Pub Date : 2025-02-05DOI: 10.1001/jamacardio.2024.5410
Thomas Gaziano, David Kapaon, Jacques D. du Toit, Nigel J. Crowther, Alisha N. Wade, June Fabian, Carlos Riumallo-Herl, F. Carla Roberts-Toler, Xavier Gómez-Olivé, Stephen Tollman
ImportanceReductions in dietary salt are associated with blood pressure reductions; however, national governments that have passed laws to reduce sodium intake have not measured these laws’ impact.ObjectiveTo determine if South African regulations restricting sodium content in processed foods were associated with reductions in sodium consumption and blood pressure.Design, Setting, and ParticipantsThe HAALSI (Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study is a population-based cohort study among adults aged 40 years or older randomly selected from individuals living in rural Mpumalanga Province in South Africa. This study incorporated 3 waves of data (2014/2015, 2018/2019, and 2021/2022) from the HAALSI study to examine how 24-hour urine sodium (24HrNa) excretion changed among a population-based cohort following mandatory sodium regulations. Spot urine samples were collected across 3 waves, and data analysis was performed from 2023 to 2024.ExposuresSouth African regulations introduced in 2013 that reduced levels for the maximum amount of sodium in milligrams per 100 mg of food product by 25% to 80% across 13 processed food categories by 2019.Main Outcomes and Measures24HrNa was estimated using the INTERSALT equation, and generalized estimating equations were used to assess changes in sodium excretion and blood pressure.ResultsAmong 5059 adults 40 years or older, mean (SD) age was 62.43 years (13.01), and 2713 participants (53.6%) were female. Overall mean (SD) estimated 24HrNa excretion at baseline was 3.08 g (0.78). There was an overall reduction in mean 24HrNa excretion of 0.22 g (95% CI, −0.27 to −0.17; P < .001) between the first 2 waves and a mean reduction of 0.23 g (95% CI, −0.28 to −0.18; P < .001) between the first and third waves. The reductions were larger when analysis was restricted to those with samples in all 3 waves (−0.26 g for both waves 2 and 3 compared to wave 1). Every gram of sodium reduction was associated with a −1.30 mm Hg reduction (95% CI, 0.65-1.96; P = .00) in systolic blood pressure. The proportion of the study population that achieved ideal sodium consumption (<2 g per day) increased from 7% to 17%.Conclusion and RelevanceIn this cohort study, following South African regulations limiting sodium in 13 categories of processed foods, there was a significant reduction in 24HrNa excretion among this rural South African population, which was sustained with reductions in blood pressure consistent with levels of sodium excreted. These results support the potential health effects anticipated by effective implementation of population-based salt reformulation policies.
{"title":"Sodium Reduction Legislation and Urinary Sodium and Blood Pressure in South Africa","authors":"Thomas Gaziano, David Kapaon, Jacques D. du Toit, Nigel J. Crowther, Alisha N. Wade, June Fabian, Carlos Riumallo-Herl, F. Carla Roberts-Toler, Xavier Gómez-Olivé, Stephen Tollman","doi":"10.1001/jamacardio.2024.5410","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5410","url":null,"abstract":"ImportanceReductions in dietary salt are associated with blood pressure reductions; however, national governments that have passed laws to reduce sodium intake have not measured these laws’ impact.ObjectiveTo determine if South African regulations restricting sodium content in processed foods were associated with reductions in sodium consumption and blood pressure.Design, Setting, and ParticipantsThe HAALSI (Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study is a population-based cohort study among adults aged 40 years or older randomly selected from individuals living in rural Mpumalanga Province in South Africa. This study incorporated 3 waves of data (2014/2015, 2018/2019, and 2021/2022) from the HAALSI study to examine how 24-hour urine sodium (24HrNa) excretion changed among a population-based cohort following mandatory sodium regulations. Spot urine samples were collected across 3 waves, and data analysis was performed from 2023 to 2024.ExposuresSouth African regulations introduced in 2013 that reduced levels for the maximum amount of sodium in milligrams per 100 mg of food product by 25% to 80% across 13 processed food categories by 2019.Main Outcomes and Measures24HrNa was estimated using the INTERSALT equation, and generalized estimating equations were used to assess changes in sodium excretion and blood pressure.ResultsAmong 5059 adults 40 years or older, mean (SD) age was 62.43 years (13.01), and 2713 participants (53.6%) were female. Overall mean (SD) estimated 24HrNa excretion at baseline was 3.08 g (0.78). There was an overall reduction in mean 24HrNa excretion of 0.22 g (95% CI, −0.27 to −0.17; <jats:italic>P</jats:italic> &amp;lt; .001) between the first 2 waves and a mean reduction of 0.23 g (95% CI, −0.28 to −0.18; <jats:italic>P</jats:italic> &amp;lt; .001) between the first and third waves. The reductions were larger when analysis was restricted to those with samples in all 3 waves (−0.26 g for both waves 2 and 3 compared to wave 1). Every gram of sodium reduction was associated with a −1.30 mm Hg reduction (95% CI, 0.65-1.96; <jats:italic>P</jats:italic> = .00) in systolic blood pressure. The proportion of the study population that achieved ideal sodium consumption (&amp;lt;2 g per day) increased from 7% to 17%.Conclusion and RelevanceIn this cohort study, following South African regulations limiting sodium in 13 categories of processed foods, there was a significant reduction in 24HrNa excretion among this rural South African population, which was sustained with reductions in blood pressure consistent with levels of sodium excreted. These results support the potential health effects anticipated by effective implementation of population-based salt reformulation policies.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"23 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143125368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1001/jamacardio.2024.5312
Sadiya S Khan
{"title":"The Cardiovascular Disease Divide-A Tale of 2 High-Income Nations.","authors":"Sadiya S Khan","doi":"10.1001/jamacardio.2024.5312","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5312","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1001/jamacardio.2024.5417
Xiong Ding, Xinyi Zhang, Liping Huang, Shangzhi Xiong, Zhifang Li, Yi Zhao, Bo Zhou, Xuejun Yin, Bingqing Xu, Yanfeng Wu, Bruce Neal, Maoyi Tian, Lijing L. Yan
ImportanceThe direct effect of consumption of salt substitutes on recurrent stroke and mortality among patients with stroke remains unclear.ObjectiveTo evaluate the effects of salt substitutes vs regular salt on the incidence of recurrent stroke and mortality among patients with stroke.Design, Setting, and ParticipantsThe Salt Substitute and Stroke Study (SSaSS), an open-label, cluster randomized clinical trial, was conducted in 600 northern Chinese villages (clusters). Patients who self-reported a hospital diagnosis of stroke were included in this prespecified subgroup analysis. Data were analyzed from November 2023 to August 2024.InterventionsParticipants were assigned to use either a salt substitute, consisting of 75% sodium chloride and 25% potassium chloride by mass, or regular salt.Main Outcomes and MeasuresThe primary outcome was recurrent stroke.ResultsAfter excluding 5746 persons without a baseline history of stroke, 15 249 patients with stroke (mean [SD] age, 64.1 [8.8] years; 6999 [45.9%] female; 8250 male [54.1%]) were included. Over a median (IQR) follow-up of 61.2 (60.9-61.6) months, the mean difference in systolic blood pressure was −2.05 mm Hg (95% CI, −3.03 to −1.08 mm Hg). A total of 2735 recurrent stroke events (691 fatal and 2044 nonfatal) and 3242 deaths were recorded. Recurrent stroke was significantly lower in the salt substitute vs regular salt group (rate ratio [RR], 0.86; 95% CI, 0.77-0.95; P = .005), with larger effects on hemorrhagic stroke (relative reduction, 30%; P = .002). Death rates were also significantly lower (RR, 0.88; 95% CI, 0.82-0.96; P = .003), with larger effects on stroke-related deaths (relative reduction 21%; P = .01). No significant difference was observed for hyperkalemia (RR, 1.01; 95% CI, 0.74-1.38; P = .96).Conclusions and RelevanceResults of this cluster trial demonstrate that salt substitution was safe, along with reduced risks of stroke recurrence and death, which underscores large health gains from scaling up this low-cost intervention among patients with stroke.Trial RegistrationClinicalTrials.gov Identifier: NCT02092090
{"title":"Salt Substitution and Recurrent Stroke and Death","authors":"Xiong Ding, Xinyi Zhang, Liping Huang, Shangzhi Xiong, Zhifang Li, Yi Zhao, Bo Zhou, Xuejun Yin, Bingqing Xu, Yanfeng Wu, Bruce Neal, Maoyi Tian, Lijing L. Yan","doi":"10.1001/jamacardio.2024.5417","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5417","url":null,"abstract":"ImportanceThe direct effect of consumption of salt substitutes on recurrent stroke and mortality among patients with stroke remains unclear.ObjectiveTo evaluate the effects of salt substitutes vs regular salt on the incidence of recurrent stroke and mortality among patients with stroke.Design, Setting, and ParticipantsThe Salt Substitute and Stroke Study (SSaSS), an open-label, cluster randomized clinical trial, was conducted in 600 northern Chinese villages (clusters). Patients who self-reported a hospital diagnosis of stroke were included in this prespecified subgroup analysis. Data were analyzed from November 2023 to August 2024.InterventionsParticipants were assigned to use either a salt substitute, consisting of 75% sodium chloride and 25% potassium chloride by mass, or regular salt.Main Outcomes and MeasuresThe primary outcome was recurrent stroke.ResultsAfter excluding 5746 persons without a baseline history of stroke, 15 249 patients with stroke (mean [SD] age, 64.1 [8.8] years; 6999 [45.9%] female; 8250 male [54.1%]) were included. Over a median (IQR) follow-up of 61.2 (60.9-61.6) months, the mean difference in systolic blood pressure was −2.05 mm Hg (95% CI, −3.03 to −1.08 mm Hg). A total of 2735 recurrent stroke events (691 fatal and 2044 nonfatal) and 3242 deaths were recorded. Recurrent stroke was significantly lower in the salt substitute vs regular salt group (rate ratio [RR], 0.86; 95% CI, 0.77-0.95; <jats:italic>P</jats:italic> = .005), with larger effects on hemorrhagic stroke (relative reduction, 30%; <jats:italic>P</jats:italic> = .002). Death rates were also significantly lower (RR, 0.88; 95% CI, 0.82-0.96; <jats:italic>P</jats:italic> = .003), with larger effects on stroke-related deaths (relative reduction 21%; <jats:italic>P</jats:italic> = .01). No significant difference was observed for hyperkalemia (RR, 1.01; 95% CI, 0.74-1.38; <jats:italic>P</jats:italic> = .96).Conclusions and RelevanceResults of this cluster trial demonstrate that salt substitution was safe, along with reduced risks of stroke recurrence and death, which underscores large health gains from scaling up this low-cost intervention among patients with stroke.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT02092090\">NCT02092090</jats:ext-link>","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"15 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143125373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1001/jamacardio.2024.5430
Daniel W Jones, Brent M Egan, Daniel Thomas Lackland
{"title":"Dietary Sodium- and Potassium-Enriched Salt Substitutes-The Tipping Point?","authors":"Daniel W Jones, Brent M Egan, Daniel Thomas Lackland","doi":"10.1001/jamacardio.2024.5430","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5430","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1001/jamacardio.2024.5303
Frederikke Held Berg, Mats C. Højbjerg Lassen, Muthiah Vaduganathan, Gregg C. Fonarow, Robert W. Yeh, ZhaoNian Zheng, Gunnar H. Gislason, Tor Biering-Sørensen, Rishi K. Wadhera
ImportanceCardiovascular disease is the leading cause of death in the US. However, it remains unclear how the burden of cardiovascular events in the US compares with that of other high-income countries with distinct health care systems like Denmark, both overall and by income.ObjectiveTo compare cardiovascular hospitalization rates (acute myocardial infarction [MI], heart failure [HF], ischemic stroke) and associated outcomes among adults 65 years or older, overall and by income, between the US and Denmark.Design, Setting, and ParticipantsThis population-based cross-sectional study used national data from the US and Denmark from January 1, 2021, to January 1, 2022. The study population included all Medicare beneficiaries 65 years or older in the US and all adults 65 years or older in Denmark.Main Outcomes and MeasuresThe primary outcome was age- and sex-standardized hospitalization rates for MI, HF, and ischemic stroke, as well as 30-day all-cause mortality rates.ResultsThe US study population included 58 614 110 adults 65 years or older (mean [SE] age, 74.6 [7.7] years; 32 179 146 female [54.9%]) of whom 1 171 058 (2.0%) were hospitalized for a cardiovascular event. The Danish study population included 1 176 542 adults 65 years or older (mean [SE] age, 75.3 [7.1] years; 634 217 female [53.9%]) of whom 16 305 (1.4%) were hospitalized with a cardiovascular event. The overall age- and sex-standardized cardiovascular hospitalization rate was significantly higher in the US compared with Denmark (risk ratio [RR], 1.50; 95% CI, 1.47-1.52), as were associated 30-day all-cause mortality rates (RR, 1.12; 95% CI, 1.06-1.17). Across conditions, the risk of hospitalization for MI (RR, 1.56; 95% CI, 1.51-1.61) and HF (RR, 2.37; 95% CI, 2.31-2.43) was significantly higher in the US compared with Denmark, whereas hospitalizations for ischemic stroke were lower (RR, 0.90; 95% CI, 0.88-0.93). Overall cardiovascular hospitalization rates in the US were more than 2-fold higher among low-income adults compared with higher-income adults (RR, 2.38; 95% CI, 2.25-2.47), whereas the magnitude of income-based disparities was smaller in Denmark (RR, 1.45; 95% CI, 1.39-1.50).Conclusions and RelevanceIn this international cross-sectional study, cardiovascular hospitalization rates were significantly higher in the US compared with Denmark. There were income-based differences in the burden of cardiovascular hospitalizations in both countries, although the magnitude of these disparities was much greater in the US.
{"title":"Cardiovascular Hospitalizations Among Older Adults in the US and Denmark","authors":"Frederikke Held Berg, Mats C. Højbjerg Lassen, Muthiah Vaduganathan, Gregg C. Fonarow, Robert W. Yeh, ZhaoNian Zheng, Gunnar H. Gislason, Tor Biering-Sørensen, Rishi K. Wadhera","doi":"10.1001/jamacardio.2024.5303","DOIUrl":"https://doi.org/10.1001/jamacardio.2024.5303","url":null,"abstract":"ImportanceCardiovascular disease is the leading cause of death in the US. However, it remains unclear how the burden of cardiovascular events in the US compares with that of other high-income countries with distinct health care systems like Denmark, both overall and by income.ObjectiveTo compare cardiovascular hospitalization rates (acute myocardial infarction [MI], heart failure [HF], ischemic stroke) and associated outcomes among adults 65 years or older, overall and by income, between the US and Denmark.Design, Setting, and ParticipantsThis population-based cross-sectional study used national data from the US and Denmark from January 1, 2021, to January 1, 2022. The study population included all Medicare beneficiaries 65 years or older in the US and all adults 65 years or older in Denmark.Main Outcomes and MeasuresThe primary outcome was age- and sex-standardized hospitalization rates for MI, HF, and ischemic stroke, as well as 30-day all-cause mortality rates.ResultsThe US study population included 58 614 110 adults 65 years or older (mean [SE] age, 74.6 [7.7] years; 32 179 146 female [54.9%]) of whom 1 171 058 (2.0%) were hospitalized for a cardiovascular event. The Danish study population included 1 176 542 adults 65 years or older (mean [SE] age, 75.3 [7.1] years; 634 217 female [53.9%]) of whom 16 305 (1.4%) were hospitalized with a cardiovascular event. The overall age- and sex-standardized cardiovascular hospitalization rate was significantly higher in the US compared with Denmark (risk ratio [RR], 1.50; 95% CI, 1.47-1.52), as were associated 30-day all-cause mortality rates (RR, 1.12; 95% CI, 1.06-1.17). Across conditions, the risk of hospitalization for MI (RR, 1.56; 95% CI, 1.51-1.61) and HF (RR, 2.37; 95% CI, 2.31-2.43) was significantly higher in the US compared with Denmark, whereas hospitalizations for ischemic stroke were lower (RR, 0.90; 95% CI, 0.88-0.93). Overall cardiovascular hospitalization rates in the US were more than 2-fold higher among low-income adults compared with higher-income adults (RR, 2.38; 95% CI, 2.25-2.47), whereas the magnitude of income-based disparities was smaller in Denmark (RR, 1.45; 95% CI, 1.39-1.50).Conclusions and RelevanceIn this international cross-sectional study, cardiovascular hospitalization rates were significantly higher in the US compared with Denmark. There were income-based differences in the burden of cardiovascular hospitalizations in both countries, although the magnitude of these disparities was much greater in the US.","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":"135 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143125374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1001/jamacardio.2024.4335
John G F Cleland
{"title":"Aspirin for Secondary Prevention of Atherosclerosis-Evidence or Dogma?","authors":"John G F Cleland","doi":"10.1001/jamacardio.2024.4335","DOIUrl":"10.1001/jamacardio.2024.4335","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"114-116"},"PeriodicalIF":14.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1001/jamacardio.2024.4300
Robert O Bonow, Patrick T O'Gara
{"title":"TAVR in Young Patients With Aortic Stenosis: Appropriate Use or Indication Creep?","authors":"Robert O Bonow, Patrick T O'Gara","doi":"10.1001/jamacardio.2024.4300","DOIUrl":"10.1001/jamacardio.2024.4300","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"136"},"PeriodicalIF":14.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1001/jamacardio.2024.4266
Suzanne V Arnold, John A Spertus, Kensey Gosch, Shannon M Dunlay, Danielle M Olds, Philip G Jones, Fraser D Bocell, Changfu Wu, David J Cohen
<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the psychometric properties of the KCCQ in patients with TR.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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 i
{"title":"Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation.","authors":"Suzanne V Arnold, John A Spertus, Kensey Gosch, Shannon M Dunlay, Danielle M Olds, Philip G Jones, Fraser D Bocell, Changfu Wu, David J Cohen","doi":"10.1001/jamacardio.2024.4266","DOIUrl":"10.1001/jamacardio.2024.4266","url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the psychometric properties of the KCCQ in patients with TR.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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 i","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"117-125"},"PeriodicalIF":14.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11525660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1001/jamacardio.2024.4809
Catherine P Benziger, W Schuyler Jones
{"title":"Sex Differences in the Effectiveness and Safety of Aspirin-Reply.","authors":"Catherine P Benziger, W Schuyler Jones","doi":"10.1001/jamacardio.2024.4809","DOIUrl":"10.1001/jamacardio.2024.4809","url":null,"abstract":"","PeriodicalId":14657,"journal":{"name":"JAMA cardiology","volume":" ","pages":"201"},"PeriodicalIF":14.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1001/jamacardio.2024.3764
Gregg C Fonarow, James E Udelson, Clyde W Yancy
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