Journal: Circ Cardiovasc Qual Outcomes

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Abstract

Joint Modeling of Longitudinal Markers and Time-to-Event Outcomes: An Application and Tutorial in Patients After Surgical Repair of Transposition of the Great Arteries.

Baart SJ, van der Palen RLF, Putter H, Tsonaka R, ... Rizopoulos D, van Geloven N
Background
Most patients with congenital heart disease survive into adulthood; however, residual abnormalities remain and management of the patients is life-long and personalized. Patients with surgical repair of transposition of the great arteries, for example, face the risk to develop neoaortic valve regurgitation. Cardiologists update the prognosis of the patient intuitively with updated information of the cardiovascular status of the patient, for instance from echocardiographic imaging.
Methods
Usually a time-dependent version of the Cox model is used to analyze repeated measurements with a time-to-event outcome. New statistical methods have been developed with multiple advantages, of which the most prominent one being the joint model for longitudinal and time-to-event outcome. In this tutorial, the joint modeling framework is introduced and applied to patients with transposition of the great arteries after surgery with a long-term follow-up, where repeated echocardiographic values of the neoaortic root are evaluated against the risk of neoaortic valve regurgitation.
Results
The data are analyzed with the time-dependent Cox model as benchmark method, and the results are compared with a joint model, leading to different conclusions. The flexibility of the joint model is shown by adding the growth rate of the neoaortic root to the model and adding repeated values of body surface area to obtain a multimarker model. Lastly, it is demonstrated how the joint model can be used to obtain personalized dynamic predictions of the event.
Conclusions
The joint model for longitudinal and time-to-event data is an attractive method to analyze data in follow-up studies with repeated measurements. Benefits of the method include using the estimated natural trajectory of the longitudinal outcome, great flexibility through multiple extensions, and dynamic individualized predictions.



Circ Cardiovasc Qual Outcomes: 21 Oct 2021:CIRCOUTCOMES120007593; epub ahead of print
Baart SJ, van der Palen RLF, Putter H, Tsonaka R, ... Rizopoulos D, van Geloven N
Circ Cardiovasc Qual Outcomes: 21 Oct 2021:CIRCOUTCOMES120007593; epub ahead of print | PMID: 34674542
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Abstract

Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012-2018.

Nathan AS, Yang L, Yang N, Khatana SAM, ... Giri J, Fanaroff AC
Background
Despite the benefits of novel therapeutics, inequitable diffusion of new technologies may generate disparities. We examined the growth of transcatheter aortic valve replacement (TAVR) in the United States to understand the characteristics of hospitals that developed TAVR programs and the socioeconomic status of patients these hospitals served.
Methods
We identified fee-for-service Medicare beneficiaries aged 66 years or older who underwent TAVR between January 1, 2012, and December 31, 2018, and hospitals that developed TAVR programs (defined as performing ≥10 TAVRs over the study period). We used linear regression models to compare socioeconomic characteristics of patients treated at hospitals that did and did not establish TAVR programs and described the association between core-based statistical area level markers of socioeconomic status and TAVR rates.
Results
Between 2012 and 2018, 583 hospitals developed new TAVR programs, including 572 (98.1%) in metropolitan areas, and 293 (50.3%) in metropolitan areas with preexisting TAVR programs. Compared with hospitals that did not start TAVR programs, hospitals that did start TAVR programs treated fewer patients with dual eligibility for Medicaid (difference of -2.83% [95% CI, -3.78% to -1.89%], P≤0.01), higher median household incomes (difference $2447 [95% CI, $1348-$3547], P=0.03), and from areas with lower distressed communities index scores (difference -4.02 units [95% CI, -5.43 to -2.61], P≤0.01). After adjusting for the age, clinical comorbidities, race and ethnicity and socioeconomic status, areas with TAVR programs had higher rates of TAVR and TAVR rates per 100 000 Medicare beneficiaries were higher in core-based statistical areas with fewer dual eligible patients, higher median income, and lower distressed communities index scores.
Conclusions
During the initial growth phase of TAVR programs in the United States, hospitals serving wealthier patients were more likely to start programs. This pattern of growth has led to inequities in the dispersion of TAVR, with lower rates in poorer communities.



Circ Cardiovasc Qual Outcomes: 20 Oct 2021:CIRCOUTCOMES121008260; epub ahead of print
Nathan AS, Yang L, Yang N, Khatana SAM, ... Giri J, Fanaroff AC
Circ Cardiovasc Qual Outcomes: 20 Oct 2021:CIRCOUTCOMES121008260; epub ahead of print | PMID: 34670405
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Abstract

Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials.

Wang R, Kawashima H, Hara H, Gao C, ... Onuma Y, Serruys PW
Background
In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown.
Methods
Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods.
Results
In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively.
Conclusions
In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.



Circ Cardiovasc Qual Outcomes: 19 Oct 2021:CIRCOUTCOMES121008055; epub ahead of print
Wang R, Kawashima H, Hara H, Gao C, ... Onuma Y, Serruys PW
Circ Cardiovasc Qual Outcomes: 19 Oct 2021:CIRCOUTCOMES121008055; epub ahead of print | PMID: 34666500
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Abstract

Risk Adjustment Model for Preserved Health Status in Patients With Heart Failure and Reduced Ejection Fraction: The CHAMP-HF Registry.

Tran AT, Fonarow GC, Arnold SV, Jones PG, ... Albert NM, Spertus JA
Background
Health status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available.
Methods
We built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites\' unadjusted and adjusted rates.
Results
Among 3932 participants (median age [interquartile range] 68 years [59-75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment.
Conclusions
Through leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites\' proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients\' perspectives.



Circ Cardiovasc Qual Outcomes: 06 Oct 2021:CIRCOUTCOMES121008072; epub ahead of print
Tran AT, Fonarow GC, Arnold SV, Jones PG, ... Albert NM, Spertus JA
Circ Cardiovasc Qual Outcomes: 06 Oct 2021:CIRCOUTCOMES121008072; epub ahead of print | PMID: 34615366
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Abstract

Performance Metrics for the Comparative Analysis of Clinical Risk Prediction Models Employing Machine Learning.

Huang C, Li SX, Caraballo C, Masoudi FA, ... Mortazavi BJ, Krumholz HM
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.



Circ Cardiovasc Qual Outcomes: 03 Oct 2021:CIRCOUTCOMES120007526; epub ahead of print
Huang C, Li SX, Caraballo C, Masoudi FA, ... Mortazavi BJ, Krumholz HM
Circ Cardiovasc Qual Outcomes: 03 Oct 2021:CIRCOUTCOMES120007526; epub ahead of print | PMID: 34601947
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Abstract

Associations of Medicaid Expansion With Access to Care, Severity, and Outcomes for Acute Ischemic Stroke.

McGee BT, Seagraves KB, Smith EE, Xian Y, ... Schwamm LH, Fonarow GC
Background
Multiple states have not expanded Medicaid under the Affordable Care Act, resulting in higher uninsured rates in states with high stroke burdens. This study aimed to evaluate the association of Medicaid expansion with changes in health insurance coverage, severity of presentation, access to care, and outcomes among patients with acute ischemic stroke.
Methods
A retrospective, difference-in-differences analysis of Get With The Guidelines-Stroke registry data. The study population comprised first-time ischemic stroke admissions from 2012 to 2018 for patients aged 19 to 64 in 45 states (27 that expanded Medicaid and 18 that did not). A probable low-income cohort was defined based on having Medicaid, no insurance/self-pay, or undocumented insurance. Outcomes analyzed were indicators of health insurance status, stroke severity, use of emergency services, time to acute care, in-hospital mortality, receipt of rehabilitation, discharge disposition, and level of disability.
Results
In the starting population (N=342 765), Medicaid-covered stroke admissions rose from 12.2% to 18.1% in expansion states and from 10.0% to only 10.6% in nonexpansion states, while uninsured admissions declined from 15.0% to 6.7% in expansion states and from 24.0% to 19.2% in nonexpansion states. In the low-income cohort (N=95 086; 28% of starting population), Medicaid expansion was associated with increased odds of discharge to a skilled nursing facility (adjusted odds ratio, 1.33 [95% CI, 1.12-1.59]) and transfer to any rehabilitation facility among those eligible (adjusted odds ratio, 1.24 [95% CI, 1.08-1.41]) and lower odds of discharge home (adjusted odds ratio, 0.89 [95% CI, 0.80-0.98]). Expansion was not associated with any other outcomes.
Conclusions
Medicaid expansion is associated with fewer uninsured hospitalizations for acute ischemic stroke and increased rehabilitation at skilled nursing facilities. More targeted interventions may be needed to improve other stroke outcomes in the low-income US population. Future research should evaluate the impact of health care reform on primary stroke prevention.



Circ Cardiovasc Qual Outcomes: 29 Sep 2021:CIRCOUTCOMES121007940; epub ahead of print
McGee BT, Seagraves KB, Smith EE, Xian Y, ... Schwamm LH, Fonarow GC
Circ Cardiovasc Qual Outcomes: 29 Sep 2021:CIRCOUTCOMES121007940; epub ahead of print | PMID: 34587752
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Abstract

Million Hearts Cardiac Rehabilitation Think Tank: Accelerating New Care Models.

Beatty AL, Brown TM, Corbett M, Diersing D, ... Wall HK, Sperling LS
This article describes the October 2020 proceedings of the Million Hearts Cardiac Rehabilitation Think Tank: Accelerating New Care Models, convened with representatives from professional organizations, cardiac rehabilitation (CR) programs, academic institutions, federal agencies, payers, and patient representative groups. As CR delivery evolves, terminology is evolving to reflect not where activities occur (eg, center, home) but how CR is delivered: in-person synchronous, synchronous with real-time audiovisual communication (virtual), or asynchronous (remote). Patients and CR staff may interact through ≥1 delivery modes. Though new models may change how CR is delivered and who can access CR, new models should not change what is delivered-a multidisciplinary program addressing CR core components. During the coronavirus disease 2019 (COVID-19) public health emergency, Medicare issued waivers to allow virtual CR; it is unclear whether these waivers will become permanent policy post-public health emergency. Given CR underuse and disparities in delivery, new models must equitably address patient and health system contributors to disparities. Strategies for implementing new CR care models address safety, exercise prescription, monitoring, and education. The available evidence supports the efficacy and safety of new CR care models. Still, additional research should study diverse populations, impact on patient-centered outcomes, effect on long-term outcomes and health care utilization, and implementation in diverse settings. CR is evolving to include in-person synchronous, virtual, and remote modes of delivery; there is significant enthusiasm for implementing new care models and learning how new care models can broaden access to CR, improve patient outcomes, and address health inequities.



Circ Cardiovasc Qual Outcomes: 29 Sep 2021:CIRCOUTCOMES121008215; epub ahead of print
Beatty AL, Brown TM, Corbett M, Diersing D, ... Wall HK, Sperling LS
Circ Cardiovasc Qual Outcomes: 29 Sep 2021:CIRCOUTCOMES121008215; epub ahead of print | PMID: 34587751
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Abstract

Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department.

Stubblefield WB, Jenkins CA, Liu D, Storrow AB, ... Sterling SA, Collins SP
Background
We conducted a secondary analysis of changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 over 30 days in a randomized trial of self-care coaching versus structured usual care in patients with acute heart failure who were discharged from the emergency department.
Methods
Patients in 15 emergency departments completed the KCCQ-12 at emergency department discharge and at 30 days. We compared change in KCCQ-12 scores between the intervention and usual care arms, adjusted for enrollment KCCQ-12 and demographic characteristics. We used linear regression to describe changes in KCCQ-12 summary scores and logistic regression to characterize clinically meaningful KCCQ-12 subdomain changes at 30 days.
Results
There were 350 patients with both enrollment and 30-day KCCQ summary scores available; 166 allocated to usual care and 184 to the intervention arm. Median age was 64 years (interquartile range, 55-70), 37% were female participants, 63% were Black, median KCCQ-12 summary score at enrollment was 47 (interquartile range, 33-64). Self-care coaching resulted in significantly greater improvement in health status compared with structured usual care (5.4-point greater improvement, 95% CI, 1.12-9.68; P=0.01). Improvements in health status in the intervention arm were driven by improvements within the symptom frequency (adjusted odds ratio, 1.62 [95% CI, 1.01-2.59]) and quality of life (adjusted odds ratio, 2.39 [95% CI, 1.46-3.90]) subdomains.
Conclusions
In this secondary analysis, patients with acute heart failure who received a tailored, self-care intervention after emergency department discharge had clinically significant improvements in health status at 30 days compared with structured usual care largely due to improvements within the symptom frequency and quality of life subdomains of the KCCQ-12.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02519283.



Circ Cardiovasc Qual Outcomes: 23 Sep 2021:CIRCOUTCOMES121007956; epub ahead of print
Stubblefield WB, Jenkins CA, Liu D, Storrow AB, ... Sterling SA, Collins SP
Circ Cardiovasc Qual Outcomes: 23 Sep 2021:CIRCOUTCOMES121007956; epub ahead of print | PMID: 34555929
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Abstract

Physician Network Connections Associated With Faster De-Adoption of Dronedarone for Permanent Atrial Fibrillation.

Stecher C, Everhart A, Smith LB, Jena A, ... Shah N, Karaca-Mandic P
Background
Physicians\' professional networks are an important source of new medical information and have been shown to influence the adoption of new treatments, but it is unknown how physician networks impact the de-adoption of harmful practices.
Methods
We analyzed changes in physicians\' use of dronedarone after the PALLAS trial (Palbociclib Collaborative Adjuvant Study; November 2011) showed that dronedarone increased the risk of death from cardiovascular events among patients with permanent atrial fibrillation. Deidentified administrative claims from the OptumLabs Data Warehouse were combined with physicians\' demographic information from the Doximity database and publicly available data on physicians\' patient-sharing relationships compiled by the Centers for Medicare and Medicaid Services. We used a linear probability model with an interrupted linear time trend specification to model the impact of the PALLAS trial on physicians\' dronedarone usage between 2009 and 2014.
Results
Before the PALLAS trial, the use of dronedarone was increasing by 0.22 percentage points per quarter (95% CI, 0.19-0.25) in our Medicare Advantage sample (N=343 429 patient-quarter observations) and 0.63 percentage points per quarter (95% CI, 0.52-0.75) in our commercially insured sample (N=44 402 patient-quarter observations). After the PALLAS trial and subsequent United States Food and Drug Administration black box warning, physicians in the Medicare Advantage sample with an above-median number of network connections to other physicians decreased their quarterly usage of dronedarone by 0.12 percentage points more per quarter (95% CI, -0.20 to -0.04; P=0.031) than physicians with equal to or below the median number of network connections. Similar patterns existed in the commercially insured sample (P=0.0318).
Conclusions
After controlling for a wide range of patient, physician, and geographic characteristics, physicians with a greater number of network connections were faster de-adopters of dronedarone for patients with permanent atrial fibrillation after the PALLAS trial and subsequent United States Food and Drug Administration black box warning detailed the harmfulness of dronedarone for these patients. Policies for improving physicians\' responsiveness to new medical information should consider utilizing the influence of these important professional network relationships.



Circ Cardiovasc Qual Outcomes: 23 Sep 2021:CIRCOUTCOMES121008040; epub ahead of print
Stecher C, Everhart A, Smith LB, Jena A, ... Shah N, Karaca-Mandic P
Circ Cardiovasc Qual Outcomes: 23 Sep 2021:CIRCOUTCOMES121008040; epub ahead of print | PMID: 34555928
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Abstract

Association Between Early Trauma and Ideal Cardiovascular Health Among Black Americans: Results From the Morehouse-Emory Cardiovascular (MECA) Center for Health Equity.

Islam SJ, Hwan Kim J, Joseph E, Topel M, ... Quyyumi AA, Lewis TT
Background
Early trauma (general, emotional, physical, and sexual abuse before age 18 years) has been associated with both cardiovascular disease risk and lifestyle-related risk factors for cardiovascular disease, including smoking, obesity, and physical inactivity. Despite higher prevalence, the association between early trauma and cardiovascular health (CVH) has been understudied in Black Americans, especially those from low-income backgrounds, who may be doubly vulnerable. Therefore, we investigated the association between early trauma and CVH, particularly among low-income Black Americans.
Methods
We recruited 457 Black adults (age 53±10, 38% male) without known cardiovascular disease from the Atlanta, GA, metropolitan area using personalized, community-based recruitment methods. The Early Trauma Inventory was administered to assess overall early traumatic life experiences which include physical, sexual, emotional abuse, and general trauma. Our primary outcome was the American Heart Association Life\'s Simple 7, which is a set of 7 CVH metrics, including 4 lifestyle-related factors (smoking, body mass index, physical activity, and diet) and three physiologically measured health factors (blood pressure, total blood cholesterol, and blood glucose). We used linear regression models adjusting for age, sex, socioeconomic status, and depression to test the association between early trauma and CVH and tested the early trauma by household income (<$50 000) interaction.
Results
Higher levels of early trauma were associated with lower Life\'s Simple 7 scores (β, -0.05 [95% CI, -0.09 to -0.01], P=0.02, per 1 unit increase in the Early Trauma Inventory score) among lower, but not higher, income Black participants (P value for interaction=0.04). Subtypes of early trauma linked to Life\'s Simple 7 were general trauma, emotional abuse, and sexual abuse. Exploratory analyses demonstrated that early trauma was only associated with the body mass index and smoking components of Life\'s Simple 7.
Conclusions
Early trauma, including general trauma, emotional abuse, and sexual abuse, may be associated with worse CVH among low-, but not higher-income Black adults.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007904
Islam SJ, Hwan Kim J, Joseph E, Topel M, ... Quyyumi AA, Lewis TT
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007904 | PMID: 34380328
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Abstract

Predictors of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibitor Prescriptions for Secondary Prevention of Clinical Atherosclerotic Cardiovascular Disease.

Blumenthal DM, Maddox TM, Aragam K, Sacks CA, Virani SS, Wasfy JH
Background
Little is known about patterns of PCSK9i (proprotein convertase subtilisin/kexin type 9 inhibitor) use among patients with established clinical atherosclerotic cardiovascular disease. This study\'s objective was to describe PCSK9i prescribing patterns among patients with atherosclerotic cardiovascular disease.
Methods
We used a national outpatient clinic registry linked to zip-code level on household income from the US Census to assess characteristics of patients with atherosclerotic cardiovascular disease and LDL-C (low-density lipoprotein cholesterol) <190 mg/dL between September 1, 2015, and September 30, 2019, who did and did not receive PCSK9i prescriptions and practice-level and temporal variation in PCSK9i prescriptions. We assessed predictors of PCSK9i prescription with a multivariable mixed effects regression model which included patient covariates as fixed effects and the cardiology practice as a random effect. Adjusted practice-level variation in PCSK9i prescribing was evaluated with median odds ratio (OR).
Results
Of 2 148 100 patients meeting study inclusion criteria, 27 249 (1.3%) received PCSK9i prescriptions. Receiving a PCSK9i prescription was associated with White race (versus non-White: OR, 1.78 [95% CI, 1.55-1.83]); high estimated household income (versus low income: OR, 1.18 [95% CI, 1.08-1.29]), and urban or suburban (versus rural) practice location (urban: OR, 1.47 [95% CI, 1.32-1.64]; suburban: OR, 1.25 [95% CI, 1.13-1.39]). Hispanics had lower odds of receiving PCSK9i prescriptions (OR, 0.66 [95% CI, 0.57-0.76]). The adjusted median odds ratio was 2.68 (95% CI, 2.46-2.94), consistent with clinically significant practice-level variation in PCSK9i prescriptions. No differences in quarterly PCSK9i prescription rates were observed before and after price reductions for evolocumab and alirocumab initiated during the fourth quarter of 2018 and first quarter of 2019, respectively.
Conclusions
This study highlights racial, socioeconomic, geographic, and practice-level variations in early PCSK9i prescriptions which persist despite adjustment for clinical and demographic factors. After adjustment, 2 randomly selected practices would differ in likelihood of PCSK9i prescription by a factor of >2.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007237
Blumenthal DM, Maddox TM, Aragam K, Sacks CA, Virani SS, Wasfy JH
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007237 | PMID: 34404223
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Abstract

Cardiovascular Disease Risk-Based Statin Utilization and Associated Outcomes in a Primary Prevention Cohort: Insights From a Large Health Care Network.

Saeed A, Zhu J, Thoma F, Marroquin O, ... Ballantyne C, Mulukutla S
Background
Current American College of Cardiology/American Heart Association guidelines recommend using the 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide statin therapy for primary prevention. Real-world data on adherence and consequences of nonadherence to the guidelines in primary are limited. We investigated the guideline-directed statin intensity (GDSI) and associated outcomes in a large health care system, stratified by ASCVD risk.
Methods
Statin prescription in patients without coronary artery disease, peripheral vascular disease, or ischemic stroke were evaluated within a large health care network (2013-2017) using electronic medical health records. Patient categories constructed by the 10-year ASCVD risk were borderline (5%-7.4%), intermediate (7.5%-19.9%), or high (≥20%). The GDSI (before time of first event) was defined as none or any intensity for borderline, and at least moderate for intermediate and high-risk groups. Mean (±SD) time to start/change to GDSI from first interaction in health care and incident rates (per 1000 person-years) for each outcome were calculated. Cox regression models were used to calculate hazard ratios for incident ASCVD and mortality across risk categories stratified by statin utilization.
Results
Among 282 298 patients (mean age ≈50 years), 29 134 (10.3%), 63 299 (22.4%), and 26 687 (9.5%) were categorized as borderline, intermediate, and high risk, respectively. Among intermediate and high-risk categories, 27 358 (43%) and 8300 (31%) patients did not receive any statin, respectively. Only 17 519 (65.6%) high-risk patients who were prescribed a statin received GDSI. The mean time to GDSI was ≈2 years among the intermediate and high-risk groups. At a median follow-up of 6 years, there was a graded increase in risk of ASCVD events in intermediate risk (hazard ratio=1.15 [1.07-1.24]) and high risk (hazard ratio=1.27 [1.17-1.37]) when comparing no statin use with GDSI therapy. Similarly, mortality risk among intermediate and high-risk groups was higher in no statin use versus GDSI.
Conclusions
In a real-world primary prevention cohort, over one-third of statin-eligible patients were not prescribed statin therapy. Among those receiving a statin, mean time to GDSI was ≈2 years. The consequences of nonadherence to guidelines are illustrated by greater incident ASCVD and mortality events. Further research can develop and optimize health care system strategies for primary prevention.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007485
Saeed A, Zhu J, Thoma F, Marroquin O, ... Ballantyne C, Mulukutla S
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007485 | PMID: 34455825
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Abstract

Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction.

Ozaki AF, Krumholz HM, Mody FV, Tran TT, ... Yokota M, Jackevicius CA
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.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007665
Ozaki AF, Krumholz HM, Mody FV, Tran TT, ... Yokota M, Jackevicius CA
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007665 | PMID: 34465124
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Abstract

Recommendations and Associated Levels of Evidence for Statin Use in Primary Prevention of Cardiovascular Disease: A Comparison at Population Level of the American Heart Association/American College of Cardiology/Multisociety, US Preventive Services Task Force, Department of Veterans Affairs/Department of Defense, Canadian Cardiovascular Society, and European Society of Cardiology/European Atherosclerosis Society Clinical Practice Guidelines.

Pavlović J, Greenland P, Franco OH, Kavousi M, ... Ikram MA, Leening MJG
Background
Despite using identical evidence to support practice guidelines for lipid-lowering treatment in primary prevention of cardiovascular disease (CVD), it is unclear to what extent the 2018 American Heart Association/American College of Cardiology/Multisociety, 2016 US Preventive Services Task Force (USPSTF), 2020 Department of Veterans Affairs/Department of Defense, 2021 Canadian Cardiovascular Society, and 2019 European Society of Cardiology/European Atherosclerosis Society guidelines differ in grading and assigning levels of evidence and classes of recommendations (LOE/class) at a population level.
Methods
We included 7262 participants, aged 45 to 75 years, without history of CVD from the prospective population-based Rotterdam Study. Per guideline, proportions of the population recommended statin therapy by LOE/class, sensitivity and specificity for CVD events, and numbers needed to treat at 10 years were calculated.
Results
Mean age was 61.1 (SD 6.9) years; 58.2% were women. American Heart Association/American College of Cardiology/Multisociety, USPSTF, Department of Veterans Affairs/Department of Defense, Canadian Cardiovascular Society, and European Society of Cardiology/European Atherosclerosis Society strongly recommended statin initiation in respective 59.4%, 40.2%, 45.2%, 73.7%, and 42.1% of the eligible population based on high-quality evidence. Sensitivity for CVD events for treatment recommendations supported with strong LOE/class was 86.3% for American Heart Association/American College of Cardiology/Multisociety (IA or IB), 69.4% for USPSTF (USPSTF-B), 74.5% for Department of Veterans Affairs/Department of Defense (strong for), 93.3% for Canadian Cardiovascular Society (strong), and 66.6% for European Society of Cardiology/European Atherosclerosis Society (IA). Specificity was highest for the USPSTF at 45.3% and lowest for European Society of Cardiology/European Atherosclerosis Society at 10.0%. Estimated numbers needed to treat at 10 years for those with the strongest LOE/class were ranging from 20 to 26 for moderate-intensity and 12 to 16 for high-intensity statins.
Conclusions
Sensitivity, specificity, and numbers needed to treat at 10 years for assigned LOE/class varied greatly among 5 CVD prevention guidelines. The level of variability seems to be driven by differences in how the evidence is graded and translated into LOE/class underlying the treatment recommendations by different professional societies. Efforts towards harmonizing evidence grading systems for clinical guidelines in primary prevention of CVD may reduce ambiguity and reinforce updated evidence-based recommendations.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007183
Pavlović J, Greenland P, Franco OH, Kavousi M, ... Ikram MA, Leening MJG
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007183 | PMID: 34546786
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Abstract

Ecological Associations Between Inclusionary Zoning Policies and Cardiovascular Disease Risk Prevalence: An Observational Study.

Jones A, Squires GD, Nixon C
Background
Providing an adequate supply of affordable housing has become an increasingly difficult challenge for US cities. Inclusionary zoning (IZ) policies have become an increasingly popular response. Substantial research has demonstrated the health benefits of stable, affordable housing. There is anecdotal but not systematic evidence that IZ policies may be associated with some health benefits of affordable housing.
Methods
We rely on data from the 2017 500 Cities Project, the 2016 to 2017 Lincoln Institute for Land Policy survey, and the 2011 to 2015 American Community Survey. We perform bivariate tests and cluster ordinary least squares regression to examine associations at the municipal level between having inclusionary zoning (IZ) policies, the attributes of those policies, and the prevalence of several cardiovascular outcomes.
Results
Cardiovascular outcomes and socioeconomic characteristics were uniformly better in cities with IZ policies. IZ policies were associated with lower blood pressure (95% CI, -0.50 to -0.13), cholesterol (CI, -0.89 to -0.31), and blood pressure medication (CI, -0.57 to -0.03) prevalence. Some characteristics of IZ programs such as being mandatory, prioritizing rental development, and allocating a larger share of affordable housing are associated with cardiovascular risk prevalence.
Conclusions
Characteristics of IZ programs that ultimately benefit low-income residents are associated with favorable municipal-level cardiovascular health. Further, IZ policies could potentially address complex health challenges among economically vulnerable households.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007807
Jones A, Squires GD, Nixon C
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007807 | PMID: 34493068
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Abstract

Improving Outcome Predictions for Patients Receiving Mechanical Circulatory Support by Optimizing Imputation of Missing Values.

Jaeger BC, Cantor R, Sthanam V, Xie R, Kirklin JK, Rudraraju R
Background
Risk prediction models play an important role in clinical decision making. When developing risk prediction models, practitioners often impute missing values to the mean. We evaluated the impact of applying other strategies to impute missing values on the prognostic accuracy of downstream risk prediction models, that is, models fitted to the imputed data. A secondary objective was to compare the accuracy of imputation methods based on artificially induced missing values. To complete these objectives, we used data from the Interagency Registry for Mechanically Assisted Circulatory Support.
Methods
We applied 12 imputation strategies in combination with 2 different modeling strategies for mortality and transplant risk prediction following surgery to receive mechanical circulatory support. Model performance was evaluated using Monte-Carlo cross-validation and measured based on outcomes 6 months following surgery using the scaled Brier score, concordance index, and calibration error. We used Bayesian hierarchical models to compare model performance.
Results
Multiple imputation with random forests emerged as a robust strategy to impute missing values, increasing model concordance by 0.0030 (25th-75th percentile: 0.0008-0.0052) compared with imputation to the mean for mortality risk prediction using a downstream proportional hazards model. The posterior probability that single and multiple imputation using random forests would improve concordance versus mean imputation was 0.464 and >0.999, respectively.
Conclusions
Selecting an optimal strategy to impute missing values such as random forests and applying multiple imputation can improve the prognostic accuracy of downstream risk prediction models.



Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007071
Jaeger BC, Cantor R, Sthanam V, Xie R, Kirklin JK, Rudraraju R
Circ Cardiovasc Qual Outcomes: 30 Aug 2021; 14:e007071 | PMID: 34517728
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Abstract

Spouse\'s Cardiovascular Disease As a Risk Factor for Cardiovascular Disease in Middle-Aged Adults: A Matched-Pair Cohort Study.

Ohbe H, Yasunaga H
Background
Little is known about the risk of subsequent cardiovascular events in individuals whose spouse has a history of cardiovascular diseases. We assessed whether the spouse\'s history of cardiovascular disease is associated with a greater risk of cardiovascular events.
Methods
Using data on married couples from the Japan Medical Data Center database (April 2008-August 2018), we conducted a matched-pair cohort study by matching individuals who had no history of cardiovascular disease and whose spouse had a history of cardiovascular disease at their first health check-up (exposure group) with up to 4 individuals who had no history of cardiovascular disease and whose spouse had no history of cardiovascular disease at their first health check-up (nonexposure group) matched for birth year, sex, and first health check-up year. We compared severe cardiovascular events after the first health check-up between the 2 groups.
Results
Among 236 527 eligible married couples (473 054 spouses), we identified 13 759 individuals in the exposure group who were matched with 55 027 individuals in the nonexposure group. During the mean 95-month observational period from the first health check-up, the percentage of individuals with severe cardiovascular events was higher in the exposure group than in the nonexposure group (0.6% [82/13 759] versus 0.4% [224/55 027], respectively), with a hazard ratio of 1.48 (95% CI, 1.15-1.90). Analyses stratified by sex showed that the hazard ratios of the exposure to the spouse\'s history of cardiovascular disease for severe cardiovascular events in women and men were 1.22 (95% CI, 0.82-1.83) and 1.68 (95% CI, 1.22-2.32), respectively.
Conclusions
This study suggests that a spouse\'s history of cardiovascular disease can be a risk factor for subsequent cardiovascular events in men but not in women. Further studies are needed to confirm our findings and to explore effective primary prevention strategies for these individuals.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007649
Ohbe H, Yasunaga H
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007649 | PMID: 34238013
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Abstract

Early Increased Physical Activity, Cardiac Rehabilitation, and Survival After Implantable Cardioverter-Defibrillator Implantation.

Atwater BD, Li Z, Pritchard J, Greiner MA, Nabutovsky Y, Hammill BG
Background
Increased physical activity (PA) through cardiac rehabilitation (CR) improves outcomes in patients with heart failure and coronary disease, but CR referral remains infrequent. Implantable cardioverter-defibrillators (ICDs) can provide daily PA measurements to patients that may motivate them to increase PA, but it remains unclear if increased ICD measured PA is associated with improved outcomes with and without CR.
Methods
This is a retrospective observational study of 41 731 Medicare beneficiaries with ICD implantation between January 1, 2014 and December 31, 2016. We linked daily ICD PA measurements and Medicare claims data to determine if increased PA is associated with a reduction in the likelihood of death or heart failure hospitalization. To determine if CR participation altered the effect of PA on outcomes, we performed two additional analyses matching CR participants and nonparticipants using propensity scores. The first match included demographics, comorbidities, and baseline PA measurements. The second match also included the change in PA measured during CR or the same time frame after ICD implant among nonparticipants.
Results
The mean age was 75 (SD, 10) years, 30 182 beneficiaries (72.3%) were male, and 1324 (3%) participated in CR. Increased ICD detected PA was associated with improved survival. CR participants had a mean PA change of +9.7 (SD, 57.8) min/d, whereas nonparticipants had a mean change of -1.0 (SD, 59.7) min/d (P<0.001). After matching for demographics, comorbidities and baseline PA, CR participants had significantly lower 1- to 3-year mortality (hazard ratio, 0.76 [95% CI, 0.69-0.85], P=0.03). After additionally matching for the ICD measured change in PA during CR there were no differences in mortality with and without CR (hazard ratio, 1.00 [95% CI, 0.82-1.21], P=0.87). Every 10 minutes of increased daily PA was associated with a 1.1% reduction in all-cause mortality in both groups.
Conclusions
Among Medicare beneficiaries with ICDs, small increases in PA were associated with significant reductions in all-cause mortality.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007580
Atwater BD, Li Z, Pritchard J, Greiner MA, Nabutovsky Y, Hammill BG
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007580 | PMID: 34284598
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Abstract

Trajectories of Pain After Cardiac Surgery: Implications for Measurement, Reporting, and Individualized Treatment.

Mori M, Brooks C, Dhruva SS, Lu Y, ... Allore HG, Krumholz HM
Background
Postoperative pain after cardiac surgery is a significant problem, but studies often report pain value as an average of the study cohort, obscuring clinically meaningful differences in pain trajectories. We sought to characterize heterogeneity in postoperative pain experiences.
Methods
We enrolled patients undergoing a cardiac surgery at a tertiary care center between January 2019 and February 2020. Participants received an electronically-delivered questionnaire every 3 days for 30 days to assess incision site pain level. We evaluated the variability in pain trajectories over 30 days by the cohort-level mean with confidence band and latent classes identified by group-based trajectory model. Group-based trajectory model estimated the probability of belonging to a specific trajectory of pain.
Results
Of 92 patients enrolled, 75 provided ≥3 questionnaire responses. The cohort-level mean showed a gradual and consistent decline in the mean pain level, but the confidence bands covered most of the pain score range. The individual-level trajectories varied substantially across patients. Group-based trajectory model identified 4 pain trajectories: persistently low (n=9, 12%), moderate declining (initially mid-level, followed by decline; n=26, 35%), high declining (initially high-level, followed by decline; n=33, 44%), and persistently high pain (n=7, 9%). Persistently high pain and high declining groups did not seem to be clearly distinguishable until approximately postoperative day 10. Patients in persistently low pain trajectory class had a numerically lower median age than the other 3 classes and were below the lower confidence band of the cohort-level approach. Patients in the persistently high pain trajectory class had a longer median length of hospital stay than the other 3 classes and were often higher than the upper confidence band of the cohort-level approach.
Conclusions
We identified 4 trajectories of postoperative pain that were not evident from a cohort-level mean, which has been a common way of reporting pain level. This study provides key information about the patient experience and indicates the need to understand variation among sites and surgeons and to investigate determinants of different experience and interventions to mitigate persistently high pain.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007781
Mori M, Brooks C, Dhruva SS, Lu Y, ... Allore HG, Krumholz HM
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007781 | PMID: 34304586
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Abstract

Risk Stratification of Patients Undergoing Percutaneous Repair of Mitral and Tricuspid Valves Using a Multidimensional Geriatric Assessment.

Schäfer M, Körber MI, Vimalathasan R, Mauri V, ... Polidori MC, Pfister R
Background
Given their advanced age and high comorbidity, individual risk assessment is crucial in patients undergoing transcatheter mitral and tricuspid valve repair. Therefore, we evaluated the use of a comprehensive geriatric assessment score, the multidimensional prognostic index (MPI), for risk stratification in these patients.
Methods
We conducted a prospective, observational single-center study, including 226 patients undergoing percutaneous repair for mitral or tricuspid regurgitation. The MPI was calculated preprocedural and covers 8 domains (activities of daily living, instrumental activities of daily living, mental status, nutrition, risk of pressure ulcers, comorbidity, medication, and marital/cohabitation status). We sought to identify an association of MPI score with procedural outcomes and 6-month mortality.
Results
A total of 53.1% of patients were stratified as low risk according to MPI (MPI-1 group), 44.2% as medium risk (MPI-2 group), and 2.7% as high risk (MPI-3 group). Procedural efficacy and safety were similar between groups. The estimated survival rate at 6 months was 97±2% in MPI-1 group, 79±4% in MPI-2 group (hazard ratio, 6.90 [95% CI, 2.36-12.2]; P≤0.001) and 50±20% in MPI-3 group (hazard ratio, 20.3 [95% CI, 4.51-91.3]; P<0.001). An increase in 1 SD of the MPI score (0.14 points, possible range of MPI score 0-1) was associated with a hazard ratio of 2.13 (95% CI, 1.58-2.73; P≤0.001) for death after 6 months. The risk association of the MPI with mortality remained significant in multivariate analysis including risk factors, such as peripheral artery disease and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels.
Conclusions
A comprehensive geriatric assessment with the MPI score provides additional information on mortality risk beyond established cardiovascular risk factors.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007624
Schäfer M, Körber MI, Vimalathasan R, Mauri V, ... Polidori MC, Pfister R
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007624 | PMID: 34325515
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Abstract

External Validations of Cardiovascular Clinical Prediction Models: A Large-Scale Review of the Literature.

Wessler BS, Nelson J, Park JG, McGinnes H, ... Paulus JK, Kent DM
Background
There are many clinical prediction models (CPMs) available to inform treatment decisions for patients with cardiovascular disease. However, the extent to which they have been externally tested, and how well they generally perform has not been broadly evaluated.
Methods
A SCOPUS citation search was run on March 22, 2017 to identify external validations of cardiovascular CPMs in the Tufts Predictive Analytics and Comparative Effectiveness CPM Registry. We assessed the extent of external validation, performance heterogeneity across databases, and explored factors associated with model performance, including a global assessment of the clinical relatedness between the derivation and validation data.
Results
We identified 2030 external validations of 1382 CPMs. Eight hundred seven (58%) of the CPMs in the Registry have never been externally validated. On average, there were 1.5 validations per CPM (range, 0-94). The median external validation area under the receiver operating characteristic curve was 0.73 (25th-75th percentile [interquartile range (IQR)], 0.66-0.79), representing a median percent decrease in discrimination of -11.1% (IQR, -32.4% to +2.7%) compared with performance on derivation data. 81% (n=1333) of validations reporting area under the receiver operating characteristic curve showed discrimination below that reported in the derivation dataset. 53% (n=983) of the validations report some measure of CPM calibration. For CPMs evaluated more than once, there was typically a large range of performance. Of 1702 validations classified by relatedness, the percent change in discrimination was -3.7% (IQR, -13.2 to 3.1) for closely related validations (n=123), -9.0 (IQR, -27.6 to 3.9) for related validations (n=862), and -17.2% (IQR, -42.3 to 0) for distantly related validations (n=717; P<0.001).
Conclusions
Many published cardiovascular CPMs have never been externally validated, and for those that have, apparent performance during development is often overly optimistic. A single external validation appears insufficient to broadly understand the performance heterogeneity across different settings.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007858
Wessler BS, Nelson J, Park JG, McGinnes H, ... Paulus JK, Kent DM
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007858 | PMID: 34340529
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Abstract

Innovative Managed Care May Be Related to Improved Prognosis for Acute Myocardial Infarction Survivors.

Jankowski P, Topór-Mądry R, Gąsior M, Cegłowska U, ... Witkowski A, Szumowski Ł
Background
Mortality following discharge in myocardial infarction survivors remains high. Therefore, we compared outcomes in myocardial infarction survivors participating and not participating in a novel, nationwide managed care program for myocardial infarction survivors in Poland.
Methods
We used public databases. We included all patients hospitalized due to acute myocardial infarction in Poland between October 1, 2017 and December 31, 2018. We excluded from the analysis all patients aged <18 years as well as those who died during hospitalization or within 10 days following discharge from hospital. All patients were prospectively followed. The primary end point was defined as death from any cause.
Results
The mean follow-up was 324.8±140.5 days (78 034.1 patient-years; 340.0±131.7 days in those who did not die during the observation). Participation in the managed care program was related to higher odds ratio of participating in cardiac rehabilitation (4.67 [95% CI, 4.44-4.88]), consultation with a cardiologist (7.32 [6.83-7.84]), implantable cardioverter-defibrillator (1.40 [1.22-1.61]), and cardiac resynchronization therapy with cardioverter-defibrillator implantation (1.57 [1.22-2.03]) but lower odds of emergency (0.88 [0.79-0.98]) and nonemergency percutaneous coronary intervention (0.88 [0.83-0.93]) and coronary artery bypass grafting (0.82 [0.71-0.94]) during the follow-up. One-year all-cause mortality was 4.4% among the program participants and 6.0% in matched nonparticipants. The end point consisting of all-cause death, myocardial infarction, or stroke occurred in 10.6% and 12.0% (P<0.01) of participants and nonparticipants respectively, whereas all-cause death or hospitalization for cardiovascular reasons in 42.2% and 47.9% (P<0.001) among participants and nonparticipants, respectively. The difference in outcomes between patients participating and not participating in the managed care program could be explained by improved access to cardiac rehabilitation, cardiac care, and cardiac procedures.
Conclusions
Managed care following myocardial infarction may be related to improved prognosis as it may facilitate access to cardiac rehabilitation and may provide a higher standard of outpatient cardiac care.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007800
Jankowski P, Topór-Mądry R, Gąsior M, Cegłowska U, ... Witkowski A, Szumowski Ł
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007800 | PMID: 34380330
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Abstract

Neoplasm Reports in Food and Drug Administration Adverse Event Reporting System Following Angiotensin Receptor Blocker Recalls.

Cohen Sedgh R, Moon J, Jackevicius CA
Background
A worldwide voluntary recall of valsartan in July 2018 due to the potential carcinogen N-nitrosodimethylamine received extensive media and public attention. This was followed by more Food and Drug Administration (FDA) recalls regarding other contaminated ARB (angiotensin receptor blocker) products. Our study investigated the association between the FDA recalls and ARB neoplasm adverse events (AEs) reported to the FDA adverse event reporting system.
Methods
In this cross-sectional study, data were retrospectively collected from the FDA adverse event reporting system database from January 2015 to December 2019. Reporting odds ratios (RORs) were estimated to detect signals of association between ARBs (valsartan, irbesartan, and losartan) and reported neoplasm AEs using negative (amoxicillin and sertraline) and positive (omeprazole and ranitidine) control exposures. The χ2 was used to compare categorical variables.
Results
A total of 2 181 524 AEs, including 10 461 nonmetastatic neoplasm AEs were analyzed. Monthly RORs (95% CI) of valsartan-associated neoplasms versus controls (ROR*: valsartan/negative exposures; ROR†: valsartan/omeprazole; and ROR‡: valsartan/ranitidine) showed the highest signals after the recall date in July 2018 (7.64 [4.78-12.19]*; 4.77 [3.36-6.79]†; 4.13 [2.50-6.84]‡) and August 2018 (7.87 [5.19-11.94]*; 5.65 [4.12-7.75]†; and 7.20 [4.46-11.63]‡). In contrast, the highest cancer signals for the irbesartan and losartan recalls detected in March 2019 (4.80*; 4.06†; and 3.38‡) and April 2019 (3.63*; 3.69†; and 2.52‡) respectively, were lower. One-year postrecall reported neoplasm AEs were ≈2-fold higher for valsartan than irbesartan (OR, 1.77 [95% CI, 1.47-2.13], P<0.0001) and losartan (OR, 2.07 [95% CI, 1.85-2.32], P<0.0001). Although all ARBs had the same nitrosamine contamination, we found 1-year postrecall versus prerecall cancer signals for valsartan were 3-fold higher versus control exposures, while the changes in RORs for irbesartan and losartan were only 20-30% higher.
Conclusions
Significantly more postrecall neoplasms were reported for valsartan, with higher valsartan-associated cancer signals compared with irbesartan and losartan, although they all contained the same carcinogenic contaminant. Extensive media coverage of the FDA valsartan recall may have alarmed patients and generated these abrupt, biologically infeasible cancer signals.



Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007476
Cohen Sedgh R, Moon J, Jackevicius CA
Circ Cardiovasc Qual Outcomes: 30 Jul 2021; 14:e007476 | PMID: 34380327
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Impact:

This program is still in alpha version.