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Background: The ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial randomized participants with chronic coronary disease (CCD) to guideline-directed medical therapy with or without angiography and revascularization. The study examined the association of nonadherence with health status outcomes., Objectives: The study sought to compare 12-month health status outcomes of adherent and nonadherent participants with CCD with an a priori hypothesis that nonadherent patients would have better health status if randomized to invasive management., Methods: Self-reported medication-taking behavior was assessed at randomization with a modified 4-item Morisky-Green-Levine Adherence Scale, and participants were classified as adherent or nonadherent. Twelve-month health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ-7) summary score (SS), which ranges from 0 to 100 (higher score = better). The association of adherence with outcomes was evaluated using Bayesian proportional odds models, including an interaction by study arm (conservative vs invasive)., Results: Among 4,480 randomized participants, 1,245 (27.8%) were nonadherent at baseline. Nonadherent participants had worse baseline SAQ-7 SS in both conservative (72.9 ± 19.3 vs 75.6 ± 18.4) and invasive (71.0 ± 19.8 vs 74.2 ± 18.7) arms. In adjusted analyses, adherence was associated with higher 12-month SAQ-7 SS in both treatment groups (mean difference in SAQ-7 SS with conservative treatment = 1.6 [95% credible interval: 0.3-2.9] vs with invasive management = 1.9 [95% credible interval: 0.8-3.1]), with no interaction by treatment., Conclusions: More than 1 in 4 participants reported medication nonadherence, which was associated with worse health status in both conservative and invasive treatment strategies at baseline and 12 months. Strategies to improve medication adherence are needed to improve health status outcomes in CCD, regardless of treatment strategy. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522)., Competing Interests: Funding Support and Author Disclosures Dr Garcia is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number 5T32H110837. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr Spertus owns the copyright to the Kansas City Cardiomyopathy Questionnaire and Seattle Angina Questionnaire; unrelated to this work, he has served as a consultant on patient-reported outcomes for Janssen, Pfizer, Bristol Myers Squibb, Bayer, Merck, Novartis, Corvia, Terumo, and Abbott; has received research grants from the American College of Cardiology Foundation, Janssen, MyoKardia, and Abbott Vascular; has served on the scientific advisory board for United Healthcare; and has served on the Board of Directors of Blue Cross Blue Shield of Kansas City. Dr Newman has received funding from the National Heart, Lung, and Blood Institute. Dr Bangalore has served as a consultant to Abbott Vascular, Biotronik, Pfizer, and Amgen; and has received research grants from the National Heart, Lung, and Blood Institute and Abbott Vascular. Dr Stone has received speaker honoraria from Cook and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and owns equity or options in Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds. Dr. Reynolds has received funding from the National Heart, Lung, and Blood Institute; and has received in-kind donations for unrelated research from Abbott Vascular, Siemens, and BioTelemetry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. All rights reserved.)

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 <0.001) presented with severe depressive symptoms. In the adjusted model, patients with depressive symptoms had worse health status at each time point (all P <0.0001). Results were similar for EQ-5D Visual Analogue Scale scores. The magnitude in 1-year change in health status scores did not differ by sex. Depressive symptoms explained 19% of the association between sex differences in 1-year Peripheral Artery Questionnaire summary scores. Conclusions Women with PAD have a high burden of depressive symptoms. Depressive symptoms were associated with a strikingly worse disease-specific health status recovery path over the year following PAD diagnosis in men and women. Developing and testing interventions to address depressive symptoms in PAD are urgently needed. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.

Background: In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status., Methods: We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy., Results: Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4)., Conclusions: Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.)., (Copyright © 2020 Massachusetts Medical Society.)

Background Survival and health status (eg, symptoms and quality of life) are key outcomes in clinical trials of heart failure treatment. However, health status can only be recorded on survivors, potentially biasing treatment effect estimates when there is differential survival across treatment groups. Joint modeling of survival and health status can address this bias. Methods and Results We analyzed patient-level data from the PARTNER 1B trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement versus standard care. Health status was quantified with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization, 1, 6, and 12 months. We compared hazard ratios for survival and mean differences in KCCQ scores at 12 months using several models: the original growth curve model for KCCQ scores (ignoring death), separate Bayesian models for survival and KCCQ scores, and a Bayesian joint longitudinal-survival model fit to either 12 or 30 months of survival follow-up. The benefit of transcatheter aortic valve replacement on 12-month KCCQ scores was greatest in the joint-model fit to all survival data (mean difference, 33.7 points; 95% credible intervals [CrI], 24.2-42.4), followed by the joint-model fit to 12 months of survival follow-up (32.3 points; 95% CrI, 22.5-41.5), a Bayesian model without integrating death (30.4 points; 95% CrI, 21.4-39.3), and the original growth curve model (26.0 points; 95% CI, 18.7-33.3). At 12 months, the survival benefit of transcatheter aortic valve replacement was also greater in the joint model (hazard ratio, 0.50; 95% CrI, 0.32-0.73) than in the nonjoint Bayesian model (0.54; 95% CrI, 0.37-0.75) or the original Kaplan-Meier estimate (0.55; 95% CI, 0.40-0.74). Conclusions In patients with severe symptomatic aortic stenosis and prohibitive surgical risk, the estimated benefits of transcatheter aortic valve replacement on survival and health status compared with standard care were greater in joint Bayesian models than other approaches.

Background: Although the Seattle Angina Questionnaire (SAQ) has been widely used to assess disease-specific health status in patients with ischemic heart disease, it was originally developed in a predominantly male population and its validity in women has been questioned., Methods: Using data from 8892 men and 4013 women across 2 multicenter trials and 5 registries, we assessed the construct validity, test-retest reliability, responsiveness to clinical change, and predictive validity of the SAQ Summary Score (SS) and its 5 subdomains (Physical Limitation (PL), Anginal Stability (AS), Angina Frequency (AF), Treatment Satisfaction (TS), and Quality of Life (QoL)) separately in men and women., Results: Comparable correlations of the SAQ SS with Canadian Cardiovascular Society class was demonstrated in both men and women (-0.48 for men, -0.46 for women). Similar correlations between the SAQ PL scale with treadmill exercise duration and Short Form-12 (SF-12) Physical Component Summary were observed in women and men (0.34-0.63 and 0.40-0.63, respectively). SAQ AS scores were significantly lower for both men and women with acute syndromes compared with 1 month later. The SAQ AF scale was strongly correlated with daily angina diaries (0.62 for men and 0.66 for women). The SAQ QoL scores were moderately correlated with the EQ5D visual analog scale and SF-12 general health question in men (0.43-0.50) and women (0.33-0.39). All SAQ scales demonstrated excellent reliability (intraclass correlation ≥0.78) in both men and women with stable CAD and were very sensitive to change after percutaneous coronary intervention (≥15-point difference in scores, standardized response mean ≥ 0.67). The SAQ SS was similarly predictive of 1-year mortality and cardiac re-hospitalizations for both men and women., Conclusion: The SAQ demonstrates similar psychometric properties in men and women with CAD. These findings provide evidence for validity of the SAQ in assessing women with IHD., (Copyright © 2018 Elsevier Inc. All rights reserved.)

In older patients with non-ST-elevation myocardial infarction, an initial invasive strategy reduces cardiovascular events compared with an ischemia-guided approach; however its association with health status outcomes is unknown. Among patients with non-ST-elevation myocardial infarction from 2 multicenter US acute myocardial infarction (AMI) registries, health status was assessed at baseline and at 1, 6, and 12 months after AMI using the Seattle Angina Questionnaire (SAQ) and the 12-item Short-Form Health Survey (SF-12). Routine invasive management was defined as coronary angiography within 72 hours of admission without a preceding stress test. Among 3,559 patients with NSTEMI, 2,455 (69.0%) were treated with routine invasive treatment, which was more common in younger patients. In propensity-adjusted analyses, invasive treatment was associated with higher SAQ physical limitation, angina frequency, and summary scores over the year after AMI; however, the differences were small (<5 points, all p <0.05). Although there was a trend toward worse health status in patients aged ≥85 years treated with an initial invasive treatment, the interaction between age and treatment for any health status measure (all p ≥0.09) was not significant, except for SF-12 physical component score (p = 0.02), where worse scores were observed with invasive treatment in patients 85 years or older. In conclusion, an initial invasive treatment for patients with NSTEMI is associated with a small benefit in health status of marginal clinical significance, mainly in younger patients. The oldest old group trended toward less health status benefit from a routine invasive strategy-results that will need to be confirmed in a larger study., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Quantifying quality of life (QoL) after left ventricular assist device (LVAD) remains challenging. Heart failure (HF)-specific health status measures are ideal for assessing symptoms of HF; however, if patients' QoL is limited by other factors, they may experience improved HF-specific QoL but no concurrent improvement in generic QoL. We sought to examine and predict discrepancies between disease-specific and generic QoL measures after LVAD., Methods: We examined HF-specific and generic QoL with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol-5D Visual Analog Scale (VAS), respectively, among 1,888 patients with advanced heart failure who underwent LVAD implantation from 2012 to 2014 as part of the INTERMACS registry., Results: Both measures showed substantial improvement, on average, at 6 months after LVAD, with mean changes of 32.7 ± 25.0 and 27.6 ± 27.4, respectively. Among the 1,539 patients (81.5%) with moderate/large improvement in KCCQ, 334 (21.7%) had discordant changes in generic QoL (i.e., VAS did not substantially increase despite improvement in KCCQ). In a multivariable logistic regression model, baseline VAS score was the strongest predictor of KCCQ-VAS discordance, whereas post-LVAD complications were not significant predictors of discordance., Conclusions: Most patients have major improvements in both HF-specific and generic QoL after LVAD implantation, and discordance in these measures after LVAD is uncommon. When it did occur, discordance was primarily observed in patients who reported good generic QoL on the VAS before LVAD (despite substantial impairment due to congestive HF). These results support the continued use of HF-specific health status measures to monitor QoL before and after LVAD implantation., (Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Early invasive management improves outcomes in non-ST-elevation myocardial infarction (NSTEMI). The association between preinfarct health status and the selecting patients for early invasive management is unknown. The Prospective Registry Evaluating outcomes after Myocardial Infarctions: Events and Recovery and Translational Research Investigating Underlying disparities in acute Myocardial infarction Patients' Health status are consecutive US multicenter registries, in which the associations between preinfarct angina frequency and quality of life (both assessed by the Seattle Angina Questionnaire on admission) and the Global Registry of Acute Coronary Events (GRACE) risk score and referral to early invasive management (coronary angiography within 48 hours) were evaluated using Poisson regression, after adjusting for site, demographics, and clinical and psychosocial variables. Of 3,768 patients with NSTEMI, 2,182 (57.9%) patients were referred for early invasive treatment. Patients with excellent, good, or very good baseline angina-specific quality of life, respectively, were more likely to receive early angiography, even after adjustment, as compared with patients reporting poor baseline quality of life because of angina (62.1.0%, 60.9%, 59.6%, vs 51.2%; adjusted relative risk [RR] = 1.09, 95% confidence interval [CI] 1.04 to 1.16; RR = 1.13, 95% CI 1.01 to 1.27; RR 1.14, 95% CI 0.99 to 1.31, respectively). Finally, patients with a GRACE score in the highest risk decile (199.5 to <321.4) had significantly lower rates of early invasive treatment (42.7%) than patients in the lowest decile of risk (67.6%; adjusted RR for continuous GRACE score per SD [1 SD = 40 points], 0.96, 95% CI 0.92 to 0.99, p = 0.019). In conclusion, in this real-world NSTEMI cohort, patients with the highest mortality risk and worst health status were less likely to be referred for early invasive management. Further work is needed to understand the role of preinfarct health status and in-hospital treatment strategy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Rehospitalizations after acute myocardial infarction for unplanned coronary revascularization and unstable angina (UA) are common. However, despite the inclusion of these events in composite end points of many clinical trials, their association with health status has not been studied., Methods and Results: We included 3283 patients with acute myocardial infarction enrolled in a prospective, 24-center US study who had rehospitalizations independently classified by experienced cardiologists. Health status was assessed using Seattle Angina Questionnaire and EuroQol-5D Visual Analog Scale. In the propensity-matched cohorts, 1-year health status was compared between those who did and did not experience rehospitalization for UA or revascularization using a hierarchical linear model. Overall, mean age was 59 years, 33% were women, and 70% were white. Rehospitalization rates for UA and unplanned revascularization at 1 year were 4.3% and 4.7%. One-year Seattle Angina Questionnaire summary scores were worse in patients with rehospitalizations for UA (mean difference, -10.1; 95% confidence interval, -12.4 to -7.9) and unplanned revascularization (mean difference, -5.7; 95% confidence interval, -8.8 to -2.5) when compared with patients without such rehospitalizations. Similarly, EuroQol-5D Visual Analog Scale scores were worse among patients with such readmissions. Individual Seattle Angina Questionnaire domains indicated worse 1-year angina and quality of life outcomes among patients rehospitalized for UA or unplanned revascularization., Conclusions: Within the first year after acute myocardial infarction, rehospitalizations for UA and unplanned revascularization are associated with worse health status. These findings highlight the impact of such events from a patient's perspective, beyond their economic impact and support the use of UA and unplanned revascularization as elements of composite end points., (© 2016 American Heart Association, Inc.)

Purpose: Interpreting the clinical significance of changes in patient-reported outcomes (PROs) is critically important. The most commonly used approach is to anchor mean changes on PRO scores against a global assessment of change. Whether the assessor of global change should be patients or their physicians is unknown. We compared patients' and physicians' assessments of change over time to examine which was more aligned with patients' changes in PRO measures., Methods: A total of 459 chronic heart failure patients aged >30 years were enrolled from 13 US centers. Data were obtained by medical record abstraction, physical assessments, and patient interviews at a baseline clinic visit and 6 weeks later. Health status was measured with the disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ), and both patients and physicians completed a validated 15-level global assessment of change, ranging from large deterioration to large improvement., Results: There was substantial variation between physicians/patients' global assessment of clinical change (weighted kappa = 0.36, 95 % CI 0.28, 0.43). Overall, physician assessments were more strongly correlated with change on the KCCQ summary score than were patients' assessments (physician R = 0.37, patient R = 0.29)., Conclusion: There was substantial variation between patients' and physicians' global assessment of 6-week change in heart failure status. Physician assessments of the importance of clinical changes were more strongly associated with changes in all domains of patient-reported health status, as assessed by the KCCQ, and may provide a more consistent method for defining the clinical importance of changes in patients' health status.

Background: Drug-eluting stents (DES) reduce restenosis, as compared with bare-metal stents (BMS); however, the relationship between stent type and health status is unknown. We examined whether stent type was associated with health status outcomes in patients undergoing percutaneous coronary intervention (PCI)., Methods and Results: We evaluated 6- and 12-month health status in 2,694 patients with acute myocardial infarction (AMI) enrolled in the TRIUMPH and PREMIER registries who underwent PCI with DES (n = 1,361) or BMS (n = 1,333). Health status was assessed with the Seattle Angina Questionnaire, Medical Outcomes Study Short Form-12, and Patient Health Questionnaire depression scale. Propensity matching was performed to account for baseline differences in patient characteristics, resulting in a comparison cohort of 784 patients treated with DES and 784 patients treated with BMS. Both groups experienced significant improvements in health status at 6 and 12 months after PCI. Drug-eluting stent use was associated with a small improvement in Seattle Angina Questionnaire quality of life and functional limitation scores at 6 months (3.6 [95% CI 0.96-6.21], P = .007, and 3.8 [1.55-6.01], P < .001, respectively), but not at 12 months (2.3 [-0.46 to 5.03], P = .10, and 0.3 [-2.04 to 2.48], P = .85, respectively)., Conclusions: In patients with AMI undergoing PCI, DES use was associated with transient but unsustained health status benefits over 12 months after AMI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: There is a growing demand to collect patients' experiences of their health status (their symptoms, function, and quality of life) in clinical trials, quality assessment initiatives, and in routine clinical care. In heart failure, the 23-item, disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) has been shown to be valid, reliable, sensitive to clinical change, and prognostic of both clinical events and costs. However, its use has been limited, in part, by its length. We sought to develop a shortened version of the instrument that maintains the psychometric properties of the full KCCQ., Methods and Results: Using data from 3 clinical studies incorporating 4168 patients, we derived and validated a 12-item KCCQ, the KCCQ-12, to capture symptom frequency, physical and social limitations, and quality of life impairment as a result of heart failure, as well as an overall summary score. The KCCQ-12 scores had high correlations with the original scales (>0.93 for all scales in all clinical settings), high test–retest reliability (>0.76 for all domains), high responsiveness (16–31 point improvements after discharge from hospitalization; standardized response mean =0.61–1.12), and comparable prognostic significance and interpretation of clinically important differences as compared with the full KCCQ., Conclusions: The KCCQ-12 is a shorter version of the original 23-item instrument that should be more feasible to implement while preserving the psychometric properties of the full instrument.

Background: Smoking cessation after acute myocardial infarction (AMI) decreases the risk of recurrent AMI and mortality by 30% to 50%, but many patients continue to smoke. The association of smoking with angina and health-related quality of life (HRQOL) after AMI is unclear., Methods and Results: Patients in 2 US multicenter AMI registries (n=4003) were assessed for smoking and HRQOL at admission and 1, 6, and 12 months after AMI. Angina and HRQOL were measured with the Seattle Angina Questionnaire and Short Form-12 Physical and Mental Component Scales. At admission, 29% never had smoked, 34% were former smokers (quit before AMI), and 37% were active smokers, of whom 46% quit by 1 year (recent quitters). In hierarchical, multivariable, regression models that adjusted for sociodemographic, clinical and treatment factors, never and former smokers had similar and the best HRQOL in all domains. Recent quitters had intermediate HRQOL levels, with angina and Short Form-12 Mental Component Scale scores similar to never smokers. Persistent smokers had worse HRQOL in all domains compared with never smokers and worse Short Form-12 Mental Component Scale scores than recent quitters., Conclusions: Smoking after AMI is associated with more angina and worse HRQOL in all domains, whereas smokers who quit after AMI have similar angina levels and mental health as never smokers. These observations may help encourage patients to stop smoking after AMI.

Background: Patients who smoke at the time of percutaneous coronary intervention (PCI) would ideally have a strong incentive to quit, but most do not. We sought to compare the health status outcomes of those who did and did not quit smoking after PCI with those who were not smoking before PCI., Methods and Results: A cohort of 2765 PCI patients from 10 US centers were categorized into never, past (smoked in the past but had quit before PCI), quitters (smoked at time of PCI but then quit), and persistent smokers. Health status was measured with the disease-specific Seattle Angina Questionnaire and the EuroQol 5 dimensions, adjusted for baseline characteristics. In unadjusted analyses, persistent smokers had worse disease-specific and overall health status when compared with other groups. In fully adjusted analyses, persistent smokers showed significantly worse health-related quality of life when compared with never smokers. Importantly, of those who smoked at the time of PCI, quitters had significantly better adjusted Seattle Angina Questionnaire angina frequency scores (mean difference, 2.73; 95% confidence interval, 0.13-5.33) and trends toward higher disease specific (Seattle Angina Questionnaire quality of life mean difference, 1.97; 95% confidence interval, -1.24 to 5.18), and overall (EuroQol 5 dimension visual analog scale scores mean difference, 2.45; 95% confidence interval, -0.58 to 5.49) quality of life when compared with persistent smokers at 12 months., Conclusions: Smokers at the time of PCI have worse health status at 1 year than those who never smoked, whereas smokers who quit after PCI have less angina at 1 year than those who continue smoking., (© 2015 American Heart Association, Inc.)

Health disparities by socioeconomic status (SES) exist for many outcomes, including patients' subjective health status after myocardial infarction (MI). The Reserve Capacity Model (RCM), a theoretical means to understand such disparities, was tested to examine the possible mediating effects of cognitive-emotional factors on the association between SES and health status. Data from 2,348 post-MI patients in PREMIER were used. Indicators of SES were collected during hospitalization via personal interviews, while participants completed measures of stress and reserves at 1 month, depressive symptoms at 6 months, and health status at 1 year through telephone interviews. Structural equation model results provide partial support for the RCM, as cognitive-emotional factors partially mediated the association between SES and mental health status. For physical health status, results supported direct rather than indirect effects of SES. Findings suggest psychosocial interventions with patients of low SES will have their greatest effects on appraisals of psychological health status.

Background: Despite calls to expand measurement of acute myocardial infarction (AMI) outcomes to include symptom burden, little has been done to describe hospital-level variation in this patient-centered outcome, or its association with mortality. Understanding the relationship between symptoms and longer-term mortality could inform the importance of these outcomes for monitoring quality of care., Methods and Results: Among 4316 patients with AMI treated at 24 hospitals participating in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study, we assessed risk-standardized 1-year symptom burden as measured by the Seattle Angina Questionnaire Angina Frequency Score and mortality attributed to the hospital that provided AMI care. Median odds ratios were used to assess outcome variation and reflect the relative odds of an outcome for 2 patients with identical covariates at different, randomly selected, hospitals. We then evaluated the correlation between hospital-level mortality and angina. Finally, we determined the extent to which variation in mortality and angina was explained by achievement of AMI performance measures. We observed hospital variation in risk-adjusted 1-year mortality (range, 4.9%-8.6%; median odds ratio, 1.30; P=0.01) and angina (range, 17.7%-29.4%; median odds ratio, 1.34; P<0.001). At the hospital level, mortality and angina at 1 year were weakly correlated (r=0.40; 95% confidence interval, 0.00-0.68; P=0.05). Accounting for the quality of AMI care did not attenuate variation in risk-adjusted 1-year mortality or angina., Conclusions: Symptom burden and mortality vary at the hospital level after AMI and are only weakly correlated. These findings suggest that symptom burden should be considered a separate quality domain that is not well captured by current quality metrics., (© 2014 American Heart Association, Inc.)

Background: Clinical trials and national performance measures increasingly mandate reporting patients' perspectives of their health status: their symptoms, function, and quality of life. Although the Seattle Angina Questionnaire (SAQ) is a validated disease-specific health status instrument for coronary artery disease (CAD) with high test-retest reliability, predictive power, and responsiveness, its use in routine clinical practice has been limited, in part, by its length (19 items)., Methods and Results: Using data from 10 408 patients with CAD from 5 multicenter registries, we derived and validated a shortened version of the SAQ (SAQ-7) among patients presenting with stable CAD, undergoing percutaneous coronary intervention, and after acute myocardial infarction. We examined the psychometric properties of the SAQ-7 as compared with the full SAQ. Seven items from the Physical Limitation, Angina Frequency, and Quality of Life domains were identified for the SAQ-7, with high levels of concordance (0.88-1.00) with each original SAQ domain. The SAQ-7 demonstrated good construct validity (compared with Canadian Cardiovascular Society class for angina), with a correlation of 0.62 and 0.38 for patients with stable CAD and undergoing percutaneous coronary intervention, respectively. It was highly reproducible in patients with stable CAD (intraclass correlation, ≥0.78) and exhibited excellent responsiveness in patients after percutaneous coronary intervention (≥18 points in each SAQ domain). Finally, the SAQ-7 was predictive of 1-year mortality and readmission., Conclusions: To increase the feasibility of measuring patient-reported outcomes in patients with CAD, we developed and validated a shortened 7-item SAQ instrument for use in clinical trials and routine care., (© 2014 American Heart Association, Inc.)

Background: Despite the growing epidemic of heart failure with preserved ejection fraction (HFpEF), no valid measure of patients' health status (symptoms, function, and quality of life) exists. We evaluated the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of HF with reduced EF, in patients with HFpEF., Methods and Results: Using a prospective HF registry, we dichotomized patients into HF with reduced EF (EF≤ 40) and HFpEF (EF≥50). The associations between New York Heart Association class, a commonly used criterion standard, and KCCQ Overall Summary and Total Symptom domains were evaluated using Spearman correlations and 2-way ANOVA with differences between patients with HF with reduced EF and HFpEF tested with interaction terms. Predictive validity of the KCCQ Overall Summary scores was assessed with Kaplan-Meier curves for death and all-cause hospitalization. Covariate adjustment was made using Cox proportional hazards models. Internal reliability was assessed with Cronbach's α. Among 849 patients, 200 (24%) had HFpEF. KCCQ summary scores were strongly associated with New York Heart Association class in both patients with HFpEF (r=-0.62; P<0.001) and HF with reduced EF (r=-0.55; P=0.27 for interaction). One-year event-free rates by KCCQ category among patients with HFpEF were 0 to 25=13.8%, 26 to 50=59.1%, 51 to 75=73.8%, and 76 to 100=77.8% (log rank P<0.001), with no significant interaction by EF (P=0.37). The KCCQ domains demonstrated high internal consistency among patients with HFpEF (Cronbach's α=0.96 for overall summary and ≥0.69 in all subdomains)., Conclusions: Among patients with HFpEF, the KCCQ seems to be a valid and reliable measure of health status and offers excellent prognostic ability. Future studies should extend and replicate our findings, including the establishment of its responsiveness to clinical change.

Considerable attention has been devoted to the effect of social support on patient outcomes after acute myocardial infarction (AMI). However, little is known about the relation between patient living arrangements and outcomes. Thus, we used data from PREMIER, a registry of patients hospitalized with AMI at 19 United States centers from 2003 through 2004, to assess the association of living alone with outcomes after AMI. Outcome measurements included 4-year mortality, 1-year readmission, and 1-year health status using the Seattle Angina Questionnaire (SAQ) and the Short Form-12 Physical Health Component scales. Patients who lived alone had higher crude 4-year mortality (21.8% vs 14.5%, p <0.001) but comparable rates of 1-year readmission (41.6% vs 38.3%, p = 0.79). Living alone was associated with lower unadjusted quality of life (mean SAQ -2.40, 95% confidence interval [CI] -4.44 to -0.35, p = 0.02) but had no impact on Short Form-12 Physical Health Component (-0.45, 95% CI -1.65 to 0.76, p = 0.47) compared to patients who did not live alone. After multivariable adjustment, patients who lived alone had a comparable risk of mortality (hazard ratio 1.35, 95% CI 0.94 to 1.93) and readmission (hazard ratio 0.99, 95% CI 0.76 to 1.28) as patients who lived with others. Mean quality-of-life scores remained lower in patients who lived alone (SAQ -2.91, 95% CI -5.56 to -0.26, p = 0.03). In conclusion, living alone may be associated with poorer angina-related quality of life 1 year after MI but is not associated with mortality, readmission, or other health status measurements after adjusting for other patient and treatment characteristics., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Data on the health status benefits of percutaneous coronary intervention for coronary chronic total occlusions (CTOs), a principal indication for the procedure, are lacking., Methods and Results: In the FlowCardia Approach to CTO Recanalization (FACTOR) trial, patients (n=125) completed the Seattle Angina Questionnaire (SAQ) at baseline and 1 month after percutaneous coronary intervenion. One-month health status outcomes were compared by multivariable analysis, adjusting for group differences between those whose CTO was successfully and unsuccessfully recanalized. These changes were also analyzed according to baseline symptoms. Procedural success was 55% (n=64) and independently associated with angina relief (difference between those with successful and unsuccessful percutaneous coronary intervention [Delta] in SAQ angina frequency=9.5 points; 95% confidence interval, 1.6 to 17.5; P=0.019), improved physical function (Delta in SAQ physical limitation=13.1 points; 95% confidence interval, 5.1 to 21.1; P=0.001), and enhanced quality of life (Delta in SAQ quality of life [QoL]=20.3 points; 95% confidence interval, 11.9 to 28.6; P<0.001). The benefit of successful percutaneous coronary intervention was greatest in symptomatic patients as compared with asymptomatic patients although statistically significantly so only for QoL (DeltaSAQ angina frequency domain=10.3 versus 4.3 points, P=0.51, Deltaphysical limitation =15.9 versus 6.3 points, P=0.25; DeltaQoL=27.3 versus 8.5 points, P=0.047)., Conclusions: Successful CTO recanalization is associated with significant early improvements in patient symptoms, function, and QoL but only among symptomatic patients. Percutaneous treatment of a CTO offers the potential to provide significant health status benefits in symptomatic patients.

Background: Prior studies have associated low social support (SS) with increased rehospitalization and mortality after acute myocardial infarction. However, relatively little is known about whether similar patterns exist for other outcomes, such as health status and depressive symptoms, and whether these patterns vary by sex., Methods and Results: Using data from 2411 English- or Spanish-speaking patients with acute myocardial infarction enrolled in a 19-center prospective study, we examined the association of SS (low, moderate, high) with health status (angina, disease-specific quality of life, general physical and mental functioning) and depressive symptoms over the first year of recovery. Overall and sex-stratified associations were evaluated using mixed-effects Poisson and linear regression, adjusting for site, baseline health status, baseline depressive symptoms, and demographic and clinical factors. Patients with the lowest SS (relative to those with the highest) had increased risk of angina (relative risk, 1.27; 95% confidence interval [CI], 1.10, 1.48); lower disease-specific quality of life (mean difference [beta]=-3.33; 95% CI, -5.25, -1.41), lower mental functioning (beta=-1.72; 95% CI, -2.65, -0.79), and more depressive symptoms (beta=0.94; 95% CI, 0.51, 1.38). A nonsignificant trend toward lower physical functioning (beta=-0.87; 95% CI, -1.95, 0.20) was observed. In sex-stratified analyses, the relationship between SS and outcomes was stronger for women than for men, with a significant SS-by-sex interaction for disease-specific quality of life, physical functioning, and depressive symptoms (all P<0.02)., Conclusions: Lower SS is associated with worse health status and more depressive symptoms over the first year of acute myocardial infarction recovery, particularly for women.

Background: Although a variety of prognostic tools have been shown to predict rehospitalization and mortality in heart failure patients, their utility in assessing future costs is less clear. We assessed whether health status assessment with the Kansas City Cardiomyopathy Questionnaire (KCCQ) predicts future costs in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction., Methods and Results: We evaluated 12-month cost utilization data from 1516 heart failure outpatients enrolled in the Quality-of-Life Substudy of the Eplerenone Post-Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS). Multivariable hierarchical models assessed whether the KCCQ (categorized as 0 to <25, 25 to <50, 50 to <75, and 75 to 100) was an independent predictor of future resource use. At baseline, 685 patients (45.2%) had good health status (KCCQ scores > or =75), whereas 510 (33.6%), 262 (17.3%), and 59 (3.9%) had fair (KCCQ, 50 to 74), poor (KCCQ, 25 to 49), and the worst (KCCQ <25) health status, respectively. After multivariable adjustment, compared with patients with good health status, patients with fair health status incurred incremental 1-year costs of $1520 (cost ratio, 1.23; 95% confidence interval, 1.05 to 1.43), whereas patients with poor and the worst health status incurred incremental 1-year costs of $4265 (cost ratio, 1.63; 95% confidence interval, 1.34 to 1.99) and $8999 (cost ratio, 2.34; 95% confidence interval, 1.62 to 3.38), respectively (P<0.0001 for association with KCCQ). Further adjustment for New York Heart Association class led to only partial attenuation of this relationship (P=0.0002)., Conclusions: Health status assessment predicts resource use and costs over the next year in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction.

Background: Older age is a risk factor for higher mortality after acute myocardial infarction (AMI), but the association with health status outcomes is largely unexplored., Methods: In a prospective cohort of 2498 patients in the PREMIER study, we compared health-related quality of life (HRQL) and burden of angina symptoms among survivors of AMI by age strata (age groups > or = 75, 65-74, 50-64, and 19-49 years) using the Seattle Angina Questionnaire. Multivariable analyses assessed the relationship between age and 1-year HRQL and angina burden, adjusting for differences in clinical characteristics, treatment, and baseline health status., Results: Older patients comprised a majority: 20.1% were > or = 75 years of age, 41.7% were 65 to 74 years of age, 20.7% were 50 to 64 years of age, and 17.4% were < 50 years of age. At 12 months, older patients had higher mortality (17.0% vs 8.7% vs 6.1% vs 3.2% for age groups > or = 75, 65-74, 50-64, 19-49; P < .001). Among survivors of AMI, increasing age was associated with less angina and better HRQL. By 12 months, older patients reported less angina (10.9% vs 12.7% vs 19.3% vs 23.4% for age groups > or = 75, 65-74, 50-64, 19-49; P < .0001) and better HRQL (scores 89.1 vs 88.1 vs 82.5 vs 80.0, respectively; P < .0001), which persisted after adjustment for baseline angina, HRQL, and other demographic, clinical, disease severity, and treatment differences., Conclusions: Although older patients have higher mortality after AMI, those who survive experience fewer symptoms and better HRQL at 1 year than younger patients. Angina remains present in a number of patients across the spectrum of age, supporting strategies to systematically assess and treat symptoms after AMI.

Objectives: We tested the hypothesis that one health status measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), provides prognostic information independent of other clinical data in outpatients with heart failure (HF)., Background: Health status measures are used to describe a patient's clinical condition and have been shown to predict mortality in some populations. Their prognostic value may be particularly useful among patients with HF for identifying candidates for disease management in whom increased care may reduce hospitalizations and prevent death., Methods: We evaluated 505 HF patients from 13 outpatient clinics who had an ejection fraction <40% using the KCCQ summary score. Proportional hazards regression was used to evaluate the association between the KCCQ summary score (range, 0 to 100; higher scores indicate better health status) and the primary outcome of death or HF admission, adjusting for baseline patient characteristics, 6-min walk distance, and B-type natriuretic peptide (BNP)., Results: The mean age was 61 years, 76% of patients were male, 51% had an ischemic HF etiology, and 5% were New York Heart Association functional class IV. At 12 months, among the 9% of patients with a KCCQ score <25, 37% had been admitted for HF and 20% had died, compared with 7% (HF admissions) and 5% (death) of those with a KCCQ score > or =75 (33% of patients, p < 0.0001 for both comparisons). In sequential multivariable models adjusting for clinical variables, 6-min walk, and BNP levels, the KCCQ score remained significantly associated with survival free of HF hospitalization., Conclusions: A low KCCQ score is an independent predictor of poor prognosis in outpatients with HF.

Background: Little is known about medication nonadherence in heart failure populations. We evaluated the association between 1 aspect of medication nonadherence, patient-reported difficulty taking medications as directed, and health status among heart failure outpatients, and then examined whether this association was explained by depression., Methods and Results: A total of 522 outpatients with left ventricular ejection fraction <0.40 completed clinical evaluation, Kansas City Cardiomyopathy Questionnaire (KCCQ), Medical Outcomes Study-Depression questionnaire, and categorized their difficulty taking medications (5-level Likert-scale question). Multivariable regression was used to evaluate the cross-sectional association between difficulty taking medications and health status, with incremental adjustment for medical history and depressive symptoms. Patients with difficulty taking medications (n = 64; 12.2%) had worse health status (8.2 +/- 2.7 point lower mean KCCQ summary scores; P = .008) and more depressive symptoms (43.8% versus 27.1%; P = .006). Adjusting for demographic and clinical factors had little effect on the association between difficulty taking medications and health status (8.0 +/- 3.2 point lower KCCQ scores; P = .01); however, the relationship was attenuated with adjustment for depressive symptoms (4.7 +/- 2.9 point lower KCCQ scores; P = .11)., Conclusions: Among heart failure outpatients, difficulty taking medications is associated with worse health status. This association appears to be explained, in part, by coexistent depression. Future studies should evaluate interventions such as depression treatment to improve medication adherence and health status.

Background: The importance of repeated clinical assessments of patients with heart failure is widely accepted. The frequency of such follow-up is not established and is likely to depend on the natural history and variability of patients' health status and the availability and use of appropriate treatments., Methods and Results: We analyzed data from a multicenter prospective cohort study of heart failure outpatients comparing baseline variables including New York Heart Association (NYHA) class, summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ), and performance on a 6-minute walk test with results of a repeat evaluation at 6 weeks. We also compared patient and physician assessment of change in disease status among patients with advanced symptoms (NYHA class III with a recent antecedent hospitalization or class IV) and those with milder degrees of limitation (NYHA classes I, II, and stable III). Patients with advanced symptoms had greater short-term variability in health status as reflected by the KCCQ summary score and a visual analog scale. A greater proportion of patients with advanced heart failure experienced moderate or greater clinical change. Patient and physician global assessments were congruent with more direct measures of health status., Conclusion: Patients with advanced heart failure have greater short-term variability in status, supporting the need for frequent clinical follow-up and appropriate power calculations for clinical trials that are designed to measure meaningful changes over a short period.

BackgroundHealth status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available.MethodsWe built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites' unadjusted and adjusted rates.ResultsAmong 3932 participants (median age [interquartile range] 68 years [59-75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment.ConclusionsThrough leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites' proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients' perspectives.

IntroductionEvaluation of health status benefits, cost-effectiveness, and value of new heart failure therapies is critical for supporting their use. The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures patients' heart failure-specific health status but does not provide utilities needed for cost-effectiveness analyses. We mapped the KCCQ scores to EQ-5D scores so that estimates of societal-based utilities can be generated to support economic analyses.MethodsUsing data from two US cohort studies, we developed models for predicting EQ-5D utilities (3L and 5L versions) from the KCCQ (23- and 12-item versions). In addition to predicting scores directly, we considered predicting the five EQ-5D health state items and deriving utilities from the predicted responses, allowing different countries' health state valuations to be used. Model validation was performed internally via bootstrap and externally using data from two clinical trials. Model performance was assessed using R2, mean prediction error, mean absolute prediction error, and calibration of observed vs. predicted values.ResultsThe EQ-5D-3L models were developed from 1000 health status assessments in 547 patients with heart failure and reduced ejection fraction (HFrEF), while the EQ-5D-5L model was developed from 3925 patients with HFrEF. For both versions, models predicting individual EQ-5D items performed as well as those predicting utilities directly. The selected models for the 3L had internally validated R2 of 48.4-50.5% and 33.7-45.6% on external validation. The 5L version had validated R2 of 57.7%.ConclusionMappings from the KCCQ to the EQ-5D can yield the estimates of societal-based utilities to support cost-effectiveness analyses when EQ-5D data are not available.

BACKGROUND: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been psychometrically evaluated in multiple heart failure (HF) populations, but the comparability of its psychometric properties between men and women is unknown. METHODS: Data from 3 clinical trials (1 in stable HF with preserved ejection fraction, 1 each in stable and acute HF with reduced ejection fraction) and 1 prospective cohort study (stable HF with reduced ejection fraction), incorporating 6773 men and 3612 women with HF, were used to compare the construct validity, internal and test-retest reliability, ability to detect change, predict mortality and hospitalizations and minimally important differences between the 2 sexes. Interactions of the KCCQ overall summary and subdomain scores by sex were independently examined. RESULTS: The KCCQ-Overall Summary score correlated well with New York Heart Association functional class in both sexes across patients with stable (correlation coefficient: -0.40 in men versus -0.49 in women) and acute (-0.37 in men versus -0.34 in women) HF. All KCCQ subdomains demonstrated concordant relationships with relevant comparison standards with no significant interactions by sex in 19 of 21 of these construct validity analyses. All KCCQ scores were equally predictive and other psychometric evaluations showed similar results by sex: test-retest reliability (intraclass correlation coefficient 0.94 in men versus 0.92 in women), responsive to change (standardized response mean 1.01 in both sexes), as were the minimally important differences and internal reliability. CONCLUSIONS: The psychometric properties of the KCCQ, in terms of validity, prognosis, reliability, and sensitivity to change, are comparable in men and women with HF with preserved ejection fraction and HF with reduced ejection fraction. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the association of baseline left ventricular diastolic dysfunction (LVDD) with health status outcomes of patients undergoing transcatheter aortic valve replacement (TAVR). Although LVDD in patients with aortic stenosis is associated with higher mortality after TAVR, it is unknown if it is also associated with health status recovery. In a cohort of 304 patients with interpretable echocardiograms, undergoing TAVR, LVDD was categorized at baseline as absent (grade 0), mild (grade 1), moderate (grade 2), or severe (grade 3). Disease-specific health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at baseline and at 1-month and 12-month follow-up. Association of baseline LVDD with health status at baseline and follow-up after TAVR was assessed using a linear trend test, and association with health status recovery (change in KCCQ-OS) was examined using a linear mixed model adjusting for baseline KCCQ-OS. Twenty-four (7.9%), 54 (17.8%), 186 (61.2%), and 40 (13.2%) patients had LVDD grades of 0, 1, 2, and 3, respectively. Baseline KCCQ-OS was 61.3 ± 22.7, 51.0 ± 26.1, 44.7 ± 25.7, and 44.4 ± 21.9 (p = 0.004) in patients with LVDD grades of 0, 1,2 and 3. At 1 and 12 months after TAVR, LVDD was not associated with KCCQ-OS. Recovery in KCCQ-OS after TAVR was substantial and similar in patients across all severities of LVDD. Although LVDD is associated with health status prior to TAVR, patients across all severities of LVDD have similar recovery in health status after TAVR. [ABSTRACT FROM AUTHOR]

Background: Myocardial perfusion imaging (MPI) identifies abnormalities that occur early in the ischemic cascade leading to angina. Our aim was to study the association between ischemic measures on positron emission tomography MPI and patients' health status; their symptoms, function, and quality of life. Methods: Health status was collected using the Seattle Angina Questionnaire (SAQ-7, 0-100, higher=better) and Rose Dyspnea Score (RDS) on 1515 outpatients with known or suspected coronary artery disease presenting for clinically indicated pharmacological 82Rb positron emission tomography MPI from July 2018 to July 2019. Adjusted multivariable ordinal regression models were used to assess the association between MPI findings of ischemia and the SAQ physical limitation, angina frequency, quality of life, summary score, and the RDS. Results: The mean SAQ and RDS scores of the cohort (mean age 71.7 years, 55% male, 37.6% prior myocardial infarction or revascularization) were 73.8+/-28.6 (physical limitation), 87.4+/-21.7 (angina frequency), 79.0+/-26.1 (quality of life), 81.3+/-19.0 (summary score), and 2+/-2 (RDS). No perfusion, flow or function abnormalities were significantly associated with SAQ angina frequency scores. Low left ventricular ejection fraction reserve (<=0%), low global and regional myocardial blood flow reserve (<2) were independently associated with worse SAQ Physical Limitation score, SAQ summary score, and RDS (30% to 57% greater odds; all P <=0.01), but reversible perfusion defects were not. /2)>/p> Conclusions: Impaired augmentation of left ventricular ejection fraction and myocardial blood flow with stress is associated with significant angina-associated functional limitation, health status, and dyspnea in patients who underwent positron emission tomography MPI, but not the frequency of their angina. Future studies should evaluate whether therapies that improve stress-induced abnormalities in systolic function and myocardial flow may improve patients' health status. [ABSTRACT FROM AUTHOR]

The article explores the study Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH), which aims to find out the impact of racial differences in patients with myocardial infarction (MI). TRIUMPH was participated by 6,152 people with eligible MI and 4,340 patients from 24 U.S. centers. According to the author, TRIUMPH is a helpful tool for practitioners in terms of examining factors that could affect their patients.

The article discusses a study that seeks to quantify the early health status benefits of patients who underwent successful chronic total occlusion (CTO) recanalization as compared to those with unsuccessful percutaneous coronary intervention (PCI) of CTOs. The study supports the use of PCI for treating CTOs in symptomatic patients and suggests that a successful recanalization of CTO improves a patient's symptoms, functions and quality of life.

Abstract: Background: Although B-type natriuretic peptide (BNP) levels have been proposed as a means of assessing disease severity in patients with heart failure, it is not known if BNP levels are correlated with health status (symptom burden, functional limitation, and quality of life). Methods and Results: We studied 342 outpatients with systolic heart failure from 14 centers at baseline and 6 ± 2 weeks with BNP levels and the Kansas City Cardiomyopathy Questionnaire (KCCQ), a heart-failure-specific health status instrument. We assessed the correlation between KCCQ scores and BNP at baseline and changes in KCCQ according to changes in BNP levels between baseline and follow-up. Mean baseline BNP levels were 379 ± 387 pg/mL and mean KCCQ summary scores were 62 ± 23 points. Although baseline BNP and KCCQ were both associated with New York Heart Association classification (P < .001 for both), BNP and KCCQ were not correlated (r2 =0.008, P =.15). There was no significant relationship between changes in BNP and KCCQ regardless of the threshold used to define a clinically meaningful BNP change. For example, using >50% BNP change threshold, KCCQ improved by 3.7 ± 14.2 in patients with decreasing BNP, improved by 1.7 ± 13.6 in patients with no BNP change, and improved by 1.0 ± 13.4 in patients with increasing BNP (P =.6). Conclusion: BNP and health status are not correlated in outpatients with heart failure in the short term. This suggests that these measures may assess different aspects of heart failure severity, and that physiologic measures do not reflect patients'' perceptions of the impact of heart failure on their health status. [Copyright &y& Elsevier]

Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown.Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability (R2) explained by sequentially adding these variables to the model was quantified.Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score (R2=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume.Conclusions: There is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr. [ABSTRACT FROM AUTHOR]

Background: Many clinical investigations depend on participant self-report as a principal method of identifying health care events. If self-report is used as the trigger to collect and adjudicate medical records, any event that is not reported by the patient will be missed by the investigators, reducing the power of the study and misrepresenting the risk of its participants. We sought to determine the rates and predictors of underreporting hospitalization events during the follow-up period of a prospective study of patients hospitalized with an acute myocardial infarction.Methods and Results: The TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status) registry, a longitudinal multicenter cohort study of people with acute myocardial infarction in the United States, queried patients for hospitalization events during interviews at 1, 6, and 12 months. To validate these self-reports, medical records for all events at every hospital where the patient reported receiving care were acquired for adjudication, not just those for the reported events. Of the 4340 participants in TRIUMPH, 1209 (28%) reported at least one hospitalization. After medical records abstraction and adjudication, we identified 1086 hospitalizations from 639 participants (60.2±12 years of age, 38.2% women). Of these hospitalizations, 346 (31.9%) were underreported by the participants. Rates of underreporting ranged from 22.5% to 55.6% based on different patient characteristics. The odds of underreporting were highest for those not currently working (adjusted odds ratio, 1.66 [95% CI, 1.04-2.63]), lowest for those married (adjusted odds ratio, 0.50 [95% CI, 0.33-0.76]), and increased the longer the elapsed time between the admission and the patient's follow-up interview (adjusted odds ratio per month, 1.16 [95% CI, 1.08-1.24]). There was a substantial within-individual variation on the accuracy of reporting.Conclusions: Hospitalizations after acute myocardial infarction are commonly underreported in interviews and should not be used alone to determine event rates in clinical studies. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To examine changes in social support during early recovery after acute myocardial infarction (AMI) and determine whether these changes influence outcomes within the first year. Methods: Among 1951 AMI patients enrolled in a 19-center prospective study, we examined changes in social support between baseline (index hospitalization) and 1month post-AMI to longitudinally assess their association with health status and depressive symptoms within the first year. We further examined whether 1-month support predicted outcomes independent of baseline support. Hierarchical repeated-measures regression evaluated associations, adjusting for site, baseline outcome level, baseline depressive symptoms, sociodemographic characteristics, and clinical factors. Results: During the first month of recovery, 5.6% of patients had persistently low support, 6.4% had worsened support, 8.1% had improved support, and 80.0% had persistently high support. In risk-adjusted analyses, patients with worsened support (vs. persistently high) had greater risk of angina (relative risk=1.46), lower disease-specific quality of life (β=7.44), lower general mental functioning (β=4.82), and more depressive symptoms (β=1.94) (all p≤.01). Conversely, patients with improved support (vs. persistently low) had better outcomes, including higher disease-specific quality of life (β=6.78), higher general mental functioning (β=4.09), and fewer depressive symptoms (β=1.48) (all p≤.002). In separate analyses, low support at 1month was significantly associated with poorer outcomes, independent of baseline support level (all p≤.002). Conclusion: Changes in social support during early AMI recovery were not uncommon and were important for predicting outcomes. Intervening on low support during early recovery may provide a means of improving outcomes. [Copyright &y& Elsevier]