Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial.

BACKGROUND: Medication adherence is generally low and challenging to address because patient actions control healthcare delivery outside of medical environments. Behavioral nudging changes clinician behavior, but nudging patient decision-making requires further testing. This trial evaluated whether behavioral nudges can increase statin adherence, measured as the proportion of days covered (PDC). METHODS: In a 12-month parallel-group, unblinded, randomized controlled trial, adult patients in Intermountain Healthcare cardiology clinics were enrolled. Inclusion required an indication for statins and membership in SelectHealth insurance. Subjects were randomized 1:1 to control or nudges. Nudge content, timing, frequency, and delivery route were personalized by CareCentra using machine learning of subject motivations and abilities from psychographic assessment, demographics, social determinants, and the Intermountain Mortality Risk Score. PDC calculation used SelectHealth claims data. RESULTS: Among 182 subjects, age averaged 63.2±8.5 years, 25.8% were female, baseline LDL-C was 82.5±32.7 mg/dL, and 93.4% had coronary disease. Characteristics were balanced between nudge (n = 89) and control arms (n = 93). The statin PDC was greater at 12 months in the nudge group (PDC: 0.742±0.318) compared to controls (PDC: 0.639±0.358, P = 0.042). Adherent subjects (PDC ≥80%) were more concentrated in the nudge group (66.3% vs controls: 50.5%, P = 0.036) while a composite of death, myocardial infarction, stroke, and revascularization was non-significant (nudges: 6.7% vs control: 10.8%, P = 0.44). CONCLUSIONS: Persuasive behavioral nudges driven by artificial intelligence resulted in a clinically important increase in statin adherence in general cardiology patients. This precision patient decision support utilized computerized nudge design and delivery with minimal on-going human input.

Risk score-guided multidisciplinary team-based Care for Heart Failure Inpatients is associated with lower 30-day readmission and lower 30-day mortality.

OBJECTIVE: Using augmented intelligence clinical decision tools and a risk score-guided multidisciplinary team-based care process (MTCP), this study evaluated the MTCP for heart failure (HF) patients' 30-day readmission and 30-day mortality across 20 Intermountain Healthcare hospitals. BACKGROUND: HF inpatient care and 30-day post-discharge management require quality improvement to impact patient health, optimize utilization, and avoid readmissions. METHODS: HF inpatients (N = 6182) were studied from January 2013 to November 2016. In February 2014, patients began receiving care via the MTCP based on a phased implementation in which the 8 largest Intermountain hospitals (accounting for 89.8% of HF inpatients) were crossed over sequentially in a stepped manner from control to MTCP over 2.5 years. After implementation, patient risk scores were calculated within 24 hours of admission and delivered electronically to clinicians. High-risk patients received MTCP care (n = 1221), while lower-risk patients received standard HF care (n = 1220). Controls had their readmission and mortality scores calculated retrospectively (high risk: n = 1791; lower risk: n = 1950). RESULTS: High-risk MTCP recipients had 21% lower 30-day readmission compared to high-risk controls (adjusted P = .013, HR = 0.79, CI = 0.66, 0.95) and 52% lower 30-day mortality (adjusted P < .001, HR = 0.48, CI = 0.33, 0.69). Lower-risk patients did not experience increased readmission (adjusted HR = 0.88, P = .19) or mortality (adjusted HR = 0.88, P = .61). Some utilization was higher, such as prescription of home health, for MTCP recipients, with no changes in length of stay or overall costs. CONCLUSIONS: A risk score-guided MTCP was associated with lower 30-day readmission and 30-day mortality in high-risk HF inpatients. Further evaluation of this clinical management approach is required.

Free thyroxine within the normal reference range predicts risk of atrial fibrillation.

INTRODUCTION: Hyperthyroidism is a known precipitating factor for atrial fibrillation (AF). However, recent reports have suggested an increased risk of AF with free thyroxine (fT4) levels even within the upper reference (normal) range. We sought to test whether higher fT4 levels within the reference range are associated with an increased risk of AF. METHODS AND RESULTS: All patients in the Intermountain Healthcare electronic medical record database with an fT4 level not on thyroid medication were included. The reference range of fT4 was divided into quartiles (Q), and associations with prevalent and incident AF were assessed by multivariable regression. Similar analyses were performed for thyroid stimulating hormone (TSH) and total and free T3. A total of 174 914 patients were included and followed for 7.0 ± 4.9 years. Of these, 7.4%, 88.4%, and 4.2% had fT4 levels below, within, and above the reference range. As expected, prevalent AF was greater with elevated fT4. However, gradients also were noted within the reference range, comparing Q4 to Q1, for prevalent AF (adjusted odds ratio 1.4, P < .0001) and incident AF (adjusted hazard ratio 1.16, P < .0001). In contrast, no relationship with AF prevalence and incidence was noted for total and free T3 within their reference ranges, and the pattern for TSH was uninformative. CONCLUSION: Higher fT4 levels within the reference range were associated with an increased prevalence and incidence of AF. These findings in a large dataset prospectively validate earlier reports and may have important implications, including a redefinition of the normal range and fT4 targets for replacement therapy.

Predictors of Statin Intolerance in Patients With a New Diagnosis of Atherosclerotic Cardiovascular Disease Within a Large Integrated Health Care Institution: The IMPRES Study.

Statins are among the most prescribed medications because of the well-documented benefits of safely lowering low-density lipoprotein cholesterol. However, many patients are unable or unwilling to continue statin therapy because of real or perceived adverse effects. This study sought to increase understanding about which patients are unlikely to tolerate statin therapy. The Intermountain Healthcare's electronic data repository was queried from January 1, 1999, to December 31, 2013, to identify all adults who survived their first encounter of coronary artery disease (CAD), cerebral vascular disease, or peripheral artery disease and received statin therapy during follow-up. Statin intolerance (SI) was identified by the documentation of clinician-noted intolerance or allergy or by the use of pitavastatin. Patients were followed up for ≥3 years or until death. Of the 48,997 patients evaluated, 3049 (6.2%) were documented with SI. Of those with SI, 9.8% were prescribed a low-intensity, 73.4% a moderate-intensity, and 16.8% a high-intensity statin dose. After adjustment for covariables, significant predictors of SI were female sex [odds ratio (OR) = 1.47, P < 0.0001], age (65-74 vs. <65: OR = 1.15, P = 0.002; ≥75 vs. <65: OR = 0.90, P = 0.03), hypertension (OR = 1.11, P = 0.01), hyperlipidemia (OR = 1.31, P < 0.0001), smoking (OR = 0.88, P = 0.001), renal failure (OR = 1.20, P = 0.009), heart failure (OR = 1.26, P < 0.0001), sleep apnea (OR = 1.22, P < 0.0001), prior malignancy (OR = 1.18, P = 0.007), depression (OR = 1.13, P = 0.04), and index atherosclerotic cardiovascular disease diagnosis (CAD vs. cerebral vascular disease: OR = 1.71, P < 0.0001; CAD vs. peripheral artery disease: OR = 1.23, P = 0.02). In this study, the strongest identified clinical predictor of future SI was female sex. Many standard cardiovascular risk factors were also associated with SI, suggesting that patients with multiple comorbidities are more likely to be vulnerable.

GlycA and hsCRP are independent and additive predictors of future cardiovascular events among patients undergoing angiography: The intermountain heart collaborative study.

BACKGROUND: GlycA is an inflammatory marker that is raised in patients with cardiometabolic diseases and associated with cardiovascular (CV) events. We sought to determine if GlycA adds independent value to hsCRP for CV risk prediction. METHODS: Patients in the Intermountain Heart Collaborative Study who underwent coronary angiography and had plasma GlycA and hsCRP levels were studied (n = 2996). Patients were followed for 7.0 ±â€¯2.8 years. GlycA and hsCRP were moderately correlated (r = 0.46, P < .0001). GlycA and hsCRP concentrations were stratified into high and low categories by their median values. Multivariable cox hazard regression was utilized to determine the associations of GlycA quartiles, as well as high and low categories of GlycA and hsCRP, with major adverse cardiovascular events (MACE) defined as the composite of death, myocardial infarction (MI), heart failure (HF) hospitalization, and stroke. RESULTS: The highest GlycA quartile was associated with future MACE [HR: 1.43; 95% CI: 1.22-1.69; P < .0001]. Patients with high GlycA and high hsCRP had more diabetes, hyperlipidemia, hypertension, HF, renal failure and MI, but not coronary artery disease. High GlycA and hsCRP (H/H) versus low GlycA and hsCRP (L/L) was associated with MACE, death and HF hospitalization, but not MI or stroke. Combined MACE rates were 33.5%, 41.3%, 35.7% and 49.1% for L/L, L/H, H/L and H/H categories of GlycA/hsCRP, respectively (P-trend < .0001). The interaction between GlycA and hsCRP was significant for the outcome of death (P = .03). CONCLUSION: In this study, levels of GlycA and hsCRP were independent and additive markers of risk for MACE, death and HF hospitalization.

Predicting readmission risk shortly after admission for CABG surgery.

BACKGROUND: Reducing preventable hospital readmissions after coronary artery bypass graft (CABG) surgery has become a national priority. Predictive models can be used to identify patients at high risk for readmission. However, the majority of the existing models are based on data available at discharge. We sought to develop a model to predict hospital readmission using data available soon after admission for isolated CABG surgery. METHODS: Fifty risk factors were included in a bivariate analysis, 16 of which were significantly associated (P < 0.05) with readmissions and were entered into a multivariate logistic regression and removed stepwise, using backward elimination procedures. The derived model was then validated on 896 prospective isolated CABG cases. RESULTS: Of 2589 isolated CABG patients identified between December 1, 2010, and June 30, 2014, 237(9.15%) were readmitted within 30 days. Five risk factors were predictive of 30-day all-cause readmission: age (odds ratio [OR] = 1.03; 95% confidence interval [CI]: 1.01-1.05; P = 0.004), prior heart failure (OR = 1.55; 95%CI: 1.07-2.24; P = 0.020), total albumin prior to surgery (OR = 0.68; 95%CI: 0.05-0.94; P = 0.021), previous myocardial infarction (OR = 1.44; 95%CI: 1.00-2.08; P = 0.50), and history of diabetes (OR = 1.54; 95%CI: 1.09-2.19; P = 0.015). The area under the curve c-statistic was 0.63 in the derivation sample and 0.65 in the validation sample showing good discrimination. CONCLUSIONS: A 30-day all-cause readmission among isolated CABG patients can be predicted soon after admission with a small number of risk factors.

Early inpatient calculation of laboratory-based 30-day readmission risk scores empowers clinical risk modification during index hospitalization.

Improving 30-day readmission continues to be problematic for most hospitals. This study reports the creation and validation of sex-specific inpatient (i) heart failure (HF) risk scores using electronic data from the beginning of inpatient care for effective and efficient prediction of 30-day readmission risk. METHODS: HF patients hospitalized at Intermountain Healthcare from 2005 to 2012 (derivation: n=6079; validation: n=2663) and Baylor Scott & White Health (North Region) from 2005 to 2013 (validation: n=5162) were studied. Sex-specific iHF scores were derived to predict post-hospitalization 30-day readmission using common HF laboratory measures and age. Risk scores adding social, morbidity, and treatment factors were also evaluated. RESULTS: The iHF model for females utilized potassium, bicarbonate, blood urea nitrogen, red blood cell count, white blood cell count, and mean corpuscular hemoglobin concentration; for males, components were B-type natriuretic peptide, sodium, creatinine, hematocrit, red cell distribution width, and mean platelet volume. Among females, odds ratios (OR) were OR=1.99 for iHF tertile 3 vs. 1 (95% confidence interval [CI]=1.28, 3.08) for Intermountain validation (P-trend across tertiles=0.002) and OR=1.29 (CI=1.01, 1.66) for Baylor patients (P-trend=0.049). Among males, iHF had OR=1.95 (CI=1.33, 2.85) for tertile 3 vs. 1 in Intermountain (P-trend <0.001) and OR=2.03 (CI=1.52, 2.71) in Baylor (P-trend < 0.001). Expanded models using 182-183 variables had predictive abilities similar to iHF. CONCLUSIONS: Sex-specific laboratory-based electronic health record-delivered iHF risk scores effectively predicted 30-day readmission among HF patients. Efficient to calculate and deliver to clinicians, recent clinical implementation of iHF scores suggest they are useful and useable for more precise clinical HF treatment.

Real world MRI experience with nonconditional and conditional cardiac rhythm devices after MagnaSafe.

INTRODUCTION: The recent MagnaSafe Registry demonstrated safety of nonthoracic magnetic resonance imaging (MRI) with nonconditional cardiac implantable electronic devices (CIEDs). However, independent validation and extension to thoracic MRIs are needed. METHODS AND RESULTS: We prospectively examined 178 consecutive patients with CIEDs who underwent 212 MRI scans (62 with implantable cardioverter/defibrillators) for clinical reasons between February 2014 and August 2016. Scans were done in standard modes with a limit of 2 W/kg. Pacing modes were ODO or OVO for intrinsic rates > 40 and DOO or VOO for rates ≤ 40. Patients were cleared prescan by both radiology and cardiology, and pre- and postscan CIED interrogations were performed. Primary outcome events were death and generator or lead failure. Secondary events included battery voltage loss > 0.04 V, decrease in P wave voltage > 50% or R wave voltage > 25%, threshold increase of > 0.5 V, and impedance change > 50 Ω. Scan sites were 87 (41%) C-spine/head/neck, 28 (13%) T-spine/cardiac/shoulder (thoracic), 69 (33%) L-spine/abdomen/pelvis, and 28 (13%) lower extremity. No primary or secondary outcome events occurred, and no periscan disruption of pacing was noted. CONCLUSION: In a real-world MRI experience in patients with CIEDs representing a broad range of models, types, and scan sites (including thoracic scans), no adverse safety signals were noted. This experience validates and extends that of the large but inclusion-restricted MagnaSafe Registry, profiles MRI scanning in CIED patients in general clinical practice, and argues against replacing nonconditional with conditional devices when MRI is performed in a carefully controlled environment.

Clinical Decision Support to Efficiently Identify Patients Eligible for Advanced Heart Failure Therapies.

BACKGROUND: Patients who need and receive timely advanced heart failure (HF) therapies have better long-term survival. However, many of these patients are not identified and referred as soon as they should be. METHODS: A clinical decision support (CDS) application sent secure email notifications to HF patients' providers when they transitioned to advanced disease. Patients identified with CDS in 2015 were compared with control patients from 2013 to 2014. Kaplan-Meier methods and Cox regression were used in this intention-to-treat analysis to compare differences between visits to specialized and survival. RESULTS: Intervention patients were referred to specialized heart facilities significantly more often within 30 days (57% vs 34%; P < .001), 60 days (69% vs 44%; P < .0001), 90 days (73% vs 49%; P < .0001), and 180 days (79% vs 58%; P < .0001). Age and sex did not predict heart facility visits, but renal disease did and patients of nonwhite race were less likely to visit specialized heart facilities. Significantly more intervention patients were found to be alive at 30 (95% vs 92%; P = .036), 60 (95% vs 90%; P = .0013), 90 (94% vs 87%; P = .0002), and 180 days (92% vs 84%; P = .0001). Age, sex, and some comorbid diseases were also predictors of mortality, but race was not. CONCLUSIONS: We found that CDS can facilitate the early identification of patients needing advanced HF therapy and that its use was associated with significantly more patients visiting specialized heart facilities and longer survival.

Improvement in the predictive ability of the Intermountain Mortality Risk Score by adding routinely collected laboratory tests such as albumin, bilirubin, and white cell differential count.

BACKGROUND: The Intermountain Mortality Risk Score (IMRS), a sex-specific mortality-prediction metric, has proven to be effective in various populations. IMRS is comprised of the complete blood count (CBC), basic metabolic panel (BMP), and age. Whether the addition of factors from the comprehensive metabolic panel (CMP) and white blood cell (WBC) differential count improves risk stratification is unknown. METHODS: Patients with baseline complete metabolic panel (CMP) and IMRS measurements were randomly assigned (60%/40%) to independent derivation (n=84,913) and validation (n=56,584) populations. A sex-specific risk score based on IMRS methods was computed in the derivation population using adjusted multivariable regression weights from all significant and noncollinear CMP [expanded IMRS (eIMRS)] and, when available, WBC differential components (eIMRS+diff). RESULTS: Age averaged 67±16 years for females and 67±15 years for males. Receiver operator characteristic (ROC) c-statistics for 30-day death showed marked improvement for the eIMRS compared to the IMRS in both females [0.895 (0.882, 0.908) vs. 0.865 (0.850, 0.880)] and males [0.861 (0.847, 0.876) vs. 0.824 (0.807, 0.841)]. These results persisted for 1-year death: females [0.854 (0.847, 0.862) vs. 0.828 (0.819, 0.836)] and males [0.835 (0.826, 0.844) vs. 0.796 (0.789, 0.808)]. In addition, the eIMRS significantly improved risk reclassification. Further precision was seen when WBC differential components were included. CONCLUSIONS: The addition of the CMP components to the IMRS improved risk prediction. WBC differential also improved risk score predictive ability. These results suggest that the eIMRS may function even better than IMRS as a tool in patient care, risk-adjustment, and clinical research settings for predicting outcomes.

Coronary artery plaque volume and obesity in patients with diabetes: the factor-64 study.

PURPOSE: To determine the relationship between coronary plaque detected with coronary computed tomographic (CT) angiography and clinical parameters and cardiovascular risk factors in asymptomatic patients with diabetes. MATERIALS AND METHODS: All patients signed institutional review board-approved informed consent forms before enrollment. Two hundred twenty-four asymptomatic diabetic patients (121 men; mean patient age, 61.8 years; mean duration of diabetes, 10.4 years) underwent coronary CT angiography. Total coronary artery wall volume in all three vessels was measured by using semiautomated software. The coronary plaque volume index (PVI) was determined by dividing the wall volume by the coronary length. The relationship between the PVI and cardiovascular risk factors was determined with multivariable analysis. RESULTS: The mean PVI (±standard deviation) was 11.2 mm(2) ± 2.7. The mean coronary artery calcium (CAC) score (determined with the Agatston method) was 382; 67% of total plaque was noncalcified. The PVI was related to age (standardized ß = 0.32, P < .001), male sex (standardized ß = 0.36, P < .001), body mass index (BMI) (standardized ß = 0.26, P < .001), and duration of diabetes (standardized ß = 0.14, P = .03). A greater percentage of soft plaque was present in younger individuals with a shorter disease duration (P = .02). The soft plaque percentage was directly related to BMI (P = .002). Patients with discrepancies between CAC score and PVI rank quartiles had a higher percentage of soft and fibrous plaque (18.7% ± 3.3 vs 17.4% ± 3.5 [P = .008] and 52.2% ± 7.2 vs 47.2% ± 8.8 [P < .0001], respectively). CONCLUSION: In asymptomatic diabetic patients, BMI was the primary modifiable risk factor that was associated with total and soft coronary plaque as assessed with coronary CT angiography.

Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial.

IMPORTANCE: Coronary artery disease (CAD) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus, yet CAD often is asymptomatic prior to myocardial infarction (MI) and coronary death. OBJECTIVE: To assess whether routine screening for CAD by coronary computed tomography angiography (CCTA) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes. DESIGN, SETTING, AND PARTICIPANTS: The FACTOR-64 study was a randomized clinical trial in which 900 patients with type 1 or type 2 diabetes of at least 3 to 5 years' duration and without symptoms of CAD were recruited from 45 clinics and practices of a single health system (Intermountain Healthcare, Utah), enrolled at a single-site coordinating center, and randomly assigned to CAD screening with CCTA (n = 452) or to standard national guidelines-based optimal diabetes care (n = 448) (targets: glycated hemoglobin level <7.0%, low-density lipoprotein cholesterol level <100 mg/dL, systolic blood pressure <130 mm Hg). All CCTA imaging was performed at the coordinating center. Standard therapy or aggressive therapy (targets: glycated hemoglobin level <6.0%, low-density lipoprotein cholesterol level <70 mg/dL, high-density lipoprotein cholesterol level >50 mg/dL [women] or >40 mg/dL [men], triglycerides level <150 mg/dL, systolic blood pressure <120 mm Hg), or aggressive therapy with invasive coronary angiography, was recommended based on CCTA findings. Enrollment occurred between July 2007 and May 2013, and follow-up extended to August 2014. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization; the secondary outcome was ischemic major adverse cardiovascular events (composite of CAD death, nonfatal MI, or unstable angina). RESULTS: At a mean follow-up time of 4.0 (SD, 1.7) years, the primary outcome event rates were not significantly different between the CCTA and the control groups (6.2% [28 events] vs 7.6% [34 events]; hazard ratio, 0.80 [95% CI, 0.49-1.32]; P = .38). The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups (4.4% [20 events] vs 3.8% [17 events]; hazard ratio, 1.15 [95% CI, 0.60-2.19]; P = .68). CONCLUSIONS AND RELEVANCE: Among asymptomatic patients with type 1 or type 2 diabetes, use of CCTA to screen for CAD did not reduce the composite rate of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization at 4 years. These findings do not support CCTA screening in this population. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00488033.

Intracardiac ultrasound for esophageal anatomic assessment and localization during left atrial ablation for atrial fibrillation.

BACKGROUND: Esophageal injury during left atrial ablation is associated with a significant risk of mortality and morbidity. There are no validated approaches to reduce injury outside of avoidance, a strategy critically dependent on a precise understanding of the esophageal anatomy and location. Intracardiac ultrasound (ICE) can provide a real-time assessment of the esophagus during ablation. We hypothesized that ICE can accurately define esophageal anatomy and location to enhance avoidance strategies during ablation. METHODS: Fifty patients underwent atrial fibrillation (AF) ablation. The left atrium and pulmonary vein anatomies were rendered by traditional electroanatomic mapping (CARTO). A Navistar catheter within the esophagus was used to create a traditional electroanatomic esophageal anatomy. ICE imaging was used to create a second geometry of the esophagus. The traditional and ICE anatomies of the esophagus were compared and the greatest border dimensions used to avoid injury. RESULTS: The average age was 66 ± 10 years, 45% had persistent/longstanding persistent AF, and 18% had a prior AF ablation. The esophagus location was leftward in 17 (34%), midline in 22 (44%), and rightward in 11 (22%). Traditional esophagus and ICE imaging correlated within 1 cm in the greatest distance in 26 (52%) patients. Traditional imaging underestimated the esophageal location by >1-1.5 cm in 9 (18%) and >1.5 cm in 15 (30%). In those with poor correlation (>1.5 cm), the most common cause was the presence of a hiatal hernia. Ablation energy delivery was performed outside the greatest esophagus anatomy borders. Of those with 12-month follow-up, 75% were AF/atrial flutter free without antiarrhythmic drugs. No esophageal injuries were observed. One patient experienced a TIA greater than 6 months postablation. CONCLUSION: These data demonstrate that traditional means of mapping the esophagus using a catheter within the esophagus are insufficient and often grossly underestimate the actual anatomy. Imaging techniques that define the complete esophageal lumen should be considered to truly minimize esophageal injury risk.

Impact of Active vs Passive Statin Selection for Primary Prevention: The CorCal Vanguard Trial.

Background: Statins can improve outcomes in high-risk primary prevention populations. However, application in clinical practice has lagged. Objectives: The objective of this study was to compare an active vs a passive strategy (ie, usual care) to statin prescription for primary prevention of atherosclerotic cardiovascular disease (ASCVD). Methods: A total of 3,770 patients ≥50 years of age without a history of ASCVD or statin use were invited to enroll in CorCal, with 601 consenting to participate. These patients were randomized 1:1 to statin initiation guided by the pooled cohort equation or by coronary artery calcium scoring (CACS). Outcomes (2.8-year follow-up) compared patients managed actively vs passively (randomly invited but declined or did not respond). Results: Patient demographics were well matched. Statin recommendation was common among enrolled patients (41.7%). During follow-up, 25.3% of active patients were taking a statin vs 9.8% managed passively (P < 0.0001). Active patients had more lipid panels (median 2.0 vs 1.0), lower low-density lipoprotein cholesterol (109 vs 117 mg/dL) (both P < 0.0001), and a low rate of major adverse cardiovascular events during follow-up (0.6% vs 1.0%, P = 0.47). Statistical comparisons included t-tests, chi-squared tests, nonparametric tests, and time-to-event tests as appropriate. Conclusions: An active approach to statin selection for primary ASCVD prevention identified a large treatment opportunity and led to over twice as many patients on statins compared to passive (usual care) management. A large CorCal Outcomes Trial is underway to more definitively assess the impact on outcomes of active management of statins for primary prevention.

Real-world clinical burden and economic assessment associated with hyperkalaemia in a large integrated healthcare system: a retrospective analysis.

BACKGROUND: Hyperkalaemia (HK) is a serious and potentially life-threatening condition. Both acute and chronic conditions may alter potassium homeostasis. Our aim is to describe HK incidence, clinical outcomes, and associated resource use within a large, integrated healthcare system. METHODS: Adult patients seen at Intermountain Healthcare facilities with a serum potassium (sK) result between January 1, 2003 and December 31, 2018 were retrospectively studied. Descriptive assessment of a population with detected HK, defined by any sK > 5.0 mmol/L and HK frequency and severity to associated resource use and characteristics of HK predictors were made. Multivariable Cox hazard regression was used to evaluate HK to outcomes. RESULTS: Of 1,208,815 patients included, 13% had HK. Compared to no-HK, HK patients were older (60 ± 18 vs 43 ± 18 years, P < 0.001), male (51% vs 41%, P < 0.001), and had greater disease burden (Charlson Comorbidity Index 3.5 ± 2.8 vs 1.7 ± 1.4, P < 0.001). At 3 years, more HK patients experienced major adverse cardiovascular events (MACEs) (19 vs 3%, P < 0.001), persisting post-adjustment (multivariable hazard ratio = 1.60, P < 0.001). They incurred higher costs for emergency department services ($552 ± 7,574 vs $207 ± 1,930, P < 0.001) and inpatient stays ($10,956 ± 93,026 vs $1,477 ± 21,423, P < 0.001). HyperK Risk Scores for the derivation and validation cohorts were: 44% low-risk, 45% moderate-risk, 11% high-risk. Strongest HK predictors were renal failure, dialysis, aldosterone blockers, diabetes, and smoking. CONCLUSION: Within this large system, HK was associated with a large clinical burden, affecting over 1 in 10 patients; HK was also associated with increased 3-year MACE risk and higher medical costs. Although risk worsened with more severe or persistently recurring HK, even mild or intermittent HK episodes were associated with significantly greater adverse clinical outcomes and medical costs. The HyperK Score predicted patients who may benefit from closer management to reduce HK risk and associated costs. It should be remembered that our assumptions are valid only for detected HK and not HK per se.

High-statin adherence over 5 years of follow-up is associated with improved cardiovascular outcomes in patients with atherosclerotic cardiovascular disease: results from the IMPRES study.

AIMS: Despite proven benefits of LDL-C lowering among those with atherosclerotic cardiovascular disease (ASCVD), statin adherence remains low. Very little real-world data exist on the effect of long-term statin adherence on cardiovascular outcomes. METHODS AND RESULTS: A total of 7339 patients ≥18 years first diagnosed with ASCVD with a statin prescription within 12 months of diagnosis who had 5 years of continuous Select Health insurance or died during Years 2-5, while a member was studied. The proportion of days covered (PDC) was calculated using pharmacy claims for statin use by year, and patients were stratified into pre-defined categories: fully adherent [PDC ≥ 80% for Years 1-5 or until death, n = 353 (4.8%)], short-term-adherent [PDC ≥ 80% for Years 1-3, n = 330 (4.5%)], early-adherent only [PDC ≥ 80% for Year 1, n = 890 (12.1%)], complex-adherent (PDC ≥ 80% in any of Years 2-5, but not Year 1, n = 1292 [17.6%]), and non-adherent [PDC < 80% for Years 1-5 or until death, n = 3942 (72.1%)]. Patients were followed for major adverse clinical events (MACE = death, myocardial infarction, and stroke). Patients averaged 56.4 ± 9.6 years and 76.5% were male. During Year 1, statin adherence was poor, with PDC < 20% in 4007 (54.6%) patients and PDC ≥80% in 1573 (21.4%) patients, which dropped to 16.9% by Year 5. Increased adherence was associated with significantly fewer MACE (11.6%, 17.9%, 21.9%, 21.1%, and 26.4% for those fully adherent, short-term adherent, early-adherent only, complex-adherent, and non-adherent, respectively, P-trend < 0.0001). After adjustment, fully adherent was associated with a significant decrease in MACE (hazard ratio = 0.51, 0.37-0.71). CONCLUSION: Among ASCVD patients with at least 5 years of continuous pharmacy benefits, long-term adherence to statins was associated with decreased long-term MACE in a linear-fashion.

Coronary Artery Calcium Versus Pooled Cohort Equations Score for Primary Prevention Guidance: Randomized Feasibility Trial.

OBJECTIVES: This study sought to determine the feasibility of performing an extensive randomized outcomes trial comparing a coronary artery calcium (CAC)- versus a pooled cohort equations (PCE) risk score-based strategy for initiating statin therapy for primary atherosclerotic cardiovascular disease (ASCVD) prevention. BACKGROUND: Statin therapy is standard for the primary prevention of ASCVD in subjects at increased risk. National guidelines recommend using the American College of Cardiology/American Heart Association PCE risk score to guide a statin recommendation. Whether guidance by a CAC score is equivalent or superior is unknown. METHODS: CorCal (Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events) was a randomized trial consenting 601 patients without known ASCVD, diabetes, or prior statin therapy recruited from primary care clinics and randomized to CAC- (n = 302) or PCE guidance (n = 299) of statin initiation for primary prevention. Enrolled subjects and their physicians made final treatment decisions. Primary outcomes compared the proportion of statin recommendations received and subject adherence over 1 year between CAC- and PCE-arm subjects. Modeled medical costs, adverse effects, and low-density lipoprotein-cholesterol (LDL-C) were additional measures of interest. RESULTS: Subjects were well matched, and 540 (89.9%) completed entry testing and received a protocol-based recommendation. A statin was recommended in 101 (35.9%) CAC-arm and 124 (47.9%) PCE-arm subjects (P = 0.005). Compared to PCE-based recommendations, CAC-arm subjects were reclassified from statin to no statin in 36.0% and from no statin to statin in 5.6% of cases, resulting in a total reclassification of 20.6%. Physicians accepted the study-dictated recommendation to start a statin in 88.1% of CAC-arm vs 75.0% of PCE-arm subjects (P = 0.01). Patient-reported adherence to this recommendation at 3 months was 62.2% vs 42.2%, respectively (P = 0.009). At 1 year, statin adherence remained superior, LDL-C levels were lower, estimated costs were similar or reduced in CAC subjects, and few events occurred. CONCLUSIONS: CAC guidance may be a more efficient, personalized, cost-effective, and motivating approach to statin initiation and maintenance in primary prevention. This feasibility phase of CorCal should be regarded as hypothesis-generating with respect to cardiovascular outcomes, which is being addressed in a large, longer-term outcomes trial. (Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events [CorCal]; NCT03439267).

Parathyroid hormone, vitamin D, renal dysfunction, and cardiovascular disease: dependent or independent risk factors?

BACKGROUND: Vitamin D (Vit D) deficiency has been associated with prevalent and incident cardiovascular (CV) disease, suggesting a role for bioregulators of bone and mineral metabolism in CV health. Vitamin D deficiency leads to secondary hyperparathyroidism, and both primary and secondary hyperparathyroidism are associated with CV pathology. Parathyroid hormone (PTH) is an important regulator of calcium homeostasis, and its impact on CV disease risk is of interest. We tested whether elevated PTH is associated with CV disease and whether risk associations depend on Vit D status and renal function. METHODS: Patients in the Intermountain Healthcare system with concurrent PTH and Vit D as 25-hydroxy-vitamin D (25[OH]D) levels were studied (N = 9,369, age 63 ± 16 years, 36% male). Parathyroid hormone levels were defined as low (<15 pg/mL), normal (15-75 pg/mL), or elevated (>75 pg/mL). Prevalence and incidence of hypertension, diabetes, hyperlipidemia, coronary artery disease/myocardial infarction, heart failure, stroke, and peripheral vascular disease were determined by the International Classification of Diseases, Ninth Revision codes documented in electronic medical records at baseline and, for incident events, during an average of 2.0 ± 1.5 years (maximum 7.5 years) of follow-up. RESULTS: Parathyroid hormone elevation at baseline was noted in 26.1% of the study population. Highly significant differential CV prevalence/incidence rates for most CV risk factors, disease diagnoses, and mortality were noted for PTH >75 pg/mL (by 1.25- to 3-fold). Parathyroid hormone correlated only weakly (r = -0.15) with 25(OH)D and moderately with glomerular filtration rate (r = -0.36). 25(OH)D, standard risk factors, and renal dysfunction variably attenuated PTH risk associations, but risk persisted after full multivariable adjustment. CONCLUSIONS: Elevated PTH is associated with a greater prevalence and incidence of CV risk factors and predicts a greater likelihood of prevalent and incident disease, including mortality. Risk persists when adjusted for 25(OH)D, renal function, and standard risk factors. Parathyroid hormone represents an important new CV risk factor that adds complementary and independent predictive value for CV disease and mortality.

A strategy of rapid cardioversion minimizes the significance of early recurrent atrial tachyarrhythmias after ablation for atrial fibrillation.

BACKGROUND: The significance of early recurrent atrial tachyarrhythmias after atrial fibrillation (AF) ablation is unclear. Atrial remodeling driven by these tachyarrhythmias can result in electrical, contractile, and structural changes that may impair long-term therapy success. Aggressive attempts to restore sinus rhythm in the temporal period of healing after ablation might improve outcomes. METHODS: A total of 1,759 AF ablations were performed at Intermountain Medical Center or LDS Hospital. A total of 455 of those were among patients requiring repeat ablations. Patients were instructed to take their pulse daily and, if greater than 100 bpm or irregular, present the following business day fasting to the clinic for evaluation and cardioversion if AF or atrial flutter (AFL) were present. RESULTS: Of the ablations performed, a total of 515 (29%, age: 65.6 ± 11.2 years, male: 57.9%) developed AF/AFL that required cardioverison. The majority of these arrhythmias first occurred in the initial 90 days (63.7%) postablation. During this period, 62.8% were on an antiarrhythmic drug (AAD). Only 25.1% were using an AAD at 3 months. The majority of ablations (75.6%) who experienced AF/AFL within the first 90 days after ablation were in sinus rhythm with no AAD at 1 year. Further, 48% of those with the first recurrence from 90 to 180 days were in sinus rhythm with no AAD at 1 year. CONCLUSIONS: The time at which the first recurrence of AF/AFL occurs impacts long-term outcomes. An aggressive strategy of rapid cardioversion postablation reduces the significance of recurrent AF/AFL during the first 6 months.