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Real-World Clinical Burden of Newly Diagnosed Heart failure in Thai Patients. 泰国新诊断心力衰竭患者的实际临床负担。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2024-05-06 DOI: 10.1007/s40119-024-00366-5
Thanita Boonyapiphat, Thidaporn Tangkittikasem, Artit Torpongpun, Vichai Senthong, Panyapat Jiampo

Introduction: There are limited data on the burden of newly diagnosed patients with heart failure (HF) in Thailand. Thus, this study aimed to fully understand the hospitalization, rehospitalization, mortality rates, demographics and characteristics, and quality of care in these patients.

Method: A retrospective review of all eligible adult patients' medical records from 2018 and 2019 was conducted at five hospitals. The patients were newly diagnosed with HF, as indicated by the International Classification of Diseases (ICD)-10 code "I50." Descriptive statistics was used to investigate patients' hospital burden and clinical outcome data.

Results: There were 1134 patients newly diagnosed with HF, classified as HF with reduced ejection fraction (HFrEF), HF with preserved ejection fraction (HFpEF), and HF with mildly reduced ejection fraction (HFmrEF) (44.0, 40.0, and 16.0%, respectively). The male-to-female ratios in HFmrEF and HFpEF were similar. In contrast, the proportion of men with HFrEF was greater. The mean age of all patients was 66.0 years. The hospitalization rate was 1.3. Rehospitalization rates for HF-related issues were 0.1, 0.2, 0.4, and 0.5 at 30 days, 60 days, 180 days, and 1 year, respectively. The percentage of deaths from all causes among these patients was 9.8%, while the percentage of deaths from cardiovascular-related causes was 8.5%. Only a small proportion of patients received a target dose of guideline-directed medical therapy (GDMT).

Conclusions: The study revealed that the characteristics, hospitalization rate for HF, and in-hospital mortality rate among newly diagnosed patients with HF were higher compared to similar studies conducted in Thailand and other countries. Moreover, a high quality of care is needed to improve the morbidity and mortality associated with HF in Thailand.

导言:有关泰国新诊断的心力衰竭(HF)患者负担的数据十分有限。因此,本研究旨在全面了解这些患者的住院率、再住院率、死亡率、人口统计学和特征以及护理质量:在五家医院对 2018 年和 2019 年所有符合条件的成年患者病历进行了回顾性审查。患者均为新确诊的心房颤动患者,以国际疾病分类(ICD)-10代码 "I50 "表示。采用描述性统计方法调查患者的住院负担和临床结果数据:新确诊的心房颤动患者有 1134 人,分为射血分数降低型心房颤动(HFrEF)、射血分数保留型心房颤动(HFpEF)和射血分数轻度降低型心房颤动(HFmrEF)(分别占 44.0%、40.0% 和 16.0%)。HFmrEF和HFpEF的男女比例相似。相比之下,男性 HFrEF 患者的比例更高。所有患者的平均年龄为 66.0 岁。住院率为 1.3。在30天、60天、180天和1年内,因心房颤动相关问题再次住院的比率分别为0.1、0.2、0.4和0.5。在这些患者中,死于各种原因的比例为 9.8%,而死于心血管相关原因的比例为 8.5%。只有一小部分患者接受了目标剂量的指导性药物治疗(GDMT):研究显示,与泰国和其他国家的类似研究相比,新诊断出的心房颤动患者的特征、心房颤动住院率和院内死亡率都较高。此外,要改善泰国心房颤动相关的发病率和死亡率,还需要高质量的护理。
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引用次数: 0
Real-World Heart Failure Burden in Thai Patients. 泰国心衰患者的实际负担。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2024-02-07 DOI: 10.1007/s40119-024-00355-8
Panyapat Jiampo, Thidaporn Tangkittikasem, Thanita Boonyapiphat, Vichai Senthong, Artit Torpongpun

Introduction: Heart failure (HF) is one of the leading causes of hospitalization worldwide. In Thailand, data on HF burden remains limited. This study aimed to describe comprehensive evidence detailing the HF prevalence, hospital admission rates, in-hospital mortality, and overall mortality rates at the hospital level.

Method: All eligible adult patients' medical records from 2018 and 2019 were analyzed retrospectively at five hospitals in different regions. The patients were diagnosed with HF, as indicated by the International Classification of Diseases (ICD)-10 code I50. Descriptive statistics were used to examine the hospital burden as well as patients' clinical and outcome data.

Results: A total of 7384 patients with HF were identified from five tertiary hospitals. Around half of the patients were male. The mean age was 67 years, and the main health insurance scheme was the Universal Coverage Scheme. The prevalence of HF was 0.1% in 2018 and 0.2% in 2019. Heart failure with preserved ejection fraction (HFpEF) was the most common type of HF in both visits, followed by heart failure with reduced ejection fraction (HFrEF) and heart failure with mildly reduced ejection fraction (HFmrEF). The proportion of HF hospitalizations was 1.2% in 2018 and 1.5% in 2019. The proportion of HF rehospitalizations versus hospitalizations in patients with HF was 22.7% in 2018 and 23.9% in 2019. The risk of rehospitalization was highest at 180 days after hospital discharge (87.8%). Among the patients with HF, the proportion of all-cause mortality was 9.1% in 2018 and 8.0% in 2019. Most of the deaths occurred within 30 days after hospitalization.

Conclusion: Our study demonstrated that the burden of HF in terms of hospitalization and in-hospital mortality was notably high when compared to similar studies conducted in Thailand and other countries.

简介心力衰竭(HF)是导致全球住院治疗的主要原因之一。在泰国,有关高血压负担的数据仍然有限。本研究旨在描述全面的证据,详细说明医院层面的高血压患病率、入院率、院内死亡率和总死亡率:对不同地区五家医院 2018 年和 2019 年所有符合条件的成年患者病历进行了回顾性分析。根据国际疾病分类(ICD)-10代码I50,患者被诊断为心房颤动。结果显示,共有7384名心房颤动患者接受了治疗:结果:五家三级医院共发现 7384 名心房颤动患者。约半数患者为男性。平均年龄为 67 岁,主要医疗保险计划为全民医保计划。2018年和2019年的心房颤动患病率分别为0.1%和0.2%。射血分数保留型心力衰竭(HFpEF)是两次就诊中最常见的心力衰竭类型,其次是射血分数降低型心力衰竭(HFrEF)和射血分数轻度降低型心力衰竭(HFmrEF)。2018年和2019年的HF住院比例分别为1.2%和1.5%。2018年和2019年,HF患者的HF再住院比例分别为22.7%和23.9%。出院后 180 天内再次住院的风险最高(87.8%)。在心房颤动患者中,2018 年全因死亡率为 9.1%,2019 年为 8.0%。大多数死亡发生在住院后30天内:我们的研究表明,与泰国和其他国家进行的类似研究相比,心房颤动在住院和院内死亡率方面的负担明显较高。
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引用次数: 0
Management of Heart Failure in a Resource-Limited Setting: Expert Opinion from India. 资源有限环境中的心力衰竭管理:来自印度的专家意见。
IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-06-01 Epub Date: 2024-04-30 DOI: 10.1007/s40119-024-00367-4
Peeyush Jain, Santanu Guha, Soumitra Kumar, J P S Sawhney, Kamal Sharma, K P Sureshkumar, Ashwani Mehta, Rajnish Dhediya, Kumar Gaurav, Rajan Mittal, Bhavesh Kotak

Heart failure poses a global health challenge affecting millions of individuals, and access to guideline-directed medical therapy is often limited. This limitation is frequently attributed to factors such as drug availability, slow adoption, clinical inertia, and delayed diagnosis. Despite international recommendations promoting the use of guideline-directed medical therapy for heart failure management, personalized approaches are essential in settings with resource constraints. In India, crucial treatments like angiotensin II receptor blocker neprilysin inhibitors and sodium-glucose co-transporter 2 inhibitors are not fully utilized despite their established safety and efficacy. To address this issue, an expert consensus involving 150 specialists, including cardiologists, nephrologists, and endocrinologists, was convened. They deliberated on patient profiles, monitoring, and adverse side effects and provided tailored recommendations for guideline-directed medical therapy in heart failure management. Stressing the significance of early initiation of guideline-directed medical therapy in patients with heart failure, especially with sodium-glucose co-transporter 2 inhibitors, the consensus also explored innovative therapies like vericiguat. To improve heart failure outcomes in resource-limited settings, the experts proposed several measures, including enhanced patient education, cardiac rehabilitation, improved drug access, and reforms in healthcare policies.

心力衰竭是一项全球性的健康挑战,影响着数百万人的健康,而获得指南指导下的医疗治疗往往是有限的。造成这种限制的因素通常包括药物供应、采用缓慢、临床惰性和诊断延迟。尽管国际建议提倡在心力衰竭管理中使用指导性医疗疗法,但在资源有限的情况下,个性化方法至关重要。在印度,血管紧张素 II 受体阻滞剂肾利酶抑制剂和钠-葡萄糖共转运体 2 抑制剂等重要治疗手段尽管具有公认的安全性和有效性,但并未得到充分利用。为解决这一问题,包括心脏病专家、肾病专家和内分泌专家在内的 150 名专家达成了专家共识。他们就患者概况、监测和不良副作用等问题进行了讨论,并为心力衰竭管理中的指导性药物治疗提供了有针对性的建议。共识强调了对心力衰竭患者尽早启动指南指导下的药物治疗的重要性,尤其是钠-葡萄糖协同转运体2抑制剂,同时还探讨了维利奎特等创新疗法。为改善资源有限环境下的心衰治疗效果,专家们提出了多项措施,包括加强患者教育、心脏康复、改善药物获取途径以及改革医疗保健政策。
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引用次数: 0
Add-on Sacubitril/Valsartan Therapy Induces Left Ventricular Remodeling in Non-responders to Cardiac Resynchronization Therapy to a Similar Extent as in Heart Failure Patients Without Resynchronization. 添加萨库比特利/缬沙坦疗法可诱导心脏再同步化疗法无反应者的左心室重塑,其程度与未接受再同步化治疗的心衰患者相似。
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-01-12 DOI: 10.1007/s40119-023-00346-1
Krisztina Mária Szabó, Anna Tóth, László Nagy, Vivien Rácz, Zsófia Pólik, Katalin Hodosi, Attila C Nagy, Judit Barta, Attila Borbély, Zoltán Csanádi

Introduction: Non-responders to cardiac resynchronization therapy (CRT-NR) have poor prognosis. Sacubitril/valsartan (SV) treatment improved the outcome of patients with heart failure with reduced left ventricular (LV) ejection fraction (HFrEF) in randomized trials with no data on the specific cohort of CRT-NRs. The aim of this study was to compare the echocardiographic and biomarker changes in CRT-NR patients treated with versus without SV, and in patients with HFrEF on SV therapy.

Methods: CRT-NR patients initiated on SV (group I), CRT-NR patients on angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARB) (group II), and patients with HFrEF (without CRT) initiated on SV (group III) were identified in our heart failure (HF) registry. CRT-NR was defined as < 10% improvement in left ventricular ejection fraction (LV EF) 6 months after the implantation. Echocardiographic parameters and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at baseline and at the end of follow-up were compared.

Results: A total of 275 patients (group I, 70; group II, 70; and group III, 135) were included. After a follow-up of 7.54 ± 1.8 months (mean ± standard deviation [SD]), LV EF (%) increased in group I (25.2 ± 5.7 versus 29.4% ± 6.7; p < 0.001) and in group III (26.6 ± 6.4 versus 29.9 ± 6.7; p < 0.001). LV end-systolic diameters (mm) decreased in group I (56.6 ± 9.0 versus 54.3 ± 8.7; p = 0.004) and in group III (55.9 ± 9.9 versus 54.3 ± 11.2; p = 0.021). The levels of NT-proBNP (pg/mL) decreased in group I (2058.86 [1041.07-4502.51] versus 1121.55 [545-2541]; p < 0.001) and in group III (2223.35 [1233.03-4795.96] versus 1123.09 [500.38-2651.27]; p < 0.001). The extent of improvement was similar in groups I and III (p > 0.05). No significant changes were detected in group II.

Conclusion: SV therapy induced similar improvements in echocardiographic parameters and in NT-proBNP levels in CRT-NR patients and in patients with HFrEF without resynchronization.

导言:对心脏再同步治疗(CRT-NR)无应答者预后不良。在随机试验中,沙奎利/缬沙坦(SV)治疗改善了左心室射血分数降低的心力衰竭(HFrEF)患者的预后,但没有关于 CRT-NR 特定人群的数据。本研究旨在比较接受与不接受 SV 治疗的 CRT-NR 患者以及接受 SV 治疗的 HFrEF 患者的超声心动图和生物标志物变化:我们的心力衰竭(HF)登记处确定了接受 SV 治疗的 CRT-NR 患者(I 组)、接受血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂(ACEi/ARB)治疗的 CRT-NR 患者(II 组)以及接受 SV 治疗的 HFrEF 患者(未接受 CRT)(III 组)。CRT-NR 被定义为 结果:共纳入 275 例患者(I 组 70 例;II 组 70 例;III 组 135 例)。随访 7.54 ± 1.8 个月(平均值 ± 标准差 [SD])后,I 组 LV EF(%)增加(25.2 ± 5.7 对 29.4% ± 6.7;P 0.05)。结论:SV疗法对CRT-NR患者和未进行再同步化的HFrEF患者的超声心动图参数和NT-proBNP水平有相似的改善作用。
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引用次数: 0
The Clear Value of Coronary Artery Calcification Evaluation on Non-Gated Chest Computed Tomography for Cardiac Risk Stratification. 非门控胸部计算机断层扫描的冠状动脉钙化评估对心脏风险分层的明确价值。
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-02-13 DOI: 10.1007/s40119-024-00354-9
Roos A Groen, J Wouter Jukema, Paul R M van Dijkman, Jeroen J Bax, Hildo J Lamb, M Louisa Antoni, Michiel A de Graaf

To enhance risk stratification in patients suspected of coronary artery disease, the assessment of coronary artery calcium (CAC) could be incorporated, especially when CAC can be readily assessed on previously performed non-gated chest computed tomography (CT). Guidelines recommend reporting on patients' extent of CAC on these non-cardiac directed exams and various studies have shown the diagnostic and prognostic value. However, this method is still little applied, and no current consensus exists in clinical practice. This review aims to point out the clinical utility of different kinds of CAC assessment on non-gated CTs. It demonstrates that these scans indeed represent a merely untapped and underestimated resource for risk stratification in patients with stable chest pain or an increased risk of cardiovascular events. To our knowledge, this is the first review to describe the clinical utility of different kinds of visual CAC evaluation on non-gated unenhanced chest CT. Various methods of CAC assessment on non-gated CT are discussed and compared in terms of diagnostic and prognostic value. Furthermore, the application of these non-gated CT scans in the general practice of cardiology is discussed. The clinical utility of coronary calcium assessed on non-gated chest CT, according to the current literature, is evident. This resource of information for cardiac risk stratification needs no specific requirements for scan protocol, and is radiation-free and cost-free. However, some gaps in research remain. In conclusion, the integration of CAC on non-gated chest CT in general cardiology should be promoted and research on this method should be encouraged.

为加强对疑似冠状动脉疾病患者的风险分层,可纳入冠状动脉钙化(CAC)评估,尤其是在之前进行的非门控胸部计算机断层扫描(CT)可轻松评估 CAC 的情况下。指南建议在这些非心脏导向检查中报告患者的 CAC 程度,各种研究也显示了其诊断和预后价值。然而,这种方法的应用仍然很少,目前在临床实践中也没有达成共识。本综述旨在指出非门控 CT 上不同类型 CAC 评估的临床实用性。它表明,这些扫描在对稳定型胸痛或心血管事件风险增加的患者进行风险分层方面确实是一种尚未开发和被低估的资源。据我们所知,这是第一篇描述在非门控未增强胸部 CT 上进行各种视觉 CAC 评估的临床实用性的综述。文中讨论了在非门控 CT 上进行 CAC 评估的各种方法,并就其诊断和预后价值进行了比较。此外,还讨论了这些非门控 CT 扫描在心脏病学一般实践中的应用。根据目前的文献,非门控胸部 CT 评估冠状动脉钙化的临床实用性是显而易见的。这种用于心脏风险分层的信息资源对扫描方案没有特殊要求,而且无辐射、无成本。然而,研究中仍存在一些空白。总之,应在普通心脏病学中推广将 CAC 纳入非门控胸部 CT,并鼓励对这种方法进行研究。
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引用次数: 0
Targeting Lipoprotein(a): Can RNA Therapeutics Provide the Next Step in the Prevention of Cardiovascular Disease? 靶向脂蛋白(a):RNA 疗法能否成为预防心血管疾病的下一步?
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-02-21 DOI: 10.1007/s40119-024-00353-w
Henriette Thau, Sebastian Neuber, Maximilian Y Emmert, Timo Z Nazari-Shafti

Numerous genetic and epidemiologic studies have demonstrated an association between elevated levels of lipoprotein(a) (Lp[a]) and cardiovascular disease. As a result, lowering Lp(a) levels is widely recognized as a promising strategy for reducing the risk of new-onset coronary heart disease, stroke, and heart failure. Lp(a) consists of a low-density lipoprotein-like particle with covalently linked apolipoprotein A (apo[a]) and apolipoprotein B-100, which explains its pro-thrombotic, pro-inflammatory, and pro-atherogenic properties. Lp(a) serum concentrations are genetically determined by the apo(a) isoform, with shorter isoforms having a higher rate of particle synthesis. To date, there are no approved pharmacological therapies that effectively reduce Lp(a) levels. Promising treatment approaches targeting apo(a) expression include RNA-based drugs such as pelacarsen, olpasiran, SLN360, and lepodisiran, which are currently in clinical trials. In this comprehensive review, we provide a detailed overview of RNA-based therapeutic approaches and discuss the recent advances and challenges of RNA therapeutics specifically designed to reduce Lp(a) levels and thus the risk of cardiovascular disease.

大量遗传学和流行病学研究表明,脂蛋白(a)(Lp[a])水平升高与心血管疾病之间存在关联。因此,降低脂蛋白(a)水平被广泛认为是降低新发冠心病、中风和心力衰竭风险的有效策略。脂蛋白(a)是由共价连接的载脂蛋白 A(载脂蛋白 A)和载脂蛋白 B-100 组成的低密度脂蛋白样颗粒,因此具有促血栓形成、促炎症和促动脉粥样硬化的特性。脂蛋白(a)血清浓度由载脂蛋白(a)异构体的基因决定,异构体越短,颗粒合成率越高。迄今为止,还没有获得批准的药物疗法能有效降低脂蛋白(a)水平。针对载脂蛋白(a)表达的有希望的治疗方法包括基于 RNA 的药物,如 pelacarsen、olpasiran、SLN360 和 lepodisiran,这些药物目前正在进行临床试验。在这篇综述中,我们详细介绍了基于 RNA 的治疗方法,并讨论了专为降低脂蛋白(a)水平从而降低心血管疾病风险而设计的 RNA 疗法的最新进展和挑战。
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引用次数: 0
Prevalence of CYP2C19*2 and CYP2C19*3 Allelic Variants and Clopidogrel Use in Patients with Cardiovascular Disease in Trinidad & Tobago. 特立尼达和多巴哥心血管疾病患者中 CYP2C19*2 和 CYP2C19*3 等位基因变异的患病率和氯吡格雷的使用情况。
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-01-29 DOI: 10.1007/s40119-024-00348-7
Daniele Jones, Shana Persad-Ramdeensingh, Sheherazade Crystal Abrahim, Naveen Seecheran, Rajini Rani Haraksingh

Introduction: Trinidad & Tobago has the highest prevalence of cardiovascular disease (CVD) in the Caribbean and clopidogrel is a ubiquitously used treatment. Yet, the extent of genetically mediated clopidogrel resistance is unknown. To determine this, we investigated whether the association between CYP2C19*2 and CYP2C19*3 genetic variants and clopidogrel resistance holds, and calculated the frequencies of these in the Trinidadian CVD population.

Methods: Demographic data, clinical data, and a saliva sample were collected under informed consent from 22 patients with CVD on dual anti-platelet therapy whose biochemical resistance to clopidogrel is known, and a further 162 patients accessing the main public CVD clinic in Trinidad and who are either currently being treated or are likely to be treated with clopidogrel. A polymerase chain reaction (PCR) and restriction enzyme digestion procedure was used to genotype each patient for the CYP2C19*2 and CYP2C19*3 allelic variants. Genotype was compared to known clopidogrel resistance in the 22 patients, and to disease status and clopidogrel usage in the larger cohort.

Results: CYP2C19*2 genotype was concordant with clopidogrel resistance. CYP2C19*2 was detected in 61.1% (99/162) of patients and CYP2C19*3 was undetected. Clopidogrel was the most prescribed antiplatelet therapy (42%). A total of 120 people presented with coronary artery disease (CAD) and 52.5% of these (n = 63/120) are currently prescribed clopidogrel. 63.5% (40/63) of patients with CAD who are prescribed clopidogrel carry the CYP2C19*2 allele; ten homozygous and 30 heterozygous. Indian patients comprised 65% of the cohort and were four times more likely to carry the CYP2C19*2 allele than African patients.

Conclusions: A large proportion of Trinidadian patients with CVD who are prescribed or may be prescribed clopidogrel carry genetic variants associated with clopidogrel resistance. These results emphasize the clinical need for further investigation into whether CYP2C19*2 genotype should guide clopidogrel use for the cardiovascular disease population in Trinidad & Tobago. A slide deck is available for this article.

简介特立尼达和多巴哥是加勒比地区心血管疾病(CVD)发病率最高的国家,氯吡格雷是一种普遍使用的治疗药物。然而,基因介导的氯吡格雷耐药程度尚不清楚。为了确定这一点,我们调查了 CYP2C19*2 和 CYP2C19*3 基因变异与氯吡格雷耐药性之间是否存在关联,并计算了这些变异在特立尼达心血管疾病人群中的频率:在知情同意的情况下,收集了22名正在接受双重抗血小板治疗且已知对氯吡格雷具有生化耐药性的心血管疾病患者的人口统计学数据、临床数据和唾液样本,以及162名在特立尼达岛主要公共心血管疾病诊所就诊且目前正在接受或可能接受氯吡格雷治疗的患者的人口统计学数据、临床数据和唾液样本。采用聚合酶链式反应(PCR)和限制性酶消化程序对每位患者进行 CYP2C19*2 和 CYP2C19*3 等位基因变异的基因分型。将基因型与22名患者已知的氯吡格雷耐药性进行比较,并与更大群体中的疾病状态和氯吡格雷使用情况进行比较:结果:CYP2C19*2基因型与氯吡格雷耐药性一致。61.1%的患者(99/162)检测到CYP2C19*2,未检测到CYP2C19*3。氯吡格雷是处方最多的抗血小板疗法(42%)。共有 120 人患有冠状动脉疾病(CAD),其中 52.5% 的患者(n = 63/120)目前正在接受氯吡格雷治疗。63.5%(40/63)处方氯吡格雷的冠心病患者携带CYP2C19*2等位基因,其中10人为同型,30人为异型。印度患者占队列的 65%,携带 CYP2C19*2 等位基因的可能性是非洲患者的四倍:结论:在处方或可能处方氯吡格雷的特立尼达心血管疾病患者中,有很大一部分携带与氯吡格雷抗性相关的基因变异。这些结果表明,临床上需要进一步研究CYP2C19*2基因型是否应指导特立尼达和多巴哥心血管疾病患者使用氯吡格雷。本文附有幻灯片。
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引用次数: 0
Factor XI Inhibitors: A New Horizon in Anticoagulation Therapy. 因子 XI 抑制剂:抗凝疗法的新视野。
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-02-02 DOI: 10.1007/s40119-024-00352-x
João Presume, Jorge Ferreira, Regina Ribeiras

Anticoagulation therapy has undergone significant evolution, marked by the emergence of direct oral anticoagulants with distinct advantages. Despite these advancements, challenges persist in managing residual thrombotic and bleeding risks, particularly among vulnerable populations. The pursuit of alternative drugs has honed in on factor XI/XIa inhibitors. This comprehensive review delves into several key aspects regarding this new target: (i) the role of factor XI in the coagulation cascade; (ii) the genetic evidence and pathophysiologic rationale supporting factor XI inhibition as a therapeutic target; (iii) an exploration of the various types of factor XI/XIa inhibitors currently under investigation; (iv) potential applications of these medications, spanning thromboprophylaxis after orthopedic surgery, stroke prevention in atrial fibrillation, secondary prevention after acute coronary syndrome, non-cardioembolic stroke, thromboprophylaxis after foreign material implantation, end-stage renal disease, and patients with cancer; and (v) an overview of ongoing studies, recent findings, and the future trajectory of research into these drugs.

抗凝疗法经历了重大演变,其标志是具有独特优势的直接口服抗凝剂的出现。尽管取得了这些进步,但在管理残余血栓和出血风险方面仍存在挑战,尤其是在易感人群中。对替代药物的追求已聚焦于因子 XI/XIa 抑制剂。本综述深入探讨了有关这一新靶点的几个关键方面:(i) XI 因子在凝血级联中的作用;(ii) 支持将 XI 因子抑制作为治疗靶点的遗传学证据和病理生理学原理;(iii) 探讨目前正在研究的各类 XI/XIa 因子抑制剂;(iv) 这些药物的潜在应用,包括矫形手术后的血栓预防、心房颤动的中风预防、急性冠状动脉综合征后的二级预防、非心肌栓塞性中风、异物植入后的血栓预防、终末期肾病和癌症患者;以及 (v) 正在进行的研究、最新发现和这些药物的未来研究轨迹概述。
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引用次数: 0
Real-World Safety and Effectiveness of a 4-Factor Prothrombin Complex Concentrate in Japanese Patients Experiencing Major Bleeding: A Post-marketing Surveillance Study. 日本大出血患者使用 4 因子凝血酶原复合物浓缩物的实际安全性和有效性:上市后监测研究》。
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-02-06 DOI: 10.1007/s40119-024-00357-6
Masahiro Yasaka, Michiyasu Suzuki, Shigeki Kushimoto, Ayako Kiyonaga, Antoinette Mangione, Yuki Niwa, Naoki Terasaka

Introduction: Limited data are available regarding the safety and effectiveness of 4-factor prothrombin complex concentrate (4F-PCC) in patients experiencing major hemorrhage or requiring expeditious surgical intervention, both globally and within Japan.

Methods: We executed a prospective, observational post-marketing surveillance study of patients receiving 4F-PCC for the first time between September 19, 2017 and August 15, 2018 in Japan. Patients were subjected to a comprehensive follow-up for a duration of 4 weeks.

Results: Of 1381 eligible patients, 1271 (92%) received a vitamin K antagonist. Among these, 58% were aged ≥ 75 years, 49% manifested atrial fibrillation, 17% presented with valvular heart disease, and 6% exhibited venous thromboembolism. The median (range) international normalized ratio was 2.67 (0.96-27.11) at baseline and 1.21 (0.45-6.61) at first measurement post-administration of 4F-PCC. The most common reason for 4F-PCC administration was intracranial hemorrhage (59.6%), followed by gastrointestinal bleeding (6.6%). Hemostatic effectiveness was achieved in 85.8% of patients. The incidences of adverse drug reactions (ADRs) and serious ADRs were 3.9% and 2.8%, respectively. Thromboembolic events (TEEs) occurred in 20 (1.5%) patients, with a mean onset of 10 days. The majority of TEEs were classified as nervous system disorders (55%). At the time of TEE, only 13% of patients resumed anticoagulant therapy.

Conclusion: The incidence of TEEs following treatment with 4F-PCC did not surpass those observed in phase 3 trials. No novel safety signals were identified. The safety and effectiveness of 4F-PCC in Japanese real-world practice were in harmony with the observations of prior studies.

简介:关于 4 因子凝血酶原复合物浓缩物(4F-PCC)在大出血或需要快速外科干预的患者中的安全性和有效性,目前在全球和日本国内都只有有限的数据:我们对2017年9月19日至2018年8月15日期间在日本首次接受4F-PCC治疗的患者进行了一项前瞻性、观察性的上市后监测研究。对患者进行了为期 4 周的全面随访:在 1381 名符合条件的患者中,1271 人(92%)接受了维生素 K 拮抗剂治疗。其中,58%的患者年龄≥75岁,49%表现为心房颤动,17%患有瓣膜性心脏病,6%表现为静脉血栓栓塞。基线时国际标准化比值的中位数(范围)为 2.67(0.96-27.11),使用 4F-PCC 后首次测量时为 1.21(0.45-6.61)。使用 4F-PCC 的最常见原因是颅内出血(59.6%),其次是消化道出血(6.6%)。85.8%的患者取得了止血效果。药物不良反应(ADR)和严重药物不良反应的发生率分别为 3.9% 和 2.8%。血栓栓塞事件(TEE)发生在 20 例(1.5%)患者中,平均发病时间为 10 天。大多数 TEE 被归类为神经系统疾病(55%)。TEE发生时,只有13%的患者恢复了抗凝治疗:结论:使用 4F-PCC 治疗后的 TEE 发生率并未超过 3 期试验中观察到的发生率。未发现新的安全信号。在日本的实际应用中,4F-PCC 的安全性和有效性与之前研究的观察结果一致。
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引用次数: 0
The Utility of Screening Fetal Echocardiograms Following Normal Level II Ultrasounds in Fetuses with Maternal Congenital Heart Disease. 对母体患有先天性心脏病的胎儿进行正常二级超声检查后进行胎儿超声心动图筛查的实用性。
IF 3.4 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-03-01 Epub Date: 2024-01-23 DOI: 10.1007/s40119-024-00350-z
Sophia Calcara, Amanda Paeltz, Bernadette Richards, Tracey Sisk, Corey Stiver, Oluseyi Ogunleye, Karen Texter, May Ling Mah, Clifford L Cua

Introduction: Fetal echocardiograms (F-echo) are recommended in all pregnancies when maternal congenital heart disease (CHD) is present, even if there was a prior level II ultrasound (LII-US) that was normal. The goal of this study was to evaluate if any diagnosis of a critical CHD was missed in a fetus with maternal CHD who had a normal LII-US.

Methods: A retrospective chart review of all F-echoes where the indication was maternal CHD between 1/1/2015 to 12/31/2022 was performed. Fetuses were included if they had a LII-US that was read as normal and had an F-echo. Critical CHD was defined as CHD requiring catheterization or surgical intervention < 1 month of age.

Results: A total of 296 F-echoes on fetuses with maternal CHD were evaluated, of which 175 met inclusion criteria. LII-US was performed at 19.8 ± 2.9 weeks gestational age and F-echo was performed at 24.2 ± 2.8 weeks gestational age. No patient with a normal LII-US had a diagnosis of a critical CHD by F-echo (negative predictive value = 100%). Evaluating those patients that had a negative LII-US, ten patients were diagnosed with non-critical CHD postnatally (negative predictive value = 94.3%). F-echo correctly diagnosed two of the ten missed LII-US CHD.

Conclusions: Critical CHD was not missed with a normal LII-US in this at risk population. F-echo also missed the majority of CHD when a LII-US was read as normal. A cost-benefit analysis of screening F-echo in fetuses with maternal CHD should be conducted if a normal LII-US has been performed.

简介:如果母体患有先天性心脏病(CHD),即使之前的二级超声检查(LII-US)正常,也建议所有孕妇进行胎儿超声心动图检查(F-echo)。本研究的目的是评估母体有先天性心脏病但 LII-US 正常的胎儿是否漏诊了严重的先天性心脏病:方法:对2015年1月1日至2022年12月31日期间所有以母体CHD为指征的F-回波进行回顾性病历审查。如果胎儿的 LII-US 被判读为正常且有 F 回波,则将其包括在内。重症 CHD 被定义为需要进行导管检查或手术干预的 CHD:共评估了 296 例母体患有先天性心脏病的胎儿的 F 回波,其中 175 例符合纳入标准。LII-US 在胎龄(19.8 ± 2.9)周时进行,F-回波在胎龄(24.2 ± 2.8)周时进行。没有一名 LII-US 正常的患者被 F-echo 诊断为危重先天性心脏病(阴性预测值 = 100%)。在对 LII-US 阴性的患者进行评估后,有 10 名患者在产后被诊断为非危重先天性心脏病(阴性预测值 = 94.3%)。F-回波正确诊断了10例LII-US漏诊的心脏病中的2例:结论:在这一高危人群中,正常的 LII-US 不会漏诊重症心脏病。当 LII-US 被判读为正常时,F-回波也会漏诊大部分冠心病。如果 LII-US 正常,则应对母体有先天性心脏病的胎儿进行 F-回波筛查的成本效益分析。
{"title":"The Utility of Screening Fetal Echocardiograms Following Normal Level II Ultrasounds in Fetuses with Maternal Congenital Heart Disease.","authors":"Sophia Calcara, Amanda Paeltz, Bernadette Richards, Tracey Sisk, Corey Stiver, Oluseyi Ogunleye, Karen Texter, May Ling Mah, Clifford L Cua","doi":"10.1007/s40119-024-00350-z","DOIUrl":"10.1007/s40119-024-00350-z","url":null,"abstract":"<p><strong>Introduction: </strong>Fetal echocardiograms (F-echo) are recommended in all pregnancies when maternal congenital heart disease (CHD) is present, even if there was a prior level II ultrasound (LII-US) that was normal. The goal of this study was to evaluate if any diagnosis of a critical CHD was missed in a fetus with maternal CHD who had a normal LII-US.</p><p><strong>Methods: </strong>A retrospective chart review of all F-echoes where the indication was maternal CHD between 1/1/2015 to 12/31/2022 was performed. Fetuses were included if they had a LII-US that was read as normal and had an F-echo. Critical CHD was defined as CHD requiring catheterization or surgical intervention < 1 month of age.</p><p><strong>Results: </strong>A total of 296 F-echoes on fetuses with maternal CHD were evaluated, of which 175 met inclusion criteria. LII-US was performed at 19.8 ± 2.9 weeks gestational age and F-echo was performed at 24.2 ± 2.8 weeks gestational age. No patient with a normal LII-US had a diagnosis of a critical CHD by F-echo (negative predictive value = 100%). Evaluating those patients that had a negative LII-US, ten patients were diagnosed with non-critical CHD postnatally (negative predictive value = 94.3%). F-echo correctly diagnosed two of the ten missed LII-US CHD.</p><p><strong>Conclusions: </strong>Critical CHD was not missed with a normal LII-US in this at risk population. F-echo also missed the majority of CHD when a LII-US was read as normal. A cost-benefit analysis of screening F-echo in fetuses with maternal CHD should be conducted if a normal LII-US has been performed.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"163-171"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10899149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139519642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Cardiology and Therapy
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