Journal: Circ Cardiovasc Qual Outcomes

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Abstract

Medical Therapy Utilization and Long-Term Outcomes Following Percutaneous Coronary Intervention: Five-Year Results From the Veterans Affairs Clinical Assessment, Reporting, and Tracking System Program.

Xie JX, Gunzburger EC, Kaun L, Plomondon ME, ... Maddox TM, Mavromatis K
Background
Optimal medical therapy is endorsed by national guidelines in the management of ischemic heart disease; however, few studies have examined its long-term utilization following percutaneous coronary intervention (PCI) and association with clinical outcomes. We sought to assess longitudinal trends in medical therapy use after PCI and its prognostic significance.
Methods and results
From the Veteran Affairs Clinical Assessment, Reporting, and Tracking System Program, we retrospectively identified 57 900 Veteran\'s Affairs patients undergoing PCI from January 2005 to May 2014. Using prescription fill dates, the utilization of 4 classes of medical therapy including statins, β-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, P2Y12 inhibitors, and their composites were assessed at discharge, 6 months, 1, 3, and 5 years post-PCI. Multivariable Cox regression models were developed to assess the association between medical therapy status and major adverse cardiovascular events, defined as all-cause mortality, rehospitalization for myocardial infarction, rehospitalization for stroke, or repeat revascularization. At discharge following PCI, 58.3% of patients received all 4 classes of medical therapy. Utilization of statins, β-blockers, and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers decreased from 89%, 84.9%, and 72.2% on discharge, respectively, to 72.7%, 67.9%, and 57.9% at 5 years. Prescription refills of P2Y12 inhibitors declined from 96.5% on discharge to 28.3% at 5 years, driven by a large decline in P2Y12 inhibitor use after 1 year. Use of each class of medical therapy, and its composite use, was associated with a significant reduction in major adverse cardiovascular events at 5 years, with the largest effect size seen by the use of statins (HR, 0.77; 95% CI, 0.75-0.79; <0.0001) and P2Y12 inhibitors (HR, 0.82; 95% CI, 0.79-0.85; <0.0001).
Conclusions
Consistent declines in medical therapy use following PCI were observed over time, which is associated with worse outcomes. Further efforts are needed to promote long-term adherence to secondary prevention therapies after revascularization.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005455
Xie JX, Gunzburger EC, Kaun L, Plomondon ME, ... Maddox TM, Mavromatis K
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005455 | PMID: 31665896
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Abstract

Dog Ownership and Survival: A Systematic Review and Meta-Analysis.

Kramer CK, Mehmood S, Suen RS
Background
Dog ownership has been associated with decreased cardiovascular risk. Recent reports have suggested an association of dog companionship with lower blood pressure levels, improved lipid profile, and diminished sympathetic responses to stress. However, it is unclear if dog ownership is associated with improved survival as previous studies have yielded inconsistent results. Thus, we performed a systematic review and meta-analysis to evaluate the association of dog ownership with all-cause mortality, with and without prior cardiovascular disease, and cardiovascular mortality.
Methods and results
Studies published between 1950 and May 24, 2019 were identified by searching Embase and PubMed. Observational studies that evaluated baseline dog ownership and subsequent all-cause mortality or cardiovascular mortality. Two independent reviewers extracted the data. We assessed pooled data using random-effects model. A possible limitation was that the analyses were not adjusted for confounders. Ten studies were included yielding data from 3 837 005 participants (530 515 events; mean follow-up 10.1 years). Dog ownership was associated with a 24% risk reduction for all-cause mortality as compared to nonownership (relative risk, 0.76; 95% CI, 0.67-0.86) with 6 studies demonstrating significant reduction in the risk of death. Notably, in individuals with prior coronary events, living in a home with a dog was associated with an even more pronounced risk reduction for all-cause mortality (relative risk, 0.35; 95% CI, 0.17-0.69; , 0%). Moreover, when we restricted the analyses to studies evaluating cardiovascular mortality, dog ownership conferred a 31% risk reduction for cardiovascular death (relative risk, 0.69; 95% CI, 0.67-0.71; , 5.1%).
Conclusions
Dog ownership is associated with lower risk of death over the long term, which is possibly driven by a reduction in cardiovascular mortality. Systematic Review Registration URL: http://www.crd.york.ac.uk/prospero/. Unique identifier: CRD42018111048.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005554
Kramer CK, Mehmood S, Suen RS
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005554 | PMID: 31592726
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Abstract

Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial.

Barsuk JH, Wilcox JE, Cohen ER, Harap RS, ... Wayne DB, Cameron KA
Background
No recognized standards exist for teaching patients and their caregivers ventricular assist device (VAD) self-care skills. We compared the effectiveness of a VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training.
Methods and results
VAD patients and their caregivers were randomized to SBML or usual training during their implant hospitalization. The SBML group completed a pretest on 3 VAD self-care skills (controller, power source, and dressing change), then viewed videos and participated in deliberate practice on a simulator. SBML participants took a posttest and were required to meet or exceed a minimum passing standard for each of the skills. The usual training group completed the existing institutional VAD self-care teaching protocol. Before hospital discharge, the SBML and usual training groups took the same 3 VAD self-care skills tests. We compared demographic and clinical information, self-confidence, total participant training time, and skills performance between groups. Forty participants completed the study in each group. There were no differences in demographic and clinical information, self-confidence, or training time between groups. More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%]; =0.001), power source (36/40 [90%] versus 9/40 [23%]; <0.001), and dressing change skills (19/20 [95%] versus 0/20; <0.001).
Conclusions
SBML provided superior VAD self-care skills learning outcomes compared with usual training. This study has important implications for patients due to the morbidity and mortality associated with improper VAD self-care.
Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT03073005.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005794
Barsuk JH, Wilcox JE, Cohen ER, Harap RS, ... Wayne DB, Cameron KA
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005794 | PMID: 31601111
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Abstract

Hospital-Based Quality Improvement Interventions for Patients With Acute Coronary Syndrome: A Systematic Review.

Bahiru E, Agarwal A, Berendsen MA, Baldridge AS, ... Bukachi F, Huffman MD
Background
Quality improvement initiatives have been developed to improve acute coronary syndrome care largely in high-income country settings. We sought to synthesize the effect size and quality of evidence from randomized controlled trials (RCTs) and nonrandomized studies for hospital-based acute coronary syndrome quality improvement interventions on clinical outcomes and process of care measures for their potential implementation in low- and middle-income country settings.
Methods and results
We conducted a bibliometric search of databases and trial registers and a hand search in 2016 and performed an updated search in May 2018 and May 2019. We performed data extraction, risk of bias assessment, and quality of evidence assessments in duplicate. We assessed differences in outcomes by study design comparing RCTs to nonrandomized quasi-experimental studies and by country income status. A meta-analysis was not feasible due to substantial, unexplained heterogeneity among the included studies, and thus, we present a qualitative synthesis. We screened 5858 records and included 32 studies (14 RCTs [n=109 763] and 18 nonrandomized quasi-experimental studies [n=54-423]). In-hospital mortality ranged from 2.1% to 4.8% in the intervention groups versus 3.3% to 5.1% in the control groups in 5 RCTs (n=55 942). Five RCTs (n=64 313) reported 3.0% to 31.0% higher rates of reperfusion for patients with ST-segment-elevation myocardial infarction in the intervention groups. The effect sizes for in-hospital and discharge medical therapies in a majority of RCTs were 3.0% to 10.0% higher in the intervention groups. There was no significant difference in 30-day mortality evaluated by 4 RCTs (n=42 384), which reported 2.5% to 15.0% versus 5.9% to 22% 30-day mortality rates in the intervention versus control groups. In contrast, nonrandomized quasi-experimental studies reported larger effect sizes compared to RCTs. There were no significant consistent differences in outcomes between high-income and middle-income countries. Low-income countries were not represented in any of the included studies.
Conclusions
Hospital-based acute coronary syndrome quality improvement interventions have a modest effect on process of care measures but not on clinical outcomes with expected differences by study design. Although quality improvement programs have an ongoing and important role for acute coronary syndrome quality of care in high-income country settings, further research will help to identify key components for contextualizing and implementing such interventions to new settings to achieve their desired effects. Systematic Review Registration: URL: https://www.crd.york.ac.uk/PROSPERO/. Unique identifier: CRD42016047604.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005513
Bahiru E, Agarwal A, Berendsen MA, Baldridge AS, ... Bukachi F, Huffman MD
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005513 | PMID: 31525081
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Abstract

Treatments and Mortality Trends in Cases With and Without Dialysis Who Have an Acute Myocardial Infarction: An 18-Year Nationwide Experience.

Szummer K, Lindhagen L, Evans M, Spaak J, ... Carrero JJ, Jernberg T
Background
Patients on dialysis who have an acute myocardial infarction (AMI) have an exceedingly poor prognosis, but it is unknown to what extent guideline-recommended interventions and treatments are used and to which benefit. We aimed to assess temporal changes in the use of treatments and survival rates in dialysis patients with an AMI.
Methods and results
All consecutive AMI cases from 1996 to 2013 enrolled in the SWEDEHEART registry (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) were included. The Swedish Renal Registry identified all chronic dialysis cases. Multivariable adjusted standardized 1-year mortality was estimated. An age-sex-calendar year-matched dialysis background population from the Swedish Renal Registry was used to obtain a standardized incidence ratio. All analyses were performed in 2-year blocks, where each individual could be included several times but in different time blocks; hence the term AMI cases and not patients is used. Of 289 699 cases with AMI, 1398 (0.5%) were on dialysis (73.6% hemodialysis; 26.4% peritoneal dialysis). Among dialysis cases, 29.4% were women, and 21.0% had ST-segment-elevation myocardial infarction. Through 1996 to 2013, dialysis cases had similar age (median, 70 years [interquartile range, 62-77];for trend, 0.14), but the proportion with diabetes mellitus increased (36.0%-55.3%;for trend, 0.005). Dialysis cases admitted with AMI were treated more invasively and received more discharge medications in the later years. From 1995 to 2013, in-hospital and 1-year mortality decreased from 25.4% to 9.4% and from 59.6% to 41.2%, respectively. The standardized in-hospital and 1-year mortality decreased from 25.7% to 9.4% and from 54.6% to 41.2%. Yet, compared with the matched dialysis population, the odds of death remained as high in 2012/2013 as in 1996/1997 (odds ratio, 2.04; 95% CI, 1.62-2.58 and odds ratio, 1.99; 95% CI, 1.52-2.60, respectively;for trend, 0.34).
Conclusions
Over the last 18 years, more patients on dialysis with AMI have been treated with evidence-based therapies. Overall, dialysis cases with AMI have an improved in-hospital and 1-year survival in the more recent years compared with earlier years. However, this appears largely to be because of improved survival in the general dialysis population.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005879
Szummer K, Lindhagen L, Evans M, Spaak J, ... Carrero JJ, Jernberg T
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005879 | PMID: 31510770
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Abstract

Michigan Stroke Transitions Trial.

Reeves MJ, Fritz MC, Woodward AT, Hughes AK, ... Nasiri M, Freddolino PP
Background
To test whether access to home-based social worker-led case management (SWCM) program or SWCM program combined with a website providing stroke-related information improves patient-reported outcomes in patients with stroke, relative to usual care.
Methods and results
The MISTT (Michigan Stroke Transitions Trial), an open (unblinded) 3-group parallel-design clinical trial, randomized 265 acute patients with stroke to 3 treatment groups: Usual Care (group-1), SWCM (group-2), and SWCM+MISTT website (group-3). Patients were discharged directly home or returned home within 4 weeks of discharge to a rehabilitation facility. The SWCM program provided in-home and phone-based case management services. The website provided patient-orientated information covering stroke education, prevention, recovery, and community resources. Both interventions were provided for up to 90 days. Outcomes data were collected by telephone at 7 and 90 days. Primary patient-reported outcomes included Patient-Reported Outcomes Measurement Information System Global-10 Quality-of-Life (Physical and Mental Health subscales) and the Patient Activation Measure. Treatment efficacy was determined by comparing the change in mean response (90 days minus 7 days) between the 3 treatment groups using a group-by-time interaction. Subjects were aged 66 years on average, 49% were female, 21% nonwhite, and 86% had ischemic stroke. There were statistically significant changes in Patient-Reported Outcomes Measurement Information System Physical Health ( P=0.003) and Patient Activation Measure ( P=0.042), but not Patient-Reported Outcomes Measurement Information System Mental Health ( P=0.56). The mean change in Patient-Reported Outcomes Measurement Information System Physical Health scores for group-3 (SWCM+MISTT Website) was significantly higher than both group-2 (SWCM; difference, +2.4; 95% CI, 0.46-4.34; P=0.02) and group-1 (usual care; difference, +3.4; 95% CI, 1.41-5.33; P<0.001). The mean change in Patient Activation Measure scores for group-3 was significantly higher than group-2 (+6.7; 95% CI, 1.26-12.08; P=0.02) and marginally higher than group-1 (+5.0; 95% CI, -0.47 to 10.52; P=0.07).
Conclusions
An intervention that combined SWCM with access to online stroke-related information produced greater gains in patient-reported physical health and activation compared with usual care or case management alone. There was no intervention effect on mental health.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02653170.



Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e005493
Reeves MJ, Fritz MC, Woodward AT, Hughes AK, ... Nasiri M, Freddolino PP
Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e005493 | PMID: 31296043
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Abstract

Privacy-Preserving Generative Deep Neural Networks Support Clinical Data Sharing.

Beaulieu-Jones BK, Wu ZS, Williams C, Lee R, ... Byrd JB, Greene CS
Background
Data sharing accelerates scientific progress but sharing individual-level data while preserving patient privacy presents a barrier.
Methods and results
Using pairs of deep neural networks, we generated simulated, synthetic participants that closely resemble participants of the SPRINT trial (Systolic Blood Pressure Trial). We showed that such paired networks can be trained with differential privacy, a formal privacy framework that limits the likelihood that queries of the synthetic participants\' data could identify a real a participant in the trial. Machine learning predictors built on the synthetic population generalize to the original data set. This finding suggests that the synthetic data can be shared with others, enabling them to perform hypothesis-generating analyses as though they had the original trial data.
Conclusions
Deep neural networks that generate synthetic participants facilitate secondary analyses and reproducible investigation of clinical data sets by enhancing data sharing while preserving participant privacy.



Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e005122
Beaulieu-Jones BK, Wu ZS, Williams C, Lee R, ... Byrd JB, Greene CS
Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e005122 | PMID: 31284738
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Abstract

Clinic-Based Strategies to Reach United States Million Hearts 2022 Blood Pressure Control Goals.

Bellows BK, Ruiz-Negrón N, Bibbins-Domingo K, King JB, ... Moran AE, Fontil V
Background
The Centers for Disease Control and Prevention\'s Million Hearts initiative includes an ambitious ≥80% blood pressure control goal in US adults with hypertension by 2022. We used the validated Blood Pressure Control Model to quantify changes in clinic-based hypertension management processes needed to attain ≥80% blood pressure control.
Methods and results
The Blood Pressure Control Model simulates patient blood pressures weekly using 3 key modifiable hypertension management processes: office visit frequency, clinician treatment intensification given uncontrolled blood pressure, and continued antihypertensive medication use (medication adherence rate). We compared blood pressure control rates (using the Seventh Joint National Committee on hypertension targets) achieved over 4 years between usual care and the best-observed values for management processes identified from the literature (1-week return visit interval, 20%-44% intensification rate, and 76% adherence rate). We determined the management process values needed to achieve ≥80% blood pressure control in US adults. In adults with uncontrolled blood pressure, usual care achieved 45.6% control (95% uncertainty interval, 39.6%-52.5%) and literature-based best-observed values achieved 79.7% control (95% uncertainty interval, 79.3%-80.1%) over 4 years. Increasing treatment intensification rates to 62% of office visits with an uncontrolled blood pressure resulted in ≥80% blood pressure control, even when the return visit interval and adherence remained at usual care values. Improving to best-observed values for all 3 management processes would achieve 78.1% blood pressure control in the overall US population with hypertension, approaching the ≥80% Million Hearts 2022 goal.
Conclusions
Achieving the Million Hearts blood pressure control goal by 2022 will require simultaneously increasing visit frequency, overcoming therapeutic inertia, and improving patient medication adherence. As the relative importance of each of these 3 processes will depend on local characteristics, simulation models like the Blood Pressure Control Model can help local healthcare systems tailor strategies to reach local and national benchmarks.



Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005624
Bellows BK, Ruiz-Negrón N, Bibbins-Domingo K, King JB, ... Moran AE, Fontil V
Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005624 | PMID: 31163981
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Abstract

Cardiovascular Disease Risk Factors and Myocardial Infarction in the Transgender Population.

Alzahrani T, Nguyen T, Ryan A, Dwairy A, ... Mazhari R, Reiner J
Background
As of 2016, ≈1.4 million people in the United States identify as transgender. Despite their growing number and increasing specific medical needs, there has been a lack of research on cardiovascular disease (CVD) and CVD risk factors in this population. Recent studies have reported that the transgender population had a significantly higher rate of CVD risk factors without a significant increase in overall CVD morbidity and mortality. These studies are limited by their small sample sizes and their predominant focus on younger transgender populations. With a larger sample size and inclusion of broader age range, our study aims to provide insight into the association between being transgender and cardiovascular risk factors, as well as myocardial infarction.
Methods and results
The Behavioral Risk Factor Surveillance System data from 2014 to 2017 were used to evaluate the cross-sectional association between being transgender and the reported history of myocardial infarction and CVD risk factors. A logistic regression model was constructed to study the association between being transgender and myocardial infarction after adjusting for CVD risk factors including age, diabetes mellitus, hypertension, hypercholesterolemia, chronic kidney disease, smoking, and exercise. Multivariable analysis revealed that transgender men had a >2-fold and 4-fold increase in the rate of myocardial infarction compared with cisgender men (odds ratio, 2.53; 95% CI, 1.14-5.63; P=0.02) and cisgender women (odds ratio, 4.90; 95% CI, 2.21-10.90; P<0.01), respectively. Conversely, transgender women had >2-fold increase in the rate of myocardial infarction compared with cisgender women (odds ratio, 2.56; 95% CI, 1.78-3.68; P<0.01) but did not have a significant increase in the rate of myocardial infarction compared with cisgender men.
Conclusions
The transgender population had a higher reported history of myocardial infarction in comparison to the cisgender population, except for transgender women compared with cisgender men, even after adjusting for cardiovascular risk factors.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005597
Alzahrani T, Nguyen T, Ryan A, Dwairy A, ... Mazhari R, Reiner J
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005597 | PMID: 30950651
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Abstract

Physician-Specific Practice Patterns About Discharge Readiness and Heart Failure Utilization Outcomes.

Bhatt AB, Cheeran DD, Shemisa K, Roy L, ... de Lemos JA, Das SR
Background
Although hospitalization for acute decompensated heart failure (HF) is common and associated with poor outcomes and high costs, few evidence-based recommendations are available to guide patient management. Thus, management of inpatient HF remains heterogeneous. We evaluated if physician-specific self-reported HF practice patterns were associated with 2 important contributors to resource utilization: length of stay (LOS) and 30-day readmission.
Methods and results
A 5-point Likert scale survey was created to assess physician-specific HF discharge strategies and administered to all cardiologists and hospitalists at a single large academic teaching hospital. Practice patterns potentially impacting LOS and discharge decisions were queried, including use of physical examination findings, approaches to diuretic use and influence of kidney function. Likert scale responses are reported as means with any value above 3.00 considered more influential and any value below 3.00 considered less influential. Physician-specific LOS and 30-day readmission rates from July 1, 2015, to June 30, 2016, were extracted from the electronic record. We received survey responses and HF utilization metrics from 58 of 69 surveyed physicians (32 hospitalists and 26 cardiologists), encompassing 753 HF discharges over a 1-year period. Median LOS was 4.5 days (interquartile range, 4.0-5.8) and total 30-day readmission rate was 17.0% (128 unique readmissions). Physicians with below-median LOS placed less importance on observing a patient on oral diuretics for 24 hours before discharge (Likert 2.54 versus 3.30, P=0.01), reaching documented dry weight (Likert 2.93 versus 3.60, P=0.02), and complete resolution of dyspnea on exertion (Likert 3.64 versus 4.10, P=0.03) when compared with those above-median LOS. In contrast, no surveyed discharge practices were associated with physician-specific 30-day readmission.
Conclusions
We identified specific inpatient HF discharge practice patterns that associated with shorter LOS but not with readmission rates. These may be targets for future interventions aimed at cost reduction; additional larger studies are needed for further exploration.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004365
Bhatt AB, Cheeran DD, Shemisa K, Roy L, ... de Lemos JA, Das SR
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004365 | PMID: 30571338
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Abstract

Recurrent Neural Networks for Early Detection of Heart Failure From Longitudinal Electronic Health Record Data: Implications for Temporal Modeling With Respect to Time Before Diagnosis, Data Density, Data Quantity, and Data Type.

Chen R, Stewart WF, Sun J, Ng K, Yan X
Background
We determined the impact of data volume and diversity and training conditions on recurrent neural network methods compared with traditional machine learning methods.
Methods and results
Using longitudinal electronic health record data, we assessed the relative performance of machine learning models trained to detect a future diagnosis of heart failure in primary care patients. Model performance was assessed in relation to data parameters defined by the combination of different data domains (data diversity), the number of patient records in the training data set (data quantity), the number of encounters per patient (data density), the prediction window length, and the observation window length (ie, the time period before the prediction window that is the source of features for prediction). Data on 4370 incident heart failure cases and 30 132 group-matched controls were used. Recurrent neural network model performance was superior under a variety of conditions that included (1) when data were less diverse (eg, a single data domain like medication or vital signs) given the same training size; (2) as data quantity increased; (3) as density increased; (4) as the observation window length increased; and (5) as the prediction window length decreased. When all data domains were used, the performance of recurrent neural network models increased in relation to the quantity of data used (ie, up to 100% of the data). When data are sparse (ie, fewer features or low dimension), model performance is lower, but a much smaller training set size is required to achieve optimal performance compared with conditions where data are more diverse and includes more features.
Conclusions
Recurrent neural networks are effective for predicting a future diagnosis of heart failure given sufficient training set size. Model performance appears to continue to improve in direct relation to training set size.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005114
Chen R, Stewart WF, Sun J, Ng K, Yan X
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005114 | PMID: 31610714
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Abstract

Health Equity and Implementation Science in Heart, Lung, Blood, and Sleep-Related Research: Emerging Themes From the 2018 Saunders-Watkins Leadership Workshop.

Sterling MR, Echeverría SE, Commodore-Mensah Y, Breland JY, Nunez-Smith M

Disparities in health outcomes for heart, lung, blood, and sleep-related health conditions are pervasive in the United States, with an unequal burden experienced among structurally disadvantaged populations. One reason for this disparity is that despite the existence of effective interventions that promote health equity, few have been translated and implemented consistently in the healthcare system. To achieve health equity, there is a dire need to implement and disseminate effective evidence-based interventions that account for the complex and multilayered social determinants of health among marginalized groups across healthcare settings. To that end, the National Heart, Lung, and Blood Institute\'s Center for Translation Research and Implementation Science invited early stage investigators to participate in the inaugural Saunders-Watkins Leadership Workshop in May of 2018 at the National Institutes of Health. The goals of the workshop were to: (1) present an overview of health equity research, including areas which require ongoing investigation; (2) review how the fields of health equity and implementation science are related; (3) demonstrate how implementation science could be utilized to advance health equity; and (4) foster early stage investigator career success in heart, lung, blood, and sleep-related research. Herein, we highlight key themes from the 2-day workshop and offer recommendations for the future direction of health equity and implementation science research in the context of heart, lung, blood, and sleep-related health conditions.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005586
Sterling MR, Echeverría SE, Commodore-Mensah Y, Breland JY, Nunez-Smith M
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005586 | PMID: 31610713
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Abstract

Atrial Fibrillation Burden Signature and Near-Term Prediction of Stroke: A Machine Learning Analysis.

Han L, Askari M, Altman RB, Schmitt SK, ... Narayan SM, Turakhia MP
Background
Atrial fibrillation (AF) increases the risk of stroke 5-fold and there is rising interest to determine if AF severity or burden can further risk stratify these patients, particularly for near-term events. Using continuous remote monitoring data from cardiac implantable electronic devices, we sought to evaluate if machine learned signatures of AF burden could provide prognostic information on near-term risk of stroke when compared to conventional risk scores.
Methods and results
We retrospectively identified Veterans Health Administration serviced patients with cardiac implantable electronic device remote monitoring data and at least one day of device-registered AF. The first 30 days of remote monitoring in nonstroke controls were compared against the past 30 days of remote monitoring before stroke in cases. We trained 3 types of models on our data: (1) convolutional neural networks, (2) random forest, and (3) L1 regularized logistic regression (LASSO). We calculated the CHADS-VASc score for each patient and compared its performance against machine learned indices based on AF burden in separate test cohorts. Finally, we investigated the effect of combining our AF burden models with CHADS-VASc. We identified 3114 nonstroke controls and 71 stroke cases, with no significant differences in baseline characteristics. Random forest performed the best in the test data set (area under the curve [AUC]=0.662) and convolutional neural network in the validation dataset (AUC=0.702), whereas CHADS-VASc had an AUC of 0.5 or less in both data sets. Combining CHADS-VASc with random forest and convolutional neural network yielded a validation AUC of 0.696 and test AUC of 0.634, yielding the highest average AUC on nontraining data.
Conclusions
This proof-of-concept study found that machine learning and ensemble methods that incorporate daily AF burden signature provided incremental prognostic value for risk stratification beyond CHADS-VASc for near-term risk of stroke.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005595
Han L, Askari M, Altman RB, Schmitt SK, ... Narayan SM, Turakhia MP
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005595 | PMID: 31610712
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Abstract

Sex-Based Differences in Presentation, Treatment, and Complications Among Older Adults Hospitalized for Acute Myocardial Infarction: The SILVER-AMI Study.

Nanna MG, Hajduk AM, Krumholz HM, Murphy TE, ... Chaudhry SI, Dodson JA
Background
Studies of sex-based differences in older adults with acute myocardial infarction (AMI) have yielded mixed results. We, therefore, sought to evaluate sex-based differences in presentation characteristics, treatments, functional impairments, and in-hospital complications in a large, well-characterized population of older adults (≥75 years) hospitalized with AMI.
Methods and results
We analyzed data from participants enrolled in SILVER-AMI (Comprehensive Evaluation of Risk Factors in Older Patients With Acute Myocardial Infarction)-a prospective observational study consisting of 3041 older patients (44% women) hospitalized for AMI. Participants were stratified by AMI subtype (ST-segment-elevation myocardial infarction [STEMI] and non-STEMI [NSTEMI]) and subsequently evaluated for sex-based differences in clinical presentation, functional impairments, management, and in-hospital complications. Among the study sample, women were slightly older than men (NSTEMI: 82.1 versus 81.3, <0.001; STEMI: 82.2 versus 80.6, <0.001) and had lower rates of prior coronary disease. Women in the NSTEMI subgroup presented less frequently with chest pain as their primary symptom. Age-associated functional impairments at baseline were more common in women in both AMI subgroups (cognitive impairment, NSTEMI: 20.6% versus 14.3%, <0.001; STEMI: 20.6% versus 12.4%, =0.001; activities of daily living disability, NSTEMI: 19.7% versus 11.4%, <0.001; STEMI: 14.8% versus 6.4%, <0.001; impaired functional mobility, NSTEMI: 44.5% versus 30.7%, <0.001; STEMI: 39.4% versus 22.0%, <0.001). Women with AMI had lower rates of obstructive coronary disease (NSTEMI: <0.001; STEMI: =0.02), driven by lower rates of 3-vessel or left main disease than men (STEMI: 38.8% versus 58.7%; STEMI: 24.3% versus 32.1%), and underwent revascularization less commonly (NSTEMI: 55.6% versus 63.6%, <0.001; STEMI: 87.3% versus 93.3%, =0.01). Rates of bleeding were higher among women with STEMI (26.2% versus 15.6%, <0.001) but not NSTEMI (17.8% versus 15.7%, =0.21). Women had a higher frequency of bleeding following percutaneous coronary intervention with both NSTEMI (11.0% versus 7.8%, =0.04) and STEMI (22.6% versus 14.8%, =0.02).
Conclusions
Among older adults hospitalized with AMI, women had a higher prevalence of age-related functional impairments and, among the STEMI subgroup, a higher incidence of overall bleeding events, which was driven by higher rates of nonmajor bleeding events and bleeding following percutaneous coronary intervention. These differences may have important implications for in-hospital and posthospitalization needs.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005691
Nanna MG, Hajduk AM, Krumholz HM, Murphy TE, ... Chaudhry SI, Dodson JA
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005691 | PMID: 31607145
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Impact:
Abstract

Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.

Magnuson EA, Chinnakondepalli K, Vilain K, Kearon C, ... Vedantham S, Cohen DJ
Background
In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.
Methods and results
Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.
Conclusions
With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005659
Magnuson EA, Chinnakondepalli K, Vilain K, Kearon C, ... Vedantham S, Cohen DJ
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005659 | PMID: 31592728
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Impact:
Abstract

Dog Ownership and Survival After a Major Cardiovascular Event: A Register-Based Prospective Study.

Mubanga M, Byberg L, Egenvall A, Ingelsson E, Fall T
Background
Dog ownership is associated with increased physical activity levels and increased social support, both of which could improve the outcome after a major cardiovascular event. Dog ownership may be particularly important in single-occupancy households where ownership provides substitutive companionship and motivation for physical activity.
Methods and results
We used the Swedish National Patient Register to identify all patients aged 40 to 85 presenting with an acute myocardial infarction (n=181 696; 5.7% dog ownership) or ischemic stroke (n=154 617; 4.8% dog ownership) between January 1, 2001 and December 31, 2012. Individual information was linked across registers for cause of death, sociodemographic, and dog ownership data. We evaluated all-cause mortality and risk of recurrent hospitalization for the same cause until December 31, 2012. Models were adjusted for socioeconomic, health, and demographic factors at study inclusion such as age, marital status, the presence of children in the home, area of residence, and income, as well as all registered comorbidities and hospitalization for cardiovascular disease in the past 5 years. Dog owners had a lower risk of death after hospitalization for acute myocardial infarction during the full follow-up period of 804 137 person-years, with an adjusted hazard ratio (HR) of 0.67 (95% CI, 0.61 to 0.75) for those who lived alone, and HR of 0.85 (95% CI, 0.80 to 0.90) for those living with a partner or a child. Similarly, after an ischemic stroke, dog owners were at lower risk of death during the full follow-up of 638 219 person-years adjusted HR of 0.73 (95% CI, 0.66 to 0.80) for those who lived alone and HR of 0.88 (95% CI, 0.83 to 0.93) for those living with a partner or a child. We further found an association of dog ownership with reduced risk of hospitalization for recurrent myocardial infarction (HR, 0.93; 95% CI, 0.87 to 0.99).
Conclusions
We found evidence of an association of dog ownership with a better outcome after a major cardiovascular event. Although our models are adjusted for many potential confounders, there are also unmeasured confounders such as smoking that prevent us from drawing conclusions regarding a possible causal effect.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005342
Mubanga M, Byberg L, Egenvall A, Ingelsson E, Fall T
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005342 | PMID: 31592725
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Impact:
Abstract

Increased Cardiovascular Disease Risk in Veterans With Mental Illness.

Vance MC, Wiitala WL, Sussman JB, Pfeiffer P, Hayward RA
Background
Although previous studies have demonstrated an association between various mental illnesses and cardio-cerebrovascular disease (CVD) risk, few have compared the strength of association between different mental illnesses and CVD risk.
Methods and results
We assessed the association of psychiatric diagnoses (psychosis, bipolar disorder, depression, anxiety, and posttraumatic stress disorder) with major CVD outcomes (CVD events and CVD mortality) over 5 years, using a national primary prevention cohort of military veterans receiving care in the Department of Veterans Affairs. Data were linked from the Department of Veterans Affairs, Centers for Medicare and Medicaid Services, and Centers for Disease Control and Prevention National Death Index databases. We used multiple logistic regression to examine how the presence of a psychiatric diagnosis at baseline (2005-2009) was associated with CVD outcomes over the next 5 years (January 1, 2010, to December 31, 2014) stratified by sex, adjusting for other psychiatric diagnoses, as well as age, race, conventional CVD risk factors as calculated by the Veterans Affairs Risk Score-CVD, and antipsychotic and anticonvulsant/mood stabilizer medication prescriptions. Approximately 1.52 million men and over 94 000 women met our inclusion criteria. In the fully adjusted model, among men, we found that depression, psychosis, and bipolar disorder were predictive of both CVD events and CVD mortality, with psychosis having the largest effect size (eg, adjusted odds ratio, 1.48; CI, 1.41-1.56; <0.001 for psychosis and CVD mortality). Among women, only psychosis and bipolar disorder were predictive of both CVD events and CVD mortality, again with psychosis having the largest effect size (eg, adjusted odds ratio, 1.97; CI, 1.52-2.57; <0.001 for psychosis and CVD mortality). Anxiety was associated with only CVD mortality in men, and depression was associated with only CVD events in women.
Conclusions
Consistent with the hypothesis that chronic stress leads to greater CVD risk, multiple mental illnesses were associated with an increased risk of CVD outcomes, with more severe mental illnesses (eg, primary psychotic disorders) having the largest effect sizes even after controlling for other psychiatric diagnoses, conventional CVD risk factors, and psychotropic medication use.



Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005563
Vance MC, Wiitala WL, Sussman JB, Pfeiffer P, Hayward RA
Circ Cardiovasc Qual Outcomes: 29 Sep 2019; 12:e005563 | PMID: 31547692
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Impact:
Abstract

Automated and Interpretable Patient ECG Profiles for Disease Detection, Tracking, and Discovery.

Tison GH, Zhang J, Delling FN, Deo RC
Background
The ECG remains the most widely used diagnostic test for characterization of cardiac structure and electrical activity. We hypothesized that parallel advances in computing power, machine learning algorithms, and availability of large-scale data could substantially expand the clinical inferences derived from the ECG while at the same time preserving interpretability for medical decision-making.
Methods and results
We identified 36 186 ECGs from the University of California, San Francisco database that would enable training of models for estimation of cardiac structure or function or detection of disease. We segmented the ECG into standard component waveforms and intervals using a novel combination of convolutional neural networks and hidden Markov models and evaluated this segmentation by comparing resulting electrical intervals against 141 864 measurements produced during the clinical workflow. We then built a patient-level ECG profile, a 725-element feature vector and used this profile to train and interpret machine learning models for examples of cardiac structure (left ventricular mass, left atrial volume, and mitral annulus e-prime) and disease (pulmonary arterial hypertension, hypertrophic cardiomyopathy, cardiac amyloid, and mitral valve prolapse). ECG measurements derived from the convolutional neural network-hidden Markov model segmentation agreed with clinical estimates, with median absolute deviations as a fraction of observed value of 0.6% for heart rate and 4% for QT interval. Models trained using patient-level ECG profiles enabled surprising quantitative estimates of left ventricular mass and mitral annulus e\' velocity (median absolute deviation of 16% and 19%, respectively) with good discrimination for left ventricular hypertrophy and diastolic dysfunction as binary traits. Model performance using our approach for disease detection demonstrated areas under the receiver operating characteristic curve of 0.94 for pulmonary arterial hypertension, 0.91 for hypertrophic cardiomyopathy, 0.86 for cardiac amyloid, and 0.77 for mitral valve prolapse.
Conclusions
Modern machine learning methods can extend the 12-lead ECG to quantitative applications well beyond its current uses while preserving the transparency that is so fundamental to clinical care.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005289
Tison GH, Zhang J, Delling FN, Deo RC
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005289 | PMID: 31525078
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Impact:
Abstract

Cardiologist Participation in Accountable Care Organizations and Changes in Spending and Quality for Medicare Patients With Cardiovascular Disease.

Sukul D, Ryan AM, Yan P, Markovitz A, ... Lewis VA, Hollingsworth JM
Background
Despite widespread adoption of Medicare accountable care organizations (ACOs), healthcare spending reductions have been modest. This may relate to variable participation in ACOs by specialist physicians, who disproportionately drive spending. To examine whether specialist participation in Medicare ACOs was associated with changes in healthcare spending and clinical quality, we analyzed national Medicare data.
Methods and results
Working with a 20% random sample of Medicare beneficiaries (2008 to 2015), we identified those with cardiovascular disease. We estimated linear regression models at the beneficiary-quarter level to evaluate changes in healthcare spending and clinical quality after the start of the Shared Savings Program in 2012. We then examined whether changes in spending and quality across ACOs were conditional on cardiologist participation. Our study included ≈1.6 million beneficiaries per year. Although the number of ACOs increased over the study period (from 114 in 2012 to 392 in 2015), the proportion with any cardiologist participation remained stable (from 80% in 2012 to 83% in 2015). Compared with unaligned beneficiaries, those cared for by ACOs without cardiologist participation were associated with a spending reduction (per quarter) of -$75 (95% CI, -$105 to -$46; <0.001). Care receipt in an ACO with cardiologist participation was associated with an additional difference in spending of -$56 (95% CI, -$87 to -$25; <0.001), driven by lower spending for skilled nursing facilities, evaluation and management services, procedural care, and testing. While heart failure admission rates were similar among aligned and unaligned beneficiaries, ACO care was associated with fewer all-cause readmissions (<0.001) and emergency department visits (<0.001). Rates of these outcomes did not vary by cardiologist participation.
Conclusions
Annual spending for beneficiaries with cardiovascular disease was ≈$200 lower when cared for by ACOs with cardiologist participation (compared with those without). These spending reductions did not come at the expense of clinical quality.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005438
Sukul D, Ryan AM, Yan P, Markovitz A, ... Lewis VA, Hollingsworth JM
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005438 | PMID: 31522529
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Impact:
Abstract

Direct Assessment of Health Utilities Using the Standard Gamble Among Patients With Primary Intracerebral Hemorrhage.

Slaughter KB, Meyer EG, Bambhroliya AB, Meeks JR, ... Savitz SI, Vahidy FS
Background
Standard gamble (SG) directly measures patients\' valuation of their health state. We compare in-hospital and day-90 SG utilities (SGU) among intracerebral hemorrhage patients and report a 3-way association between SGU, EuroQoL-5 dimension, and modified Rankin Scale at day 90.
Methods and results
Patients with intracerebral hemorrhage underwent in-hospital and day-90 assessments for the modified Rankin Scale, EuroQoL-5 dimension, and SG. SG provides patients a choice between their current health state and a hypothetical treatment with varying chances of either perfect health or a painless death. Higher SGU (scale, 0-1) indicates lower risk tolerance and thus higher valuation of the current health state. Logistic regression was used to estimate the likelihood of low SGU (≤0.6), and Wilcoxon paired signed-rank test compared in-hospital and day-90 SGU. In-hospital and day-90 SG was obtained from 381 and 280 patients, respectively, including 236 paired observations. Median (interquartile range) in-hospital and day-90 SGUs were 0.85 (0.40-0.98) and 0.98 (0.75-1.00; <0.001). In-hospital SGUs were lower with advancing age (=0.007), higher National Institutes of Health Stroke Scale, and intracerebral hemorrhage scores (<0.001). Proxy-based assessments resulted in lower SGUs; median difference (95% CI), -0.2 (-0.33 to -0.07). After adjustment, higher National Institutes of Health Stroke Scale and proxy assessments were independently associated with lower SGU, along with an effect modification of age by race. Day-90 SGU and modified Rankin Scale were significantly correlated; however, SGUs were higher than the EuroQoL-5 dimension utilities at higher modified Rankin Scale levels.
Conclusions
Divergence between directly (SGU) and indirectly (EuroQoL-5 dimension) assessed utilities at high levels of functional disability warrant careful prognostication of intracerebral hemorrhage outcomes and should be considered in designing early end-of-life care discussions with families and patients.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005606
Slaughter KB, Meyer EG, Bambhroliya AB, Meeks JR, ... Savitz SI, Vahidy FS
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005606 | PMID: 31514521
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Impact:
Abstract

Qualitative Methodology in Cardiovascular Outcomes Research: A Contemporary Look.

McIlvennan CK, Morris MA, Guetterman TC, Matlock DD, Curry L

Qualitative research offers unique opportunities to contribute to cardiovascular outcomes research. Despite the growth in qualitative research over the last decade, outcomes investigators in cardiology still have relatively little guidance on when and how best to implement these methods in their investigations, leaving the full potential of these methods unrealized. We offer a contemporary look at qualitative methods, including publication trends of qualitative studies in cardiology journals from 1998 to 2018, novel emerging data collection and analytic methods, and current use and examples of cardiovascular outcomes research that apply qualitative methods such as user-centered design, preimplementation evaluation, implementation evaluation, effectiveness evaluation, and policy analysis.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005828
McIlvennan CK, Morris MA, Guetterman TC, Matlock DD, Curry L
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e005828 | PMID: 31510771
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Impact:
Abstract

Examining the Prevalence of Adverse Childhood Experiences and Associated Cardiovascular Disease Risk Factors Among Low-Income Uninsured Adults.

Allen H, Wright BJ, Vartanian K, Dulacki K, Li HF
Background
Adverse childhood experiences (ACEs) are linked to poor adult health outcomes, including cardiovascular disease. However, little is known about its prevalence, specifically in low-income populations. The objective of this study was to estimate the extent of ACEs in a low-income, nonclinical, uninsured adult population and assess the relationship between ACEs and cardiovascular disease risk factors.
Methods and results
This study leverages the OHIE\'s (Oregon Health Insurance Experiment) study population, uninsured adults who were randomly selected to apply for Medicaid, and data collected through in-person health screenings. We objectively measured obesity, cholesterol, blood pressure, and blood sugar. Smoking, physical activity, and history of chronic disease were self-reported. Independent variables were the 10-item ACEs questions covering neglect, abuse, and household dysfunction. The sample consisted of 12 229 low-income, nonelderly uninsured adults who participated in the OHIE health screenings from 2009 to 2010. A total of 5929 (48%) returned a follow-up survey reporting ACEs in 2012. ACEs were more prevalent in low-income adults compared with previous estimates in a general clinical population, with notably high rates of emotional abuse, emotional neglect, and household dysfunction. ACEs were statistically associated with higher rates of obesity, smoking, and physical inactivity, but not high cholesterol or diabetes mellitus. We detected a strong relationship between ACEs and a self-reported history of a hypertension diagnosis but no statistically significant differences in being hypertensive.
Conclusions
This study design allowed us to assess the prevalence of ACEs among uninsured low-income adults and the association between ACEs and clinical indicators of cardiovascular disease risk that are difficult to ordinarily observe. Low-income adults have high rates of ACEs than previous prevalence estimates and ACEs were associated with higher rates of multiple cardiovascular disease risk factors. As states continue to expand Medicaid to the previously uninsured, providers may want to consider incorporating trauma-based approaches to care delivery.



Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e004391
Allen H, Wright BJ, Vartanian K, Dulacki K, Li HF
Circ Cardiovasc Qual Outcomes: 30 Aug 2019; 12:e004391 | PMID: 31450964
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Impact:
Abstract

Sex Differences in the Use of Statins in Community Practice.

Nanna MG, Wang TY, Xiang Q, Goldberg AC, ... Peterson ED, Navar AM
Background
Female patients have historically received less aggressive lipid management than male patients. Contemporary care patterns and the potential causes for these differences are unknown.
Methods and results
Examining the Patient and Provider Assessment of Lipid Management Registry-a nationwide registry of outpatients with or at risk for atherosclerotic cardiovascular disease-we compared the use of statin therapy, guideline-recommended statin dosing, and reasons for undertreatment. We specifically analyzed sex differences in statin treatment and guideline-recommended statin dosing using multivariable logistic regression. Among 5693 participants (43% women) eligible for 2013 American College of Cardiology/American Heart Association Cholesterol Guideline-recommended statin treatment, women were less likely than men to be prescribed any statin therapy (67.0% versus 78.4%; P<0.001) or to receive a statin at the guideline-recommended intensity (36.7% versus 45.2%; P<0.001). Women were more likely to report having previously never been offered statin therapy (18.6% versus 13.5%; P<0.001), declined statin therapy (3.6% versus 2.0%; P<0.001), or discontinued their statin (10.9% versus 6.1%; P<0.001). Women were also less likely than men to believe statins were safe (47.9% versus 55.2%; P<0.001) or effective (68.0% versus 73.2%; P<0.001) and more likely to report discontinuing their statin because of a side effect (7.9% versus 3.6%; P<0.001). Sex differences in both overall and guideline-recommended intensity statin use persisted after adjustment for demographics, socioeconomic factors, clinical characteristics, patient beliefs, and provider characteristics (adjusted odds ratio, 0.70; 95% CI, 0.61-0.81; P<0.001; and odds ratio, 0.82; 95% CI, 0.73-0.92; P<0.01, respectively). Sex differences were consistent across primary and secondary prevention indications for statin treatment.
Conclusions
Women eligible for statin therapy were less likely than men to be treated with any statin or guideline-recommended statin intensity. A combination of women being offered statin therapy less frequently, while declining and discontinuing treatment more frequently, accounted for these sex differences in statin use.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005562
Nanna MG, Wang TY, Xiang Q, Goldberg AC, ... Peterson ED, Navar AM
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005562 | PMID: 31416347
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Impact:
Abstract

Joint Shock/Death Risk Prediction Model for Patients Considering Implantable Cardioverter-Defibrillators.

Reeder HT, Shen C, Buxton AE, Haneuse SJ, Kramer DB
Background
The risk of death or appropriate therapy varies widely among recipients of implantable cardioverter-defibrillators (ICDs). The goals of this study were to develop a risk prediction tool that jointly considers future outcome probabilities of ICD shock and death.
Methods and results
We performed a secondary analysis of patients receiving ICDs as part of the SCD-HeFT trial (Sudden Cardiac Death in Heart Failure Trial). We applied an illness-death regression model to jointly model both ICD shocks and death under the semi-competing risks framework, which predicts for each patient their probability of having received ICD shocks, dying, or both at any given point in time. Among 803 ICD recipients (mean age, 60 years; 23% women) followed for a median of 41.1 months, 430 (53.5%) patients completed the study without dying or receiving an ICD shock, 206 (25.7%) received at least 1 shock but survived, 113 (14.1%) died before experiencing a shock, and 54 (6.7%) received at least 1 shock and subsequently died. Predicted outcome probabilities based on baseline demographic and clinical variables reveal substantial heterogeneity in joint shock and death risks, both between patients at each time point and for each single patient across time. Overall, predictive performance for ICD shock and death individually was adequate, based on area under the curve at 5 years of 0.65 for shocks and of 0.79 for death.
Conclusions
Our analysis of outcomes after ICD implantation provides an alternative predictive model for individual risk of death or ICD shocks. If validated, this may provide a useful tool for individualized counseling regarding likely outcomes after device implantation, while also informing the design of further studies to focus the clinical effectiveness and cost-effectiveness of ICD therapy.
Clinical trial registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00000609.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005675
Reeder HT, Shen C, Buxton AE, Haneuse SJ, Kramer DB
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005675 | PMID: 31412732
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Impact:
Abstract

Intravenous Tissue Plasminogen Activator in Stroke Mimics.

Ali-Ahmed F, Federspiel JJ, Liang L, Xu H, ... Peterson ED, Xian Y
Background
The necessity for rapid evaluation and treatment of acute ischemic stroke with intravenous tPA (tissue-type plasminogen activator) may increase the risk of administrating tPA to patients presenting with noncerebrovascular conditions that closely resemble stroke (stroke mimics). However, there are limited data on thrombolysis safety in stroke mimics.
Methods and results
Using data from the Get With The Guidelines-Stroke Registry, we identified 72 582 patients with suspected ischemic stroke treated with tPA from 485 US hospitals between January 2010 and December 2017. We documented the use of tPA in stroke mimics, defined as patients who present with stroke-like symptoms, but after workup are determined not to have suffered from a stroke or transient ischemic attack, and compared characteristics and outcomes in stroke mimics versus those with ischemic stroke. Overall, 3.5% of tPA treatments were given to stroke mimics. Among them, 38.2% had a final nonstroke diagnoses of migraine, functional disorder, seizure, and electrolyte or metabolic imbalance. Compared with tPA-treated true ischemic strokes, tPA-treated mimics were younger (median 54 versus 71 years), had a less severe National Institute of Health Stroke Scale (median 6 versus 8), and a lower prevalence of cardiovascular risk factors, except for a higher prevalence of prior stroke/transient ischemic attack (31.3% versus 26.1%, all P<0.001). The rate of symptomatic intracranial hemorrhage was lower in stroke mimics (0.4%) as compared with 3.5% in ischemic strokes (adjusted odds ratio, 0.29; 95% CI, 0.17-0.50). In-hospital mortality rate was significantly lower in stroke mimics (0.8% versus 6.2%, adjusted odds ratio, 0.31; 95% CI, 0.20-0.49). Patients with stroke mimics were more likely to be discharged to home (83.8% versus 49.3%, adjusted odds ratio, 2.97; 95% CI, 2.59-3.42) and to ambulate independently at discharge (78.6% versus 50.6%, adjusted odds ratio, 1.86; 95% CI, 1.61-2.14).
Conclusions
In this large cohort of patients treated with tPA, relatively few patients who received tPA for presumed stroke were ultimately not diagnosed with a stroke or transient ischemic attack. The complication rates associated with tPA in stroke mimics were low. Despite the potential risk of administering tPA to stroke mimics, opportunity remains for continued improvement in the rapid and accurate diagnosis and treatment of ischemic stroke.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005609
Ali-Ahmed F, Federspiel JJ, Liang L, Xu H, ... Peterson ED, Xian Y
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005609 | PMID: 31412730
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Impact:
Abstract

More- Versus Less-Intensive Lipid-Lowering Therapy.

Toyota T, Morimoto T, Yamashita Y, Shiomi H, ... Ono K, Kimura T
Background
It has not been yet adequately addressed whether the addition of the nonstatin LDL-C (low-density lipoprotein cholesterol)-lowering agents on top of statins has the same magnitude of risk reduction in the cardiovascular events as compared with more-intensive statin therapy.
Methods and results
We performed a systematic review and meta-analysis of RCTs (randomized controlled trials) comparing more- versus less-intensive lipid-lowering therapy (LLT) on clinical outcomes in patients with atherosclerotic cardiovascular risk. We included 23 studies involving 133 037 patients (more-intensive LLT: 67 691 patients and less-intensive LLT: 65 346 patients). We evaluated 3 types of more- versus less-intensive LLT including more versus less statins (57 672 patients), combination therapy of ezetimibe versus statins alone (20 688 patients), or a PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitor with statins versus statins alone (54 677 patients). The odds for major adverse cardiovascular events (MACE; equivalent to the composite of coronary heart death, nonfatal myocardial infarction, stroke, or coronary revascularization) were significantly lower in the more-intensive LLT group compared with the less-intensive LLT group in the entire study population (odds ratio, 0.84; 95% CI, 0.79-0.88; P<0.001), and in all the 3 categories of more-intensive LLT strategies (more-intensive statin therapy: odds ratio, 0.83; 95% CI, 0.76-0.90; P<0.001, ezetimibe: odds ratio, 0.90; 95% CI, 0.85-0.96; P<0.001, and PCSK9 inhibitors: odds ratio, 0.81; 95% CI, 0.73-0.90; P<0.001) with numerically greater relative odds reduction by more-intensive statin therapy and PCSK9 inhibitors than by ezetimibe. Odds reduction for MACE per 20 mg/dL LDL-C reduction was also different across the 3 types of more-intensive LLT (more-intensive statin therapy: 17.4%, ezetimibe: 11.0%, and PCSK9 inhibitors: 6.6%).
Conclusions
In this meta-analysis, more-intensive LLT as compared with less-intensive LLT was associated with significant odds reduction for MACE in the entire study population and in all the 3 categories of more-intensive LLT such as more-intensive statin therapy, ezetimibe, and PCSK9 inhibitors. However, overall odds reduction for MACE and odds reduction for MACE per 20 mg/dL LDL-C reduction were different across the 3 types of more-intensive LLT. Registration: URLs: https://www.crd.york.ac.uk/PROSPERO/ and http://www.umin.ac.jp/ctr. Unique identifiers: PROSPERO: CRD42018081196, and UMIN-CTR: R000036229.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005460
Toyota T, Morimoto T, Yamashita Y, Shiomi H, ... Ono K, Kimura T
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005460 | PMID: 31412729
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Impact:
Abstract

A Network Approach to Stroke Systems of Care.

Zachrison KS, Dhand A, Schwamm LH, Onnela JP

The landscape of stroke systems of care is evolving as patients are increasingly transferred between hospitals for access to higher levels of care. This is driven by time-sensitive disability-reducing interventions such as mechanical thrombectomy. However, coordination and triage of patients for such treatment remain a challenge worldwide, particularly given complex eligibility criteria and varying time windows for treatment. Network analysis is an approach that may be applied to this problem. Hospital networks interlinked by patients moved from facility to facility can be studied using network modeling that respects the interdependent nature of the system. This allows understanding of the central hubs, the change of network structure over time, and the diffusion of innovations. This topical review introduces the basic principles of network science and provides an overview on the applications and potential interventions in stroke systems of care.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005526
Zachrison KS, Dhand A, Schwamm LH, Onnela JP
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005526 | PMID: 31405293
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Impact:
Abstract

Endovascular-First Treatment Is Associated With Improved Amputation-Free Survival in Patients With Critical Limb Ischemia.

Lin JH, Brunson A, Romano PS, Mell MW, Humphries MD
Background
Critical limb ischemia remains a difficult disease to treat, with limited level one data. The BEST-CLI trial (Best Endovascular vs Best Open Surgical Therapy in Patients with Critical Limb Ischemia) is attempting to answer whether initial treatment with open surgical bypass or endovascular therapy improves outcomes, although it remains in enrollment. This study aims to compare amputation-free survival and reintervention rates in patients treated with initial open surgical bypass or endovascular intervention for ischemic ulcers of the lower extremities.
Methods and results
Using California nonfederal hospital data linked to statewide death data, all patients with lower extremity ulcers and a diagnosis of peripheral artery disease who underwent a revascularization procedure from 2005 to 2013 were identified. Propensity scores were formulated from baseline patient characteristics. Inverse probability weighting was used with Kaplan-Meier analysis to determine amputation-free survival and time to reintervention for open versus endovascular treatment. Mixed-effects Cox proportional hazards modeling was used to adjust for patient ability to manage their disease and hospital revascularization volume. A total of 16 800 patients were identified. Open surgical bypass was the initial treatment in 5970 (36%) while 10 830 (64%) underwent endovascular interventions. Patients in the endovascular group were slightly younger compared with the open group (70 versus 71 years, ±12 years; P<0.001). Endovascular-first patients were more likely to have comorbid renal failure (36% versus 24%), coronary artery disease (34% versus 32%), congestive heart failure (19% versus 15%), and diabetes mellitus (65% versus 58%; all P values <0.05). After inverse propensity weighting as well as adjustment for patient ability to manage their disease and hospital revascularization experience, open surgery first was associated with a worse amputation-free survival (hazard ratio, 1.16; 95% CI, 1.13-1.20) with no difference in mortality (hazard ratio, 0.94; 95% CI, 0.89-1.11). Endovascular first was associated with higher rates of reintervention (hazard ratio, 1.19; 95% CI, 1.14-1.23).
Conclusions
Patients with critical limb ischemia have multiple comorbidities, and initial surgical bypass is associated with poorer amputation-free survival compared with an endovascular-first approach, perhaps due to increased severity of wounds at the time of presentation.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005273
Lin JH, Brunson A, Romano PS, Mell MW, Humphries MD
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005273 | PMID: 31357888
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Abstract

Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes.

Myers KD, Farboodi N, Mwamburi M, Howard W, ... Wilemon K, Rader DJ
Background
Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitors) reduce low-density lipoprotein cholesterol levels and cardiovascular event rates. However, PCSK9i prescriptions are rejected at high rates by payers, and use is often delayed or eventually abandoned as a treatment option. We tested the hypothesis that acute coronary syndromes, coronary interventions, stroke, and cardiac arrest are more prevalent in patients with rejected or abandoned PCSK9i prescriptions than for those with paid PCSK9i prescriptions.
Methods and results
We identified 139 036 individuals aged ≥18 years who met the following 3 criteria: prescribed PCSK9i between August 2015 and December 2017, had claims history, and had an established date of exposure for paid, rejected, or abandoned status. To compare the effects of rejected versus paid and abandoned versus paid status, propensity score matching was performed to minimize confounding because of baseline differences in patient groups. Cox regression analyses and incidence density rates for cardiovascular events were estimated on the propensity score-matched cohorts. Patients who received 168 or more days of paid PCSK9i medication within a 12-month period were defined as paid. The hazard ratios for composite cardiovascular events outcome in propensity score-matched analyses were 1.10 (95% CI, 1.01-1.19; P=0.02) for rejected versus paid and 1.12 (95% CI, 1.01-1.24; P=0.03) for abandoned versus paid. In a stricter analysis where paid patients were defined by receiving 338 or more days of therapy within 12-months, hazard ratio was 1.16 (95% CI, 1.02-1.30; P=0.04) for rejected versus paid and 1.21 (95% CI, 1.04-1.38; P=0.03) for the abandoned versus paid status. Higher PCSK9i rejection rates were observed with women, racial minorities, and lower-income groups.
Conclusions
Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort. Rejection, abandonment, and disparities related to PCSK9i prescriptions are related to higher cardiovascular outcome rates.



Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005404
Myers KD, Farboodi N, Mwamburi M, Howard W, ... Wilemon K, Rader DJ
Circ Cardiovasc Qual Outcomes: 30 Jul 2019; 12:e005404 | PMID: 31331194
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Abstract

Comparative Effectiveness of β-Blocker Use Beyond 3 Years After Myocardial Infarction and Long-Term Outcomes Among Elderly Patients.

Shavadia JS, Holmes DN, Thomas L, Peterson ED, ... Roe MT, Wang TY
Background
The benefit of β-blocker use beyond 3 years after a myocardial infarction (MI) has not been clearly determined.
Methods and results
Using data from the CRUSADE Registry (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines) linked with Medicare claims, we studied patients ≥65 years of age with MI, discharged on β-blocker therapy and alive 3 years later without a recurrent MI to evaluate β-blocker use and dose (none, <50%, and ≥50% of the recommended target) at 3 years. Using inverse probability of treatment weighting, we then examined the adjusted association between β-blocker use (and dose) at 3 years and the cardiovascular composite of all-cause mortality, hospitalization for recurrent MI, ischemic stroke, or heart failure over the subsequent 5 years. Of the 6893 patients ≥65 years age, β-blocker use at 3 years was 72.2% (n=4980); 43% (n=2162) of these were treated with ≥50% of the target β-blocker dose. β-blocker use was not associated with a significant difference on the composite outcome (52.4% versus 55.4%, adjusted hazard ratio, 0.95; 95% CI, 0.88-1.03; P=0.23). Neither low dose (<50% target dose) nor high dose (≥50% target dose) β-blocker use was associated with a significant difference in risk when compared with no β-blocker use. Results were also consistent in patients with and without heart failure or systolic dysfunction ( P interaction =0.30).
Conclusions
In this observational analysis, β-blocker use beyond 3 years post-MI, regardless of the dose achieved, was not associated with improved outcomes. The role of prolonged β-blocker use, particularly in older adults, needs further investigation.



Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e005103
Shavadia JS, Holmes DN, Thomas L, Peterson ED, ... Roe MT, Wang TY
Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e005103 | PMID: 31284739
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Abstract

Performance of the Meta-Analysis Global Group in Chronic Heart Failure Score in Black Patients Compared With Whites.

Radjef R, Peterson EL, Michaels A, Liu B, ... Williams LK, Lanfear DE
Background
Risk stratification is critical in heart failure (HF) and the Meta-Analysis Global Group in Chronic HF (MAGGIC) score is a validated tool derived from ~40,000 patients. However, few of these patients self-identified as black, raising uncertainty regarding performance in blacks with HF.
Methods and results
This study analyzed a racially diverse group of 4046 patients (1646 black and 2400 white) from a single center from 2007 to 2015. Baseline characteristics were collected to tabulate MAGGIC score and test its discrimination and calibration within race groups. The primary end point was all-cause mortality. Death was detected using system records and the social security death master file. Discrimination was tested using Cox models of MAGGIC score stratified by race, and combined analysis including MAGGIC, race, and MAGGIC×race. Calibration was assessed using linear regression models and plots of observed versus predicted data. Overall, 901 (21%) patients died during 1-year follow-up. MAGGIC score discrimination was similar in both race groups in terms of C statistic (0.707±0.027 versus 0.725±0.014, for black versus white; P=0.556) and the hazard ratio (HR) per MAGGIC point was 1.12 in black patients (95% CI, 1.10-1.14) and 1.13 in white patients (95% CI, 1.12-1.14). Race was a significant correlate of survival, with better survival in black patients compared with white (HR, 0.66; 95% CI, 0.56-0.78), but the interaction of MAGGIC×race was not significant (β=-0.013; P=0.16), and adding race to the model did not improve discrimination (C statistic for MAGGIC versus MAGGIC+race, 0.721 versus 0.722; P=0.79). In calibration testing, the slope was not significantly different from 1 in either group, but the groups differed from each other, and it was closer to unity among black patients (0.94 versus 1.4; P=0.004).
Conclusions
These data support the use of the MAGGIC score to risk stratify black patients with HF.



Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e004714
Radjef R, Peterson EL, Michaels A, Liu B, ... Williams LK, Lanfear DE
Circ Cardiovasc Qual Outcomes: 29 Jun 2019; 12:e004714 | PMID: 31266369
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Abstract

Integrating Quality of Life and Survival Outcomes Cardiovascular Clinical Trials.

Spertus JV, Hatfield LA, Cohen DJ, Arnold SV, ... Zuckerman B, Spertus JA

Background Survival and health status (eg, symptoms and quality of life) are key outcomes in clinical trials of heart failure treatment. However, health status can only be recorded on survivors, potentially biasing treatment effect estimates when there is differential survival across treatment groups. Joint modeling of survival and health status can address this bias. Methods and Results We analyzed patient-level data from the PARTNER 1B trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement versus standard care. Health status was quantified with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization, 1, 6, and 12 months. We compared hazard ratios for survival and mean differences in KCCQ scores at 12 months using several models: the original growth curve model for KCCQ scores (ignoring death), separate Bayesian models for survival and KCCQ scores, and a Bayesian joint longitudinal-survival model fit to either 12 or 30 months of survival follow-up. The benefit of transcatheter aortic valve replacement on 12-month KCCQ scores was greatest in the joint-model fit to all survival data (mean difference, 33.7 points; 95% credible intervals [CrI], 24.2-42.4), followed by the joint-model fit to 12 months of survival follow-up (32.3 points; 95% CrI, 22.5-41.5), a Bayesian model without integrating death (30.4 points; 95% CrI, 21.4-39.3), and the original growth curve model (26.0 points; 95% CI, 18.7-33.3). At 12 months, the survival benefit of transcatheter aortic valve replacement was also greater in the joint model (hazard ratio, 0.50; 95% CrI, 0.32-0.73) than in the nonjoint Bayesian model (0.54; 95% CrI, 0.37-0.75) or the original Kaplan-Meier estimate (0.55; 95% CI, 0.40-0.74). Conclusions In patients with severe symptomatic aortic stenosis and prohibitive surgical risk, the estimated benefits of transcatheter aortic valve replacement on survival and health status compared with standard care were greater in joint Bayesian models than other approaches.



Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005420
Spertus JV, Hatfield LA, Cohen DJ, Arnold SV, ... Zuckerman B, Spertus JA
Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005420 | PMID: 31189406
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Abstract

Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention.

Hirai T, Qintar M, Grantham JA, Sapontis J, ... Spertus JA, Salisbury AC

Background Prior research has shown that providers may infrequently adjust antianginal medications (AAMs) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patient characteristics associated with AAM titration and the variation in postprocedure AAM management after CTO PCI across hospitals have not been reported. We sought to determine the frequency and potential correlates of AAM escalation and de-escalation after CTO PCI. Methods and Results Using the 12-center OPEN CTO registry (Outcomes, Patient Health Status, and Efficiency iN Chronic Total Occlusion Hybrid Procedures), we assessed AAM use at baseline and 6 months after CTO PCI. Escalation was defined as any addition of a new class of AAM or dose increase, whereas de-escalation was defined as a reduction in the number of AAMs or dose reduction. Angina was assessed 6 months after the index CTO PCI attempt using the Seattle Angina Questionnaire Angina Frequency domain. Potential correlates of AAM escalation (vs no change) or de-escalation (vs no change) were evaluated using multivariable modified Poisson regression models. Adjusted variation across sites was evaluated using median rate ratios. AAMs were escalated in 158 (17.5%), de-escalated in 351 (39.0%), and were unchanged at 6-month follow-up in 392 (43.5%). Patient characteristics associated with escalation included lung disease, ongoing angina, and periprocedural major adverse cardiac and cerebral events (periprocedural myocardial infarction, stroke, death, emergent cardiac surgery, or clinically significant perforation), whereas de-escalation was more frequent among patients taking more AAMs, those treated with complete revascularization, and after treatment of non-CTO lesions at the time of the index procedure. There was minimal variation in either escalation (median rate ratio, 1.11; P=0.36) or de-escalation (median rate ratio, 1.10; P=0.20) compared to no change of AAMs across sites. Conclusions Escalation or de-escalation of AAMs was less common than continuation following CTO PCI, with little variation across sites. Further research is needed to identify patients who may benefit from AAM titration after CTO PCI and develop strategies to adjust these medications in follow-up. Clinical Trial registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02026466.



Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005287
Hirai T, Qintar M, Grantham JA, Sapontis J, ... Spertus JA, Salisbury AC
Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005287 | PMID: 31185735
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Abstract

Association of Physician Specialty With Long-Term Implantable Cardioverter-Defibrillator Complication and Reoperations Rates.

Chui PW, Wang Y, Ranasinghe I, Mitiku TY, ... Enriquez AD, Curtis JP

Background Patients undergoing implantable cardioverter-defibrillator (ICD) implantations have high rates of long-term device-related complications and reoperations. Whether physician specialty training is associated with differences in long-term outcomes following ICD implantation is unclear. Methods and Results We linked data from the National Cardiovascular Data Registry ICD Registry with Medicare fee-for-service claims to identify physicians who performed ≥10 index ICDs from 2006 to 2009. We used data from the American Board of Medical Specialties to group the specialty of the implanting physician into mutually exclusive categories: electrophysiologists, interventional cardiologists, general cardiologists, thoracic surgeons, and other specialties. Primary outcomes were long-term device-related complications requiring reoperations or hospitalizations and reoperations for reasons other than complications. We compared the cumulative incidence rates and case-mix adjusted rates of long-term outcomes of index ICD implantations across physician specialties. Our analysis had a median follow-up of 47 months and included 107 966 index ICD implantations. Electrophysiologists had the lowest rates of incident long-term device-related complications (14.1%; interventional cardiologists, 15.3%; general cardiologists, 15.4%; thoracic surgeons, 16.4%; other specialists, 15.2%; P<0.001) and reoperations for reasons other than complications (electrophysiologists, 16.7%; interventional cardiologists, 17.0%; general cardiologists, 18.0%; thoracic surgeons, 18.4%; other specialists, 18.0%; P<0.001). Compared with patients whose ICDs were implanted by electrophysiologists, patients with implantations performed by nonelectrophysiologists were at higher risk of having long-term device-related complications (relative risk for interventional cardiologists: 1.16 [95% CI, 1.08-1.25]; general cardiologists: 1.13 [1.08-1.18]; thoracic surgeons: 1.20 [1.06-1.37]; all P<0.001, but not other specialists: 1.08 [0.99-1.17]; P=0.07). Compared to patients with implantations performed by electrophysiologists, patients with implantations performed by general cardiologists and thoracic surgeons were at higher risk of reoperation for noncomplication causes (relative risk for general cardiologists: 1.10 [1.05-1.15]; thoracic surgeons: 1.16 [1.00-1.33]; both P<0.05). Conclusions Patients with ICD implantations performed by electrophysiologists had the lowest risks of having long-term device-related complications and reoperations for noncomplication causes. Consideration of physician specialty before ICD implantation may represent an opportunity to minimize long-term adverse outcomes.



Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005374
Chui PW, Wang Y, Ranasinghe I, Mitiku TY, ... Enriquez AD, Curtis JP
Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005374 | PMID: 31185734
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Abstract

Cluster Randomized Trial Examining the Impact of Automated Best Practice Alert on Rates of Implantable Defibrillator Therapy.

Lee J, Szeto L, Pasupula DK, Hussain A, ... Lee JS, Saba S

Background Implantable cardioverter-defibrillators (ICDs) are indicated in patients with left ventricular ejection fraction ≤35%, but many eligible patients do not receive this therapy. In this cluster randomized trial, we investigated the impact of a best practice alert (BPA) through the electronic health records on the rates of electrophysiology referrals, ICD implantations, and all-cause mortality in severe cardiomyopathy patients. Methods and Results Providers in the Heart and Vascular Institute (n=106) and in General Internal Medicine (n=89) were randomized to receive or not receive a BPA recommending consideration for ICD implantation. Patients belonging to the BPA and no BPA groups of providers were followed to the end points of electrophysiology referrals, ICD implantations, and all-cause mortality. Between 2013 and 2015, patients with reduced left ventricular ejection fraction were managed by 93 providers in the BPA (n=997 patients) and 102 providers in the no BPA (n=909 patients) groups. Patients in the 2 groups had comparable baseline characteristics. After a median follow-up of 36 months, 638 (33%) patients were referred to electrophysiology, 536 (27%) received an ICD, and 445 (23%) died. Patients in the BPA group were more likely to be referred to electrophysiology (hazard ratio=1.23; P=0.026), to receive ICD therapy (hazard ratio=1.35; P=0.006), and exhibited a trend towards slightly lower mortality (hazard ratio=0.85; P=0.091). Conclusions Delivering a BPA through the electronic health record recommending to providers consideration of ICD implantation when the left ventricular ejection fraction is ≤35% improves the rates of electrophysiology referrals and ICD therapy in patients with severe left ventricular dysfunction.



Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005024
Lee J, Szeto L, Pasupula DK, Hussain A, ... Lee JS, Saba S
Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005024 | PMID: 31181957
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Abstract

Mortality From Ischemic Heart Disease.

Nowbar AN, Gitto M, Howard JP, Francis DP, Al-Lamee R

Background Ischemic heart disease (IHD) has been considered the top cause of mortality globally. However, countries differ in their rates and there have been changes over time. Methods and Results We analyzed mortality data submitted to the World Health Organization from 2005 to 2015 by individual countries. We explored patterns in relationships with age, sex, and income and calculated age-standardized mortality rates for each country in addition to crude death rates. In 5 illustrative countries which provided detailed data, we analyzed trends of mortality from IHD and 3 noncommunicable diseases (lung cancer, stroke, and chronic lower respiratory tract diseases) and examined the simultaneous trends in important cardiovascular risk factors. Russia, United States, and Ukraine had the largest absolute numbers of deaths among the countries that provided data. Among 5 illustrative countries (United Kingdom, United States, Brazil, Kazakhstan, and Ukraine), IHD was the top cause of death, but mortality from IHD has progressively decreased from 2005 to 2015. Age-standardized IHD mortality rates per 100 000 people per year were much higher in Ukraine (324) and Kazakhstan (97) than in United States (60), Brazil (54), and the United Kingdom (46), with much less difference in other causes of death. All 5 countries showed a progressive decline in IHD mortality, with a decline in smoking and hypertension and in all cases a rise in obesity and type II diabetes mellitus. Conclusions IHD remains the single largest cause of death in countries of all income groups. Rates are different between countries and are falling in most countries, indicating great potential for further gains. On the horizon, future improvements may become curtailed by increasing hypertension in some developing countries and more importantly global growth in obesity.



Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005375
Nowbar AN, Gitto M, Howard JP, Francis DP, Al-Lamee R
Circ Cardiovasc Qual Outcomes: 30 May 2019; 12:e005375 | PMID: 31163980
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Abstract

Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases.

Torbicki A, Bacchi M, Delcroix M, Farber HW, ... Channick R, Benza R

Background Conducting randomized controlled trials to investigate survival in a rare disease like pulmonary arterial hypertension has considerable ethical and logistical constraints. In many studies, such as the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) randomized controlled trial, evaluating survival is further complicated by bias introduced by allowing active therapy among placebo-treated patients who clinically deteriorate. Methods and Results SERAPHIN enrolled and followed patients in the same time frame as the US Registry to Evaluate Early And Long-term PAH Disease Management, providing an opportunity to compare observed survival for SERAPHIN patients with predicted survival had they received real-world treatment as in the Registry to Evaluate Early And Long-term PAH Disease Management. From the Registry to Evaluate Early And Long-term PAH Disease Management (N=3515), 734 patients who met SERAPHIN eligibility criteria were selected and their data used to build a prediction model for time to death up to 3 years based on 10 baseline prognostic variables. The model was used to predict a survival curve for each of the 742 SERAPHIN patients via their baseline variables. The average of these predicted survival curves was compared with observed survival of the placebo (n=250) and macitentan 10 mg (n=242) groups using a log-rank test and Cox proportional hazard model. Observed mortality risk for patients randomized to placebo, 62% of whom were taking background pulmonary arterial hypertension therapy, tended to be lower than that predicted for all SERAPHIN patients (16% lower; P=0.259). The observed placebo survival curve closely approximated the predicted survival curve for the first 15 months. Beyond that time, observed risk of mortality decreased compared with predicted mortality, potentially reflecting the impact of crossover of patients in the placebo group to active therapy. Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010). Conclusions These analyses show that, in a rare disease, real-world observational data can complement randomized controlled trial data to overcome some challenges associated with assessing survival in the setting of a randomized controlled trial. Clinical Trial registration https://www.clinicaltrials.gov . Unique identifiers: NCT00660179 and NCT00370214.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005095
Torbicki A, Bacchi M, Delcroix M, Farber HW, ... Channick R, Benza R
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005095 | PMID: 31109190
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Abstract

Causes of Mortality After Percutaneous Coronary Intervention.

Bricker RS, Valle JA, Plomondon ME, Armstrong EJ, Waldo SW

Background Public reporting of percutaneous coronary intervention (PCI) often uses periprocedural (30 days) mortality as a surrogate for procedural quality, though it is unclear how often death is attributable to the PCI. The cause of death among patients who died within 30 days of PCI in a national healthcare system was thus evaluated. Methods and Results We identified all patients who died within 30 days of PCI in the Veterans Affairs (VA) Healthcare System from October 2005 to September 2016. Causes of death were classified through a detailed chart review using definitions from the Academic Research Consortium. Of 115 191 patients undergoing PCI during the study period, 1674 patients died within 30 days of PCI (1.5%). A detailed chart review demonstrated that the majority of patients had an undifferentiated death not definitively attributable to a single cause (981, 59%), whereas a minority had a death directly attributable to a cardiovascular cause (467, 28%). The majority of cardiovascular deaths were unrelated to the interventional procedure (335, 72%). Cardiovascular deaths were more likely to occur in the inpatient setting (95%) compared with noncardiac (89%) or undifferentiated deaths (49%, P<0.001). Conclusions A minority of deaths occurring after percutaneous revascularization were definitively due to cardiac causes, with an even smaller proportion related to the PCI. With such a small proportion of deaths directly attributable to the PCI, these data suggest that 30-day mortality may be an inappropriate metric to assess procedural quality.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005355
Bricker RS, Valle JA, Plomondon ME, Armstrong EJ, Waldo SW
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005355 | PMID: 31104472
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Abstract

Thirty-Day Hospital Readmission After Acute Myocardial Infarction in China.

Li J, Dharmarajan K, Bai X, Masoudi FA, ... Dreyer RP, Krumholz HM

Background Readmission after acute myocardial infarction in low- and middle-income countries like China is not well characterized. Methods and Results We approached consecutive patients with acute myocardial infarction hospitalized within 24 hours of symptom onset and discharged alive from 53 geographically diverse hospitals in China. We described rates of unplanned 30-day readmission, their timing and admitting diagnoses, and fit Cox proportional hazards models to identify factors associated with readmission. Among 3387 patients, median (interquartile range) age was 61 (52-69) years, and 76.9% were men. The index median length of stay was 11 (8-14) days. Unplanned 30-day readmission occurred in 6.3% of the cohort; most readmissions (77.7%) were for cardiovascular diagnoses. Nearly half (41.9% of all-cause readmissions; 44.3% of cardiovascular readmissions) occurred within 5 days of discharge. Mini-Global Registry of Acute Coronary Events scores at admission (hazard ratio [HR], 1.15 for every 10-point increase; 95% CI, 1.05-1.25), longer length of stay (HR, 1.03; 95% CI, 1.00-1.06 for each extra day), and in-hospital recurrent angina (HR, 1.40; 95% CI, 1.04-1.89) were associated with higher unplanned all-cause readmission. Revascularization during the index hospitalization (70.2% of the cohort) was associated with lower risks of all-cause readmission (HR, 0.27; 95% CI, 0.18-0.42). In addition, left ventricular ejection fraction <0.4 (HR, 1.79; 95% CI, 1.05-3.07) and in-hospital complication (HR, 1.20; 95% CI, 1.03-1.39) were associated with higher risk of unplanned cardiovascular readmission, and ST-segment-elevation myocardial infarction (HR, 0.60; 95% CI, 0.36-0.98) was associated with lower risk of unplanned cardiovascular readmission. Sex, family income, depression, stress level, lower social support, disease-specific health status, and medications were not associated with readmission. Conclusions In China, most readmissions are for cardiovascular events, and almost half occur within 5 days of discharge. Clinical factors identify patients at higher and lower unplanned readmissions. Clinical Trial registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01624909.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005628
Li J, Dharmarajan K, Bai X, Masoudi FA, ... Dreyer RP, Krumholz HM
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005628 | PMID: 31092023
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Abstract

Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score.

Holmes DN, Piccini JP, Allen LA, Fonarow GC, ... Peterson ED, Thomas L

Background The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire has recently been validated to measure the impact of atrial fibrillation on quality of life, but a clinically important difference in AFEQT score has not been well defined. Methods and Results To determine the clinically important difference in overall AFEQT (score range= 0 [worst] to 100 [best]) and selected subscales, we analyzed data in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry, a United States-based outpatient atrial fibrillation registry. AFEQT was assessed at baseline and 1 year in a subset of 1347 ORBIT-AF patients from 80 US sites participating in ORBIT-AF from June 2010 to August 2011. The mean change method was used to relate changes in 1-year AFEQT scores to clinically important changes in the physician assessment of European Heart Rhythm Association functional status (1 class improvement and separately 1 class deterioration). Clinically important differences and 95% CI corresponding to either a 1 European Heart Rhythm Association class improvement or deterioration were 5.4 (3.6-7.2) and -4.2 (-6.9 to -1.5) AFEQT points, respectively. Similarly, clinically important difference values were seen for a 1 European Heart Rhythm Association class improvement for the AFEQT subscales Activities of Daily Living and Symptoms: 5.1 (2.5-7.6) and 7.1 (5.3-9.0) AFEQT points, respectively. Conclusions Based on the anchor of 1 European Heart Rhythm Association class change, changes in AFEQT score of + or -5 points are clinically important changes in patients\' health. Clinical Trial registration URL: https://clinicaltrials.gov . Unique identifier: NCT01165710.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005358
Holmes DN, Piccini JP, Allen LA, Fonarow GC, ... Peterson ED, Thomas L
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005358 | PMID: 31092022
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Abstract

Hospital-Level Cardiovascular Management Practices in Kerala, India.

Yoo SGK, Davies D, Mohanan PP, Baldridge AS, ... Prabhakaran D, Huffman MD

Background Hospital management practices are associated with cardiovascular process of care measures and patient outcomes. However, management practices related to acute cardiac care in India has not been studied. Methods and Results We measured management practices through semistructured, in-person interviews with hospital administrators, physician managers, and nurse managers in Kerala, India between October and November 2017 using the adapted World Management Survey. Trained interviewers independently scored management interview responses (range: 1-5) to capture management practices ranging from performance data tracking to setting targets. We performed univariate regression analyses to assess the relationship between hospital-level factors and management practices. Using Pearson correlation coefficients and mixed-effect logistic regression models, we explored the relationship between management practices and 30-day major adverse cardiovascular events defined as all-cause mortality, reinfarction, stroke, or major bleeding. Ninety managers from 37 hospitals participated. We found suboptimal management practices across 3 management levels (mean [SD]: 2.1 [0.5], 2.0 [0.3], and 1.9 [0.3] for hospital administrators, physician managers, and nurse managers, respectively [ P=0.08]) with lowest scores related to setting organizational targets. Hospitals with existing healthcare quality accreditation, more cardiologists, and private ownership were associated with higher management scores. In our exploratory analysis, higher physician management practice scores related to operation, performance, and target management were correlated with lower 30-day major adverse cardiovascular event. Conclusions Management practices related to acute cardiac care in participating Kerala hospitals were suboptimal but were correlated with clinical outcomes. We identified opportunities to strengthen nonclinical practices to improve patient care.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005251
Yoo SGK, Davies D, Mohanan PP, Baldridge AS, ... Prabhakaran D, Huffman MD
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005251 | PMID: 31092020
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Impact:
Abstract

Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial Infarction.

Spaulding EM, Marvel FA, Lee MA, Yang WE, ... Allen JK, Martin SS
Background
Unplanned readmissions after hospitalization for acute myocardial infarction are among the leading causes of preventable morbidity, mortality, and healthcare costs. Digital health interventions could be an effective tool in promoting self-management, adherence to guideline-directed therapy, and cardiovascular risk reduction. A digital health intervention developed at Johns Hopkins-the Corrie Health Digital Platform (Corrie)-includes the first cardiology Apple CareKit smartphone application, which is paired with an Apple Watch and iHealth Bluetooth-enabled blood pressure cuff. Corrie targets: (1) self-management of cardiac medications, (2) self-tracking of vital signs, (3) education about cardiovascular disease through articles and animated videos, and (4) care coordination that includes outpatient follow-up appointments.
Methods and results
The 3 phases of the MiCORE study (Myocardial infarction, Combined-device, Recovery Enhancement) include (1) the development of Corrie, (2) a pilot study to assess the usability and feasibility of Corrie, and (3) a prospective research study to primarily compare time to first readmission within 30 days postdischarge among patients with Corrie to patients in the historical standard of care comparison group. In Phase 2, the feasibility of deploying Corrie in an acute care setting was established among a sample of 60 patients with acute myocardial infarction. Phase 3 is ongoing and patients from 4 hospitals are being enrolled as early as possible during their hospital stay if they are 18 years or older, admitted with acute myocardial infarction (ST-segment-elevation myocardial infarction or type I non-ST-segment-elevation myocardial infarction), and own a smartphone. Patients are either being enrolled with their own personal devices or they are provided an iPhone and/or Apple Watch for the duration of the study. Phase 3 started in October 2017 and we aim to recruit 140 participants.
Conclusions
This article will provide an in-depth understanding of the feasibility associated with implementing a digital health intervention in an acute care setting and the potential of Corrie as a self-management tool for acute myocardial infarction recovery.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005509
Spaulding EM, Marvel FA, Lee MA, Yang WE, ... Allen JK, Martin SS
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005509 | PMID: 31043065
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Impact:
Abstract

Tree-Based Analysis.

Banerjee M, Reynolds E, Andersson HB, Nallamothu BK

Tree-based methods have become one of the most flexible, intuitive, and powerful data analytic tools for exploring complex data structures. Tree-based methods provide a natural framework for creating patient subgroups for risk classification. In this article, we review methodological and practical aspects of tree-based methods, with a focus on diagnostic classification (binary outcome) and prognostication (censored survival outcome). Creating an ensemble of trees improves prediction accuracy and addresses instability in a single tree. Ensemble methods are described that rely on resampling from the original data. Finally, we present methods to identify a representative tree from the ensemble that can be used for clinical decision-making. The methods are illustrated using data on ischemic heart disease classification, and data from the SPRINT trial (Systolic Blood Pressure Intervention Trial) on adverse events in patients with high blood pressure.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e004879
Banerjee M, Reynolds E, Andersson HB, Nallamothu BK
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e004879 | PMID: 31043064
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Impact:
Abstract

Assessing the Quality of Abstracts in Randomized Controlled Trials Published in High Impact Cardiovascular Journals.

Khan MS, Shaikh A, Ochani RK, Akhtar T, ... Doukky R, Krasuski RA
Background
In the busy world of cardiovascular medicine, abstracts may be the only part of a publication that clinicians read. Therefore, it is critical for abstracts to accurately reflect article content. The extended CONSORT (Consolidated Standards of Reporting Trials) Statement for Abstracts was developed to ensure high abstract quality. However, it is unknown how often adherence to CONSORT guidelines occurs among cardiovascular journals.
Methods and results
We searched MEDLINE for randomized controlled trials published in 3 major cardiovascular journals ( Circulation, Journal of the American College of Cardiology, and European Heart Journal) from 2011 to 2017. Post hoc, interim, and cost-effective analyses of randomized controlled trials were excluded. Two independent investigators extracted the data using a prespecified data collection form and a third investigator adjudicated the data. The primary outcome was frequency of subcategory adherence to CONSORT guidelines. A total of 478 abstracts were included in the analysis. Approximately half of the abstracts (53%; 255/478; 95% CI, 49%-57%) identified the article as randomized in the title. All abstracts detailed the interventions for both study groups (100%) and 81% (95% CI, 78%-85%) reported trial registration. Methodological quality reporting was relatively low: 9% (45/478; 95% CI, 6%-12%) described participant eligibility criteria with settings for data collection, 43% (204/478; 95% CI, 39%-47%) reported details of blinding, and <1% (4/478; 95% CI, 0%-2%) reported allocation concealment. Approximately 60% (301/478; 95% CI, 59%-67%) of the included abstracts provided primary outcome results while 55% (262/478; 95% CI, 51%-60%) reported harms or adverse effects.
Conclusions
There is a high prevalence of nonadherence to CONSORT guidelines among leading cardiovascular journals. Efforts by editors, authors, and reviewers should be made to increase adherence and promote transparent and unbiased presentation of study results.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005260
Khan MS, Shaikh A, Ochani RK, Akhtar T, ... Doukky R, Krasuski RA
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005260 | PMID: 31030545
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Impact:
Abstract

Thirty-Day Readmission Risk Model for Older Adults Hospitalized With Acute Myocardial Infarction.

Dodson JA, Hajduk AM, Murphy TE, Geda M, ... Gill TM, Chaudhry SI
Background
Early readmissions among older adults hospitalized for acute myocardial infarction (AMI) are costly and difficult to predict. Aging-related functional impairments may inform risk prediction but are unavailable in most studies. Our objective was to, therefore, develop and validate an AMI readmission risk model for older patients who considered functional impairments and was suitable for use before hospital discharge.
Methods and results
SILVER-AMI (Comprehensive Evaluation of Risk in Older Adults with AMI) is a prospective cohort study of 3006 patients of age ≥75 years hospitalized with AMI at 94 US hospitals. Participants underwent in-hospital assessment of functional impairments including cognition, vision, hearing, and mobility. Other variables plausibly associated with readmissions were also collected. The outcome was all-cause readmission at 30 days. We used backward selection and Bayesian model averaging to derive (N=2004) a risk model that was subsequently validated (N=1002). Mean age was 81.5 years, 44.4% were women, and 10.5% were nonwhite. Within 30 days, 547 participants (18.2%) were readmitted. Readmitted participants were older, had more comorbidities, and had a higher prevalence of functional impairments, including activities of daily living disability (17.0% versus 13.0%; P=0.013) and impaired functional mobility (72.5% versus 53.6%; P<0.001). The final risk model included 8 variables: functional mobility, ejection fraction, chronic obstructive pulmonary disease, arrhythmia, acute kidney injury, first diastolic blood pressure, P2Y12 inhibitor use, and general health status. Functional mobility was the only functional impairment variable retained but was the strongest predictor. The model was well calibrated (Hosmer-Lemeshow P value >0.05) with moderate discrimination (C statistics: 0.65 derivation cohort and 0.63 validation cohort). Functional mobility significantly improved performance of the risk model (net reclassification improvement index =20%; P<0.001).
Conclusions
In our final risk model, functional mobility, previously not included in readmission risk models, was the strongest predictor of 30-day readmission among older adults after AMI. The modest discrimination indicates that much of the variability in readmission risk among this population remains unexplained by patient-level factors.
Clinical trial registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01755052.



Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005320
Dodson JA, Hajduk AM, Murphy TE, Geda M, ... Gill TM, Chaudhry SI
Circ Cardiovasc Qual Outcomes: 29 Apr 2019; 12:e005320 | PMID: 31010300
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Impact:
Abstract

Association Between Secondary Prevention Medication Use and Outcomes in Frail Older Adults After Acute Myocardial Infarction.

Zullo AR, Mogul A, Corsi K, Shah NR, ... Berard-Collins C, Steinman MA

Background Secondary prevention medications are often not prescribed to frail, older adults following acute myocardial infarction, potentially because of the absence of data to support use, perceived lack of benefit, and concern over possible harms. We examined the effect of using more guideline-recommended medications after myocardial infarction on mortality, rehospitalization, and functional decline in the frailest and oldest segment of the US population-long-stay nursing home residents. Methods and Results We conducted a retrospective cohort study of nursing home residents aged ≥65 years using 2007 to 2010 national US Minimum Data Set clinical assessment data and Medicare claims. Exposure was the number of secondary prevention medications (antiplatelets, β-blockers, statins, and renin-angiotensin-aldosterone system inhibitors) initiated after myocardial infarction. Outcomes were 90-day death, rehospitalization, and functional decline. We compared outcomes for new users of 2 versus 1 and 3 or 4 versus 1 medications using the inverse probability of treatment-weighted odds ratios with 95% CI. The cohort comprised 4787 residents, with a total of 509 death, 820 functional decline, and 1226 rehospitalization events. Compared with individuals who initiated 1 medication, mortality odds ratios were 0.98 (95% CI, 0.79-1.22) and 0.74 (95% CI, 0.57-0.97) for users of 2 and 3 or 4 medications, respectively. Rehospitalization odds ratios were 1.00 (95% CI, 0.85-1.17) for 2 and 0.97 (95% CI, 0.8-1.17) for 3 or 4 medications. Functional decline odds ratios were 1.04 (95% CI, 0.85-1.28) for 2 and 1.12 (95% CI, 0.89-1.40) for 3 or 4 medications. In a stability analysis excluding antiplatelet drugs from the exposure definition, more medication use was associated with functional decline. Conclusions Use of more guideline-recommended medications after myocardial infarction was associated with decreased mortality in older, predominantly frail adults, but no difference in rehospitalization. Results for functional decline from the main and stability analyses were discordant and did not rule out an increased risk associated with more medication use.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e004942
Zullo AR, Mogul A, Corsi K, Shah NR, ... Berard-Collins C, Steinman MA
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e004942 | PMID: 31002274
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Impact:
Abstract

Clinical and Angiographic Predictors of Patient-Reported Angina 1 Year After Coronary Artery Bypass Graft Surgery.

Hattler B, Carr BM, Messenger J, Spertus J, ... Grover FL, Shroyer ALW
Background
Studies of the relationship between patient self-reported angina symptoms using the Seattle Angina Questionnaire (SAQ) and angiographic findings after coronary artery bypass grafting surgery (CABG) are lacking. Nested within a randomized controlled trial, this prospective observational cohort comparison study aimed to assess which clinical characteristics and angiographic findings are associated with self-reported angina 1 year after CABG.
Methods and results
Patients from the ROOBY trial (Randomized On/Off Bypass) with protocol-specified 1-year post-CABG coronary angiography and SAQ assessments were included (n=1258). Patients reporting no angina (62.3%) within 4 weeks before the 1-year post-CABG study visit on the SAQ angina frequency domain were compared with patients reporting angina (37.7%). Multivariable modeling identified clinical variables and angiographic findings associated with angina. Sequential univariate and multivariable modeling found the following demographic and clinical factors were associated with angina after CABG: younger age, worse preoperative SAQ angina frequency score, smoking, diabetes mellitus, and pre-CABG depression. The only 1-year angiographic finding significantly associated with angina was incomplete revascularization of the left anterior descending (LAD) territory. Graft occlusions, incomplete revascularization of non-LAD territories, and ≥70% lesions in nonrevascularized native coronary arteries were not correlated with the presence or absence of angina. Further, only 30.6% of subjects reporting angina at 1 year had a residual major coronary artery stenosis of ≥70%.
Conclusions
Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression. The only angiographic finding associated with angina was a poorly revascularized LAD territory. These results may help guide physicians when counseling patients on expected improvements in angina symptoms and in making decisions regarding the need for coronary angiography after CABG. Whether intensive treatment of these comorbidities improves post-CABG angina symptoms requires further study.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00032630.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005119
Hattler B, Carr BM, Messenger J, Spertus J, ... Grover FL, Shroyer ALW
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005119 | PMID: 31001997
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Impact:
Abstract

Racial, Ethnic, and Socioeconomic Inequities in the Prescription of Direct Oral Anticoagulants in Patients With Venous Thromboembolism in the United States.

Nathan AS, Geng Z, Dayoub EJ, Khatana SAM, ... Giri J, Groeneveld PW
Background
Beginning in 2012, direct oral anticoagulants (DOACs) were approved for treatment and prevention of venous thromboembolism. Prior investigations have demonstrated slow rates of adoption of novel therapeutics for black patients. We assessed the association of racial/ethnic and socioeconomic factors with DOAC use among commercially insured venous thromboembolism patients.
Methods and results
We performed a retrospective cohort analysis of adult patients with an incident diagnosis of venous thromboembolism between January 2010 and December 2016 using OptumInsight\'s Clinformatics Data Mart. We identified the first filled oral anticoagulant prescription within 30 days of discharge of an inpatient admission. We performed a multivariable logistic regression, adjusting for age, sex, race/ethnicity, region, zip code-linked household income, and clinical covariates to identify factors associated with the use of DOACs. Race and ethnicity were determined in this database through a combination of public records, self-report, and proprietary ethnicity code tables. There were 14 140 patients included in the analysis. Treatment with DOACs increased from <0.1% in 2010 to 65.6% in 2016. In multivariable analyses, black patients were less likely to receive a DOAC compared with white patients (odds ratio, 0.86; 95% CI, 0.77-0.97; P=0.02). There were no differences in DOAC utilization among Asian (odds ratio, 1.06; 95% CI, 0.75-1.49; P=0.74) or Hispanic patients (odds ratio, 1.04; 95% CI, 0.88-1.22; P=0.66) compared with whites. Patients with a household income over $100 000 per year were more likely to receive DOAC therapy compared with patients with a household income of <$40 000 per year (odds ratio, 1.50; 95% CI, 1.33-1.69; P<0.0001).
Conclusions
Although DOAC adoption has increased steadily since 2012, among a commercially insured population, black race and low household income were associated with lower use of DOACs for incident venous thromboembolism despite controlling for other clinical and socioeconomic factors. These findings suggest the possibility of both racial and socioeconomic inequity in access to this novel pharmacotherapy.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005600
Nathan AS, Geng Z, Dayoub EJ, Khatana SAM, ... Giri J, Groeneveld PW
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005600 | PMID: 30950652
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Impact:
Abstract

Association of Long-Term Exposure to Particulate Matter and Ozone With Health Status and Mortality in Patients After Myocardial Infarction.

Malik AO, Jones PG, Chan PS, Peri-Okonny PA, Hejjaji V, Spertus JA
Background
Long-term exposure to particulate matter <2.5 µm in diameter (PM) and ozone has been associated with the development and progression of cardiovascular disease and, in the case of PM, higher cardiovascular mortality. Whether exposure to PM and ozone is associated with patients\' health status and quality of life is unknown. We used data from 2 prospective myocardial infarction (MI) registries to assess the relationship between long-term PM and ozone exposure with health status outcomes 1 year after an MI.
Methods and results
TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction) and PREMIER (Prospective Registry Evaluating Myocardial Infarction: Events and Recovery) enrolled patients presenting with MI at 31 US hospitals between 2003 and 2008. One year later, patients were assessed with the disease-specific Seattle Angina Questionnaire, and 5-year mortality was assessed with the Centers for Disease Control\'s National Death Index. Individual patients\' exposures to PM and ozone over the year after their MI were estimated from the Environment Protection Agency\'s Fused Air Quality Surface Using Downscaling tool that integrates monitoring station data and atmospheric models to predict daily air pollution exposure at the census tract level. We assessed the association of exposure to ozone and PM with 1-year health status and mortality over 5 years using regression models adjusting for age, sex, race, socioeconomic status, date of enrollment, and comorbidities. In completely adjusted models, higher PM and ozone exposure were independently associated with poorer Seattle Angina Questionnaire summary scores at 1-year (β estimate per +1 SD increase =-0.8 [95% CI, -1.4 to -0.3; P=0.002] for PM and -0.9 [95% CI, -1.3 to -0.4; P<0.001] for ozone). Moreover, higher PM exposure, but not ozone, was independently associated with greater mortality risk (hazard ratio =1.13 per +1 SD [95% CI, 1.07-1.20; P<0.001]).
Conclusions
In our study, greater exposure to PM and ozone was associated with poorer 1-year health status following an MI, and PM was associated with increased risk of 5-year death.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005598
Malik AO, Jones PG, Chan PS, Peri-Okonny PA, Hejjaji V, Spertus JA
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005598 | PMID: 30950650
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Impact:
Abstract

Rationale and Design of EMPOWER, a Pragmatic Randomized Trial of Automated Hovering in Patients With Congestive Heart Failure.

Mehta SJ, Volpp KG, Asch DA, Goldberg LR, ... Iannotte LG, Troxel AB
Background
Congestive heart failure is a major cause of morbidity, mortality, and cost. Disease management programs have shown promise but lack firm evidence of effectiveness and scalability. We describe the motivation, design, and planned analyses of EMPOWER (Electronic Monitoring of Patients Offers Ways to Enhance Recovery), a randomized clinical trial of an innovative intervention incorporating behavioral economic principles with remote monitoring technology embedded within a healthcare system.
Methods and results
EMPOWER is an ongoing, pragmatic, randomized clinical trial comparing usual care to an automated hovering intervention that includes patient-level incentives for daily weight monitoring and diuretic adherence combined with automated feedback into the clinical care pathway, enabling real-time response to concerning clinical symptoms. Identification of eligible patients began in May 2016, and implementation of the intervention is feasible. Trial processes are embedded into existing clinical pathways. The primary outcome is time to readmission for any cause. Cost-effectiveness analyses are planned to evaluate the healthcare costs and health outcomes of the approach.
Conclusions
The EMPOWER trial incorporates leading-edge approaches in human motivation, derived from behavioral economics, with contemporary technology to provide scale and exception handling at low cost. The trial is also implemented within the naturalized environment of a health system, as much as possible taking advantage of the existing journeys of patients and workflows of clinicians. A goal of this pragmatic design is to limit resource utilization and also to test an intervention that would need minimal modification to be translated from research into a new way of practice.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02708654.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005126
Mehta SJ, Volpp KG, Asch DA, Goldberg LR, ... Iannotte LG, Troxel AB
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005126 | PMID: 30939922
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Impact:
Abstract

Stress, Resilience, and Cardiovascular Disease Risk Among Black Women.

Felix AS, Lehman A, Nolan TS, Sealy-Jefferson S, ... Jackson RD, Williams KP
Background
Empirical data on the link between stress and cardiovascular disease (CVD) risk among black women is limited. We examined associations of stressful life events and social strain with incident CVD among black women and tested for effect modification by resilience.
Methods and results
Our analysis included 10 785 black women enrolled in the Women\'s Health Initiative Observational Study and Clinical Trials cohort. Participants were followed for CVD for up to 23 years (mean, 12.5). Multivariable Cox regression was used to estimate hazard ratios and 95% CIs for associations between stress-related exposures and incident CVD. We included interactions between follow-up time (age) and stressful life events because of evidence of nonproportional hazards. Effect modification by resilience was examined in the sub-cohort of 2765 women with resilience and stressful life events measures. Higher stressful life events were associated with incident CVD at ages 55 (hazard ratio for highest versus lowest quartile=1.80; 95% CI, 1.27-2.54) and 65 (hazard ratio for highest versus lowest quartile=1.40; 95% CI, 1.16-1.68), but not at older ages. Adjustment for CVD risk factors attenuated these associations. Similar associations were observed for social strain. In the sub-cohort of women with updated stressful life events and resilience measures, higher stressful life events were associated with incident CVD in multivariable-adjusted models (hazard ratio=1.61; 95% CI, 1.04-2.51). Resilience did not modify this association nor was resilience independently associated with incident CVD.
Conclusions
In this cohort of older black women, recent reports of stressful life events were related to incident CVD. Resilience was unrelated to incident CVD.
Clinical trials registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00000611.



Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005284
Felix AS, Lehman A, Nolan TS, Sealy-Jefferson S, ... Jackson RD, Williams KP
Circ Cardiovasc Qual Outcomes: 30 Mar 2019; 12:e005284 | PMID: 30909729
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Impact:
Abstract

Sex-Specific Determinants of Outcomes After Transcatheter Aortic Valve Replacement.

Pighi M, Piazza N, Martucci G, Lachapelle K, ... Trnkus A, Afilalo J

Background Women account for a large proportion of patients treated with transcatheter aortic valve replacement, yet there remain conflicting reports about the effect of sex on outcomes. Moreover, the sex-specific prevalence and prognostic impact of frailty has not been systematically studied in the context of transcatheter aortic valve replacement. Methods and Results A preplanned analysis of the FRAILTY-AVR study (Frailty Aortic Valve Replacement) was performed to analyze the determinants of outcomes in older women and men undergoing transcatheter aortic valve replacement. FRAILTY-AVR was a multinational, prospective, observational cohort assembled at 14 institutions in North America and Europe from 2012 to 2017. Multivariable logistic regression models were stratified by sex and adjusted for covariates. Interaction between sex and each of these covariates was assessed. The primary outcome was 12-month mortality, and the secondary outcome was 1-month composite mortality or major morbidity. The cohort consisted of 340 women and 419 men. Women were older and had higher predicted risk of mortality. Women were more likely to have physical frailty traits, but not cognitive or psychosocial frailty traits, and global indices of frailty were similarly associated with adverse events regardless of sex. Women were more likely to require discharge to a rehabilitation facility, particularly those with physical frailty at baseline, although their functional status was similar to men at 12 months. The risk of 1-month mortality or major morbidity was greater in women, particularly those treated with larger prostheses. The risk of 12-month mortality was not greater in women, with the exception of those with pulmonary hypertension, in whom, there was a significant interaction for increased mortality. Conclusions The present study highlights sex-specific differences in older adults undergoing transcatheter aortic valve replacement and draws attention to the impact of physical frailty in women and their potential risk associated with oversized prostheses and pulmonary hypertension.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005363
Pighi M, Piazza N, Martucci G, Lachapelle K, ... Trnkus A, Afilalo J
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005363 | PMID: 30879326
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Impact:
Abstract

Do-Not-Resuscitate Status and Risk-Standardized Mortality and Readmission Rates Following Acute Myocardial Infarction.

Bruckel J, Nallamothu BK, Ling F, Howell EH, ... Mehta A, Walkey AJ

Background Important administrative-based measures of hospital quality, including those used by Centers for Medicare and Medicaid Services, may not adequately account for patient illness and social factors that vary between hospitals and can strongly affect outcomes. Do-not-resuscitate (DNR) order on admission (within the first 24 hours) is one such factor that may reflect higher preadmission illness burden as well as patients\' desire for less-intense therapeutic interventions and has been shown to vary widely between hospitals. We sought to evaluate how accounting for early DNR affected hospital quality measures for acute myocardial infarction. Methods AND RESULTS We identified all patients admitted with acute myocardial infarction using the California State Inpatient Database, which captures early DNR use within 24 hours of admission. We generated hospital risk-standardized mortality and readmissions using random-effects logistic regression, before and after including early DNR status, to examine changes in overall model fit and hospital outlier designations. We included 109 521 patients from 289 hospitals and found that 8.5% (9356) patients had early DNR. Early DNR use varied widely, with median (interquartile range) hospital rates of 7.9% (4.1%-14.0%). Including early DNR in models used to assess hospital quality resulted in improvement in the mortality model (C statistics from 0.754 [0.748-0.759] to 0.784 [0.779-0.789]) but not the readmissions model. Of the hospitals designated high outliers for mortality and readmissions by the Centers for Medicare/Medicaid Services model, and therefore destined for a financial penalty, 6/25 (24%) were reclassified as nonoutliers for mortality and 2/14 (14.3%) for readmissions after including DNR status. Agreement in outlier status between the models before and after inclusion of early DNR status was moderate for mortality (κ, 0.603 [0.482-0.724]; P<0.001) and high for readmissions (κ, 0.888 [0.800-0.977]; P<0.001). Conclusions Including early DNR status in risk-adjustment models significantly improved model fit and resulted in substantial reclassification of hospital performance rankings for mortality and moderate reclassification for readmissions. DNR status at hospital admission should be considered when reporting risk-standardized hospital mortality.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005196
Bruckel J, Nallamothu BK, Ling F, Howell EH, ... Mehta A, Walkey AJ
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005196 | PMID: 30879325
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Impact:
Abstract

Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial

Huo X, Krumholz HM, Bai X, Spatz ES, ... Masoudi FA, Zheng X
Background
Mobile health interventions may support risk factor management and are readily scalable in healthcare systems. We aim to evaluate the efficacy of a text messaging-based intervention to improve glycemic control in patients with coronary heart disease and diabetes mellitus in China.
Methods and results
The CHAT-DM study (Cardiovascular Health and Texting-Diabetes Mellitus) was a parallel-group, single-blind, randomized clinical trial that included 502 patients with both coronary heart disease and diabetes mellitus from 34 hospitals in China. The intervention group (n=251) received 6 text messages per week for 6 months in addition to usual care. Messages were theory driven and culturally tailored to provide educational and motivational information on glucose monitoring, blood pressure control, medication adherence, physical activity, and lifestyle. The control group (n=251) received usual care and 2 thank you messages per month. The primary outcome was change in glycated hemoglobin (HbA [hemoglobin A]) from baseline to 6 months. Secondary outcomes were change in proportion of patients achieving HbA <7%, fasting blood glucose, systolic blood pressure, LDL (low-density lipoprotein) cholesterol, body mass index, and physical activity from baseline to 6 months. The end points were assessed using analyses of covariance. The follow-up rate was 99%. When compared with control group at 6 months, the intervention group had a greater reduction in HbA (-0.2% versus 0.1%; P=0.003) and a greater proportion of participants who achieved HbA <7% (69.3% versus 52.6%; P=0.004). Change in fasting blood glucose was larger in the intervention group (between-group difference: -0.6 mmol/L; 95% CI, -1.1 to -0.2; P=0.011), but no other outcome differences were observed. Nearly all participants reported that messages were easy to understand (97.1%) and useful (94.1%).
Conclusions
A text message intervention resulted in better glycemic control in patients with diabetes mellitus and coronary heart disease. While the mechanism of this benefit remains to be determined, the results suggest that a simple, culturally sensitive mobile text messaging program may provide an effective and feasible way to improve disease self-management.
Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02883842.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005805
Huo X, Krumholz HM, Bai X, Spatz ES, ... Masoudi FA, Zheng X
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005805 | PMID: 31474119
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Impact:
Abstract

Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial

Zheng X, Spatz ES, Bai X, Huo X, ... Masoudi FA, Krumholz HM
Background
Mobile health technologies are low cost, scalable interventions with the potential to promote patient engagement and behavior change. We aimed to test whether a culturally sensitive text messaging intervention supporting secondary prevention improves the control of risk factors in patients with coronary heart disease in China.
Methods and results
In this multicenter, single-blinded randomized controlled trial, 822 patients (mean age, 56.4 [SD, 9.5] years; 14.1% women) with coronary heart disease and without diabetes mellitus from 37 hospitals in China were enrolled between August 2016 and March 2017. In addition to usual care, the control group (n=411) received 2 thank you messages/month; the intervention group (n=411) received 6 text messages/week for 6 months delivered by an automated computerized system. The messages provided educational and motivational information related to disease-specific knowledge, risk factor control, physical activity, and medication adherence. The primary end point was change in systolic blood pressure from baseline to 6 months. Secondary end points included the proportion with systolic blood pressure <140 mm Hg, smoking status, and change in body mass index, LDL-C (low-density lipoprotein cholesterol), and physical activity (assessed using the International Physical Activity Questionnaire). The end points were assessed using analyses of covariance. Follow-up was 99.6%. At 6 months, systolic blood pressure was not significantly lower in the intervention group compared with the control group, with a mean change (SD) of 3.2 (14.3) mm Hg and 2.0 (15.0) mm Hg ( P>0.05) from baseline, respectively (mean net change, -1.3 mm Hg [95% CI, -3.3 to 0.8]; P=0.221). There were no significant differences in the change in LDL-C level, physical activity, body mass index, or smoking status between the 2 groups. Nearly all patients in the intervention group reported the text messages to be useful (96.1%), easy to understand (98.8%), appropriate in frequency (93.8%), and reported being willing to receive future text messages (94.8%).
Conclusions
Text messages supporting secondary prevention among patients with coronary heart disease did not lead to a greater reduction in blood pressure at 6 months. Mobile phone text messaging for secondary prevention was feasible and highly acceptable to patients.
Clinical trial registration
URL: https://clinicaltrials.gov . Unique identifier: NCT02888769.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005616
Zheng X, Spatz ES, Bai X, Huo X, ... Masoudi FA, Krumholz HM
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005616 | PMID: 30998400
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Impact:
Abstract

Epidemiology of Shock in Contemporary Cardiac Intensive Care Units.

Berg DD, Bohula EA, van Diepen S, Katz JN, ... Vikram F, Morrow DA

Background Clinical investigations of shock in cardiac intensive care units (CICUs) have primarily focused on acute myocardial infarction (AMI) complicated by cardiogenic shock (AMICS). Few studies have evaluated the full spectrum of shock in contemporary CICUs. Methods and Results The Critical Care Cardiology Trials Network is a multicenter network of advanced CICUs in North America. Anytime between September 2017 and September 2018, each center (n=16) contributed a 2-month snap-shot of all consecutive medical admissions to the CICU. Data were submitted to the central coordinating center (TIMI Study Group, Boston, MA). Shock was defined as sustained systolic blood pressure <90 mm Hg with end-organ dysfunction ascribed to the hypotension. Shock type was classified by site investigators as cardiogenic, distributive, hypovolemic, or mixed. Among 3049 CICU admissions, 677 (22%) met clinical criteria for shock. Shock type was varied, with 66% assessed as cardiogenic shock (CS), 7% as distributive, 3% as hypovolemic, 20% as mixed, and 4% as unknown. Among patients with CS (n=450), 30% had AMICS, 18% had ischemic cardiomyopathy without AMI, 28% had nonischemic cardiomyopathy, and 17% had a cardiac cause other than primary myocardial dysfunction. Patients with mixed shock had cardiovascular comorbidities similar to patients with CS. The median CICU stay was 4.0 days (interquartile range [IQR], 2.5-8.1 days) for AMICS, 4.3 days (IQR, 2.1-8.5 days) for CS not related to AMI, and 5.8 days (IQR, 2.9-10.0 days) for mixed shock versus 1.9 days (IQR, 1.0-3.6) for patients without shock ( P<0.01 for each). Median Sequential Organ Failure Assessment scores were higher in patients with mixed shock (10; IQR, 6-13) versus AMICS (8; IQR, 5-11) or CS without AMI (7; IQR, 5-11; each P<0.01). In-hospital mortality rates were 36% (95% CI, 28%-45%), 31% (95% CI, 26%-36%), and 39% (95% CI, 31%-48%) in AMICS, CS without AMI, and mixed shock, respectively. Conclusions The epidemiology of shock in contemporary advanced CICUs is varied, and AMICS now represents less than one-third of all CS. Despite advanced therapies, mortality in CS and mixed shock remains high. Investigation of management strategies and new therapies to treat shock in the CICU should take this epidemiology into account.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005618
Berg DD, Bohula EA, van Diepen S, Katz JN, ... Vikram F, Morrow DA
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005618 | PMID: 30879324
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Abstract

Trends in Performance and Opportunities for Improvement on a Composite Measure of Acute Myocardial Infarction Care.

Desai NR, Udell JA, Wang Y, Spatz ES, ... Krumholz HM, Curtis JP

Background Despite improvements on individual process of care measures for acute myocardial infarction (AMI), little is known about performance on a composite measure of AMI care that assesses the delivery of many components of high-quality AMI care. We sought to examine trends in patient- and hospital-level performance on a composite defect-free care measure, identify disparities in the performance across sociodemographic groups, and identify opportunities to further improve quality and outcomes. Methods and Results We calculated the proportion of patients in the National Cardiovascular Data Registry-Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (now known as the Chest Pain - Myocardial Infarction Registry) between January 1, 2010, and December 31, 2017, receiving defect-free AMI care including guideline-recommended pharmacotherapy, timely provision of medical and reperfusion therapy, assessment of ventricular function, referral to cardiac rehabilitation, and smoking cessation counseling for patients with AMI. A total of 522 800 patients at 222 hospitals were included. Overall, the proportion of patients receiving defect-free care significantly increased from 66.0% in 2010 to 77.1% in 2017 ( P<0.001). Improvements in performance were observed across all sociodemographic subgroups, with the greatest absolute improvement observed for black and Hispanic patients ( P<0.001). However, absolute performance was consistently lower among older patients, women, black and Hispanic patients, and those with government insurance in 2017 ( P<0.001 for all). Improvements in care and reduced variation in performance were observed at the hospital level overall (2010, median [IQR] 67.2% [40.7%-76.3%]; 2017, median [IQR] 80.7% [73.1%-88.1%]; P<0.001) as well as across region, safety net status, teaching status, and proportion of patients who are nonwhite and have Medicaid insurance coverage ( P<0.001 for all). Conclusions Despite improvements in the proportion of patients with AMI receiving defect-free care overall and across sociodemographic groups, nearly 1 in 4 patients in 2017 still did not receive optimal care and absolute performance was consistently lower among older patients, women, black, and Hispanic patients. Composite measures of cardiovascular care, which assess the delivery of several evidence-based processes of care, can illuminate opportunities to improve the quality of care beyond that provided by conventional process measures.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004983
Desai NR, Udell JA, Wang Y, Spatz ES, ... Krumholz HM, Curtis JP
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004983 | PMID: 30871375
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Abstract

Association Between Hospital Recognition for Resuscitation Guideline Adherence and Rates of Survival for In-Hospital Cardiac Arrest.

Khera R, Tang Y, Link MS, Krumholz HM, Girotra S, Chan PS

Background Hospitals participating in the national Get With The Guidelines-Resuscitation registry receive an award for high rates of adherence to quality metrics for in-hospital cardiac arrest. We sought to evaluate whether awards based on these quality metrics can be considered a proxy for performance on cardiac arrest survival. Methods and Results Among 195 hospitals with continuous participation in Get With The Guidelines-Resuscitation between 2012 and 2015, we identified 78 that received an award (Gold or Silver) for ≥85% compliance for all 4 metrics for in-hospital cardiac arrest-time to chest compressions, ≤1 minute; time to defibrillation, ≤2 minutes; device confirmation of endotracheal tube placement; and a monitored/witnessed arrest-for at least 12 consecutive months during 2014 to 2015. Award hospitals had higher cardiac arrest volumes than nonaward hospitals but otherwise had similar site characteristics. During 2014 to 2015, award hospitals had higher rates of return of spontaneous circulation for in-hospital cardiac arrest than nonaward hospitals (median [interquartile range], 71% [64%-77%] versus 66% [59%-74%]; Spearman ρ, 0.19; P=0.009). However, rates of risk-standardized survival to discharge at award hospitals (median, 25% [interquartile range, 22%-30%]) were similar to nonaward hospitals (median, 24% [interquartile range, 12%-27%]; Spearman ρ, 0.13; P=0.06). Among hospitals in the best tertile for survival to discharge in 2014 to 2015, 55.4% (36/65) did not receive an award, with poor discrimination of high-performing hospitals by award status (C statistic, 0.53). Similarly, there was only a weak association between hospitals\' award status in 2014 to 2015 and their rates of survival to discharge in the preceding 2-year period (Spearman ρ, 0.16; P=0.03). Conclusions The current recognition mechanism within a national registry for in-hospital cardiac arrest captures hospital performance on return of spontaneous circulation but is not well correlated with survival to discharge. This suggests that current awards for resuscitation quality may not adequately capture hospital performance on overall survival-the outcome of greatest interest to patients.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005429
Khera R, Tang Y, Link MS, Krumholz HM, Girotra S, Chan PS
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005429 | PMID: 30871337
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Abstract

Disability-Adjusted Life Years Following Adult Out-of-Hospital Cardiac Arrest in the United States.

Coute RA, Nathanson BH, Panchal AR, Kurz MC, ... Neumar RW, Mader TJ

Background Disability-adjusted life years (DALY) are a common public health metric used to consistently estimate and compare health loss because of both fatal and nonfatal disease burden. The annual number of DALY because of adult out-of-hospital cardiac arrest (OHCA) in the United States is unknown. Our objective was to estimate the DALY after adult nontraumatic, emergency medical services-treated OHCA, and to compare OHCA DALY to other leading causes of death and disability in the US. Methods and Results The DALY were calculated as the sum of years of life lost and years lived with disability. The years of life lost were calculated using all adult nontraumatic emergency medical services-treated OHCA with complete data from the national Cardiac Arrest Registry to Enhance Survival database for 2016, and actuarial data for remaining life expectancy at the age of death. Cerebral performance category scores from the Cardiac Arrest Registry to Enhance Survival database and previously established disability weights were used to estimate years lived with disability. The cohort\'s calculated DALY were extrapolated to a national level to estimate total US DALY. Data were reported as total, mean, and DALY per 100 000 individuals. A total of 59 752 OHCA met study inclusion criteria. The DALY for the study population were 1 194 993 (years of life lost, 1 194 069; years lived with disability, 924) in 2016. The estimated total DALY following adult nontraumatic emergency medical services-treated OHCA in the US were 4 354  192 (years of life lost, 4 350  825; years lived with disability, 3365) for the index year 2016. The rate of OHCA DALY were 1347 per 100 000 population, which ranked third in the US behind ischemic heart disease (2447) and low back and neck pain (1565). Sensitivity analyses yielded similar findings. Conclusions Adult nontraumatic OHCA is a leading cause of annual DALY in the US and should be a focus of public health policy and resources.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004677
Coute RA, Nathanson BH, Panchal AR, Kurz MC, ... Neumar RW, Mader TJ
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004677 | PMID: 30859852
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Abstract

Detecting Anomalies Among Practice Sites Within Multicenter Trials.

Berkowitz SA, Rudolph KE, Basu S
Background
Recent multisite trials reveal striking heterogeneities in results between trial sites. These may be because of population differences indicating different treatment benefits among different types of participants or site anomalies, such as failures to adhere to study protocols that could negatively affect study validity. We sought to determine whether a new data analysis strategy-transportability methods-could suggest site anomalies not readily identified through standard methods.
Methods and results
We applied transportability methods to 2 large, multicenter cardiovascular disease treatment trials: the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist; n=3445) comparing spironolactone to placebo for heart failure (for which site anomalies were suspected) and the ACCORD BP trial (Action to Control Cardiovascular Risk in Diabetes-Blood Pressure; n=4733) comparing intensive-to-standard blood pressure treatment (for which site anomalies were not suspected). The transportability methods give expected results by standardizing from one site to another using data on participant covariates. The difference between the expected and observed results was assessed using calibration tests to identify whether treatment-effect differences between sites could be explained by participant population characteristics. Standard regression methods did not detect heterogeneities in TOPCAT between Russia/Georgia study sites suspected of study protocol violations and sites in the Americas ( P=0.12 for difference in primary cardiovascular outcome; P=0.20 for difference in total mortality). The transportability methods, however, detected the difference between Russia/Georgia sites and sites in the Americas ( P<0.001) and found that measured participant characteristics did not explain the between-site discrepancies. The transport methods found no such discrepancies between sites in ACCORD BP, suggesting participant characteristics explained between-site differences.
Conclusions
Transportability methods may be superior to standard approaches for detecting anomalies within multicenter randomized trials and assist data monitoring boards to determine whether important treatment-effect heterogeneities can be attributed to participant differences or potentially to site performance differences requiring further investigation.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004907
Berkowitz SA, Rudolph KE, Basu S
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004907 | PMID: 30857413
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Abstract

Predicting Future Cardiovascular Events in Patients With Peripheral Artery Disease Using Electronic Health Record Data.

Ross EG, Jung K, Dudley JT, Li L, Leeper NJ, Shah NH
Background
Patients with peripheral artery disease (PAD) are at risk of major adverse cardiac and cerebrovascular events. There are no readily available risk scores that can accurately identify which patients are most likely to sustain an event, making it difficult to identify those who might benefit from more aggressive intervention. Thus, we aimed to develop a novel predictive model-using machine learning methods on electronic health record data-to identify which PAD patients are most likely to develop major adverse cardiac and cerebrovascular events.
Methods and results
Data were derived from patients diagnosed with PAD at 2 tertiary care institutions. Predictive models were built using a common data model that allowed for utilization of both structured (coded) and unstructured (text) data. Only data from time of entry into the health system up to PAD diagnosis were used for modeling. Models were developed and tested using nested cross-validation. A total of 7686 patients were included in learning our predictive models. Utilizing almost 1000 variables, our best predictive model accurately determined which PAD patients would go on to develop major adverse cardiac and cerebrovascular events with an area under the curve of 0.81 (95% CI, 0.80-0.83).
Conclusions
Machine learning algorithms applied to data in the electronic health record can learn models that accurately identify PAD patients at risk of future major adverse cardiac and cerebrovascular events, highlighting the great potential of electronic health records to provide automated risk stratification for cardiovascular diseases. Common data models that can enable cross-institution research and technology development could potentially be an important aspect of widespread adoption of newer risk-stratification models.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004741
Ross EG, Jung K, Dudley JT, Li L, Leeper NJ, Shah NH
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e004741 | PMID: 30857412
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Abstract

Clinical Value of Predicting Individual Treatment Effects for Intensive Blood Pressure Therapy.

Duan T, Rajpurkar P, Laird D, Ng AY, Basu S
Background
The absolute risk reduction (ARR) in cardiovascular events from therapy is generally assumed to be proportional to baseline risk-such that high-risk patients benefit most. Yet newer analyses have proposed using randomized trial data to develop models that estimate individual treatment effects. We tested 2 hypotheses: first, that models of individual treatment effects would reveal that benefit from intensive blood pressure therapy is proportional to baseline risk; and second, that a machine learning approach designed to predict heterogeneous treatment effects-the X-learner meta-algorithm-is equivalent to a conventional logistic regression approach.
Methods and results
We compared conventional logistic regression to the X-learner approach for prediction of 3-year cardiovascular disease event risk reduction from intensive (target systolic blood pressure <120 mm Hg) versus standard (target <140 mm Hg) blood pressure treatment, using individual participant data from the SPRINT (Systolic Blood Pressure Intervention Trial; N=9361) and ACCORD BP (Action to Control Cardiovascular Risk in Diabetes Blood Pressure; N=4733) trials. Each model incorporated 17 covariates, an indicator for treatment arm, and interaction terms between covariates and treatment. Logistic regression had lower C statistic for benefit than the X-learner (0.51 [95% CI, 0.49-0.53] versus 0.60 [95% CI, 0.58-0.63], respectively). Following the logistic regression\'s recommendation for individualized therapy produced restricted mean time until cardiovascular disease event of 1065.47 days (95% CI, 1061.04-1069.35), while following the X-learner\'s recommendation improved mean time until cardiovascular disease event to 1068.71 days (95% CI, 1065.42-1072.08). Calibration was worse for logistic regression; it over-estimated ARR attributable to intensive treatment (slope between predicted and observed ARR of 0.73 [95% CI, 0.30-1.14] versus 1.06 [95% CI, 0.74-1.32] for the X-learner, compared with the ideal of 1). Predicted ARRs using logistic regression were generally proportional to baseline pretreatment cardiovascular risk, whereas the X-learner observed-correctly-that individual treatment effects were often not proportional to baseline risk.
Conclusions
Predictions for individual treatment effects from trial data reveal that patients may experience ARRs not simply proportional to baseline cardiovascular disease risk. Machine learning methods may improve discrimination and calibration of individualized treatment effect estimates from clinical trial data.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifiers: NCT01206062; NCT00000620.



Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005010
Duan T, Rajpurkar P, Laird D, Ng AY, Basu S
Circ Cardiovasc Qual Outcomes: 27 Feb 2019; 12:e005010 | PMID: 30857410
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Abstract

Effect of Coronary Anatomy and Myocardial Ischemia on Long-Term Survival in Patients with Stable Ischemic Heart Disease.

Weintraub WS, Hartigan PM, Mancini GBJ, Teo KK, ... Berman D, Boden WE

Background The severity of coronary artery disease (CAD) and of ischemia are evaluated to guide therapy, but their relative prognostic importance remains uncertain. Accordingly, we sought to clarify their association with long-term survival in the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). Methods and Results Survival data from after the original trial period ended was obtained at 15 Veterans Affairs sites and 13 of 18 United States non-Veterans Affairs sites. Date of death was obtained from the Veterans Affairs system-wide Corporate Data Warehouse and the National Death Index. Of the original 2287 patients in COURAGE, 1370 (60%) had both stress perfusion imaging and quantitative coronary angiography available, with extended survival evaluated in 767 subjects. Survival was calculated by the Kaplan-Meier method, and a Cox proportional-hazards model adjusted for baseline differences. There were 369 all-cause deaths during a median follow-up of 7.9 years (range, 0-15 years). The number of coronary arteries diseased predicted survival (HR, 1.25; 95% CI, 1.09-1.43), whereas severity of ischemia did not (HR, 0.99; 95% CI, 0.80-1.22). Percutaneous coronary intervention did not offer a survival advantage over optimal medical therapy (HR, 0.95; 95% CI, 0.77-1.16) and there was no interaction between therapeutic strategy and number of coronary arteries diseased or severity of ischemia. In fully adjusted models, the number of coronary arteries diseased was not associated with increased mortality. Conclusions In univariate analysis, the number of coronary arteries diseased predicted long-term mortality, but severity of ischemia did not. Adjusted for baseline variables, neither assessment approach predicted mortality. Overall, there was no survival benefit from percutaneous coronary intervention in any subset defined by either angiographic or ischemic severity. Clinical Trial registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00007657.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005079
Weintraub WS, Hartigan PM, Mancini GBJ, Teo KK, ... Berman D, Boden WE
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005079 | PMID: 30773025
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Abstract

Sequential Monitoring of the Comparative Effectiveness and Safety of Dabigatran in Routine Care.

Schneeweiss S, Gopalakrishnan C, Bartels DB, Franklin JM, ... Kulldorff M, Huybrechts KF

Background The increasing availability of electronic healthcare data enables ongoing monitoring of the effectiveness and safety of newly marketed medications. We sought to demonstrate a 5-year prospective monitoring system of dabigatran for stroke prevention that may expedite discovery and allow ongoing evidence development. Methods and Results Between 2011 and 2015, we conducted 9 sequential analyses of dabigatran versus warfarin users in a sequential cohort design in 2 US claims databases. Analyses 4 through 9 were prespecified, and analyses 1 through 3 were added subsequently using the same methodology. New users of anticoagulants with nonvalvular atrial fibrillation were followed until a study outcome of hospitalization for stroke (hemorrhagic and ischemic) or hospitalization for major hemorrhage (intracranial and extracranial). Hazard ratios and 95% CIs were estimated after 1:1 propensity score matching. Sequential analyses 1 through 3 on stroke prevention using data through June 2012 were limited by few events leading to wide CIs. As data accumulated the effect estimate in analysis 4 visually stabilized at a 25% risk reduction with increasingly narrower CIs (-46% to +9% in December 2012 and -42% to -2% in September 2015). Improved data-adaptive confounding adjustment with high-dimensional propensity score reached a stable state already at analysis 3 and was slightly closer to the randomized clinical trial finding (-39%). The risk of major hemorrhage was 28% lower in dabigatran initiators (-35% to -20%) a finding that was stable throughout analyses 2 to 9. Conclusions Prospectively monitoring the effectiveness and safety of dabigatran for stroke prevention allowed for early insights with increasing precision over time.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005173
Schneeweiss S, Gopalakrishnan C, Bartels DB, Franklin JM, ... Kulldorff M, Huybrechts KF
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005173 | PMID: 30764655
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Abstract

Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design.

Chhatriwalla AK, Decker C, Gialde E, Catley D, ... Sun T, Spertus JA

Background Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P<0.001), reported more frequent participation in SDM (odds ratio=2.96; P<0.001), and were more likely to state a stent preference (odds ratio=2.00; P<0.001). No significant differences were observed between the use of the SDM tool without coaching and usual care. For patients who voiced a stent preference, concordance between stent desired and stent received was 98% for patients who preferred a drug-eluting stent and 50% for patients who preferred a bare metal stent. The SDM tool (with or without coaching) had no impact on stent selection or concordance. Conclusions An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients\' stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005139
Chhatriwalla AK, Decker C, Gialde E, Catley D, ... Sun T, Spertus JA
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005139 | PMID: 30764654
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Abstract

Comparative Safety of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance of the NCDR CathPCI Registry.

Majithia A, Matheny ME, Paulus JK, Marinac-Dabic D, ... Normand SL, Resnic FS

Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry. We sought to assess the ability of our surveillance strategy to avoid false safety alerts by conducting an active safety surveillance study of aspiration thrombectomy catheters using data within the National Cardiovascular Data Registry CathPCI registry, where no difference in safety outcomes were anticipated for the primary in-hospital safety outcome of death and major adverse cardiovascular events (MACE). We performed a propensity-matched analysis of 5 aspiration thrombectomy catheter devices used during percutaneous coronary intervention among 95 925 patients presenting with ST-segment-elevation myocardial infarction between January 1, 2011 and September 30, 2013. After 33 months of surveillance, no safety alerts were triggered for the primary safety endpoints of death or MACE, with no between-catheter differences observed. The absolute risk of death during acute hospitalization ranged from 5.11% to 5.32% among the most commonly used aspiration thrombectomy catheter devices, with relative risks for death ranging from 0.96 to 1.03. The absolute risk of MACE ranged from 9.78% to 10.18%, with relative risks for MACE ranging from 0.99 to 1.02. There were no statistically significant differences in the rates of death or MACE between any of the aspiration thrombectomy catheter devices analyzed. Conclusions The CathPCI DELTA study demonstrates that prospective, active safety surveillance of national clinical registries is feasible to provide near-real-time safety assessments of new medical devices.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e004666
Majithia A, Matheny ME, Paulus JK, Marinac-Dabic D, ... Normand SL, Resnic FS
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e004666 | PMID: 30764652
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Abstract

PREPARED Study: A Study of Shared Decision-Making for Coronary Artery Disease.

Doll JA, Jones WS, Lokhnygina Y, Culpepper S, ... Au DH, Patel MR

Background Guidelines recommend patient engagement in shared decision-making regarding coronary revascularization, but studies demonstrate poor patient understanding of risks, benefits, and alternatives. Effective strategies are needed to integrate informed patient preferences into clinical care, particularly for patients undergoing diagnostic coronary angiography. Methods and Results We developed a web-based decision aid to educate patients and survey their treatment preferences before angiography. We compared knowledge, attitudes, and preferences of 203 patients with and without use of the decision aid. In a pilot cluster-randomized study, cardiologists were assigned to receive versus not receive patient preferences, with subsequent assessment of treatment decisions. The median age of participants was 64 years, 62% were men, 74% were white, and a similar number had acute presentation (49% non-ST-segment-elevation myocardial infarction or unstable angina) and stable presentation (51% stable angina or atypical symptoms). Most patients preferred treatment with percutaneous coronary intervention compared with either medical therapy alone (63% versus 21%) or coronary artery bypass graft surgery (81% versus 7%). The decision aid was associated with improved performance on a 6-item knowledge scale (mean, 2.7 versus 2.2 questions correct; P<0.01) and greater interest in shared decision-making but not an overall change in patient preferences. The pilot cluster-randomized study demonstrated the feasibility of integrating patient preference information into clinical care, although providing preferences to the clinicians did not improve concordance between preference and treatment. Conclusions A web-based decision aid was associated with improved patient knowledge and greater desire to participate in shared decision-making for coronary revascularization. Most patients preferred percutaneous coronary intervention to either medical therapy alone or coronary artery bypass graft surgery. Further investigation is needed to determine the impact of patient preferences on clinical decision-making and outcomes. Clinical Trial registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02272062.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005244
Doll JA, Jones WS, Lokhnygina Y, Culpepper S, ... Au DH, Patel MR
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e005244 | PMID: 30764651
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Abstract

Bioprosthetic Aortic Valve Replacement in Nonelderly Adults: A Systematic Review, Meta-Analysis, Microsimulation

Etnel JRG, Huygens SA, Grashuis P, Pekbay B, ... Bogers AJJC, Takkenberg JJM

Background To support decision-making in aortic valve replacement in nonelderly adults, we aim to provide a comprehensive overview of reported outcome after bioprosthetic aortic valve replacement and to translate this to age-specific patient outcome estimates. Methods and Results A systematic review was conducted for papers reporting clinical outcome after aortic valve replacement with currently available bioprostheses in patients with a mean age <55 years, published between January 1, 2000, and January 9, 2016. Pooled reported event rates and time-to-event data were pooled and entered into a microsimulation model to calculate life expectancy and lifetime event risk for the ages of 25, 35, 45, and 55 years at surgery. Nineteen publications were included, encompassing a total of 2686 patients with 21 117 patient-years of follow-up (pooled mean follow-up: 7.9±4.2 years). Pooled mean age at surgery was 50.7±11.0 years. Pooled early mortality risk was 3.30% (95% CI, 2.39-4.55), late mortality rate was 2.39%/y (95% CI, 1.13-2.94), reintervention 1.82%/y (95% CI, 1.31-2.52), structural valve deterioration 1.59%/y (95% CI, 1.21-2.10), thromboembolism 0.53%/y (95% CI, 0.42-0.67), bleeding 0.22%/y (95% CI, 0.16-0.32), endocarditis 0.48%/y (95% CI, 0.37-0.62), and 20-year pooled actuarial survival was 58.7% and freedom from reintervention was 29.0%. Median time to structural valve deterioration was 17.3 years and median time to all-cause first reintervention was 16.9 years. For a 45-year-old adult, for example, this translated to a microsimulation-based estimated life expectancy of 21 years (general population: 32 years) and lifetime risk of reintervention of 78%, structural valve deterioration 71%, thromboembolism 12%, bleeding 5%, and endocarditis 9%. Conclusions Aortic valve replacement with bioprostheses in young adults is associated with high structural valve deterioration and reintervention rates and low, though not absent, hazards of thromboembolism and bleeding. Foremostly, most patients will require one or more reinterventions during their lifetime and survival is impaired in comparison with the age- and sex-matched general population. Prosthesis durability remains the main concern in nonelderly patients.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005481
Etnel JRG, Huygens SA, Grashuis P, Pekbay B, ... Bogers AJJC, Takkenberg JJM
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005481 | PMID: 30760011
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Abstract

Rural-Urban Differences in Stroke Risk Factors, Incidence, and Mortality in People With and Without Prior Stroke.

Kapral MK, Austin PC, Jeyakumar G, Hall R, ... Swartz RH, Tu JV

Background Rural residence is associated with stroke incidence and mortality, but little is known about potential rural/urban differences in ambulatory stroke care. Methods and Results We used the CANHEART (Cardiovascular Health in Ambulatory Care Research Team) cohort, created from linked administrative databases from the province of Ontario, Canada, and divided into primary (N=6 207 032) and secondary (N=75 823) prevention cohorts based on the absence or presence of prior stroke. We defined rural communities as those with a population size of ≤10 000 and within each of the primary and secondary prevention cohorts, compared cardiovascular risk factors and care between rural and urban areas. We then calculated sex-/age-standardized rates of stroke incidence and mortality per 1000 person-years between January 1, 2008 and December 31, 2012 and used cause-specific hazard models to compare outcomes in rural versus urban areas adjusting for age, sex, income, ethnicity, smoking, physical activity and comorbid conditions, and accounting for the competing risk of death in the model for the occurrence of stroke incidence. In the primary prevention cohort, rural residents were less likely than urban ones to be screened for diabetes mellitus (70.9% versus 81.3%) and hyperlipidemia (66.2% versus 78.4%) and less likely to achieve diabetes mellitus control (hemoglobin A1c ≤7% in 51.3% versus 54.3%; P<0.001 for all comparisons). In the secondary prevention cohort, the prevalence and treatment of risk factors were similar in rural and urban residents. After adjustment for sociodemographic and comorbid conditions, rural residence was associated with higher rates of stroke and all-cause mortality in both the primary prevention (adjusted hazard ratio [aHR] for stroke, 1.06; 95% CI, 1.04-1.09; aHR for mortality, 1.09; 95% CI, 1.08-1.10) and the secondary prevention cohort (aHR for stroke, 1.11; 95% CI, 1.02-1.19; aHR for mortality, 1.07; 95% CI, 1.03-1.11). Conclusions In this population-based study of over 6 million people with universal access to physician and hospital services, risk factors were more prevalent but less likely to be controlled in rural than in urban residents without prior stroke, whereas in those with prior stroke, risk factor prevalence and treatment were similar. Rural residence was associated with the rate of stroke and death even after adjustment for risk factors. Future efforts should focus not only on control of known vascular risk factors but also on addressing other determinants of health in rural communities.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e004973
Kapral MK, Austin PC, Jeyakumar G, Hall R, ... Swartz RH, Tu JV
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e004973 | PMID: 30760007
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Impact:
Abstract

Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction.

Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, ... Lloyd-Jones DM,
Background
Despite a high cardiovascular disease burden, data on patient-reported health status outcomes among individuals with cardiovascular disease in India are limited.
Methods and results
Between November 2014 and November 2016, we collected health-related quality of life data among 1261 participants in the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala). We used a translated, validated version of the Seattle Angina Questionnaire administered 30 days after discharge for acute myocardial infarction, wherein higher scores represent better health status. We compared results across sex, myocardial infarction type, and randomization status using regression models that account for clustering and temporal trends. Mean (SD) age was 60.8 (13.7) years, 62% were men, and 63% presented with ST-segment-elevation myocardial infarction. More than 2 out of 5 respondents (44%) experienced angina 30 days after hospitalization, but most (68% of respondents with angina; 27% of the total sample) experienced it less than once per week (Seattle Angina Questionnaire angina frequency score 60). Respondents rated high median (interquartile range [IQR]) scores for angina frequency (100.0 [80.0-100.0]) overall with similar unadjusted scores by sex, but between-hospitality variability was high. Median (IQR) physical limitation scale response was 58.3 (41.7-77.8), which is consistent with limitations in moderate- and high-intensity activities at 30-day follow-up. Older respondents had more angina frequency and physical limitations and lower treatment satisfaction and quality of life. Women had greater physical limitations (median [IQR], 52.8 [38.9-72.2] for women versus median [IQR], 61.1 [44.4-80.6] for men; P<0.01). Overall treatment satisfaction was high with median (IQR) score, 81.3 (75.0-93.8), but overall quality of life was lower with median (IQR) score, 66.7 (50.0-83.3). Allocation to the quality improvement intervention group had the strongest direct association with higher quality of life (difference, 4.2; P=0.03), but overall effects were modest.
Conclusions
This study represents the largest report of quality of life among myocardial infarction survivors in India with variability across age, sex, and quality improvement intervention status. Wide variability demonstrated across hospitals warrants further study.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02256657.



Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e004980
Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, ... Lloyd-Jones DM,
Circ Cardiovasc Qual Outcomes: 30 Jan 2019; 12:e004980 | PMID: 30755027
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Abstract

Association of Body Mass Index With Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Cardiovascular Disease.

Hira RS, Kataruka A, Akeroyd JM, Ramsey DJ, ... Petersen LA, Virani SS
Background
Obesity is a growing epidemic that has been linked to the development of cardiovascular disease (CVD). Guideline-directed medications for secondary prevention and risk factor control are recommended for patients with all forms of CVD. The association of body mass index (BMI) with use of medications for secondary prevention and risk factor control in patients with CVD are poorly understood.
Methods and results
We identified 1 122 567 patients with CVD receiving care in 130 Veterans Affairs facilities from October 1, 2013, to September 30, 2014. Five groups were stratified by BMI-underweight (BMI, <18.5 kg/m), normal (BMI, 18.5-24.9 kg/m), overweight (BMI, 25-29.9 kg/m), obese (BMI, 30-39.9 kg/m), and extremely obese (BMI, ≥40 kg/m). A composite of 4 measures-blood pressure <140/90 mm Hg, hemoglobin A1c ≤9% in diabetic patients, statin use, and antiplatelet use-termed optimal medial therapy (OMT) was compared among groups. Multivariable logistic regression was performed with normal BMI as the referent category. Underweight patients comprised 12 623 (1.1%), normal BMI 230 471 (20.5%), overweight 413 590 (36.8%), obese 404 105 (36%), and extremely obese 61 778 (5.5%) of the cohort. Only 43.7% of the entire cohort received OMT, and this was the highest in the overweight group. Adjusted odds ratios for receiving OMT were 0.81 (95% CI, 0.77-0.85), 1.11 (95% CI, 1.10-1.13), 1.08 (95% CI, 1.06-1.09), and 0.87 (95% CI, 0.85-0.89), for patients who were underweight, overweight, obese, and extremely obese, respectively, compared with normal BMI.
Conclusions
OMT was low in the entire cohort. There is an inverse U-shaped relationship between OMT and BMI with patients who are underweight and extremely obese less likely to receive OMT compared with patients with normal BMI.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004817
Hira RS, Kataruka A, Akeroyd JM, Ramsey DJ, ... Petersen LA, Virani SS
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004817 | PMID: 30636483
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Impact:
Abstract

Preparedness and Mutuality Affect Quality of Life for Patients With Mechanical Circulatory Support and Their Caregivers.

Magasi S, Buono S, Yancy CW, Ramirez RD, Grady KL
Background
Clinical and US regulatory guidelines for patients with mechanical circulatory support (MCS) require the identification of a caregiver to assist with MCS care. There is limited understanding of the impact of MCS caregiving on patients and caregivers. The purpose of this study was to examine how living with MCS affects the quality of life (QoL) of patients and their caregivers through the lens of preparedness and mutuality.
Methods and results
The sample included 30 MCS patients and their caregivers. Semistructured qualitative interviews about factors contributing to QoL were conducted with patients and caregivers and analyzed using a 2-phase thematic process. Caregiving impacts QoL of MCS patients and their caregivers long term. When there was limited time to engage in decision-making about MCS implantation, people entered MCS caregiving relationships naive to its full demands. Although most people adjusted to the task demands, MCS caregiving had a significant impact, both positive and negative, on interpersonal relationships. We applied the concepts of preparedness and mutuality to help frame the understanding of the emergent themes of forced choice, adjustment, gratitude, relationship change, strain, and burden (both caregiver and patient perceived). Availability of networks of support was identified as a crucial resource.
Conclusions
MCS caregiving affects QoL for both patients and caregivers. Specifically, preparedness, mutuality, and availability of supportive networks influence QoL of MCS patients and their caregivers. Caregiving relationships change over time. Long-term support by the MCS clinical team can help ensure that physical and emotional needs of MCS patients and caregivers are identified and addressed.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004414
Magasi S, Buono S, Yancy CW, Ramirez RD, Grady KL
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004414 | PMID: 30636480
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Abstract

Medication Discontinuation in the IMPROVE-IT Trial.

Navar AM, Roe MT, White JA, Cannon CP, ... Califf RM, Blazing MA
Background
Although cholesterol-lowering medications can reduce the risk of recurrent cardiovascular events, premature discontinuation limits effectiveness. Discontinuation rates have not been systematically reported for lipid-lowering trials.
Methods and results
We evaluated medication discontinuation in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial), which evaluated placebo+simvastatin versus ezetimibe+simvastatin in patients hospitalized with the acute coronary syndrome and followed longitudinally postdischarge. Reasons for discontinuation were evaluated from randomization through study end (median 71.9 [interquartile range 51.8-85.8] months). Kaplan-Meier (KM) discontinuation rates were evaluated at 30 days, 1 year, and through year 7, and compared by treatment arm and region, with Cox proportional hazards modeling used to evaluate predictors of discontinuation. Overall, 46.7% of subjects discontinued study medication (KM rate by study end 50.9% [95% CI, 50.1%-51.7%]). The risk of discontinuation was highest early in the trial but decreased with increasing time, with a terminal KM rate per 100 person-years of 8.4 (8.2-8.6) from years 1 to 7. Discontinuation was higher in the placebo+simvastatin versus ezetimibe+simvastatin arm (KM rate 52.0% versus 49.8%, P=0.049) and was highest in the United States (7-year KM rate 57.4%). In multivariable modeling, smoking, prior revascularization, hypertension, unstable angina, female sex, nonwhite race, and US location were associated with higher discontinuation rates.
Conclusions
Although discontinuation was highest early and stabilized to 8% per year, because of prolonged follow-up, most discontinuation occurred after year 1. Adding ezetimibe to statin therapy did not increase discontinuation risk. Geographic differences and patient-level factors should be considered in trial design and analysis.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00202878.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005041
Navar AM, Roe MT, White JA, Cannon CP, ... Califf RM, Blazing MA
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005041 | PMID: 30630361
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Impact:
Abstract

In-Hospital Management and Outcomes After ST-Segment-Elevation Myocardial Infarction in Medicaid Beneficiaries Compared With Privately Insured Individuals.

Patel N, Gupta A, Doshi R, Kalra R, ... Arora G, Arora P
Background
Medicaid expansion among previously uninsured individuals has led to improved healthcare access. However, considerably lower reimbursement rates of Medicaid have raised concerns on the unintended consequence of lower utilization of life-saving therapies and inferior outcomes compared with private insurance. We examined the rates of revascularization and in-hospital mortality among Medicaid beneficiaries versus privately insured individuals hospitalized with ST-segment-elevation myocardial infarction (STEMI).
Methods and results
We queried the National Inpatient Sample from 2012 to 2015 for STEMI hospitalizations with Medicaid or private insurance as primary payer. Hospitalizations with the following criteria were excluded: (1) age <18 or ≥65 years, (2) transfer to another acute care facility, and (3) left against medical advice. Outcomes were compared in propensity score-matched cohort based on demographics, socioeconomic status (income based), clinical comorbidities, including drug and alcohol use, STEMI acuity (cardiac arrest and cardiogenic shock), and hospital characteristics. A total of 42 645 and 171 545 STEMI hospitalizations were identified as having Medicaid and private insurance, respectively. In unadjusted analyses, Medicaid beneficiaries with STEMI had lower rates of coronary revascularization (88.9% versus 92.3%; odds ratio, 0.67; 95% CI, 0.65-0.70) and higher rates of in-hospital mortality (4.9% versus 2.8%; odds ratio, 1.81; 95% CI, 1.72-1.91) compared with privately insured individuals ( P<0.001 for both). In propensity-matched cohort of 40 870 hospitalizations per group, similar results for lower rates of revascularization (89.1% versus 91.1%; odds ratio, 0.80; 95% CI, 0.76-0.84) and higher in-hospital mortality (4.9% versus 3.7%; odds ratio, 1.35; 95% CI, 1.26-1.45) were observed in Medicaid compared with private insurance, despite extensive matching ( P<0.001 for both).
Conclusions
Medicaid beneficiaries with STEMI had lower rates of revascularization, although small absolute difference, and higher in-hospital mortality compared with privately insured individuals. Further studies are needed to identify and understand the variation in STEMI outcomes by insurance status.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004971
Patel N, Gupta A, Doshi R, Kalra R, ... Arora G, Arora P
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004971 | PMID: 30606054
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Impact:
Abstract

Impact of Participation in a Telestroke Network on Clinical Outcomes.

Zhang D, Shi L, Ido MS, Green DE, ... Su D, Hess DC
Background
A telestroke program, known as the Remote Evaluation for Acute Ischemic Stroke program, has been implemented in Georgia since 2003. This study examined whether a hospital\'s participation in a telestroke network was associated with improvement in clinical outcomes and quality indicators.
Methods and results
An observational study was conducted using data from the Georgia Coverdell Acute Stroke Registry between September 2005 and September 2016 for patients aged ≥18 years with ischemic stroke. We use a difference-in-differences approach to compare the following clinical outcomes and quality indicators among those admitted at hospitals within and outside of the Remote Evaluation for Acute Ischemic Stroke network: tPA (tissue-type plasminogen activator) use, complications related to tPA use, door-to-needle time, ambulation at discharge, discharge status, and destination. Logistic regression models and a propensity score weighting approach were performed to adjust for patients\' age, sex, race, insurance coverage, arrival mode, ambulatory status before the current stroke, stroke severity, medical history, admission time, and hospital bed size. A total of 25 494 patients with ischemic stroke admitted at 15 nonteaching hospitals located outside of the Atlanta metropolitan area were included in the analysis. After propensity score weighting, hospitals participated in a telestroke network was not associated with a significant increase in the rate of tPA use, while it was significantly associated with a modest decline in the rate of complications related to tPA (-5.9%; 95% CI, -9.2% to -2.6%). Telestroke participation showed no significant difference in other clinical outcomes and quality measures except for a marginally significant decrease in in-hospital mortality (-1.1%; 95% CI, -2.2% to -0.1%).
Conclusions
Although a slight decrease in tPA complication was observed among hospitals participating in the telestroke network, overall the impact of telestroke participation on a hospital\'s stroke care quality was not statistically significant based on our observational study.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005147
Zhang D, Shi L, Ido MS, Green DE, ... Su D, Hess DC
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e005147 | PMID: 30606053
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Impact:
Abstract

Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk.

Baber U, Leisman DE, Cohen DJ, Gibson CM, ... Pocock SJ, Mehran R
Background
Balancing ischemic and bleeding risk is an evolving framework.
Methods and results
Our objectives were to simulate changes in risks for adverse events and event-driven costs with use of ticagrelor or prasugrel versus clopidogrel according to varying levels of ischemic and bleeding risk. Using the validated PARIS risk functions, we estimated 1-year ischemic (myocardial infarction or stent thrombosis) and bleeding (Bleeding Academic Research Consortium types 3 or 5) event rates among PARIS study participants who underwent percutaneous coronary intervention with drug-eluting stent implantation for an acute coronary syndrome and were discharged with aspirin and clopidogrel (n=1497). Simulated changes in adverse events with ticagrelor or prasugrel were calculated by applying treatment effects from randomized trials for a 1-year time horizon. Event costs were estimated using National Inpatient Sample data. Net costs were calculated between antiplatelet therapy groups according to level of ischemic and bleeding risk. After weighting events for quality-of-life impact, we calculated event rates and costs for risk-tailored treatment versus clopidogrel under multiple drug pricing assumptions. One-year rates (per 1000 person-years) for ischemic events were 12.6, 24.1, and 66.1, respectively, among those at low (n=630), intermediate (n=536), and high (n=331) ischemic risk. Analogous bleeding rates were 11.0, 23.9, and 66.2, respectively, among low (n=728), intermediate (n=634), and high (n=135) bleeding risk patients. Mean per event costs were $22 174 (ischemic) and $12 203 (bleeding). When risks for ischemia matched or exceeded bleeding, simulated utility-weighted event rates favored ticagrelor/prasugrel, whereas clopidogrel reduced utility-weighted events when bleeding exceeded ischemic risk. One-year costs were sensitive to drug pricing assumptions, and risk-tailored treatment with either agent progressed from cost incurring to cost saving with increasing generic market share.
Conclusions
Tailoring antiplatelet therapy intensity to patient risk may improve health utility and could produce cost savings in the first year after percutaneous coronary intervention.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00998127.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004945
Baber U, Leisman DE, Cohen DJ, Gibson CM, ... Pocock SJ, Mehran R
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004945 | PMID: 30606052
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Impact:
Abstract

Impact of Socioeconomic Status on Clinical Outcomes in Patients With ST-Segment-Elevation Myocardial Infarction.

Biswas S, Andrianopoulos N, Duffy SJ, Lefkovits J, ... Reid CM, Stub D
Background
Low socioeconomic status (SES) has been previously shown to be associated with worse cardiovascular outcomes. However, unlike in Australia, many of these studies have been performed in countries without universal healthcare where SES may be expected to have a greater impact on care and outcomes. We sought to determine whether there is an association between SES and baseline characteristics, clinical outcomes and use of secondary prevention therapy in patients with ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI).
Methods and results
We prospectively collected data on 5665 consecutive ST-segment-elevation myocardial infarction PCI patients between 2005 and 2015 from 6 government-funded hospitals participating in a multicenter registry. Patients were categorized into SES quintiles using the Index of Relative Socioeconomic Disadvantage system, a score allocated to each residential postcode based on factors like income, educational level, and employment status by the Australian Bureau of Statistics. In our study, lower SES patients were more likely to have diabetes mellitus, smoke, and initially present to a non-PCI capable hospital (all P≤0.01). Among primary PCI patients, the median time to reperfusion was slightly higher in lower SES groups (211 [144-337] versus 193 [145-285] minutes, P<0.001). Drug-eluting stent use was higher in the higher SES groups ( P<0.001). At 12 months after PCI, lower SES patients had higher rates of ongoing smoking and lower use of guideline-recommended secondary prevention therapy (both P<0.01). Despite these differences, SES group was not found to be an independent predictor of 12-month major adverse cardiovascular events.
Conclusions
Lower SES patients have more comorbidities and experienced slightly longer reperfusion times but otherwise similar care. Despite these baseline differences, clinical outcomes after ST-segment-elevation myocardial infarction PCI were similar regardless of SES.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004979
Biswas S, Andrianopoulos N, Duffy SJ, Lefkovits J, ... Reid CM, Stub D
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004979 | PMID: 30606051
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Impact:
Abstract

Clinical Utility of Patient-Reported Outcome Measurement Information System Domain Scales.

Lapin B, Thompson NR, Schuster A, Katzan IL
Background
Patient-reported outcome measures are increasingly being utilized in clinical care and research to evaluate outcomes following stroke. To optimize the clinical utility of these measures, we aimed to quantify meaningful change by establishing minimal important differences (MIDs), or responder definitions, for 4 domains affected in ischemic and hemorrhagic stroke patients.
Methods and results
We performed a retrospective cohort study of stroke patients seen in the Cleveland Clinic cerebrovascular center between September 2, 2012 and November 7, 2017. Four Patient-Reported Outcome Measurement Information System (PROMIS) scales were completed within 1 month poststroke and again at 6 months. MIDs were estimated using an anchor-based approach based on a global impression of change question and supported using 3 distribution-based methods. Cumulative distribution functions assessed responder thresholds. MIDs were additionally derived across sex, race, and varying levels of severity as defined by the modified Rankin Score and baseline PROMIS score. During the study period, 337 incident stroke patients completed at least 1 PROMIS domain scale at both time points (average age 61±14, 56% female). Estimates from the 4 methods were triangulated to provide a MID range across PROMIS domain: 2.5 to 6.5 T-score points for physical function and fatigue, 2.5 to 7.5 for social role satisfaction, and 3.0 to 8.0 for anxiety. Cumulative distribution functions plots identified between 30% and 40% of patients as having meaningful improvement based on the anchor-based estimates across all 4 domains. Meaningful change thresholds remained consistent across categories of sex and race. Anchor-based MIDs increased with increasing severity, whereas distribution-based MIDs remained consistent across severity levels.
Conclusions
Our study is the first to evaluate interpretability of changes in PROMIS scores for stroke survivors. Future studies can utilize these thresholds to identify responders of stroke interventions. Based on our estimated MID ranges, researchers and clinicians can choose a responder threshold for comparing change in domain score at the group level, individual level, or by severity.



Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004753
Lapin B, Thompson NR, Schuster A, Katzan IL
Circ Cardiovasc Qual Outcomes: 30 Dec 2018; 12:e004753 | PMID: 30587028
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Impact:
Abstract

Periprocedural Stroke and Myocardial Infarction as Risks for Long-Term Mortality in CREST.

Jones MR, Howard G, Roubin GS, Blackshear JL, ... Brott TG,
Background
The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) previously reported increased mortality in patients who sustained a periprocedural stroke or cardiac event (myocardial infarction [MI] or biomarker only) in follow-up to 4 years. We now extend these observations to 10 years.
Methods and results
CREST is a randomized controlled trial designed to compare the outcomes of carotid stenting versus carotid endarterectomy. Proportional hazards models were used to assess the association between mortality and periprocedural stroke, MI, or biomarker-only events. For 10-year follow-up, patients with periprocedural stroke were at 1.74× the risk of death compared with those without stroke (adjusted hazard ratio [HR]=1.74; 95% CI, 1.21-2.50; P<0.003). This increased risk was driven by increased early (between 0 and 90 days) mortality (adjusted HR=14.41; 95% CI, 5.33-38.94; P<0.0001), with no significant increase in late (between 91 days and 10 years) mortality (adjusted HR=1.40; 95% CI, 0.93-2.10; P=0.11). Patients with a protocol MI were at 3.61× increased risk of death compared with those without MI (adjusted HR=3.61; 95% CI, 2.28-5.73; P<0.0001), with an increased hazard both early (adjusted HR=8.20; 95% CI, 1.86-36.2; P=0.006) and late (adjusted HR=3.40; 95% CI, 2.09-5.53; P<0.0001). Patients with a biomarker-only event were at 2.04× increased risk overall (adjusted HR=2.04; 95% CI, 1.09-3.84; P=0.03) than those without MI, with an increased early hazard (adjusted HR=8.44; 95% CI, 1.09-65.5; P=0.04) and a suggestive but nonsignificant association toward higher 91-day to 10-year risk (1.88; 95% CI, 0.97-3.64; P=0.062) contributing to the increased risk.
Conclusions
In the CREST trial, patients with periprocedural events demonstrate a substantial increase in future mortality to 10 years. For stroke, this risk is largely confined to an early time frame while periprocedural MI or biomarker-only events confer a continuous increased mortality for 10 years. Strategies to reduce periprocedural events and to optimize the evaluation and management of patients with cardiac events should be considered in efforts to reduce not only early but also long-term mortality.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00004732.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004663
Jones MR, Howard G, Roubin GS, Blackshear JL, ... Brott TG,
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004663 | PMID: 30571337
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Impact:
Abstract

Hospital Variation in the Utilization and Implementation of Targeted Temperature Management in Out-of-Hospital Cardiac Arrest.

Khera R, Humbert A, Leroux B, Nichol G, ... Chan PS, Kurz MC

Background Targeted temperature management (TTM) for out-of-hospital cardiac arrest is associated with improved functional survival and is a class I recommendation in resuscitation guidelines. However, patterns of utilization of TTM and adherence to recommended TTM guidelines in contemporary practice are unknown. Methods and Results In a multicenter, prospective cohort of consecutive adults with non-traumatic out-of-hospital cardiac arrest in the Resuscitation Outcomes Consortium in 2012 to 2015, we identified all adults (≥18 years) who were potential candidates for TTM. Of 37 898 out-of-hospital cardiac arrest patients at 186 hospitals across 10 Resuscitation Outcomes Consortium sites, 8313 survived for ≥4 hours after hospital arrival, of which, 2878 (34.6%) received TTM. Mean age was 61.5 years and 36.3% were women. Median hospital rate of TTM use was 27% (interquartile range [IQR]: 14%, 45%), with an over 2-fold difference across sites after accounting for differences in presentation characteristics (median odds ratio, 2.10 [1.83-2.26]). Notably, TTM utilization decreased during the study period (57.5% [2012] to 26.5% [2015], P<0.001) including among shockable out-of-hospital cardiac arrest (73.4% to 46.3%, P<0.001). When administered, the median rate of deviation from one or more recommended practices was 60% (IQR: 40%, 78%). The median rate for delayed onset of TTM was 13% (IQR: 0%, 25%), varying by 70% for identical patients across 2 randomly chosen hospitals (median odds ratio 1.70 [1.39-1.97]). Similarly, the median rate for TTM <24 hours was 20% (IQR: 0%, 34%) and for achieved temperature <32°C was 18% (IQR: 0%, 39%), with marked variation across sites (median odds ratios of 1.44 [1.18-1.64] and 1.98 [1.62-2.31], respectively). Conclusions There has been a substantial decline in the utilization of TTM with significant variation in its real-world implementation. Further standardization of contemporary post-resuscitation practices, like TTM, is critical to ensure that their potential survival benefit is realized.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004829
Khera R, Humbert A, Leroux B, Nichol G, ... Chan PS, Kurz MC
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004829 | PMID: 30571336
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Impact:
Abstract

Impact of High Deductible Health Plans on Cardiovascular Medication Adherence and Health Disparities.

Lewey J, Gagne JJ, Franklin J, Lauffenburger JC, Brill G, Choudhry NK
Background
High deductible health plans (HDHP) are associated with high levels of patient cost-sharing and are becoming increasingly used in the United Status as a means of reducing healthcare utilization and spending. Our objective is to determine whether HDHP enrollment is associated with a change in adherence to evidence-based medications to treat cardiovascular risk factors and whether such changes vary based on race/ethnicity or socioeconomic status.
Methods and results
We conducted a retrospective cohort study using an interrupted time series with concurrent control group design among beneficiaries of Aetna-a national commercial insurer. We included 14 866 patients who filled prescriptions for medications to treat hypertension, high cholesterol, or diabetes mellitus between 2009 and 2014 and who switched from a traditional plan into an HDHP and 14 866 controls who did not switch to an HDHP matched based on calendar time, medication class, race/ethnicity, socioeconomic status, and propensity score. We were specifically interested in evaluating 4 prespecified subgroups based on race/ethnicity (white versus nonwhite) and socioeconomic status (higher versus lower). The main outcome was medication adherence as measured by proportion of days covered. The overall cohort had an average age of 53 years, and 44% were women. Baseline adherence was the lowest in the nonwhite patient group. Switching to an HDHP was associated with a decrease in the level of adherence of 5 percentage points across all 4 subgroups (change in level, -5.0%; 95% CI, -5.9% to -4.0%; P<0.0001).
Conclusions
HDHP enrollment was associated with a reduction in adherence to medications to treat cardiovascular risk factors. The magnitude of this effect did not vary based on race/ethnicity or socioeconomic status. Because racial/ethnic minorities have lower rates of medication adherence, future studies should evaluate whether HDHP-associated changes in adherence have greater clinical consequences for these patients.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004632
Lewey J, Gagne JJ, Franklin J, Lauffenburger JC, Brill G, Choudhry NK
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004632 | PMID: 30571335
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Impact:
Abstract

Collaborative Quality Improvement Reduces Postoperative Pneumonia After Isolated Coronary Artery Bypass Grafting Surgery.

Likosky DS, Harrington SD, Cabrera L, DeLucia A, ... Strobel RJ, Prager RL
Background
To date, studies evaluating outcome improvements associated with participation in physician-led collaboratives have been limited by the absence of a contemporaneous control group. We examined post cardiac surgery pneumonia rates associated with participation in a statewide, quality improvement collaborative relative to a national physician reporting program.
Methods and results
We evaluated 911 754 coronary artery bypass operations (July 1, 2011, to June 30, 2017) performed across 1198 hospitals participating in a voluntary national physician reporting program (Society of Thoracic Surgeons [STS]), including 33 that participated in a Michigan-based collaborative (MI-Collaborative). Unlike STS hospitals not participating in the MI-Collaborative (i.e., STSnonMI) that solely received blinded reports, MI-Collaborative hospitals received a multi-faceted intervention starting November 2012 (quarterly in-person meetings showcasing unblinded data, webinars, site visits). Eighteen of the MI-Collaborative hospitals received additional support to implement recommended pneumonia prevention practices (\"MI-CollaborativePlus\"), whereas 15 did not (\"MI-CollaborativeOnly\"). We evaluated rates of postoperative pneumonia, adjusting for patient mix and hospital effects. Baseline patient characteristics were qualitatively similar between groups and time. During the pre-intervention period, there was a 2.53% per quarter reduction in the adjusted neumonia odds ratio for STS hospitals not participating in the MI-Collaborative ( P<0.001), which was equivalent to the MI-Collaborative ( P>0.05). During the intervention period, there was a significant 2% reduction in the adjusted odds ratio for pneumonia for MI-Collaborative hospitals relative to the STS hospitals not participating in the MI-Collaborative, although was 3% significantly lower among the MI-CollaborativeOnly hospitals. The STS hospitals not participating in the MI-Collaborative had a 1.96% reduction in risk-adjusted pneumonia, which was less than the MI-Collaborative (3.23%, P=0.011). The MI-CollaborativePlus reduced adjusted pneumonia rates by 10.29%, P=0.001.
Conclusions
Participation in a physician-led collaborative was associated with significant reductions in pneumonia relative to a national quality reporting program. Interventions including collaborative learning may yield superior outcomes relative to solely using physician feedback reporting.
Clinical trial registration
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02068716.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004756
Likosky DS, Harrington SD, Cabrera L, DeLucia A, ... Strobel RJ, Prager RL
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004756 | PMID: 30571334
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Abstract

Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus.

Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD
Background
Some studies have shown that body weight variability is a risk factor for cardiovascular events, but this has not been studied in subjects with diabetes mellitus.
Methods and results
We measured intraindividual variations in body weight from baseline and follow-up visits in 6408 subjects with type 2 diabetes mellitus from 3 clinical trials. The primary end point, any coronary event, was a composite of coronary heart disease death, myocardial infarction, resuscitated cardiac arrest, coronary revascularization, and unstable or new-onset angina. After adjustment for risk factors, baseline lipid levels, mean body weight, and weight change, each increase of 1 SD in body weight variability, measured as average successive variability and used as a time-dependent covariate, was associated with an increase in the risk of any coronary event (hazard ratio, 1.08; 95% CI, 1.01-1.14; P=0.017), major coronary event (hazard ratio, 1.12; 95% CI, 1.04-1.20; P=0.002), any cardiovascular event (hazard ratio, 1.08; 95% CI, 1.03-1.14; P=0.0015), and death (hazard ratio, 1.16; 95% CI, 1.10-1.22; P<0.0001). Among patients in the quintile with the highest variation in body weight compared with the lowest, the risk of any coronary event was 59% higher; the risk of a major coronary event, 82% higher; any cardiovascular event, 75% higher; death, 82% higher; myocardial infarction, 99% higher; and stroke, 92% higher in adjusted models. The results were consistent in a number of sensitivity analyses.
Conclusions
Among subjects with type 2 diabetes mellitus, fluctuation in body weight was associated with higher mortality and a higher rate of cardiovascular events, independent of traditional cardiovascular risk factors.
Clinical trial registration
URL: http://www.clinicaltrials.gov . Unique identifier: NCT00327691 and NCT00327418.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004724
Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004724 | PMID: 30571333
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Abstract

Fish Oil and Perioperative Bleeding.

Akintoye E, Sethi P, Harris WS, Thompson PA, ... Libby P, Mozaffarian D

Background Fish oil is among the most common natural supplements for treatment of hypertriglyceridemia or prevention of cardiovascular disease. However, concerns about theoretical bleeding risk have led to recommendations that patients should stop taking fish oil before surgery or delay in elective procedures for patients taking fish oil by some health care professionals. Methods and Results We tested the effect of fish oil supplementation on perioperative bleeding in a multinational, placebo-controlled trial involving 1516 patients who were randomized to perioperative fish oil (eicosapentaenoic acid+docosahexaenoic acid; 8-10 g for 2-5 days preoperatively, and then 2 g/d postoperatively) or placebo. Primary outcome was major perioperative bleeding as defined by the Bleeding Academic Research Consortium. Secondary outcomes include perioperative bleeding per thrombolysis in myocardial infarction and International Society on Thrombosis and Hemostasis definitions, chest tube output, and total units of blood transfused. Participants\' mean (SD) age was 63 (13) years, and planned surgery included coronary artery bypass graft (52%) and valve surgery (50%). The primary outcome occurred in 92 patients (6.1%). Compared with placebo, risk of Bleeding Academic Research Consortium bleeding was not higher in the fish oil group: odds ratio, 0.81; 95% CI, 0.53-1.24; absolute risk difference, 1.1% lower (95% CI, -3.0% to 1.8%). Similar findings were seen for secondary bleeding definitions. The total units of blood transfused were significantly lower in the fish oil group compared with placebo (mean, 1.61 versus 1.92; P<0.001). Evaluating achieved plasma phospholipid omega-3 polyunsaturated fatty acids levels with supplementation (on the morning of surgery), higher levels were associated with lower risk of Bleeding Academic Research Consortium bleeding, with substantially lower risk in the third (odds ratio, 0.30 [95% CI, 0.11-0.78]) and fourth (0.36 [95% CI, 0.15-0.87]) quartiles, compared with the lowest quartile. Conclusions Fish oil supplementation did not increase perioperative bleeding and reduced the number of blood transfusions. Higher achieved n-3-PUFA levels were associated with lower risk of bleeding. These novel findings support the need for reconsideration of current recommendations to stop fish oil or delay procedures before cardiac surgery. Clinical Trial registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00970489.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004584
Akintoye E, Sethi P, Harris WS, Thompson PA, ... Libby P, Mozaffarian D
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004584 | PMID: 30571332
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Abstract

Sex Disparities in Authorship Order of Cardiology Scientific Publications.

Ouyang D, Sing D, Shah S, Hu J, ... Harrington RA, Rodriguez F
Background
Despite advances in the representation of women in medical training, women continue to be underrepresented in cardiology, academic medicine, and more specifically, in senior positions within academic medicine. Identifying disparities in research productivity and acknowledgment can highlight barriers to female representation in academic cardiology leadership, as well as in academic promotion.
Methods and results
This bibliometric analysis included all authors of original research articles between 1980 and 2017 from 3 high-impact cardiology journals ( Journal of the American College of Cardiology, Circulation, and European Heart Journal). We identified 71 345 unique authors of 55 085 primary research articles during our study period. Female authors accounted for 33.1% of all authors; however, they represented only 26.7% of first authors and 19.7% of senior authors. Looking at the most prolific authors within this time period, female authors were not well represented, accounting for only 5% of the top 100 authors. Articles with a female senior author had more female middle authors than articles with a male senior author (mean 1.41 versus 0.97, P<0.001) and were more likely to have a female first author (0.37 versus 0.18, P<0.001). There was an increased representation of female authors as first and senior authors compared with the total number of articles with female authors over time ( P<0.001 for trend); however, female senior authorship rates continued to lag first authorship rates.
Conclusions
Using a large database of published manuscripts, we found that female representation in published cardiology research has increased over the past 4 decades. However, women continue to be not well represented as first authors, senior authors, and in the number of publications. When women were senior authors, they published more articles with female first authors and had more female authors. In addition to recruiting more women into the field of cardiology, additional work is needed to identify and address barriers to academic advancement for female physician-scientists.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e005040
Ouyang D, Sing D, Shah S, Hu J, ... Harrington RA, Rodriguez F
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e005040 | PMID: 30562072
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Abstract

Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator.

Kramer DB, Normand ST, Volya R, Hatfield LA
Background
Little is known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-P) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices.
Methods and results
Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6× higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant.
Conclusions
CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004763
Kramer DB, Normand ST, Volya R, Hatfield LA
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004763 | PMID: 30562069
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Abstract

Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes.

Fanaroff AC, Cyr D, Neely ML, Bakal J, ... Ohman EM, Roe MT

Background Cardiovascular clinical trials have traditionally incorporated separate time-to-first-event analyses for their primary efficacy and safety comparisons, but this framework has a number of limitations, including limited patient-centeredness and a traditional requirement for central adjudication. Days alive and out of the hospital (DAOH) has the potential to provide additional insight. Methods and Results TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a randomized, multinational clinical trial that compared the effect of prasugrel versus clopidogrel in patients stabilized after non-ST segment elevation acute coronary syndrome treated without revascularization; the trial had a neutral result. DAOH was calculated for each patient using site-submitted adverse event reporting data. We described patterns of DAOH overall, and among younger adults (<75 years old), older adults (≥75 years old), and frail/prefrail patients over 12 months follow-up and used Poisson regression to compare DAOH for patients randomized to prasugrel versus clopidogrel. Of 9249 patients in the overall trial population, 500 (5.4%) died, and 2504 (27.1%) were hospitalized 4150 times over 12 months\' follow-up; the mean±SD DAOH was 317±86. The distribution of DAOH over 12 months was left-skewed, with median DAOH 363 days. Among younger adults, older adults, and frail/prefrail patients, mean DAOH were 323, 293, and 304 days, respectively. There were no differences in DAOH by treatment arm in the overall population (rate ratio, 1.00; 95% CI, 0.99-1.01) or any subgroup. Conclusions These results support the feasibility of determining DAOH, a patient-centered outcome that can potentially overcome many of the disadvantages of the traditional time-to-composite-event framework in the clinical trial setting. Clinical Trial registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00699998.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004755
Fanaroff AC, Cyr D, Neely ML, Bakal J, ... Ohman EM, Roe MT
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004755 | PMID: 30562068
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Abstract

Annual Incidence of Adult and Pediatric In-Hospital Cardiac Arrest in the United States

Holmberg MJ, Ross CE, Fitzmaurice GM, Chan PS, ... Andersen LW,
Background
Previous incidence estimates may no longer reflect the current public health burden of cardiac arrest in hospitalized adult and pediatric patients across the United States. The aim of this study was to estimate the contemporary annual incidence of in-hospital cardiac arrest in adults and children across the United States and to describe trends in incidence between 2008 and 2017.
Methods and results
Using the Get With The Guidelines– Resuscitation registry, we developed a negative binomial regression model to estimate the incidence of index pulseless in-hospital cardiac arrest based on hospital-level characteristics. The model was used to predict the number of in-hospital cardiac arrests in all US hospitals, using data from the American Hospital Association Annual Survey. We performed separate analyses for adult (≥18 years) and pediatric (<18 years) cardiac arrests. Additional analyses were performed for recurrent cardiac arrests and pediatric patients requiring cardiopulmonary resuscitation for poor perfusion (nonpulseless events). The average annual incidence of in-hospital cardiac arrest in the United States was estimated at 292 000 (95% prediction interval, 217 600–503 500) adult and 15 200 pediatric cases, of which 7100 (95% prediction interval, 4400–9900) cases were pulseless cardiac arrests and 8100 (95% prediction interval, 4700–11 500) cases were nonpulseless events. The rate of adult cardiac arrests increased over time, while pediatric events remained more stable. When including both index and recurrent inhospital cardiac arrests, the average annual incidence was estimated at 357 900 (95% prediction interval, 247 100–598 400) adult and 19 900 pediatric cases, of which 8300 (95% prediction interval, 4900–11 200) cases were pulseless cardiac arrests and 11 600 (95% prediction interval, 6400–16 700) cases were nonpulseless events.
Conclusions
There are ≈292 000 adult in-hospital cardiac arrests and 15 200 pediatric in-hospital events in the United States each year. This study provides contemporary estimates of the public health burden of cardiac arrest among hospitalized patients.

© 2019 American Heart Association, Inc.

Circ Cardiovasc Qual Outcomes: 08 Jul 2019; 12:e005580
Holmberg MJ, Ross CE, Fitzmaurice GM, Chan PS, ... Andersen LW,
Circ Cardiovasc Qual Outcomes: 08 Jul 2019; 12:e005580 | PMID: 31545574
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Impact:
Abstract

Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe Ischemic Mitral Regurgitation: A Randomized Clinical Trial From the Cardiothoracic Surgical Trials Network

Ferket BS, Ailawadi G, Gelijns AC, Acker M, ... Moskowitz AJ, Cardiothoracic Surgical Trials Network (CTSN) Investigators
Background
The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe ischemic mitral regurgitation (MR) randomized to mitral valve repair or replacement. However, replacement provided more durable correction of MR and fewer cardiovascular readmissions. Yet, costeffectiveness outcomes have not been addressed.
Methods and results
We conducted a cost-effectiveness analysis of the surgical treatment of ischemic MR based on the CTSN trial (n=126 for repair; n=125 for replacement). Patient-level data on readmissions, survival, qualityof- life, and US hospital costs were used to estimate costs and quality-adjusted life years per patient over the trial duration and a 10-year time horizon. We performed microsimulation for extrapolation of outcomes beyond the 2 years of trial data. Bootstrap and deterministic sensitivity analyses were done to address parameter uncertainty. In-hospital cost estimates were $78 216 for replacement versus $72 761 for repair (difference: $5455; 95% uncertainty interval [UI]: −7784–21 193) while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI: −16 253–17 172), respectively. Quality-adjusted life years at 2 years were 1.18 for replacement versus 1.23 for repair (difference: −0.05; 95% UI: −0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in cardiovascular readmission rates with replacement increased, and survival minimally improved compared with repair. At 5 years, cumulative costs and quality-adjusted life years showed no difference on average, but by 10 years, there was a small, uncertain benefit for replacement: $118 023 versus $119 837 (difference: −$1814; 95% UI: −27 144 to 22 602) and qualityadjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI: −0.87 to 1.08). After 10 years, the incremental cost-effectiveness of replacement continued to improve.
Conclusions
Our cost-effectiveness analysis predicts potential savings in cost and gains in quality-adjusted survival at 10 years when mitral valve replacement is compared with repair for severe ischemic MR. These projected benefits, however, were small and subject to variability. Efforts to further delineate predictors of long-term outcomes in patients with severe ischemic MR are needed to optimize surgical decisions for individual patients, which should yield more cost-effective care.
Clinical trial registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00807040.

2018 American Heart Association, Inc.

Circ Cardiovasc Qual Outcomes: 13 Jan 2018; 11:e004466
Ferket BS, Ailawadi G, Gelijns AC, Acker M, ... Moskowitz AJ, Cardiothoracic Surgical Trials Network (CTSN) Investigators
Circ Cardiovasc Qual Outcomes: 13 Jan 2018; 11:e004466 | PMID: 30785252
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Abstract

Development and Preliminary Validation of a Medicare Claims-Based Model to Predict Left Ventricular Ejection Fraction Class in Patients With Heart Failure.

Desai RJ, Lin KJ, Patorno E, Barberio J, ... Wang SV, Schneeweiss S
Background
Ejection fraction (EF) class is an important predictor of treatment response in heart failure (HF); however, administrative claims databases lack information on EF, limiting their usefulness in clinical and health services research of HF.
Methods and results
We linked Medicare claims data to electronic medical records containing EF measurements for a cohort of 11 073 patients with HF from 2 academic medical centers. A a claims-based model predicting EF class was constructed using data from center 1 (\"training sample\") and validated using data from center 2 (\"testing sample). Linear and logistic regression models with least absolute square shrinkage operator and Bayesian information criteria were developed to select the relevant predictor variables out of the total 57 candidate variables in the training sample. Higher accuracy was noted in the testing sample with models classifying patients into 2 EF classes (reduced EF <0.45) versus preserved EF (≥0.45) when compared with classifying patients into 3 EF classes (reduced, <0.40, moderately reduced, 0.40-0.49, or preserved, ≥0.50). In the testing sample, the most efficient model had 35 predictors and resulted in 83% of patients being correctly classified (95% CI, 82%-84%). The model had positive predictive value of 0.73 (95% CI, 0.68-0.78) and 0.84 (95% CI, 0.83-0.86) and sensitivity of 0.29 (95% CI, 0.25-0.32) and 0.97 (95% CI, 0.97-0.98) for reduced and preserved EF, respectively. In addition to HF-specific diagnosis codes, other factors including age, sex, medication use, and comorbidities, such as myocardial infarction and valve disorders, were important discriminators between EF classes.
Conclusions
The claims-based model developed in this study may be used to identify patient subgroups with specific EF class in studies evaluating the health outcomes, utilization patterns, and cost, of HF patients in routine care when EF measurements are not available.



Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004700
Desai RJ, Lin KJ, Patorno E, Barberio J, ... Wang SV, Schneeweiss S
Circ Cardiovasc Qual Outcomes: 30 Dec 2017; 11:e004700 | PMID: 30562067
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Impact:

This program is still in alpha version.