gold standard. In the Framingham-validated cohort, 2,035 patients had HF; 1,172 (58%) had HFpEF. One in-patient or two out-patient diagnosis codes of ICD-9 428.3X or ICD-10 I50.3X had 46% sensitivity, 88% specificity, 84% PPV, and 54% NPV. The addition of a BNP/NT-proBNP test code reduced sensitivity to 35% while increasing specificity to 91% (PPV = 84%, NPV = 51%). Broadening the diagnostic codes to ICD-9 428.0, 428.3X, and 428.9/ICD-10 I50.3X and I50.9 increased sensitivity at the expense of decreasing specificity (diagnostic code-only model: 87% sensitivity, 8% specificity, 56% PPV, 30% NPV; diagnostic code and BNP lab code model: 61% sensitivity, 43% specificity, 60% PPV, 45% NPV). In an analysis conducted to mimic real-world use of the computable phenotypes, any one in-patient or out-patient code of ICD-9 428/ICD-10 150 among the broader population (N = 3,755) resulted in lower PPV values compared with the Framingham cohort. However, one in-patient or two out-patient instances of ICD-9 428.0, 428.9, or 428.3X/ICD-10 150.3X or 150.9 brought the PPV values from the two cohorts closer together. While some misclassification remains, the computable phenotypes defined here may be used in claims databases to identify HFpEF patients and to gain a greater understanding of the characteristics of patients with HFpEF.
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http://dx.doi.org/10.1002/prp2.676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7596663PMC
December 2020

Patient-centered communication and outcomes in heart failure.

Am J Manag Care 2020 10;26(10):425-430

Department of Health Sciences Research, Mayo Clinic, 200 First St SW, Rochester, MN 55905. Email:

Objectives: To measure the impact of patient-centered communication on mortality and hospitalization among patients with heart failure (HF).

Study Design: This was a survey study of 6208 residents of 11 counties in southeast Minnesota with incident HF (first-ever International Classification of Diseases, Ninth Revision code 428 or International Classification of Diseases, Tenth Revision code I50) between January 1, 2013, and March 31, 2016.

Methods: Perceived patient-centered communication was assessed with the health care subscale of the Chronic Illness Resources Survey and measured as a composite score on three 5-point scales. We divided our cohort into tertiles and defined them as having fair/poor (score < 12), good (score of 12 or 13), and excellent (score ≥ 14) patient-centered communication. The survey was returned by 2868 participants (response rate: 45%), and those with complete data were retained for analysis (N = 2398). Cox and Andersen-Gill models were used to determine the association of patient-centered communication with death and hospitalization, respectively.

Results: Among 2398 participants (median age, 75 years; 54% men), 233 deaths and 1194 hospitalizations occurred after a mean (SD) follow-up of 1.3 (0.6) years. Compared with patients with fair/poor patient-centered communication, those with good (HR, 0.70; 95% CI, 0.51-0.97) and excellent (HR, 0.70; 95% CI, 0.51-0.96) patient-centered communication experienced lower risks of death after adjustment for various confounders (Ptrend = .020). Patient-centered communication was not associated with hospitalization.

Conclusions: Among community patients living with HF, excellent and good patient-centered communication is associated with a reduced risk of death. Patient-centered communication can be easily assessed, and consideration should be given toward implementation in clinical practice.
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http://dx.doi.org/10.37765/ajmc.2020.88500DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7587036PMC
October 2020

Association of New-Onset Atrial Fibrillation After Noncardiac Surgery With Subsequent Stroke and Transient Ischemic Attack.

JAMA 2020 09;324(9):871-878

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.

Importance: Outcomes of postoperative atrial fibrillation (AF) after noncardiac surgery are not well defined.

Objective: To determine the association of new-onset postoperative AF vs no AF after noncardiac surgery with risk of nonfatal and fatal outcomes.

Design, Setting, And Participants: Retrospective cohort study in Olmsted County, Minnesota, involving 550 patients who had their first-ever documented AF within 30 days after undergoing a noncardiac surgery (postoperative AF) between 2000 and 2013. Of these patients, 452 were matched 1:1 on age, sex, year of surgery, and type of surgery to patients with noncardiac surgery who were not diagnosed with AF within 30 days following the surgery (no AF). The last date of follow-up was December 31, 2018.

Exposures: Postoperative AF vs no AF after noncardiac surgery.

Main Outcomes And Measures: The primary outcome was ischemic stroke or transient ischemic attack (TIA). Secondary outcomes included subsequent documented AF, all-cause mortality, and cardiovascular mortality.

Results: The median age of the 452 matched patients was 75 years (IQR, 67-82 years) and 51.8% of patients were men. Patients with postoperative AF had significantly higher CHA2DS2-VASc scores than those in the no AF group (median, 4 [IQR, 2-5] vs 3 [IQR, 2-5]; P < .001). Over a median follow-up of 5.4 years (IQR, 1.4-9.2 years), there were 71 ischemic strokes or TIAs, 266 subsequent documented AF episodes, and 571 deaths, of which 172 were cardiovascular related. Patients with postoperative AF exhibited a statistically significantly higher risk of ischemic stroke or TIA (incidence rate, 18.9 vs 10.0 per 1000 person-years; absolute risk difference [RD] at 5 years, 4.7%; 95% CI, 1.0%-8.4%; HR, 2.69; 95% CI, 1.35-5.37) compared with those with no AF. Patients with postoperative AF had statistically significantly higher risks of subsequent documented AF (incidence rate 136.4 vs 21.6 per 1000 person-years; absolute RD at 5 years, 39.3%; 95% CI, 33.6%-45.0%; HR, 7.94; 95% CI, 4.85-12.98), and all-cause death (incidence rate, 133.2 vs 86.8 per 1000 person-years; absolute RD at 5 years, 9.4%; 95% CI, 4.9%-13.7%; HR, 1.66; 95% CI, 1.32-2.09). No significant difference in the risk of cardiovascular death was observed for patients with and without postoperative AF (incidence rate, 42.5 vs 25.0 per 1000 person-years; absolute RD at 5 years, 6.2%; 95% CI, 2.2%-10.4%; HR, 1.51; 95% CI, 0.97-2.34).

Conclusions And Relevance: Among patients undergoing noncardiac surgery, new-onset postoperative AF compared with no AF was associated with a significant increased risk of stroke or TIA. However, the implications of these findings for the management of postoperative AF, such as the need for anticoagulation therapy, require investigation in randomized trials.
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http://dx.doi.org/10.1001/jama.2020.12518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489856PMC
September 2020

Poor quality of life in patients with and without frailty: Co-prevalence and prognostic implications in patients undergoing percutaneous coronary interventions and cardiac catheterization.

Eur Heart J Qual Care Clin Outcomes 2020 08 21. Epub 2020 Aug 21.

Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.

Background: We hypothesize that poor QOL is highly prevalent in frail older adults and is associated with worse prognosis.

Methods And Results: Predismissal standardized tests for frailty and QOL were prospectively administered to patients included in 2 cohorts. In cohort 1, 629 patients ≥ 65 years who underwent percutaneous coronary intervention (PCI) from 2005-2008, frailty (Fried criteria) and QOL [SF-36 and Seattle Angina Questionnaires (SAQ)] were ascertained. Cohort 2 included 921 patients ≥55 years who underwent cardiac catheterization (535 had PCI) from 2014-18 and frailty was determined by Rockwood criteria and QOL by single-item, self-reported health questionnaire. In cohort 1, 19% were frail and 20% patients in cohort 2 were frail with a frailty index>0.30. The median SAQ for physical limitation (58.9 vs. 82.2, p < 0.001); physical (29.5 vs. 43.9, p < 0.001) and mental (49.2 vs. 57.4, p < 0.001) component scores of SF-36 in cohort 1 were lower and self-rating of fair/poor health (56% vs 18%, p < 0.001) in cohort 2 was significantly higher in frail patients. As compared to patients without frailty, frail patients were 5 times more likely (59% vs. 11%, p < 0.001) in cohort 1 and 7 times more likely (56% vs. 8%) in cohort 2 to be classified with poor QOL. Age- and gender-adjusted three year all-cause death and death or myocardial infarction (MI) was significantly higher for patients undergoing PCI with frailty; [HR (95% CI) death, 4.20 (2.63, 6.68, p < 0.001) and death or MI HR 2.72 (1.91, 3.87, p < 0.001)] and with poor QOL [HR death 2.47 (1.59, 3.84, p < 0.001) and death or MI 1.61 (1.16, 2.24, p < 0.001). There was no significant interaction between frailty and QOL (p = 0.64) and only modest attenuation was observed when considered together indicating their independent prognostic influence.

Conclusions: In elderly patients undergoing cardiac catheterization or PCI, poor QOL is seen more frequently in frail patients. Both frailty and poor QOL had significant and independent association with long-term survival.
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http://dx.doi.org/10.1093/ehjqcco/qcaa065DOI Listing
August 2020

Indoor Environment and Viral Infections.

Mayo Clin Proc 2020 08;95(8):1581-1583

Well Living Lab, Rochester, Minnesota; Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota; Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. Electronic address:

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http://dx.doi.org/10.1016/j.mayocp.2020.05.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395586PMC
August 2020

Next-Generation Sequencing of CYP2C19 in Stent Thrombosis: Implications for Clopidogrel Pharmacogenomics.

Cardiovasc Drugs Ther 2021 Jun;35(3):549-559

Department of Cardiovascular Medicine, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.

Purpose: Describe CYP2C19 sequencing results in the largest series of clopidogrel-treated cases with stent thrombosis (ST), the closest clinical phenotype to clopidogrel resistance. Evaluate the impact of CYP2C19 genetic variation detected by next-generation sequencing (NGS) with comprehensive annotation and functional studies.

Methods: Seventy ST cases on clopidogrel identified from the PLATO trial (n = 58) and Mayo Clinic biorepository (n = 12) were matched 1:1 with controls for age, race, sex, diabetes mellitus, presentation, and stent type. NGS was performed to cover the entire CYP2C19 gene. Assessment of exonic variants involved measuring in vitro protein expression levels. Intronic variants were evaluated for potential splicing motif variations.

Results: Poor metabolizers (n = 4) and rare CYP2C19*8, CYP2C19*15, and CYP2C19*11 alleles were identified only in ST cases. CYP2C19*17 heterozygote carriers were observed more frequently in cases (n = 29) than controls (n = 18). Functional studies of CYP2C19 exonic variants (n = 11) revealed 3 cases and only 1 control carrying a deleterious variant as determined by in vitro protein expression studies. Greater intronic variation unique to ST cases (n = 169) compared with controls (n = 84) was observed with predictions revealing 13 allele candidates that may lead to a potential disruption of splicing and a loss-of-function effect of CYP2C19 in ST cases.

Conclusion: NGS detected CYP2C19 poor metabolizers and paradoxically greater number of so-called rapid metabolizers in ST cases. Rare deleterious exonic variation occurs in 4%, and potentially disruptive intronic alleles occur in 16% of ST cases. Additional studies are required to evaluate the role of these variants in platelet aggregation and clopidogrel metabolism.
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http://dx.doi.org/10.1007/s10557-020-06988-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779664PMC
June 2021

Sex Differences in Outcomes After Myocardial Infarction in the Community.

Am J Med 2021 01 3;134(1):114-121. Epub 2020 Jul 3.

Department of Cardiovascular Diseases; Department of Health Sciences Research, Mayo Clinic, Rochester, Minn. Electronic address:

Purpose: Prior studies observed that women experienced worse outcomes than men after myocardial infarction but did not convincingly establish an independent effect of female sex on outcomes, thus failing to impact clinical practice. Current data remain sparse and information on long-term nonfatal outcomes is lacking. To address these gaps in knowledge, we examined outcomes after incident myocardial infarction for women compared with men.

Methods: We studied a population-based myocardial infarction incidence cohort in Olmsted County, Minnesota, between 2000 and 2012. Patients were followed for recurrent myocardial infarction, heart failure, and death. A propensity score was constructed to balance the clinical characteristics between men and women; Cox models were weighted using inverse probabilities of the propensity scores.

Results: Among 1959 patients with incident myocardial infarction (39% women; mean age 73.8 and 64.2 for women and men, respectively), 347 recurrent myocardial infarctions, 464 heart failure episodes, 836 deaths, and 367 cardiovascular deaths occurred over a mean follow-up of 6.5 years. Women experienced a higher occurrence of each adverse event (all P <0.01). After propensity score weighting, women had a 28% increased risk of recurrent myocardial infarction (hazard ratio: 1.28, 95% confidence interval: 1.03-1.59), and there was no difference in risk for any other outcomes (all P >0.05).

Conclusion: After myocardial infarction, women experience a large excess risk of recurrent myocardial infarction but not of heart failure or death independently of clinical characteristics. Future studies are needed to understand the mechanisms driving this association.
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http://dx.doi.org/10.1016/j.amjmed.2020.05.040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752831PMC
January 2021

Outcomes of incident atrial fibrillation in heart failure with preserved or reduced ejection fraction: A community-based study.

J Cardiovasc Electrophysiol 2020 09 16;31(9):2275-2283. Epub 2020 Jul 16.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Introduction: The best management strategy for patients with atrial fibrillation (AF) with heart failure (HF) and preserved left ventricular ejection fraction (LVEF) is unknown.

Methods And Results: This cohort study was conducted in Olmsted County, Minnesota, with resources of the Rochester Epidemiology Project. Patients with incident AF occurring between 2000 and 2014 with a prior or concurrent HF were included. Patients with LVEF ≥ 50% were designated as HF and preserved ejection fraction (HFpEF) and those with LVEF < 50% were designated as HF and reduced ejection fraction (HFrEF). Rhythm control in the first year after AF diagnosis was defined as prescriptions for an antiarrhythmic drug, catheter ablation, or maze procedure. The primary endpoint was all-cause mortality. The secondary endpoints were cardiovascular death, cardiovascular hospitalization, and stroke or transient ischemic attack. Of 859 patients (age, 77.2 ± 12.1 years; 49.2%, female), 447 had HFpEF-AF, and 412 had HFrEF-AF. There was no difference in all-cause mortality (10-year mortality, 83% vs 79%; p = .54) or secondary endpoints between the HFpEF-AF and HFrEF-AF, respectively. Compared with the rate control strategy, rhythm control in HFpEF-AF patients (n = 40, 15.9%) offered no survival benefits (adjusted HR, 0.70; 95% CI, 0.42-1.16; p = .16), whereas rhythm control in HFrEF-AF patients (n = 52, 22.5%) decrease cardiovascular mortality (HR, 0.38; 95% CI, 0.17-0.86; p = .02).

Conclusions: Patients with HFpEF-AF and HFrEF-AF had similar poor prognoses. Rhythm control strategy was seldom adopted in community care in patients with HF and AF. A rhythm control strategy may provide survival benefit for patients with HFrEF-AF and the benefit of rhythm control in patients with HFpEF-AF warrants further study.
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http://dx.doi.org/10.1111/jce.14632DOI Listing
September 2020

Beliefs, risk perceptions, and lipid management among patients with and without diabetes: Results from the PALM registry.

Am Heart J 2020 07 30;225:88-96. Epub 2020 Apr 30.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.

Intensive lipid management is critical to reduce cardiovascular (CV) risk for patients with diabetes mellitus (DM).

Methods: We performed an observational study of 7628 patients with (n = 2943) and without DM (n = 4685), enrolled in the Provider Assessment of Lipid Management (PALM) registry and treated at 140 outpatient clinics across the United States in 2015. Patient self-estimated CV risk, patient-perceived statin benefit and risk, observed statin therapy use and dosing were assessed.

Results: Patients with DM were more likely to believe that their CV risk was elevated compared with patients without DM (39.1% vs 29.3%, P < .001). Patients with DM were more likely to receive a statin (74.2% vs 63.5%, P < .001) but less likely to be treated with guideline-recommended statin intensity (36.5% vs 46.9%, P < .001), driven by the low proportion (16.5%) of high risk (ASCVD risk ≥7.5%) primary prevention DM patients treated with a high intensity statin. Patients with DM treated with guideline-recommended statin intensity were more likely to believe they were at high CV risk (44.9% vs 38.4%, P = .005) and that statins can reduce this risk (41.1% vs 35.6%, P = .02), compared with patients treated with lower than guideline-recommended statin intensity. Compared with patients with an elevated HgbA1c, patients with well-controlled DM were no more likely to be on a statin (77.9% vs 79.3%, P = .43).

Conclusions: In this nationwide study, the majority of patients with DM were treated with lower than guideline-recommended statin intensity. Patient education and engagement may help providers improve lipid therapy for these high-risk patients.
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http://dx.doi.org/10.1016/j.ahj.2020.04.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539544PMC
July 2020

Health Literacy and Outcomes Among Patients With Heart Failure: A Systematic Review and Meta-Analysis.

JACC Heart Fail 2020 06;8(6):451-460

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota; Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. Electronic address:

Objectives: The purpose of this study was to determine if health literacy is associated with mortality, hospitalizations, or emergency department (ED) visits among patients living with heart failure (HF).

Background: Growing evidence suggests an association between health literacy and health-related outcomes in patients with HF.

Methods: We searched Embase, MEDLINE, PsycINFO, and EBSCO CINAHL from inception through January 1, 2019, with the help of a medical librarian. Eligible studies evaluated health literacy among patients with HF and assessed mortality, hospitalizations, and ED visits for all causes with no exclusion by time, geography, or language. Two reviewers independently selected studies, extracted data, and assessed the methodological quality of the identified studies.

Results: We included 15 studies, 11 with an overall high methodological quality. Among the observational studies, an average of 24% of patients had inadequate or marginal health literacy. Inadequate health literacy was associated with higher unadjusted risk for mortality (risk ratio [RR]: 1.67; 95% confidence interval [CI]: 1.18 to 2.36), hospitalizations (RR: 1.19; 95% CI: 1.09 to 1.29), and ED visits (RR: 1.17; 95% CI: 1.03 to 1.32). When the adjusted measurements were combined, inadequate health literacy remained statistically associated with mortality (RR: 1.41; 95% CI: 1.06 to 1.88) and hospitalizations (RR: 1.12; 95% CI: 1.01 to 1.25). Among the 4 interventional studies, 2 effectively improved outcomes among patients with inadequate health literacy.

Conclusions: In this study, the estimated prevalence of inadequate health literacy was high, and inadequate health literacy was associated with increased risk of death and hospitalizations. These findings have important clinical and public health implications and warrant measurement of health literacy and deployment of interventions to improve outcomes.
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http://dx.doi.org/10.1016/j.jchf.2019.11.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263350PMC
June 2020

Participation Bias in a Survey of Community Patients With Heart Failure.

Mayo Clin Proc 2020 05;95(5):911-919

Department of Health Sciences Research, Mayo Clinic, Rochester, MN; Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address:

Objective: To identify differences between participants and nonparticipants in a survey of physical and psychosocial aspects of health among a population-based sample of patients with heart failure (HF).

Patients And Methods: Residents from 11 Minnesota counties with a first-ever code for HF (International Classification of Diseases, Ninth Revision 428 and Tenth Revision I50) between January 1, 2013, and December 31, 2016, were identified. Participants completed a questionnaire by mail or telephone. Characteristics and outcomes were extracted from medical records and compared between participants and nonparticipants. Response rate was calculated using guidelines of the American Association for Public Opinion Research. The association between nonparticipation and outcomes was examined using Cox proportional hazards regression for death and Andersen-Gill modeling for hospitalizations.

Results: Among 7911 patients, 3438 responded to the survey (American Association for Public Opinion Research response rate calculated using formula 2 = 43%). Clinical and demographic differences between participants and nonparticipants were noted, particularly for education, marital status, and neuropsychiatric conditions. After a mean ± SD of 1.5±1.0 years after survey administration, 1575 deaths and 5857 hospitalizations occurred. Nonparticipation was associated with a 2-fold increased risk for death (hazard ratio, 2.29; 95% CI, 2.05-2.56) and 11% increased risk for hospitalization (hazard ratio, 1.11; 95% CI, 1.02-1.22) after adjusting for age, sex, time from HF diagnosis to index date, marital status, coronary disease, arrhythmia, hyperlipidemia, diabetes, cancer, chronic kidney disease, arthritis, osteoporosis, depression, and anxiety.

Conclusion: In a large survey of patients with HF, participation was associated with notable differences in clinical and demographic characteristics and outcomes. Examining the impact of participation is critical to draw inference from studies of patient-reported measures.
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http://dx.doi.org/10.1016/j.mayocp.2019.11.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7213075PMC
May 2020

Artificial Intelligence in Cardiology: Present and Future.

Mayo Clin Proc 2020 05;95(5):1015-1039

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.

Artificial intelligence (AI) is a nontechnical, popular term that refers to machine learning of various types but most often to deep neural networks. Cardiology is at the forefront of AI in medicine. For this review, we searched PubMed and MEDLINE databases with no date restriction using search terms related to AI and cardiology. Articles were selected for inclusion on the basis of relevance. We highlight the major achievements in recent years in nearly all areas of cardiology and underscore the mounting evidence suggesting how AI will take center stage in the field. Artificial intelligence requires a close collaboration among computer scientists, clinical investigators, clinicians, and other users in order to identify the most relevant problems to be solved. Best practices in the generation and implementation of AI include the selection of ideal data sources, taking into account common challenges during the interpretation, validation, and generalizability of findings, and addressing safety and ethical concerns before final implementation. The future of AI in cardiology and in medicine in general is bright as the collaboration between investigators and clinicians continues to excel.
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http://dx.doi.org/10.1016/j.mayocp.2020.01.038DOI Listing
May 2020

Impact of air quality on the gastrointestinal microbiome: A review.

Environ Res 2020 07 7;186:109485. Epub 2020 Apr 7.

Department of Health Sciences Research, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA; Department of Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Electronic address:

Background: Poor air quality is increasingly associated with several gastrointestinal diseases suggesting a possible association between air quality and the human gut microbiome. However, details on this remain largely unexplored as current available research is scarce. The aim of this comprehensive rigorous review was to summarize the existing reports on the impact of indoor or outdoor airborne pollutants on the animal and human gut microbiome and to outline the challenges and suggestions to expand this field of research.

Methods And Results: A comprehensive search of several databases (inception to August 9, 2019, humans and animals, English language only) was designed and conducted by an experienced librarian to identify studies describing the impact of air pollution on the human gut microbiome. The retrieved articles were assessed independently by two reviewers. This process yielded six original research papers on the animal GI gastrointestinal microbiome and four on the human gut microbiome. β-diversity analyses from selected animal studies demonstrated a significantly different composition of the gut microbiota between control and exposed groups but changes in α-diversity were less uniform. No consistent findings in α or β-diversity were reported among the human studies. Changes in microbiota at the phylum level disclosed substantial discrepancies across animal and human studies.

Conclusions: A different composition of the gut microbiome, particularly in animal models, is associated with exposure to air pollution. Air pollution is associated with various taxa changes, which however do not follow a clear pattern. Future research using standardized methods are critical to replicate these initial findings and advance this emerging field.
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http://dx.doi.org/10.1016/j.envres.2020.109485DOI Listing
July 2020

Association Between Blood Pressure and Later-Life Cognition Among Black and White Individuals.

JAMA Neurol 2020 07;77(7):810-819

Cognitive Health Services Research Program, Department of Internal Medicine, University of Michigan, Ann Arbor.

Importance: Black individuals are more likely than white individuals to develop dementia. Whether higher blood pressure (BP) levels in black individuals explain differences between black and white individuals in dementia risk is uncertain.

Objective: To determine whether cumulative BP levels explain racial differences in cognitive decline.

Design, Setting, And Participants: Individual participant data from 5 cohorts (January 1971 to December 2017) were pooled from the Atherosclerosis Risk in Communities Study, Coronary Artery Risk Development in Young Adults Study, Cardiovascular Health Study, Framingham Offspring Study, and Northern Manhattan Study. Outcomes were standardized as t scores (mean [SD], 50 [10]); a 1-point difference represented a 0.1-SD difference in cognition. The median (interquartile range) follow-up was 12.4 (5.9-21.0) years. Analysis began September 2018.

Main Outcomes And Measures: The primary outcome was change in global cognition, and secondary outcomes were change in memory and executive function.

Exposures: Race (black vs white).

Results: Among 34 349 participants, 19 378 individuals who were free of stroke and dementia and had longitudinal BP, cognitive, and covariate data were included in the analysis. The mean (SD) age at first cognitive assessment was 59.8 (10.4) years and ranged from 5 to 95 years. Of 19 378 individuals, 10 724 (55.3%) were female and 15 526 (80.1%) were white. Compared with white individuals, black individuals had significantly faster declines in global cognition (-0.03 points per year faster [95% CI, -0.05 to -0.01]; P = .004) and memory (-0.08 points per year faster [95% CI, -0.11 to -0.06]; P < .001) but significantly slower declines in executive function (0.09 points per year slower [95% CI, 0.08-0.10]; P < .001). Time-dependent cumulative mean systolic BP level was associated with significantly faster declines in global cognition (-0.018 points per year faster per each 10-mm Hg increase [95% CI, -0.023 to -0.014]; P < .001), memory (-0.028 points per year faster per each 10-mm Hg increase [95% CI, -0.035 to -0.021]; P < .001), and executive function (-0.01 points per year faster per each 10-mm Hg increase [95% CI, -0.014 to -0.007]; P < .001). After adjusting for cumulative mean systolic BP, differences between black and white individuals in cognitive slopes were attenuated for global cognition (-0.01 points per year [95% CI, -0.03 to 0.01]; P = .56) and memory (-0.06 points per year [95% CI, -0.08 to -0.03]; P < .001) but not executive function (0.10 points per year [95% CI, 0.09-0.11]; P < .001).

Conclusions And Relevance: These results suggest that black individuals' higher cumulative BP levels may contribute to racial differences in later-life cognitive decline.
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http://dx.doi.org/10.1001/jamaneurol.2020.0568DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154952PMC
July 2020

Coronary Disease Surveillance in the Community: Angiography and Revascularization.

J Am Heart Assoc 2020 04 2;9(7):e015231. Epub 2020 Apr 2.

Department of Health Sciences Research Mayo Clinic Rochester MN.

Background Temporal declines in cardiac stress tests results, coronary revascularization, and cardiovascular mortality have suggested a decline in the population burden of coronary disease until the 2000s. However, recent data indicate these favorable trends could be ending. We aimed to assess the evolution of the population burden of coronary disease in the community by examining trends in angiography and revascularization. Methods and Results We analyzed age- and sex-adjusted trends from all coronary angiographic diagnostic procedures and revascularizations performed in Olmsted County, MN from 2000 to 2018. A total of 12 981 invasive angiograms were performed among 9049 individuals (64% men; 55% aged ≥65 years). Adjusted angiography rates decreased by 30% (95% CI, 25%-34%) between 2000 and 2009 and leveled off thereafter. Including computed tomography, angiography uncovered an increase in angiography use in recent years (risk ratio=1.15 [95% CI, 1.07-1.23] for 2018 versus 2014) and a decline in the prevalence of anatomic CAD from 2000 to 2018. CAD severity declined substantially from 2000 to 2009, followed by a plateau. Among 6570 revascularizations (72% men; 57% aged ≥65 years), 77% were percutaneous coronary interventions and 23% coronary artery bypass graft surgeries. The adjusted revascularization rates declined by 34% (95% CI, 27%-39%) from 2000 to 2009, followed by a plateau (risk ratio=1.10 [95% CI, 1.00-1.22]). Conclusions Between 2000 and 2018 in the community, coronary angiography use declined initially, leveled off, and then increased. Trends in CAD severity and revascularization use decreased then plateaued. The most recent trends are concerning as they suggest the burden of coronary disease is no longer declining. This warrants reinvigorated primary prevention and population surveillance.
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http://dx.doi.org/10.1161/JAHA.119.015231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428619PMC
April 2020

Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial.

JAMA Cardiol 2020 05;5(5):598-607

Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, Minneapolis.

Importance: Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.

Objective: To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method.

Design, Setting, And Participants: This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020.

Interventions: Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily.

Main Outcomes And Measures: The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment.

Conclusions And Relevance: As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD.

Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.
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http://dx.doi.org/10.1001/jamacardio.2020.0116DOI Listing
May 2020

Medicine and society: social determinants of health and cardiovascular disease.

Eur Heart J 2020 03;41(11):1179-1181

Department of Cardiovascular Diseases and Department of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, USA.

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http://dx.doi.org/10.1093/eurheartj/ehaa134DOI Listing
March 2020

Recommendations for Cardiovascular Health and Disease Surveillance for 2030 and Beyond: A Policy Statement From the American Heart Association.

Circulation 2020 03 29;141(9):e104-e119. Epub 2020 Jan 29.

The release of the American Heart Association's 2030 Impact Goal and associated metrics for success underscores the importance of cardiovascular health and cardiovascular disease surveillance systems for the acquisition of information sufficient to support implementation and evaluation. The aim of this policy statement is to review and comment on existing recommendations for and current approaches to cardiovascular surveillance, identify gaps, and formulate policy implications and pragmatic recommendations for transforming surveillance of cardiovascular disease and cardiovascular health in the United States. The development of community platforms coupled with widespread use of digital technologies, electronic health records, and mobile health has created new opportunities that could greatly modernize surveillance if coordinated in a pragmatic matter. However, technology and public health and scientific mandates must be merged into action. We describe the action and components necessary to create the cardiovascular health and cardiovascular disease surveillance system of the future, steps in development, and challenges that federal, state, and local governments will need to address. Development of robust policies and commitment to collaboration among professional organizations, community partners, and policy makers are critical to ultimately reduce the burden of cardiovascular disease and improve cardiovascular health and to evaluate whether national health goals are achieved.
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http://dx.doi.org/10.1161/CIR.0000000000000756DOI Listing
March 2020