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Effects of trimetazidine on heart failure with reduced ejection fraction and associated clinical outcomes: a systematic review and meta-analysis. 曲美他嗪对射血分数降低型心力衰竭的影响及相关临床结果:系统综述和荟萃分析。
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-08 DOI: 10.1136/openhrt-2023-002579
Soufiane Nassiri, Arno A Van de Bovenkamp, Sharon Remmelzwaal, Olimpia Sorea, Frances de Man, M Louis Handoko

Background: Despite maximal treatment, heart failure (HF) remains a major clinical challenge. Besides neurohormonal overactivation, myocardial energy homoeostasis is also impaired in HF. Trimetazidine has the potential to restore myocardial energy status by inhibiting fatty acid oxidation, concomitantly enhancing glucose oxidation. Trimetazidine is an interesting adjunct treatment, for it is safe, easy to use and comes at a low cost.

Objective: We conducted a systematic review to evaluate all available clinical evidence on trimetazidine in HF. We searched Medline/PubMed, Embase, Cochrane CENTRAL and ClinicalTrials.gov to identify relevant studies.

Methods: Out of 213 records, we included 28 studies in the meta-analysis (containing 2552 unique patients), which almost exclusively randomised patients with HF with reduced ejection fraction (HFrEF). The studies were relatively small (median study size: N=58) and of short duration (mean follow-up: 6 months), with the majority (68%) being open label.

Results: Trimetazidine in HFrEF was found to significantly reduce cardiovascular mortality (OR 0.33, 95% CI 0.21 to 0.53) and HF hospitalisations (OR 0.42, 95% CI 0.29 to 0.60). In addition, trimetazidine improved (New York Heart Association) functional class (mean difference: -0.44 (95% CI -0.49 to -0.39), 6 min walk distance (mean difference: +109 m (95% CI 105 to 114 m) and quality of life (standardised mean difference: +0.52 (95% CI 0.32 to 0.71). A similar pattern of effects was observed for both ischaemic and non-ischaemic cardiomyopathy.

Conclusions: Current evidence supports the potential role of trimetazidine in HFrEF, but this is based on multiple smaller trials of varying quality in study design. We recommend a large pragmatic randomised clinical trial to establish the definitive role of trimetazidine in the management of HFrEF.

背景:尽管进行了最大限度的治疗,心力衰竭(HF)仍是一项重大的临床挑战。除了神经激素过度激活外,心力衰竭患者的心肌能量平衡也会受损。曲美他嗪有可能通过抑制脂肪酸氧化来恢复心肌能量状态,同时促进葡萄糖氧化。曲美他嗪是一种有趣的辅助治疗药物,因为它安全、易用且价格低廉:我们进行了一项系统性综述,以评估有关曲美他嗪治疗高血压的所有可用临床证据。我们检索了 Medline/PubMed、Embase、Cochrane CENTRAL 和 ClinicalTrials.gov,以确定相关研究:在 213 条记录中,我们将 28 项研究纳入了荟萃分析(包含 2552 名患者),这些研究几乎都是随机研究射血分数降低的心房颤动患者(HFrEF)。这些研究规模相对较小(研究规模中位数:N=58),持续时间较短(平均随访时间:6个月),大部分(68%)为开放标签研究:结果:研究发现,曲美他嗪可显著降低 HFrEF 患者的心血管死亡率(OR 0.33,95% CI 0.21 至 0.53)和 HF 住院率(OR 0.42,95% CI 0.29 至 0.60)。此外,曲美他嗪还能改善(纽约心脏协会)功能分级(平均差异:-0.44(95% CI)-0.53(95% CI)):-0.44(95% CI -0.49至-0.39)、6分钟步行距离(平均差异:+109米(95% CI+109米(95% CI 105至114米)和生活质量(标准化平均差异:+0.52(95% CI 105至114米)):+0.52(95% CI 0.32 至 0.71)。缺血性和非缺血性心肌病的疗效模式相似:目前的证据支持曲美他嗪在高频低氧血症中的潜在作用,但这是基于多项研究设计质量参差不齐的小型试验。我们建议开展一项大型实用随机临床试验,以确定曲美他嗪在 HFrEF 治疗中的确切作用。
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引用次数: 0
Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke. 缺血性或隐源性脑卒中后,植入式回路记录器与外部监护仪的相关效果、使用率和成本。
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-08 DOI: 10.1136/openhrt-2024-002714
Sanket S Dhruva, Jaime Murillo, Omid Ameli, Christine E Chaisson, Rita F Redberg, Ken Cohen

Objective: Implantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation to reduce risk of adverse clinical outcomes. There is a need to determine the effectiveness of different rhythm monitoring strategies in this context.

Methods: We conducted a retrospective cohort analysis of individuals with commercial and Medicare Advantage insurance in Optum Labs Data Warehouse who had incident ischaemic or cryptogenic stroke and no prior cardiovascular implantable electronic device from 1 January 2016 to 30 June 2021. Patients were stratified by rhythm monitoring strategy: ILR, long-term continuous external cardiac monitor (>48 hours to 30 days) or Holter monitor (≤48 hours). The primary outcome was risk-adjusted all-cause mortality at 12 months. Secondary outcomes included new diagnosis of AF and oral anticoagulation, bleeding, and costs.

Results: Among 48 901 patients with ischaemic or cryptogenic stroke, 9235 received an ILR, 29 103 long-term continuous external monitor and 10 563 Holter monitor only. Mean age was 69.9 (SD 11.9) years and 53.5% were female. During the 12-month follow-up period, patients who received ILRs compared with those who received long-term continuous external monitors had a higher odds of new diagnosis of AF and oral anticoagulant initiation (adjusted OR 2.27, 95% CI 2.09 to 2.48). Compared with patients who received long-term continuous external monitors, those who received ILRs had similar 12-month mortality (HR 1.00; 95% CI 0.89 to 1.12), with approximately $13 000 higher costs at baseline (including monitor cost) and $2500 higher costs during 12-month follow-up.

Conclusions: In this large real-world study of patients with ischaemic or cryptogenic stroke, ILR placement resulted in more diagnosis of AF and initiation of oral anticoagulation, but no difference in mortality compared with long-term continuous external monitors.

目的:植入式回路记录器(ILR)越来越多地用于缺血性和隐源性卒中后的长期心律监测,目的是检测心房颤动(AF)并随后开始口服抗凝药以降低不良临床结局的风险。在这种情况下,需要确定不同心律监测策略的有效性:我们对 Optum 实验室数据仓库中 2016 年 1 月 1 日至 2021 年 6 月 30 日期间患有缺血性或隐源性卒中且之前未植入心血管植入式电子设备的商业保险和医疗保险优势人群进行了回顾性队列分析。根据心律监测策略对患者进行分层:ILR、长期连续体外心脏监护仪(>48 小时至 30 天)或 Holter 监护仪(≤48 小时)。主要结果是12个月时风险调整后的全因死亡率。次要结果包括新诊断房颤和口服抗凝药、出血和费用:在 48 901 名缺血性或隐源性脑卒中患者中,9235 人接受了 ILR,29 103 人接受了长期持续外部监护,10 563 人仅接受了 Holter 监护。平均年龄为 69.9 (SD 11.9)岁,53.5% 为女性。在 12 个月的随访期间,与接受长期连续外部监护仪的患者相比,接受 ILR 的患者新诊断为房颤和开始口服抗凝药的几率更高(调整后 OR 为 2.27,95% CI 为 2.09 至 2.48)。与接受长期连续外部监护仪的患者相比,接受ILR的患者12个月死亡率相似(HR 1.00;95% CI 0.89至1.12),基线成本(包括监护仪成本)高出约13000美元,12个月随访期间成本高出2500美元:在这项针对缺血性或隐源性脑卒中患者的大型真实世界研究中,植入 ILR 会导致更多的房颤诊断和口服抗凝治疗,但与长期持续的体外监护仪相比,死亡率并无差异。
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引用次数: 0
Continuous heart monitoring to evaluate treatment effects in pulmonary hypertension 连续心脏监测评估肺动脉高压的治疗效果
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 DOI: 10.1136/openhrt-2024-002710
Mads Ørbæk Andersen, Soren Zoga Diederichsen, Jesper Hastrup Svendsen, Jørn Carlsen
Background The treatment of pulmonary hypertension (PH) has improved rapidly in recent decades. There is increasing evidence to support the role of early intervention and treatment in affecting clinical outcomes in PH. Objectives To assess treatment effects before and after the escalation of specific PH treatments using continuous heart monitoring with a Reveal LINQ loop recorder. Methods Patients were compared before and after treatment escalation. Treatment escalation was defined as an additional pulmonary arterial hypertension (PAH) drug, pulmonary endarterectomy, percutaneous balloon angioplasty or bilateral lung transplantation. Specifically, changes in heart rate variability (HRV), heart rate (HR) and physical activity were assessed. Results In this prospective study, 41 patients (27 with PAH and 14 with chronic thromboembolic pulmonary hypertension (CTEPH)) were enrolled. Among them, 15 (36.6%) patients underwent PH treatment escalation. Prior to escalation, patients were monitored for a median of 100 (range: 68–100) days and after therapy escalation for a median duration of 165 (range: 89–308) days. In the escalation group, there was a significant increase in HRV, physical activity indexed by daytime HR and a significant decrease in nighttime HR assessed at baseline and after treatment escalation in both the PAH and CTEPH groups. This was paralleled by significant improvements in WHO functional class, 6-min walking distance and N-terminal pro-b-type natriuretic peptide. Conclusions This is the first study to demonstrate an association between specific PH therapies and changes in HRV, HR nighttime and physical activity. This indicates the potential of continuous monitoring in the evaluation of treatment effects in PH. Data are available upon reasonable request.
背景 近几十年来,肺动脉高压(PH)的治疗水平迅速提高。越来越多的证据表明,早期干预和治疗在影响 PH 的临床预后方面发挥着重要作用。目的 使用 Reveal LINQ 循环记录仪进行连续心脏监测,评估特定 PH 治疗升级前后的治疗效果。方法 对治疗升级前后的患者进行比较。治疗升级的定义是额外使用肺动脉高压(PAH)药物、肺动脉内膜切除术、经皮球囊血管成形术或双侧肺移植。具体来说,研究人员评估了心率变异性(HRV)、心率(HR)和体力活动的变化。结果 在这项前瞻性研究中,共招募了 41 名患者(27 名 PAH 患者和 14 名慢性血栓栓塞性肺动脉高压(CTEPH)患者)。其中,15 名患者(36.6%)接受了肺动脉高压治疗升级。治疗升级前,患者接受监测的中位时间为 100 天(范围:68-100),治疗升级后,患者接受监测的中位时间为 165 天(范围:89-308)。在治疗升级组中,PAH 组和 CTEPH 组的心率变异和以日间心率为指标的体力活动均显著增加,而在基线和治疗升级后评估的夜间心率均显著下降。与此同时,WHO 功能分级、6 分钟步行距离和 N 端前 b 型钠尿肽也有明显改善。结论 这是第一项证明特定 PH 疗法与心率变异、夜间心率和体力活动变化之间存在关联的研究。这表明持续监测在评估 PH 治疗效果方面具有潜力。如有合理要求,可提供相关数据。
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引用次数: 0
Heterogeneity of right ventricular echocardiographic parameters in systemic lupus erythematosus among four clinical subgroups, as stratified by clinical organ involvement in observational cohort 系统性红斑狼疮患者右心室超声心动图参数在四个临床亚组中的异质性,并根据观察队列中的临床器官受累情况进行分层
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 DOI: 10.1136/openhrt-2024-002615
Corentin Bourg, Erwan Le Tallec, Elizabeth Curtis, Charlotte Lee, Guillaume Bouzille, Emmanuel Oger, Alain Lescort, Erwan Donal
Background Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease. Cardiac involvement in SLE is rare but plays an important prognostic role. The degree of cardiac involvement according to SLE subsets defined by non-cardiac manifestations is unknown. The objective of this study was to identify differences in transthoracic echocardiography (TTE) parameters associated with different SLE subgroups. Methods One hundred eighty-one patients who fulfilled the 2019 American College of Rheumatology/EULAR classification criteria for SLE and underwent baseline TTE were included in this cross-sectional study. We defined four subsets of SLE based on the predominant clinical manifestations. A multivariate multinomial regression analysis was performed to determine whether TTE parameters differed between groups. Results Four clinical subsets were defined according to non-cardiac clinical manifestations: group A (n=37 patients) showed features of mixed connective tissue disease, group B (n=76 patients) had primarily cutaneous involvement, group C (n=18) exhibited prominent serositis and group D (n=50) had severe, multi-organ involvement, including notable renal disease. Forty TTE parameters were assessed between groups. Per multivariate multinomial regression analysis, there were statistically significant differences in early diastolic tricuspid annular velocity (RV-Ea, p<0.0001), RV S’ wave (p=0.0031) and RV end-diastolic diameter (p=0.0419) between the groups. Group B (primarily cutaneous involvement) had the lowest degree of RV dysfunction. Conclusion When defining clinical phenotypes of SLE based on organ involvement, we found four distinct subgroups which showed notable differences in RV function on TTE. Risk-stratifying patients by clinical phenotype could help better tailor cardiac follow-up in this population. Data are available on reasonable request.
背景 系统性红斑狼疮(SLE)是一种异质性自身免疫性疾病。系统性红斑狼疮的心脏受累很少见,但对预后起着重要作用。根据非心脏表现定义的系统性红斑狼疮亚群的心脏受累程度尚不清楚。本研究旨在确定与不同系统性红斑狼疮亚群相关的经胸超声心动图(TTE)参数的差异。方法 这项横断面研究纳入了 181 名符合 2019 年美国风湿病学会/EULAR 系统性红斑狼疮分类标准并接受了基线 TTE 检查的患者。我们根据主要临床表现定义了四个系统性红斑狼疮亚组。我们进行了多变量多项式回归分析,以确定不同组间的 TTE 参数是否存在差异。结果 根据非心脏临床表现定义了四个临床亚组:A组(37名患者)表现为混合性结缔组织病,B组(76名患者)主要是皮肤受累,C组(18名患者)表现为突出的血清炎,D组(50名患者)有严重的多器官受累,包括明显的肾脏疾病。对各组之间的 40 项 TTE 参数进行了评估。通过多变量多项式回归分析,各组间舒张早期三尖瓣环速度(RV-Ea,P<0.0001)、RV S'波(P=0.0031)和 RV 舒张末期直径(P=0.0419)存在显著统计学差异。B 组(主要是皮肤受累)的 RV 功能障碍程度最低。结论 在根据器官受累情况定义系统性红斑狼疮的临床表型时,我们发现四个不同的亚组在 TTE 上显示出明显的 RV 功能差异。根据临床表型对患者进行风险分层有助于更好地对这一人群进行心脏随访。如有合理要求,可提供相关数据。
{"title":"Heterogeneity of right ventricular echocardiographic parameters in systemic lupus erythematosus among four clinical subgroups, as stratified by clinical organ involvement in observational cohort","authors":"Corentin Bourg, Erwan Le Tallec, Elizabeth Curtis, Charlotte Lee, Guillaume Bouzille, Emmanuel Oger, Alain Lescort, Erwan Donal","doi":"10.1136/openhrt-2024-002615","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002615","url":null,"abstract":"Background Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease. Cardiac involvement in SLE is rare but plays an important prognostic role. The degree of cardiac involvement according to SLE subsets defined by non-cardiac manifestations is unknown. The objective of this study was to identify differences in transthoracic echocardiography (TTE) parameters associated with different SLE subgroups. Methods One hundred eighty-one patients who fulfilled the 2019 American College of Rheumatology/EULAR classification criteria for SLE and underwent baseline TTE were included in this cross-sectional study. We defined four subsets of SLE based on the predominant clinical manifestations. A multivariate multinomial regression analysis was performed to determine whether TTE parameters differed between groups. Results Four clinical subsets were defined according to non-cardiac clinical manifestations: group A (n=37 patients) showed features of mixed connective tissue disease, group B (n=76 patients) had primarily cutaneous involvement, group C (n=18) exhibited prominent serositis and group D (n=50) had severe, multi-organ involvement, including notable renal disease. Forty TTE parameters were assessed between groups. Per multivariate multinomial regression analysis, there were statistically significant differences in early diastolic tricuspid annular velocity (RV-Ea, p<0.0001), RV S’ wave (p=0.0031) and RV end-diastolic diameter (p=0.0419) between the groups. Group B (primarily cutaneous involvement) had the lowest degree of RV dysfunction. Conclusion When defining clinical phenotypes of SLE based on organ involvement, we found four distinct subgroups which showed notable differences in RV function on TTE. Risk-stratifying patients by clinical phenotype could help better tailor cardiac follow-up in this population. Data are available on reasonable request.","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"31 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140833195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Review of codelists used to define hypertension in electronic health records and development of a codelist for research 审查电子健康记录中用于定义高血压的代码表,并制定用于研究的代码表
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2024-002640
Georgie May Massen, Philip W Stone, Harley H Y Kwok, Gisli Jenkins, Richard J Allen, Louise V Wain, Iain Stewart, Jennifer Kathleen Quint
Background and aims Hypertension is a leading risk factor for cardiovascular disease. Electronic health records (EHRs) are routinely collected throughout a person’s care, recording all aspects of health status, including current and past conditions, prescriptions and test results. EHRs can be used for epidemiological research. However, there are nuances in the way conditions are recorded using clinical coding; it is important to understand the methods which have been applied to define exposures, covariates and outcomes to enable interpretation of study findings. This study aimed to identify codelists used to define hypertension in studies that use EHRs and generate recommended codelists to support reproducibility and consistency. Eligibility criteria Studies included populations with hypertension defined within an EHR between January 2010 and August 2023 and were systematically identified using MEDLINE and Embase. A summary of the most frequently used sources and codes is described. Due to an absence of Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) codelists in the literature, a recommended SNOMED CT codelist was developed to aid consistency and standardisation of hypertension research using EHRs. Findings 375 manuscripts met the study criteria and were eligible for inclusion, and 112 (29.9%) reported codelists. The International Classification of Diseases (ICD) was the most frequently used clinical terminology, 59 manuscripts provided ICD 9 codelists (53%) and 58 included ICD 10 codelists (52%). Informed by commonly used ICD and Read codes, usage recommendations were made. We derived SNOMED CT codelists informed by National Institute for Health and Care Excellence guidelines for hypertension management. It is recommended that these codelists be used to identify hypertension in EHRs using SNOMED CT codes. Conclusions Less than one-third of hypertension studies using EHRs included their codelists. Transparent methodology for codelist creation is essential for replication and will aid interpretation of study findings. We created SNOMED CT codelists to support and standardise hypertension definitions in EHR studies. All data relevant to the study are included in the article or uploaded as supplementary information. All works included in this analysis are referenced in the supplementary Excel file. No additional data not located within the manuscripts were used.
背景和目的 高血压是心血管疾病的主要风险因素。电子健康记录(EHR)是在个人护理过程中定期收集的,记录了健康状况的各个方面,包括当前和过去的状况、处方和检查结果。电子健康记录可用于流行病学研究。然而,使用临床编码记录病情的方式存在细微差别;了解用于定义暴露、协变量和结果的方法对于解释研究结果非常重要。本研究旨在确定使用电子病历的研究中用于定义高血压的代码表,并生成推荐的代码表,以支持可重复性和一致性。资格标准 研究纳入了 2010 年 1 月至 2023 年 8 月期间电子病历中定义的高血压人群,并通过 MEDLINE 和 Embase 进行了系统识别。本文概述了最常用的来源和代码。由于文献中缺乏系统化医学临床术语(SNOMED CT)编码表,因此开发了一个推荐的 SNOMED CT 编码表,以帮助使用电子病历进行高血压研究的一致性和标准化。研究结果 有 375 篇手稿符合研究标准并有资格纳入,其中 112 篇(29.9%)报告了编码表。国际疾病分类 (ICD) 是最常用的临床术语,59 篇稿件提供了 ICD 9 编码表(53%),58 篇提供了 ICD 10 编码表(52%)。根据常用的 ICD 和 Read 代码,我们提出了使用建议。我们根据美国国家健康与护理卓越研究所(National Institute for Health and Care Excellence)的高血压管理指南得出了 SNOMED CT 编码表。建议在使用 SNOMED CT 代码的电子病历中使用这些代码表来识别高血压。结论 在使用电子病历的高血压研究中,只有不到三分之一的研究纳入了其代码表。透明的代码表创建方法对于复制至关重要,并有助于解释研究结果。我们创建了 SNOMED CT 编码表,以支持电子病历研究中的高血压定义并使之标准化。所有与研究相关的数据均包含在文章中或作为补充信息上传。本分析中包含的所有作品均在补充 Excel 文件中提供了参考。未使用手稿中没有的其他数据。
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引用次数: 0
Outcomes of subsequent pregnancy in women with peripartum cardiomyopathy: a systematic review and meta-analysis 围产期心肌病妇女的后续妊娠结局:系统回顾和荟萃分析
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2024-002626
Matthew Aldo Wijayanto, Risalina Myrtha, Graciella Angelica Lukas, Annisa Aghnia Rahma, Shafira Nur Hanifa, Hadiqa Almas Zahira, Muhana Fawwazy Ilyas
Introduction The primary concern for women who have experienced peripartum cardiomyopathy (PPCM) is the safety of a subsequent pregnancy (SSP). To maximie decision-making, facilitate effective patient counselling, and ultimately improve maternal and fetal outcomes as a whole, it is critical to comprehend the outcomes of SSP in women who have previously experienced PPCM. This study aimed to evaluate the outcomes of SSP in women with PPCM. Methods Three databases (PubMed, Scopus, and ScienceDirect) were used to identify relevant studies prior to 17 October 2023. A total of 662 studies were reviewed. Following the abstract and full-text screenings, 18 observational studies were included, out of which 2 were deemed suitable for inclusion in this meta-analysis. The quality assessment was conducted using the Newcastle-Ottawa Scale. Results This study has a total of 487 SSPs. Although recovered left ventricular (LV) function before entering SSP has the potential to be a beneficial prognostic factor, recovered LV function still has a substantial risk of relapse. The mortality rate of PPCM in an SSP ranged from 0% to 55.5%. Persistent LV dysfunction was significantly associated with an increased mortality rate (OR 13.17; 95% CI 1.54 to 112.28; p=0.02) and lower LV ejection fraction (MD −12.88; 95% CI −21.67 to −4.09; p=0.004). Diastolic and right ventricular functions remained unchanged before SSP and at follow-up. The majority of the SSP was observed alongside hypertension, while pre-eclampsia emerged as the predominant hypertensive complication in most studies. Conclusion SSP increases the risk of relapse and mortality in women with a previous history of PPCM. Persistent LV dysfunction prior to the SSP has a higher mortality risk compared with recovered LV function. SSP was also associated with the worsening of LV echocardiography parameters. All data relevant to the study are included in the article or uploaded as online supplemental information.
引言 曾患围产期心肌病 (PPCM) 的妇女最关心的问题是再次妊娠 (SSP) 的安全性。为了最大限度地帮助患者做出决策,为患者提供有效的咨询,并最终改善孕产妇和胎儿的整体预后,了解曾经历过 PPCM 的妇女的 SSP 预后至关重要。本研究旨在评估 SSP 对 PPCM 患者的治疗效果。方法 使用三个数据库(PubMed、Scopus 和 ScienceDirect)查找 2023 年 10 月 17 日之前的相关研究。共查阅了 662 项研究。经过摘要和全文筛选,共纳入 18 项观察性研究,其中 2 项被认为适合纳入本荟萃分析。研究采用纽卡斯尔-渥太华量表进行质量评估。结果 本研究共有 487 个 SSP。虽然进入 SSP 前左心室(LV)功能的恢复可能是一个有利的预后因素,但恢复后的左心室功能仍有很大的复发风险。在 SSP 中,PPCM 的死亡率从 0% 到 55.5% 不等。持续的左心室功能障碍与死亡率增加(OR 13.17;95% CI 1.54 至 112.28;P=0.02)和左心室射血分数降低(MD -12.88;95% CI -21.67 至 -4.09;P=0.004)显著相关。舒张功能和右心室功能在 SSP 前和随访时保持不变。大多数 SSP 与高血压同时发生,而在大多数研究中,先兆子痫是主要的高血压并发症。结论 SSP 会增加既往有 PPCM 病史的妇女的复发和死亡风险。与已恢复的左心室功能相比,SSP 前持续存在的左心室功能障碍具有更高的死亡风险。SSP 还与左心室超声心动图参数恶化有关。该研究的所有相关数据均包含在文章中或作为在线补充信息上传。
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引用次数: 0
Virtual reality to reduce periprocedural anxiety during invasive coronary angiography: rationale and design of the VR InCard trial 虚拟现实技术减轻有创冠状动脉造影术的围手术期焦虑:VR InCard 试验的原理和设计
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2024-002628
Esther Helena Wouda Breunissen, Tjitske Diederike Groenveld, Linda Garms, Judith L Bonnes, Harry van Goor, Peter Damman
Introduction Patients undergoing invasive coronary angiography (ICA) experience anxiety due to various reasons. Procedural anxiety can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. Virtual reality (VR) is a promising non-pharmacological intervention to reduce anxiety in patients undergoing ICA. Methods and analysis A single-centre open-label randomised controlled trial is conducted assessing the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing ICA and experiencing anxiety in a periprocedural setting. The primary outcome is the Numeric Rating Scale (NRS) anxiety score measured just before obtaining arterial access. Secondary outcomes include postarterial puncture and postprocedural anxiety, patient-reported outcome measures (PROMs) of anxiety and physiological measurements associated with anxiety. The NRS anxiety level and physiological measurements are assessed five times during the procedure. The PROM State-Trait Anxiety Inventory and Perceived Stress Scale are completed preprocedure, and the PROM STAI and the Igroup Presence Questionnaire are performed postprocedure. Ethics and dissemination The protocol of this study has been approved by the Research Ethics Committee of the Radboud University Medical Centre, the Netherlands (CMO Arnhem-Nijmegen, 2023–16586). Informed consent is obtained from all patients. The trial is conducted according to the principles of the Helsinki Declaration and in accordance with Dutch guidelines, regulations, and acts (Medical Research involving Human Subjects Act, WMO). Registration details Trial registration number: [NCT06215456][1]. No data are available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06215456&atom=%2Fopenhrt%2F11%2F1%2Fe002628.atom
导言接受有创冠状动脉造影术(ICA)的患者会因各种原因而产生焦虑。手术焦虑可导致生理和心理并发症,影响患者的舒适度和整体手术效果。苯二氮卓类药物常用于减轻围手术期焦虑,但效果一般。虚拟现实(VR)是一种很有前景的非药物干预方法,可减轻接受 ICA 患者的焦虑。方法和分析 对 100 名接受 ICA 并在围手术期感到焦虑的患者进行了单中心开放标签随机对照试验,以评估附加 VR 治疗对焦虑的效果。主要结果是在获得动脉通路之前测量的数值评定量表(NRS)焦虑评分。次要结果包括动脉穿刺后和手术后焦虑、患者报告的焦虑结果测量(PROMs)以及与焦虑相关的生理测量。在手术过程中,将对 NRS 焦虑水平和生理测量进行五次评估。术前完成 PROM 状态-特质焦虑量表和知觉压力量表,术后进行 PROM STAI 和 Igroup Presence 问卷调查。伦理和传播 本研究方案已获得荷兰拉德布德大学医学中心研究伦理委员会的批准(CMO Arnhem-Nijmegen, 2023-16586)。所有患者均已获得知情同意。试验按照《赫尔辛基宣言》的原则进行,并符合荷兰的指导方针、法规和法案(《涉及人类受试者的医学研究法》,WMO)。注册详细信息 试验注册号:[NCT06215456][1]。暂无数据。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06215456&atom=%2Fopenhrt%2F11%2F1%2Fe002628.atom
{"title":"Virtual reality to reduce periprocedural anxiety during invasive coronary angiography: rationale and design of the VR InCard trial","authors":"Esther Helena Wouda Breunissen, Tjitske Diederike Groenveld, Linda Garms, Judith L Bonnes, Harry van Goor, Peter Damman","doi":"10.1136/openhrt-2024-002628","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002628","url":null,"abstract":"Introduction Patients undergoing invasive coronary angiography (ICA) experience anxiety due to various reasons. Procedural anxiety can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. Virtual reality (VR) is a promising non-pharmacological intervention to reduce anxiety in patients undergoing ICA. Methods and analysis A single-centre open-label randomised controlled trial is conducted assessing the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing ICA and experiencing anxiety in a periprocedural setting. The primary outcome is the Numeric Rating Scale (NRS) anxiety score measured just before obtaining arterial access. Secondary outcomes include postarterial puncture and postprocedural anxiety, patient-reported outcome measures (PROMs) of anxiety and physiological measurements associated with anxiety. The NRS anxiety level and physiological measurements are assessed five times during the procedure. The PROM State-Trait Anxiety Inventory and Perceived Stress Scale are completed preprocedure, and the PROM STAI and the Igroup Presence Questionnaire are performed postprocedure. Ethics and dissemination The protocol of this study has been approved by the Research Ethics Committee of the Radboud University Medical Centre, the Netherlands (CMO Arnhem-Nijmegen, 2023–16586). Informed consent is obtained from all patients. The trial is conducted according to the principles of the Helsinki Declaration and in accordance with Dutch guidelines, regulations, and acts (Medical Research involving Human Subjects Act, WMO). Registration details Trial registration number: [NCT06215456][1]. No data are available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06215456&atom=%2Fopenhrt%2F11%2F1%2Fe002628.atom","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"51 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140580759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analysis of core outcome set reporting in coronary intervention trials 冠状动脉介入试验的核心结果集报告分析
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2023-002581
Aaron Duncan, Frances Shiely
Background This paper will focus on outcome reporting within percutaneous coronary intervention (PCI) trials. A core outcome set (COS) is a standardised set of outcomes that are recommended to be reported in every clinical trial. Using a COS can help to ensure that all relevant outcomes are consistently reported across clinical trials. In 2018, the European Society of Cardiology outlined the only COS published for PCI trials. Methods We searched the literature for all randomised controlled trials published between 2014 and 2022. PCI trials included were late-phase trials and must investigate coronary intervention. The primary outcome was the proportion of trials that reported all of the COS-defined outcomes within their publication as either a primary, secondary or safety endpoint. The secondary outcomes included; the number of primary outcomes reported per study, the proportion of studies which use patient and public involvement (PPI) during trial design, outcome variability and outcome consistency. Results 9580 trials were screened and 115 studies met inclusion/exclusion criteria. Our study demonstrated that 55% (34/62) of PCI trials used a COS when it was available, compared with 40% (21/53) before the availability of a PCI COS set, p=0.121. Fewer primary outcomes were reported after the implementation of the COS, 2 compared with 2.3, p=0.014. There was no difference in the use of PPI between either group. There was a higher level of variability in outcomes reported before the availability of the COS, while the consistency of outcome reporting remained similar. Conclusion The use of a COS in PCI trials is low. This study provides evidence that there still is a lack of awareness of the COS among those who design clinical trials. We also presented the inconsistency and heterogenicity in reporting clinical trial outcomes. Finally, there was a clear lack of PPI utilisation in PCI trials. Data sharing not applicable as no data sets generated and/or analysed for this study.
背景 本文将重点讨论经皮冠状动脉介入治疗(PCI)试验中的结果报告。核心结果集(COS)是建议在每项临床试验中报告的一组标准化结果。使用 COS 有助于确保在各项临床试验中一致地报告所有相关结果。2018 年,欧洲心脏病学会概述了唯一针对 PCI 试验发布的 COS。方法 我们检索了 2014 年至 2022 年间发表的所有随机对照试验文献。纳入的 PCI 试验均为晚期试验,且必须研究冠状动脉介入治疗。主要结果是在其发表的论文中将所有 COS 定义的结果作为主要、次要或安全终点进行报告的试验比例。次要结果包括:每项研究报告的主要结果数量、在试验设计过程中利用患者和公众参与(PPI)的研究比例、结果的可变性和结果的一致性。结果 筛选出 9580 项试验,115 项研究符合纳入/排除标准。我们的研究表明,55%(34/62)的PCI试验在COS可用时使用了COS,而在PCI COS集可用之前,只有40%(21/53)的试验使用了COS,P=0.121。使用 COS 后报告的主要结果较少,仅为 2 例(2.3 例),P=0.014。两组在使用 PPI 方面没有差异。在使用 COS 之前,结果报告的可变性较高,而结果报告的一致性保持相似。结论 PCI 试验中 COS 的使用率较低。本研究提供的证据表明,临床试验设计者对 COS 仍缺乏认识。我们还介绍了临床试验结果报告的不一致性和异质性。最后,PCI 试验中明显缺乏对 PPI 的使用。由于本研究未生成和/或分析数据集,因此不适用数据共享。
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引用次数: 0
New era in heart failure management: implementing cutting-edge therapies effectively 心力衰竭管理的新时代:有效实施尖端疗法
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2024-002659
Anastasia Shchendrygina, Clara Saldarriaga
Pharmacological therapy for heart failure (HF) has evolved significantly in recent years. Conventional disease-modifying medical therapy HF with reduced ejection fraction (HFrEF), beta-blockers (BB), angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and mineralocorticoid receptor antagonists (MRAs), was complemented by two novel drug classes including angiotensin receptor neprilysin inhibitors (ARNIs) and sodium-glucose co-transporter-2 inhibitors (SGLT-2is) which further improve outcomes in patients with HFrEF considerably. Major heart failure clinical practice guidelines advocate for the early initiation and uptitration of ‘quadruple’ medical therapy in HFrEF.1 2 However, implementation gaps still exist.3 There is an unmet need for evidence-based implementation strategies to achieve optimal guideline-directed medical treatment (GDMT). Treatment approaches in subgroups of patients with HF under-represented in clinical trials remain of significant clinical importance. The identification of the barriers to GDMT implementation in the real world is required. The scope of the Topic Collection was to gather emerging data on best practices of GDMT implementation in the real world, embracing the diversity of HF and psychosocial health patients with HF and capturing the broad spectrum of endpoints and …
近年来,心力衰竭(HF)的药物治疗有了长足的发展。射血分数降低型心力衰竭(HFrEF)的传统药物治疗包括β受体阻滞剂(BB)、血管紧张素转换酶抑制剂(ACEIs)或血管紧张素受体阻滞剂(ARBs)以及矿物质皮质激素受体拮抗剂(MRAs)、血管紧张素受体肾酶抑制剂(ARNIs)和钠-葡萄糖共转运体-2 抑制剂(SGLT-2is)这两类新型药物对其进行了补充,从而进一步大大改善了心衰患者的治疗效果。主要的心力衰竭临床实践指南都主张对 HFrEF 患者及早启动和升级 "四重 "药物治疗。临床试验中代表性不足的高血压亚组患者的治疗方法仍具有重要的临床意义。需要确定在现实世界中实施 GDMT 的障碍。专题收集的范围是收集现实世界中实施 GDMT 最佳实践的新兴数据,包括心房颤动和社会心理健康心房颤动患者的多样性,并捕捉广泛的终点和...
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引用次数: 0
Arrhythmias and cardiac MRI associations in patients with established cardiac dystrophinopathy 已确诊的心脏肌营养不良症患者的心律失常与心脏磁共振成像的关系
IF 2.7 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2023-002590
John Bourke, Margaret Tynan, Hannah Stevenson, Leslie Bremner, Oscar Gonzalez-Fernandez, Adam K McDiarmid
Aims Some patients with cardiac dystrophinopathy die suddenly. Whether such deaths are preventable by specific antiarrhythmic management or simply indicate heart failure overwhelming medical therapies is uncertain. The aim of this prospective, cohort study was to describe the occurrence and nature of cardiac arrhythmias recorded during prolonged continuous ECG rhythm surveillance in patients with established cardiac dystrophinopathy and relate them to abnormalities on cardiac MRI. Methods and results A cohort of 10 patients (36.3 years; 3 female) with LVEF<40% due to Duchenne (3) or Becker muscular (4) dystrophy or Duchenne muscular dystrophy-gene carrying effects in females (3) were recruited, had cardiac MRI, ECG signal-averaging and ECG loop-recorder implants. All were on standard of care heart medications and none had prior history of arrhythmias. No deaths or brady arrhythmias occurred during median follow-up 30 months (range 13–35). Self-limiting episodes of asymptomatic tachyarrhythmia (range 1–29) were confirmed in 8 (80%) patients (ventricular only 2; ventricular and atrial 6). Higher ventricular arrhythmia burden correlated with extent of myocardial fibrosis (extracellular volume%, p=0.029; native T1, p=0.49; late gadolinium enhancement, p=0.49), but not with LVEF% (p=1.0) on MRI and atrial arrhythmias with left atrial dilatation. Features of VT episodes suggested various underlying arrhythmia mechanisms. Conclusions The overall prevalence of arrhythmias was low. Even in such a small sample size, higher arrhythmia counts occurred in those with larger scar burden and greater ventricular volume, suggesting key roles for myocardial stretch as well as disease progression in arrhythmogenesis. These features overlap with the stage of left ventricular dysfunction when heart failure also becomes overt. The findings of this pilot study should help inform the design of a definitive study of specific antiarrhythmic management in dystrophinopathy. Trial registration number [ISRCTN15622536][1]. All data relevant to the study are included in the article or uploaded as online supplemental information. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN15622536
目的 一些心脏营养不良症患者会突然死亡。这种死亡是可以通过特定的抗心律失常治疗来预防,还是仅仅表明心脏衰竭无法承受药物治疗,目前尚不确定。这项前瞻性队列研究旨在描述已确诊的心肌营养不良症患者在长时间连续心电图节律监测期间记录到的心律失常的发生率和性质,并将其与心脏磁共振成像的异常情况联系起来。方法和结果 共招募了 10 例因杜氏肌营养不良(3 例)或贝克尔肌营养不良(4 例)或女性杜氏肌营养不良基因携带效应(3 例)导致 LVEF<40% 的患者(36.3 岁;3 例女性),他们都接受了心脏核磁共振成像、心电图信号平均化和心电图环形记录器植入。所有患者均服用标准的心脏药物,无心律失常病史。中位随访时间为 30 个月(13-35 个月),无死亡或缓慢性心律失常发生。8例(80%)患者(仅室性 2例;室性和房性 6例)被确诊为无症状快速性心律失常的自限性发作(范围 1-29)。较高的室性心律失常负荷与心肌纤维化程度相关(细胞外体积%,p=0.029;原生 T1,p=0.49;晚期钆增强,p=0.49),但与 MRI 上的 LVEF% 无关(p=1.0),与左心房扩张的房性心律失常无关。VT 发作的特征提示了各种潜在的心律失常机制。结论 心律失常的总体发病率较低。即使样本量很小,瘢痕负荷较大和心室容积较大的患者心律失常发生率也较高,这表明心肌伸展和疾病进展在心律失常发生中起着关键作用。这些特征与左心室功能障碍阶段重叠,此时心力衰竭也变得明显。这项试验性研究的结果将有助于为肌营养不良症特定抗心律失常治疗的最终研究设计提供参考。试验注册号[ISRCTN15622536][1]。与该研究相关的所有数据均包含在文章中或作为在线补充信息上传。[1]:/external-ref?link_type=ISRCTN&access_num=ISRCTN15622536
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引用次数: 0
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Open Heart
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