719 results on '"Krumholz, Harlan M."'
Search Results
2. Cost-effectiveness of bevacizumab therapy in the care of patients with hereditary hemorrhagic telangiectasia
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Wang, Daniel, Ito, Satoko, Waldron, Christina, Butt, Ayesha, Zhang, Ellen, Krumholz, Harlan M., Al-Samkari, Hanny, and Goshua, George
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•Longitudinal systemic bevacizumab is a cost-saving therapeutic option in the care of patients with HHT with moderate-to-severe bleeding.•Cost savings are mediated by decreased need for iron and red blood cell supplementation, hemostatic procedures, and hospitalizations.
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- 2024
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3. A Multimodal Video-Based AI Biomarker for Aortic Stenosis Development and Progression
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Oikonomou, Evangelos K., Holste, Gregory, Yuan, Neal, Coppi, Andreas, McNamara, Robert L., Haynes, Norrisa A., Vora, Amit N., Velazquez, Eric J., Li, Fan, Menon, Venu, Kapadia, Samir R., Gill, Thomas M., Nadkarni, Girish N., Krumholz, Harlan M., Wang, Zhangyang, Ouyang, David, and Khera, Rohan
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IMPORTANCE: Aortic stenosis (AS) is a major public health challenge with a growing therapeutic landscape, but current biomarkers do not inform personalized screening and follow-up. A video-based artificial intelligence (AI) biomarker (Digital AS Severity index [DASSi]) can detect severe AS using single-view long-axis echocardiography without Doppler characterization. OBJECTIVE: To deploy DASSi to patients with no AS or with mild or moderate AS at baseline to identify AS development and progression. DESIGN, SETTING, AND PARTICIPANTS: This is a cohort study that examined 2 cohorts of patients without severe AS undergoing echocardiography in the Yale New Haven Health System (YNHHS; 2015-2021) and Cedars-Sinai Medical Center (CSMC; 2018-2019). A novel computational pipeline for the cross-modal translation of DASSi into cardiac magnetic resonance (CMR) imaging was further developed in the UK Biobank. Analyses were performed between August 2023 and February 2024. EXPOSURE: DASSi (range, 0-1) derived from AI applied to echocardiography and CMR videos. MAIN OUTCOMES AND MEASURES: Annualized change in peak aortic valve velocity (AV-Vmax) and late (>6 months) aortic valve replacement (AVR). RESULTS: A total of 12 599 participants were included in the echocardiographic study (YNHHS: n = 8798; median [IQR] age, 71 [60-80] years; 4250 [48.3%] women; median [IQR] follow-up, 4.1 [2.4-5.4] years; and CSMC: n = 3801; median [IQR] age, 67 [54-78] years; 1685 [44.3%] women; median [IQR] follow-up, 3.4 [2.8-3.9] years). Higher baseline DASSi was associated with faster progression in AV-Vmax (per 0.1 DASSi increment: YNHHS, 0.033 m/s per year [95% CI, 0.028-0.038] among 5483 participants; CSMC, 0.082 m/s per year [95% CI, 0.053-0.111] among 1292 participants), with values of 0.2 or greater associated with a 4- to 5-fold higher AVR risk than values less than 0.2 (YNHHS: 715 events; adjusted hazard ratio [HR], 4.97 [95% CI, 2.71-5.82]; CSMC: 56 events; adjusted HR, 4.04 [95% CI, 0.92-17.70]), independent of age, sex, race, ethnicity, ejection fraction, and AV-Vmax. This was reproduced across 45 474 participants (median [IQR] age, 65 [59-71] years; 23 559 [51.8%] women; median [IQR] follow-up, 2.5 [1.6-3.9] years) undergoing CMR imaging in the UK Biobank (for participants with DASSi ≥0.2 vs those with DASSi <.02, adjusted HR, 11.38 [95% CI, 2.56-50.57]). Saliency maps and phenome-wide association studies supported associations with cardiac structure and function and traditional cardiovascular risk factors. CONCLUSIONS AND RELEVANCE: In this cohort study of patients without severe AS undergoing echocardiography or CMR imaging, a new AI-based video biomarker was independently associated with AS development and progression, enabling opportunistic risk stratification across cardiovascular imaging modalities as well as potential application on handheld devices.
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- 2024
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4. Burden of Ischemic and Hemorrhagic Stroke Across the US From 1990 to 2019
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Renedo, Daniela, Acosta, Julian N., Leasure, Audrey C., Sharma, Richa, Krumholz, Harlan M., de Havenon, Adam, Alahdab, Fares, Aravkin, Aleksandr Y., Aryan, Zahra, Bärnighausen, Till Winfried, Basu, Sanjay, Burkart, Katrin, Coberly, Kaleb, Criqui, Michael H., Dai, Xiaochen, Desai, Rupak, Dharmaratne, Samath Dhamminda, Doshi, Rajkumar, Elgendy, Islam Y., Feigin, Valery L., Filip, Irina, Gad, Mohamed M., Ghozy, Sherief, Hafezi-Nejad, Nima, Kalani, Rizwan, Karaye, Ibraheem M., Kisa, Adnan, Krishnamoorthy, Vijay, Lo, Warren, Mestrovic, Tomislav, Miller, Ted R., Misganaw, Awoke, Mokdad, Ali H., Murray, Christopher J. L., Natto, Zuhair S., Radfar, Amir, Ram, Pradhum, Roth, Gregory A., Seylani, Allen, Shah, Nilay S., Sharma, Purva, Sheikh, Aziz, Singh, Jasvinder A., Song, Suhang, Sotoudeh, Houman, Vervoort, Dominique, Wang, Cong, Xiao, Hong, Xu, Suowen, Zand, Ramin, Falcone, Guido J., and Sheth, Kevin N.
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IMPORTANCE: Stroke is a leading cause of death and disability in the US. Accurate and updated measures of stroke burden are needed to guide public health policies. OBJECTIVE: To present burden estimates of ischemic and hemorrhagic stroke in the US in 2019 and describe trends from 1990 to 2019 by age, sex, and geographic location. DESIGN, SETTING, AND PARTICIPANTS: An in-depth cross-sectional analysis of the 2019 Global Burden of Disease study was conducted. The setting included the time period of 1990 to 2019 in the US. The study encompassed estimates for various types of strokes, including all strokes, ischemic strokes, intracerebral hemorrhages (ICHs), and subarachnoid hemorrhages (SAHs). The 2019 Global Burden of Disease results were released on October 20, 2020. EXPOSURES: In this study, no particular exposure was specifically targeted. MAIN OUTCOMES AND MEASURES: The primary focus of this analysis centered on both overall and age-standardized estimates, stroke incidence, prevalence, mortality, and DALYs per 100 000 individuals. RESULTS: In 2019, the US recorded 7.09 million prevalent strokes (4.07 million women [57.4%]; 3.02 million men [42.6%]), with 5.87 million being ischemic strokes (82.7%). Prevalence also included 0.66 million ICHs and 0.85 million SAHs. Although the absolute numbers of stroke cases, mortality, and DALYs surged from 1990 to 2019, the age-standardized rates either declined or remained steady. Notably, hemorrhagic strokes manifested a substantial increase, especially in mortality, compared with ischemic strokes (incidence of ischemic stroke increased by 13% [95% uncertainty interval (UI), 14.2%-11.9%]; incidence of ICH increased by 39.8% [95% UI, 38.9%-39.7%]; incidence of SAH increased by 50.9% [95% UI, 49.2%-52.6%]). The downturn in stroke mortality plateaued in the recent decade. There was a discernible heterogeneity in stroke burden trends, with older adults (50-74 years) experiencing a decrease in incidence in coastal areas (decreases up to 3.9% in Vermont), in contrast to an uptick observed in younger demographics (15-49 years) in the South and Midwest US (with increases up to 8.4% in Minnesota). CONCLUSIONS AND RELEVANCE: In this cross-sectional study, the declining age-standardized stroke rates over the past 3 decades suggest progress in managing stroke-related outcomes. However, the increasing absolute burden of stroke, coupled with a notable rise in hemorrhagic stroke, suggests an evolving and substantial public health challenge in the US. Moreover, the significant disparities in stroke burden trends across different age groups and geographic locations underscore the necessity for region- and demography-specific interventions and policies to effectively mitigate the multifaceted and escalating burden of stroke in the country.
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- 2024
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5. Optimizing antithrombotic therapy in patients with coexisting cardiovascular and gastrointestinal disease
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Talasaz, Azita H., Sadeghipour, Parham, Ortega-Paz, Luis, Kakavand, Hessam, Aghakouchakzadeh, Maryam, Beavers, Craig, Fanikos, John, Eikelboom, John W., Siegal, Deborah M., Monreal, Manuel, Jimenez, David, Vaduganathan, Muthiah, Castellucci, Lana A., Cuker, Adam, Barnes, Geoffrey D., Connors, Jean M., Secemsky, Eric A., Van Tassell, Benjamin W., De Caterina, Raffaele, Kurlander, Jacob E., Aminian, Ali, Piazza, Gregory, Goldhaber, Samuel Z., Moores, Lisa, Middeldorp, Saskia, Kirtane, Ajay J., Elkind, Mitchell S. V., Angiolillo, Dominick J., Konstantinides, Stavros, Lip, Gregory Y. H., Stone, Gregg W., Cushman, Mary, Krumholz, Harlan M., Mehran, Roxana, Bhatt, Deepak L., and Bikdeli, Behnood
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Balancing the safety and efficacy of antithrombotic agents in patients with gastrointestinal disorders is challenging because of the potential for interference with the absorption of antithrombotic drugs and for an increased risk of bleeding. In this Review, we address considerations for enteral antithrombotic therapy in patients with cardiovascular disease and gastrointestinal comorbidities. For those with gastrointestinal bleeding (GIB), we summarize a general scheme for risk stratification and clinical evidence on risk reduction approaches, such as limiting the use of concomitant medications that increase the risk of GIB and the potential utility of gastrointestinal protection strategies (such as proton pump inhibitors or histamine type 2 receptor antagonists). Furthermore, we summarize the best available evidence and potential gaps in our knowledge on tailoring antithrombotic therapy in patients with active or recent GIB and in those at high risk of GIB but without active or recent GIB. Finally, we review the recommendations provided by major medical societies, highlighting the crucial role of teamwork and multidisciplinary discussions to customize the antithrombotic regimen in patients with coexisting cardiovascular and gastrointestinal diseases.
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- 2024
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6. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America.
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Bozkurt, Biykem, Ahmad, Tariq, Alexander, Kevin M., Baker, William L., Bosak, Kelly, Breathett, Khadijah, Fonarow, Gregg C., Heidenreich, Paul, Ho, Jennifer E., Hsich, Eileen, Ibrahim, Nasrien E., Jones, Lenette M., Khan, Sadiya S., Khazanie, Prateeti, Koelling, Todd, Krumholz, Harlan M., Khush, Kiran K., Lee, Christopher, Morris, Alanna A., and Page II, Robert L.
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- 2023
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7. Transformational Journey of Outcomes Research: Looking Back From the Future.
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Krumholz, Harlan M.
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- 2024
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8. Eligibility for Cardiovascular Risk Reduction Therapy in the United States Based on SELECT Trial Criteria: Insights From the National Health and Nutrition Examination Survey.
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Yuan Lu, Yuntian Liu, Jastreboff, Ania M., Khera, Rohan, Ndumele, Chima D., Rodriguez, Fatima, Watson, Karol E., and Krumholz, Harlan M.
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- 2024
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9. Do PCI Facility Openings and Closures Affect AMI Outcomes Differently in High- vs Average-Capacity Markets?
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Shen, Yu-Chu, Krumholz, Harlan M., and Hsia, Renee Y.
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Disparities in access to percutaneous coronary intervention (PCI) for patients with acute myocardial infarction may result from openings and closures of PCI-providing hospitals, potentially leading to low hospital PCI volume, which is associated with poor outcomes. The authors sought to determine whether openings and closures of PCI hospitals have differentially impacted patient health outcomes in high- vs average-capacity PCI markets. In this retrospective cohort study, the authors identified PCI hospital availability within a 15-minute driving time of zip code communities. The authors categorized communities by baseline PCI capacity and identified changes in outcomes associated with PCI-providing hospital openings and closures using community fixed-effects regression models. From 2006 to 2017, 20% and 16% of patients in average- and high-capacity markets, respectively, experienced a PCI hospital opening within a 15-minute drive. In average-capacity markets, openings were associated with a 2.6 percentage point decrease in admission to a high-volume PCI facility; high-capacity markets saw an 11.6 percentage point decrease. After an opening, patients in average-capacity markets experienced a 5.5% and 7.6% relative increase in likelihood of same-day and in-hospital revascularization, respectively, as well as a 2.5% decrease in mortality. PCI hospital closures were associated with a 10.4% relative increase in admission to high-volume PCI hospitals and a 1.4 percentage point decrease in receipt of same-day PCI. There was no change observed in high-capacity PCI markets. After openings, patients in average-capacity markets derived significant benefits, whereas those in high-capacity markets did not. This suggests that past a certain threshold, facility opening does not improve access and health outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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10. Detection of Left Ventricular Systolic Dysfunction From Electrocardiographic Images
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Sangha, Veer, Nargesi, Arash A., Dhingra, Lovedeep S., Khunte, Akshay, Mortazavi, Bobak J., Ribeiro, Antônio H., Banina, Evgeniya, Adeola, Oluwaseun, Garg, Nadish, Brandt, Cynthia A., Miller, Edward J., Ribeiro, Antonio Luiz P., Velazquez, Eric J., Giatti, Luana, Barreto, Sandhi M., Foppa, Murilo, Yuan, Neal, Ouyang, David, Krumholz, Harlan M., and Khera, Rohan
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- 2023
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11. Temporal trends in postoperative and ventilator-associated pneumonia in the United States
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Metersky, Mark L., Wang, Yun, Klompas, Michael, Eckenrode, Sheila, Mathew, Jasie, and Krumholz, Harlan M.
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AbstractObjective:To determine change in rates of postoperative pneumonia and ventilator-associated pneumonia among patients hospitalized in the United States during 2009–2019.Design:Retrospective cohort study.Patients:Patients hospitalized for major surgical procedures, acute myocardial infarction, heart failure, and pneumonia.Methods:We conducted a retrospective review of data from the Medicare Patient Safety Monitoring System, a chart-abstraction–derived database including 21 adverse-event measures among patients hospitalized in the United States. Changes in observed and risk-adjusted rates of postoperative pneumonia and ventilator-associated pneumonia were derived.Results:Among 58,618 patients undergoing major surgical procedures between 2009 and 2019, the observed rate of postoperative pneumonia from 2009–2011 was 1.9% and decreased to 1.3% during 2017–2019. The adjusted annual risk each year, compared to the prior year, was 0.94 (95% CI, 0.92–0.96). Among 4,007 patients hospitalized for any of these 4 conditions at risk for ventilator-associated pneumonia during 2009–2019, we did not detect a significant change in observed or adjusted rates. Observed rates clustered around 10%, and adjusted annual risk compared to the prior year was 0.99 (95% CI, 0.95–1.02).Conclusions:During 2009–2019, the rate of postoperative pneumonia decreased statistically and clinically significantly in among patients hospitalized for major surgical procedures in the United States, but rates of ventilator-associated pneumonia among patients hospitalized for major surgical procedures, acute myocardial infarction, heart failure, and pneumonia did not change.
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- 2023
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12. Opportunities and Achievement of Medication Initiation Among Inpatients With Heart Failure With Reduced Ejection Fraction
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Swat, Stanley A., Xu, Haolin, Allen, Larry A., Greene, Stephen J., DeVore, Adam D., Matsouaka, Roland A., Goyal, Parag, Peterson, Pamela N., Hernandez, Adrian F., Krumholz, Harlan M., Yancy, Clyde W., Fonarow, Gregg C., and Hess, Paul L.
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Initiation of evidence-based medications for patients with heart failure with reduced ejection fraction (HFrEF) during hospitalization in contemporary practice is unknown.
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- 2023
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13. Developing Validated Tools to Identify Pulmonary Embolism in Electronic Databases: Rationale and Design of the PE-EHR+ Study
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Bikdeli, Behnood, Lo, Ying-Chih, Khairani, Candrika D., Bejjani, Antoine, Jimenez, David, Barco, Stefano, Mahajan, Shiwani, Caraballo, César, Secemsky, Eric A., Klok, Frederikus A., Hunsaker, Andetta R., Aghayev, Ayaz, Muriel, Alfonso, Wang, Yun, Hussain, Mohamad A., Appah-Sampong, Abena, Lu, Yuan, Lin, Zhenqiu, Aneja, Sanjay, Khera, Rohan, Goldhaber, Samuel Z., Zhou, Li, Monreal, Manuel, Krumholz, Harlan M., and Piazza, Gregory
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- 2023
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14. Foundation models for generalist medical artificial intelligence
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Moor, Michael, Banerjee, Oishi, Abad, Zahra Shakeri Hossein, Krumholz, Harlan M., Leskovec, Jure, Topol, Eric J., and Rajpurkar, Pranav
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The exceptionally rapid development of highly flexible, reusable artificial intelligence (AI) models is likely to usher in newfound capabilities in medicine. We propose a new paradigm for medical AI, which we refer to as generalist medical AI (GMAI). GMAI models will be capable of carrying out a diverse set of tasks using very little or no task-specific labelled data. Built through self-supervision on large, diverse datasets, GMAI will flexibly interpret different combinations of medical modalities, including data from imaging, electronic health records, laboratory results, genomics, graphs or medical text. Models will in turn produce expressive outputs such as free-text explanations, spoken recommendations or image annotations that demonstrate advanced medical reasoning abilities. Here we identify a set of high-impact potential applications for GMAI and lay out specific technical capabilities and training datasets necessary to enable them. We expect that GMAI-enabled applications will challenge current strategies for regulating and validating AI devices for medicine and will shift practices associated with the collection of large medical datasets.
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- 2023
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15. Identifying quality of life outcome patterns to inform treatment choices in ischemic cardiomyopathy.
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Mori, Makoto, Mark, Daniel B., Khera, Rohan, Lin, Haiqun, Jones, Philip, Huang, Chenxi, Lu, Yuan, Geirsson, Arnar, Velazquez, Eric J., Spertus, John A., and Krumholz, Harlan M.
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The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that routine use of coronary artery bypass surgery (CABG) improved mean quality of life (QoL) scores relative to guideline-directed medical therapy (GDMT) in patients with ischemic cardiomyopathy. However, mean differences in QoL scores do not provide what patients want to know when facing a high-risk/high-benefit treatment choice. We analyzed Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary scores in CABG and GDMT patients over 36 months using a combination of statistical methods to group QoL data into clinically relevant outcome patterns (phenotype trajectories) and to then identify the main baseline predictors of each phenotype. QoL outcome phenotypes were developed using mixture models to define the dominant phenotype trajectories present in STICH QoL data. Logistic regression models were used to predict each patient's probability of achieving each outcome pattern with each treatment. In STICH, 592 patients underwent CABG and 607 were managed with GDMT. Our analyses identified 3 phenotype trajectory patterns in both treatment groups. Two of the 3 trajectories showed improving patterns, and were classified as "good QoL trajectories," seen in 498 (84.1%) CABG and 449 (73.9%) GDMT patients. Defining a consequential CABG-GDMT treatment difference as a >10% higher absolute predicted probability of belonging to good QoL trajectories, 277 (23.5%) patients were more likely to have good outcome with CABG while 45 (3.8%) patients were more likely to have a good outcome with GDMT. For 644 (54.7%) patients, CABG and GDMT probabilities of a good outcome were within 5% of each other. The pattern of QoL outcomes after CABG compared with GDMT in STICH followed 3 main phenotypic trajectories, which could be predicted based on individual baseline features. Patient-specific predictions about expected QoL outcomes with different treatment choices provide an intuitive framework for personalizing patient decision making. [ABSTRACT FROM AUTHOR]
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- 2022
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16. Variation in Risk-standardized Rates and Causes of Unplanned Hospital Visits Within 7 Days of Hospital Outpatient Surgery.
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Desai, Mayur M., Zogg, Cheryl K., Ranasinghe, Isuru, Parzynski, Craig S., Lin, Zhenqiu, Gorbaty, Marianna, Merrill, Angela, Krumholz, Harlan M., and Drye, Elizabeth E.
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Objectives: The objectives of this study were to compare risk-standardized hospital visit ratios of the predicted to expected number of unplanned hospital visits within 7 days of same-day surgeries performed at US hospital outpatient departments (HOPDs) and to describe the causes of hospital visits. Summary of Background Data: More than half of procedures in the US are performed in outpatient settings, yet little is known about facility-level variation in short-term safety outcomes. Methods: The study cohort included 1,135,441 outpatient surgeries performed at 4058 hospitals between October 1, 2015 and September 30, 2016 among Medicare Fee-for-Service beneficiaries aged ≥65 years. Hospital-level, risk-standardized measure scores of unplanned hospital visits (emergency department visits, observation stays, and unplanned inpatient admissions) within 7 days of hospital outpatient surgery were calculated using hierarchical logistic regression modeling that adjusted for age, clinical comorbidities, and surgical procedural complexity. Results: Overall, 7.8% of hospital outpatient surgeries were followed by an unplanned hospital visit within 7 days. Many of the leading reasons for unplanned visits were for potentially preventable conditions, such as urinary retention, infection, and pain. We found considerable variation in the risk-standardized ratio score across hospitals. The 203 best-performing HOPDs, at or below the 5th percentile, had at least 22% fewer unplanned hospital visits than expected, whereas the 202 worst-performing HOPDs, at or above the 95th percentile, had at least 29% more post-surgical visits than expected, given their case and surgical procedure mix. Conclusions: Many patients experience an unplanned hospital visit within 7 days of hospital outpatient surgery, often for potentially preventable reasons. The observed variation in performance across hospitals suggests opportunities for quality improvement. [ABSTRACT FROM AUTHOR]
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- 2022
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17. Distinguishing features of long COVID identified through immune profiling
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Klein, Jon, Wood, Jamie, Jaycox, Jillian R., Dhodapkar, Rahul M., Lu, Peiwen, Gehlhausen, Jeff R., Tabachnikova, Alexandra, Greene, Kerrie, Tabacof, Laura, Malik, Amyn A., Silva Monteiro, Valter, Silva, Julio, Kamath, Kathy, Zhang, Minlu, Dhal, Abhilash, Ott, Isabel M., Valle, Gabrielee, Peña-Hernández, Mario, Mao, Tianyang, Bhattacharjee, Bornali, Takahashi, Takehiro, Lucas, Carolina, Song, Eric, McCarthy, Dayna, Breyman, Erica, Tosto-Mancuso, Jenna, Dai, Yile, Perotti, Emily, Akduman, Koray, Tzeng, Tiffany J., Xu, Lan, Geraghty, Anna C., Monje, Michelle, Yildirim, Inci, Shon, John, Medzhitov, Ruslan, Lutchmansingh, Denyse, Possick, Jennifer D., Kaminski, Naftali, Omer, Saad B., Krumholz, Harlan M., Guan, Leying, Dela Cruz, Charles S., van Dijk, David, Ring, Aaron M., Putrino, David, and Iwasaki, Akiko
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Post-acute infection syndromes may develop after acute viral disease1. Infection with SARS-CoV-2 can result in the development of a post-acute infection syndrome known as long COVID. Individuals with long COVID frequently report unremitting fatigue, post-exertional malaise, and a variety of cognitive and autonomic dysfunctions2–4. However, the biological processes that are associated with the development and persistence of these symptoms are unclear. Here 275 individuals with or without long COVID were enrolled in a cross-sectional study that included multidimensional immune phenotyping and unbiased machine learning methods to identify biological features associated with long COVID. Marked differences were noted in circulating myeloid and lymphocyte populations relative to the matched controls, as well as evidence of exaggerated humoral responses directed against SARS-CoV-2 among participants with long COVID. Furthermore, higher antibody responses directed against non-SARS-CoV-2 viral pathogens were observed among individuals with long COVID, particularly Epstein–Barr virus. Levels of soluble immune mediators and hormones varied among groups, with cortisol levels being lower among participants with long COVID. Integration of immune phenotyping data into unbiased machine learning models identified the key features that are most strongly associated with long COVID status. Collectively, these findings may help to guide future studies into the pathobiology of long COVID and help with developing relevant biomarkers.
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- 2023
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18. Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High–risk Pulmonary Embolism: The CANARY Randomized Clinical Trial
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Sadeghipour, Parham, Jenab, Yaser, Moosavi, Jamal, Hosseini, Kaveh, Mohebbi, Bahram, Hosseinsabet, Ali, Chatterjee, Saurav, Pouraliakbar, Hamidreza, Shirani, Shapour, Shishehbor, Mehdi H., Alizadehasl, Azin, Farrashi, Melody, Rezvani, Mohammad Ali, Rafiee, Farnaz, Jalali, Arash, Rashedi, Sina, Shafe, Omid, Giri, Jay, Monreal, Manuel, Jimenez, David, Lang, Irene, Maleki, Majid, Goldhaber, Samuel Z., Krumholz, Harlan M., Piazza, Gregory, and Bikdeli, Behnood
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IMPORTANCE: The optimal treatment of intermediate-high–risk pulmonary embolism (PE) remains unknown. OBJECTIVE: To assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high–risk PE. DESIGN, SETTING, AND PARTICIPANTS: The Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High–Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high–risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020. INTERVENTIONS: Patients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy. MAIN OUTCOMES AND MEASURES: The proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes. RESULTS: The study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group. CONCLUSIONS AND RELEVANCE: This prematurely terminated randomized clinical trial of patients with intermediate-high–risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05172115
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- 2022
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19. Variation in Risk-standardized Rates and Causes of Unplanned Hospital Visits Within 7 Days of Hospital Outpatient Surgery
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Desai, Mayur M., Zogg, Cheryl K., Ranasinghe, Isuru, Parzynski, Craig S., Lin, Zhenqiu, Gorbaty, Marianna, Merrill, Angela, Krumholz, Harlan M., and Drye, Elizabeth E.
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- 2022
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20. 12th Korea Healthcare Congress 2021 김치국부터 마시지 말라: The Time for Digital Health is Almost Here.
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Krumholz, Harlan M.
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We are now on the cusp of massive adoption of digital health technologies. Medicine is becoming an information science intertwined with technology and data science. This talk aims to describe the current state of digital transformation in healthcare, to identify reasons for enthusiasm and caution, and to provide a framework for thinking about what is necessary for hospitals and health systems to be confident about incorporating these innovations into practice. I have three key recommendations. First, we should buy results, not claims. Those in positions that influence decisions about endorsing or purchasing digital products designed to improve care or outcomes ought to buy results, not claims or intermediate results. Moreover, although analytic validity and clinical validity are important, they sometimes do not reflect the impact of a product in its entirety. Ultimately, we need to know whether patients benefit. Second, we should insist on transparency. The performance of a product cannot be a secret. The basis on which developers make claims about their products should be open to all, including patients. Better yet, data on which experts reach a conclusion should be shared, just as many companies share research data on drugs and devices. Third, we should be aware of unintended adverse consequences. We should evaluate every intervention for unintended adverse consequences. Changes to systems, with all good intentions, can always go awry. In conclusion, insistence on good and evolving evidence is the best way to arrive at our destination: the use of innovations to improve outcomes. [ABSTRACT FROM AUTHOR]
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- 2022
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21. Association of Neighborhood-Level Material Deprivation With Atrial Fibrillation Care in a Single-Payer Health Care System: A Population-Based Cohort Study
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Abdel-Qadir, Husam, Akioyamen, Leo E., Fang, Jiming, Pang, Andrea, Ha, Andrew C.T., Jackevicius, Cynthia A., Alter, David A., Austin, Peter C., Atzema, Clare L., Bhatia, R. Sacha, Booth, Gillian L., Johnston, Sharon, Dhalla, Irfan, Kapral, Moira K., Krumholz, Harlan M., McNaughton, Candace D., Roifman, Idan, Tu, Karen, Udell, Jacob A., Wijeysundera, Harindra C., Ko, Dennis T., Schull, Michael J., and Lee, Douglas S.
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- 2022
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22. Efficacy and Safety Considerations With Dose-Reduced Direct Oral Anticoagulants: A Review
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Bikdeli, Behnood, Zahedi Tajrishi, Farbod, Sadeghipour, Parham, Talasaz, Azita H., Fanikos, John, Lippi, Giuseppe, Siegal, Deborah M., Eikelboom, John W., Monreal, Manuel, Jimenez, David, Connors, Jean M., Ageno, Walter, Barnes, Geoffrey D., Piazza, Gregory, Angiolillo, Dominick J., Parikh, Sahil A., Kirtane, Ajay J., Lopes, Renato D., Bhatt, Deepak L., Weitz, Jeffrey I., Mehran, Roxana, Krumholz, Harlan M., Goldhaber, Samuel Z., and Lip, Gregory Y. H.
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IMPORTANCE: Dose-reduced regimens of direct oral anticoagulants (DOACs) may be used for 2 main purposes: dose-adjusted treatment intended as full-intensity anticoagulation (eg, for stroke prevention in atrial fibrillation [AF] in patients requiring dose reduction) or low-intensity treatment (eg, extended-duration treatment of venous thromboembolism [VTE]). We reviewed randomized clinical trials (RCTs) to understand the scenarios in which dose-adjusted or low-intensity DOACs were tested and reviewed the labeled indications by regulatory authorities, using data from large registries to assess whether the use of dose-reduced DOACs in routine practice aligned with the findings of RCTs. OBSERVATIONS: Among 4191 screened publications, 35 RCTs that used dose-adjusted DOACs were identified for dabigatran, apixaban, rivaroxaban, and edoxaban. Of these 35 RCTs, 29 were related to stroke prevention in AF. Efficacy and safety results for dose-adjusted DOACs in large RCTs of AF were similar to those found for full-dose DOACs. To our knowledge, dabigatran, apixaban, and rivaroxaban have not been studied as dose-adjusted therapy for acute VTE treatment. Low-intensity DOACs were identified in 37 RCTs. Low-intensity DOACs may be used for extended-duration treatment of VTE (apixaban and rivaroxaban), primary prevention in orthopedic surgeries (dabigatran, apixaban, and rivaroxaban), primary prevention in ambulatory high-risk cancer patients (apixaban and rivaroxaban) or (postdischarge) high-risk medical patients (rivaroxaban), in stable atherosclerotic vascular disease, or after a recent revascularization for peripheral artery disease in conjunction with aspirin (rivaroxaban). Minor variations exist between regulatory authorities in different regions regarding criteria for dose adjustment of DOACs. Data from large registries indicated that dose-reduced DOACs were used occasionally with doses or for clinical scenarios different from those studied in RCTs or recommended by regulatory authorities. CONCLUSIONS AND RELEVANCE: Dose adjustment and low-intensity treatment are 2 different forms of dose-reduced DOACs. Dose adjustment is mostly relevant for AF and should be done based on the approved criteria. Dose adjustment of DOACs should not be used for acute VTE treatment in most cases. In contrast, low-intensity DOACs may be used for primary or secondary VTE prevention for studied and approved indications. Attention should be given to routine practice patterns to align the daily clinical practice with existing evidence of safety and efficacy.
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- 2022
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23. National Trends in Racial and Ethnic Disparities in Antihypertensive Medication Use and Blood Pressure Control Among Adults With Hypertension, 2011-2018.
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Lu, Yuan, Liu, Yuntian, Dhingra, Lovedeep Singh, Massey, Daisy, Caraballo, César, Mahajan, Shiwani, Spatz, Erica S., Onuma, Oyere, Herrin, Jeph, and Krumholz, Harlan M.
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Poor hypertension awareness and underuse of guideline-recommended medications are critical factors contributing to poor hypertension control. Using data from 8095 hypertensive people aged ≥18 years from the National Health and Nutrition Examination Survey (2011-2018), we examined recent trends in racial and ethnic differences in awareness and antihypertensive medication use, and their association with racial and ethnic differences in hypertension control. Between 2011 and 2018, age-adjusted hypertension awareness declined for Black, Hispanic, and White individuals, but the 3 outcomes increased or did not change for Asian individuals. Compared with White individuals, Black individuals had a similar awareness (odds ratio, 1.20 [0.96-1.45]) and overall treatment rates (1.04 [0.84-1.25]), and received more intensive antihypertensive medication if treated (1.41 [1.27-1.56]), but had a lower control rate (0.72 [0.61-0.83]). Asian and Hispanic individuals had significantly lower awareness rates (0.69 [0.52-0.85] and 0.74 [0.59-0.89]), overall treatment rates (0.72 [0.57-0.88] and 0.69 [0.55-0.82]), received less intensive medication if treated (0.60 [0.50-0.72] and 0.86 [0.75-0.96]), and had lower control rates (0.66 [0.54-0.79] and 0.69 [0.57-0.81]). The racial and ethnic differences in awareness, treatment, and control persisted over the study period and were consistent across age, sex, and income strata. Lower awareness and treatment were significantly associated with lower control in Asian and Hispanic individuals (P<0.01 for all) but not in Black individuals. These findings highlight the need for interventions to improve awareness and treatment among Asian and Hispanic individuals, and more investigation into the downstream factors that may contribute to the poor hypertension control among Black individuals. [ABSTRACT FROM AUTHOR]
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- 2022
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24. Association of STEMI regionalization of care with de facto NSTEMI regionalization.
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Montoy, Juan Carlos C., Shen, Yu-Chu, Krumholz, Harlan M, and Hsia, Renee Y.
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The regionalization of care for ST elevation myocardial infarction (STEMI) may unintentionally concentrate patients with non-ST elevation myocardial infarction (NSTEMI) into percutaneous coronary intervention (PCI) capable hospitals. This could lead to benefits such as increased access to PCI-capable hospitals, but could cause harms such as crowding in some hospitals with decreased patient volume and revenue in others. We set out to assess whether STEMI regionalization programs concentrated patients with NSTEMI at STEMI-receiving hospitals. [ABSTRACT FROM AUTHOR]
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- 2021
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25. Performance Metrics for the Comparative Analysis of Clinical Risk Prediction Models Employing Machine Learning.
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Chenxi Huang, Shu-Xia Li, Caraballo, César, Masoudi, Frederick A., Rumsfeld, John S., Spertus, John A., Normand, Sharon-Lise T., Mortazavi, Bobak J., Krumholz, Harlan M., Huang, Chenxi, and Li, Shu-Xia
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Background: New methods such as machine learning techniques have been increasingly used to enhance the performance of risk predictions for clinical decision-making. However, commonly reported performance metrics may not be sufficient to capture the advantages of these newly proposed models for their adoption by health care professionals to improve care. Machine learning models often improve risk estimation for certain subpopulations that may be missed by these metrics.Methods and Results: This article addresses the limitations of commonly reported metrics for performance comparison and proposes additional metrics. Our discussions cover metrics related to overall performance, discrimination, calibration, resolution, reclassification, and model implementation. Models for predicting acute kidney injury after percutaneous coronary intervention are used to illustrate the use of these metrics.Conclusions: We demonstrate that commonly reported metrics may not have sufficient sensitivity to identify improvement of machine learning models and propose the use of a comprehensive list of performance metrics for reporting and comparing clinical risk prediction models. [ABSTRACT FROM AUTHOR]- Published
- 2021
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26. Use of Open Science Practices in Surgical Journals
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Pathak, Kavya, Marwaha, Jayson S., Chen, Hao Wei, Krumholz, Harlan M., and Matthews, Jeffrey B.
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- 2024
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27. Prioritizing the Exposome to Reduce Cardiovascular Disease Burden
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Spatz, Erica S., Chen, Kai, and Krumholz, Harlan M.
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- 2024
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28. Trends in 10-Year Outcomes Among Medicare Beneficiaries Who Survived an Acute Myocardial Infarction
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Wang, Yun, Leifheit, Erica C., and Krumholz, Harlan M.
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IMPORTANCE: Short-term outcomes after acute myocardial infarction (AMI) have improved, but little is known about longer-term outcomes. OBJECTIVE: To evaluate trends in 10-year all-cause mortality and hospitalization for recurrent AMI by demographic subgroups and examine the association between recurrence and mortality. DESIGN, SETTING, AND PARTICIPANTS: Medicare fee-for-service beneficiaries who survived after AMI from 1995 to 2019. Subgroups were defined by age, sex, race, dual Medicare-Medicaid–eligible status, and residence in health priority areas (geographic areas with persistently high adjusted mortality and hospitalization rates). Data were analyzed from October 2020 to February 2022. EXPOSURE: Medicare fee-for-service beneficiaries who survived an AMI. MAIN OUTCOMES AND MEASURES: Ten-year all-cause mortality and hospitalization for recurrent AMI, beginning 30 days from the index AMI admission. RESULTS: Of an included 3 982 266 AMI survivors, 1 952 450 (49.0%) were female, and the mean (SD) age was 78.0 (7.4) years. Ten-year mortality and recurrent AMI rates were 72.7% (95% CI, 72.6-72.7) and 27.1% (95% CI, 27.0-27.2), respectively. Adjusted annual reductions were 1.5% (95% CI, 1.4-1.5) for mortality and 2.7% (95% CI, 2.6-2.7) for recurrence. In subgroup analyses balancing patient characteristics, hazard ratios (HRs) for mortality and recurrence were 1.13 (95% CI, 1.12-1.13) and 1.07 (95% CI, 1.06-1.07), respectively, for men vs women; 1.05 (95% CI, 1.05-1.06) and 1.08 (95% CI, 1.07-1.09) for Black vs White patients; 0.96 (95% CI, 0.95-0.96) and 1.00 (95% CI, 1.00-1.01) for other race (including American Indian and Alaska Native, Asian, Hispanic, other race or ethnicity, and unreported) vs White patients; 1.24 (95% CI, 1.24-1.24) and 1.21 (95% CI, 1.20-1.21) for dual Medicare-Medicaid–eligible vs non–dual Medicare-Medicaid–eligible patients; and 1.06 (95% CI, 1.06-1.07) and 1.00 (95% CI, 1.00-1.01) for patients in health priority areas vs other areas. For patients hospitalized in 2007 to 2009, the last 3 years for which full 10-year follow-up data were available, 10-year mortality risk was 13.9% lower than for those hospitalized in 1995 to 1997 (adjusted HR, 0.86; 95% CI, 0.85-0.87) and 10-year recurrence risk was 22.5% lower (adjusted HR, 0.77; 95% CI, 0.76-0.78). Mortality within 10 years after the initial AMI was higher for patients with a recurrent AMI (80.6%; 95% CI, 80.5-80.7) vs those without recurrence (72.4%; 95% CI, 72.3-72.5). CONCLUSIONS AND RELEVANCE: In this study, 10-year mortality and hospitalization for recurrence rates improved over the last decades for patients who survived the acute period of AMI. There were marked differences in outcomes and temporal trends across demographic subgroups, emphasizing the urgent need for prioritization of efforts to reduce inequities in long-term outcomes.
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- 2022
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29. A prescription for the US FDA for the regulation of health misinformation
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Kadakia, Kushal T., Beckman, Adam L., and Krumholz, Harlan M.
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The US Food and Drug Administration should address health misinformation through existing and new regulatory approaches, including modernizing product labeling, investing in infodemic surveillance and addressing the roles of the internet and social media.
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- 2023
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30. Cardiac Status Among Heart Failure Patients With Implantable Cardioverter Defibrillators Before, During, and After COVID-19 Lockdown.
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Lu, Yuan, Jones, Paul W., Caraballo, César, Mahajan, Shiwani, Massey, Daisy S., Ahmed, Rezwan, Bader, Eric M., and Krumholz, Harlan M.
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- 2022
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31. Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction.
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Ozaki, Aya F., Krumholz, Harlan M., Mody, Freny Vaghaiwalla, Tran, Tien T., Le, Quan T., Mai Yokota, Jackevicius, Cynthia A., and Yokota, Mai
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AMINOBUTYRIC acid ,COMBINATION drug therapy ,CROSS-sectional method ,BIPHENYL compounds ,ANGIOTENSIN receptors ,STROKE volume (Cardiac output) ,HEART failure ,MEDICARE - Abstract
Background: Slow uptake of sacubitril/valsartan in patients with heart failure with reduced ejection fraction has been reported, which may negatively impact clinical outcomes. We characterized prior authorization (PA) burden, prescription copayment, and utilization of sacubitril/valsartan by insurance plan type to identify potential barriers to its use.Methods: We conducted a national population-level, cross-sectional study using PA data from an insurance coverage website accessed in March 2019 and IQVIA National Prescription Audit data from August 2018 to July 2019. Primary outcomes were proportion of plans requiring PA, frequency of specific PA criteria, number of sacubitril/valsartan prescriptions, and copayments per insurance plan type.Results: Overall, 48.1% (1394/2896) of insurance plans required PA for sacubitril/valsartan. Fewer Medicare (27.7%) than commercial (57.2%) plans required PA (P<0.001). For both plan types, the most frequently required PA criteria were ejection fraction (71.6%, 90.9%) and New York Heart Association class (60.4%, 90.8%) for Medicare and commercial plans, respectively. Copayment amounts varied by plan type, with more sacubitril/valsartan prescriptions for commercial plans not requiring a patient copayment (32.4%) compared with Medicare plans (19.3%; P<0.001). There were 814 437 sacubitril/valsartan prescriptions for Medicare and 822 292 for commercial plans dispensed from August 2018 to July 2019. Based on estimated heart failure with reduced ejection fraction populations for each plan type, 4-fold more sacubitril/valsartan prescriptions were dispensed in commercial than in Medicare plans (820 versus 215 prescriptions/1000 individuals in the heart failure with reduced ejection fraction population). The estimated proportion of heart failure with reduced ejection fraction patients prescribed sacubitril/valsartan was 3.6% (1.5%-6.8%) for Medicare and 13.7% (4.9%-31.8%) for commercial plan populations.Conclusions: Despite commercial plans having greater PA requirements than Medicare, population-adjusted use of sacubitril/valsartan was higher in commercial plans. Given that commercial plans had more prescriptions with low copayments than Medicare, copayment policies may be more influential on sacubitril/valsartan use than its PA policies. Low sacubitril/valsartan use in both plan types highlights the multifactorial nature of medication underutilization that includes factors beyond the drug policies that we evaluated. [ABSTRACT FROM AUTHOR]- Published
- 2021
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32. Comparative First-Line Effectiveness and Safety of ACE (Angiotensin-Converting Enzyme) Inhibitors and Angiotensin Receptor Blockers: A Multinational Cohort Study.
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RuiJun Chen, Suchard, Marc A., Krumholz, Harlan M., Schuemie, Martijn J., Shea, Steven, Duke, Jon, Pratt, Nicole, Reich, Christian G., Madigan, David, You, Seng Chan, Ryan, Patrick B., Hripcsak, George, and Chen, RuiJun
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[Figure: see text]. [ABSTRACT FROM AUTHOR]
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- 2021
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33. National Trends in the Use of Sacubitril/Valsartan.
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Ozaki, Aya F., Krumholz, Harlan M., Mody, Freny V., and Jackevicius, Cynthia A.
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Background: Better understanding of recent sacubitril/valsartan prescription patterns may help identify factors that influence its use. The aim of the study was to characterize sacubitril/valsartan use and dosage patterns nationally.Methods and Results: We conducted a population-level cohort study using IQVIA Inc. National Prescription Audit™ data in the United States from August 2016 to July 2019. Over 3 years, there was a 5.6-fold increase in the number of sacubitril/valsartan prescriptions dispensed per month, totaling 3.3 million prescriptions. For the most recent year, this extrapolates to a best-case scenario of 13.8% of patients with heart failure with reduced ejection fraction using sacubitril/valsartan, representing at most one-half of those eligible for sacubitril/valsartan use. During the most recent year, 48.7% of dispensed prescriptions were for the lowest strength (24/26 mg) and only 20.6% for the target strength (97/103 mg). A greater proportion of the target strength was used in younger patients (< 65years: 24.6%; ≥ 85: 11.1%; P<0.0001). Cardiologists prescribed 59.0% of all dispensed prescriptions, and noncardiologists showed a greater increase (7.5-fold vs 4.9-fold; P<0.0001) over time.Conclusions: Recent use of sacubitril/valsartan has increased greatly in the United States; however, a substantial proportion of eligible patients with heart failure with reduced ejection fraction did not receive treatment, and only 1 in 5 prescriptions dispensed were for the target strength. Further exploration of barriers to the use of sacubitril/valsartan and dosing uptitration and their clinical implications warrant further evaluation. [ABSTRACT FROM AUTHOR]- Published
- 2021
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34. Unscheduled Care Access in the United States-A Tale of Two Emergency Departments.
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Venkatesh, Arjun K., Greenwood-Ericksen, Margaret B., Mei, Hao, Rothenberg, Craig, Lin, Zhenqiu, and Krumholz, Harlan M.
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Background: Rural communities face challenges in accessing healthcare services due to physician shortages and limited unscheduled care capabilities in office settings. As a result, rural hospital-based Emergency Departments (ED) may disproportionately provide acute, unscheduled care needs. We sought to examine differences in ED utilization and the relative role of the ED in providing access to unscheduled care between rural and urban communities.Methods: Using a 20% sample of the 2012 Medicare Chronic Condition Warehouse, we studied the overall ED visit rate and the unscheduled care rate by geography using the Dartmouth Atlas' hospital referral regions (HRR). We calculated HRR urbanicity as the proportion of beneficiaries residing in an urban zip code within each HRR. We report descriptive statistics and utilize K-means clustering based on the ED visit rates and unscheduled care rates.Results: We found rural ED use is more common and disproportionately the site of unscheduled care delivery when compared to urban communities. The ED visit and. unscheduled care proportions were negatively correlated with increased urbanicity (r =. -0.48, p < 0.001; r = -0.58, p < 0.001).Conclusion: The use and role of EDs by Medicare beneficiaries appears to be substantially different between urban and rural areas. This suggests that the ED may play a distinct role within the healthcare delivery system of rural communities that face disproportionate barriers to care access. [ABSTRACT FROM AUTHOR]- Published
- 2021
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35. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
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Kadakia, Kushal T., Beckman, Adam L., Ross, Joseph S., and Krumholz, Harlan M.
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IMPORTANCE: Strengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of device safety and oversight that mandate attention. OBJECTIVES: To review the regulatory history and clinical evidence of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) and use the device recall as a case study of the challenges associated with clinical evaluation, transparency, and oversight of medical devices in the US. EVIDENCE: Regulatory history and clinical evidence for the Penumbra medical devices were analyzed through a qualitative review of decision letters in the Access FDA database for medical devices and medical device reports in the Manufacturer and User Facility Device Experience database and a review of market data (eg, earnings calls, company communications) and clinical literature. FINDINGS: The JET 7 device was subjected to a class I recall following more than 200 adverse event reports, 14 of which involved patient deaths. Regulatory analysis indicated that each of the Penumbra reperfusion catheters was cleared under the 510(k) pathway (which allows devices to be authorized with limited to no clinical evidence), with limited submission of either new clinical or animal data. Clinical evidence for Penumbra devices was generated from nonrandomized, single-arm trials with small sample sizes. The regulatory issues raised by JET 7 are reflective of broader challenges for medical device regulation. Opportunities for reform include strengthening premarket evidence requirements, requiring safety reporting with unique device identifiers, and mandating active methods of postmarket surveillance. CONCLUSIONS AND RELEVANCE: The case study of JET 7 highlights the long-standing gaps in medical device oversight and renews the impetus to build on the Institute of Medicine recommendations and reform FDA medical device regulation to protect public health.
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- 2022
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36. Leading Causes of Death Among Adults Aged 25 to 44 Years by Race and Ethnicity in Texas During the COVID-19 Pandemic, March to December 2020
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Faust, Jeremy Samuel, Chen, Alexander Junxiang, Nguemeni Tiako, Max Jordan, Du, Chengan, Li, Shu-Xia, Krumholz, Harlan M., and Barnett, Michael L.
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- 2022
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37. Intermediate-Dose versus Standard-Dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to the Intensive Care Unit: 90-Day Results from the INSPIRATION Randomized Trial
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Bikdeli, Behnood, Talasaz, Azita H., Rashidi, Farid, Bakhshandeh, Hooman, Rafiee, Farnaz, Rezaeifar, Parisa, Baghizadeh, Elahe, Matin, Samira, Jamalkhani, Sepehr, Tahamtan, Ouria, Sharif-Kashani, Babak, Beigmohammadi, Mohammad Taghi, Farrokhpour, Mohsen, Sezavar, Seyed Hashem, Payandemehr, Pooya, Dabbagh, Ali, Moghadam, Keivan Gohari, Khalili, Hossein, Yadollahzadeh, Mahdi, Riahi, Taghi, Abedini, Atefeh, Lookzadeh, Somayeh, Rahmani, Hamid, Zoghi, Elnaz, Mohammadi, Keyhan, Sadeghipour, Pardis, Abri, Homa, Tabrizi, Sanaz, Mousavian, Seyed Masoud, Shahmirzaei, Shaghayegh, Amin, Ahmad, Mohebbi, Bahram, Parhizgar, Seyed Ehsan, Aliannejad, Rasoul, Eslami, Vahid, Kashefizadeh, Alireza, Dobesh, Paul P., Kakavand, Hessam, Hosseini, Seyed Hossein, Shafaghi, Shadi, Ghazi, Samrand Fattah, Najafi, Atabak, Jimenez, David, Gupta, Aakriti, Madhavan, Mahesh V., Sethi, Sanjum S., Parikh, Sahil A., Monreal, Manuel, Hadavand, Naser, Hajighasemi, Alireza, Maleki, Majid, Sadeghian, Saeed, Piazza, Gregory, Kirtane, Ajay J., Van Tassell, Benjamin W., Stone, Gregg W., Lip, Gregory Y. H., Krumholz, Harlan M., Goldhaber, Samuel Z., and Sadeghipour, Parham
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- 2022
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38. Toward Dynamic Risk Prediction of Outcomes After Coronary Artery Bypass Graft: Improving Risk Prediction With Intraoperative Events Using Gradient Boosting.
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Mori, Makoto, Durant, Thomas J. S., Chenxi Huang, Mortazavi, Bobak J., Coppi, Andreas, Jean, Raymond A., Geirsson, Arnar, Schulz, Wade L., Krumholz, Harlan M., and Huang, Chenxi
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Background: Intraoperative data may improve models predicting postoperative events. We evaluated the effect of incorporating intraoperative variables to the existing preoperative model on the predictive performance of the model for coronary artery bypass graft.Methods: We analyzed 378 572 isolated coronary artery bypass graft cases performed across 1083 centers, using the national Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2014 and 2016. Outcomes were operative mortality, 5 postoperative complications, and composite representation of all events. We fitted models by logistic regression or extreme gradient boosting (XGBoost). For each modeling approach, we used preoperative only, intraoperative only, or pre+intraoperative variables. We developed 84 models with unique combinations of the 3 variable sets, 2 variable selection methods, 2 modeling approaches, and 7 outcomes. Each model was tested in 20 iterations of 70:30 stratified random splitting into development/testing samples. Model performances were evaluated on the testing dataset using the C statistic, area under the precision-recall curve, and calibration metrics, including the Brier score.Results: The mean patient age was 65.3 years, and 24.7% were women. Operative mortality, excluding intraoperative death, occurred in 1.9%. In all outcomes, models that considered pre+intraoperative variables demonstrated significantly improved Brier score and area under the precision-recall curve compared with models considering pre or intraoperative variables alone. XGBoost without external variable selection had the best C statistics, Brier score, and area under the precision-recall curve values in 4 of the 7 outcomes (mortality, renal failure, prolonged ventilation, and composite) compared with logistic regression models with or without variable selection. Based on the calibration plots, risk restratification for mortality showed that the logistic regression model underestimated the risk in 11 114 patients (9.8%) and overestimated in 12 005 patients (10.6%). In contrast, the XGBoost model underestimated the risk in 7218 patients (6.4%) and overestimated in 0 patients (0%).Conclusions: In isolated coronary artery bypass graft, adding intraoperative variables to preoperative variables resulted in improved predictions of all 7 outcomes. Risk models based on XGBoost may provide a better prediction of adverse events to guide clinical care. [ABSTRACT FROM AUTHOR]- Published
- 2021
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39. Obesity Prevalence and Risks Among Chinese Adults: Findings From the China PEACE Million Persons Project, 2014-2018.
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Lin Mu, Jiamin Liu, Guohai Zhou, Chaoqun Wu, Bowang Chen, Yuan Lu, Jiapeng Lu, Xiaofang Yan, Zhihong Zhu, Nasir, Khurram, Spatz, Erica S., Krumholz, Harlan M., Xin Zheng, Mu, Lin, Liu, Jiamin, Zhou, Guohai, Wu, Chaoqun, Chen, Bowang, Lu, Yuan, and Lu, Jiapeng
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OBESITY ,RESEARCH ,CROSS-sectional method ,RESEARCH methodology ,MEDICAL cooperation ,EVALUATION research ,COMPARATIVE studies ,WAIST circumference ,DISEASE prevalence ,RESEARCH funding ,BODY mass index - Abstract
Background: China has seen a burgeoning epidemic of obesity in recent decades, but few studies reported nationally on obesity across socio-demographic subgroups. We sought to assess the prevalence and socio-demographic associations of obesity nationwide.Methods: We assessed the prevalence of overall obesity (body mass index ≥28 kg/m2) and abdominal obesity (waist circumference ≥85/90 cm for women/men) among 2.7 million community-dwelling adults aged 35 to 75 years in the China PEACE Million Persons Project from 2014 to 2018 and quantified the socio-demographic associations of obesity using multivariable mixed models.Results: Age-standardized rates of overall and abdominal obesity were 14.4% (95% CI, 14.3%-14.4%) and 32.7% (32.6%-32.8%) in women and 16.0% (15.9%-16.1%) and 36.6% (36.5%-36.8%) in men. Obesity varied considerably across socio-demographic subgroups. Older women were at higher risk for obesity (eg, adjusted relative risk [95% CI] of women aged 65-75 versus 35-44 years: 1.29 [1.27-1.31] for overall obesity, 1.76 [1.74-1.77] for abdominal obesity) while older men were not. Higher education was associated with lower risk in women (eg, adjusted relative risk [95% CI] of those with college or university education versus below primary school: 0.47 [0.46-0.48] for overall obesity, 0.61 [0.60-0.62] for abdominal obesity) but higher risk in men (1.07 [1.05-1.10], 1.17 [1.16-1.19]).Conclusions: In China, over 1 in 7 individuals meet criteria for overall obesity, and 1 in 3 for abdominal obesity. Wide variation exists across socio-demographic subgroups. The associations of age and education with obesity are significant and differ by sex. Understanding obesity in contemporary China has broad domestic policy implications and provides a valuable international reference. [ABSTRACT FROM AUTHOR]- Published
- 2021
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40. Comprehensive Comparative Effectiveness and Safety of First-Line β-Blocker Monotherapy in Hypertensive Patients: A Large-Scale Multicenter Observational Study.
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Chan You, Seng, Krumholz, Harlan M., Suchard, Marc A., Schuemie, Martijn J., Hripcsak, George, Chen, RuiJun, Shea, Steven, Duke, Jon, Pratt, Nicole, Reich, Christian G., Madigan, David, Ryan, Patrick B., Woong Park, Rae, and Park, Sungha
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[Figure: see text]. [ABSTRACT FROM AUTHOR]
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- 2021
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41. How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice.
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Carter, Alexander W., Jayawardana, Sahan, Costa-Font, Joan, Nasir, Khurram, Krumholz, Harlan M., and Mossialos, Elias
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BACKGROUND: Quasi-experimental methods (QEMs) are a family of techniques used to estimate causal relationships when randomized controlled trials are unfeasible or unethical. They offer a powerful alternative to observational studies by introducing random assignment of individuals or groups into their design, thereby offering stronger means of establishing causation. The use of QEMs in cardiovascular research has not been systematically examined to determine steps toward improving and expanding their use. METHODS: We identified 4 main techniques using a systematic search strategy from 2016 to 2021: instrumental variable analysis, interrupted time series analysis, difference-in-differences analysis, and regression discontinuity designs. QEMs are examined as alternatives to randomized controlled trials and traditional observational studies; as more observational data becomes available to researchers, there are more opportunities to apply these techniques. Eligible articles were selected based on publication in high-ranked journals. The quality of eligible articles was appraised using the Joanna Briggs Institute checklist for quasi-experimental studies. RESULTS: Data from 380 studies were extracted based on our inclusion criteria. Forty-two of these studies were published in the top 10 medical or top 20 cardiovascular disease journals, and 25 studies were included after quality appraisal. The review identifies the main features and limitations associated with each technique, providing readers with practical guidance on how to apply these to their research. A graphical decision aid was developed to facilitate the routine use of QEMs. CONCLUSIONS: The use of QEMs in cardiovascular research published in contemporary, high-impact articles was examined. Findings are biased toward this segment of literature, which represents the latest developments in this growing area of cardiovascular research. The decision aid is a novel schematic that researchers can adopt into practice. [ABSTRACT FROM AUTHOR]
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- 2024
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42. Changes in Functional Status and Health-Related Quality of Life in Older Adults After Surgical, Interventional, or Medical Management of Acute Myocardial Infarction.
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Mori, Makoto, Djulbegovic, Mia, Hajduk, Alexandra M., Holland, Margaret L., Krumholz, Harlan M., and Chaudhry, Sarwat I.
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Functional status and health-related quality of life (HRQoL) are important outcomes, particularly among older patients. However, data on such patient-centered outcomes after cardiac surgery are limited. We evaluated the incidence and predictors of decline in functional status and HRQoL among older patients hospitalized for acute myocardial infarction (AMI). Participants were age 75 years or older hospitalized for AMI at 94 US sites. We examined decline in functional status (defined as decline in 1 or more activities of daily living, ADLs), as well as mental (MCS) and physical component scales (PCS) of the SF-12 to assess HRQoL (5-point decline or greater in each scale) between 1 month prior to the hospitalization and 6 months after. Multivariable model compared the risk of decline after coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) and medical management. Among 3041 patients (1708 PCI, 362 CABG, and 971 medical management), 1525 (50.2%) experienced decline in 1 or more domain: 633 (20.8%) declined in ADLs, 786 (25.9%) declined in the MCS, and 1078 (35.5%) declined in the PCS. The unadjusted incidence of ADL decline was the lowest among patients who underwent CABG (n = 50, 13.8%) compared with PCI (n = 271, 15.9%) or medical management (n = 312, 32.1%). Patients who underwent CABG and PCI had lower adjusted risk of decline in functional and HRQoL compared with those who received medical therapy. The risks after CABG and PCI were not significantly different. Over half of older patients significantly declined in function or HRQoL after AMI. Compared with medical management, risk of decline was lower in those who underwent revascularization. [ABSTRACT FROM AUTHOR]
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- 2021
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43. Administrative Claims Measure for Profiling Hospital Performance Based on 90-Day All-Cause Mortality Following Coronary Artery Bypass Graft Surgery.
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Makoto Mori, Nasir, Khurram, Haikun Bao, Jimenez, Andreina, Legore, Shani S., Yongfei Wang, Grady, Jacqueline, Lama, Sonam D., Brandi, Nina, Zhenqiu Lin, Kurlansky, Paul, Geirsson, Arnar, Bernheim, Susannah M., Krumholz, Harlan M., Suter, Lisa G., Mori, Makoto, Bao, Haikun, Wang, Yongfei, and Lin, Zhenqiu
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HOSPITALS ,RESEARCH ,CORONARY artery bypass ,RESEARCH methodology ,PATIENT readmissions ,MEDICAL cooperation ,EVALUATION research ,HOSPITAL mortality ,COMPARATIVE studies ,MEDICARE - Abstract
Background: Coronary artery bypass graft (CABG) surgery is a focus of bundled and alternate payment models that capture outcomes up to 90 days postsurgery. While clinical registry risk models perform well, measures encompassing mortality beyond 30 days do not currently exist. We aimed to develop a risk-adjusted hospital-level 90-day all-cause mortality measure intended for assessing hospital performance in payment models of CABG surgery using administrative data.Methods: Building upon Centers for Medicare and Medicaid Services hospital-level 30-day all-cause CABG mortality measure specifications, we extended the mortality timeframe to 90 days after surgery and developed a new hierarchical logistic regression model to calculate hospital risk-standardized 90-day all-cause mortality rates for patients hospitalized for isolated CABG. The model was derived from Medicare claims data for a 3-year cohort between July 2014 to June 2017. The data set was randomly split into 50:50 development and validation samples. The model performance was evaluated with C statistics, overfitting indices, and calibration plot. The empirical validity of the measure result at the hospital level was evaluated against the Society of Thoracic Surgeons composite star rating.Results: Among 137 819 CABG procedures performed in 1183 hospitals, the unadjusted mortality rate within 30 and 90 days were 3.1% and 4.7%, respectively. The final model included 27 variables. Hospital-level 90-day risk-standardized mortality rates ranged between 2.04% and 11.26%, with a median of 4.67%. C statistics in the development and validation samples were 0.766 and 0.772, respectively. We identified a strong positive correlation between 30- and 90-day risk-standardized mortality rates, with a regression slope of 1.09. Risk-standardized mortality rates also showed a stepwise trend of lower 90-day mortality with higher Society of Thoracic Surgeons composite star ratings.Conclusions: We present a measure of hospital-level 90-day risk-standardized mortality rates following isolated CABG. This measure complements Centers for Medicare and Medicaid Services' existing 30-day CABG mortality measure by providing greater insight into the postacute recovery period. It offers a balancing measure to ensure efforts to reduce costs associated with CABG recovery and rehabilitation do not result in unintended consequences. [ABSTRACT FROM AUTHOR]- Published
- 2021
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44. Association Between Sociodemographic Determinants and Disparities in Stroke Symptom Awareness Among US Young Adults.
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Mszar, Reed, Mahajan, Shiwani, Valero-Elizondo, Javier, Yahya, Tamer, Sharma, Richa, Grandhi, Gowtham R., Khera, Rohan, Virani, Salim S., Lichtman, Judith, Khan, Safi U., Cainzos-Achirica, Miguel, Vahidy, Farhaan S., Krumholz, Harlan M., and Nasir, Khurram
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- 2020
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45. Use of Machine Learning Models to Predict Death After Acute Myocardial Infarction
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Khera, Rohan, Haimovich, Julian, Hurley, Nathan C., McNamara, Robert, Spertus, John A., Desai, Nihar, Rumsfeld, John S., Masoudi, Frederick A., Huang, Chenxi, Normand, Sharon-Lise, Mortazavi, Bobak J., and Krumholz, Harlan M.
- Abstract
IMPORTANCE: Accurate prediction of adverse outcomes after acute myocardial infarction (AMI) can guide the triage of care services and shared decision-making, and novel methods hold promise for using existing data to generate additional insights. OBJECTIVE: To evaluate whether contemporary machine learning methods can facilitate risk prediction by including a larger number of variables and identifying complex relationships between predictors and outcomes. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used the American College of Cardiology Chest Pain-MI Registry to identify all AMI hospitalizations between January 1, 2011, and December 31, 2016. Data analysis was performed from February 1, 2018, to October 22, 2020. MAIN OUTCOMES AND MEASURES: Three machine learning models were developed and validated to predict in-hospital mortality based on patient comorbidities, medical history, presentation characteristics, and initial laboratory values. Models were developed based on extreme gradient descent boosting (XGBoost, an interpretable model), a neural network, and a meta-classifier model. Their accuracy was compared against the current standard developed using a logistic regression model in a validation sample. RESULTS: A total of 755 402 patients (mean [SD] age, 65 [13] years; 495 202 [65.5%] male) were identified during the study period. In independent validation, 2 machine learning models, gradient descent boosting and meta-classifier (combination including inputs from gradient descent boosting and a neural network), marginally improved discrimination compared with logistic regression (C statistic, 0.90 for best performing machine learning model vs 0.89 for logistic regression). Nearly perfect calibration in independent validation data was found in the XGBoost (slope of predicted to observed events, 1.01; 95% CI, 0.99-1.04) and the meta-classifier model (slope of predicted-to-observed events, 1.01; 95% CI, 0.99-1.02), with more precise classification across the risk spectrum. The XGBoost model reclassified 32 393 of 121 839 individuals (27%) and the meta-classifier model reclassified 30 836 of 121 839 individuals (25%) deemed at moderate to high risk for death in logistic regression as low risk, which were more consistent with the observed event rates. CONCLUSIONS AND RELEVANCE: In this cohort study using a large national registry, none of the tested machine learning models were associated with substantive improvement in the discrimination of in-hospital mortality after AMI, limiting their clinical utility. However, compared with logistic regression, XGBoost and meta-classifier models, but not the neural network, offered improved resolution of risk for high-risk individuals.
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- 2021
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46. How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice
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Carter, Alexander W., Jayawardana, Sahan, Costa-Font, Joan, Nasir, Khurram, Krumholz, Harlan M., and Mossialos, Elias
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- 2024
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47. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial
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Song, Jiali, Wang, Xiuling, Wang, Bin, Ge, Yilan, Bi, Lei, Jing, Fuyu, Jin, Huijun, Li, Teng, Gu, Bo, Wang, Lili, Hao, Jun, Zhao, Yanyan, Liu, Jiamin, Zhang, Haibo, Li, Xi, Li, Jing, Ma, Wenjun, Wang, Jiguang, Normand, Sharon-Lise T, Herrin, Jeph, Armitage, Jane, Krumholz, Harlan M, and Zheng, Xin
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ObjectiveTo evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China.DesignPragmatic, open label, cluster randomised trial.Setting94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen (south China, including two regions).Participants94 practices were randomised (46 to CDSS, 48 to usual care). 12 137 participants with hypertension who used up to two classes of antihypertensives and had a systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg were included.InterventionsPrimary care practices were randomised to use an electronic health record based CDSS, which recommended a specific guideline accordant regimen for initiation, titration, or switching of antihypertensive (the intervention), or to use the same electronic health record without CDSS and provide treatment as usual (control).Main outcome measuresThe primary outcome was the proportion of hypertension related visits during which an appropriate (guideline accordant) treatment was provided. Secondary outcomes were the average reduction in systolic blood pressure and proportion of participants with controlled blood pressure (<140/90 mm Hg) at the last scheduled follow-up. Safety outcomes were patient reported antihypertensive treatment related events, including syncope, injurious fall, symptomatic hypotension or systolic blood pressure <90 mm Hg, and bradycardia.Results5755 participants with 23 113 visits in the intervention group and 6382 participants with 27 868 visits in the control group were included. Mean age was 61 (standard deviation 13) years and 42.5% were women. During a median 11.6 months of follow-up, the proportion of visits at which appropriate treatment was given was higher in the intervention group than in the control group (77.8% (17 975/23 113) v62.2% (17 328/27 868); absolute difference 15.2 percentage points (95% confidence interval (CI) 10.7 to 19.8); P<0.001; odds ratio 2.17 (95% CI 1.75 to 2.69); P<0.001). Compared with participants in the control group, those in the intervention group had a 1.6 mm Hg (95% CI −2.7 to −0.5) greater reduction in systolic blood pressure (−1.5 mm Hg v0.3 mm Hg; P=0.006) and a 4.4 percentage point (95% CI −0.7 to 9.5) improvement in blood pressure control rate (69.0% (3415/4952) v64.6% (3778/5845); P=0.07). Patient reported antihypertensive treatment related adverse effects were rare in both groups.ConclusionsUse of a CDSS in primary care in China improved the provision of guideline accordant antihypertensive treatment and led to a modest reduction in blood pressure. The CDSS offers a promising approach to delivering better care for hypertension, both safely and efficiently.Trial registrationClinicalTrials.gov NCT03636334.
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- 2024
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48. Cost-effectiveness of rapid vs in-house vs send-out ADAMTS13 testing for immune thrombotic thrombocytopenic purpura
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Allen, Cecily, Ito, Satoko, Butt, Ayesha, Purcell, Adriana, Richmond, Rhys, Tormey, Christopher A., Krumholz, Harlan M., Cuker, Adam, and Goshua, George
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•Rapid ADAMTS13 assay utilization is a cost-saving strategy in the care of patients with intermediate and high PLASMIC scores.•Cost savings with the rapid ADAMTS13 assay are greatest in the context of empiric treatment with caplacizumab.
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- 2024
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49. Variation in Reader-Reported Severity of Paradoxical Low-Flow Low-Gradient Aortic Stenosis
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Shah, Nimish N., Sugeng, Lissa, Zhang, Zhiyuan, Wang, Kangxin, McNamara, Robert L., Agarwal, Vratika, Hur, David J., Lombo, Bernardo, Bellumkonda, Lavanya, Mankbadi, Michael, Basem Dajani, Abdel Rahman, Forrest, John K., Krumholz, Harlan M., Reinhardt, Samuel W., Velazquez, Eric J., and Faridi, Kamil F.
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- 2024
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50. Interplay of Coronary Artery Calcium and Risk Factors for Predicting CVD/CHD Mortality: The CAC Consortium.
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Grandhi, Gowtham R., Mirbolouk, Mohammadhassan, Dardari, Zeina A., Al-Mallah, Mouaz H., Rumberger, John A., Shaw, Leslee J., Blankstein, Ron, Miedema, Michael D., Berman, Daniel S., Budoff, Matthew J., Krumholz, Harlan M., Blaha, Michael J., and Nasir, Khurram
- Abstract
This study sought to evaluate the association and burden of coronary artery calcium (CAC) with long-term, cause-specific mortality across the spectrum of baseline risk. Although CAC is a known predictor of short-term, all-cause mortality, data on long-term and cause-specific mortality are inadequate. The CAC Consortium cohort is a multicenter cohort of 66,636 participants without coronary heart disease (CHD) who underwent CAC testing. The following risk factors (RFs) were considered: 1) current cigarette smoking; 2) dyslipidemia; 3) diabetes mellitus; 4) hypertension; and 5) family history of CHD. During the 12.5-years median follow-up, 3,158 (4.7%) deaths occurred; 32% were cardiovascular disease (CVD) deaths. Participants with CAC scores ≥400 had a significantly increased risk for CHD and CVD mortality (hazard ratio [HR]: 5.44; 95% confidence interval [CI]: 3.88 to 7.62; and HR: 4.15; 95% CI: 3.29 to 5.22, respectively) compared with CAC of 0. Participants with ≥3 RFs had a smaller increased risk for CHD and CVD mortality (HR: 2.09; 95% CI: 1.52 to 2.85; and HR: 1.84; 95% CI: 1.46 to 2.31, respectively) compared with those without RFs. Across RF strata, CAC added prognostic information. For example, participants without RFs but with CAC ≥400 had significantly higher all-cause, non-CVD, CVD, and CHD mortality rates compared with participants with ≥3 RFs and CAC of 0. Across the spectrum of RF burden, a higher CAC score was strongly associated with long-term, all-cause mortality and a greater proportion of deaths due to CVD and CHD. Absence of CAC identified people with a low risk over 12 years of follow-up, with most deaths being non-CVD in nature, regardless of RF burden. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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