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

Net Clinical Benefit of Oral Anticoagulation Among Older Adults With Atrial Fibrillation.

Shah SJ, Singer DE, Fang MC, Reynolds K, Go AS, Eckman MH
Background
While guidelines recommend anticoagulation for all atrial fibrillation (AF) patients ≥75 years, evidence for the net clinical benefit (NCB) of anticoagulant in older adults is sparse. We sought to determine the association between age and NCB of anticoagulation in older adults with AF.
Methods and results
We examined adults ≥75 years with incident AF in the Anticoagulation and Risk Factors in Atrial Fibrillation-Cardiovascular Research Network cohort. Using a Markov state transition model, we estimated the lifetime NCB of warfarin and apixaban relative to no treatment in quality-adjusted life years (QALYs). In the decision model, each month patients face a chance of stroke, hemorrhage, or death from a competing cause; the likelihood of each is a function of individual patients\' stroke risk, hemorrhage risk, and life expectancy. We defined minimal clinically relevant lifetime benefit as 0.10 QALYs. In a sensitivity analysis, we examined the effect of competing risks of death on NCB using 2 models, one including competing risks and the second without competing risks. We included 14 946 patients, with a median age of 81 years and median CHADS-VASc score of 4. In the main analysis, after age 87, NCB associated with warfarin decreased below 0.10 lifetime QALYs while NCB associated with apixaban did not decrease below 0.10 lifetime QALYs until after age 92. In sensitivity analyses, over a 3-year horizon, removing competing risks of death resulted in higher NCB (at 90 years, median difference using warfarin 0.010 QALYs [95% CI, 0.009-0.013], median difference using apixaban 0.025 QALYs [95% CI, 0.024-0.026]).
Conclusions
The NCB of anticoagulation decreases with advancing age. The competing risk of death diminishes the NCB of anticoagulation for older patients with AF. Physicians should consider competing mortality risks when recommending anticoagulants to older adults with AF.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006212
Shah SJ, Singer DE, Fang MC, Reynolds K, Go AS, Eckman MH
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006212 | PMID: 31707823
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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

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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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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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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Abstract

Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.

Schwartz LM, Woloshin S, Lu Z, Ross KM, ... Peter D, Kesselheim AS
Background
Recent court decisions have thrown into question the Food and Drug Administration\'s rules limiting manufacturer promotion of prescription drugs for unapproved uses. We assessed how providing pro forma disclosures or more descriptive evidence context about the data supporting an off-label claim affected physicians\' beliefs about drug efficacy.
Methods and results
In online and mailed surveys, we randomized national samples of board-certified, clinically active cardiologists, internists, and endocrinologists to receive 1 of 3 information scenarios about a hypothetical drug derived verbatim from excerpts on the website for Vascepa, a prescription fish oil for which Food and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit. The scenarios presented information about the approved on-label indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but not conclusive evidence for use as an add-on to a statin for patients reaching low-density lipoprotein goal but with persistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 trials failing to demonstrate cardiovascular benefit of other triglyceride-lowering drugs for such patients). Among 686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose. Off-label prescribing was 5 times higher among physicians who received such off-label information (38% versus 7%, <0.001). For the hypothetical drug, the proportion of physicians endorsing the unproven claim that the drug reduced cardiovascular risk was similar among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% versus 37% [95% CI, -6% to 11%]), but substantially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI, -24% to 7%]).
Conclusions
Physicians who received company information about the unapproved use of Vascepa were more likely to report prescribing it off-label. Supplementing off-label claims with evidence context improved the prescribers\' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006073
Schwartz LM, Woloshin S, Lu Z, Ross KM, ... Peter D, Kesselheim AS
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006073 | PMID: 31707825
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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

Comparative Performance of Prediction Models for Contrast-Associated Acute Kidney Injury After Percutaneous Coronary Intervention.

Ma B, Allen DW, Graham MM, Har BJ, ... Pannu N, James MT
Background
Identifying patients at increased risk of contrast-associated acute kidney injury (CA-AKI) can help target risk mitigation strategies toward these individuals during percutaneous coronary intervention. Illuminating which risk models best stratify risk is an important foundation for such quality improvement efforts.
Methods and results
Seven previously published risk prediction models for CA-AKI and 3 models for kidney injury requiring dialysis were validated using 2 definitions for CA-AKI (the Kidney Disease: Improving Global Outcomes definition of ≥0.3 mg/dL within 48 hours or ≥50% increase in serum creatinine from baseline within 7 days and the historical definition of ≥0.5 mg/dL or ≥25% increase in serum creatinine from baseline within 48 hours), and AKI requiring dialysis within 30 days of percutaneous coronary intervention. Model performance was compared based on discrimination, calibration, and categorical net reclassification index before and after model recalibration. Among 7888 patients who underwent percutaneous coronary intervention in Alberta Canada, CA-AKI occurred in 330 patients (4.2%) when CA-AKI was defined using the Kidney Disease: Improving Global Outcomes definition and 571 (7.3%) when using the historical definition. CA-AKI requiring dialysis occurred in 42 (0.6%) patients. When validated using the Kidney Disease: Improving Global Outcomes definition for CA-AKI, the 2 most recently published models for CA-AKI showed better discrimination (C statistics, 0.75-0.76) than older models (C statistics, 0.61-0.68). C statistics of models for kidney injury requiring dialysis ranged from 0.70 to 0.86. The calibration of all models for CA-AKI deviated from ideal, and the proportion of patients classified into different risk categories for CA-AKI differed substantially for the 2 most recent models. Recalibration significantly improved risk stratification of patients into clinical risk categories for some models.
Conclusions
Recent prediction models for CA-AKI show better discrimination compared with older models; however, model recalibration should be examined in external cohorts to improve the accuracy of predictions, particularly if predicted risk strata are used to guide management approaches.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005854
Ma B, Allen DW, Graham MM, Har BJ, ... Pannu N, James MT
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005854 | PMID: 31722540
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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

Baseline Predictors of Low-Density Lipoprotein Cholesterol and Systolic Blood Pressure Goal Attainment After 1 Year in the ISCHEMIA Trial.

Newman JD, Alexander KP, Gu X, O\'Brien SM, ... Hochman JS, Maron DJ
Background
Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described.
Methods and results
The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIA participants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]).
Conclusions
In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006002
Newman JD, Alexander KP, Gu X, O'Brien SM, ... Hochman JS, Maron DJ
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006002 | PMID: 31718297
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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

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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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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Impact:
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

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

Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial.

Szarek M, Steg PG, DiCenso D, Bhatt DL, ... Zeiher AM, Schwartz GG
Background
In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18 924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. The present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES.
Methods and results
In prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16 629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00]; =0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007]; =0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986]; =0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13]; =0.03).
Conclusions
Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome.
Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005858
Szarek M, Steg PG, DiCenso D, Bhatt DL, ... Zeiher AM, Schwartz GG
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005858 | PMID: 31707826
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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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Abstract

Doubly Robust Estimation of Causal Effect: Upping the Odds of Getting the Right Answers.

Li X, Shen C

Propensity score-based methods or multiple regressions of the outcome are often used for confounding adjustment in analysis of observational studies. In either approach, a model is needed: A model describing the relationship between the treatment assignment and covariates in the propensity score-based method or a model for the outcome and covariates in the multiple regressions. The 2 models are usually unknown to the investigators and must be estimated. The correct model specification, therefore, is essential for the validity of the final causal estimate. We describe in this article a doubly robust estimator which combines both models propitiously to offer analysts 2 chances for obtaining a valid causal estimate and demonstrate its use through a data set from the Lindner Center Study.



Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e006065
Li X, Shen C
Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e006065 | PMID: 31888348
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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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Abstract

Low-Value Transthoracic Echocardiography, Healthcare Utilization, and Clinical Outcomes in Patients With Coronary Artery Disease.

Tharmaratnam T, Bouck Z, Sivaswamy A, Wijeysundera HC, ... Weiner RB, Bhatia RS
Background
The relationship between ordering frequency of rarely appropriate transthoracic echocardiograms on healthcare utilization and patient outcomes in coronary artery disease (CAD) is not known. Our objective was to investigate practice patterns of cardiologists who order a high frequency of low-value transthoracic echocardiograms in patients with CAD and whether practice behavior influences patient outcomes.
Methods and results
A retrospective cohort of outpatient CAD patients was accrued by identifying patients with at least 1 visit to 1 of 35 Ontario-based cardiologists in the EchoWISELY randomized clinical trial (Will Inappropriate Scenarios for Echocardiography Lessen Significantly) control group. The main outcomes of interest were patient-level receipt of diagnostic tests, physician visits, medication prescriptions, and clinical outcomes at 1 year. Our cohort consisted of 3966 patients with CAD (mean [SD] age, 67.8 [12.0] years; 72% men), with an outpatient visit to 1 of 35 eligible cardiologists, stratified into 3 ordering tertiles. Patients of cardiologists in the top ordering tertile of rarely appropriate transthoracic echocardiograms had significantly lower odds of receiving the following services at 1 year compared with patients in the low ordering group: cholesterol assessment (odds ratio [OR], 0.77 [95% CI, 0.65-0.91]); hemoglobin A1c assessment (OR, 0.79 [95% CI, 0.66-0.94]); β-blocker prescription (OR, 0.70 [95% CI, 0.55-0.90]); and aldosterone receptor antagonist prescription (OR, 0.46 [95% CI, 0.22-0.98]). Patients of high ordering cardiologists had greater odds of all-cause mortality at 1 year (OR, 1.54 [95% CI, 1.04-2.28]), although all other outcomes were similar.
Conclusions
Patients with CAD seen by cardiologist who ordered a high rate of rarely appropriate transthoracic echocardiograms were less likely to receive potentially high-value screening tests and evidence-based medications than low ordering cardiologists.
Clinical trial registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02038101.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006123
Tharmaratnam T, Bouck Z, Sivaswamy A, Wijeysundera HC, ... Weiner RB, Bhatia RS
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e006123 | PMID: 31707824
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Impact:
Abstract

Effect of Variable Selection Strategy on the Performance of Prognostic Models When Using Multiple Imputation.

Austin PC, Lee DS, Ko DT, White IR
Background
Variable selection is an important issue when developing prognostic models. Missing data occur frequently in clinical research. Multiple imputation is increasingly used to address the presence of missing data in clinical research. The effect of different variable selection strategies with multiply imputed data on the external performance of derived prognostic models has not been well examined.
Methods and results
We used backward variable selection with 9 different ways to handle multiply imputed data in a derivation sample to develop logistic regression models for predicting death within 1 year of hospitalization with an acute myocardial infarction. We assessed the prognostic accuracy of each derived model in a temporally distinct validation sample. The derivation and validation samples consisted of 11 524 patients hospitalized between 1999 and 2001 and 7889 patients hospitalized between 2004 and 2005, respectively. We considered 41 candidate predictor variables. Missing data occurred frequently, with only 13% of patients in the derivation sample and 31% of patients in the validation sample having complete data. Regardless of the significance level for variable selection, the prognostic model developed using only the complete cases in the derivation sample had substantially worse performance in the validation sample than did the models for which variables were selected using the multiply imputed versions of the derivation sample. The other 8 approaches to handling multiply imputed data resulted in prognostic models with performance similar to one another.
Conclusions
Ignoring missing data and using only subjects with complete data can result in the derivation of prognostic models with poor performance. Multiple imputation should be used to account for missing data when developing prognostic models.



Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005927
Austin PC, Lee DS, Ko DT, White IR
Circ Cardiovasc Qual Outcomes: 30 Oct 2019; 12:e005927 | PMID: 31718298
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Impact:
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

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

Safety and Outcomes of Intravenous tPA in Acute Ischemic Stroke Patients With Prior Stroke Within 3 Months: Findings From Get With The Guidelines-Stroke.

Shah S, Liang L, Kosinski A, Hernandez AF, ... Peterson ED, Xian Y

Background Guidelines recommend against the use of intravenous tPA (tissue-type plasminogen activator; IV tPA) in acute ischemic stroke patients with prior ischemic stroke within 3 months. However, there are limited data on the safety of IV tPA in this population. Methods and Results A retrospective observational study of patients ≥66 years of age linked to Medicare claims and treated with IV tPA at Get With The Guidelines-Stroke hospitals (February 2009 to December 2015). We identified 293 patients treated with IV tPA who had a prior ischemic stroke within 3 months and 30 655 with no history of stroke. Patients with prior stroke had a higher stroke severity (median National Institutes of Health Stroke Scale, 11 [6-19] versus 11 [6-18]; absolute standardized difference, 11.2%) and a higher prevalence of cardiovascular comorbidities. Patients with prior stroke had a higher unadjusted risk for symptomatic intracranial hemorrhage (7.7% versus 4.8%) and in-hospital mortality (12.6% versus 8.9%), but these differences were not statistically significant after adjustment. When stratified by prespecified time epochs, the elevated risk for symptomatic intracranial hemorrhage was seen only within the first 14 days (16.3% versus 4.8%; adjusted odds ratio [aOR], 3.7 [95% CI, 1.62-8.43]) but not in other epochs (2.1% versus 4.8%; aOR, 0.38 [95% CI, 0.05-2.79] for 15-30 days and 7.4% versus 4.8%; aOR, 1.36 [95% CI, 0.77-2.40] for 31-90 days). In addition, patients with prior stroke were significantly more likely to have a combined outcome of in-hospital mortality or discharge to hospice (25.9% versus 17.0%; aOR, 1.70 [95% CI, 1.21-2.38]), less likely to be discharged to home (28.3% versus 32.3%; aOR, 0.72 [95% CI, 0.54-0.98]), or to have good functional outcomes at discharge (modified Rankin Scale, 0-1; 11.3% versus 20.0%; aOR, 0.46 [95% CI, 0.24-0.89]). Conclusions Stroke providers need to continue to be vigilant about the safety of IV tPA in patients with prior stroke, particularly those with an event in the previous 14 days.



Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e006031
Shah S, Liang L, Kosinski A, Hernandez AF, ... Peterson ED, Xian Y
Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e006031 | PMID: 31903770
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Impact:
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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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

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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Impact:
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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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

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

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

Cardiac Rehabilitation Dose Around the World: Variation and Correlates.

Chaves G, Turk-Adawi K, Supervia M, Santiago de Araújo Pio C, ... Lopez Jimenez F, Grace SL
Background
Cardiac rehabilitation (CR) is recommended in clinical practice guidelines, but dose prescribed varies highly by country. This study characterized the dose offered in supervised CR programs and alternative models worldwide and their potential correlates.
Methods and results
In this cross-sectional study, an online survey was administered to CR programs globally. Cardiac associations and local champions facilitated program identification. Countries were classified based on region and income categories. Dose was operationalized as program duration×sessions per week. Generalized linear mixed models were performed to assess correlates. Of 203 countries in the world, 111 (54.7%) offered CR; data were collected in 93 (83.8% country response rate; n=1082 surveys, 32.1% program response rate). Globally, supervised CR programs were a median of 24 sessions (n=619, 57.3% programs ≥12 sessions); home-based and community-based programs offered 6 and 20 sessions, respectively. There was significant variation in supervised CR dose by region (≤0.001), with the Americas (median, 36 sessions) offering a significantly greater dose than several other regions; there was also a trend for variation by country income classification. There was no difference in home-based dose by region (=0.43) but there was for community-based programs (<0.05; Americas offering greater dose). There was a significant dose variation in both home- and community-based programs by income classification (=0.002 and <0.001, respectively), with higher doses offered by upper-middle-income than high-income countries. Correlates of supervised CR dose included more involvement of physicians (=0.026), proximity to other programs (=0.002), and accepting patients with noncardiac indications (=0.037).
Conclusions
CR programs in many countries may need to increase their dose, which could be supported through physician champions.



Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e005453
Chaves G, Turk-Adawi K, Supervia M, Santiago de Araújo Pio C, ... Lopez Jimenez F, Grace SL
Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e005453 | PMID: 31918580
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Impact:
Abstract

Association Between Hospital Teaching Status and Outcomes After Out-of-Hospital Cardiac Arrest.

Czarnecki A, Qiu F, Koh M, Cheskes S, ... Scales DC, Ko DT
Background
Controversy exists about how best to organize systems of care for patients with out-of-hospital cardiac arrest (OHCA), as little evidence exists to guide policy-makers. In Canada, teaching hospitals are mainly cardiac referral centers that are potentially well suited towards treating patients with OHCA. Our objective was to determine whether patients with OHCA are more likely to survive if they present to teaching hospitals.
Methods and results
We conducted a retrospective observational cohort study by linking several population-based administrative databases in Ontario, Canada. All patients >20 years old who arrived alive to hospital after OHCA between April 1, 2007, and March 31, 2014, were eligible for inclusion. Patients with ST-segment-elevation myocardial infarction were excluded. The primary outcome was survival at 30 days. To determine the association between teaching status and 30-day survival, logistic regression models were used to adjust for baseline differences in patient characteristics. Prespecified analysis was performed stratified by age: ≤65, 66 to 80, and >80 years old. A total of 25 346 patients were included: 5413 at teaching and 19 933 at nonteaching hospitals. Survival at 30 days was 13.9% in teaching and 11.0% (<0.001) in nonteaching hospitals. Hospital teaching status was associated with a significantly higher adjusted odds of 30-day survival (odds ratio, 1.38 [95% CI, 1.14-1.67]). This improvement in survival was observed in younger patients (≤65 years: odds ratio, 1.41 [95% CI, 1.14-1.74]; 66 to 80 years: odds ratio,1.37 [95% CI, 1.13-1.67]), but there was no significant difference in the elderly (>80 years: odds ratio, 1.07 [95% CI, 0.79-1.44]).
Conclusions
Patients with OHCA treated at teaching hospitals were more likely to survive to 30 days. These findings support current recommendations suggesting that treatment of these patients should be provided at specialized hospitals.



Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005349
Czarnecki A, Qiu F, Koh M, Cheskes S, ... Scales DC, Ko DT
Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005349 | PMID: 31822122
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Impact:
Abstract

Utilization of Cardiac Surveillance Tests in Survivors of Breast Cancer and Lymphoma After Anthracycline-Based Chemotherapy.

Ruddy KJ, Sangaralingham LR, Van Houten H, Nowsheen S, ... Shah ND, Herrmann J
Background
The National Comprehensive Cancer Network and American Society of Clinical Oncology recommend consideration of the use of echocardiography 6 to 12 months after completion of anthracycline-based chemotherapy in at-risk populations. Assessment of BNP (B-type natriuretic peptide) has also been suggested by the American College of Cardiology/American Heart Association/Heart Failure Society of America for the identification of Stage A (at risk) heart failure patients. The real-world frequency of the use of these tests in patients after receipt of anthracycline therapy, however, has not been studied previously.
Methods and results
In this retrospective study, using administrative claims data from the OptumLabs Data Warehouse, we identified 31 447 breast cancer and lymphoma patients (age ≥18 years) who were treated with an anthracycline in the United States between January 1, 2008 and January 31, 2018. Continuous medical and pharmacy coverage was required for at least 6 months before the initial anthracycline dose and 12 months after the final dose. Only 36.1% of patients had any type of cardiac surveillance (echocardiography, BNP, or cardiac imaging) in the year following completion of anthracycline therapy (29.7% echocardiography). Surveillance rate increased from 37.5% in 2008 to 42.7% in 2018 (25.6% in 2008 to 40.5% echocardiography in 2018). Lymphoma patients had a lower likelihood of any surveillance compared with patients with breast cancer (odds ratio, 0.79 [95% CI, 0.74-0.85]; <0.001). Patients with preexisting diagnoses of coronary artery disease and arrhythmia had the highest likelihood of cardiac surveillance (odds ratio, 1.54 [95% CI, 1.39-1.69] and odds ratio, 1.42 [95% CI, 1.3-1.53]; <0.001 for both), although no single comorbidity was associated with a >50% rate of surveillance.
Conclusions
The majority of survivors of breast cancer and lymphoma who have received anthracycline-based chemotherapy do not undergo cardiac surveillance after treatment, including those with a history of cardiovascular comorbidities, such as heart failure.



Circ Cardiovasc Qual Outcomes: 28 Feb 2020; 13:e005984
Ruddy KJ, Sangaralingham LR, Van Houten H, Nowsheen S, ... Shah ND, Herrmann J
Circ Cardiovasc Qual Outcomes: 28 Feb 2020; 13:e005984 | PMID: 32106704
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Impact:
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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Impact:
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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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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Impact:
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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Impact:
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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Impact:
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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Impact:
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

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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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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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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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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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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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

Trends in Outcomes of Patients With Ischemic Stroke Treated Between 2002 and 2016: Insights From a Chinese Cohort.

Liu J, Zheng L, Cheng Y, Zhang S, ... Wu S, Liu M
Background
Little is known about long-term trends in outcomes of patients with ischemic stroke in China. We aimed to assess longitudinal trends in these outcomes over the past 15 years in China and explore possible factors behind the trends.
Methods and results
Patients with ischemic stroke admitted to the Department of Neurology at West China Hospital were prospectively and consecutively enrolled in a central registry since 2002, and the present study analyzed data from those admitted to hospital within 7 days of stroke during the period 2002 to 2016. Patients were binned into three 5-year intervals for temporal analysis. Death, disability, and death/disability at 3 and 12 months after stroke were compared among the time intervals across the entire sample and in subsets stratified by age (<65 or ≥65 years). To explore the possible factors related to the trends in outcomes, interaction between the factors and time on outcomes was entered separately into the multivariable logistic regression model. Of 6462 patients with ischemic stroke in the final analysis, 3837 (59.4%) were men, and mean age was 64.2 years (SD, 13.7). Mean age at stroke onset and National Institutes of Health Stroke Scale score at admission decreased significantly during the 15-year period (<0.001). Between 2002 to 2006 and 2012 to 2016, cumulative incidences declined significantly for death at 3 months (from 9.6% to 6.4%), disability at 3 months (from 36.8% to 28.7%), and death/disability at 3 months (from 42.9% to 33.3%), as well as for death at 12 months (from 15.9% to 10.7%), disability at 12 months (from 23.2% to 17.6%), and death/disability at 12 months (from 35.4% to 26.4%; all <0.001). The decreases in disability and death/disability at 3 and 12 months between 2002 to 2006 and 2012 to 2016 remained significant after adjusting for confounders, and the results were similar for the entire cohort and for subgroups of patients <65 or ≥65 years. Only interactions of National Institutes of Health Stroke Scale score on admission and time period (2012-2016) were found to significantly correlate with disability and death/disability at 3 and 12 months (all ≤0.03).
Conclusions
Our study from a large medical center in southwest China suggests that since 2002, risks of disability and death/disability at 3 and 12 months after ischemic stroke have declined. This appears to be due, at least in part, to a significant decline in National Institutes of Health Stroke Scale score on admission, which may reflect greater public awareness of stroke detection, willingness to seek medical attention, and ease of access to healthcare infrastructure. The factors behind this apparent improvement require further study.



Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005610
Liu J, Zheng L, Cheng Y, Zhang S, ... Wu S, Liu M
Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005610 | PMID: 31830825
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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

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

Fragility Index in Cardiovascular Randomized Controlled Trials.

Khan MS, Ochani RK, Shaikh A, Usman MS, ... Doukky R, Krasuski RA
Background
Efficacy of an intervention is commonly evaluated usingvalues, in addition to effect size measures such as absolute risk reduction, relative risk reduction, and numbers needed to treat. However, these measures are not always intuitive to clinicians. The fragility index (FI) is a more intuitive number that can facilitate interpretation but can only be used with binary outcomes. FI is the minimum number of patients who must be moved from the nonevent group to the event group to turn a significant result nonsignificant. In this retrospective analysis, we assessed the robustness of cardiovascular randomized controlled trials (RCTs), which report a positive (statistically significant) primary outcome by using the FI.
Methods and results
We searched Medline from 2007 to 2017 to identify cardiovascular RCTs published in 6 high impact journals (, , , ,and ). Only RCTs with sample sizes >500 and a 2-by-2 factorial design or dichotomous primary outcomes were selected. FI was calculated using a defined approach. Among the cohort of 123 RCTs that met inclusion criteria, median FI was 13 (interquartile range, 5-26). In 28 trials (22.8%), FI ranged between 1 and 4. In 37 trials (30.1%), number of patients lost to follow-up was higher than the FI. Pharmaceutical interventions had higher FI compared with other interventions, FI=19 (7-52; =0.002). Median FI varied according to subspecialty (electrophysiology=2; heart failure=11; interventional cardiology=8; =0.020) and multiregional RCTs had higher FI=22 (12-53.25; =0.023). FI did not differ based on risk of bias indicators, funding, or publication year.
Conclusions
Considerable variations in FI were observed among cardiovascular trials, suggesting the need for careful interpretation of results, particularly when number of patients lost to follow-up exceeds FI.



Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005755
Khan MS, Ochani RK, Shaikh A, Usman MS, ... Doukky R, Krasuski RA
Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005755 | PMID: 31822121
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Abstract

Utilization of Advanced Cardiovascular Therapies in the United States and Canada: An Observational Study of New York and Ontario Administrative Data.

Cram P, Girotra S, Matelski J, Koh M, ... Lee DS, Ko DT
Background
Endovascular aortic aneurysm repair (EVAR), left ventricular assist device (LVAD), and transcatheter aortic valve replacement (TAVR) are expensive cardiovascular technologies with potential to benefit large numbers of patients. There are few population-based studies comparing utilization between countries. Our objective was to compare patient characteristics and utilization patterns of EVAR, LVAD, and TAVR in Ontario, Canada, and New York State, United States.
Methods and results
We performed a retrospective cohort study using administrative data to identify all adults who received EVAR, LVAD, or TAVR in Ontario and New York between 2012 and 2015. We compared socio-demographics of EVAR, LVAD, and TAVR recipients in Ontario and New York. We compared standardized utilization rates between jurisdictions for each procedure. We identified 3295 EVAR recipients from Ontario and 6236 from New York (mean age 74.6 versus 74.5 years; =0.61): 136 LVAD recipients from Ontario and 686 from New York (age, 57.4 versus 57.7 years; =0.80): 1708 TAVR recipients from Ontario and 4838 from New York (age, 83.1 versus 83.1; =1.0). A significantly smaller percentage of EVAR and TAVR recipients in Ontario were female compared to New York (EVAR, 15.8% versus 22.1% female; <0.001; TAVR, 45.9% versus 51.8%; <0.001), but for LVAD the percentage female was similar (21.3% versus 20.8%; =0.99). Utilization was significantly higher in New York for all procedures: EVAR (12.8 procedures per-100 000 adults per-year in Ontario, 20.2 in New York; <0.001); LVAD (0.3 in Ontario versus 1.3 in New York; <0.001); and TAVR (6.6 in Ontario, 14.3 in New York; <0.001). Higher utilization of EVAR and TAVR in New York relative to Ontario increased substantially with increasing age.
Conclusions
We observed significantly higher utilization of EVAR, LVAD, and TAVR in New York compared to Ontario. Our results highlight important differences in how 2 different countries are using advanced cardiovascular therapies.



Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e006037
Cram P, Girotra S, Matelski J, Koh M, ... Lee DS, Ko DT
Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e006037 | PMID: 31957474
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Impact:
Abstract

Randomized Trial of an Intervention to Improve Blood Pressure Control in Stroke Survivors.

Owolabi MO, Gebregziabher M, Akinyemi RO, Akinyemi JO, ... Fakunle A, Ovbiagele B
Background
We conducted the first-of-its kind randomized stroke trial in Africa to test whether a THRIVES (Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke) intervention improved blood pressure (BP) control among patients with stroke.
Methods and results
Intervention comprised a patient global risk factor control report card, personalized phone text-messaging, and educational video. Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ≥18 years with stroke-onset within one-year, were randomized to THRIVES intervention and control group. The control group also received text messages, and both groups received modest financial incentives. The primary outcome was mean change in systolic BP (SBP) at 12 months. There were 36.5% females, 72.3% with ischemic stroke; mean age was 57.2±11.7 years; 93.5% had hypertension and mean SBP was 138.33 (23.64) mm Hg. At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, =0.82). In an exploratory analysis of subjects with baseline BP >140/90 mm Hg (n=168), THRIVES showed a significant mean SBP (diastolic BP) decrease of 11.7 (7.0) mm Hg while control group showed a significant mean SBP (diastolic BP) decrease of 11.2 (7.9) mm Hg at 12 months.
Conclusions
THRIVES intervention did not significantly reduce SBP compared with controls. However, there was similar significant decrease in mean BP in both treatment arms in the subgroup with baseline hypertension. As text-messaging and a modest financial incentive were the common elements between both treatment arms, further research is required to establish whether these measures alone can improve BP control among stroke survivors.
Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01900756.



Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005904
Owolabi MO, Gebregziabher M, Akinyemi RO, Akinyemi JO, ... Fakunle A, Ovbiagele B
Circ Cardiovasc Qual Outcomes: 29 Nov 2019; 12:e005904 | PMID: 31805787
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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

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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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

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

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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Abstract

Novel Risk Modeling Approach of Atrial Fibrillation With Restricted Mean Survival Times: Application in the Framingham Heart Study Community-Based Cohort.

Staerk L, Preis SR, Lin H, Casas JP, ... Benjamin EJ, Trinquart L
Background
Risk prediction models for atrial fibrillation (AF) do not give information about when AF might develop. Restricted mean survival time (RMST) quantifies risk into the time domain. Our objective was to use RMST to re-express individualized AF risk predictions.
Methods and results
We included AF-free participants from the Framingham Heart Study community-based cohorts. We predicted new-onset AF over 10-year follow-up according to baseline covariates: age, height, weight, systolic blood pressure, diastolic blood pressure, current smoking, antihypertensive treatment, diabetes mellitus, prevalent heart failure, and prevalent myocardial infarction. First, we fitted a Cox regression model and estimated the 10-year predicted risk of AF. Second, we fitted an RMST model and estimated the predicted mean time free of AF and alive over a time horizon of 10 years. We included 7586 AF-free participants contributing to 11 088 examinations (mean age 61±11 years, 44% were men). During 10-year follow-up, 822 participants developed AF. The Cox and RMST models were in agreement regarding the direction, strength, and statistical significance of associations for all covariates. Low (<5%), intermediate (5%-15%), and high (>15%) 10-year predicted risk of AF corresponded to predicted mean time alive and free of AF of 9.9, 9.6, and 8.8 years, respectively. A 60-year-old woman with a body mass index of 25 kg/m, no use of hypertension treatment and no history of heart failure had a predicted mean time alive and free of AF of 9.9 years, whereas a 70-year-old man with a body mass index of 30 kg/m, use of hypertension treatment, and with prevalent heart failure had a predicted mean time alive and free of AF of 7.9 years.
Conclusions
The RMST can be used to develop risk prediction models to express results in a time scale. RMST may offer a complementary risk communication tool for AF in clinical practice.



Circ Cardiovasc Qual Outcomes: 30 Mar 2020:CIRCOUTCOMES119005918; epub ahead of print
Staerk L, Preis SR, Lin H, Casas JP, ... Benjamin EJ, Trinquart L
Circ Cardiovasc Qual Outcomes: 30 Mar 2020:CIRCOUTCOMES119005918; epub ahead of print | PMID: 32228064
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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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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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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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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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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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Abstract

Trends in Telestroke Care Delivery: A 15-Year Experience of an Academic Hub and Its Network of Spokes.

Sharma R, Zachrison KS, Viswanathan A, Matiello M, ... Feske SK, Schwamm LH
Background
Telestroke provides access to vascular neurology expertise for hospitals lacking stroke coverage, and its use has risen rapidly in the past decade. We aim to characterize consultations, spoke behavior, and the relationship between spoke telestroke utilization (number of telestroke consults per year) and spoke alteplase treatment metrics in an academic telestroke network.
Methods and results
We analyzed prospectively collected data on all telestroke consults from 2003 to 2018. Trends in network performance and spoke characteristics were analyzed using generalized estimating equations and Kendall τβ nonparametric tests as appropriate. Unadjusted and adjusted linear regression models determined associations between telestroke utilization and treatment metrics. The network included 2 hubs and 43 spokes with 12 803 consults performed during the study period. Network growth overall was +1.8 spokes per year, and median duration of spoke participation was 7.9 years. The numbers of consults and alteplase-treated patients increased annually, even after adjusting for the number of spokes in the network (<0.01 for both). Although times from last seen well to spoke emergency department arrival and to consult request increased, door-to-needle time, time from teleconsult request to callback, and time from teleconsult to alteplase administration all decreased (all <0.01). With time, the network included more spokes without a Primary Stroke Center designation. In adjusted analyses, for every 10 telestroke consults requested by a spoke, the spoke door-to-needle decreased by 1.8 minutes (=0.02), number of patients treated with alteplase was an additional 1.7 (<0.01), and the percent of eligible patients treated with alteplase increased by 8% (=0.03).
Conclusions
Telestroke network size and utilization increased over time. Increased use of teleconsults was associated with increased and timely use of alteplase. Over time, the delivery of timely emergency care has improved significantly among emergency departments participating in this telestroke network. Replication of these findings in other networks is warranted.



Circ Cardiovasc Qual Outcomes: 28 Feb 2020; 13:e005903
Sharma R, Zachrison KS, Viswanathan A, Matiello M, ... Feske SK, Schwamm LH
Circ Cardiovasc Qual Outcomes: 28 Feb 2020; 13:e005903 | PMID: 32126805
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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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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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Abstract

Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative.

Ritchey MD, Maresh S, McNeely J, Shaffer T, ... Schieb L, Wright J
Background
Despite cardiac rehabilitation (CR) being shown to improve health outcomes among patients with heart disease, its use has been suboptimal. In response, the Million Hearts Cardiac Rehabilitation Collaborative developed a road map to improve CR use, including increasing participation rates to ≥70% by 2022. This observational study provides current estimates to measure progress and identifies the populations and regions most at risk for CR service underutilization.
Methods and results
We identified Medicare fee-for-service beneficiaries who were CR eligible in 2016, and assessed CR participation (≥1 CR session attended), timely initiation (participation within 21 days of event), and completion (≥36 sessions attended) through 2017. Measures were assessed overall, by beneficiary characteristics and geography, and by primary CR-qualifying event type (acute myocardial infarction hospitalization; coronary artery bypass surgery; heart valve repair/replacement; percutaneous coronary intervention; or heart/heart-lung transplant). Among 366 103 CR-eligible beneficiaries, 89 327 (24.4%) participated in CR, of whom 24.3% initiated within 21 days and 26.9% completed CR. Eligibility was highest in the East South Central Census Division (14.8 per 1000). Participation decreased with increasing age, was lower among women (18.9%) compared with men (28.6%; adjusted prevalence ratio: 0.91 [95% CI, 0.90-0.93]) was lower among Hispanics (13.2%) and non-Hispanic blacks (13.6%) compared with non-Hispanic whites (25.8%; adjusted prevalence ratio: 0.63 [0.61-0.66] and 0.70 [0.67-0.72], respectively), and varied by hospital referral region and Census Division (range: 18.6% [East South Central] to 39.1% [West North Central]) and by qualifying event type (range: 7.1% [acute myocardial infarction without procedure] to 55.3% [coronary artery bypass surgery only]). Timely initiation varied by geography and qualifying event type; completion varied by geography.
Conclusions
Only 1 in 4 CR-eligible Medicare beneficiaries participated in CR and marked disparities were observed. Reinforcement of current effective strategies and development of new strategies will be critical to address the noted disparities and achieve the 70% participation goal.



Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e005902
Ritchey MD, Maresh S, McNeely J, Shaffer T, ... Schieb L, Wright J
Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e005902 | PMID: 31931615
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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

Over-Testing for Suspected Pulmonary Embolism in American Emergency Departments: The Continuing Epidemic.

Kline JA, Garrett JS, Sarmiento EJ, Strachan CC, Courtney DM
Background
No recent data have investigated rates of diagnostic testing for pulmonary embolism (PE) in US emergency departments (EDs), and no data have examined computed tomographic pulmonary angiography (CTPA) rates in subgroups at high risk for adverse imaging outcomes, including young women and children. We hypothesized that over-testing for PE remains a problem.
Methods and results
We used electronic health record and billing data for 16 EDs in Indiana and 11 hospitals in the Dallas-Fort Worth area from 2016 to 2019 to locate ED patients who had any of the following: D-dimer, CTPA, scintillation ventilation perfusion lung scanning or formal pulmonary angiography. The primary outcomes were ED encounter volume-adjusted CTPA rate, PE yield rate with subgroup reporting for children (<18 years) and women under 45 years. We also examined the most frequent diagnoses. From a total visit volume of 1 828 010 patient encounters, 97 125 (5.3% of the total volume) had a diagnostic test for PE, including 25 870 patients who had CTPA order without D-dimer (59% of all tests for PE). The yield rate for PE from CTPA scans was 1.3% (1.1%-1.5%) in Indiana and 4.8% (4.2%-5.1%) in Dallas-Fort Worth (pooled rate 3.1%). Linear regression showed that increased D-dimer ordering correlated with increased PE yield rate (Pearson\'s R=0.43; <0.001). From the pooled sample, 59% of CTPAs done were in women, with 21% of all CTPAs performed on women under 45 years of age, and 1.4% (1.3%-1.5%) on children. The most frequent diagnoses were symptom-based descriptions of chest pain (34%) and shortness of breath (6.5%) and the condition-based diagnosis of pneumonia (4.1%).
Conclusions
Over-testing for PE in American EDs remains a major public health problem. Centers with higher D-dimer ordering had higher yield of PE on CTPA. These data suggest the potential for implementation of D-dimer based protocols to reduce low-yield CTPA ordering.



Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e005753
Kline JA, Garrett JS, Sarmiento EJ, Strachan CC, Courtney DM
Circ Cardiovasc Qual Outcomes: 30 Dec 2019; 13:e005753 | PMID: 31957477
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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

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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Impact:
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

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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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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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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Abstract

Rivaroxaban Versus Apixaban for Stroke Prevention in Atrial Fibrillation: An Instrumental Variable Analysis of a Nationwide Cohort.

Bonde AN, Martinussen T, Lee CJ, Lip GYH, ... Olesen JB, Hlatky MA
Background
The comparative effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) is uncertain, as they have not been compared directly in randomized trials. Previous observational comparisons of NOACs are likely to be biased by unmeasured confounders. We sought to compare the efficacy and safety of rivaroxaban and apixaban for stroke prevention in patients with atrial fibrillation (AF), using practice variation in preference for NOAC as an instrumental variable.
Methods and results
Patients started on apixaban or rivaroxaban after newly diagnosed AF were identified using Danish nationwide registries. Patients were categorized according to facility preferences for type of NOAC, independent of actual treatment, measured as fraction of the prior 20 patients with AF initiated on rivaroxaban in the same facility. Facility preference for NOAC was used as an instrumental variable. The occurrence of stroke/thromboembolism, major bleeding, myocardial infarction, and all-cause mortality over 2 years of follow-up were investigated using adjusted Cox regressions. We analyzed 6264 patients with AF initiated on rivaroxaban or apixaban. NOAC preference was strongly related to actual choice of treatment but not associated with any other measured baseline characteristics. Patients treated in facilities that had preference for rivaroxaban had more major bleeding: compared with patients treated in facilities that used rivaroxaban in 0% to 20% of cases, the adjusted hazard ratio for bleeding was 1.06 when treated in a facility with 25% to 40% use; 1.41 with 45% to 60% use; 1.51 with 65% to 80% use; and 1.81 with 0% to 100% use (=0.01). Higher facility preference for rivaroxaban was not significantly associated with increased risk of stroke/thromboembolism (=0.06), myocardial infarction (=0.65), or all-cause mortality (=0.89). When we used the instrumental variable to model the causal relationship between choice of NOAC and major bleeding, relative risk with rivaroxaban was 1.89 (95% CI, 1.06-2.72) compared with apixaban.
Conclusions
Using instrumental variable estimation in a cohort of patients with AF, rivaroxaban was associated with higher risk of major bleeding compared with apixaban. No significant associations to other outcomes were found in main analyses.



Circ Cardiovasc Qual Outcomes: 13 Apr 2020:CIRCOUTCOMES119006058; epub ahead of print
Bonde AN, Martinussen T, Lee CJ, Lip GYH, ... Olesen JB, Hlatky MA
Circ Cardiovasc Qual Outcomes: 13 Apr 2020:CIRCOUTCOMES119006058; epub ahead of print | PMID: 32283966
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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

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

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

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

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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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

Deriving a Passive Surveillance Stroke Severity Indicator From Routinely Collected Administrative Data: The PaSSV Indicator.

Yu AYX, Austin PC, Rashid M, Fang J, ... Hill MD, Kapral MK
Background
Adjusting for stroke severity is crucial for stroke outcomes research. However, this information is not available in administrative healthcare data. We aimed to derive an indicator of baseline stroke severity using these data.
Methods and results
We identified patients with stroke enrolled in a population-based registry in Ontario, Canada, and used the Canadian Neurological Scale (CNS), documented in the registry, as a measure of stroke severity. We derived an estimated CNS from a linear regression model in which we regressed the observed CNS on predictor variables: age, sex, arrival by ambulance, interhospital transfer, mechanical ventilation, and an emergency department triage score. The effect of stroke severity on the estimated hazard ratios for 30-day mortality was determined in 3 Cox-proportional hazards models with (1) no CNS, (2) observed CNS, and (3) estimated CNS, all adjusted for age, sex, Charlson index, and stroke type. We assessed model discrimination using C statistics. To assess for construct validity, we repeated these analyses in a subset of patients with documented National Institute of Health Stroke Scale and in a cohort of patients with stroke external to the registry. We derived the estimated stroke severity in 41 481 patients (48.7% female, median age of 75 years [interquartile range, 64- 83]). The magnitude of the association between stroke severity and mortality was similar for the observed and estimated CNS. The discriminative ability of the Cox-proportional hazards models to predict mortality was highest when the observed CNS was included (C statistic, 0.82 [95% CI, 0.81-0.82]), moderate with estimated CNS (0.76 [0.75-0.76]), and lowest without CNS (0.69 [0.69-0.70]. Our findings were replicated with the National Institute of Health Stroke Scale and in the external cohort.
Conclusions
We derived an estimated measure of stroke severity using administrative data. This can be applied for risk adjustment in population-based stroke outcomes research and in assessments of health system performance.



Circ Cardiovasc Qual Outcomes: 30 Jan 2020; 13:e006269
Yu AYX, Austin PC, Rashid M, Fang J, ... Hill MD, Kapral MK
Circ Cardiovasc Qual Outcomes: 30 Jan 2020; 13:e006269 | PMID: 32069092
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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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This program is still in alpha version.