INNOVATIONS IN DIGITAL HEALTH TO IMPROVE CARE DELIVERY: THE BJC HEALTHCARE/WASHINGTON UNIVERSITY SCHOOL OF MEDICINE HEALTHCARE INNOVATION LAB.

The Healthcare Innovation Lab, established by BJC HealthCare and Washington University School of Medicine, has catalyzed care delivery innovations since 2017. Focusing on digital health to enhance care delivery and patient outcomes, the Lab emphasizes predictive analytics, digital point-of-care tools, and remote patient monitoring. The Lab identifies innovative ideas that align with the health system mission and deliver empiric value to its patients and care teams. Since its inception, the Lab has vetted 507 ideas, piloting 98, with a success rate of 40%. Examples include a predictive model to improve palliative care referrals and goal-of-care discussions, a digital approach to non-emergent medical transportation that enhances access and equity, and a COVID-19 home monitoring program that proved essential during the pandemic. These initiatives underscore the importance of integrating digital technology with health care, balancing innovation with practical application, and using a data-informed approach to innovation selection and assessment.

Post-hospitalization remote monitoring for patients with heart failure or chronic obstructive pulmonary disease in an accountable care organization.

BACKGROUND: Post-hospitalization remote patient monitoring (RPM) has potential to improve health outcomes for high-risk patients with chronic medical conditions. The purpose of this study is to determine the extent to which RPM for patients with congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) is associated with reductions in post-hospitalization mortality, hospital readmission, and ED visits within an Accountable Care Organization (ACO). METHODS: Nonrandomized prospective study of patients in an ACO offered enrollment in RPM upon hospital discharge between February 2021 and December 2021. RPM comprised of vital sign monitoring equipment (blood pressure monitor, scale, pulse oximeter), tablet device with symptom tracking software and educational material, and nurse-provided oversight and triage. Expected enrollment was for at least 30-days of monitoring, and outcomes were followed for 6 months following enrollment. The co-primary outcomes were (a) the composite of death, hospital admission, or emergency care visit within 180 days of eligibility, and (b) time to occurrence of this composite. Secondary outcomes were each component individually, the composite of death or hospital admission, and outpatient office visits. Adjusted analyses involved doubly robust estimation to address confounding by indication. RESULTS: Of 361 patients offered remote monitoring (251 with CHF and 110 with COPD), 140 elected to enroll (106 with CHF and 34 with COPD). The median duration of RPM-enrollment was 54 days (IQR 34-85). Neither the 6-month frequency of the co-primary composite outcome (59% vs 66%, FDR p-value = 0.47) nor the time to this composite (median 29 vs 38 days, FDR p-value = 0.60) differed between the groups, but 6-month mortality was lower in the RPM group (6.4% vs 17%, FDR p-value = 0.02). After adjustment for confounders, RPM enrollment was associated with nonsignificantly decreased odds for the composite outcome (adjusted OR [aOR] 0.68, 99% CI 0.25-1.34, FDR p-value 0.30) and lower 6-month mortality (aOR 0.41, 99% CI 0.00-0.86, FDR p-value 0.20). CONCLUSIONS: RPM enrollment may be associated with improved health outcomes, including 6-month mortality, for selected patient populations.

Association of Race and Neighborhood Disadvantage with Patient Engagement in a Home-Based COVID-19 Remote Monitoring Program.

BACKGROUND: COVID-positive outpatients may benefit from remote monitoring, but such a program often relies on smartphone apps. This may introduce racial and socio-economic barriers to participation. Offering multiple methods for participation may address these barriers. OBJECTIVES: (1) To examine associations of race and neighborhood disadvantage with patient retention in a monitoring program offering two participation methods. (2) To measure the association of the program with emergency department visits and hospital admissions. DESIGN: Retrospective propensity-matched cohort study. PARTICIPANTS: COVID-positive outpatients at a single university-affiliated healthcare system and propensity-matched controls. INTERVENTIONS: A home monitoring program providing daily symptom tracking via patient portal app or telephone calls. MAIN MEASURES: Among program enrollees, retention (until 14 days, symptom resolution, or hospital admission) by race and neighborhood disadvantage, with stratification by program arm. In enrollees versus matched controls, emergency department utilization and hospital admission within 30 days. KEY RESULTS: There were 7592 enrolled patients and 9710 matched controls. Black enrollees chose the telephone arm more frequently than White enrollees (68% versus 44%, p = 0.009), as did those from more versus less disadvantaged neighborhoods (59% versus 43%, p = 0.02). Retention was similar in Black enrollees and White enrollees (63% versus 62%, p = 0.76) and in more versus less disadvantaged neighborhoods (63% versus 62%, p = 0.44). When stratified by program arm, Black enrollees had lower retention than White enrollees in the app arm (49% versus 55%, p = 0.01), but not in the telephone arm (69% versus 71%, p = 0.12). Compared to controls, enrollees more frequently visited the emergency department (HR 1.71 [95% CI 1.56-1.87]) and were admitted to the hospital (HR 1.16 [95% CI 1.02-1.31]). CONCLUSIONS: In a COVID-19 remote patient monitoring program, Black enrollees preferentially selected, and had higher retention in, telephone- over app-based monitoring. As a result, overall retention was similar between races. Remote monitoring programs with multiple modes may reduce barriers to participation.

Use of oral anticoagulants in patients with valvular atrial fibrillation: findings from the NCDR PINNACLE Registry.

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Myocardial infarction with non-obstructive coronary arteries as compared with myocardial infarction and obstructive coronary disease: outcomes in a Medicare population.

AIMS: The prognosis of patients with MINOCA (myocardial infarction with non-obstructive coronary arteries) is poorly understood. We examined major adverse cardiac events (MACE) defined as all-cause mortality, re-hospitalization for acute myocardial infarction (AMI), heart failure (HF), or stroke 12-months post-AMI in patients with MINOCA versus AMI patients with obstructive coronary artery disease (MICAD). METHODS AND RESULTS: Multicentre, observational cohort study of patients with AMI (≥65 years) from the National Cardiovascular Data Registry CathPCI Registry (July 2009-December 2013) who underwent coronary angiography with linkage to the Centers for Medicare and Medicaid (CMS) claims data. Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis. The primary endpoint was MACE at 12 months, and secondary endpoints included the components of MACE over 12 months. Among 286 780 AMI admissions (276 522 unique patients), 16 849 (5.9%) had MINOCA. The 12-month rates of MACE (18.7% vs. 27.6%), mortality (12.3% vs. 16.7%), and re-hospitalization for AMI (1.3% vs. 6.1%) and HF (5.9% vs. 9.3%) were significantly lower for MINOCA vs. MICAD patients (P < 0.001), but was similar between MINOCA and MICAD patients for re-hospitalization for stroke (1.6% vs. 1.4%, P = 0.128). Following risk-adjustment, MINOCA patients had a 43% lower risk of MACE over 12 months (hazard ratio = 0.57, 95% confidence interval 0.55-0.59), in comparison to MICAD patients. This pattern was similar for adjusted risks of the MACE components. CONCLUSION: This study confirms an unfavourable prognosis in elderly patients with MINOCA undergoing coronary angiography, with one in five patients with MINOCA suffering a major adverse event over 12 months.

Association of Glycemic Control Trajectory with Short-Term Mortality in Diabetes Patients with High Cardiovascular Risk: a Joint Latent Class Modeling Study.

BACKGROUND: The relationship between risk factor or biomarker trajectories and contemporaneous short-term clinical outcomes is poorly understood. In diabetes patients, it is unknown whether hemoglobin A1c (HbA1c) trajectories are associated with clinical outcomes and can inform care in scenarios in which a single HbA1c is uninformative, for example, after a diagnosis of coronary artery disease (CAD). OBJECTIVE: To compare associations of HbA1c trajectories and single HbA1c values with short-term mortality in diabetes patients evaluated for CAD DESIGN: Retrospective observational cohort study PARTICIPANTS: Diabetes patients (n = 7780) with and without angiographically defined CAD MAIN MEASURES: We used joint latent class mixed models to simultaneously fit HbA1c trajectories and estimate association with 2-year mortality after cardiac catheterization, adjusting for clinical and demographic covariates. KEY RESULTS: Three HBA1c trajectory classes were identified: individuals with stable glycemia (class A; n = 6934 [89%]; mean baseline HbA1c 6.9%), with declining HbA1c (class B; n = 364 [4.7%]; mean baseline HbA1c 11.6%), and with increasing HbA1c (class C; n = 482 [6.2%]; mean baseline HbA1c 8.5%). HbA1c trajectory class was associated with adjusted 2-year mortality (3.0% [95% CI 2.8, 3.2] for class A, 3.1% [2.1, 4.2] for class B, and 4.2% [3.4, 4.9] for class C; global P = 0.047, P = 0.03 comparing classes A and C, P > 0.05 for other pairwise comparisons). Baseline HbA1c was not associated with 2-year mortality (P = 0.85; hazard ratios 1.01 [0.96, 1.06] and 1.02 [0.95, 1.10] for HbA1c 7-9% and ≥ 9%, respectively, relative to HbA1c < 7%). The association between HbA1c trajectories and mortality did not differ between those with and without CAD (interaction P = 0.1). CONCLUSIONS: In clinical settings where single HbA1c measurements provide limited information, HbA1c trajectories may help stratify risk of complications in diabetes patients. Joint latent class modeling provides a generalizable approach to examining relationships between biomarker trajectories and clinical outcomes in the era of near-universal adoption of electronic health records.

Variation in contrast-associated acute kidney injury prophylaxis for percutaneous coronary intervention: insights from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) program.

BACKGROUND: Contrast-Associated Acute Kidney Injury (CA-AKI) is a serious complication associated with percutaneous coronary intervention (PCI). Patients with chronic kidney disease (CKD) have an elevated risk for developing this complication. Although CA-AKI prophylactic measures are available, the supporting literature is variable and inconsistent for periprocedural hydration and N-acetylcysteine (NAC), but is stronger for contrast minimization. METHODS: We assessed the prevalence and variability of CA-AKI prophylaxis among CKD patients undergoing PCI between October 2007 and September 2015 in any cardiac catheterization laboratory in the VA Healthcare System. Prophylaxis included periprocedural hydration with normal saline or sodium bicarbonate, NAC, and contrast minimization (contrast volume to glomerular filtration rate ratio ≤ 3). Multivariable hierarchical logistic regression models quantified site-specific prophylaxis variability. As secondary analyses, we also assessed CA-AKI prophylaxis measures in all PCI patients regardless of kidney function, periprocedural hydration in patients with comorbid CHF, and temporal trends in CA-AKI prophylaxis. RESULTS: From 2007 to 2015, 15,729 patients with CKD underwent PCI. 6928 (44.0%) received periprocedural hydration (practice-level median rate 45.3%, interquartile range (IQR) 35.5-56.7), 5107 (32.5%) received NAC (practice-level median rate 28.3%, IQR 22.8-36.9), and 4656 (36.0%) received contrast minimization (practice-level median rate 34.5, IQR 22.6-53.9). After adjustment for patient characteristics, there was significant site variability with a median odds ratio (MOR) of 1.80 (CI 1.56-2.08) for periprocedural hydration, 1.95 (CI 1.66-2.29) for periprocedural hydration or NAC, and 2.68 (CI 2.23-3.15) for contrast minimization. These trends were similar among all patients (with and without CKD) undergoing PCI. Among patients with comorbid CHF (n = 5893), 2629 (44.6%) received periprocedural hydration, and overall had less variability in hydration (MOR of 1.56 (CI 1.38-1.76)) compared to patients without comorbid CHF (1.89 (CI 1.65-2.18)). Temporal trend analysis showed a significant and clinically relevant decrease in NAC use (64.1% of cases in 2008 (N = 1059), 6.2% of cases in 2015 (N = 128, p = < 0.0001)) and no significant change in contrast-minimization (p = 0.3907). CONCLUSIONS: Among patients with CKD undergoing PCI, there was low utilization and significant site-level variability for periprocedural hydration and NAC independent of patient-specific risk. This low utilization and high variability, however, was also present for contrast minimization, a well-established measure. These findings suggest that a standardized approach to CA-AKI prophylaxis, along with continued development of the evidence base, is needed.

Risk of obstructive coronary artery disease and major adverse cardiac events in patients with noncoronary atherosclerosis: Insights from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program.

We sought to determine the risk of obstructive coronary artery disease (oCAD) associated with noncoronary atherosclerosis (cerebrovascular disease [CVD] or peripheral arterial disease [PAD]) and major adverse cardiac events following percutaneous coronary intervention (PCI). METHODS: Rates of the angiographic end point of oCAD were compared among patients with and without noncoronary atherosclerosis undergoing coronary angiography within the Veterans Health Administration between October 2007 and August 2015. The primary angiographic end point of oCAD was defined as left main stenosis ≥50% or any stenosis ≥70% in 1, 2, or 3 vessels. In patients who proceeded to PCI, the rate of the composite clinical end point of death, myocardial infarction, or stroke was compared among those with concomitant noncoronary atherosclerosis (CVD, PAD, or CVD + PAD) versus isolated CAD. RESULTS: Among 233,353 patients undergoing angiography, 9.6% had CVD, 12.4% had PAD, and 6.1% had CVD + PAD. Rates of oCAD were 57.9% for neither CVD nor PAD, 66.4% for CVD, 73.6% for PAD, and 80.9% for CVD + PAD. Compared with patients without noncoronary atherosclerosis, the adjusted risk of oCAD with CVD, PAD, or CVD + PAD was 1.03 (95% CI 1.02-1.04), 1.10 (95% CI 1.09-1.11), and 1.12 (95% CI 1.11-1.13), respectively. In patients who underwent PCI, the adjusted hazard for death, myocardial infarction, or stroke among those with CVD, PAD, or CVD + PAD was 1.36 (95% CI 1.26-1.45), 1.53 (95% CI 1.45-1.62), and 1.72 (95% CI 1.59-1.86), respectively. CONCLUSIONS: In patients undergoing coronary angiography, noncoronary atherosclerosis was associated with increased burden of oCAD and adverse events post-PCI.

The Learning Healthcare System and Cardiovascular Care: A Scientific Statement From the American Heart Association.

The learning healthcare system uses health information technology and the health data infrastructure to apply scientific evidence at the point of clinical care while simultaneously collecting insights from that care to promote innovation in optimal healthcare delivery and to fuel new scientific discovery. To achieve these goals, the learning healthcare system requires systematic redesign of the current healthcare system, focusing on 4 major domains: science and informatics, patient-clinician partnerships, incentives, and development of a continuous learning culture. This scientific statement provides an overview of how these learning healthcare system domains can be realized in cardiovascular disease care. Current cardiovascular disease care innovations in informatics, data uses, patient engagement, continuous learning culture, and incentives are profiled. In addition, recommendations for next steps for the development of a learning healthcare system in cardiovascular care are presented.

Association of insurance type with receipt of oral anticoagulation in insured patients with atrial fibrillation: A report from the American College of Cardiology NCDR PINNACLE registry.

BACKGROUND: It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs). METHODS: We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC). RESULTS: In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, P<.001; NOAC: Military 24%, Private 19%, Medicare 17%, Other 17%, Medicaid 8%, P<.001). After adjustment for patient characteristics and facility, private, Medicaid, and other insurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription. CONCLUSIONS: In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies.

Patterns of glucose-lowering medication use in patients with type 2 diabetes and heart failure. Insights from the Diabetes Collaborative Registry (DCR).

BACKGROUND: Optimal glucose-lowering strategies in patients with both heart failure (HF) and type 2 diabetes mellitus (T2D) are not well defined, particularly as novel medication classes emerge.We sought to evaluate current patterns of glucose-lowering medication use in adults with T2D with and without HF. METHODS: The DCR is a US-based outpatient registry of adults with diabetes; currently includes 3074 providers in 203 practices. We used hierarchical, modified Poisson regression models to examine the relationship between concomitant HF with use of each glucose-lowering medication class, adjusting for other factors that could impact selection of one medication class over another: age, chronic kidney disease (CKD), coronary artery disease (CAD), number of glucose-lowering medications, and insurance. RESULTS: Among 456,106 adults with T2D, 125,161 (27%) had a diagnosis of HF (30% HFrEF, 15%HFmrEF, 55% HFpEF). Patients with T2D and HF were more likely to be older and male, and to have CAD, atrial fibrillation, and CKD. In the multivariable models, HF was associated with a greater use of insulin (RR 1.39, 95% CI 1.36-1.42) and lower use of thiazolidinediones (RR 0.79, 95% CI 0.74-0.83), SGLT2 inhibitors (RR 0.83, 95% CI 0.79-0.89), and metformin (RR 0.84, 95% CI 0.82-0.86). Among the subgroup of patients with HF, thiazolidinediones, GLP-1 receptor agonists, and SGLT2 inhibitors were used even less often in patients with lower ejection fraction, indicating that both the diagnosis of clinical HF and ejection fraction may influence the choice of glucose-lowering medications. CONCLUSION: In a large US-based outpatient registry, we found that a quarter of adults with T2D had a diagnosis of HF, which was predominantly HFpEF. Although certain T2D medication use in patients with HF appeared consistent with evidence (less use of thiazolidinediones), others appeared contrary to evidence (less use of metformin and SGLT2 inhibitors).

Predictors of oral anticoagulant non-prescription in patients with atrial fibrillation and elevated stroke risk.

BACKGROUND: Many patients with atrial fibrillation (AF) and elevated stroke risk are not prescribed oral anticoagulation (OAC) despite evidence of benefit. Identification of factors associated with OAC non-prescription could lead to improvements in care. METHODS AND RESULTS: Using NCDR PINNACLE, a United States-based ambulatory cardiology registry, we examined factors associated with OAC non-prescription in patients with non-valvular AF at elevated stroke risk (CHA2DS2-VASc ≥2) between January 5, 2008 and December 31, 2014. Among 674,841 patients, 57% were treated with OAC (67% of whom were treated with warfarin). OAC prescription varied widely (28%-75%) across preselected strata of age, stroke risk (CHA2DS2-VASc), and bleeding risk (HAS-BLED), generally indicating that older patients at high stroke and low bleeding risk are commonly treated with OAC. Other factors associated with OAC non-prescription included reversible AF etiology; female sex; liver, renal, or vascular disease; and physician versus non-physician provider. Antiplatelet use was common (57%) and associated with the greatest risk of OAC non-prescription (odds ratio [OR] 4.44, 95% confidence interval [CI] 4.39-4.49). CONCLUSIONS: In this registry of AF patients, older patients at elevated stroke and low bleeding risk were commonly treated with OAC. However, a variety of factors were associated with OAC non-prescription. Specifically, antiplatelet use was prevalent and associated with the highest likelihood of OAC non-prescription. Future studies are warranted to understand provider and patient rationale that may underlie observed associations with OAC non-prescription.

Coronary atherectomy is associated with improved procedural and clinical outcomes among patients with calcified coronary lesions: Insights from the VA CART program.

OBJECTIVES: We sought to evaluate the prevalence of calcified coronary lesions and the association between the use of atherectomy and clinical outcomes. BACKGROUND: Calcified coronary arteries are associated with an increased risk of procedural complications during percutaneous coronary intervention (PCI). The outcomes of coronary atherectomy for adjunctive treatment of calcified coronary lesions are not well described. METHODS: We identified all patients treated for calcified coronary lesions at VA hospitals. A propensity weighted cohort was created for those treated with or without adjunctive atherectomy to evaluate the complications and outcomes between groups. RESULTS: From 2007 to 2015, 9,719 patients underwent single-vessel PCI for treatment of naïve native calcific coronary lesions. The proportion of patients undergoing revascularization of calcified lesions increased over the study period (P = 0.03) and 1,731 patients (18%) were treated with atherectomy. Adjunctive atherectomy was more likely to be used in high-risk lesions (76.5% vs. 46.8%, P < 0.001). After propensity weighting, coronary atherectomy was associated with a 38% decrease in the odds of procedural complications and a 54% decrease in the odds of clinical complications (both P = 0.005). There was no difference in rates of 2-year death (HR: 1.07; 95% CI: 0.92-1.24), myocardial infarction (HR: 0.96; 95% CI: 0.75-1.23) or target vessel revascularization (HR: 0.96; 95% CI: 0.78-1.19) CONCLUSIONS: Percutaneous treatment of calcified coronary lesions has increased over time. The adjunctive use of coronary atherectomy was associated with a reduction in procedural complications among patients with calcified coronary arteries. Two-year TVR, MI and overall mortality were similar between the two groups.

Incidence, procedural management, and clinical outcomes of coronary in-stent restenosis: Insights from the National VA CART Program.

BACKROUND: In-stent restenosis (ISR) remains a common clinical problem associated with significant morbidity. We sought to evaluate the temporal trends in incidence and procedural management of coronary restenosis as well as evaluate the association between different treatment modalities and clinical outcomes. METHODS: We identified all patients treated for coronary ISR within the Veterans Affairs Healthcare System from October 1, 2006 to September 30, 2014. The temporal trends in incidence as well as intraprocedural management were assessed. Among patients treated for single vessel restenosis, a propensity matched cohort was created for those treated with drug-eluting stents (DES) or other treatment modalities. Target vessel revascularization (TVR) and mortality were compared between the two subpopulations. RESULTS: From 2006 to 2014, 65,443 patients underwent percutaneous coronary intervention and 6,872 patients (10.5%) with 8,921 lesions were treated for ISR. The proportion of patients undergoing revascularization for restenosis increased 0.28% per year (P = 0.055). Among a propensity-matched cohort of 6,231, the rates of TVR (subdistribution HR: 0.623, 95% CI: 0.511-0.760) and mortality (HR: 0.730, 95% CI: 0.641-0.830) were significantly lower among patients treated with a DES compared with other treatments. After adjustment for known risk factors, treatment with DES continued to be associated with a reduction in mortality rate (Adjusted HR: 0.802, 95% CI: 0.704-0.913). CONCLUSIONS: There is a trend toward an increasing proportion of coronary interventions for ISR in a national cohort of Veterans and treatment with a DES is associated with the lowest rate of TVR and overall mortality.

Reference effect measures for quantifying, comparing and visualizing variation from random and fixed effects in non-normal multilevel models, with applications to site variation in medical procedure use and outcomes.

BACKGROUND: Multilevel models for non-normal outcomes are widely used in medical and health sciences research. While methods for interpreting fixed effects are well-developed, methods to quantify and interpret random cluster variation and compare it with other sources of variation are less established. Random cluster variation, sometimes referred to as general contextual effects (GCE), may be the main focus of a study; therefore, easily interpretable methods are needed to quantify GCE. We propose a Reference Effect Measure (REM) approach to 1) quantify GCE and compare it to individual subject and cluster covariate effects, and 2) quantify relative magnitudes of GCE and variation from sets of measured factors. METHODS: To illustrate REM, we consider a two-level mixed logistic model with patients clustered within hospitals and a random intercept for hospitals. We compare patients at hospitals at given percentiles of the estimated random effect distribution to patients at a median or 'reference' hospital. These estimates are then compared numerically and graphically to individual fixed effects to quantify GCE in the context of effects of other measured variables (aim 1). We then extend this approach by comparing variation from the random effect distribution to variation from sets of fixed effects to understand their magnitudes relative to overall outcome variation (aim 2). RESULTS: Using an example of initiation of rhythm control treatment in atrial fibrillation (AF) patients within the Veterans Affairs (VA), we use REM to demonstrate that random variation across hospitals (GCE) in initiation of treatment is substantially greater than that due to most individual patient factors, and explains at least as much variation in treatment initiation as do all patient factors combined. These results are contrasted with a relatively small GCE compared with patient factors in 1 year mortality following hospitalization for AF patients. CONCLUSIONS: REM provides a means of quantifying random effect variation (GCE) with multilevel data and can be used to explore drivers of outcome variation. This method is easily interpretable and can be presented visually. REM offers a simple, interpretable approach for evaluating questions of growing importance in the study of health care systems.

Correction to: ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease.

To more clearly reflect the relationship between iFR (instantaneous wave-free ratio) and FFR (fractional flow reserve), this Correction document highlights the following changes to the original document published in the Journal of Nuclear Cardiology; the version available at JACC [1] has been updated to reflect the changes, with JACC's Correction document available at [2].

Depression and long-term prognostic outcomes following peripheral endovascular interventions in the VA Healthcare System.

The association between depression and peripheral artery disease (PAD) outcomes remains widely understudied. In patients with PAD undergoing a peripheral vascular intervention (PVI) who have a recent diagnosis of depression, it is unknown what their long-term outcomes are and what factors may mediate an adverse risk. We therefore studied 797 consecutive patients undergoing PVI across 33 Veterans Affairs (VA) centers. Depression and outcomes were documented from patients' medical records. Outcomes included: (1) all-cause death; (2) non-fatal cardiovascular events (myocardial infarction, stroke); and (3) PAD-related events (including repeat PVI or amputation). Cox proportional hazards frailty models were constructed, adjusting for age. Additional covariates were selected if they resulted in at least 5% change in the age-adjusted hazard ratio (HR) for depression on outcomes. Overall, 265 (33%) patients had a diagnosis of depression. After a median follow-up of 955 days (range 1-6.25 years), 52 (6.5%) patients died, 30 (3.8%) experienced non-fatal cardiovascular events, and 176 (22.1%) had PAD-related events. Compared to patients without depression, depressed patients had higher rates of non-fatal cardiovascular events (6.4% vs 2.4%, p-value 0.0055). No differences for the other outcomes were noted. Higher risk for non-fatal cardiovascular events persisted after adjustment for age (HR 1.6, 95% CI 1.05-2.47). The only additional covariate that met our selection criteria was hypertension. After adjusting for hypertension, the association between depression and non-fatal cardiovascular outcomes attenuated (HR 1.53, 95% CI 0.99-2.35). In conclusion, a diagnosis of depression in veterans undergoing PVI was associated with increased risk of non-fatal cardiovascular events, mediated by age and hypertension.

Relationship Between Psychological Safety and Reporting Nonadherence to a Safety Checklist.

Patient safety checklists are ubiquitous in health care. Nurses bear significant responsibility for ensuring checklist adherence. To report nonadherence to a checklist and stop an unsafe procedure, a workplace climate of psychological safety is needed. Thus, an analysis of organizational data was conducted to examine the relationship between psychological safety and reports of nonadherence to the central line bundle checklist. Results showed varied perceptions of psychological safety but no relationship with nonadherence. Considerations for this finding and assessing psychological safety are provided.

Association of Borderline Pulmonary Hypertension With Mortality and Hospitalization in a Large Patient Cohort: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BACKGROUND: Pulmonary hypertension (PH) is associated with increased morbidity across the cardiopulmonary disease spectrum. Based primarily on expert consensus opinion, PH is defined by a mean pulmonary artery pressure (mPAP) ≥25 mm Hg. Although mPAP levels below this threshold are common among populations at risk for PH, the relevance of mPAP <25 mm Hg to clinical outcome is unknown. METHODS AND RESULTS: We analyzed retrospectively all US veterans undergoing right heart catheterization (2007-2012) in the Veterans Affairs healthcare system (n=21,727; 908-day median follow-up). Cox proportional hazards models were used to evaluate the association between mPAP and outcomes of all-cause mortality and hospitalization, adjusted for clinical covariates. When treating mPAP as a continuous variable, the mortality hazard increased beginning at 19 mm Hg (hazard ratio [HR]=1.183; 95% confidence interval [CI], 1.004-1.393) relative to 10 mm Hg. Therefore, patients were stratified into 3 groups: (1) referent (≤18 mm Hg; n=4,207); (2) borderline PH (19-24 mm Hg; n=5,030); and (3) PH (≥25 mm Hg; n=12,490). The adjusted mortality hazard was increased for borderline PH (HR=1.23; 95% CI, 1.12-1.36; P<0.0001) and PH (HR=2.16; 95% CI, 1.96-2.38; P<0.0001) compared with the referent group. The adjusted hazard for hospitalization was also increased in borderline PH (HR=1.07; 95% CI, 1.01-1.12; P=0.0149) and PH (HR=1.15; 95% CI, 1.09-1.22; P<0.0001). The borderline PH cohort remained at increased risk for mortality after excluding the following high-risk subgroups: (1) patients with pulmonary artery wedge pressure >15 mm Hg; (2) pulmonary vascular resistance ≥3.0 Wood units; or (3) inpatient status at the time of right heart catheterization. CONCLUSIONS: These data illustrate a continuum of risk according to mPAP level and that borderline PH is associated with increased mortality and hospitalization. Future investigations are needed to test the generalizability of our findings to other populations and study the effect of treatment on outcome in borderline PH.

Seasonal and circadian variations of acute myocardial infarction: Findings from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program.

BACKGROUND: Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ST-segment elevation. It is unclear whether seasonal and circadian variations are equally present in warmer and colder regions. We investigated whether seasonal and circadian variations in acute myocardial infarction (AMI) are more prominent in colder northern states compared with warmer southern states. We also investigated the peak time of admission to better understand the circadian rhythm. METHODS: Data from the GWTG-CAD database were used. We analyzed 82,971 consecutive acute myocardial infarction (AMI) patients treated at 276 US centers from 2003 to 2008. The country was geographically divided into warmer southern and colder northern states using latitude 35 degrees for this purpose. RESULTS: Overall, acute myocardial infarction (AMI) admissions varied across seasons (P < .01), and were higher in winter (winter vs. spring n = 21,483 vs. 20,291, respectively). When stratified based on type of AMI, non-ST-segment elevation myocardial infarction (NSTEMI) admissions varied across seasons (P < .01) and were highest in winter and lowest in spring. Seasonal variation was not significant in STEMI admissions (P = .30). Seasonal variation with winter predominance was noted in AMI patients in warmer southern states (P < .01), but not in colder states. The distributions of length of stay for AMI patients and door to balloon times for STEMI patients were minimally different across all four seasons (P < .01) with longest occurring in winter. Most patients with AMI presented during daytime with a peak close to 11 am and a nadir at approximately 4 am. CONCLUSIONS: Seasonal variation with winter predominance exists in AMI admissions and was significant in NSTEMI admissions but not in STEMI admissions. Seasonal variation was only significant in warmer southern states.