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Progressive Cardiogenic Shock After Catheter Ablation in a Man Aged 78 Years. 一名 78 岁男子导管消融术后出现进行性心源性休克
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1001/jamacardio.2024.2199
Karim Benali, Benjamin Seguy, Frederic Sacher
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引用次数: 0
Addressing Evidence Gaps in Coronary Revascularization Trials. 解决冠状动脉血运重建试验中的证据差距。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1001/jamacardio.2024.2778
Gregg W Stone, Clyde W Yancy, Mario Gaudino
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引用次数: 0
Redefining Cardiac Involvement and Targets of Treatment in Systemic Immunoglobulin AL Amyloidosis. 重新定义全身性免疫球蛋白 AL 淀粉样变性的心脏受累情况和治疗目标。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1001/jamacardio.2024.2555
Aldostefano Porcari, Ambra Masi, Ana Martinez-Naharro, Yousuf Razvi, Rishi Patel, Adam Ioannou, Muhammad U Rauf, Giulio Sinigiani, Brendan Wisniowski, Stefano Filisetti, Jasmine Currie-Cathey, Sophie O'Beara, Tushar Kotecha, Dan Knight, James C Moon, Gianfranco Sinagra, Ruta Virsinskaite, Janet Gilbertson, Lucia Venneri, Aviva Petrie, Helen Lachmann, Carol Whelan, Peter Kellman, Sriram Ravichandran, Oliver Cohen, Shameem Mahmood, Charlotte Manisty, Philip N Hawkins, Julian D Gillmore, Ashutosh D Wechalekar, Marianna Fontana

Importance: Cardiac amyloid infiltration is the key determinant of survival in systemic light-chain (AL) amyloidosis. Current guidelines recommend early switching therapy in patients with a nonoptimal or suboptimal response regardless of the extent of cardiac amyloid infiltration.

Objective: To assess the differences between serum biomarkers, echocardiography, and cardiovascular magnetic resonance (CMR) with extracellular volume (ECV) mapping in characterizing cardiac amyloid, the independent prognostic role of these approaches, and the role of ECV mapping to guide treatment strategies.

Design, setting, and participants: Consecutive patients newly diagnosed with systemic AL amyloidosis (2015-2021) underwent echocardiography, cardiac biomarkers, and CMR with ECV mapping at diagnosis. Data were analyzed from January to June 2024.

Main outcomes and measures: The primary outcomes of the study were all-cause mortality and hematological response as defined according to validated criteria: no response (NR), partial response (PR), very good partial response (VGPR), and complete response (CR). Secondary outcomes were the depth and speed of hematological response and overall survival according to ECV.

Results: Of 560 patients with AL amyloidosis, the median (IQR) age was 68 years (59-74 years); 346 patients were male (61.8%) and 214 female (38.2%). Over a median (IQR) 40.5 months 9-58 months), ECV was independently associated with mortality. In the landmark analysis at 1 month, long-term survival was independent of the achieved hematological response in ECV less than 0.30% and ECV of 0.31% to 0.40%, while it was dependent on the depth of the hematological response in ECV greater than 0.40%. In the landmark analysis at 6 months, survival was independent of the achieved hematological response in ECV less than 0.30% and dependent on achieving at least PR in ECV of 0.31% to 0.40%. Survival was dependent on achieving CR in ECV of 0.41% to 0.50% and ECV greater than 0.50%. Achieving a deep hematological response at 1 month was associated with better survival compared with 6 months in patients with ECV greater than 0.40% but not with ECV less than 0.40%.

Conclusions and relevance: This study found that ECV mapping, in systemic AL amyloidosis, is an independent predictor of prognosis, can help define the hematological response associated with better long-term outcomes for each patient and potentially inform treatment strategies.

重要性:心脏淀粉样蛋白浸润是决定全身性轻链(AL)淀粉样变性存活的关键因素。目前的指南建议,无论心脏淀粉样蛋白浸润程度如何,非最佳或次佳反应患者都应尽早更换治疗方案:目的:评估血清生物标志物、超声心动图和心血管磁共振(CMR)与细胞外容积(ECV)图谱在表征心脏淀粉样蛋白方面的差异、这些方法的独立预后作用以及ECV图谱在指导治疗策略方面的作用:新诊断为系统性AL淀粉样变性的连续患者(2015-2021年)在诊断时接受了超声心动图、心脏生物标记物和带有ECV图谱的CMR检查。数据分析时间为 2024 年 1 月至 6 月:研究的主要结果是全因死亡率和根据有效标准定义的血液学反应:无反应(NR)、部分反应(PR)、非常好的部分反应(VGPR)和完全反应(CR)。次要结果是血液学反应的深度和速度,以及根据 ECV 确定的总生存期:在560名AL淀粉样变性患者中,中位(IQR)年龄为68岁(59-74岁);男性346人(61.8%),女性214人(38.2%)。在中位数(IQR)为 40.5 个月 9-58 个月的时间里,ECV 与死亡率密切相关。在1个月的标志性分析中,ECV小于0.30%和ECV为0.31%至0.40%的患者的长期生存率与所达到的血液学反应无关,而ECV大于0.40%的患者的长期生存率则取决于血液学反应的深度。在6个月的标志性分析中,在ECV小于0.30%的情况下,存活率与血液学反应无关,而在ECV为0.31%至0.40%的情况下,存活率取决于至少达到PR。在ECV为0.41%至0.50%和ECV大于0.50%的情况下,存活率取决于是否达到CR。与6个月相比,ECV大于0.40%但ECV小于0.40%的患者在1个月时获得深度血液学反应与更好的生存率相关:本研究发现,在全身性 AL 淀粉样变性中,ECV 图谱是预后的独立预测指标,有助于确定与每位患者更好的长期预后相关的血液学反应,并有可能为治疗策略提供依据。
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引用次数: 0
Sudden Hemodynamic Deterioration of a 75-Year-Old Woman With Progressive Jaw Pain. 一名 75 岁女性突发血流动力学恶化,并伴有持续性下颌疼痛。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1001/jamacardio.2024.2695
Sven L Van Laer, Pieterjan Van Rijckeghem, Vincent F M Segers
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引用次数: 0
Prevalence, Cardiac Phenotype, and Outcomes of Transthyretin Variants in the UK Biobank Population. 英国生物库人群中转铁蛋白变异体的患病率、心脏表型和预后。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-11-01 DOI: 10.1001/jamacardio.2024.2190
Nay Aung, Hannah L Nicholls, C Anwar A Chahal, Mohammed Y Khanji, Elisa Rauseo, Sucharitha Chadalavada, Steffen E Petersen, Patricia B Munroe, Perry M Elliott, Luis R Lopes
<p><strong>Importance: </strong>The population prevalence of cardiac transthyretin amyloidosis (ATTR) caused by pathogenic variation in the TTR gene (vATTR) is unknown.</p><p><strong>Objective: </strong>To estimate the population prevalence of disease-causing TTR variants and evaluate associated phenotypes and outcomes.</p><p><strong>Design, setting, and participants: </strong>This population-based cohort study analyzed UK Biobank (UKB) participants with whole-exome sequencing, electrocardiogram, and cardiovascular magnetic resonance data. Participants were enrolled from 2006 to 2010, with a median follow-up of 12 (IQR, 11-13) years (cutoff date for the analysis, March 12, 2024). Sixty-two candidate TTR variants were extracted based on rarity (minor allele frequency ≤0.0001) and/or previously described associations with amyloidosis if more frequent.</p><p><strong>Exposure: </strong>Carrier status for TTR variants.</p><p><strong>Main outcomes and measures: </strong>Associations of TTR carrier status with vATTR prevalence and cardiovascular imaging and electrocardiogram traits were explored using descriptive statistics. Associations between TTR carrier status and atrial fibrillation, conduction disease, heart failure, and all-cause mortality were evaluated using adjusted Cox proportional hazards models. Genotypic and diagnostic concordance was examined using International Statistical Classification of Diseases, Tenth Revision codes from the hospital record.</p><p><strong>Results: </strong>The overall cohort included 469 789 UKB participants (mean [SD] age, 56.5 [8.1] years; 54.2% female and 45.8% male). A likely pathogenic/pathogenic (LP/P) TTR variant was detected in 473 (0.1%) participants, with Val142Ile being the most prevalent (367 [77.6%]); 91 individuals (0.02%) were carriers of a variant of unknown significance . The overall prevalence of LP/P variants was 0.02% (105 of 444 243) in participants with European ancestry and 4.3% (321 of 7533) in participants with African ancestry. The LP/P variants were associated with higher left ventricular mass indexed to body surface area (β = 4.66; 95% CI, 1.87-7.44), and Val142Ile was associated with a longer PR interval (β = 18.34; 95% CI, 5.41-31.27). The LP/P carrier status was associated with a higher risk of heart failure (hazard ratio [HR], 2.68; 95% CI, 1.75-4.12) and conduction disease (HR, 1.88; 95% CI, 1.25-2.83). Higher all-cause mortality risk was observed for non-Val142Ile LP/P variants (HR, 1.98; 95% CI, 1.06-3.67). Thirteen participants (2.8%) with LP/P variants had diagnostic codes compatible with cardiac or neurologic amyloidosis. Variants of unknown significance were not associated with outcomes.</p><p><strong>Conclusions and relevance: </strong>This study found that approximately 1 in 1000 UKB participants were LP/P TTR variant carriers, exceeding previously reported prevalence. The findings emphasize the need for clinical vigilance in identifying individuals at risk of developing vATT
重要性:由 TTR 基因致病变异(vATTR)引起的心脏转甲状腺素淀粉样变性病(ATTR)的人群患病率尚不清楚:估计致病TTR变异的人群患病率,并评估相关表型和结果:这项基于人群的队列研究分析了英国生物库(UKB)参与者的全外显子组测序、心电图和心血管磁共振数据。参与者于2006年至2010年期间入组,中位随访时间为12(IQR,11-13)年(分析截止日期为2024年3月12日)。根据稀有性(小等位基因频率≤0.0001)和/或先前描述的与淀粉样变性的关联(如果更常见),提取了62个候选TTR变体:主要结果和测量:采用描述性统计方法探讨 TTR 携带者状态与 vATTR 患病率、心血管成像和心电图特征之间的关联。使用调整后的 Cox 比例危险模型评估了 TTR 携带者状态与心房颤动、传导疾病、心力衰竭和全因死亡率之间的关系。使用医院记录中的国际疾病统计分类第十版代码对基因型和诊断的一致性进行了检查:总体队列包括 469 789 名 UKB 参与者(平均 [SD] 年龄为 56.5 [8.1] 岁;54.2% 为女性,45.8% 为男性)。473名参与者(0.1%)检测到可能致病/致病(LP/P)的TTR变异,其中Val142Ile最为普遍(367人[77.6%]);91人(0.02%)为意义不明的变异携带者。在欧洲血统的参与者中,LP/P变异体的总体流行率为0.02%(444 243人中有105人),在非洲血统的参与者中,LP/P变异体的流行率为4.3%(7533人中有321人)。LP/P变异与体表面积指数较高的左心室质量相关(β = 4.66;95% CI,1.87-7.44),Val142Ile与较长的PR间期相关(β = 18.34;95% CI,5.41-31.27)。LP/P 携带者与较高的心力衰竭风险(危险比 [HR],2.68;95% CI,1.75-4.12)和传导疾病风险(HR,1.88;95% CI,1.25-2.83)相关。非Val142Ile LP/P变异体的全因死亡风险更高(HR,1.98;95% CI,1.06-3.67)。13名患有LP/P变异的参与者(2.8%)的诊断代码与心脏或神经系统淀粉样变性相符。意义不明的变异与结果无关:本研究发现,约每 1000 名 UKB 参与者中就有 1 人是 LP/P TTR 变异携带者,超过了之前报道的患病率。研究结果强调,临床上需要提高警惕,识别有可能患上 vATTR 和相关不良预后的个体。
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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 : 2024-10-30 DOI: 10.1001/jamacardio.2024.4300
Robert O Bonow, Patrick T O'Gara
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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 : 2024-10-30 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。
{"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":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate the psychometric properties of the KCCQ in patients with TR.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;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":""},"PeriodicalIF":14.8,"publicationDate":"2024-10-30","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}
引用次数: 0
Measuring Health Status in Patients With Tricuspid Regurgitation. 测量三尖瓣反流患者的健康状况。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-30 DOI: 10.1001/jamacardio.2024.4287
Eldrin F Lewis
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引用次数: 0
Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era. 低风险时代年轻患者接受球囊扩张经导管主动脉瓣置换术的疗效。
IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-30 DOI: 10.1001/jamacardio.2024.4237
Megan Coylewright, Kendra J Grubb, Suzanne V Arnold, Wayne Batchelor, Abhijeet Dhoble, Aaron Horne, Martin B Leon, Vinod Thourani, Tamim M Nazif, Brian R Lindman, Molly Szerlip
<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Intervention: </strong>Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>Among US patients receiving BEV
重要性:指南建议心脏团队对所有主动脉瓣狭窄患者进行评估,建议 65 岁以下或预期寿命超过 20 年的患者进行主动脉瓣置换手术。如果选择生物人工瓣膜,由于组织瓣膜的耐久性有限,可能需要重复手术;然而,年轻的主动脉瓣狭窄患者可能有严重的合并症,会限制预期寿命,从而影响决策:目的:描述接受经导管主动脉瓣置换术(TAVR)的65岁以下患者的特征,并将他们的治疗结果与65至80岁的患者进行比较:这项基于注册表的回顾性分析使用了胸外科医师协会/美国心脏病学会经导管瓣膜治疗(TVT)注册表中139 695名患者的数据,包括2019年8月至2023年9月期间接受TAVR的80岁及以下患者:干预措施:使用 SAPIEN 系列设备进行球囊扩张瓣膜 (BEV) TAVR:与65至80岁的患者相比,65岁以下患者的合并症(心衰、冠心病、透析等)和结局(死亡、中风和再入院):在调查的年份中,13 849 名登记患者(5.7%)小于 65 岁,125 846 名(52.1%)65 至 80 岁,101 725 名(42.1%)80 岁及以上。在 65 岁以下的患者中,平均年龄(标准差)为 59.7(4.8)岁,13 849 名患者中有 9068 名男性(65.5%)。在 65 至 80 岁的患者中,平均年龄(标准差)为 74.1 (4.2)岁,125 843 名患者中有 77 817 名男性(61.8%)。与 65 至 80 岁的患者相比,65 岁以下的患者更有可能患有主动脉瓣二尖瓣(分别为 3472/13 755 [25.2%] vs 9552/125 001 [7.6%];P 结论及意义:在低手术风险时代,接受 BEV TAVR 治疗重度主动脉瓣狭窄的美国患者中,65 岁以下的患者只占一小部分。与年龄较大的患者相比,65 岁以下的患者合并症较多,1 年后的死亡率和再入院率较高。这些观察结果表明,心脏团队对这一年龄组的大多数患者进行 TAVR 的决策在临床上是有效的。
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引用次数: 0
Cerebral Embolic Protection by Geographic Region 按地理区域划分的脑栓塞保护
IF 24 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-10-29 DOI: 10.1001/jamacardio.2024.4278
Raj R. Makkar, Aakriti Gupta, Thomas E. Waggoner, Samuel Horr, Juhana Karha, Lowell Satler, Robert C. Stoler, Jorge Alvarez, Rahul Sakhuja, Lee MacDonald, Rodrigo Modolo, Martin B. Leon, Axel Linke, Samir R. Kapadia
ImportanceTranscatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated.ObjectiveTo explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR.Design, Setting, and ParticipantsThis post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024.InterventionTAVR with or without CEP.Main Outcomes and MeasuresThe primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes.ResultsThe Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort.Conclusion and RelevanceThe PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis gene
重要性经导管主动脉瓣置换术(TAVR)是许多严重症状性主动脉瓣狭窄患者的既定治疗方案,但手术过程中脱落的碎片可能导致栓塞性中风。设计、设置和参与者2020年2月至2022年1月期间,美国、欧洲和澳大利亚的51家医院开展了一项前瞻性、上市后随机临床试验,对使用或不使用CEP进行的TAVR进行了评估。试验纳入了接受经股动脉 TAVR 治疗的无症状主动脉瓣狭窄患者。根据中心、手术风险和预定的TAVR瓣膜类型进行分层随机化。如果左侧颈总动脉或肱动脉狭窄超过70%,或解剖结构不允许放置CEP装置,则排除患者。主要结果和测量指标主要终点是出院时或TAVR术后72小时(以先到者为准)所有卒中事件的发生率。结果经导管主动脉瓣置换术(PROTECTED TAVR)期间哨兵卒中保护试验招募并随机分配了 3000 名患者(1803 名 [60.1%] 男性;平均 [SD] 年龄 78.9 [7.8] 岁):美国队列中有 1833 名患者(单纯 TAVR:919 名,TAVR 联合 CEP:914 名),美国以外队列中有 1167 名患者(单纯 TAVR:580 名,TAVR 联合 CEP:587 名)。与美国以外队列相比,美国队列的患者更年轻,男性占多数,心房颤动发病率较低,主动脉瓣二尖瓣、糖尿病和外周血管疾病发病率较高。在主要试验中,TAVR 术后 72 小时内或出院前中风的发生率在 CEP 组和对照组之间没有显著差异,也没有因地理区域而产生交互作用。在这项事后分析中,与单纯 TAVR 相比,美国队列中接受 CEP 治疗的患者总体中风的相对风险降低了 50%,致残性中风的相对风险降低了 73%;在美国本土队列中未观察到治疗对降低中风风险的影响。虽然地理区域之间没有明显的交互作用,但这一探索性事后分析表明,美国队列有更大程度减少卒中的趋势,而其他国家队列则没有。这些发现是假设性的,还需要进一步研究以确定患者特征或手术方法的地区差异是否会影响 CEP 的疗效:NCT04149535
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JAMA cardiology
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