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Opportunistic atrial fibrillation screening in primary care in Ireland: results of a pilot screening programme. 爱尔兰初级保健中的机会性心房颤动筛查:试点筛查计划的结果。
IF 2.8
Open Heart Pub Date : 2024-05-09 DOI: 10.1136/openhrt-2023-002563
Aileen Callanan, Diarmuid Quinlan, Patricia M Kearney, Susanne O'Sullivan, Gerald Tan Ying Zhi, Alyssa Crichton, Mackenzie Wynn Howell, Colin Bradley, Claire Buckley
{"title":"Opportunistic atrial fibrillation screening in primary care in Ireland: results of a pilot screening programme.","authors":"Aileen Callanan, Diarmuid Quinlan, Patricia M Kearney, Susanne O'Sullivan, Gerald Tan Ying Zhi, Alyssa Crichton, Mackenzie Wynn Howell, Colin Bradley, Claire Buckley","doi":"10.1136/openhrt-2023-002563","DOIUrl":"10.1136/openhrt-2023-002563","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF), a common, frequently asymptomatic cardiac arrhythmia, is a major risk factor for stroke. Identification of AF enables effective preventive treatment to be offered, potentially reducing stroke risk by up to two-thirds. There is international consensus that opportunistic AF screening is valuable though uncertainty remains about the optimum screening location and method. Primary care has been identified as a potential location for AF screening using one-lead ECG devices.</p><p><strong>Methods: </strong>A pilot AF screening programme is in primary care in the south of Ireland. General practitioners (GPs) were recruited from Cork and Kerry. GPs invited patients ≥65 years to undergo AF screening. The screening comprised a one-lead ECG device, Kardia Mobile, blood pressure check and ascertainment of smoking status. Possible AF on one-lead ECG was confirmed with a 12-lead ECG. GPs also recorded information including medical history, current medication and onward referral. The Keele Decision Support tool was used to assess patients for oral anticoagulation (OAC).</p><p><strong>Results: </strong>3555 eligible patients, attending 52 GPs across 34 GP practices, agreed to undergo screening. 1720 (48%) were female, 1780 (50%) were hypertensive and 285 (8%) were current smokers. On the one-lead ECG, 3282 (92%) were in normal sinus rhythm, 101 (3%) had possible AF and among 124 (4%) the one-lead ECG was unreadable or unclassified. Of the 101 patients with possible AF, 45 (45%) had AF confirmed with 12-lead ECG, an incidence rate of AF of 1.3%. Among the 45 confirmed AF cases, 27 (60%) were commenced on OAC therapy by their GP.</p><p><strong>Conclusion: </strong>These findings suggest that AF screening in primary care may prove useful for early detection of AF cases that can be assessed for treatment. One-lead ECG devices may be useful in the detection of paroxysmal AF in this population and setting. Current OAC of AF may be suboptimal.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 1","pages":""},"PeriodicalIF":2.8,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086480/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899255","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
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
Open Heart 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
{"title":"Effects of trimetazidine on heart failure with reduced ejection fraction and associated clinical outcomes: a systematic review and meta-analysis.","authors":"Soufiane Nassiri, Arno A Van de Bovenkamp, Sharon Remmelzwaal, Olimpia Sorea, Frances de Man, M Louis Handoko","doi":"10.1136/openhrt-2023-002579","DOIUrl":"10.1136/openhrt-2023-002579","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086535/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140891598","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
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
Open Heart 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
{"title":"Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke.","authors":"Sanket S Dhruva, Jaime Murillo, Omid Ameli, Christine E Chaisson, Rita F Redberg, Ken Cohen","doi":"10.1136/openhrt-2024-002714","DOIUrl":"10.1136/openhrt-2024-002714","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"11 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140891593","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
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
Open Heart Pub Date : 2024-05-01 DOI: 10.1136/openhrt-2024-002710
Mads Ørbæk Andersen, Soren Zoga Diederichsen, Jesper Hastrup Svendsen, Jørn Carlsen
{"title":"Continuous heart monitoring to evaluate treatment effects in pulmonary hypertension","authors":"Mads Ørbæk Andersen, Soren Zoga Diederichsen, Jesper Hastrup Svendsen, Jørn Carlsen","doi":"10.1136/openhrt-2024-002710","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002710","url":null,"abstract":"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.","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"24 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140889964","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
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
Open Heart 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
{"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
Open Heart 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
{"title":"Review of codelists used to define hypertension in electronic health records and development of a codelist for research","authors":"Georgie May Massen, Philip W Stone, Harley H Y Kwok, Gisli Jenkins, Richard J Allen, Louise V Wain, Iain Stewart, Jennifer Kathleen Quint","doi":"10.1136/openhrt-2024-002640","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002640","url":null,"abstract":"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.","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"45 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140580307","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
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
Open Heart 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
{"title":"Outcomes of subsequent pregnancy in women with peripartum cardiomyopathy: a systematic review and meta-analysis","authors":"Matthew Aldo Wijayanto, Risalina Myrtha, Graciella Angelica Lukas, Annisa Aghnia Rahma, Shafira Nur Hanifa, Hadiqa Almas Zahira, Muhana Fawwazy Ilyas","doi":"10.1136/openhrt-2024-002626","DOIUrl":"https://doi.org/10.1136/openhrt-2024-002626","url":null,"abstract":"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.","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"85 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140580385","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
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
Open Heart 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
{"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
Open Heart Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2023-002581
Aaron Duncan, Frances Shiely
{"title":"Analysis of core outcome set reporting in coronary intervention trials","authors":"Aaron Duncan, Frances Shiely","doi":"10.1136/openhrt-2023-002581","DOIUrl":"https://doi.org/10.1136/openhrt-2023-002581","url":null,"abstract":"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.","PeriodicalId":19505,"journal":{"name":"Open Heart","volume":"57 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140833192","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
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
Open Heart Pub Date : 2024-04-01 DOI: 10.1136/openhrt-2024-002659
Anastasia Shchendrygina, Clara Saldarriaga
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