Reducing Cardiovascular Risk in the Medicare Million Hearts Risk Reduction Model: Insights From the National Cardiovascular Data Registry PINNACLE Registry.

BACKGROUND: The Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high-risk (ASCVD ≥30%) Medicare patients. To estimate average practice-level ASCVD risk reduction, we applied optimal trial outcomes to a real-world population with high ASCVD risk. METHODS: This study uses observational registry data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence Registry from January 2013 to June 2016. We modeled ASCVD risk reductions using historical clinical trial data (reducing cholesterol by 26.5%, reducing systolic blood pressure by 10.9%, reducing smoking rates by 21.8%) the average reduction in ASCVD risk associated with individual and combined risk factor modifications, and then percentage of practices achieving the various incentive thresholds for the Million Hearts Model. RESULTS: The final study population included 135 166 patients, with 16 248 (12.0%) with 10-year ASCVD risk of ≥30%, but without existing ASCVD. The mean 10-year ASCVD risk was 41.9% (±1 SD of 11.6). Using risk factor reductions from clinical trials, lowering cholesterol, blood pressure, and smoking rates reduced 10-year ASCVD risk by 3.3% (±3.1), 6.3% (±1.1) and 0.5% (±1.3), respectively. Combining all 3 reductions resulted in a 9.7% (±3.6) reduction, with 67 (27.0%) of practices achieving a patient-level average 10-year ASCVD risk reduction of ≥10%, 181 (73.0%) achieving a 2 to 10% reduction, and no practice achieving <2% reduction. CONCLUSIONS: In cardiology practices, about 1 out of 8 patients have a 10-year ASCVD risk ≥30% and qualify as high risk in the Million Hearts Model. If practices target the three main modifiable risk factors and achieve reductions similar to clinical trial results, ASCVD risk could be substantially lowered and all practices could receive incentive payments. These findings support the potential benefit of the Million Hearts Model and provide guidance to participating practices.

Prevalence of Angina Among Primary Care Patients With Coronary Artery Disease.

Importance: Angina pectoris is associated with morbidity and mortality. Angina prevalence and frequency among contemporary US populations with coronary artery disease (CAD) remain incompletely defined. Objective: To ascertain the angina prevalence and frequency among stable outpatients with CAD. Design, Setting, and Participants: This cross-sectional survey study involved telephone-based administration of the Seattle Angina Questionnaire-7 (SAQ-7) between February 1, 2017, and July 31, 2017, to a nonconvenience sample of adults with established CAD who receive primary care through a large US integrated primary care network. Data analysis was performed from August 2017 to August 2019. Exposure: SAQ-7 administration. Main Outcomes and Measures: Angina prevalence and frequency were assessed using SAQ-7 question 2. Covariates associated with angina were assessed in univariable and multivariable regression. Results: Of 4139 eligible patients, 1612 responded to the survey (response rate, 38.9%). The mean (SD) age of the respondents was 71.8 (11.0) years, 577 (35.8%) were women, 1447 (89.8%) spoke English, 147 (9.1%) spoke Spanish, 1336 (82.8%) were White, 76 (4.7%) were Black, 92 (5.7%) were Hispanic, 974 (60.4%) had Medicare, and 83 (5.2%) had Medicaid. Among respondents, 342 (21.2%) reported experiencing angina at least once monthly; among those, 201 (12.5%) reported daily or weekly angina, and 141 respondents (8.7%) reported monthly angina. The mean (SD) SAQ-7 score was 93.7 (13.7). After multivariable adjustment, speaking a language other than Spanish or English (odds ratio [OR], 5.07; 95% CI, 1.39-18.50), Black race (OR, 2.01; 95% CI, 1.08-3.75), current smoking (OR, 1.88; 95% CI, 1.27-2.78), former smoking (OR, 1.69; 95% CI, 1.13-2.51), atrial fibrillation (OR, 1.52; 95% CI, 1.02-2.26), and chronic obstructive pulmonary disease (OR, 1.61; 95% CI, 1.18-2.18) were associated with more frequent angina. Male sex (OR, 0.63; 95% CI, 0.47-0.86), peripheral artery disease (OR, 0.63; 95% CI, 0.44-0.90), and novel oral anticoagulant use (OR, 0.19; 95% CI, 0.08-0.48) were associated with less frequent angina. Conclusions and Relevance: Among stable outpatients with CAD receiving primary care through an integrated primary care network, 21.2% of surveyed patients reported experiencing angina at least once monthly. Several objective demographic and clinical characteristics were associated with angina frequency. Proactive assessment of angina symptoms using validated assessment tools and estimation of patients at higher risk of suboptimally controlled angina may be associated with reduced morbidity.

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.

Priorities for Patient-Centered Research in Valvular Heart Disease: A Report From the National Heart, Lung, and Blood Institute Working Group.

Over the past decade, the field of valvular heart disease (VHD) has rapidly transformed, largely as a result of the development and improvement of less invasive transcatheter approaches to valve repair or replacement. This transformation has been supported by numerous well-designed randomized trials, but they have centered almost entirely on devices and procedures. Outside this scope of focus, however, myriad aspects of therapy and management for patients with VHD have either no guidelines or recommendations based only on expert opinion and observational studies. Further, research in VHD has often failed to engage patients to inform study design and identify research questions of greatest importance and relevance from a patient perspective. Accordingly, the National Heart, Lung, and Blood Institute convened a Working Group on Patient-Centered Research in Valvular Heart Disease, composed of clinician and research experts and patient advocacy experts to identify gaps and barriers to research in VHD and identify research priorities. While recognizing that important research remains to be done to test the safety and efficacy of devices and procedures to treat VHD, we intentionally focused less attention on these areas of research as they are more commonly pursued and supported by industry. Herein, we present the patient-centered research gaps, barriers, and priorities in VHD and organized our report according to the "patient journey," including access to care, screening and diagnosis, preprocedure therapy and management, decision making when a procedure is contemplated (clinician and patient perspectives), and postprocedure therapy and management. It is hoped that this report will foster collaboration among diverse stakeholders and highlight for funding bodies the pressing patient-centered research gaps, opportunities, and priorities in VHD in order to produce impactful patient-centered research that will inform and improve patient-centered policy and care.

Surgical timing in infective endocarditis complicated by intracranial hemorrhage.

Given the growing incidence of infective endocarditis (IE), understanding the risks and benefits of valvular surgery is critical. This decision is particularly complex for the 1 in 10 cases complicated by intracranial hemorrhage (ICH). While guideline recommendations currently favor early surgery in general, delayed intervention of at least 4 weeks is still recommended for patients with ICH. To date, there are no randomized controlled trials that inform management of patients with an indication for surgery but concomitant ICH, and even reported observational data are rare. This paper reviews the current literature on timing of surgery with a specific focus on cases of ICH. It emphasizes a growing body of literature challenging the current paradigm that surgery within 4 weeks is associated with neurologic deterioration and high mortality rates by demonstrating favorable outcomes for patients with pre-operative ICH who undergo early valvular surgery. Based on these data, we propose a practical management algorithm to facilitate decisions on surgical timing in these complicated cases. Since more rigorous evidence may never be available, clinicians should make patient-specific surgical timing decisions that attempt to balance the competing risks of neurologic versus cardiac complications.

Surgery Does Not Improve Survival in Patients With Isolated Severe Tricuspid Regurgitation.

BACKGROUND: Patients with isolated tricuspid regurgitation (TR) in the absence of left-sided valvular dysfunction are often managed nonoperatively. OBJECTIVES: The purpose of this study was to assess the impact of surgery for isolated TR, comparing survival for isolated severe TR patients who underwent surgery with those who did not. METHODS: A longitudinal echocardiography database was used to perform a retrospective analysis of 3,276 adult patients with isolated severe TR from November 2001 to March 2016. All-cause mortality for patients who underwent surgery versus those who did not was analyzed in the entire cohort and in a propensity-matched sample. To assess the possibility of immortal time bias, the analysis was performed considering time from diagnosis to surgery as a time-dependent covariate. RESULTS: Of 3,276 patients with isolated severe TR, 171 (5%) underwent tricuspid valve surgery, including 143 (84%) repairs and 28 (16%) replacements. The remaining 3,105 (95%) patients were medically managed. When considering surgery as a time-dependent covariate in a propensity-matched sample, there was no difference in overall survival between patients who received medical versus surgical therapy (hazard ratio: 1.34; 95% confidence interval: 0.78 to 2.30; p = 0.288). In the subgroup that underwent surgery, there was no difference in survival between tricuspid repair versus replacement (hazard ratio: 1.53; 95% confidence interval: 0.74 to 3.17; p = 0.254). CONCLUSIONS: In patients with isolated severe TR, surgery is not associated with improved long-term survival compared to medical management alone after accounting for immortal time bias.

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.

A Survey of Interventional Cardiologists' Attitudes and Beliefs About Public Reporting of Percutaneous Coronary Intervention.

Importance: Public reporting of procedural outcomes has been associated with lower rates of percutaneous coronary intervention (PCI) and worse outcomes after myocardial infarction. Contemporary data are limited on the influence of public reporting on interventional cardiologists' clinical decision making. Objective: To survey a contemporary cohort of interventional cardiologists in Massachusetts and New York about how public reporting of PCI outcomes influences clinical decision making. Design, Setting, and Participants: An online survey was developed with public reporting experts and administered electronically to eligible physicians in Massachusetts and New York who were identified by Doximity (an online physician networking site) and 2014 Medicare fee-for-service claims for PCI procedures. The personal and hospital characteristics of participants were ascertained via a comprehensive database from Doximity and the American Hospital Association annual surveys of US hospitals (2012 and 2013) and linked to survey responses. Associations between survey responses and characteristics of participants were evaluated in univariable and multivariable analyses. Main Outcomes and Measures: Reported rate of avoidance of performing PCIs in high-risk patients and of perception of pressure from colleagues to avoid performing PCIs. Results: Of the 456 physicians approached, 149 (32.7%) responded, including 67 of 129 (51.9%) in Massachusetts and 82 of 327 (25.1%) in New York. The mean (SD) age was 49 (9.2) years; 141 of 149 participants (94.6%) were men. Most participants reported practicing at medium to large, nonprofit hospitals with high-volume cardiac catheterization laboratories and cardiothoracic surgery capabilities. In 2014, participants had higher annual PCI volumes among Medicare patients than nonparticipants did (median, 31; interquartile range [IQR], 13-47 vs median, 17; IQR, 0-41; P < .001). Among participants, 65% reported avoiding PCIs on at least 2 occasions becase of concern that a bad outcome would negatively impact their publicly reported outcomes; 59% reported sometimes or often being pressured by colleagues to avoid performing PCIs because of a concern about the patient's risk of death. After multivariable adjustment, more years of experience practicing interventional cardiology was associated with lower odds of PCI avoidance. The state of practice was not associated with survey responses. Conclusions and Relevance: Current PCI public reporting programs can foster risk-averse clinical practice patterns, which do not vary significantly between interventional cardiologists in New York and Massachusetts. Coordinated efforts by policy makers, health systems leadership, and the interventional cardiology community are needed to mitigate these unintended consequences.

Aortic valve replacement associated with survival in severe regurgitation and low ejection fraction.

OBJECTIVES: Although guidelines support aortic valve replacement (AVR) in patients with severe aortic regurgitation (AR) and left ventricular ejection fraction (LVEF) <50%, severe left ventricular dysfunction (LVEF <35%) is thought to confer high surgical risk. We sought to determine if a survival benefit exists with AVR compared with medical management in this high-risk, relatively rare population. METHODS: A large institutional echocardiography database was queried to identify patients with severe AR and LVEF <35%. Manual chart review was performed. Due to small sample size and population heterogeneity, corrected group prognosis method was applied, which calculates the adjusted survival curve for each individual using fitted Cox proportional hazard model. Average survival adjusted for comorbidities and age was then calculated using the weighted average of the individual survival curves. RESULTS: Initially, 2 54 614 echocardiograms were considered, representing 1 45 785 unique patients, of which 40 patients met inclusion criteria. Of those, 18 (45.0%) underwent AVR and 22 (55.0%) were managed medically. Absolute mortality was 27.8% in the AVR group and 91.2% in the medical management group. After multivariate adjustment, end-stage renal disease (HR=17.633, p=0.0335) and peripheral arterial disease (HR=6.050, p=0.0180) were associated with higher mortality. AVR was associated with lower mortality (HR=0.143, p=0.0490). Mean follow-up time of the study cohort was 6.58 years, and mean survival for patients undergoing AVR was 6.31 years. CONCLUSIONS: Even after adjustment for clinical characteristics and patient age, AVR is associated with higher survival for patients with low LVEF and severe AR. Although treatment selection bias cannot be completely eliminated by this analysis, these results provide some evidence that surgery may be associated with prolonged survival in this high-risk patient group.

Variation in the Echocardiographic Surveillance of Primary Mitral Regurgitation.

BACKGROUND: Clinical outcomes after surgical treatment of mitral regurgitation are worse if intervention occurs after deterioration of left ventricular size and function. Transthoracic echocardiographic (TTE) surveillance of patients with mitral regurgitation is indicated to avoid adverse ventricular remodeling. Overly frequent TTEs can impair patient access and reduce value in care delivery. This balance between timely surveillance and overutilization of TTE in valvular disease provides a model to study variation in the delivery of healthcare services. We investigated patient and provider factors contributing to variation in TTE utilization and hypothesized that variation was attributable to provider practice even after adjustment for patient characteristics. METHODS AND RESULTS: We obtained records of all TTEs from 2001 to 2016 completed at a large echocardiography laboratory. The outcome variable was time interval between TTEs. We constructed a mixed-effects linear regression model with the individual physician as the random effect in the model and used intraclass correlation coefficient to assess the proportion of outcome variation because of provider practice. Our study cohort was 55 773 TTEs corresponding to 37 843 intervals ordered by 635 providers. The mean interval between TTEs was 12.4 months, 17.0 months, 18.3 months, and 17.4 months for severe, moderate, mild, and trace mitral regurgitation, respectively, with 20% of providers deemed overutilizers of TTEs and 25% underutilizers. CONCLUSIONS: We conclude that there is substantial variation in follow-up intervals for TTE assessment of mitral regurgitation, despite risk-adjustment for patient variables, likely because of provider factors.

The Impact of First Procedure Success Rate on the Economics of Atrial Fibrillation Ablation.

OBJECTIVES: The purpose of this study was to compare health care costs associated with repeat ablation of atrial fibrillation (AF) with health care costs associated with a successful first procedure. BACKGROUND: Catheter ablation has become established as a rhythm control strategy for symptomatic paroxysmal and persistent AF. The economic impact of ablation is not completely understood, and it may be affected by repeat procedures performed for recurrent AF. METHODS: The source of data was the MarketScan (Truven Health, Ann Arbor, Michigan) administrative claims dataset from April 2008 to March 2013, including U.S. patients with private and Medicare supplemental insurance. Patients who underwent an outpatient atrial ablation procedure and a diagnosis of AF were identified. Total health care cost was calculated for 1 year before and after the ablation. Patients were categorized as having undergone a repeat ablation if an additional ablation was performed in the following year. RESULTS: Of 12,027 patients included in the study, repeat ablation was performed in 2,066 (17.2%) within 1 year. Patients with repeat ablation had higher rates of emergency department visits (43.4% vs. 32.2%; < 0.001) and subsequent hospitalization (35.6% vs. 21.5%; p < 0.001), after excluding hospitalizations for the repeat procedure. Total medical cost was higher for patients with repeat ablation ($52,821 vs. $13,412; p < 0.001), and it remained 46% higher even after excluding the cost associated with additional ablations ($19,621 vs. $13,412; p < 0.001). CONCLUSIONS: Health care costs are significantly higher for patients with a repeat ablation for AF than for patients with only a single ablation procedure, even though both groups have similar baseline characteristics. The increased costs persist even after excluding the cost of the repeat ablation itself. These results emphasize the economic benefit of procedural success in AF ablation.

Reprising Ramadan-Related Angina Pectoris: A Potential Strategy for Risk Reduction.

BACKGROUND A preponderance of evidence supports short-term aspirin usage to reduce transiently increased cardiovascular risk in clinical conditions that promote acute myocardial ischemia. CASE REPORT We report on the case of a 69-year-old male of Muslim Indian heritage with multiple cardiovascular risk factors who experienced the onset of angina pectoris while fasting for Ramadan for more than 16 hours daily for 30 days in July 2015. While symptom free for 2 months on medical management after ending his fast, he underwent quadruple coronary artery bypass surgery for severe 4-vessel disease following an acute anterior myocardial infarction. A percutaneous coronary intervention with stent placement was subsequently required for persistent myocardial ischemia on stress-MIBI testing due to occlusion of the graft to left anterior descending artery. Presently asymptomatic, he decided to forgo fasting for Ramadan in June 2016. CONCLUSIONS Based on this case, measures for primary cardiovascular prevention among the 1.2 billion susceptible males at similar high short-term cardiac risk while fasting for Ramadan are proposed. The value of aspirin for attenuating high short-term cardiovascular risk in clinical conditions conferring transient inflammatory stress is considered. Low-dose aspirin usage at evening meals while fasting for Ramadan is prudent for primary cardiovascular protection of males who may have non-obstructive coronary atherosclerosis to mitigate the risk for rupture of potentially vulnerable plaques. Based in part on conclusive evidence for protection of middle-aged males from first myocardial infarction in a randomized prospective primary prevention trial, this measure is concordant with recommendations from sub-specialty societies for primary cardiovascular prevention for persons at above-average risk demonstrated by validated biomarkers and from the United States Preventive Services Task Force.

Enhancing the Prediction of 30-Day Readmission After Percutaneous Coronary Intervention Using Data Extracted by Querying of the Electronic Health Record.

BACKGROUND: Early readmission after percutaneous coronary intervention is an important quality metric, but prediction models from registry data have only moderate discrimination. We aimed to improve ability to predict 30-day readmission after percutaneous coronary intervention from a previously validated registry-based model. METHODS AND RESULTS: We matched readmitted to non-readmitted patients in a 1:2 ratio by risk of readmission, and extracted unstructured and unconventional structured data from the electronic medical record, including need for medical interpretation, albumin level, medical nonadherence, previous number of emergency department visits, atrial fibrillation/flutter, syncope/presyncope, end-stage liver disease, malignancy, and anxiety. We assessed differences in rates of these conditions between cases/controls, and estimated their independent association with 30-day readmission using logistic regression conditional on matched groups. Among 9288 percutaneous coronary interventions, we matched 888 readmitted with 1776 non-readmitted patients. In univariate analysis, cases and controls were significantly different with respect to interpreter (7.9% for cases and 5.3% for controls; P=0.009), emergency department visits (1.12 for cases and 0.77 for controls; P<0.001), homelessness (3.2% for cases and 1.6% for controls; P=0.007), anticoagulation (33.9% for cases and 22.1% for controls; P<0.001), atrial fibrillation/flutter (32.7% for cases and 28.9% for controls; P=0.045), presyncope/syncope (27.8% for cases and 21.3% for controls; P<0.001), and anxiety (69.4% for cases and 62.4% for controls; P<0.001). Anticoagulation, emergency department visits, and anxiety were independently associated with readmission. CONCLUSIONS: Patient characteristics derived from review of the electronic health record can be used to refine risk prediction for hospital readmission after percutaneous coronary intervention.

Causes of short-term readmission after percutaneous coronary intervention.

BACKGROUND: Rehospitalization within 30 days after an admission for percutaneous coronary intervention (PCI) is common, costly, and a future target for Medicare penalties. Causes of readmission after PCI are largely unknown. METHODS AND RESULTS: To illuminate the causes of PCI readmissions, patients with PCI readmitted within 30 days of discharge between 2007 and 2011 at 2 hospitals were identified, and their medical records were reviewed. Of 9288 PCIs, 9081 (97.8%) were alive at the end of the index hospitalization. Of these, 893 patients (9.8%) were readmitted within 30 days of discharge and included in the analysis. Among readmitted patients, 341 patients (38.1%) were readmitted for evaluation of recurrent chest pain or other symptoms concerning for angina, whereas 59 patients (6.6%) were readmitted for staged PCI without new symptoms. Complications of PCI accounted for 60 readmissions (6.7%). For cases in which chest pain or other symptoms concerning for angina prompted the readmission, 21 patients (6.2%) met criteria for myocardial infarction, and repeat PCI was performed in 54 patients (15.8%). The majority of chest pain patients (288; 84.4%) underwent ≥1 diagnostic imaging test, most commonly coronary angiography, and only 9 (2.6%) underwent target lesion revascularization. CONCLUSIONS: After PCI, readmissions within 30 days were seldom related to PCI complications but often for recurrent chest pain. Readmissions with recurrent chest pain infrequently met criteria for myocardial infarction but were associated with high rates of diagnostic testing.