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Background: Black patients with myocardial infarction (MI) have worse outcomes than white patients, including higher mortality rates, more angina, and worse quality of life. The Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study was designed to examine whether racial differences in socioeconomic, clinical, genetic, metabolic, biomarker, or treatment characteristics mediate observed disparities in outcomes.Methods and Results: Between April 11, 2005, and December 31, 2008, 31 567 patients with MI were prospectively screened; 6152 had an eligible MI, and 4340 (71%) were enrolled from 24 US centers. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed baseline interview. Detailed genetic and metabolic data were obtained at hospital discharge in 2979 (69%) and 3013 patients (69%), respectively. In a subset of patients, blood and urine samples were obtained at 1 month (obtained in 27% of survivors) and blood samples at 6 months (obtained in 19% of survivors). Centralized follow-up interviews sought to quantify patients' postdischarge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). At 1, 6, and 12 months, 23%, 27%, and 24%, respectively, were lost to follow-up. Vital status was available for 99% of patients at 12 months.Conclusions: TRIUMPH is a novel MI registry with detailed information on patients' sociodemographic, clinical, treatment, health status, metabolic, and genetic characteristics. The wealth of patient data collected in TRIUMPH will provide unique opportunities to examine factors that may mediate racial differences in mortality and health status after MI and the complex interactions between genetic and environmental determinants of post-MI outcomes. [ABSTRACT FROM AUTHOR]

Importance: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a commonly used outcome in heart failure trials. While comparing means between treatment groups improves statistical power, mean treatment effects do not necessarily reflect the clinical benefit experienced by individual patients., Objective: To evaluate the association between mean KCCQ treatment effects and the proportions of patients experiencing clinically important improvements across a range of clinical trials and heart failure etiologies., Design, Setting, and Participants: A patient-level analysis of 11 randomized clinical trials, including 9977 patients, was performed to examine the association between mean treatment effects and the KCCQ Overall Summary Score (OSS) and the absolute differences in the proportions of patients experiencing clinically important (≥5 points) and moderate to large (≥10 points) improvements. There was no target date range, and included studies were those for which patient-level data were available. Validation was performed in 7 additional trials. The data were analyzed between July 1 and September 15, 2023., Main Outcomes and Measures: Proportion of patients experiencing an improvement of 5 or more and 10 or more points in their KCCQ score (with each domain transformed to a range of 0 to 100 points, where higher scores represent better health status)., Results: Group mean KCCQ-OSS differences were strongly correlated with absolute differences in clinically important changes (Spearman correlations 0.76-0.92). For example, a mean KCCQ-OSS treatment effect of 2.5 points (half of a minimally important difference for an individual patient) was associated with an absolute difference of 6.0% (95% prediction interval [PI], 4.0%-8.1%) in the proportion of patients improving 5 or more points and 5.0% (95% PI, 3.1%-7.0%) in the proportion improving 10 or more points, corresponding to a number needed to treat of 17 (95% PI, 12-25) and 20 (95% PI, 14-33), respectively., Conclusions and Relevance: Inferences about clinical impacts based on population-level mean treatment effects may be misleading, since even small between-group differences may reflect clinically important treatment benefits for individual patients. Results of this study suggest that clinical trials should explicitly describe the distributions of KCCQ change at the patient level within treatment groups to support the clinical interpretation of their results.

Importance: Guidelines advise heart team assessment for all patients with aortic stenosis, with surgical aortic valve replacement recommended for patients younger than 65 years or with a life expectancy greater than 20 years. If bioprosthetic valves are selected, repeat procedures may be needed given limited durability of tissue valves; however, younger patients with aortic stenosis may have major comorbidities that can limit life expectancy, impacting decision-making., Objective: To characterize patients younger than 65 years who received transcatheter aortic valve replacement (TAVR) and compare their outcomes with patients aged 65 to 80 years., Design, Setting, and Participants: This retrospective registry-based analysis used data on 139 695 patients from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, inclusive of patients 80 years and younger undergoing TAVR from August 2019 to September 2023., Intervention: Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices., Main Outcomes and Measures: Comorbidities (heart failure, coronary artery disease, dialysis, and others) and outcomes (death, stroke, and hospital readmission) of patients younger than 65 years compared to patients aged 65 to 80 years., Results: In the years surveyed, 13 849 registry patients (5.7%) were younger than 65 years, 125 846 (52.1%) were aged 65 to 80 years, and 101 725 (42.1%) were 80 years and older. Among those younger than 65, the mean (SD) age was 59.7 (4.8) years, and 9068 of 13 849 patients (65.5%) were male. Among those aged 65 to 80 years, the mean (SD) age was 74.1 (4.2) years, and 77 817 of 125 843 patients (61.8%) were male. Those younger than 65 years were more likely to have a bicuspid aortic valve than those aged 65 to 80 years (3472/13 755 [25.2%] vs 9552/125 001 [7.6%], respectively; P < .001). They were more likely to have congestive heart failure, chronic lung disease, diabetes, immunocompromise, and end stage kidney disease receiving dialysis. Patients younger than 65 years had worse baseline quality of life (mean [SD] Kansas City Cardiomyopathy Questionnaire score, 47.7 [26.3] vs 52.9 [25.8], respectively; P < .001) and mean (SD) gait speed (5-meter walk test, 6.6 [5.8] seconds vs 7.0 [4.9] seconds, respectively; P < .001) than those aged 65 to 80 years. At 1 year, patients younger than 65 years had significantly higher readmission rates (2740 [28.2%] vs 23 178 [26.1%]; P < .001) and all-cause mortality (908 [9.9%] vs 6877 [8.2%]; P < .001) than older patients. When propensity matched, younger patients still had higher 1-year readmission rates (2732 [28.2%] vs 2589 [26.8%]; P < .03) with similar mortality to their older counterparts (905 [9.9%] vs 827 [10.1%]; P = .55)., Conclusions and Relevance: Among US patients receiving BEV TAVR for severe aortic stenosis in the low-surgical risk era, those younger than 65 years represent a small subset. Patients younger than 65 years had a high burden of comorbidities and incurred higher rates of death and readmission at 1 year compared to their older counterparts. These observations suggest that heart team decision-making regarding TAVR for most patients in this age group is clinically valid.

Importance: Improving patients' health status is a key goal of treating tricuspid regurgitation (TR). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure disease-specific health status measure used to capture the health status impact of TR and the benefit of transcatheter tricuspid valve intervention (TTVI), but its validity in this clinical setting is unknown., Objective: To evaluate the psychometric properties of the KCCQ in patients with TR., Design, Setting, and Participants: Data were pooled from patients with severe TR enrolled in 11 manufacturer-sponsored trials of TTVI. The data were transferred to the US Food and Drug Administration to harmonize and anonymize prior to analysis by an independent center. Data were collected from December 2015 to April 2023, and data analysis was performed from July to October 2023., Main Outcomes and Measures: Prespecified analyses included evaluation of internal consistency, reproducibility, responsiveness, construct validity, and predictive validity. Outcomes were determined using Cronbach α, score comparisons, intraclass correlation, Cohen d, Spearman correlations with best available reference measures, and association of scores and changes in scores with risk of subsequent clinical events., Results: The study cohort was composed of 2693 patients enrolled in either single-arm (n = 1517) or randomized (n = 1176) investigations of TTVI. Mean (SD) patient age was 78.6 (8.0) years, 1658 of 2693 patients (61.6%) were female, and the mean (SD) baseline KCCQ Overall Summary (KCCQ-OS) score was 50 (23). There was strong internal consistency within individual domains (Cronbach α, .77-.83). Among clinically stable patients between 1 and 6 months, there were small mean changes in KCCQ domain and summary scores (differences of -0.1 to 1.9 points), demonstrating reproducibility. In contrast, domain and summary scores of patients who underwent TTVI showed large improvements at 1 month after treatment (mean changes, 12.1-21.4 points), indicating excellent perceived responsiveness. Construct validity was moderately strong when domains were compared with best available reference measures (Spearman correlations, 0.47-0.69). In both cross-sectional and longitudinal analyses, the KCCQ-OS was associated with clinical events, with lower scores associated with an increased risk of mortality (hazard ratio, 1.34 per 10-point decrement; 95% CI, 1.22-1.47) and heart failure hospitalization (hazard ratio, 1.24 per 10-point decrement; 95% CI, 1.17-1.31)., Conclusions and Relevance: In this cohort study, the KCCQ had strong psychometric properties in patients with severe TR, including reliability, responsiveness, and validity. These data support use of the KCCQ in patients with severe TR as a measure of their symptoms, function, and quality of life and also for assessing the impact of interventions, such as TTVI, in rigorously controlled trials.

Background: Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR)., Objectives: We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients., Methods: The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models., Results: The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone., Conclusions: Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062)., Competing Interests: Funding Support and Author Disclosures The TRISCEND II pivotal trial and this analysis were funded by Edwards Lifesciences. Analyses were designed and conducted independently by the academic investigators. Dr Arnold has received research grants from the U.S. Food and Drug Administration and National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts with no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry sponsored valve trials with no direct industry compensation. Dr Thourani has received research/advisor fees from Abbott Vascular, Artivion, CroíValve, Boston Scientific, and Edwards Lifesciences; has received research grants from Medtronic, Highlife, Innovalve, JenaValve, and HalfMoon; and owns equity in Dasi Simulation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, and Medtronic; and has received travel support from Edwards Lifesciences, JenaValve, Abbott Vascular, and Boston Scientific. Dr Makar has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare, and PiCardia. Dr Sharma has received consulting fees from Edwards Lifesciences. Dr Haeffele has received consulting fees from Edwards Lifesciences and Shifamed. Dr Davidson has served as an uncompensated advisor for and received research grant support from Edwards Lifesciences. Dr Narang has received speaker fees from Edwards Lifesciences, Abbott Laboratories, and Bristol Myers Squibb. Dr O’Neill has received consulting fees from Edwards Lifesciences. Dr Lee has received consulting fees from Edwards Lifesciences. Dr Yadav has received consulting and speaker fees from Edwards Lifesciences, Abbott Vascular, and Boston Scientific; has received advisory board honoraria from Dasi Simulations and Trisol; and owns equity in Dasi Simulations and Opus. Dr Zahr has received consulting fees, research grants, and educational grants from Edwards Lifesciences and Medtronic. Dr Chadderdon has received consulting fees from Edwards Lifesciences and Medtronic; and has received research funding from GE Healthcare and Siemens Healthineers. Dr Smith has received research grants from Edwards Lifesciences, Medtronic, and Artivion, which are managed through the Baylor Scott & White research institute; has received speaker fees from Edwards Lifesciences and Medtronic; and has received advisory board honoraria from Edwards Lifesciences and Enable CV. Dr Szerlip has received consulting fees from Edwards Lifesciences; has received speaker fees from Edwards Lifesciences, Cardiovascular Innovations, the Society for Cardiovascular Angiography and Interventions, and Boston Scientific; and has received advisory board honoraria from Abbott Vascular. Dr Whisenant has received consulting fees from Edwards Lifesciences and Abbott Vascular. Dr Garcia has received consulting and proctor fees from Edwards Lifesciences, Medtronic, Abbott Structural Heart, JC Medical, and Boston Scientific. Dr Grayburn has received research grants from Abbott Vascular, CardioValve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received advisory board honoraria from Abbott Vascular, CardioValve, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Sannino has received research grants from Edwards Lifesciences and Venus Medtech. Dr Mack has received consulting fees and research grants from Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and owns stock options in Innoventric. Dr Kodali has received consulting fees from Anteris, TriCares, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; has received advisory board honoraria from Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, Boston Scientific, and Abbott; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Cohen has received research grants from the U.S. Food and Drug Administration, National Institutes of Health/National Heart, Lung, and Blood Institute, Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, Philips, Corvia, Zoll Medical, and iRhythm; and has received consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: Although transcatheter aortic valve replacement (TAVR) outcomes in the US have improved substantially since 2011, it is unknown whether these trends have continued since 2019., Objective: To examine changes in risk-adjusted TAVR outcomes from 2019 to 2022 and to examine any noteworthy trends over time., Design, Setting, and Participants: This cohort study examined data from patients with severe aortic stenosis treated with TAVR at 786 US hospitals between January 1, 2019, and March 31, 2022, included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry., Exposure: Patients who underwent TAVR., Main Outcomes and Measures: The primary outcome was 30-day mortality, and the secondary outcomes were in-hospital mortality and 30-day composite adverse events. To understand factors explaining these trends, a series of logistic regression models was constructed for each outcome, with time as the primary explanatory variable. After adjusting for changing patent characteristics and procedural factors, a series of exploratory analyses was performed to examine the extent to which these findings could be explained by several plausible hypotheses., Results: This study's analytic cohort included a total of 210 495 patients. Median (IQR) patient age was 79 (73-85) years, and 91 313 patients (43.4%) were female. Median (IQR) STS predicted risk of mortality (PROM) was 3.3% (2.0%-5.3%). There were no significant changes in unadjusted 30-day mortality from quarter 1 of 2019 (2.4%) to the end of quarter 1 of 2022 (2.2%) (P for trend = .10), with an unadjusted odds ratio (OR) for time of 0.98 per year (95% CI, 0.94-1.01). After adjusting for patient characteristics, the OR increased to 1.05 per year (95% CI, 1.02-1.08), which increased further after adjusting for procedural characteristics to 1.09 per year (95% CI, 1.05-1.13). In exploratory analyses, there were no meaningful changes in the adjusted odds of death after excluding sites that entered the STS/ACC TVT Registry in 2019 or later (OR, 1.09; 95% CI, 1.05-1.13), low-volume sites (OR, 1.09; 95% CI, 1.06-1.13), low-risk patients (OR, 1.11; 95% CI, 1.07-1.15), patients with a bicuspid aortic valve (OR, 1.09; 95% CI, 1.05-1.13), in-hospital deaths (OR, 1.08; 95% CI, 1.03-1.14), or patients who experienced a major vascular complication (OR, 1.09; 95% CI, 1.05-1.12)., Conclusions and Relevance: In this observational cohort study performing a national analysis of outcomes after TAVR, it was found that risk-adjusted 30-day mortality increased modestly from January 2019 to March 2022. However, no site-level, patient-related, or process-related factors were identified that could explain these findings. Although the absolute increase in risk-adjusted mortality during the study period was relatively small, these findings warrant continued surveillance.

Background: Renal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting., Methods: We performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting versus medical therapy in patients with atherosclerotic renal-artery stenosis. Longitudinal growth curve models were used to compare the Physical Symptoms Distress Index (PSDI), SF-36, and EQ-5D scores over time between treatment groups. We also sought to validate the approach of assessing quality of life in hypertension studies., Results: Among 906 patients (mean age 69.2 ± 9.1years, 49.7% men), symptom frequency and distress due to side effects from antihypertensive medications changed minimally over time, with no significant differences between treatment groups. There were also no clinically significant differences between treatment groups for the SF-36 and its subscales or the EQ-5D. In internal validation of the quality of life measures, the PSDI correlated well with number/type of antihypertensive medications, and generic health status measures correlated with late clinical events., Conclusions: In a large, multicenter, randomized clinical trial, we found no significant benefit of routine renal-artery stenting over medical management for the treatment of atherosclerotic renal-artery stenosis in terms of disease-specific or generic quality of life measures. As these quality of life measures are important to patients and are associated with medication compliance, future studies of antihypertensive treatments should consider including these quality of life measures as secondary outcomes. Trial registration: ClinicalTrials.gov: NCT00081731., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: A primary goal of treating patients with obstructive hypertrophic cardiomyopathy (oHCM) is to improve their symptoms, function and quality of life. Although the psychometric properties of the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) have been described in oHCM, they have not been assessed for the shorter 12-item version (KCCQ-12), which is used increasingly in clinical practice., Methods and Results: Using data from the EXPLORER-HCM trial, the psychometric properties of the KCCQ-12 were evaluated. The KCCQ-12 domain and summary scores had moderate correlations with the most relevant clinical (New York Heart Association class, exercise duration, peak oxygen consumption) and patient-reported measures (EQ-5D-5L visual analog scale, Work Productivity and Activity Impairment [WPAI] questionnaire, and Hypertrophic Cardiomyopathy Symptom Questionnaire [HCMSQ]). KCCQ-12 domain scores had strong internal consistency, and test-retest reliability, demonstrated significant and proportional changes with differing magnitudes of clinical change (assessed by the patients' global impressions of change and the patients' impressions of severity), and they demonstrated close equivalence to the KCCQ-23 scores., Conclusions: The KCCQ-12 demonstrated good psychometric performance for patients with oHCM, comparable to that of the KCCQ-23, supporting its use in clinical practice to care for patients with oHCM., Competing Interests: Disclosures AJS reports receiving research funding and/or honoraria for consultative services from Abbott, Acorai, Amgen, Astra Zeneca, Bayer, Biotronik, Boston Scientific, CSL Vifor, General Prognostics, Impulse Dynamics, Medtronic, Story Health and owning stock in ISHI. CFS is supported by NHLBI award T32HL110837. MR is an employee and stockholder at IQVIA, a medical research organization that received funding from Bristol Myers Squibb for research in the EXPLORER-HCM program. YZ and KWW are employees of Bristol Myers Squibb and report stock or stock options. JL was an employee of Bristol Myers Squibb when this work was conducted. JAS reports providing consultative services on patient-reported outcomes and evidence evaluation to 4DT Medical, Abbott, Alnylam, AstraZeneca, Bayer, Bristol Myers Squibb, Cytokinetics, Edwards, Imbria, Janssen, Kiniksa, Merck, Terumo, and United Healthcare and holds research grants from Abbott Vascular, Bristol Myers Squibb, and Janssen; he owns the copyright to the Kansas City Cardiomyopathy Questionnaire, the Peripheral Artery Questionnaire and the Seattle Angina Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. The remaining authors report no disclosures., (Copyright © 2024 Bristol Myers Squibb. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Dr Spertus discloses providing consultative services on patient-reported outcomes and evidence evaluation to Abbott, Alnylam, AstraZeneca, Bayer, Janssen, Bristol Meyers Squibb, Edwards, Terumo, Cytokinetics, and Imbria. He holds research grants from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, the American College of Cardiology Foundation, Bristol Meyers Squibb, Cytokinetics, Imbria, and Janssen. He owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. Dr Singh has consulted for Lexicon Pharmaceuticals and has research funding from Novartis and Reprieve Cardiovascular unrelated to this work. The other author reports no conflicts.

Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients., Competing Interests: Funding Support and Author Disclosures This study was self-funded. Dr Huded has received consulting fees from Boston Scientific; and has received grants from Abbott. Dr Saad has received consulting fees from Boston Scientific. Dr Chhatriwalla has been a proctor with Edwards Lifesciences, Medtronic; has been on the Speakers Bureau with Abbott Vascular, Edwards Lifesciences, and Medtronic; and has received grants from Boston Scientific. Dr Abbott has received grants from Boston Scientific and Microport; and has received consulting fees from Philips, Medtronic, Abbott, Penumbra, Shockwave, and Recor. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The ISCHEMIA trial found that patients with chronic coronary disease randomized to invasive strategy had better health status than those randomized to conservative strategy. It is unclear how best to translate these population-level results to individual patients., Objectives: The authors sought to identify patient characteristics associated with health status from invasive and conservative strategies, and develop a prediction algorithm for shared decision-making., Methods: One-year disease-specific health status was assessed in ISCHEMIA with the Seattle Angina Questionnaire (SAQ) Summary Score (SAQ SS) and Angina Frequency, Physical Limitations (PL), and Quality of Life (QL) domains (range 0-100, higher = less angina/better health status)., Results: Among 4,617 patients from 320 sites in 37 countries, mean SAQ SS was 74.1 ± 18.9 at baseline and 85.7 ± 15.6 at 1 year. Lower baseline SAQ SS and younger age were associated with better 1-year health status with invasive strategy (P interaction = 0.009 and P interaction = 0.004, respectively). For the individual domains, there were significant treatment interactions for baseline SAQ score (Angina Frequency, PL), age (PL, QL), anterior ischemia (PL), and number of baseline antianginal medications (QL), with more benefit of invasive in patients with worse baseline health status, younger age, anterior ischemia, and on more antianginal medications. Parsimonious prediction models were developed for 1-year SAQ domains with invasive or conservative strategies to support shared decision-making., Conclusions: In the management of chronic coronary disease, individual patient characteristics are associated with 1-year health status, with younger age and poorer angina-related health status showing greater benefit from invasive management. This prediction algorithm can support the translation of the ISCHEMIA trial results to individual patients. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522)., Competing Interests: Funding Support and Author Disclosures The research reported in this paper was funded through grants from National Institutes of Health/National Heart, Lung, and Blood Institute grants U01HL105907, U01HL105462, U01HL105561, and U01HL105565, Arbor Pharmaceuticals, AstraZeneca Pharmaceuticals, and Clinical and Translational Science Awards from the National Center for Advancing Translational Sciences (11UL1 TR001445 and UL1 TR002243). Devices or medications were provided by Abbott Vascular, Medtronic, St Jude Medical, Volcano, Amgen, Arbor Pharmaceuticals, AstraZeneca Pharmaceuticals, Espero Pharmaceuticals, Merck Sharp & Dohme, Omron Healthcare, and Sunovion Pharmaceuticals. Contents of this paper are solely the responsibility of the authors and do not necessarily represent official views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the Department of Health and Human Services. Dr Cohen has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Philips, CathWorks, Zoll Medical, and I-Rhythm; and has received consulting income from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Reynolds has received in-kind support for unrelated research from Abbott Vascular, Siemens, and BioTelemetry. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has been a consultant to Abbott, Daiichi-Sankyo, Ablative Solutions, CorFlow, Apollo Therapeutics, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, and HighLife; holds equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; and receives institutional research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Spertus owns the copyright to the Seattle Angina Questionnaire; has received consulting income from Janssen, Bayer, AstraZeneca, Novartis, and Merck; serves on the cardiovascular scientific advisory board of United Healthcare; is on the board of directors for Blue Cross Blue Shield of Kansas City; and holds equity interest in Health Outcomes Sciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: It is unclear how the type of an atherosclerotic cardiovascular disease (ASCVD) event potentially influences patients' likelihood of smoking cessation., Methods: Using 2013 to 2018 data from the US based National Cardiovascular Data Registry Practice Innovation and Clinical Excellence outpatient cardiac registry, we identified patients who were current smokers at a clinic visit and followed them over time for a subsequent ASCVD event. Self-reported smoking status was assessed at each consecutive visit and used to determine smoking cessation after each interim ASCVD event (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, stroke/transient ischemic attack, peripheral artery disease). We constructed separate multivariable Cox models with nonproportional hazards to examine the association of each interim ASCVD event with smoking cessation, compared with not having an interim ASCVD event. We estimated the relative association of ASCVD event type with smoking cessation using contrast tests. Analyses were stratified by presence versus absence of ASCVD at baseline., Results: Across 530 cardiology practices, we identified 1 933 283 current smokers (mean age 62±15, male 54%, ASCVD at baseline 50%). Among the 322 743 patients who had an interim ASCVD event and were still smoking, 41 336 (12.8%) quit smoking by their first subsequent clinic visit, which was higher among those with baseline ASCVD (13.4%) as compared with those without baseline ASCVD (11.5%). Each type of ASCVD event was associated with an increased likelihood of smoking. Patients who had an myocardial infarction, underwent coronary artery bypass graft (hazard ratio, 1.60 [95% CI, 1.55-1.65]), or had a stroke or transient ischemic attack were more likely to quit smoking as compared with those who underwent elective percutaneous coronary intervention or had a new diagnosis of peripheral artery disease (hazard ratio, 1.20 [95% CI, 1.17-1.22])., Conclusions: Only 13% of patients reported smoking cessation after an ASCVD event, with the type of event being associated with the likelihood of smoking cessation, prompting the need for patient-centered interventions., Competing Interests: Disclosures None.

Background: In the TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal), tricuspid transcatheter edge-to-edge repair (T-TEER) reduced tricuspid regurgitation (TR) and improved health status compared with medical therapy alone with no benefit on heart failure hospitalizations or survival., Objectives: The purpose of this study was to better understand the health status benefits of T-TEER within the TRILUMINATE Pivotal trial., Methods: TRILUMINATE randomized patients with severe TR to T-TEER (n = 175) or medical therapy (n = 175). Health status was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) (range 0-100; higher = better), which was compared between treatment groups using mixed effects linear regression. Alive and well was defined as KCCQ overall summary score ≥60 and no decline from baseline of >10 points at 1 year., Results: Compared with medical therapy, T-TEER significantly improved health status at 1 month (mean between-group difference in KCCQ overall summary score 9.4 points; 95% CI: 5.3-13.4 points), with a small additional improvement at 1 year (mean between-group difference 10.4 points; 95% CI: 6.3-14.6 points). T-TEER patients were more likely to be alive and well at 1 year (T-TEER vs medical therapy: 74.8% vs 45.9%; P < 0.001), with a number needed to treat of 3.5. Interaction analyses demonstrated that the benefit of T-TEER diminished as baseline KCCQ overall summary score increased (P int  < 0.001). Exploratory analyses suggested that much of the health status benefit of T-TEER could be explained by TR reduction and that improvement in health status after T-TEER was strongly correlated with reduced 1-year mortality and heart failure hospitalization., Conclusions: T-TEER with the TriClip system resulted in substantial and sustained health status improvement in patients with severe TR compared with medical therapy alone., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial was sponsored by Abbott and designed collaboratively by the principal investigators and the sponsor. The present analysis was conducted by Abbott under the direction of the academic authors. Dr Goates is an employee of Abbott. Dr Sorajja has performed unpaid trial activity with Abbott and HighLife; and has received consulting fees from 4C Medical, Abbott Structural, Biosense Webster, Boston Scientific, Edwards Lifesciences, Foldax, Medtronic, Phillips, Shifamed, Siemens, VDyne, and WL Gore. Dr Adams has performed unpaid trial activity with Abbott, NeoChord, and Medtronic; and has received royalty payments for intellectual property with Edwards Lifesciences and Medtronic. Dr von Bardeleben has performed unpaid trial activity with Abbott, DZHK German Center for Cardiovascular Research, Edwards Lifesciences, University of Göttingen IIT trials, Jenscare, Medtronic, Neochord, and Siemens; and has received consulting fees from Abbott, Edwards Lifesciences, Medtronic, Neochord, Philips, and Siemens. Dr Cohen has received research grant support from Abbott, Edwards Lifesciences, Boston Scientific, and Abbott; and has received consulting fees from Abbott, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Little is known about the outcomes of transcatheter aortic valve replacement (TAVR) in minimally symptomatic patients., Objectives: The authors aimed to evaluate the outcomes of patients with minimally symptomatic severe aortic stenosis treated with TAVR in the STS/ACC TVT registry., Methods: Minimally symptomatic status was defined as a baseline Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) ≥75. Clinical and health status outcomes of TAVR in patients with severe aortic stenosis and normal left ventricular ejection fraction were compared between minimally symptomatic patients and those with moderate or severe symptoms., Results: Among 231,285 patients who underwent TAVR between 2015 and 2021 (median age 80.0 years [IQR: 74.0-86.0 years], 47.5% female), 20.0% were minimally symptomatic before TAVR. Survival at 1 year was higher in minimally symptomatic patients vs those with moderate or severe symptoms (adjusted HR for death: 0.70 [95% CI: 0.66-0.75]). Mean KCCQ-OS increased by 2.7 points (95% CI: 2.6-2.9 points) at 30 days and 3.8 points (95% CI: 3.6-4.0 points) at 1 year in minimally symptomatic patients compared with increases of 32.2 points (95% CI: 32.0-32.3 points) at 30 days and 34.9 points (95% CI: 34.7-35.0 points) at 1 year in more symptomatic patients. Minimally symptomatic patients had higher odds of being alive and well at 1 year (OR: 1.19 [95% CI: 1.16-1.23])., Conclusions: Although minimally symptomatic patients treated with TAVR experience only small improvements in health status, their overall outcomes are favorable with a higher likelihood of survival with good health status at 1 year compared with more symptomatic patients., Competing Interests: Funding Support and Author Disclosures This research was supported by the ACC/STS TVT Registry. The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the registry or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Huded has received consulting fees from Boston Scientific; and a grant from Abbott Vascular. Dr Cohen has received institutional research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Vemulapalli has received grants from Abbott Vascular, Boston Scientific, HeartFlow, the American College of Cardiology, the Society of Thoracic Surgeons, and the National Institutes of Health and Patient Centered Outcomes Research Institute; and serves as a consultant to Boston Scientific, Premiere, Janssen, and Zafgen. Dr Saxon is a proctor for Edwards Lifesciences and Medtronic Inc., and is on the Speaker Bureau for Abbott Vascular, Medtronic Inc, and Edwards Lifesciences. Dr Chhatriwalla has received a grant from Boston Scientific; is a proctor for Edwards Lifesciences and Medtronic Inc,; and serves on the Speaker Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic Inc. Dr Kosinski is supported by grants from the American College of Cardiology and the Society of Thoracic Surgeons. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards Lifesciences, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the board of directors for Blue Cross Blue Shield of Kansas City. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: Individually, cardiac, renal, and metabolic (CRM) conditions are common and leading causes of death, disability, and health care-associated costs. However, the frequency with which CRM conditions coexist has not been comprehensively characterized to date., Objective: To examine the prevalence and overlap of CRM conditions among US adults currently and over time., Design, Setting, and Participants: To establish prevalence of CRM conditions, nationally representative, serial cross-sectional data included in the January 2015 through March 2020 National Health and Nutrition Examination Survey (NHANES) were evaluated in this cohort study. To assess temporal trends in CRM overlap, NHANES data between 1999-2002 and 2015-2020 were compared. Data on 11 607 nonpregnant US adults (≥20 years) were included. Data analysis occurred between November 10, 2020, and November 23, 2022., Main Outcomes and Measures: Proportion of participants with CRM conditions, overall and stratified by age, defined as cardiovascular disease (CVD), chronic kidney disease (CKD), type 2 diabetes (T2D), or all 3., Results: From 2015 through March 2020, of 11 607 US adults included in the analysis (mean [SE] age, 48.5 [0.4] years; 51.0% women), 26.3% had at least 1 CRM condition, 8.0% had at least 2 CRM conditions, and 1.5% had 3 CRM conditions. Overall, CKD plus T2D was the most common CRM dyad (3.2%), followed by CVD plus T2D (1.7%) and CVD plus CKD (1.6%). Participants with higher CRM comorbidity burden were more likely to be older and male. Among participants aged 65 years or older, 33.6% had 1 CRM condition, 17.1% had 2 CRM conditions, and 5.0% had 3 CRM conditions. Within this subset, CKD plus T2D (7.3%) was most common, followed by CVD plus CKD (6.0%) and CVD plus T2D (3.8%). The CRM comorbidity burden was disproportionately high among participants reporting non-Hispanic Black race or ethnicity, unemployment, low socioeconomic status, and no high school degree. Among participants with 3 CRM conditions, nearly one-third (30.5%) did not report statin use, and only 4.8% and 3.0% used glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors, respectively. Between 1999 and 2020, the proportion of US adults with multiple CRM conditions increased significantly (from 5.3% to 8.0%; P < .001 for trend), as did the proportion having all 3 CRM conditions (0.7% to 1.5%; P < .001 for trend)., Conclusions and Relevance: This cohort study found that CRM multimorbidity is increasingly common and undertreated among US adults, highlighting the importance of collaborative and comprehensive management strategies.

Background: Cardiovascular disease remains the primary source of morbidity and mortality in type 2 diabetes (T2D). We characterized the change over time in the use of evidence-based therapies to reduce cardiovascular risk in US patients with T2D., Methods: Data from a longitudinal outpatient diabetes registry were used to calculate the prescription of SGLT2i or GLP-1RA over time and among those with high-risk comorbidities (atherosclerotic cardiovascular disease [ASCVD], heart failure [HF], chronic kidney disease [CKD]) and a diabetes cardiovascular composite score (DCCS; calculated as: #eligible medications prescribed/#eligible medications x 100 for SGLT2i, GLP-1RA, statin, antiplatelet/anticoagulant therapy, ACEi/ARB/ARNI). Scores ranged from 0% to 100% (higher=more optimal care)., Results: Among 1,001,542 outpatients from 391 US sites, 51.7% patients had ASVCD, 17.7% HF, and 23.0% CKD. The percentage of patients prescribed an SGLT2i or GLP-1RA increased over time (7.3% in 2013 to 28.8% in 2019), and 18.3% of patients with ASCVD, HF, or CKD were on at least one of these medications at last follow-up vs 25.5% of patients without any of these comorbidities. Mean DCCS was 54±36%; 54±25% in patients with ASCVD, HF, or CKD vs 52±50% in patients without any of these comorbidities (P<0.001 for both). In a hierarchical linear model, male sex, and a diagnosis of CKD were independently associated with higher DCCS whereas a diagnosis of HF or ASCVD was associated with a lower DCCS., Conclusions: In a large, contemporary cohort of patients with T2D, we found improvement in the use of SGLT2i and GLP-1RA but unexpectedly lower use in patients with ASCVD, heart failure, and CKD, highlighting a treatment-risk paradox. Further education is needed to shift the understanding of these medications as tools for glucose-lowering to cardiovascular risk reduction and to improve their implementation in clinical practice., Competing Interests: Disclosures MK: Research grants from AstraZeneca, Boehringer Ingelheim; other research support from AstraZeneca; consulting honoraria from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Amgen, GSK, Merck (Diabetes), Eisai, Intarcia, Novartis, and Glytec, NDW: research support through his institution from Novo Nordisk not related to this study., JDN: research support from the NIH and AHA unrelated to this study. CLG, CH, and JR: employees of Novo Nordisk Inc. MV: research grant support or served on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health, speaker engagements with AstraZeneca, Novartis, and Roche Diagnostics, and participates on clinical trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. SVA, KG, LSS report no relevant disclosures to the current manuscript., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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

Background: Although studies consistently show that beta-blockers reduce morbidity and mortality in patients with reduced ejection fraction (EF), data are inconsistent in patients with heart failure with mildly reduced ejection fraction (HFmrEF) and suggest potential negative effects in heart failure with preserved ejection fraction (HFpEF)., Objectives: The purpose of this study was to examine the association of beta-blockers with heart failure (HF) hospitalization and death in patients with HF and EF ≥40% METHODS: Beta-blocker use was assessed at first encounter in outpatients ≥65 years of age with HFmrEF and HFpEF in the U.S. PINNACLE Registry (2013-2017). The associations of beta-blockers with HF hospitalization, death, and the composite of HF hospitalization/death were assessed using propensity-score adjusted multivariable Cox regression models, including interactions of EF × beta-blocker use., Results: Among 435,897 patients with HF and EF ≥40% (HFmrEF, n = 75,674; HFpEF = 360,223), 289,377 (66.4%) were using a beta-blocker at first encounter; more commonly in patients with HFmrEF vs HFpEF (77.7% vs 64.0%; P < 0.001). There were significant interactions between EF × beta-blocker use for HF hospitalization, death, and composite of HF hospitalization/death (P < 0.001 for all), with higher risk with beta-blocker use as EF increased. Beta-blockers were associated with decreased risk of HF hospitalization and death in patients with HFmrEF but a lack of survival benefit and a higher risk of HF hospitalization in patients with HFpEF, particularly when EF was >60%., Conclusions: In a large, real-world, propensity score-adjusted cohort of older outpatients with HF and EF ≥40%, beta-blocker use was associated with a higher risk of HF hospitalization as EF increased, with potential benefit in patients with HFmrEF and potential risk in patients with higher EF (particularly >60%). Further studies are needed to understand the appropriateness of beta-blocker use in patients with HFpEF in the absence of compelling indications., Competing Interests: Funding Support and Author Disclosures The PINNACLE Registry is part of the National Cardiovascular Data Registry and is managed by the American College of Cardiology (ACC) and Veradigm. The sponsors of the registry had no role in data analysis or interpretation, manuscript development, publication review, or approval for this study. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Although the prevalence of heart failure has been increasing over time, the presentation of heart failure has been shifting, with a greater proportion of preserved ejection fraction and more slowly progressive symptoms that require recognition in the outpatient setting. These shifts have placed more of the diagnostic responsibility onto primary care physicians, who often are challenged to determine the etiology of common symptoms in patients who often have several other potential reasons for these symptoms. Establishing a diagnosis of heart failure requires a step-wise approach that includes physical exam (looking for multiple signs of hypervolemia), labs (B-type natriuretic peptide levels), and echocardiography (structural and functional measures). Diagnostic algorithms are particularly challenging in patients with obesity, which limits the assessment of intravascular volume on exam, the quality of cardiac imaging, and the diagnostic accuracy of B-type natriuretic peptide levels, which may be falsely low. In these challenging patients, the use of risk scores, invasive testing of intravascular volume, or empiric treatment of hypervolemia may be needed to determine whether symptoms are due to heart failure. Once a diagnosis of heart failure is established, several treatments can be beneficial, from diuretics to relieve congestion to various aspects of guideline-directed medical therapy, some of which vary according to the ejection fraction of the patient. In addition, a diagnosis of heart failure may alter the treatment plan for comorbidities, including selection of anti-hypertensive and glucose-lowering medications, and medical or surgical treatments for obesity. While a diagnosis of heart failure may be challenging in many patients with slowly progressive and non-specific symptoms, early recognition and treatment can be extremely effective at preventing hospitalizations, prolonging survival, and improving quality of life., (© 2023 John Wiley & Sons Ltd.)

Background: Over the past decade, there has been substantial improvement in outcomes after transcatheter aortic valve replacement. Many patient and procedural factors have also changed over that time, making it challenging to untangle the drivers of those improvements., Methods: Among patients who underwent transcatheter aortic valve replacement from 2012 to 2018 within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we examined the relative contribution of changes in patient factors, device modifications, improving experience/skill, and advances in periprocedural care to the observed improvement in outcomes after transcatheter aortic valve replacement. Mediator clusters included demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors, and nondevice-related procedural factors. Using logistic regression, we serially adjusted for the mediator clusters to examine the contribution of each to the observed improvement in outcomes over time., Results: Among 161 196 patients treated with transcatheter aortic valve replacement at 596 sites, outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%), and 1-year mortality (19.9% to 10.1%; all P <0.001). In sequential models, the unadjusted odds ratio for 30-day mortality was 0.82 per year (95% CI, 0.80-0.84), which was progressively attenuated with addition of each covariate cluster. Most of the improvement was explained by device factors and nondevice procedural factors. Results were similar for 30-day composite adverse events, although the observed temporal improvement was not fully explained by measured factors, suggesting improved technical skill as an additional mediator. In contrast to 30-day outcomes, each cluster of patient and procedural factors contributed similarly to the temporal improvement in 1-year mortality, indicating a greater impact of patient factors on longer-term outcomes., Conclusions: While US patients undergoing transcatheter aortic valve replacement have become younger, healthier, and lower risk over time, the most important factors contributing to improvements in short-term outcomes relate to advances in device technology and procedural factors, whereas changing patient characteristics had a greater impact on improvement in 1-year outcomes., Competing Interests: Disclosures Dr Vemulapalli received research support from the American College of Cardiology, Abbott Vascular, Cytokinetics, Society of Thoracic Surgeons, Boston Scientific, Food and Drug Administration (NESTcc) and the National Institutes of Health (R01 and SBIR); consulting/travel/honoraria fees from Medtronic, Edwards Lifesciences, HeartFlow, and the American College of Physicians. Dr Cohen received research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular. Dr Thourani received research support or consultant fees for Abbott Vascular, Artivion, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. The other authors report no potential financial conflicts.

Frailty is a syndrome of older age that reflects an impaired physiological reserve and decreased ability to recover from medical stressors. While the impact of frailty on mortality in cardiovascular disease has been well described, its impact on cardiovascular disease-specific health status-cardiac symptoms, physical functioning and quality of life-has been less well studied. In this review, we summarise the impact of frailty on health status outcomes across different cardiovascular conditions. In heart failure, frail patients have markedly impaired disease-specific health status and are at risk for subsequent health status deteriorations. However, frail patients have similar or even greater health status improvements with interventions for heart failure, such as cardiac rehabilitation or guideline-directed medical therapy. In valvular heart disease, the impact of frailty on disease-specific health status is of even greater concern since management involves physiologically taxing procedures that can worsen health status. Frailty increases the risk of poor health status outcomes after transcatheter aortic valve intervention or surgical aortic valve replacement for aortic stenosis, but there is no evidence that frail patients benefit more from one procedure versus another. In both heart failure and valvular heart disease, health status improvements may reverse frailty, highlighting the overlap between cardiovascular disease and frailty and emphasising that treatment should typically not be withheld based on the presence of frailty alone. Meanwhile, data are limited on the impact of frailty on health status outcomes in the treatment of coronary artery disease, peripheral artery disease and atrial fibrillation, and requires further research., Competing Interests: Competing interests: SA is an editorial board member of Heart., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Aim: To examine improvement in the use of optimal medical therapy (OMT) for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD) and diabetes., Materials and Methods: Patients with ASCVD (coronary, cerebrovascular, peripheral) and low-density lipoprotein-cholesterol of 70 mg/dl or higher were enrolled from December 2016 to July 2018 from 107 US sites/physicians (47% cardiology, 41% primary care, 12% other) and prospectively followed for 2 years (current analysis restricted to subgroup with diabetes). OMT was defined as high-intensity lipid-lowering (high-intensity statin, any statin + ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitor), antithrombotic (antiplatelet or anticoagulant), angiotensin-converting enzyme-inhibitor/angiotensin II receptor blocker/angiotensin receptor neprilysin inhibitor (ACE-I/ARB/ARNI) (excluding glomerular filtration rate [GFR] < 30 ml/min/1.73m 2 ) and sodium-glucose co-transporter-2 inhibitor (SGLT2i)/glucagon-like peptide-1 receptor agonist (GLP-1 RA) (excluding GFR < 30 ml/min/1.73m 2 and type 1 diabetes)., Results: Among 1590 patients with ASCVD and diabetes (96% type 2 diabetes), 58% were on high-intensity lipid-lowering therapy at the end of follow-up, 87% antithrombotic, 71% ACE-I/ARB/ARNI and 17% SGLT2i/GLP-1 RA. Overall, 11% of patients received comprehensive OMT, which modestly improved over time (vs. 8% at baseline; P = .002). Patients treated by cardiologists (vs. non-cardiologists) were more likely to be on high-intensity lipid lowering, but less likely to be on an SGLT2i/GLP-1 RA, and thus had lower rates of composite OMT (7.8% vs. 13.7%, P < .001). In a hierarchical multivariable model, older age was associated with lower odds of OMT (OR 0.74 per 10 years, 95% CI 0.60-0.90), whereas private insurance (OR 1.93, 95% CI 1.32-2.84) and coronary disease (OR 1.62, 95% CI 1.01-2.61) were associated with higher odds. The median odds ratio was 1.82 (95% CI 1.03-7.32), indicating a moderate variability in OMT use, independent of patient factors., Conclusions: We found suboptimal use of secondary prevention in US patients with ASCVD and diabetes, with minimal improvement over time. Further efforts are needed to improve the use of secondary prevention therapies in these patients with high residual risk., (© 2023 John Wiley & Sons Ltd.)

Competing Interests: Disclosures Dr Lindman is supported by R01AG073633 from the National Institutes of Health and has consulted for and received research grants from Edwards Lifesciences. Dr Fonarow reports consulting with Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Eli Lilly, Edwards Lifesciences, Janssen, Medtronic, Merck, and Novartis. Dr Szeto has served on the advisory board and as an investigator and speaker for Edwards Lifesciences and Medtronic. Dr Alger is affiliated with Anumana, Inc, and is an employee of Nference, Inc; her contributions to the present work were completed as an employee of the American Heart Association. The other authors report no conflicts.

Background: Whether initial invasive management in older vs younger adults with chronic coronary disease and moderate or severe ischemia improves health status or clinical outcomes is unknown., Objectives: The goal of this study was to examine the impact of age on health status and clinical outcomes with invasive vs conservative management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial., Methods: One-year angina-specific health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ) (score range 0-100; higher scores indicate better health status). Cox proportional hazards models estimated the treatment effect of invasive vs conservative management as a function of age on the composite clinical outcome of cardiovascular death, myocardial infarction, or hospitalization for resuscitated cardiac arrest, unstable angina, or heart failure., Results: Among 4,617 participants, 2,239 (48.5%) were aged <65 years, 1,713 (37.1%) were aged 65 to 74 years, and 665 (14.4%) were aged ≥75 years. Baseline SAQ summary scores were lower in participants aged <65 years. Fully adjusted differences in 1-year SAQ summary scores (invasive minus conservative) were 4.90 (95% CI: 3.56-6.24) at age 55 years, 3.48 (95% CI: 2.40-4.57) at age 65 years, and 2.13 (95% CI: 0.75-3.51) at age 75 years (P interaction  = 0.008). Improvement in SAQ Angina Frequency was less dependent on age (P interaction  = 0.08). There were no age differences between invasive vs conservative management on the composite clinical outcome (P interaction  = 0.29)., Conclusions: Older patients with chronic coronary disease and moderate or severe ischemia had consistent improvement in angina frequency but less improvement in angina-related health status with invasive management compared with younger patients. Invasive management was not associated with improved clinical outcomes in older or younger patients. (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches [ISCHEMIA]; NCT01471522)., Competing Interests: Funding Support and Author Disclosures This project was supported in part by National Institutes of Health grants U01HL105907, U01HL105462, U01HL105561, and U01HL105565; and in part by Clinical Translational Science Award numbers 11UL1 TR001445 and UL1 TR002243 from the National Center for Advancing Translational Sciences. The contents of this project are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences; the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the Department of Health and Human Services. Dr Nguyen is currently supported by the National Heart, Lung, and Blood Institute under Award Number T32HL110837. Dr Spertus has received grants from the National Heart, Lung, and Blood Institute during the conduct of the study; has received personal fees from Bayer, Novartis, AstraZeneca, Amgen, Janssen, and United Healthcare; has received grants from the American College of Cardiology, outside the submitted work; has a patent copyright to SAQ with royalties paid; is on the Board of Directors for Blue Cross Blue Shield of Kansas City; and has equity in Health Outcomes Sciences. Dr Newman, Dr Alexander, Mrs Stevens, Dr O'Brien, Dr Gamma, Dr Perna, Dr Garg, Dr Vertes, Dr Smanio, Dr Senior, Dr Held, and Dr Maron have received grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Mr Jones reports employment by the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Chow holds the Saul and Edna Goldfarb Chair in Cardiac Imaging Research; receives research support from TD Bank, CV Diagnostix, AusculSciences, and Siemens Healthineers; and has equity interest in General Electric. Dr White has received grants from the National Heart, Lung, and Blood Institute during the conduct of the study; has received grant support paid to the institution and fees for serving on a steering committee for the ODYSSEY OUTCOMES trial from Sanofi and Regeneron Pharmaceuticals, for the ACCELERATE study from Eli Lilly, for the STRENGTH trial from Omthera Pharmaceuticals, for the HEART-FID study from American Regent, for the CAMELLIA-TIMI study from Eisai Inc, for the dal-GenE study from DalCor Pharma UK Inc, for the AEGIS-II study from CSL Behring, for the SCORED trial and the SOLOIST-WHF trial from Sanofi Australia Pty Ltd, and for the CLEAR Outcomes Study from Esperion Therapeutics Inc. Dr White was on the Advisory Board for Genentech, Inc; and has received lecture fees from AstraZeneca. Dr Boden has received grants from the National Heart, Lung, and Blood Institute during the conduct of the study; has received grants from AbbVie, Amarin, and Amgen; and has received personal fees from Amgen, the Cleveland Clinic Clinical Coordinating Center, and Janssen, outside the submitted work. Dr Mark has received grants from the National Heart, Lung, and Blood Institute during the conduct of the study; and has received grants from HeartFlow and Merck, outside the submitted work. Dr Reynolds has received funding for this research from the National Heart, Lung, and Blood Institute; and has received in-kind donations for unrelated research from Abbott Vascular, Siemens, and Philips. Dr Bangalore has received grants from the National Heart, Lung, and Blood Institute and Abbott Vascular; and serves on the advisory board for Abbott Vascular, Pfizer, Amgen, Biotronik, Meril, and Reata. Dr Chan has received funding from the American Heart Association; and is a consultant for Optum Rx. Dr Stone has received grants and personal fees from the National Heart, Lung, and Blood Institute during the conduct of the study; has received personal fees from Terumo, Amaranth, Shockwave, TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Matrizyme, Miracor, Neovasc, V-Wave, Abiomed, Claret, Sirtex, MAIA Pharmaceuticals, and Vectorious; has received personal fees and has equity/options from VALFIX, Ancora, Qool Therapeutics, SpectraWave, and Orchestra Biomed; has equity/options from Cagent, Applied Therapeutics, BioStar family of funds, MedFocus family of funds, and Aria; and has equity/options from Cardiac Success, outside the submitted work. Dr Hochman is Principal Investigator for the ISCHEMIA trial for which, in addition to support by a National Heart, Lung, and Blood Institute grant, devices and medications were provided by Abbott Vascular, Medtronic, Inc, Abbott Laboratories (formerly St Jude Medical, Inc), Royal Philips NV (formerly Volcano Corporation), Arbor Pharmaceuticals, LLC, AstraZeneca Pharmaceuticals, LP, Merck Sharp & Dohme Corp, Omron Healthcare, Inc, Sunovion Pharmaceuticals, Inc, Espero BioPharma, and Amgen, Inc, as well as financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The extent of extravalvular cardiac damage is associated with increased risk of adverse events among patients with severe aortic stenosis undergoing aortic valve replacement (AVR)., Objectives: The goal was to describe the association of cardiac damage on health status before and after AVR., Methods: Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by echocardiographic cardiac damage stage at baseline and 1 year as previously described (stage 0-4). We examined the association between baseline cardiac damage and 1-year health status (assessed by the Kansas City Cardiomyopathy Questionnaire Overall Score [KCCQ-OS])., Results: Among 1,974 patients (794 surgical AVR, 1,180 transcatheter AVR), the extent of cardiac damage at baseline was associated with lower KCCQ scores both at baseline and at 1 year after AVR (P < 0.0001) and with increased rates of a poor outcome (death, KCCQ-OS <60, or a decrease in KCCQ-OS of ≥10 points) at 1 year (stages 0-4: 10.6% vs 19.6% vs 29.0% vs 44.7% vs 39.8%; P < 0.0001). In a multivariable model, each 1-stage increase in baseline cardiac damage was associated with a 24% increase in the odds of a poor outcome (95% CI: 9%-41%; P = 0.001). Change in stage of cardiac damage at 1 year after AVR was associated with the extent of improvement in KCCQ-OS over the same period (mean change in 1-year KCCQ-OS: improvement of ≥1 stage +26.8 [95% CI: 24.2-29.4] vs no change +21.4 [95% CI: 20.0-22.7] vs deterioration of ≥1 stage +17.5 [95% CI: 15.4-19.5]; P < 0.0001)., Conclusions: The extent of cardiac damage before AVR has an important impact on health status outcomes, both cross-sectionally and after AVR. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A), NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B [PARTNERII B], NCT02184442; PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3], NCT02675114)., Competing Interests: Funding Support And Author Disclosures The PARTNER 2 and PARTNER 3 Trials were sponsored by Edwards Lifesciences (Irvine, California). Dr Généreux has served as a consultant for Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, CARANX Medical, Cardiovascular System Inc (PI Eclipse Trial), Edwards Lifesciences (PI EARLY-TAVR trial, PI PROGRESS trial), GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Siemens, Soundbite Medical Inc, Teleflex, and 4C Medical (PI feasibility study); has served as an advisor for Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, and Medtronic; has received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, Medtronic, and Shockwave; has served as a proctor for and received an institutional research grant from Edwards Lifesciences; and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. The Cardiovascular Research Foundation (Drs Redfors, Cohen, Alu, Hahn, and Lyon) receives research funding from Edwards Lifesciences (no direct compensation). Dr Bax reports that the Department of Cardiology (LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific; and has received speaker fees from Abbott Vascular. Drs Zhao and Prince are employees of Edwards Lifesciences. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St Jude Medical; and has received consultant fees/honoraria from and served on the speaker’s bureau for Abbott Vascular, Cordis Corporation, and Medtronic. Dr Thourani is on the advisory board of Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences; served as co-primary investigator for the COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Lindman has served on the scientific advisory board for Roche Diagnostics; and has received research grants from Edwards Lifesciences and Roche Diagnostics. Dr Babaliaros has received consulting fees from Edwards Lifesciences and Abbott. Dr Russo has received grants from Edwards Lifesciences; and has served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. Dr Gillam has served as a consultant for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences and Medtronic. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifescience; has institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has equity with Navigate; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Webb is a consultant for Edwards Lifesciences. Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (non-paid); and has received institutional research grants from and has served as a nonpaid advisor for Abbott, Boston Scientific, and Medtronic; has served as a nonpaid advisor for Sinomed; and has equity in Medinol. Dr Cohen has received research grant support and consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Peripheral artery disease (PAD) and heart failure (HF) often coexist. Whether PAD influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF and severe secondary mitral regurgitation is unknown. The objectives are to assess the impact of PAD on outcomes of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF and secondary mitral regurgitation. Methods and Results The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized patients with HF with ≥moderate-to-severe secondary mitral regurgitation to TMVr with MitraClip implant plus GDMT versus GDMT alone. We evaluated the relationship between PAD and 2-year outcomes in the COAPT trial  and examined whether PAD modified the benefits of TMVr. Among 614 patients enrolled, 109 (17.8%) had PAD. By multivariable analysis, PAD was independently associated with 2-year mortality (adjusted hazard ratio [adjHR], 1.51 [95% CI, 1.07-2.15]) but not HF hospitalizations. Compared with GDMT alone, TMVr reduced the 2-year risk of death in patients without PAD (adjHR, 0.42 [95% CI, 0.30-0.60]) but not those with PAD (adjHR, 1.27 [95% CI, 0.72-2.27]; P interaction =0.001). In contrast, TMVr reduced HF hospitalizations consistently in patients with (adjHR, 0.65 [95% CI, 0.35-1.23]) and without (adjHR, 0.42 [95% CI, 0.31-0.57]) PAD ( P interaction =0.22). Improvements in health status and exercise capacity at 2 years with TMVr compared with GDMT alone were similar in degree, irrespective of PAD status ( P interaction =0.76 and 0.64, respectively). Conclusions In patients with HF and severe secondary mitral regurgitation, the reduced mortality with TMVr in the overall COAPT study population was not observed in the subgroup of patients with PAD. However, TMVr reduced HF hospitalizations and improved health status and exercise capacity consistently in patients with and without PAD. Registration Clinical Trial Name: Cardiovascular Outocmes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial); URL: https://www.clinicaltrials.gov/; Unique identifier: NCT01626079. https://clinicaltrials.gov/ct2/show/NCT01626079.

Despite its cardiometabolic benefits, bariatric surgery has historically been underused in patients with obesity and diabetes, but contemporary data are lacking. Among 1,520,182 patients evaluated from 2013 to 2019 within a multicenter, longitudinal, US registry of outpatients with diabetes, we found that 462,033 (30%) met eligibility for bariatric surgery. After a median follow-up of 854 days, 6310/384,859 patients (1.6%) underwent primary bariatric surgery, with a slight increase over time (0.38% per year [2013] to 0.68% per year [2018]). Patients who underwent bariatric surgery were more likely to be female (63% vs. 56%), white (87% vs. 82%), have higher body mass indices (42.1 ± 6.9 vs. 40.6 ± 5.9 kg/m 2 ), and depression (23% vs. 14%; p < 0.001 for all). Over a median (IQR) follow-up after surgery of 722 days (364-993), patients who underwent bariatric surgery had lost an average of 11.8 ± 18.5 kg (23% of excess body weight), 10.2% were on fewer glucose-lowering medications, and 8.4% were on fewer antihypertensives. Despite bariatric surgery being safer and more accessible over the past two decades, less than one in fifty eligible patients with diabetes receive this therapy., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: Rehospitalization is a common end point in clinical trials of structural heart interventions, but whether rehospitalization is clinically and prognostically relevant in these patients is uncertain. The aim of this study was to evaluate the risk of rehospitalization events after aortic valve replacement (AVR) and their association with mortality and health status., Methods: The study population included patients who underwent transcatheter or surgical AVR in the PARTNER I' II' and III trials (Placement of Aortic Transcatheter Valves). Health status was assessed with the Kansas City Cardiomyopathy Questionnaire-overall summary score. The primary analysis focused on heart failure hospitalization within 1 year after AVR and its association with mortality, poor outcome (death, Kansas City Cardiomyopathy Questionnaire-overall summary score <60 or decrease by ≥10), and health status at 1 year using adjusted models. Secondary analyses examined the prognostic associations of rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes., Results: Among 3403 patients treated with AVR (2008 transcatheter AVR, 1395 surgical AVR), the 1-year incidence was 6.7% for heart failure hospitalization and 9.7% for rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. Heart failure hospitalization after AVR was associated with increased risk of 1-year mortality (hazard ratio, 3.97 [2.48 to 6.36]; P <0.001), poor outcome (OR, 2.76 [1.73 to 4.40]; P <0.001), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -9.8 points [-13.8 to -5.8]; P <0.001). Rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes was similarly associated with increased 1-year mortality (hazard ratio, 4.64 [3.11 to 6.92]; P <0.001), poor outcome (OR, 2.06 [1.38 to 3.07]; P =0.0004), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -8.8 points [-11.8 to -5.7]; P <0.001). There was no effect modification by treatment type (transcatheter AVR versus surgical AVR) for these associations., Conclusions: Heart failure hospitalization and rehospitalization after AVR are associated with increased risk of mortality and worse 1-year health status. These findings confirm the clinical and prognostic relevance of rehospitalization end points for trials of AVR., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT00530894.

Background: Although secondary cardiovascular prevention is a focus among patients with type 2 diabetes (T2D) and coronary artery disease (CAD) or peripheral artery disease (PAD), the application of guideline-recommended therapy in T2D patients and isolated cerebrovascular disease (CeVD) remains unknown., Methods: In a US outpatient registry, T2D patients with established cardiovascular disease from 2014-2018 were categorized as: isolated CeVD, CeVD plus CAD or PAD, or isolated CAD/PAD. In each group, we determined the proportion with optimal secondary prevention (hemoglobin [Hb]A 1C <8%, blood pressure <130/80 mm Hg, use of antithrombotics, use of statins, non-smoking/cessation counseling, and use of glucose-lowering medications with cardioprotective effects (sodium-glucose cotransporter [SGLT]-2 inhibitors, glucagon-like peptide [GLP]-1 receptor agonists, thiazolidinediones [TZDs]). Hierarchical Poisson regression was used to estimate relative rate of achieving each target across groups, adjusted for age and chronic kidney disease (where relevant)., Results: Our study included 727,467 T2D outpatients with cardiovascular disease (isolated CeVD [n = 99,777], CeVD plus CAD/PAD [n = 158,361], isolated CAD/PAD [n = 469,329]). Compared with isolated CAD/PAD patients, isolated CeVD patients more often had an HbA 1c <8% (adjusted relative risk [aRR] 1.10; 95% confidence interval [CI], 1.08-1.11) but less often had a blood pressure of ≤130/80 mm Hg (aRR 0.93; 95% CI, 0.92-0.94) or were prescribed antithrombotics (0.84; 95% CI, 0.83-0.85), statins (0.86; 95% CI, 0.85-0.87), GLP-1 agonists (0.75; 95% CI, 0.73-0.78), SGLT2 inhibitors (0.73; 95% CI, 0.71-0.76), and TZDs (aRR 0.76; 95% CI, 0.73-0.78)., Conclusion: Among T2D patients, those with isolated CeVD had the lowest rates of secondary cardiovascular prevention goals attainment. More focus is needed on secondary prevention in patients with CeVD., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Before the development of transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV) was the only potential nonsurgical intervention for patients with aortic stenosis complicated by cardiogenic shock. Emergent TAVR is now an option and has shown acceptable outcomes compared with elective TAVR. We explored how treatment patterns for aortic stenosis and cardiogenic shock among patients received invasive intervention have shifted since TAVR was introduced., Methods: We used the Nationwide In patients Sample to identify nonelective hospitalizations for patient with aortic stenosis complicated by cardiogenic shock who received invasive treatment (TAVR, BAV, or surgical aortic valve replacement [SAVR]). We explored the proportion treated with each treatment modality over time, the patient characteristics and in-hospital mortality associated with each treatment, and used multivariable logistic regression to examine whether changes in in-hospital mortality over time differed by treatment., Results: Between 2010 and 2019, we identified 9899 hospitalizations for decompensated aortic stenosis with cardiogenic shock during which patients received invasive treatment (TAVR 17.7%, BAV 20.2%, SAVR 62.1%). Use of both TAVR and BAV has increased over time compared with SAVR (TAVR 6.6% ≥ 33.8%, BAV 8.4% ≥ 23.2%, SAVR 91.6% ≥ 43.0%; p < 0.001 for trend). The overall in-hospital mortality rate was 21.0%, which decreased over time for all treatments (TAVR 20.0% ≥ 18.8%, BAV 66.0% ≥ 25.5%, SAVR 17.7% ≥ 11.8%; linear trend p < 0.001 for each), with lower mortality for TAVR versus BAV at all time points. Patients treated with TAVR (vs. BAV) were less likely to require mechanical ventilation (36.8% vs. 46.3%, p < 0.001) or mechanical circulatory support (22.5% vs. 29.9%, p < 0.001). In the multivariable analysis, the interaction between treatment and time was not significant (p = 0.245), indicating the reduction in in-hospital mortality over time did not differ among the treatments., Conclusions: Since the introduction of TAVR, there has been a shift toward increased use of nonsurgical invasive treatments (both BAV and TAVR) for aortic stenosis and cardiogenic shock. Although in-hospital mortality has declined, it remains high in all groups, but particularly among patients treated with BAV, where the severity of cardiogenic shock appears to be higher than in those treated with other modalities., (© 2022 Wiley Periodicals LLC.)

Background: We sought to describe global patterns in achievement of risk factor control for primary prevention in patients with T2D and explore the association of country's GNI/capita with risk factor control., Methods: The DISCOVER study is a prospective, observational study of patients with T2D from 38 countries enrolled at initiation of second-line glucose-lowering therapy. We examined achievement of risk factor control (glycosylated hemoglobin <7%, blood pressure <140/90 mmHg, prescription of a statin) at 3 years among those without optimal control at baseline. Countries were stratified by gross national income (GNI)/capita, from 2017). We examined the impact of country GNI/capita with achievement of risk factor control., Findings: Our cohort included 9613 patients with T2D and without baseline cardiovascular disease (mean age 57.2 ± 8.7 years, 47.9% women). At baseline, 6354/7646 patients (83.1%) had suboptimal glucose control, 3449/9200 patients (37.5%) had suboptimal BP control, and 2800/4221 patients (66.7%) were not on an appropriate statin (sample sizes differed due to missing covariate data). Optimal control at 3 years of follow-up was achieved in 41% (glucose), 56% (blood pressure), and 29% (statins) of patients. There was significant variability in achievement of risk factor control across countries but no association between country GNI/capita with achievement of risk factor control (p > 0.08 for all)., Interpretation: In a global, prospective study of patients with T2D, we found that cardiovascular risk factor control achievement was suboptimal despite 3 years of follow-up in specialized health care systems. Neither country-level nor patient-level socioeconomic factors fully explained this finding., (Copyright © 2022 Cardiological Society of India. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.)

Aims: To estimate real-world change in weight over 3 years and the factors influencing it in participants who are overweight and live with type 2 diabetes., Materials and Methods: DISCOVER is a multinational prospective observational study that enrolled participants with type 2 diabetes between December 2014 and June 2016 at the time of initiation of a second-line glucose-lowering medication (GLM). Demographic, anthropometric, and quality-of-life data were collected at baseline, and after 6, 12, 24 and 36 months of follow-up. Using a hierarchical, repeated-measures linear regression model, we examined factors associated with weight change over time., Results: Of 10 675 participants with type 2 diabetes who were overweight/obese (mean age 57.1 ± 11.1 years, 46% women), 21% lost ≥5% weight over 3 years, which was associated with modestly improved physical and mental health. Advancing age, female sex, and higher baseline weight were associated with weight loss. Most importantly, the type of GLM prescribed at previous visit had the strongest impact on weight change over time independent of participant factors, with use of a sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide-1 receptor agonist associated with 1.0% weight loss versus a 0.6% weight gain with sulphonylureas, thiazolidinediones, meglitinides or insulin., Conclusion: In this large contemporary prospective study, approximately one in five participants with early-stage type 2 diabetes and overweight/obesity lost ≥5% weight over 3 years. The type of GLM has the most impact on weight loss over time, highlighting the need for a careful selection of agents that takes baseline weight into consideration., (© 2022 John Wiley & Sons Ltd.)