Classification Algorithm to Distinguish Between Type 1 and Type 2 Myocardial Infarction in Administrative Claims Data.

BACKGROUND: Type 2 myocardial infarction (T2MI) and type 1 myocardial infarction (T1MI) differ with respect to demographics, comorbidities, treatments, and clinical outcomes. Reliable quality and outcomes assessment depends on the ability to distinguish between T1MI and T2MI in administrative claims data. As such, we aimed to develop a classification algorithm to distinguish between T1MI and T2MI that could be applied to claims data. METHODS: Using data for beneficiaries in a Medicare accountable care organization contract in a large health care system in New England, we examined the distribution of MI diagnosis codes between 2018 to 2021 and the patterns of care and coding for beneficiaries with a hospital discharge diagnosis International Classification of Diseases, Tenth Revision code for T2MI, compared with those for T1MI. We then assessed the probability that each hospitalization was for a T2MI versus T1MI and examined care occurring in 2017 before the introduction of the T2MI code. RESULTS: After application of inclusion and exclusion criteria, 7759 hospitalizations for myocardial infarction remained (46.5% T1MI and 53.5% T2MI; mean age, 79±10.3 years; 47% female). In the classification algorithm, female gender (odds ratio, 1.26 [95% CI, 1.11-1.44]), Black race relative to White race (odds ratio, 2.48 [95% CI, 1.76-3.48]), and diagnoses of COVID-19 (odds ratio, 1.74 [95% CI, 1.11-2.71]) or hypertensive emergency (odds ratio, 1.46 [95% CI, 1.00-2.14]) were associated with higher odds of the hospitalization being for T2MI versus T1MI. When applied to the testing sample, the C-statistic of the full model was 0.83. Comparison of classified T2MI and observed T2MI suggest the possibility of substantial misclassification both before and after the T2MI code. CONCLUSIONS: A simple classification algorithm appears to be able to differentiate between hospitalizations for T1MI and T2MI before and after the T2MI code was introduced. This could facilitate more accurate longitudinal assessments of acute myocardial infarction quality and outcomes.

Financial Toxicity of Medical Management of Heart Failure: JACC Review Topic of the Week.

Optimal medical management of heart failure (HF) improves quality of life, decreases mortality, and decreases hospitalizations. Cost may contribute to suboptimal adherence to HF medications, especially angiotensin receptor-neprilysin inhibitors and sodium-glucose cotransporter-2 inhibitors. Patients' experiences with HF medication cost include financial burden, financial strain, and financial toxicity. Although there has been research studying financial toxicity in patients with some chronic diseases, there are no validated tools for measuring financial toxicity of HF, and very few data on the subjective experiences of patients with HF and financial toxicity. Strategies to decrease HF-associated financial toxicity include making systemic changes to minimize cost sharing, optimizing shared decision-making, implementing policies to lower drug costs, broadening insurance coverage, and using financial navigation services and discount programs. Clinicians may also improve patient financial wellness through various strategies in routine clinical care. Future research is needed to study financial toxicity and associated patient experiences for HF.

The assessment of cardiac risk in patients taking lamotrigine; a systematic review.

OBJECTIVE: The Food and Drug Administration (FDA) warned about lamotrigine's arrhythmogenicity based on in vitro data. This systematic review investigates lamotrigine's effect on cardiac conduction and risk of sudden cardiac death (SCD) in individuals with and without cardiovascular disease. METHODS: We searched Web of Science and PubMed from inception through August 2021. We included studies measuring electrocardiogram (ECG) changes, laboratory abnormalities, or SCD among patients taking lamotrigine. Studies examining sudden unexpected death in epilepsy were excluded for scope. Two reviewers assessed articles and extracted data. We used the Effective Public Healthcare Panacea Project tool to evaluate confidence in evidence. RESULTS: Eight randomized controlled trials, 9 nonrandomized observational studies, and 24 case reports were identified, with >3054 total participants, >1606 of whom used lamotrigine. One randomized trial of older patients found an average QRS increase of 3.5 +/- 13.1 ms. Fifteen studies reported no changes in ECG parameters. Case reports documented QRS widening (13), Brugada syndrome (6), QTc prolongation (1) and SCD (2), though many ingested toxic quantities of lamotrigine and/or other medications. CONCLUSIONS: Evidence is insufficient to support the breadth of the FDA warning concerning lamotrigine's cardiac risk. Lamotrigine at therapeutic doses may be associated with modest, non-dangerous QRS widening.

Cost and Value in Contemporary Heart Failure Clinical Guidance Documents.

OBJECTIVES: This study sought to evaluate the frequency and nature of cost/value statements in contemporary heart failure (HF) clinical guidance documents (CGDs). BACKGROUND: In an era of rising health care costs and expanding therapeutic options, there is an increasing need for formal consideration of cost and value in the development of HF CGDs. METHODS: HF CGDs published by major professional cardiovascular organizations between January 2010 and February 2021 were reviewed for the inclusion of cost/value statements. RESULTS: Overall, 33 documents were identified, including 5 (15%) appropriate use criteria, 7 (21%) clinical practice guidelines, and 21 (64%) expert consensus documents. Most CGDs (27 of 33; 82%) included at least 1 cost/value statement, and 20 (61%) CGDs included at least 1 cost/value-related citation. Most of these statements were found in expert consensus documents (77.7%). Three (9%) documents reported estimated costs of recommended interventions, but only 1 estimated out-of-pocket cost. Of 179 cost/value-related statements observed, 116 (64.8%) highlighted the economic impact of HF or HF-related care, 6 (3.4%) advocated for cost/value issues, 15 (8.4%) reported gaps in cost/value evidence, and 42 (23.5%) supported clinical guidance recommendations. Over time, patterns of inclusion of statements and citations of cost/value have been largely stable. CONCLUSIONS: Although most contemporary HF CGDs contain at least 1 cost/value statement, most CGDs focus on the high economic impact of HF and its related care; explicit inclusion of cost/value to support clinical guidance recommendations remains infrequent. These results highlight key opportunities for the integration of formalized cost/value considerations in future HF-focused CGDs.

Downstream Cascades of Care Following High-Sensitivity Troponin Test Implementation.

BACKGROUND: Patients with chest pain are often evaluated for acute myocardial infarction through troponin testing, which may prompt downstream services (cascades) of uncertain value. OBJECTIVES: This study sought to determine the association of high-sensitivity cardiac troponin (hs-cTn) assay implementation with cascade events. METHODS: Using electronic health record and billing data, this study examined patient-visits to 5 emergency departments from April 1, 2017, to April 1, 2019. Difference-in-differences analysis compared patient-visits for chest pain (n = 7,564) to patient-visits for other symptoms (n = 100,415) (irrespective of troponin testing) before and after hs-cTn assay implementation. Outcomes included presence of any cascade event potentially associated with an initial hs-cTn test (primary), individual cascade events, length of stay, and spending on cardiac services. RESULTS: Following hs-cTn implementation, patients with chest pain had a 2.8% (95% confidence interval [CI]: 0.72% to 4.9%) net increase in experiencing any cascade event. They were more likely to have multiple troponin tests (10.5%; 95% CI: 9.0% to 12.0%) and electrocardiograms (7.1 per 100 patient-visits; 95% CI: 1.8 to 12.4). However, they received net fewer computed tomography scans (-1.5 per 100 patient-visits; 95% CI: -1.8 to -1.1), stress tests (-5.9 per 100 patient-visits; 95% CI: -6.5 to -5.3), and percutaneous coronary intervention (PCI) (-0.65 per 100 patient-visits; 95% CI: -1.01 to -0.30) and were less likely to receive cardiac medications, undergo cardiology evaluation (-3.5%; 95% CI: -4.5% to 2.6%), or be hospitalized (-5.8%; 95% CI: -7.7% to -3.8%). Patients with chest pain had lower net mean length of stay (-0.24 days; 95% CI: -0.32 to -0.16) but no net change in spending. CONCLUSIONS: Hs-cTn assay implementation was associated with more net upfront tests yet fewer net stress tests, PCI, cardiology evaluations, and hospital admissions in patients with chest pain relative to patients with other symptoms.

Patient Characteristics and Clinical Outcomes of Type 1 Versus Type 2 Myocardial Infarction.

BACKGROUND: Type 2 myocardial infarction (MI) patients may have different characteristics and outcomes when compared with type 1 MI. OBJECTIVES: The purpose of this study was to compare patients with type 1 MI to those with type 2 MI in the United States. METHODS: Using the Nationwide Readmissions Database, MI patients were categorized over the 3 months following the introduction of an International Classification of Diseases-10th Revision code specific for type 2 MI. Baseline characteristics and inpatient and post-discharge outcomes among both cohorts were compared. RESULTS: There were 216,657 patients with type 1 MI, 37,765 patients with type 2 MI, and 1,525 patients with both type 1 and 2 MI. Patients with type 2 MI were older (71 years vs. 69 years; p < 0.001), were more likely to be women (47.3% vs. 40%; p < 0.001), and had higher prevalence of heart failure (27.9% vs. 10.9%; p < 0.001), kidney disease (35.7% vs. 25.7%; p < 0.001), and atrial fibrillation (31% vs. 21%; p < 0.001). Rates of coronary angiography (10.9% vs. 57.3%; p < 0.001), percutaneous coronary intervention (1.7% vs. 38.5%; p < 0.001), and coronary artery bypass grafting (0.4% vs. 7.8%; p < 0.001) were lower among type 2 MI patients. Patients with type 2 MI had lower risk of in-hospital mortality (adjusted odds ratio: 0.57 [95% confidence interval: 0.54 to 0.60]) and 30-day MI readmission (adjusted odds ratio: 0.46 [95% confidence interval: 0.35 to 0.59]). There was no difference in risk of 30-day all-cause or heart failure readmission. CONCLUSIONS: Patients with type 2 MI have a unique cardiovascular phenotype when compared with type 1 MI, and are managed in a heterogenous manner. Validated management strategies for type 2 MI are needed.

Economic Evaluation of an N-terminal Pro B-type Natriuretic Peptide-Supported Diagnostic Strategy Among Dyspneic Patients Suspected of Acute Heart Failure in the Emergency Department.

Our objective was to perform an economic evaluation of an N-terminal pro B-type natriuretic peptide (NT-proBNP)-supported diagnostic strategy in dyspneic patients suspected of acute heart failure in the emergency department (ED). A decision-tree model was developed to evaluate clinical outcomes and costs for NT-proBNP-supported assessment compared with clinical assessment alone over 6 months from the United States (US) Medicare perspective. The model considered rule-in/rule-out cutoffs identified in the ICON and ICON-RELOADED studies. Acute heart failure prevalence, diagnostic accuracies, and medical resource use conditional on disease status and test results were derived from ICON-RELOADED. Several assumptions based on previous studies of NT-proBNP acute dyspnea and verified with clinicians were applied to medical resource use and assessed in sensitivity analyses. Compared with clinical assessment alone, NT-proBNP-supported assessment improved overall probability of correct diagnosis by a relative 7% (18% for true-positive and 5% for true-negative). This led to relative reductions in medical resource use in ED and hospital, including fewer initial hospitalizations (-14%), required echocardiograms (-31%), cardiology admissions (-16%), intensive care unit admissions (-12%), ED readmissions (-3%), and hospital readmissions (-22%). NT-proBNP use decreased average inpatient management costs by a relative 10%, yielding cost savings of US$2,337 per patient ED visit. These findings were robust in sensitivity analyses. In conclusion, based on a contemporary trial of patients with acute dyspnea, this analysis reaffirmed that using NT-proBNP as a diagnostic tool may improve the management of patients with dyspnea presenting to EDs and is likely to be cost-saving from the US Medicare perspective.

Insulin-Like Growth Factor Binding Protein 7 Predicts Renal and Cardiovascular Outcomes in the Canagliflozin Cardiovascular Assessment Study.

OBJECTIVE: To analyze the association between concentrations of plasma insulin-like growth factor binding protein 7 (IGFBP7) with renal and cardiac outcomes among participants with type 2 diabetes and high cardiovascular risk. RESEARCH DESIGN AND METHODS: Associations between IGFBP7 levels and clinical outcomes were assessed among participants in the Canagliflozin Cardiovascular Assessment Study (CANVAS) with type 2 diabetes and high cardiovascular risk. RESULTS: Among CANVAS participants, 3,577 and 2,898 had IGFBP7 measured at baseline and 1 year, respectively. Per log-unit higher concentration, baseline IGFBP7 was significantly associated with the composite renal end point of sustained 40% reduction in estimated glomerular filtration rate, need for renal replacement therapy, or renal death (hazard ratio [HR] 3.51; P < 0.001) and the composite renal end point plus cardiovascular death (HR 4.90; P < 0.001). Other outcomes, including development or progression of albuminuria, were also predicted by baseline IGFBP7. Most outcomes were improved by canagliflozin regardless of baseline IGFBP7; however, those with baseline concentrations ≥96.5 ng/mL appeared to benefit more from canagliflozin relative to the first progression of albuminuria compared with those with lower baseline IGFBP7 (HR 0.64 vs. 0.95; P interaction = 0.003). Canagliflozin did not lower IGFBP7 concentrations by 1 year; however, at 1 year, higher IGFBP7 concentrations more strongly predicted the composite renal end point (HR 15.7; P < 0.001). Patients with rising IGFBP7 between baseline and 1 year had the highest number of composite renal events. CONCLUSIONS: Plasma IGFBP7 concentrations predicted renal and cardiac events among participants with type 2 diabetes and high cardiovascular risk. More data are needed regarding circulating IGFBP7 and progression of diabetic kidney disease and its complications.

Racial and Ethnic Differences in Biomarkers, Health Status, and Cardiac Remodeling in Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan.

BACKGROUND: Among patients with heart failure and reduced ejection fraction (left ventricular (LV) ejection fraction ≤40%), sacubitril/valsartan (S/V) treatment is associated with improved health status and reverse cardiac remodeling. Data regarding racial and ethnic differences in response to S/V are lacking. METHODS: This was an analysis from the PROVE-HF study (Prospective Study of Biomarkers, Symptom Improvement and Ventricular Remodeling During Entresto Therapy for Heart Failure). Longitudinal changes in NT-proBNP (N-terminal pro-B-type natriuretic peptide), cardiac reverse remodeling, and health status scores were compared between groups using multivariate latent growth curve modeling. RESULTS: Among the 782 patients included in this study, 22.7% were non-Hispanic Black (from here referred to as Black), 14.9% were Hispanic, and 62.4% were non-Hispanic White (from here referred to as White). At baseline, compared with White patients, Black and Hispanic patients had lower NT-proBNP (g=0.34) and differences between groups in baseline values for LV end-diastolic volume index and LV end-systolic volume index were negligible (g<0.10). Following S/V initiation, NT-proBNP decreased in all 3 groups (P<0.0001) associated with improvements in LV ejection fraction, LV end-diastolic volume index, and LV end-systolic volume index. Although total improvement in LV measures was similar between groups, Black patients averaged larger gains in the first half of the trial while White patients averaged larger gains in the second half. Improvements in Kansas City Cardiomyopathy Questionnaire-23 Total Symptom scores were seen in all 3 groups. Treatment with S/V was well-tolerated. CONCLUSIONS: Among Black, Hispanic, and White patients with heart failure and reduced ejection fraction, treatment with S/V was associated with similar reduction in NT-proBNP, improvement in health status, and reverse remodeling. More data regarding racial and ethnic responses to heart failure and reduced ejection fraction treatment are needed. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02887183.

Cardiac Troponin for Assessment of Myocardial Injury in COVID-19: JACC Review Topic of the Week.

Increases in cardiac troponin indicative of myocardial injury are common in patients with coronavirus disease-2019 (COVID-19) and are associated with adverse outcomes such as arrhythmias and death. These increases are more likely to occur in those with chronic cardiovascular conditions and in those with severe COVID-19 presentations. The increased inflammatory, prothrombotic, and procoagulant responses following severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection increase the risk for acute nonischemic myocardial injury and acute myocardial infarction, particularly type 2 myocardial infarction, because of respiratory failure with hypoxia and hemodynamic instability in critically ill patients. Myocarditis, stress cardiomyopathy, acute heart failure, and direct injury from SARS-CoV-2 are important etiologies, but primary noncardiac conditions, such as pulmonary embolism, critical illness, and sepsis, probably cause more of the myocardial injury. The structured use of serial cardiac troponin has the potential to facilitate risk stratification, help make decisions about when to use imaging, and inform stage categorization and disease phenotyping among hospitalized COVID-19 patients.

Echocardiographic assessment of insulin-like growth factor binding protein-7 and early identification of acute heart failure.

AIMS: Concentrations of insulin-like growth factor binding protein-7 (IGFBP7) have been linked to abnormal cardiac structure and function in patients with chronic heart failure (HF), but cardiovascular correlates of the biomarker in patients with more acute presentations are lacking. We aimed to determine the relationship between IGFBP7 concentrations and cardiac structure and to evaluate the impact of IGFBP7 on the diagnosis of acute HF among patients with acute dyspnoea. METHODS AND RESULTS: In this pre-specified subgroup analysis of the International Collaborative of N-terminal pro-B-type Natriuretic Peptide Re-evaluation of Acute Diagnostic Cut-Offs in the Emergency Department (ICON-RELOADED) study, we included 271 patients with and without acute HF. All patients presented to an emergency department with acute dyspnoea, had blood samples for IGFBP7 measurement, and detailed echocardiographic evaluation. Higher IGFBP7 concentrations were associated with numerous cardiac abnormalities, including increased left atrial volume index (LAVi; r = 0.49, P < 0.001), lower left ventricular ejection fraction (r = -0.27, P < 0.001), lower right ventricular fractional area change (r = -0.31, P < 0.001), and higher tissue Doppler E/e' ratio (r = 0.44, P < 0.001). In multivariable linear regression analyses, increased LAVi (P = 0.01), lower estimated glomerular filtration rate (P = 0.008), higher body mass index (P = 0.001), diabetes (P = 0.009), and higher concentrations of amino-terminal pro-B-type natriuretic peptide (NT-proBNP, P = 0.02) were independently associated with higher IGFBP7 concentrations regardless of other variables. Furthermore, IGFBP7 (odds ratio = 12.08, 95% confidence interval 2.42-60.15, P = 0.02) was found to be independently associated with the diagnosis of acute HF in the multivariable logistic regression analysis. CONCLUSIONS: Among acute dyspnoeic patients with and without acute HF, increased IGFBP7 concentrations are associated with a range of cardiac structure and function abnormalities. Independent association with increased LAVi suggests elevated left ventricular filling pressure is an important trigger for IGFBP7 expression and release. IGFBP7 may enhance the diagnosis of acute HF.

Home-Time After Discharge Among Patients With Type 2 Myocardial Infarction.

Background Home-time, defined as the time spent alive outside of a healthcare institution, has emerged as a patient-centered health outcome. The discharge locations and distribution of home-time after a type 2 myocardial infarction are unknown. Methods and Results Patients with a type 2 myocardial infarction between October 2017 and May 2018 at Massachusetts General Hospital were included. Patients discharged to hospice or without follow-up data were excluded. Our primary outcome was home-time defined as the number of days lived outside of a hospital, long-term acute care facility, skilled nursing facility, or rehabilitation facility. We identified 359 patients with type 2 myocardial infarction over the study period. Of those discharged alive (N=321), 62.9% were discharged home, and the remainder went to a facility or hospice. Among those with available follow-up data (N=289), the median home-time was 30 (interquartile range [IQR], 16-30) days at 30 days, 171 (IQR, 133-180) days at 180 days, and 347 (IQR, 203-362) days at 365 days. At 1 year, 29 patients (10%) with type 2 myocardial infarction had spent no time at home and only 57 patients (19.7%) spent the entire year alive and at home. At 1 year, postdischarge all-cause mortality was 23.2%, all-cause readmission was 69.2%, and major adverse cardiovascular events (composite of all-cause mortality, recurrent myocardial infarction, or stroke) was 34.9%. Home-time through 1 year correlated strongly with time-to-event all-cause mortality (τ=0.54, P<0.001) and major adverse cardiovascular events (τ=0.52, P<0.001) and modestly with a composite of all-cause mortality or readmission (τ=0.44, P<0.001). Conclusions Home-time is low after a hospitalization for type 2 myocardial infarction and correlates strongly with mortality and major adverse cardiovascular events.

Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Despite evidence that guideline-directed medical therapy (GDMT) improves outcomes in patients with heart failure (HF) and reduced ejection fraction, many patients are undertreated. The Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT) trial tested whether a strategy of using target concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) to guide optimization of GDMT could improve outcomes. Objective: To examine medical therapy for HF in GUIDE-IT and potential reasons why the intervention did not produce improvements in medical therapy. Design, Setting, and Participants: GUIDE-IT, a randomized clinical trial performed at 45 sites in the United States and Canada, was conducted from January 16, 2013, to September 20, 2016. A total of 894 patients with HF and reduced ejection fraction (≤40%) were randomized to NT-proBNP-guided treatment with a goal to suppress NT-proBNP concentrations to less than 1000 pg/mL vs usual care. This secondary analysis examined the medical therapy titration and reasons why the intervention did not produce improvements in care and outcomes. Data were analyzed March 27 to June 28, 2019. Main Outcomes and Measures: For each encounter, medication titrations were captured. A reason was requested if a modification was not made. A Cox proportional hazards regression model was used to assess the independent association of drug class with outcomes. Results: Among the 838 patients available for analysis (566 men [67.5%]; median age, 62.0 years), 6223 visits occurred during 24 months. Adjustments of HF medication were made during 2847 of 5218 qualified visits (54.6%) (all usual care visits and all guided care visits with NT-proBNP level ≥1000 pg/mL) in 862 patients (96.4%). Most adjustments occurred within the first 6 months, primarily within the first 6 weeks. The most common reasons for not adjusting were "clinically stable" and "already at maximally tolerated therapy." Only 130 patients (15.5%) achieved optimal GDMT (≥50% of the target dose of ß-blockers or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or any dose of mineralocorticoid antagonists) at 6 months, an increase from the baseline (79 of 891 [8.9%]) but not different by treatment arm. Higher doses of ß-blockers were associated with reduced risk of the composite outcome of HF hospitalization and cardiovascular death (hazard ratio [HR], 0.98; 95% CI, 0.97-1.00; P = .008) and of all-cause death (HR, 0.97; 95% CI, 0.95-0.99; P = .01). Higher doses of angiotensin-converting enzyme inhibitors (HR, 0.84; 95% CI, 0.75-0.93; P < .001) and angiotensin receptor blockers (HR, 0.84; 95% CI, 0.71-0.99; P = .04) were associated with reduced risk of all-cause death. Increasing doses of mineralocorticoid antagonists did not appear to be associated with improved outcomes. Conclusions and Relevance: Despite a protocol-driven approach, many patients in GUIDE-IT did not receive medication adjustments and did not achieve optimal GDMT, including those with known elevated NT-proBNP concentrations. These results suggest that opportunities exist to titrate medications for maximal benefit in HF. GUIDE-IT may have failed to achieve treatment benefit because of therapeutic inertia in clinical practice, or current GDMT goals may be unrealistic. Trial Registration: ClinicalTrials.gov Identifier: NCT01685840.

Association of the New Peer Group-Stratified Method With the Reclassification of Penalty Status in the Hospital Readmission Reduction Program.

Importance: Since the introduction of the Hospital Readmission Reduction Program (HRRP), readmission penalties have been applied disproportionately to institutions that serve low-income populations. To address this concern, the US Centers for Medicare & Medicaid introduced a new, stratified payment adjustment method in fiscal year (FY; October 1 to September 30) 2019. Objective: To determine whether the introduction of a new, stratified payment adjustment method was associated with an alteration in the distribution of penalties among hospitals included in the HRRP. Design, Setting, and Participants: In this retrospective cross-sectional study, US hospitals included in the HRRP for FY 2018 and FY 2019 were identified. Penalty status of participating hospitals for FY 2019 was determined based on nonstratified HRRP methods and the new, stratified payment adjustment method. Hospitals caring for the highest proportion of patients enrolled in both Medicare and Medicaid based on quintile were assigned to the low-socioeconomic status (SES) group. Exposures: Nonstratified and stratified Centers for Medicare & Medicaid payment adjustment methods. Main Outcomes and Measures: Net reclassification of penalties among all hospitals and hospitals in the low-SES group, in states participating in Medicaid expansion, and for 4 targeted medical conditions (acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, and pneumonia). Results: Penalty status by both payment adjustment methods (nonstratified and stratified) was available for 3173 hospitals. For FY 2019, the new, stratified payment method was associated with penalties for 75.04% of hospitals (2381 of 3173), while the old, nonstratified method was associated with penalties for 79.07% (2509 hospitals), resulting in a net down-classification in penalty status for all hospitals by 4.03 percentage points (95% CI, 2.95-5.11; P < .001). For the 634 low-SES hospitals in the sample, the new method was associated with penalties for 77.60% of hospitals (492 of 634), while the old method was associated with penalties for 91.64% (581 hospitals), resulting in a net down-classification in penalty status of 14.04 percentage points (95% CI, 11.18-16.90; P < .001). Among hospitals that were not low SES (quintiles 1-4), the new payment method was associated with a small decrease in penalty status (1928 vs 1889; net down-classification, 1.54 percentage points; 95% CI, 0.38-2.69; P = .01). Among target medical conditions, the greatest reduction in penalties was observed among cardiovascular conditions (net down-classification, 6.18 percentage points; 95% CI, 4.96-7.39; P < .001). Conclusions and Relevance: The new, stratified payment adjustment method for the HRRP was associated with a reduction in penalties across hospitals included in the program; the greatest reductions were observed among hospitals in the low-SES group, lessening but not eliminating the previously unbalanced penalty burden carried by these hospitals. Additional public policy research efforts are needed to achieve equitable payment adjustment models for all hospitals.

Misclassification of Myocardial Injury as Myocardial Infarction: Implications for Assessing Outcomes in Value-Based Programs.

Importance: Similar to other patients with acute myocardial infarction, patients with type 2 myocardial infarction (T2MI) are included in several value-based programs, including the Hospital Readmissions Reduction Program and the Hospital Value-Based Purchasing Program. To our knowledge, whether nonischemic myocardial injury is being misclassified as T2MI is unknown and may have implications for these programs. Objective: To determine whether patients with nonischemic myocardial injury are being miscoded as having T2MI and if this has implications for 30-day readmission and mortality rates. Design, Settings, and Participants: Using the new International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code, we identified patients who were coded as having T2MI between October 2017 and May 2018 at Massachusetts General Hospital. Strict adjudication using the fourth universal definition of MI was then applied. Main outcome and Measures: Clinical adjudication of T2MI and 30-day readmission and mortality rates as a function of T2MI or nonischemic myocardial injury. Results: Of 633 patients, 369 (58.3%) were men and 514 (81.2%) were white. After strict adjudication, 359 (56.7%) had T2MI, 265 (41.9%) had myocardial injury, 6 (0.9%) had type 1 MI, and 3 (0.5%) had unstable angina. Patients with T2MI had a higher prevalence of cardiovascular comorbidities than those with myocardial injury. Patients with T2MI and myocardial injury had high in-hospital mortality rates (10.6% and 8.7%, respectively; P = .50). Of those discharged alive (563 [88.9%]), 30-day readmission rates (22.7% vs 21.1%; P = .68) and mortality rates (4.4% vs 7.4%; P = .14) were comparable among patients with T2MI and myocardial injury. Conclusions and Relevance: A substantial percentage of patients coded as having T2MI actually have myocardial injury. Both conditions have high 30-day readmission and mortality rates. Including patients with high-risk myocardial injury may have substantial implications for value-based programs.

Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure.

BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial prospectively compared the efficacy of an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy (target NT-proBNP level <1,000 pg/ml) with optimal medical therapy alone in high-risk patients with heart failure and reduced ejection fraction. When the study was stopped for futility, 894 patients had been enrolled. OBJECTIVES: The purpose of this study was to assess treatment-related quality-of-life (QOL) and economic outcomes in the GUIDE-IT trial. METHODS: The authors prospectively collected a battery of QOL instruments at baseline and 3, 6, 12, and 24 months post-randomization (collection rates 90% to 99% of those eligible). The principal pre-specified QOL measures were the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and the Duke Activity Status Index (DASI). Cost data were collected for 735 (97%) U.S. RESULTS: Baseline variables were well balanced in the 446 patients randomized to the NT-proBNP-guided therapy and 448 to usual care. Both the KCCQ and the DASI improved over the first 6 months, but no evidence was found for a strategy-related difference (mean difference [biomarker-guided - usual care] at 24 months of follow-up 2.0 for DASI [95% confidence interval (CI): -1.3 to 5.3] and 1.1 for KCCQ [95% CI: -3.7 to 5.9]). Total winsorized costs averaged $5,919 higher in the biomarker-guided strategy (95% CI: -$1,795, +$13,602) over 15-month median follow-up. CONCLUSIONS: A strategy of NT-proBNP-guided HF therapy had higher total costs and was not more effective than usual care in improving QOL outcomes in patients with heart failure and a reduced ejection fraction. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).

Clinical Profile of Acute Myocardial Infarction Patients Included in the Hospital Readmissions Reduction Program.

Background Medicare's Hospital Readmissions Reduction Program assesses financial penalties to hospitals based on risk-standardized readmission rates after specific episodes of care, including acute myocardial infarction. Detailed information about the type of patients included in the penalty is unknown. Methods and Results Starting with administrative data from Medicare, we conducted physician-adjudicated chart reviews of all patients considered 30-day readmissions after acute myocardial infarction from July 2012 to June 2015. Of 197 readmissions, 68 (34.5%) received percutaneous coronary intervention and 18 (9.1%) underwent coronary artery bypass grafting on index hospitalization. The remaining 111 patients did not receive any intervention. Of the 197 patients, 56 patients (28.4%) were considered too high risk for invasive management, 23 (11.7%) had nonobstructive coronary artery disease on diagnostic catheterization and therefore no indication for revascularization, 19 patients had a type II myocardial infarction (9.6%) for which noninvasive, outpatient workup was recommended, and 13 (6.6%) declined further care. The most common readmission diagnoses were cardiac causes and noncardiac chest discomfort, infection, and gastrointestinal bleeding. Conclusions Our results demonstrate that more than a quarter of the patients included in the penalty do not receive revascularization either because of provider assessment of risk or patient preference, and nearly one tenth have type II myocardial infarction. As such, administrative codes for prohibitive procedural risk, patient-initiated "do not resuscitate" status, or type II myocardial infarction may improve the risk-adjustment of the metric. Furthermore, provider organizations seeking to reduce readmission rates should focus resources on the needs of these patients, such as care coordination, hospice services when requested by patients, and treatment of noncardiac conditions.