Normal-Flow Low-Gradient Aortic Stenosis: Comparing the U.S. and European Guidelines.

Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients.

Association Between Cardiovascular Event Type and Smoking Cessation Rates Among Outpatients With Atherosclerotic Cardiovascular Disease: Insights From the NCDR PINNACLE Registry.

BACKGROUND: It is unclear how the type of an atherosclerotic cardiovascular disease (ASCVD) event potentially influences patients' likelihood of smoking cessation. METHODS: Using 2013 to 2018 data from the US based National Cardiovascular Data Registry Practice Innovation and Clinical Excellence outpatient cardiac registry, we identified patients who were current smokers at a clinic visit and followed them over time for a subsequent ASCVD event. Self-reported smoking status was assessed at each consecutive visit and used to determine smoking cessation after each interim ASCVD event (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, stroke/transient ischemic attack, peripheral artery disease). We constructed separate multivariable Cox models with nonproportional hazards to examine the association of each interim ASCVD event with smoking cessation, compared with not having an interim ASCVD event. We estimated the relative association of ASCVD event type with smoking cessation using contrast tests. Analyses were stratified by presence versus absence of ASCVD at baseline. RESULTS: Across 530 cardiology practices, we identified 1 933 283 current smokers (mean age 62±15, male 54%, ASCVD at baseline 50%). Among the 322 743 patients who had an interim ASCVD event and were still smoking, 41 336 (12.8%) quit smoking by their first subsequent clinic visit, which was higher among those with baseline ASCVD (13.4%) as compared with those without baseline ASCVD (11.5%). Each type of ASCVD event was associated with an increased likelihood of smoking. Patients who had an myocardial infarction, underwent coronary artery bypass graft (hazard ratio, 1.60 [95% CI, 1.55-1.65]), or had a stroke or transient ischemic attack were more likely to quit smoking as compared with those who underwent elective percutaneous coronary intervention or had a new diagnosis of peripheral artery disease (hazard ratio, 1.20 [95% CI, 1.17-1.22]). CONCLUSIONS: Only 13% of patients reported smoking cessation after an ASCVD event, with the type of event being associated with the likelihood of smoking cessation, prompting the need for patient-centered interventions.

2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

AIM: The "2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease" provides an update to and consolidates new evidence since the "2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease" and the corresponding "2014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease." METHODS: A comprehensive literature search was conducted from September 2021 to May 2022. Clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants were identified that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. STRUCTURE: This guideline provides an evidenced-based and patient-centered approach to management of patients with chronic coronary disease, considering social determinants of health and incorporating the principles of shared decision-making and team-based care. Relevant topics include general approaches to treatment decisions, guideline-directed management and therapy to reduce symptoms and future cardiovascular events, decision-making pertaining to revascularization in patients with chronic coronary disease, recommendations for management in special populations, patient follow-up and monitoring, evidence gaps, and areas in need of future research. Where applicable, and based on availability of cost-effectiveness data, cost-value recommendations are also provided for clinicians. Many recommendations from previously published guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.

2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

AIM: The "2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease" provides an update to and consolidates new evidence since the "2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease" and the corresponding "2014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease." METHODS: A comprehensive literature search was conducted from September 2021 to May 2022. Clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants were identified that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. STRUCTURE: This guideline provides an evidenced-based and patient-centered approach to management of patients with chronic coronary disease, considering social determinants of health and incorporating the principles of shared decision-making and team-based care. Relevant topics include general approaches to treatment decisions, guideline-directed management and therapy to reduce symptoms and future cardiovascular events, decision-making pertaining to revascularization in patients with chronic coronary disease, recommendations for management in special populations, patient follow-up and monitoring, evidence gaps, and areas in need of future research. Where applicable, and based on availability of cost-effectiveness data, cost-value recommendations are also provided for clinicians. Many recommendations from previously published guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.

Use of primary bariatric surgery among patients with obesity and diabetes. Insights from the Diabetes Collaborative Registry.

Despite its cardiometabolic benefits, bariatric surgery has historically been underused in patients with obesity and diabetes, but contemporary data are lacking. Among 1,520,182 patients evaluated from 2013 to 2019 within a multicenter, longitudinal, US registry of outpatients with diabetes, we found that 462,033 (30%) met eligibility for bariatric surgery. After a median follow-up of 854 days, 6310/384,859 patients (1.6%) underwent primary bariatric surgery, with a slight increase over time (0.38% per year [2013] to 0.68% per year [2018]). Patients who underwent bariatric surgery were more likely to be female (63% vs. 56%), white (87% vs. 82%), have higher body mass indices (42.1 ± 6.9 vs. 40.6 ± 5.9 kg/m2), and depression (23% vs. 14%; p < 0.001 for all). Over a median (IQR) follow-up after surgery of 722 days (364-993), patients who underwent bariatric surgery had lost an average of 11.8 ± 18.5 kg (23% of excess body weight), 10.2% were on fewer glucose-lowering medications, and 8.4% were on fewer antihypertensives. Despite bariatric surgery being safer and more accessible over the past two decades, less than one in fifty eligible patients with diabetes receive this therapy.

Quality of Care Among Patients with Diabetes and Cerebrovascular Disease. Insights from The Diabetes Collaborative Registry.

BACKGROUND: Although secondary cardiovascular prevention is a focus among patients with type 2 diabetes (T2D) and coronary artery disease (CAD) or peripheral artery disease (PAD), the application of guideline-recommended therapy in T2D patients and isolated cerebrovascular disease (CeVD) remains unknown. METHODS: In a US outpatient registry, T2D patients with established cardiovascular disease from 2014-2018 were categorized as: isolated CeVD, CeVD plus CAD or PAD, or isolated CAD/PAD. In each group, we determined the proportion with optimal secondary prevention (hemoglobin [Hb]A1C <8%, blood pressure <130/80 mm Hg, use of antithrombotics, use of statins, non-smoking/cessation counseling, and use of glucose-lowering medications with cardioprotective effects (sodium-glucose cotransporter [SGLT]-2 inhibitors, glucagon-like peptide [GLP]-1 receptor agonists, thiazolidinediones [TZDs]). Hierarchical Poisson regression was used to estimate relative rate of achieving each target across groups, adjusted for age and chronic kidney disease (where relevant). RESULTS: Our study included 727,467 T2D outpatients with cardiovascular disease (isolated CeVD [n = 99,777], CeVD plus CAD/PAD [n = 158,361], isolated CAD/PAD [n = 469,329]). Compared with isolated CAD/PAD patients, isolated CeVD patients more often had an HbA1c <8% (adjusted relative risk [aRR] 1.10; 95% confidence interval [CI], 1.08-1.11) but less often had a blood pressure of ≤130/80 mm Hg (aRR 0.93; 95% CI, 0.92-0.94) or were prescribed antithrombotics (0.84; 95% CI, 0.83-0.85), statins (0.86; 95% CI, 0.85-0.87), GLP-1 agonists (0.75; 95% CI, 0.73-0.78), SGLT2 inhibitors (0.73; 95% CI, 0.71-0.76), and TZDs (aRR 0.76; 95% CI, 0.73-0.78). CONCLUSION: Among T2D patients, those with isolated CeVD had the lowest rates of secondary cardiovascular prevention goals attainment. More focus is needed on secondary prevention in patients with CeVD.

Impact of Frailty and Prefrailty on Outcomes of Transcatheter or Surgical Aortic Valve Replacement.

BACKGROUND: Randomized trials have shown short- and mid-term benefits with transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) for patients at intermediate or low-risk for surgery. Frailty and prefrailty could explain some of this benefit due to an impaired ability to recover fully from a major surgical procedure. METHODS: We examined 2-year outcomes (survival and Kansas City Cardiomyopathy Questionnaire [KCCQ] scores) among patients at intermediate or low surgical risk treated with transfemoral-TAVR or SAVR within the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial, SAPIEN 3 intermediate-risk registry, and PARTNER 3 trial. Frailty was examined as a continuous variable based on grip strength, gait speed, serum albumin, and activities of daily living. We tested the interaction of frailty markers by treatment (TAVR versus SAVR) in proportional hazards regression models (survival) and piecewise linear regression models (KCCQ), adjusting for patient demographic and clinical factors. RESULTS: Among the 3025 patients in the analytic cohort (2003 TAVR, 1022 SAVR; mean age 79.3 years, 61.6% men), 799 (26.4%) were nonfrail, 2041 (67.5%) were prefrail (1-2 frailty markers), and 185 (6.1%) were frail (3-4 frailty markers). Increasing frailty (none versus prefrail versus frail) was associated with higher 2-year mortality (5.5% versus 11.1% versus 22.8%; log-rank P<0.001) and worse 2-year health status among survivors (KCCQ scores adjusted for baseline: 84.8 versus 79.6 versus 77.4, P<0.001). In multivariable models, there were no significant interactions between frailty markers and treatment group for either survival (interaction P=0.39) or health status (interaction P>0.47 for all time points). CONCLUSIONS: In a cohort of older patients with severe aortic stenosis who were at low or intermediate surgical risk, increasing frailty markers were associated with worse 2-year mortality and greater health status impairment after either TAVR or SAVR, but there were no significant interactions between type of valve replacement and frailty with respect to either outcome.

Incidence rates and predictors of microvascular and macrovascular complications in patients with type 2 diabetes: Results from the longitudinal global discover study.

BACKGROUND: Micro- and macrovascular complications are a major cause of morbidity and mortality in people with type 2 diabetes (T2D). We sought to understand the global incidence rates and predictors of these complications. METHODS: We examined the incidence of vascular complications over 3 years of follow-up in the DISCOVER study-a global, observational study of people with T2D initiating second-line glucose-lowering therapy. Hierarchical Cox proportional hazards regression models examined factors associated with development of micro- and macrovascular complications during follow-up. RESULTS: Among 11,357 people with T2D from 33 countries (mean age 56.9 ± 11.7 years, T2D duration 5.7 ± 5.1 years, HbA1c 8.4 ± 1.7%), 19.0% had a microvascular complication at enrolment (most commonly neuropathy), and 13.2% had a macrovascular complication (most commonly coronary disease). Over 3 years of follow-up, 16.0% developed an incident microvascular complication, and 6.6% had an incident macrovascular complication. At the end of 3 years of follow-up, 31.5% of patients had at least one microvascular complication, and 16.6% had at least one macrovascular complication. Higher HbA1c and smoking were associated with greater risk of both incident micro- and macrovascular complications. Known macrovascular complications at baseline was the strongest predictor for development of new microvascular complications (HR 1.40, 95% CI 1.21 -1.61) and new macrovascular complications (HR 3.39, 95% CI 2.84 -4.06). CONCLUSIONS: In this global study, both the prevalence and 3-year incidence of vascular complications were high in patients with relatively short T2D duration, highlighting the need for early risk-factor modification.

Global patterns of comprehensive cardiovascular risk factor control in patients with type 2 diabetes mellitus: Insights from the DISCOVER study.

AIM: To investigate global patterns of cardiovascular risk factor control in patients with type 2 diabetes mellitus (T2D). METHODS: DISCOVER is an international, observational cohort study of patients with T2D beginning second-line glucose-lowering therapy. Risk factor management was examined among eligible patients (ie, those with the risk factor) at study baseline. Inter-country variability was estimated using median odds ratios (MORs). RESULTS: Among 14 343 patients with T2D from 34 countries, the mean age was 57.4 ± 12.0 years and the median (interquartile range) duration of T2D was 4.2 (2.0-8.0) years; 11.8% had documented atherosclerotic cardiovascular disease (ASCVD). Among eligible patients, blood pressure was controlled in 67.5% (9284/13756), statins were prescribed in 43.7% (5775/13208), angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers were prescribed in 55.6% (5292/9512), aspirin was prescribed in 53.3% of those with established ASCVD (876/1645), and 84.4% (12 102/14343) were non-smoking. Only 21.5% of patients (3088/14343) had optimal risk factor management (defined as control of all eligible measures), with wide inter-country variability (10%-44%), even after adjusting for patient and site differences (MOR 1.47, 95% confidence interval 1.24-1.66). CONCLUSION: Globally, comprehensive control of ASCVD risk factors is not being achieved in most patients, with wide variability among countries unaccounted for by patient and site differences. Better country-specific strategies are needed to implement comprehensive cardiovascular risk factor control consistently in patients with T2D to improve long-term outcomes.

Regional differences in the management of cardiovascular risk factors among adults with diabetes: An evaluation of the Diabetes Collaborative Registry.

AIMS: To compare cardiovascular risk factor control in adults with diabetes participating in a national diabetes registry to those in the general population and to ascertain regional differences in diabetes care. METHODS: Adults with diagnosed diabetes in the Diabetes Collaborative Registry (DCR) were compared with those in the National Health and Nutrition Examination Survey (NHANES) from 2015 to 2016; standardized mean difference (SMD) > 0.2 defined significance. Regional differences were assessed in the DCR cohort; p < .05 defined significance. RESULTS: The DCR cohort was older (61 vs. 57 years, SMD = 0.38), more insured (99.7% vs. 91.0%, SMD = 0.42), and less ethnically diverse (83% non-Hispanic white vs. 76%, SMD = 0.30) compared with NHANES. The proportion of overweight/obesity, A1c < 7% (<53 mmol/mol), and BP < 140/90 were similar, but DCR participants had higher proportion with LDL < 2.59 mmol/L (61% vs. 41%, SMD = 0.39) and fewer tobacco users (17% vs. 32%, SMD = 0.35). Regionally, obesity, lack of glycaemic control, and tobacco use were highest in the Midwest, BP control was the lowest in the South, and LDL control was lowest in the Northeast. CONCLUSIONS: Significant regional differences in diabetes care delivery and outcomes were identified using a national diabetes registry. Serial analyses of the DCR may supplement national evaluations to deepen our understanding of diabetes care in the US.

Comanagement of Risk Factors in Patients With Coronary Artery Disease: Insights From the APPEAR Study.

Background Effective management of cardiovascular risk factors is the foundation of secondary prevention in coronary artery disease. The physician under whose sphere these are managed can vary, primary care physicians, cardiologists, or both, and the optimal management strategy for risk factor control is unknown. Methods and Results The APPEAR (Angina Prevalence and Provider Evaluation of Angina Relief) study was a cross-sectional cohort study of outpatients with coronary artery disease (stable angina, percutaneous coronary intervention, coronary artery bypass grafting, or myocardial infarction) from 25 US cardiology practices. After each patient visit, providers noted who managed each risk factor. Blood pressure and lipid levels were recorded from charts. We compared adherence to guideline-directed risk factor control between management strategies (primary care physician alone, cardiologist alone, or comanaged). Among 1259 outpatients with coronary artery disease (mean [SD] age, 71 [11.1] years; 69% men), blood pressure and lipid management strategy varied. Mean blood pressure was 127.9/72.3 mm Hg, with 74% of patients at <140/90 mm Hg and 46% at <130/80 mm Hg. Mean low-density lipoprotein was 83.5 mg/dL, with 75% of patients at <100 mg/dL and 91% on appropriate statin therapy. Patients managed by cardiologists alone tended to have higher rates of risk factor control for both blood pressure and lipids, even after adjusting for covariates. Conclusions Although comanagement has shown benefit in some clinical situations, we found that risk factor control in patients with coronary artery disease tended to be poorer when care was shared between cardiologists and primary care physicians. Further research is needed to better define which conditions are best comanaged and how to more effectively comanage patients in the fractured US healthcare system.

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.

Cost-Effectiveness of Tafamidis Therapy for Transthyretin Amyloid Cardiomyopathy.

BACKGROUND: In patients with transthyretin amyloid cardiomyopathy, tafamidis reduces all-cause mortality and cardiovascular hospitalizations and slows decline in quality of life compared with placebo. In May 2019, tafamidis received expedited approval from the US Food and Drug Administration as a breakthrough drug for a rare disease. However, at $225 000 per year, it is the most expensive cardiovascular drug ever launched in the United States, and its long-term cost-effectiveness and budget impact are uncertain. We therefore aimed to estimate the cost-effectiveness of tafamidis and its potential effect on US health care spending. METHODS: We developed a Markov model of patients with wild-type or variant transthyretin amyloid cardiomyopathy and heart failure (mean age, 74.5 years) using inputs from the ATTR-ACT trial (Transthyretin Amyloidosis Cardiomyopathy Clinical Trial), published literature, US Food and Drug Administration review documents, healthcare claims, and national survey data. We compared no disease-specific treatment ("usual care") with tafamidis therapy. The model reproduced 30-month survival, quality of life, and cardiovascular hospitalization rates observed in ATTR-ACT; future projections used a parametric survival model in the control arm, with constant hazards reduction in the tafamidis arm. We discounted future costs and quality-adjusted life-years by 3% annually and examined key parameter uncertainty using deterministic and probabilistic sensitivity analyses. The main outcomes were lifetime incremental cost-effectiveness ratio and annual budget impact, assessed from the US healthcare sector perspective. This study was independent of the ATTR-ACT trial sponsor. RESULTS: Compared with usual care, tafamidis was projected to add 1.29 (95% uncertainty interval, 0.47-1.75) quality-adjusted life-years at an incremental cost of $1 135 000 (872 000-1 377 000), resulting in an incremental cost-effectiveness ratio of $880 000 (697 000-1 564 000) per quality-adjusted life-year gained. Assuming a threshold of $100 000 per quality-adjusted life-year gained and current drug price, tafamidis was cost-effective in 0% of 10 000 probabilistic simulations. A 92.6% price reduction from $225 000 to $16 563 would be necessary to make tafamidis cost-effective at $100 000/quality-adjusted life-year. Results were sensitive to assumptions related to long-term effectiveness of tafamidis. Treating all eligible patients with transthyretin amyloid cardiomyopathy in the United States with tafamidis (n=120 000) was estimated to increase annual healthcare spending by $32.3 billion. CONCLUSIONS: Treatment with tafamidis is projected to produce substantial clinical benefit but would greatly exceed conventional cost-effectiveness thresholds at the current US list price. On the basis of recent US experience with high-cost cardiovascular medications, access to and uptake of this effective therapy may be limited unless there is a large reduction in drug costs.

Individualizing Revascularization Strategy for Diabetic Patients With Multivessel Coronary Disease.

BACKGROUND: In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world. OBJECTIVES: To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built. METHODS: Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry. RESULTS: The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking. CONCLUSIONS: To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient's personal outcomes with both treatments.

Association Between Sacubitril/Valsartan Initiation and Health Status Outcomes in Heart Failure With Reduced Ejection Fraction.

OBJECTIVES: This study sought to describe the short-term health status benefits of angiotensin-neprilysin inhibitor (ARNI) therapy in patients with heart failure and reduced ejection fraction (HFrEF). BACKGROUND: Although therapy with sacubitril/valsartan, a neprilysin inhibitor, improved patients' health status (compared with enalapril) at 8 months in the PARADIGM-HF (Prospective Comparison of ARNI with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) study, the early impact of ARNI on patients' symptoms, functions, and quality of life is unknown. METHODS: Health status was assessed by using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ) in 3,918 outpatients with HFrEF and left ventricular ejection fraction ≤40% across 140 U.S. centers in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry. ARNI therapy was initiated in 508 patients who were matched 1:2 to 1,016 patients who were not initiated on ARNI (no-ARNI), using a nonparsimonious time-dependent propensity score (6 sociodemographic factors, 23 clinical characteristics), prior KCCQ overall summary (KCCQ-OS) score, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker status. RESULTS: Multivariate linear regression demonstrated a greater mean improvement in KCCQ-OS in patients initiated on ARNI therapy (5.3 ± 19 vs. 2.5 ± 17.4, respectively; p < 0.001) over a median (interquartile range [IQR]) of 57 (32 to 104) days. The proportions of ARNI versus no-ARNI groups with ≥10-point (large) and ≥20-point (very large) improvements in KCCQ-OS were 32.7% versus 26.9%, respectively, and 20.5% versus 12.1%, respectively, consistent with numbers needed to treat of 18 and 12, respectively. CONCLUSIONS: In routine clinical care, ARNI therapy was associated with early improvements in health status, with 20% experiencing a very large health status benefit compared with 12% who were not started on ARNI therapy. These findings support the use of ARNI to improve patients' symptoms, functions, and quality of life.

Association of Smoking Status With Long-Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement (TAVR) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/nonsmokers. A series of multivariable models examined the association between smoking status and outcomes, including 1-year mortality, rehospitalization, mean gradient, and health status (measured by the 12-item Kansas City Cardiomyopathy Questionnaire-Overall Summary Score [KCCQ-OS]) and in-hospital outcomes. A total of 4063 patients (5.6%) were smokers. Smokers presented for TAVR at a younger age (75 [68-81] years versus 83 [77-88] years) but with a greater burden of cardiovascular and lung disease. In adjusted models, smoking was associated with lower in-hospital mortality (relative risk, 0.74; 95% CI, 0.62-0.89 [P=0.001]) but not with in-hospital stroke/transient ischemic attack or myocardial infarction. Smoking status had no association with postdischarge mortality, stroke, myocardial infarction, or heart failure (HF) but was associated with slightly lower 1-year KCCQ-OS scores (2.4-point lower KCCQ-OS; 95% CI, -4.6 to -0.2 [P=0.031]) and higher mean aortic valve gradients (11.1 versus 10.2 mm Hg, P<0.001) in adjusted models. Conclusions The current/recent smoking rate in US patients with TAVR is 5.6% and smokers present at a younger age for TAVR. Smoking was associated with lower in-hospital but similar long-term survival after TAVR, slightly worse long-term health status, and marginally higher mean aortic valve gradients. Further research is needed to understand the effect of smoking cessation on outcomes.

Association of Changes in Heart Failure Treatment With Patients' Health Status: Real-World Evidence From CHAMP-HF.

OBJECTIVES: The aim of this study was to use a multicenter, observational outpatient registry of patients with heart failure with reduced ejection fraction (HFrEF) to describe the association between changes in patients' medications with changes in health status. BACKGROUND: Alleviating symptoms and improving function and quality of life for patients with HFrEF are primary treatment goals and potential indicators of quality. Whether titrating medications in routine clinical care improves patients' health status is unknown. METHODS: The association of any change in HFrEF medications with 3-month change in health status, as measured using the 12-item Kansas City Cardiomyopathy Questionnaire Overall Summary Scale, was determined in unadjusted and multivariate-adjusted (25 clinical characteristics, baseline health status) models using hierarchical linear regression. RESULTS: Among 3,313 outpatients with HFrEF from 140 centers, 21.9% had medication changes. Three months later, 23.7% and 46.4% had clinically meaningfully worse (≥5-point decrease) and improved (≥5-point increase) Kansas City Cardiomyopathy Questionnaire Overall Summary Scale scores. The 3-month median change in Kansas City Cardiomyopathy Questionnaire Overall Summary Scale score for patients whose HFrEF medications were changed was significantly larger (7.3 points; interquartile range: -3.1 to 20.8 points) than in patients whose medications were not changed (3.1 points; interquartile range: -4.7 to 12.5 points) (adjusted difference 3.0 points; 95% confidence interval: 1.4 to 4.6 points; p < 0.001). Among patients whose medications were adjusted, 26% had very large clinical improvement (≥20 points) compared with 14% whose regimens were not changed. CONCLUSIONS: In routine care of patients with HFrEF, changes in HFrEF medications were associated with significant improvements in patients' health status, suggesting that health status-based performance measures can quantify the benefits of titrating medicines in patients with HFrEF.

Provider-Level Variation in Smoking Cessation Assistance Provided in the Cardiology Clinics: Insights From the NCDR PINNACLE Registry.

Background Studies show suboptimal provision of smoking cessation assistance (counseling or pharmacotherapy) for current smokers attempting to quit. We aimed to identify smoking cessation assistance patterns in US cardiology practices. Methods and Results Among 328 749 current smokers seen between January 1, 2013, and March 31, 2016, in 348 NCDR (National Cardiovascular Data Registry) PINNACLE (Practice Innovation and Clinical Excellence)-affiliated cardiology practices, we measured the rates of cessation assistance. We used multivariable hierarchical logistic regression models to determine provider-, practice-, and patient-level predictors of cessation assistance. We measured provider variation in cessation assistance using median rate ratio (the likelihood that the same patient would receive the same assistance at by any given provider; >1.2 suggests significant variation). Smoking cessation assistance was documented in only 34% of encounters. Despite adjustment of provider, practice, and patient characteristics, there was large provider-level variation in cessation assistance (median rate ratio, 6 [95% CI , 5.76-6.32]). Practice location in the South region (odds ratio [OR], 0.48 [0.37-0.63] versus West region) and rural or suburban location (OR, 0.92 [0.88-0.95] for rural; OR, 0.94 [0.91-0.97] for suburban versus urban) were associated with lower rates of cessation assistance. Similarly, older age (OR, 0.88 [0.88-0.89] per 10-year increase), diabetes mellitus (OR, 0.84 [0.82-0.87]), and atrial fibrillation (OR, 0.93 [0.91-0.96]) were associated with lower odds of receiving cessation assistance. Conclusions In a large contemporary US registry, only 1 in 3 smokers presenting for a cardiology visit received smoking cessation assistance. Our findings suggest the presence of a large deficit and largely idiosyncratic provider-level variation in the provision of smoking cessation assistance.

ST-segment elevation myocardial infarction.

ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality. A complete thrombotic occlusion developing from an atherosclerotic plaque in an epicardial coronary vessel is the cause of STEMI in the majority of cases. Early diagnosis and immediate reperfusion are the most effective ways to limit myocardial ischaemia and infarct size and thereby reduce the risk of post-STEMI complications and heart failure. Primary percutaneous coronary intervention (PCI) has become the preferred reperfusion strategy in patients with STEMI; if PCI cannot be performed within 120 minutes of STEMI diagnosis, fibrinolysis therapy should be administered to dissolve the occluding thrombus. The initiation of networks to provide around-the-clock cardiac catheterization availability and the generation of standard operating procedures within hospital systems have helped to reduce the time to reperfusion therapy. Together with new advances in antithrombotic therapy and preventive measures, these developments have resulted in a decrease in mortality from STEMI. However, a substantial amount of patients still experience recurrent cardiovascular events after STEMI. New insights have been gained regarding the pathophysiology of STEMI and feed into the development of new treatment strategies.