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Background Right‐sided heart failure (HF) due to severe tricuspid regurgitation (TR) is associated with reduced quality of life (QoL). Here, we analyzed the impact of TR on specific QoL dimensions and the effect of transcatheter tricuspid valve intervention (TTVI) on individual QoL items. Methods and Results In this study, we included 174 patients with HF (49% women; median age, 79 years; 97% New York Heart Association ≥3) with baseline QoL assessment undergoing TTVI by transcatheter edge‐to‐edge‐repair at our center between April 2016 and March 2022. QoL was assessed by the standardized Minnesota Living With HF Questionnaire. QoL change after TTVI and correlation to functional end points were analyzed. In addition, all QoL domains and the 21 individual items of the Minnesota Living With HF Questionnaire were analyzed. TTVI significantly reduced TR (TR ≥3: baseline 95%, 1‐year‐follow‐up 7%; P

Background Aficamten, a novel cardiac myosin inhibitor, reversibly reduces cardiac hypercontractility in obstructive hypertrophic cardiomyopathy. We present a prespecified analysis of the pharmacokinetics, pharmacodynamics, and safety of aficamten in SEQUOIA‐HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). Methods and Results A total of 282 patients with obstructive hypertrophic cardiomyopathy were randomized 1:1 to daily aficamten (5–20 mg) or placebo between February 1, 2022, and May 15, 2023. Aficamten dosing targeted the lowest effective dose for achieving site‐interpreted Valsalva left ventricular outflow tract gradient

Background/Objective: To address the opioid epidemic in Kansas City, Missouri, local health systems sought to implement a referral to peer recovery coaches (PRCs) for clients presenting with opioid use disorder. Client referrals were made primarily through health system emergency departments, where PRCs met clients to facilitate linkages to recovery support for up to twelve months. This study aimed to evaluate and improve program implementation with process mapping at three local health systems. Methods: Using a five-phase conceptual framework and three development and implementation domains, providers, administrators, and PRCs were interviewed to identify the process for recognizing clients with opioid use disorders and referring them to PRCs. Serial meetings were held to validate the process maps at three health systems and a distillation of key processes was created to guide future analyses and implementation efforts. Results: A detailed process map for each health system was developed, from which a high-level process map was created to support future implementation efforts. Health system-specific process maps varied, although conceptually coherent elements were identified across each system to diagram a recovery ecosystem to support client referrals to PRCs. Conclusions: By systematically assessing the implementation of the same program across different health systems, critical steps, along with their barriers and facilitators, were identified that can be used to understand the processes of care associated with outcomes and to guide future implementation efforts.

IntroductionDespite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We examined the association between marital/partner status and 1-year all-cause readmission and explored sex differences among young AMI survivors.MethodsData were from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled young adults aged 18-55 years with AMI (2008-2012). The primary end point was all-cause readmission within 1 year of hospital discharge, obtained from medical records and patient interviews and adjudicated by a physician panel. We performed Cox proportional hazards models with sequential adjustment for demographic, socioeconomic, clinical, and psychosocial factors. Sex-marital/partner status interaction was also tested.ResultsOf the 2,979 adults with AMI (2002 women [67.2%]; mean age 48 [interquartile range, 44-52] years), unpartnered individuals were more likely to experience all-cause readmissions compared with married/partnered individuals within the first year after hospital discharge (34.6% versus 27.2%, hazard ratio [HR] = 1.31; 95% confidence interval [CI], 1.15-1.49). The association attenuated but remained significant after adjustment for demographic and socioeconomic factors (adjusted HR, 1.16; 95% CI, 1.01-1.34), and it was not significant after further adjusting for clinical factors and psychosocial factors (adjusted HR, 1.10; 95%CI, 0.94-1.28). A sex-marital/partner status interaction was not significant (p = 0.69). Sensitivity analysis using data with multiple imputation and restricting outcomes to cardiac readmission yielded comparable results.ConclusionsIn a cohort of young adults aged 18-55 years, unpartnered status was associated with 1.3-fold increased risk of all-cause readmission within 1 year of AMI discharge. Further adjustment for demographic, socioeconomic, clinical, and psychosocial factors attenuated the association, suggesting that these factors may explain disparities in readmission between married/partnered versus unpartnered young adults. Whereas young women experienced more readmission compared to similar-aged men, the association between marital/partner status and 1-year readmission did not vary by sex.

Background: Baseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR. Methods: Patients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS. Results: Of 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007). Conclusions: Change in LVDD grade was associated with change in health status 1 year following TAVR.

Background Heart failure is a common complication after myocardial infarction (MI) and is associated with increased mortality. Whether remote heart failure symptoms assessment after MI can improve risk stratification is unknown. The authors evaluated the association of the 23‐item Kansas City Cardiomyopathy Questionnaire (KCCQ) with all‐cause mortality after MI. Methods and Results Prospectively collected data from consecutive patients hospitalized for MI at a large tertiary heart center between June 2017 and September 2022 were used. Patients remotely completed the KCCQ 1 month after discharge. A total of 1135 (aged 64±12 years, 26.7% women) of 1721 eligible patients completed the KCCQ. Ranges of KCCQ scores revealed that 30 (2.6%), 114 (10.0%), 274 (24.1%), and 717 (63.2%) had scores

Background Differences in quality of life (QoL) after coronary artery bypass grafting (CABG) compared with percutaneous coronary intervention (PCI) are not well characterized. We aimed to compare the short‐ and long‐term effects of CABG versus PCI on QoL. Methods and Results We performed a systematic review and meta‐analysis of randomized controlled trials comparing CABG versus PCI using the Seattle Angina Questionnaire (SAQ)‐Angina Frequency, SAQ‐QoL, SAQ‐Physical Limitations, EuroQoL‐5D, and Short‐Form Questionnaire. We calculated mean changes within each group from baseline to 1, 6, 12, and 36 to 60 months (latest follow‐up) and the weighted mean differences between groups using inverse‐variance methods. A total of 10 760 patients were enrolled in 5 trials. From baseline to 12 months and 36 to 60 months, the mean change in SAQ‐Angina Frequency was >22 points (95% CI, 21.0–25.6) after both PCI and CABG. The mean difference in SAQ‐Angina Frequency was similar between procedures at 1 month and at 36 to 60 months but favored CABG at 12 months (1.97 [95% CI, 0.68–3.26]). SAQ‐QoL favored PCI at 1 month (−2.92 [95% CI, −4.66 to −1.18]) and CABG at 6 (2.50 [95% CI, 1.02–3.97]), 12 (3.30 [95% CI, 1.78–4.82]), and 36 to 60 months (3.17 [95% CI, 0.54 5.80). SAQ‐Physical Limitations (−12.61 [95% CI, −16.16 to −9.06]) and EuroQoL‐5D (−0.07 [95% CI, −0.08 to −0.07) favored PCI at 1 month. Short‐Form Questionnaire‐Physical Component favored CABG at 12 months (1.18 [95% CI, 0.46–1.90]). Conclusions Both PCI and CABG improved long‐term disease‐specific and generic QoL.

Background Stress experienced in a marriage or committed relationship may be associated with worse patient‐reported outcomes after acute myocardial infarction (AMI), but little is known about this association in young adults (≤55 years) with AMI. Methods and Results We used data from VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), an observational cohort study that enrolled individuals aged 18 to 55 years with AMI (2008–2012). Marital stress was self‐reported 1 month after AMI using the Stockholm Marital Stress Scale (categorized as absent/mild, moderate, and severe). Outcomes were physical/mental health (Short Form‐12), generic health status (EuroQol‐5 Dimensions), cardiac‐specific quality of life and angina (Seattle Angina Questionnaire), depressive symptoms (Patient Health Questionnaire‐9), and all‐cause readmission 1 year after AMI. Regression models were sequentially adjusted for baseline health, demographics (sex, age, race or ethnicity), and socioeconomic factors (education, income, employment, and insurance). Sex and marital stress interaction was also tested. Among 1593 married/partnered participants, 576 (36.2%) reported severe marital stress, which was more common in female than male participants (39.4% versus 30.4%, P=0.001). Severe marital stress was significantly associated with worse mental health (beta=−2.13, SE=0.75, P=0.004), generic health status (beta=−3.87, SE=1.46, P=0.008), cardiac‐specific quality of life (beta=−6.41, SE=1.65, P0.05). Conclusions The association between marital stress and worse 1‐year health outcomes was statistically significant in young patients with AMI, suggesting a need for routine screening and the creation of interventions to support patients with stress recovering from an AMI.

Background: Elevated cardiac troponin (cTn) levels in patients with COVID-19 has been associated with worse outcomes. Guidelines on best practices of those patients remain uncertain. Methods: We included patients with COVID-19 and cTn above the assay-specific upper limit of normal (ULN) enrolled in the American Heart Association's COVID-19 registry between March 2020–January 2021. Site-level variability in invasive coronary angiography, LVEF assessment, ICU utilization, and inpatient mortality were determined by calculating adjusted median odds ratio (MOR) using hierarchical logistic regression models. Temporal trends were assessed with Cochran-Armitage trend test. Results: Among 32,636 patients, we included 6234 (19.4 %) with cTn above ULN (age 68.7 ± 16.0 years, 56.5 % male, 51.5 % Caucasian), of whom 1365 (21.6 %) had ≥5-fold elevations. Across 55 sites, the median rate of invasive coronary angiography was 0.1 % with adjusted MOR 1.5(1.0,2.3), median LVEF assessment was 25.5 %, MOR 3.0(2.2,3.9), ICU utilization was 41.7 %, MOR 2.2(1.8,2.6), and mortality was 20.9 %, MOR 1.7(1.5,2.0). Over time, we noted a significant increase in invasive coronary angiography (p-trend = 0.001), and LVEF assessment (p-trend

Background: Contrast-associated acute kidney injury (CA-AKI) is a potentially preventable complication of coronary angiography and intervention. Relatively little research has been done to determine how knowledge on CA-AKI prevention can be translated into clinical practice. Methods: We developed, implemented, and surveyed end-users about the usability, acceptability, and utility of an audit and feedback process for CA-AKI prevention in Alberta, Canada. The audit and feedback reported on amount of radiocontrast dye used, hemodynamic optimization of intravenous fluids, and CA-AKI incidence for each cardiologist practicing coronary angiography or percutaneous coronary intervention, compared with peers at their site and across the province. Reports were developed through an iterative process involving interventional cardiologists throughout the design process and usability testing. Results: Cardiologists participating in usability testing indicated a preference for the visual displays of data and summarizing indicators on the front page, and endorsed the value of peer-to-peer comparisons of performance measures. Of 31 eligible cardiologists from across Alberta, 17 responded to a survey evaluating the audit and feedback process. Fifteen respondents (88.2%) agreed that the data presented in the audit and feedback report were understandable; 17 respondents (100%) agreed or strongly agreed that the presentation of the report helped them better understand their performance compared with that of their peers; and 14 (82.4%) agreed that the audit and feedback process helped them identify ways to reduce the risk of AKI for their patients. Conclusions: Conducting an audit and providing feedback was an understandable and acceptable intervention to help cardiologists identify ways to improve prevention of CA-AKI during coronary angiography or intervention. Résumé: Contexte: L’insuffisance rénale aiguë provoquée par un produit de contraste (IRA-PC) est une complication possiblement évitable de la coronarographie et de l’intervention coronarienne. Relativement peu de travaux de recherche ont été menés pour déterminer comment les connaissances sur la prévention de l’IRA-PC peuvent se traduire dans la pratique clinique. Méthodologie: Nous avons élaboré et réalisé un sondage auprès d’utilisateurs finaux sur l’utilisabilité, l’acceptabilité et l’utilité d’un processus de vérification et de rétroaction pour la prévention de l’IRA-PC en Alberta, au Canada. Ce processus visait à rendre compte des données sur la quantité de substances de contraste utilisées, de l’optimisation hémodynamique des liquides intraveineux et de la fréquence de l’IRA-PC pour chaque cardiologue pratiquant des coronarographies ou des interventions coronariennes percutanées, comparativement à leurs confères du même centre et à ceux d’ailleurs dans la province. Les rapports ont été élaborés à l’aide d’un processus itératif auquel ont participé des cardiologues interventionnels tout au long du processus de conception et des tests d’utilisabilité. Résultats: Les cardiologues participant aux tests d’utilisabilité ont indiqué une préférence pour les affichages visuels des données et des indicateurs récapitulatifs sur la première page, et approuvé la valeur des comparaisons des mesures de rendement entre pairs. Sur les 31 cardiologues admissibles de partout en Alberta, 17 ont répondu au sondage évaluant le processus de vérification et de rétroaction. Quinze répondants (88,2 %) ont convenu que les données présentées dans le rapport de vérification et de rétroaction étaient compréhensibles; 17 répondants (100 %) étaient d’accord ou fortement d’accord que la présentation du rapport les avait aidés à mieux comprendre leur rendement comparativement à celui de leurs pairs; et 14 (82,4 %) ont convenu que le processus de vérification et de rétroaction les avait aidés à trouver des façons de réduire le risque d’IRA chez leurs patients. Conclusions: Procéder à une vérification et fournir une rétroaction s’est avérée une intervention compréhensible et acceptable pour aider les cardiologues à trouver des façons d’améliorer la prévention de l’IRA-PC pendant une coronarographie ou une intervention coronaire.

Angina and Non-Obstructive Coronary Artery (ANOCA) patients often lack a clear explanation for their symptoms, and are frequently discharged with the label of “unspecified chest pain”, despite the availability of functional coronary angiography (provocative spasm and microvascular function testing) to identify potential underlying coronary vasomotor disorders. This study compared the outcomes of ANOCA patients with a coronary vasomotor disorder diagnosis post elective coronary angiography to patients discharged with unspecified chest pain. Using the CADOSA (Coronary Angiogram Database of South Australia) registry, consecutive symptomatic patients (n = 7555) from 2012 to 2018 underwent elective angiography; 30% had ANOCA (stenosis p < 0.001) and readmissions for chest pain (30% vs. 10%, p < 0.001) compared with those with unspecified chest pain. This real-world study emphasizes the importance of identifying high-risk ANOCA patients for personalized management to effectively address their symptoms.

Abstract Aims We aimed to develop a risk prediction tool that incorporated both clinical events and worsening health status for patients with heart failure (HF) with reduced ejection fraction (HFrEF). Identifying patients with HFrEF at increased risk of a poor outcome may enable proactive interventions that improve outcomes. Methods and results We used data from a longitudinal HF registry, CHAMP‐HF, to develop a risk prediction tool for poor outcomes over the next 6 months. A poor outcome was defined as death, an HF hospitalization, or a ≥20‐point decrease (or decrease below 25) in 12‐item Kansas City Cardiomyopathy Questionnaire (KCCQ‐12) overall summary score. Among 4546 patients in CHAMP‐HF, 1066 (23%) experienced a poor outcome within 6 months (1.3% death, 11% HF hospitalization, and 11% change in KCCQ‐12). The model demonstrated moderate discrimination (c‐index = 0.65) and excellent calibration with observed data. The following variables were associated with a poor outcome: age, race, education, New York Heart Association class, baseline KCCQ‐12, atrial fibrillation, coronary disease, diabetes, chronic kidney disease, smoking, prior HF hospitalization, and systolic blood pressure. We also created a simplified model with a 0–10 score using six variables (New York Heart Association class, KCCQ‐12, coronary disease, chronic kidney disease, prior HF hospitalization, and systolic blood pressure) with similar discrimination (c‐index = 0.63). Patients scoring 0–3 were considered low risk (event rate 40%). Conclusions The PROMPT‐HF risk model can identify outpatients with HFrEF at increased risk of poor outcomes, including clinical events and health status deterioration. With further validation, this model may help inform therapeutic decision making.

Background Although chronic total occlusions (CTOs) are common in older adults, they are less likely to be offered CTO percutaneous coronary intervention for angina relief than younger adults. The health status impact of CTO percutaneous coronary intervention in adults aged ≥75 years has not been studied. We sought to compare technical success rates and angina‐related health status outcomes at 12 months between adults aged ≥75 and

Background Although aldosterone antagonists improve outcomes in select individuals with heart failure and reduced ejection fraction, studies in the United States have raised concerns about underuse and overuse. Variations in the prescription of aldosterone antagonist in China are unknown. Methods and Results In the multicenter, hospital‐based, retrospective China PEACE (China Patient‐Centered Evaluative Assessment of Cardiac Events) study, we identified a nationally representative cohort of admissions for heart failure in a nationally representative sample of Chinese hospitals in 2015. Patients were classified into 1 of 3 groups according to their eligibility for spironolactone—“ideal” (left ventricular ejection fraction

Background: Health literacy (HL) is the degree to which individuals can obtain, process, and understand basic health information and services. Although low HL portends greater risk for clinical events, its association with heart failure (HF)-specific health status– patients' symptoms, function and quality of life– is poorly understood. We thus explored the association of low HL with health status outcomes in depressed patients with HF, for whom treatment regimens can be complex. Methods: Participants with HF with reduced ejection fraction and depression, from the Hopeful Heart trial, were categorized as having low or adequate HL at baseline using a validated, 1-item HL screen. HF-specific health status was measured at baseline, 3, 6, and 12 months using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Using serial risk-adjusted linear regression models, we assessed the association of HL with baseline, 12-month and 12-month change in the KCCQ Overall Summary (OS) scores (range 0–100; lower scores = worse health status). Results: Among 629 participants, 35 % had low HL. Those with low HL had lower health status at all time points, including at 12 months after discharge (−9.8 points, 95%CI [−14.3, −5.3], p

Abstract Aims Improving the health status (symptoms, function, and quality of life) of patients with heart failure with reduced ejection fraction (HFrEF) is a primary treatment goal. Angiotensin receptor neprilysin inhibitors (ARNI) improve short‐term health status in clinical practice, but the sustainability of these improvements is unknown. Methods and results In CHAMP‐HF, a multicentre observational study of outpatients with HFrEF, patients initiated on ARNI were propensity score matched 1:2 to patients not using ARNI with Cox regression modelling time to ARNI initiation, adjusted for sociodemographic and clinical variables, medical history, medications, and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Repeated measures models for the overall KCCQ score and each domain compared the health status trajectories of patients initiated on ARNI vs. not. Among 3930 participants, 746 (19.0%) began ARNI, of whom 576 were matched to 1152 non‐ARNI patients. Prior to matching, participants initiated on ARNI were younger, non‐Hispanic, had lower EFs, more commonly had a history of ventricular arrhythmia, were less likely to be taking an ACEI/ARB, and more likely to be treated with beta‐blockers and mineralocorticoid receptor antagonists. There were no differences after matching. In the matched cohort, participants initiated on ARNI experienced improved health status by 3 months that persisted through 12 months [KCCQ Overall Summary Score (OSS) = 73.4 vs. 70.8; P

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

Background: The knowledge of factors influencing disease progression in patients with established coronary heart disease (CHD) is still relatively limited. One potential pathway is related to peroxisome proliferator–activated receptor gamma coactivator-1 alpha (PPARGC1A), a transcription factor linked to energy metabolism which may play a role in the heart function. Thus, its associations with subsequent CHD events remain unclear. We aimed to investigate the effect of three different SNPs in the PPARGC1A gene on the risk of subsequent CHD in a population with established CHD.Methods: We employed an individual-level meta-analysis using 23 studies from the GENetIcs of sUbSequent Coronary Heart Disease (GENIUS-CHD) consortium, which included participants (n = 80,900) with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. Three variants in the PPARGC1A gene (rs8192678, G482S; rs7672915, intron 2; and rs3755863, T528T) were tested for their associations with subsequent events during the follow-up using a Cox proportional hazards model adjusted for age and sex. The primary outcome was subsequent CHD death or myocardial infarction (CHD death/myocardial infarction). Stratified analyses of the participant or study characteristics as well as additional analyses for secondary outcomes of specific cardiovascular disease diagnoses and all-cause death were also performed.Results: Meta-analysis revealed no significant association between any of the three variants in the PPARGC1A gene and the primary outcome of CHD death/myocardial infarction among those with established CHD at baseline: rs8192678, hazard ratio (HR): 1.01, 95% confidence interval (CI) 0.98–1.05 and rs7672915, HR: 0.97, 95% CI 0.94–1.00; rs3755863, HR: 1.02, 95% CI 0.99–1.06. Similarly, no significant associations were observed for any of the secondary outcomes. The results from stratified analyses showed null results, except for significant inverse associations between rs7672915 (intron 2) and the primary outcome among 1) individuals aged ≥65, 2) individuals with renal impairment, and 3) antiplatelet users.Conclusion: We found no clear associations between polymorphisms in the PPARGC1A gene and subsequent CHD events in patients with established CHD at baseline.

Background There are limited data on the use of angiotensin receptor neprilysin inhibitors (ARNIs) in minority populations with heart failure (HF) with reduced ejection fraction. We used data from the CHAMP‐HF (Change the Management of Patients With Heart Failure) registry to evaluate ARNI initiation and associated changes in health status and clinical outcomes across different races and ethnicities. Methods and Results CHAMP‐HF was a prospective, observational registry of US outpatients with chronic HF with reduced ejection fraction. We compared patients starting ARNI with patients not starting ARNI using a propensity‐matched analysis. Patients were grouped as Hispanic, non‐Hispanic Black, non‐Hispanic White, or non‐Hispanic other individuals, where “non‐Hispanic other” consists of all patients who did not identify as Hispanic, Black, or White. Health status was assessed using the 12‐item Kansas City Cardiomyopathy Questionnaire. Outcomes were analyzed with multivariable models that included race and ethnicity, ARNI initiation, and an interaction term between race and ethnicity and ARNI initiation. Cox proportional hazards models were used for death/HF hospitalization, and multiple regression was used for change in Kansas City Cardiomyopathy Questionnaire score. The analysis included 1516 patients, with 758 patients in each group (ARNI and no ARNI). Changes in Kansas City Cardiomyopathy Questionnaire score after ARNI initiation were similar among all race and ethnicity groups (mean [SD], non‐Hispanic White individuals, 3.5 [19.0]; non‐Hispanic Black individuals, 2.0 [17.0]; non‐Hispanic other individuals, 5.5 [20.3]; and Hispanic individuals, 3.2 [20.1]), with no statistically significant interaction between race and ethnicity and ARNI initiation (P=0.21). There was similarly no statistically significant interaction between race and ethnicity and ARNI initiation for HF hospitalization (P=0.82) or all‐cause mortality (P=0.92). Conclusions In a large registry of outpatients with HF with reduced ejection fraction, the association between ARNI initiation and outcomes did not differ by race and ethnicity. These data support the use of ARNI therapy for chronic HF with reduced ejection fraction irrespective of race and ethnicity.

The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a simple, feasible, and sensitive questionnaire developed in English for assessing the health status (symptoms, function, and quality of life) of patients with heart failure (HF). We aimed to assess the internal consistency and construct validity of the Portuguese version of KCCQ-12. We administered the KCCQ-12, the Minnesota Living Heart Failure (MLHFQ), and the New York Heart Association (NYHA) classification by telephone. Internal consistency was assessed with Cronbach’s Alpha (α-Cronbach) and construct validity with correlations to the MLHFQ and NYHA. Internal consistency was high (α-Cronbach = 0.92 for the Overall Summary score and 0.77–0.85 for the subdomains). Construct validity was supported by finding high correlations between the KCCQ-12 Physical Limitation and the Symptom Frequency domains with the physical domain of the MLHFQ (r = −0.70 and r = −0.76, p < 0.001 for both) and the Overall Summary scale with NYHA classifications (r = −0.72, p < 0.001). The Portuguese version of KCCQ-12 has high internal consistency and shows a convergent construct validity with other measures quantifying the health status of patients with chronic HF and can be used confidently in Brazil for research and clinical care.

Abstract Aims The aim of our study was to investigate heterogeneity of health status treatment response of sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF). Methods and results We leveraged data from CHAMP‐HF, an observational registry of 140 US clinics and 5026 outpatients with chronic HFrEF, where health status was serially assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ)‐12 Overall Summary Scale (range from 0 to 100; ≥20‐point improvement is a very large improvement). In 334 patients newly initiated on sacubitril/valsartan, we used hierarchical multivariable logistic regression (13 patient‐level characteristics as well as baseline KCCQ‐12 score) to calculate the odds ratio (OR) of any characteristic being associated with a very large health status improvement. A total of 104/334 (31.1%) of patients achieved the primary endpoint, where only worse baseline health status [KCCQ‐12 score of 0–60 points had an OR = 0.86/5‐point higher score (CI 0.79, 0.93)], and those with a KCCQ‐12 score of 60–80 points had an OR = 0.61/5‐point higher score (0.45–0.82), which was associated with a very large benefit. No other patient characteristic was associated with a very large health status improvement (P > 0.05). Conclusions We found that, after initiation of sacubitril/valsartan, only worse baseline health status was associated with very large health status improvement. Accordingly, a trial of therapy—particularly in those with worse symptoms, function, and quality of life—and assessing treatment response are likely to be the best prospective strategy.

Background Given that percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) is indicated primarily for symptom relief, identifying patients most likely to benefit is critically important for patient selection and shared decision‐making. Therefore, we identified factors associated with residual angina frequency after CTO PCI and developed a model to predict postprocedure anginal burden. Methods and Results Among patients in the OPEN‐CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated the association between patient characteristics and residual angina frequency at 6 months, as assessed by the Seattle Angina Questionnaire Angina Frequency Scale. We then constructed a prediction model for angina status after CTO PCI using ordinal regression. Among 901 patients undergoing CTO PCI, 28% had no angina, 31% had monthly angina, 30% had weekly angina, and 12% had daily angina at baseline. Six months later, 53% of patients had a ≥20‐point increase in Seattle Angina Questionnaire Angina Frequency Scale score. The final model to predict residual angina after CTO PCI included baseline angina frequency, baseline nitroglycerin use frequency, dyspnea symptoms, depressive symptoms, number of antianginal medications, PCI indication, and presence of multiple CTO lesions and had a C index of 0.78. Baseline angina frequency and nitroglycerin use frequency explained 71% of the predictive power of the model, and the relationship between model components and angina improvement at 6 months varied by baseline angina status. Conclusions A 7‐component OPEN‐AP (OPEN‐CTO Angina Prediction) score can predict angina improvement and residual angina after CTO PCI using variables commonly available before intervention. These findings have implications for appropriate patient selection and counseling for CTO PCI.

Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients’ preferences, or outcomes, as seen from patients’ perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Background There is a paucity of research describing health‐related quality of life (HRQOL) in older adults considered for advanced heart failure surgical therapies. Using data from our SUSTAIN‐IT (Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support) study, we aimed to compare HRQOL among 3 groups of older (60–80 years) patients with heart failure before heart transplantation (HT) or long‐term mechanical circulatory support (MCS) and identify factors associated with HRQOL: (1) HT candidates with MCS, (2) HT candidates without MCS, or (3) candidates ineligible for HT and scheduled for long‐term MCS. Methods and Results Patients from 13 US sites completed assessments, including self‐reported measures of HRQOL (EuroQol‐5 Dimension Questionnaire, Kansas City Cardiomyopathy Questionnaire–12), depressive symptoms (Personal Health Questionnaire–8), anxiety (State‐Trait Anxiety Inventory–state form), cognitive status (Montreal Cognitive Assessment), and performance‐based measures (6‐minute walk test and 5‐m gait speed). Analyses included ANOVA, χ2 tests, Fisher’s exact tests, and linear regression. The sample included 393 patients; the majority of patients were White men and married. Long‐term MCS candidates (n=154) were significantly older and had more comorbidities and a higher New York Heart Association class than HT candidates with MCS (n=118) and HT candidates without MCS (n=121). Long‐term MCS candidates had worse HRQOL than HT candidates with and without MCS (EQ‐5D visual analog scale scores, 46±23 versus 68±18 versus 54±23 [P

Background While peripheral artery disease (PAD) is associated with increased cardiovascular morbidity with mortality remaining high and challenging to predict, accurate understanding of serial PAD‐specific health status around the time of diagnosis may prognosticate long‐term mortality risk. Methods and Results Patients with new or worsening PAD symptoms enrolled in the PORTRAIT Registry across 10 US sites from 2011 to 2015 were included. Health status was assessed by the Peripheral Artery Questionnaire (PAQ) Summary score at baseline, 3‐month, and change from baseline to 3‐month follow‐up. Kaplan‐Meier using 3‐month landmark and hierarchical Cox regression models were constructed to assess the association of the PAQ with 5‐year all‐cause mortality. Of the 711 patients (mean age 68.8±9.6 years, 40.9% female, 72.7% white; mean PAQ 47.5±22.0 and 65.9±25.0 at baseline and 3‐month, respectively), 141 (19.8%) died over a median follow‐up of 4.1 years. In unadjusted models, baseline (HR, 0.90 per‐10‐point increment; 95% CI, 0.84–0.97; P=0.008), 3‐month (HR [95% CI], 0.87 [0.82–0.93]; P

Background Chronic stress in patients with cardiovascular disease (CVD), including peripheral artery disease (PAD), is independently associated worse outcomes. A model that can reliably identify factors associated with risk of chronic stress in patients with CVD is needed. Methods In a prospective myocardial infarction (MI) registry (TRIUMPH), we constructed a logistic regression model using 27 patient demographic, socioeconomic, and clinical factors, adjusting for site, to identify predictors of chronic stress over 1 year. Stress at baseline and at 1-, 6- and 12-month follow-up was measured using the 4-item Perceived Stress Scale (PSS-4) [range 0–16, scores ≥6 depicting high stress]. Chronic stress was defined as at least 2 follow-up PSS-4 scores ≥6. We identified and validated this final model in another prospective registry of patients with symptomatic PAD, the PORTRAIT study. Results Our derivation cohort consisted of 4,340 patients with MI (mean age 59.1 ± 12.3 years, 33% females, 30% non-white), of whom 30% had chronic stress at follow-up. Of the 27 factors examined, female sex, current smoking, socioeconomic status, and economic burden due to medical care were positively associated with chronic stress, and ENRICHD Social Support Instrument (ESSI) score and age were inversely related to chronic stress. In the validation cohort of 797 PAD patients (mean age 68.6±9.7 years, 42% females, 28% non-white, 18% chronic stress) the c-statistic for the model was 0.77 and calibration was excellent. Conclusions We can reliably identify factors that are independently associated with risk of chronic stress in patients with CVD. As chronic stress is associated with worse outcomes in this population, our work identifies potential targets for interventions to as well as the patients that could benefit from these.

Background Data on health status outcomes after spontaneous coronary artery dissection (SCAD) are limited. Methods and findings Using the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study we compared patients with SCAD and other acute myocardial infarction (AMI) at presentation (baseline), 1-month, and-12 months using standardized health status instruments. Among 3572 AMI patients ≤ 55 years, 67 had SCAD. SCAD patients were younger (median age (IQR) 45 (40.5–51) years vs. 48 (44–52) in other AMI, p = 0.003), more often female (92.5% vs. 66.6%), have college education (73.1% vs. 51.7%) and household income >$100,000 (43.3% vs. 17.7% (All pConclusions SCAD patients fare marginally better than other AMI patients on most health status instruments and have similar 12-month health status recovery. Better pre-event health status suggests a need to modify exercise prescriptions and cardiac rehabilitation protocols to better assist this physically active population to recover.

Background In aortic valve disease, the relationship between claims‐based frailty indices (CFIs) and validated measures of frailty constructed from in‐person assessments is unclear but may be relevant for retrospective ascertainment of frailty status when otherwise unmeasured. Methods and Results We linked adults aged ≥65 years in the US CoreValve Studies (linkage rate, 67%; mean age, 82.7±6.2 years, 43.1% women), to Medicare inpatient claims, 2011 to 2015. The Johns Hopkins CFI, validated on the basis of the Fried index, was generated for each study participant, and the association between CFI tertile and trial outcomes was evaluated as part of the EXTEND‐FRAILTY substudy. Among 2357 participants (64.9% frail), higher CFI tertile was associated with greater impairments in nutrition, disability, cognition, and self‐rated health. The primary outcome of all‐cause mortality at 1 year occurred in 19.3%, 23.1%, and 31.3% of those in tertiles 1 to 3, respectively (tertile 2 versus 1: hazard ratio, 1.22; 95% CI, 0.98–1.51; P=0.07; tertile 3 versus 1: hazard ratio, 1.73; 95% CI, 1.41–2.12; P

Background Randomized clinical trials have demonstrated that catheter ablation (CA) for atrial fibrillation improves health‐related quality of life (HRQoL). In daily practice, however, CA is performed on a wide range of patients, and outcomes may vary. We aimed to examine baseline and 1‐year HRQoL outcomes of patients with atrial fibrillation after CA in daily practice. Methods and Results Using a registry‐based cohort study designed to recruit patients with atrial fibrillation newly referred to 11 hospitals, we extracted data from 1097 consecutive patients with atrial fibrillation who underwent CA between 2012 and 2019. The Atrial Fibrillation Effects on Quality of Life Overall Summary (AFEQT‐OS) was assessed at registration and 1 year after, and a 5‐point increase in AFEQT‐OS score was considered a meaningful improvement. Overall, the median age was 64 (interquartile range, 56–70) years, 836 (76.2%) were men, and 93.0% (n=1021) of the patients answered the AFEQT questionnaire. The mean AFEQT‐OS score was 74.9 (SD, 18.0) at registration and 88.8 (SD, 12.6) at 1 year after. Notably, the incidence of meaningful improvement in HRQoL after CA was 88.6% for the patients with impaired HRQoL (AFEQT‐OS score

As research defines new treatments and policies to improve the health of patients, an increasing challenge has been to translate these insights into routine clinical practice to benefit patients and society. An important exploration is how theories of human behavior change fit into the science of implementation and quality improvement. In this paper, we begin with a brief review of the intellectual roots of implementation science and quality improvement, followed by a discussion of how theories and principles of behavior change can inform both goals and challenges in using behavior change theories. The insights offered through health behavior change theory have led to changes in how we plan for implementation and select, develop, design and tailor implementation interventions and strategies. While the degree to which organizational and external contexts influence the behavior of providers in these organizations varies widely, some degree of context external to the individual is important and needs adequate consideration. In short, health behavior change theory is essential but not sufficient to integrate in most implementation efforts, where priority must be given to both individual factors and contexts in which individuals operate.

BackgroundSleep apnea is a predictor of adverse cardiovascular outcome in many cardiovascular diseases but whether it is associated with worse health status outcomes or mortality in peripheral artery disease (PAD) is unknown.MethodsPORTRAIT is an international (US, Netherlands, Australia) prospective PAD registry that consecutively enrolled patients who presented with new-onset or recent exacerbations of PAD symptoms to any of 16 vascular specialty clinics. Health status was assessed upon presentation and at 12 months with the disease-specific Peripheral Artery Questionnaire (PAQ). Higher PAQ scores indicate better health status. A sequentially-adjusted hierarchical linear regression model examined the association between sleep apnea and 1-year PAQ symptoms, quality of life, and summary scores. Five-year survival curves by comorbid sleep apnea status for US patients were compared using the log-rank test.ResultsThe mean age of the 1204 PORTRAIT participants was 67.6 ± 9.4 years with 37.5% women and 8.3% (n = 100) having sleep apnea. Patients with sleep apnea were more likely to be from the US, more sedentary, and to have diabetes, obesity, coronary disease, more depressive symptoms and a history of prior peripheral interventions. Paradoxically, they also had higher ankle-brachial indices, but lower PAQ Summary scores at presentation and 12 months (41.2 ± 22.0 vs. 49. 9± 21.6 and 58.6 ± 27.9 vs. 71.3 ± 24.9, respectively, p = ConclusionIn patients presenting with PAD, comorbid sleep apnea is independently associated with worse health status over time. Future studies should test whether better treatment of sleep apnea can improve the health status of patients with PAD.Clinical trial registrationNCT01419080.

BackgroundThe RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrated that higher-risk patients with atrial fibrillation had lower rates of stroke or systemic embolism and a similar rate of major bleeding, on average, when treated with dabigatran 150mg compared to warfarin. Since population-level averages may not apply to individual patients, estimating the heterogeneity of treatment effect can improve application of RE-LY in clinical practice.Methods and resultsFor 18040 patients randomized in RE-LY, we used patient-level data to develop multivariable models to predict the risk for stroke or systemic embolism and for major bleeding including all three treatment groups (dabigatran 110mg, dabigatran 150mg, and warfarin) over a median follow up of 2.0 years. The mean predicted absolute risk reduction (ARR) for stroke/systemic embolism with dabigatran 150mg compared to warfarin was 1.32% (range 11.6% lower to 3.30% higher risk). The mean predicted ARR for bleeding was 0.41% (range 8.93% lower to 63.4% higher risk). Patients with increased stroke/systemic embolism risk included those with prior stroke/TIA (OR 2.01), diabetics on warfarin (OR 2.00), and older patients on dabigatran 150mg (OR 1.68 for every 10-year increase). Major bleeding risk was higher in patients on aspirin (OR 1.25), with a history of diabetes (OR 1.34) or prior stroke/TIA (OR 1.22), those with heart failure on dabigatran 110mg (OR 1.52), older patients on either dabigatran 110mg or 150mg (OR 1.57 and 1.93, respectively, for each 10-year increase), and heavier patients on dabigatran 110mg or 150mg; patients in a region outside the United States and Canada and with better renal function had lower bleeding risk.ConclusionsThere is substantial heterogeneity in the benefits and risks of dabigatran relative to warfarin among patients with atrial fibrillation. Using individualized estimates may enable shared decision making and facilitate more appropriate use of dabigatran; as such, it should be prospectively tested.Clinical trial registrationwww.clinicaltrials.gov number, NCT00262600.

Background. Health technology assessment bodies in several countries, including Japan and the United Kingdom, recommend mapping techniques to obtain utility scores in clinical trials that do not have a preference-based measure of health. This study sought to develop mapping algorithms to predict EQ-5D-3L scores from the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with heart failure (HF). Methods. Data from the randomized, double-blind PARADIGM-HF trial were analyzed, and EQ-5D-3L scores were calculated using the Japanese and UK value sets. Several different model specifications were explored to best fit EQ-5D data collected at baseline with KCCQ scores, including ordinary least square regression, two-part, Tobit, and three-part models. Generalized estimating equations models were also fitted to analyze longitudinal EQ-5D data. To validate model predictions, the data set was split into a derivation ( n = 4,465) from which the models were developed and a separate sample ( n = 1,892) for validation. Results. There were only small differences between the different model classes tested. Model performance and predictive power was better for the item-level models than for the models including KCCQ domain scores. R 2 statistics for the item-level models ranged from 0.45 to 0.52. Mean absolute error in the validation sample was 0.10 for the models using the Japanese value set and 0.114 for the UK models. All models showed some underprediction of utility above 0.75 and overprediction of utility below 0.5, but performed well for population-level estimates. Conclusions. Using data from a large clinical trial in HF, we found that EQ-5D-3L scores can be estimated from responses to the KCCQ and can facilitate cost-utility analysis from existing HF trials where only the KCCQ was administered. Future validation in other HF populations is warranted.

Background Patients with peripheral artery disease (PAD) and coexisting diabetes mellitus (DM) have greater PAD progression and adverse limb events. Our aim was to study whether PAD‐specific health status differs by DM. Methods and Results The PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) trial is a 16‐center international registry that includes patients with recent exacerbations or new‐onset symptomatic PAD presenting to specialty clinics. We assessed PAD‐specific health status initially and at 3, 6, and 12 months (Peripheral Artery Questionnaire [PAQ]). We used hierarchical, multivariable, linear regression, and repeated measures analyses to study the association between DM and baseline health status initially and over 3 to 12 months. Models were adjusted for demographics, socioeconomic factors, PAD severity, comorbidities, and psychosocial characteristics. The interaction of DM with PAD revascularization on 3‐ to 12‐month health status was also tested. Of 1204 patients, 398 (33%) had DM (94% type 2). Patients with versus those without DM had lower unadjusted PAQ summary scores at baseline and 3, 6, and 12 months (46.1 versus 50.8, 63.6 versus 68.2, 65.7 versus 71.7, and 65.4 versus 72.6; P≤0.01). In fully adjusted models, the effect of DM on baseline (mean difference, −0.65; 95% CI, −2.86 to 1.56 [P=0.56]) and over 3‐ to 12‐month PAQ summary scores (mean difference, −1.59; 95% CI, −4.06 to 0.88 [P=0.21]) was no longer significant. Twelve‐month health status gains following revascularization were similar in both groups (P=0.69). Conclusions Patients with PAD with coexisting DM have poorer health status, mostly explained by the differences in their psychosocial and other comorbidity burden. Patients with PAD and DM versus those without DM experience similar health status benefits following PAD revascularization.

Background Improving health‐related quality of life is an important goal in the management of patients with heart failure (HF). Defining health‐related quality of life changes over time in patients with HF with preserved (HFpEF) or reduced ejection fraction and showing their association with other important clinical events could support the use of health‐related quality of life as a measure of quantifying HF care. Methods and Results In the Alberta HEART (Heart Failure Aetiology and Analysis Team) cohort (n=621), patients were categorized into 4 subgroups: healthy controls (n=98), at risk (n=163), HFpEF (n=191), and HF with reduced ejection fraction (n=169). The change of the Kansas City Cardiomyopathy Questionnaire (KCCQ), EuroQOL 5 dimensions, and Functional Assessment of Cancer Therapy—Anemia over 12 months, and its association with a composite of death or rehospitalization within 3 years were assessed. At baseline, the KCCQ overall summary score was 73 (interquartile range, 53–86) in HFpEF and 78 (interquartile range, 56–90) in HF with reduced ejection fraction (P=0.22). Overall, 30.5% of patients with HF experienced ≥5‐point improvements and 32.4% had ≥5‐point worsening in KCCQ overall summary score at 12 months, which did not differ between HFpEF and HF with reduced ejection fraction (P=0.23). Clinical events were higher in patients with HF who had a decline in KCCQ over 12 months as compared with those with stable KCCQ scores (70.2% versus 52.0%, P=0.012). The results were similar for the Functional Assessment of Cancer Therapy—Anemia and EuroQOL 5 dimensions. Conclusions In patients with HF, the KCCQ quantified clinically meaningful changes over time, which were associated with important clinical outcomes in patients with HFpEF. Given the observed variability and prognostication in different patient trajectories, health‐related quality of life measures could be valuable for quantifying the quality of care in healthcare systems.

Background The association of depressive symptoms with health status in peripheral artery disease (PAD) is understudied. No reports of differential impact on women have been described. Methods and Results The PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Artery Disease Investigating Trajectories) registry enrolled 1243 patients from vascular specialty clinics with new or worsening PAD symptoms. Depressive symptoms were assessed at baseline and 3 months using the 8‐Item Patient Health Questionnaire (score ≥10 indicating clinically relevant depressive symptoms). Disease‐specific and generic health status were measured by Peripheral Artery Questionnaire and EQ‐5D Visual Analogue Scale at baseline and 3, 6, and 12 months. An adjusted general linear model for repeated measures was constructed for baseline and 3‐, 6‐, and 12‐month health status outcomes by depressive symptoms at baseline. Differences by sex were tested with interaction effects. The mean age was 67.6±9.4 years with 38% (n=470) women. More women than men (21.1% versus 12.9%; P