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Sodium Reduction Legislation and Urinary Sodium and Blood Pressure in South Africa
IF 24 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-05 DOI: 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;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;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;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}
引用次数: 0
The Cardiovascular Disease Divide-A Tale of 2 High-Income Nations.
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-05 DOI: 10.1001/jamacardio.2024.5312
Sadiya S Khan
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引用次数: 0
Salt Substitution and Recurrent Stroke and Death
IF 24 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-05 DOI: 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}
引用次数: 0
Dietary Sodium- and Potassium-Enriched Salt Substitutes-The Tipping Point? 膳食钠钾盐替代品--临界点?
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-05 DOI: 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}
引用次数: 0
Cardiovascular Hospitalizations Among Older Adults in the US and Denmark
IF 24 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-05 DOI: 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}
引用次数: 0
Aspirin for Secondary Prevention of Atherosclerosis-Evidence or Dogma? 阿司匹林二级预防动脉粥样硬化:证据还是教条?
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1001/jamacardio.2024.4335
John G F Cleland
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引用次数: 0
TAVR in Young Patients With Aortic Stenosis: Appropriate Use or Indication Creep? 年轻主动脉瓣狭窄患者的 TAVR:适当使用还是适应症蠕变?
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 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}
引用次数: 0
Validation of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation. 堪萨斯城心肌病问卷在三尖瓣反流患者中的验证
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 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
重要性:改善患者的健康状况是治疗三尖瓣反流(TR)的关键目标。堪萨斯城心肌病问卷(KCCQ)是一种心力衰竭疾病特异性健康状况测量方法,用于了解三尖瓣反流对健康状况的影响以及经导管三尖瓣介入治疗(TTVI)的益处,但其在这种临床环境中的有效性尚不清楚:目的:评估KCCQ在TR患者中的心理测量特性:数据来自参加 11 项由制造商赞助的 TTVI 试验的严重 TR 患者。在由一家独立中心进行分析之前,这些数据被移交给美国食品和药物管理局进行统一和匿名处理。数据收集时间为2015年12月至2023年4月,数据分析时间为2023年7月至10月:预设分析包括评估内部一致性、再现性、响应性、构建有效性和预测有效性。结果采用 Cronbach α、分数比较、类内相关性、Cohen d、与最佳参考指标的斯皮尔曼相关性以及分数和分数变化与后续临床事件风险的关联来确定:研究队列由 2693 名参加 TTVI 单臂(n = 1517)或随机(n = 1176)研究的患者组成。患者的平均(标清)年龄为78.6(8.0)岁,2693名患者中有1658名(61.6%)为女性,KCCQ总体摘要(KCCQ-OS)的平均(标清)基线分数为50(23)分。各领域的内部一致性很强(Cronbach α,.77-.83)。在 1 到 6 个月期间临床稳定的患者中,KCCQ 领域和总分的平均变化较小(差异为 -0.1 到 1.9 分),这表明其具有可重复性。相比之下,接受 TTVI 治疗的患者在治疗后 1 个月的领域和总分有了很大的改善(平均变化为 12.1-21.4 分),这表明患者的感知反应性非常好。当将各领域与现有最佳参考指标进行比较时,结构效度中等偏上(斯皮尔曼相关性,0.47-0.69)。在横向和纵向分析中,KCCQ-OS与临床事件相关,得分越低,死亡率(每降低10分,危险比为1.34;95% CI,1.22-1.47)和心力衰竭住院风险越高(每降低10分,危险比为1.24;95% CI,1.17-1.31):在这项队列研究中,KCCQ 在重度 TR 患者中具有很强的心理测量特性,包括可靠性、反应性和有效性。这些数据支持在重度TR患者中使用KCCQ来衡量他们的症状、功能和生活质量,也支持在严格的对照试验中评估TTVI等干预措施的影响。
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引用次数: 0
Sex Differences in the Effectiveness and Safety of Aspirin-Reply. 阿司匹林应答的有效性和安全性的性别差异。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1001/jamacardio.2024.4809
Catherine P Benziger, W Schuyler Jones
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引用次数: 0
Heart Failure With Preserved Ejection Fraction-A Role for Invasive Hemodynamics. 保留射血分数的心力衰竭--侵入性血液动力学的作用。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-02-01 DOI: 10.1001/jamacardio.2024.3764
Gregg C Fonarow, James E Udelson, Clyde W Yancy
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引用次数: 0
期刊
JAMA cardiology
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