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Summary and Comparison of the 2022 ACC/AHA/HFSA and 2021 ESC Heart Failure Guidelines. 2022 ACC/AHA/HFSA和2021 ESC心力衰竭指南的总结和比较
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-08-31 DOI: 10.1007/s40119-023-00328-3
Sarah Badger, James McVeigh, Praveen Indraratna

The guidelines released by the American College of Cardiology/American Heart Association/Heart Failure Society of America (ACC/AHA/HFSA) in 2022 and those released in 2021 by the European Society of Cardiology (ESC) play a crucial role in offering evidence-based recommendations for the diagnosis and management of heart failure (HF). This comprehensive review aims to provide an overview of these guidelines, incorporating insights from relevant clinical trials. While there is considerable alignment between the two sets of guidelines, certain notable differences arise due to variations in publication timelines, which we will outline. By presenting this summary, our objective is to empower clinicians to make informed decisions regarding HF management in their own practice, and facilitate the development of more harmonized guidelines in the future.

美国心脏病学会/美国心脏协会/美国心力衰竭学会(ACC/AHA/HFSA)于2022年发布的指南和欧洲心脏病学会(ESC)于2021年发布的指南在为心力衰竭(HF)的诊断和管理提供循证建议方面发挥着至关重要的作用。这篇全面的综述旨在提供这些指南的概述,并结合相关临床试验的见解。虽然两套指南之间有相当大的一致性,但由于出版时间表的变化,会产生某些显着差异,我们将概述这些差异。通过提出这一总结,我们的目标是使临床医生能够在自己的实践中做出关于心衰管理的明智决策,并促进未来更协调的指南的发展。
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引用次数: 0
Cardiovascular Compatibility of Proton Pump Inhibitors: Practice Recommendations. 质子泵抑制剂的心血管相容性:实践建议。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-11-10 DOI: 10.1007/s40119-023-00338-1
Jamshed Dalal, Anjan Lal Dutta, Jagdish Hiremath, Shamanna Seshadri Iyengar, Jagadish Chander Mohan, Abraham Ooman, Bhabadev Goswami, Kotacherry Thrivikrama Shenoy

This manuscript aims to critically evaluate the current evidence regarding adverse cardiovascular effects associated with proton pump inhibitors (PPIs) in patients with coronary artery disease (CAD). It also provides guidance for the selection of the most appropriate PPI within the context of cardiovascular polypharmacy and emphasizes the importance of establishing consensus among clinicians on the need to prescribe PPIs with limited cytochrome P450 (CYP450) enzyme inhibition to reduce the risk of drug interactions. PPIs are among the most widely used drugs for the treatment of gastroesophageal reflux disease (GERD) and the prevention of gastrointestinal (GI) bleeding. The manuscript reports the proceedings from the first practice recommendations meeting on the cardiovascular compatibility of PPIs in an Indian setting. A panel of eight Indian experts in cardiology and gastroenterology reviewed 14 consensus statements. Available literature was searched and summarized, and after multiple rounds of review, consensus was achieved for these statements. Based on the available evidence, the consensus panel highlights that a PPI with minimal drug-drug interaction (DDI) is recommended, especially in patients requiring clopidogrel or polypharmacy. Rabeprazole appears to be a good option in cases where co-prescription is indicated, owing to its optimal acid suppression and minimal drug interaction profile.

本文旨在批判性地评估目前有关质子泵抑制剂(PPIs)对冠状动脉疾病(CAD)患者心血管不良影响的证据。它还为在心血管多药治疗的背景下选择最合适的PPI提供了指导,并强调了临床医生之间建立共识的重要性,即需要开出具有有限细胞色素P450(CYP450)酶抑制的PPI,以降低药物相互作用的风险。PPIs是治疗胃食管反流病(GERD)和预防胃肠道出血最广泛使用的药物之一。该手稿报告了首次印度PPIs心血管兼容性实践建议会议的进展情况。一个由八名印度心脏病学和胃肠病专家组成的小组审查了14项共识声明。对现有文献进行了检索和总结,经过多轮审查,对这些陈述达成了共识。根据现有证据,共识小组强调,建议使用具有最小药物相互作用(DDI)的PPI,尤其是在需要氯吡格雷或多药治疗的患者中。雷贝拉唑在需要联合处方的情况下似乎是一个很好的选择,因为它具有最佳的抑酸作用和最小的药物相互作用。
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引用次数: 0
Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study. Idarucizumab用于紧急逆转Dabigatran的抗凝作用:日本上市后监测研究的最终结果。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-10-17 DOI: 10.1007/s40119-023-00333-6
Masahiro Yasaka, Hiroyuki Yokota, Michiyasu Suzuki, Hidesaku Asakura, Teiichi Yamane, Yukako Ogi, Takaaki Kimoto, Daisuke Nakayama

Introduction: Idarucizumab, a monoclonal antibody fragment that rapidly reverses the anticoagulant effects of dabigatran, was approved in Japan in September 2016, at which time an all-case, postmarketing surveillance (PMS) study was initiated to collect data on idarucizumab in Japanese patients. Interim results were published previously, and the final results are reported herein.

Methods: This multicenter, open-label, uncontrolled, non-interventional PMS study was conducted in Japanese patients who received idarucizumab at the approved dose (2 × 2.5 g/50 ml) and had uncontrolled bleeding (group A) or required an emergency procedure (group B). The primary endpoint was the frequency of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effects of dabigatran, within 4 h of idarucizumab administration, based on activated partial thromboplastin time (aPTT).

Results: The final analysis included 804 patients. ADRs during the idarucizumab treatment and post-treatment periods were reported in 17 of 542 patients (3.1%) in group A and 12 of 240 patients (5.0%) in group B. Thrombotic events were reported in 22 patients (4.1%) in group A and 15 patients (6.3%) in group B, and hypersensitivity occurred in four (0.7%) and five patients (2.1%), respectively. Among 793 patients evaluated for effectiveness, 78 in group A and 26 in group B had aPTT data at baseline (immediately before idarucizumab administration) and within 4 h of idarucizumab administration; in these patients, median maximum percentage reversal within 4 h of idarucizumab administration was 100%.

Conclusions: The final analysis from the PMS study confirms previous findings suggesting that idarucizumab can safely and effectively reverse the anticoagulant effects of dabigatran in Japanese patients in clinical practice. The results support the continued use of idarucizumab in Japan.

Trial registration: This study is registered with ClinicalTrials.gov (NCT02946931).

简介:伊达鲁西珠单抗是一种单克隆抗体片段,可快速逆转达比加群的抗凝作用,于2016年9月在日本获得批准,当时启动了一项全病例上市后监测(PMS)研究,以收集日本患者伊达鲁西珠单抗的数据。中期结果先前已公布,最终结果在此报告。方法:这项多中心、开放标签、非对照、非介入性PMS研究在接受批准剂量依达鲁珠单抗治疗的日本患者中进行(2 × 2.5g/50ml),并且出血失控(A组)或需要紧急手术(B组)。主要终点是药物不良反应(ADR)的发生频率。次要终点是在依达鲁珠单抗给药后4小时内,根据活化部分凝血活酶时间(aPTT),达比加群抗凝作用逆转的最大程度。结果:最终分析包括804例患者。A组542名患者中有17名(3.1%)和B组240名患者中的12名(5.0%)报告了依达鲁珠单抗治疗期间和治疗后的不良反应。A组22名(4.1%)和B区15名(6.3%)报告发生血栓事件,4名(0.7%)和5名(2.1%)分别发生超敏反应。在评估有效性的793名患者中,A组78名和B组26名患者在基线(伊达鲁珠单抗给药前)和给药后4小时内有aPTT数据;在这些患者中,给予依达鲁珠单抗后4小时内逆转的中位最大百分比为100%。结论:PMS研究的最终分析证实了先前的研究结果,即伊达鲁珠单抗在临床实践中可以安全有效地逆转达比加群对日本患者的抗凝作用。结果支持依达鲁珠单抗在日本的继续使用。试验注册:本研究注册于ClinicalTrials.gov(NCT02946931)。
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引用次数: 0
Left Atrial Appendage Closure: A Narrative Review. 左心房附件闭合术:叙述性回顾。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-11-08 DOI: 10.1007/s40119-023-00337-2
Takashi Nagasaka, Mamoo Nakamura

Atrial fibrillation (AF) is the most common cardiac arrhythmia and the cause of thromboembolic events in elderly patients worldwide. AF is associated with a significantly increased risk of morbidity and mortality due to cardiac emboli, primarily from left atrial appendage (LAA) thrombus. Oral anticoagulation therapy is the standard treatment to effectively reduce the risk of thromboembolic events in patients with AF. However, anticoagulation treatment increases bleeding risk. LAA closure (LAAC) has recently been introduced as a feasible mechanical preventive intervention for thromboembolic events while minimizing the risk of bleeding. Transcatheter LAAC devices have evolved in the past decade, and several ongoing trials have demonstrated the improvements of safety and outcomes in newer generation devices. This review summarizes the current perspectives and outcomes regarding LAAC as an alternative to pharmacologic therapy.

心房颤动(AF)是世界各地老年患者最常见的心律失常和血栓栓塞事件的原因。心房颤动与主要由左心耳血栓引起的心脏栓塞导致的发病率和死亡率显著增加有关。口服抗凝治疗是有效降低房颤患者血栓栓塞事件风险的标准治疗方法。然而,抗凝治疗会增加出血风险。LAA闭合术(LAAC)最近被引入,作为一种可行的机械预防性干预措施,用于治疗血栓栓塞事件,同时将出血风险降至最低。经导管LAAC设备在过去十年中不断发展,几项正在进行的试验已经证明了新一代设备的安全性和结果的改善。这篇综述总结了目前关于LAAC作为药物治疗替代方案的观点和结果。
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引用次数: 0
Application of Hydrogels in Cardiac Regeneration. 水凝胶在心脏再生中的应用。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-11-18 DOI: 10.1007/s40119-023-00339-0
Xuejing Yu

Myocardial infarction (MI) is a leading cause of death globally. Due to limited cardiac regeneration, infarcted myocardial tissue is gradually replaced by cardiac fibrosis, causing cardiac dysfunction, arrhythmia, aneurysm, free wall rupture, and sudden cardiac death. Thus, the development of effective methods to promote cardiac regeneration is extremely important for MI treatment. In recent years, hydrogels have shown promise in various methods for cardiac regeneration. Hydrogels can be divided into natural and synthetic types. Different hydrogels have different features and can be cross-linked in various ways. Hydrogels are low in toxicity and highly stable. Since they have good biocompatibility, biodegradability, and transformability, moderate mechanical properties, and proper elasticity, hydrogels are promising biomaterials for promoting cardiac regeneration. They can be used not only as scaffolds for migration of stem cells, but also as ideal carriers for delivery of drugs, genetic materials, stem cells, growth factors, cytokines, and small molecules. In this review, the application of hydrogels in cardiac regeneration during or post-MI is discussed in detail. Hydrogels open a promising new area in cardiac regeneration for treating MI.

心肌梗死(MI)是全球死亡的主要原因。由于心脏再生受限,梗死心肌组织逐渐被心肌纤维化所取代,导致心功能障碍、心律失常、动脉瘤、游离壁破裂、心源性猝死。因此,发展促进心脏再生的有效方法对于心肌梗死的治疗至关重要。近年来,水凝胶在心脏再生的各种方法中显示出前景。水凝胶可分为天然型和合成型。不同的水凝胶具有不同的特性,可以以不同的方式交联。水凝胶毒性低,稳定性高。水凝胶具有良好的生物相容性、生物可降解性和可转化性,力学性能适中,弹性适宜,是促进心脏再生的重要生物材料。它们不仅可以作为干细胞迁移的支架,而且可以作为输送药物、遗传物质、干细胞、生长因子、细胞因子、小分子等的理想载体。本文就水凝胶在心肌梗死期间及心肌梗死后心脏再生中的应用作一综述。水凝胶为心肌梗死的心脏再生开辟了广阔的前景。
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引用次数: 0
Evaluation of Incidence and Risk Factors of Sudden Cardiac Death in Patients with Chronic Coronary Syndrome Attending Physical Training. 参加体育锻炼的慢性冠状动脉综合征患者心源性猝死的发生率和危险因素评估。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-10-06 DOI: 10.1007/s40119-023-00331-8
Gergely Galos, Eszter Szabados, Miklos Rabai, Rita Szalai, Luca Anna Ferkai, Ildiko Papp, Kalman Toth, Barbara Sandor

Introduction: Regular physical activity is recommended to patients with chronic coronary syndrome (CCS). However, vigorous physical exercise occurs as a risk factor of sudden cardiac death (SCD). The effect of short-term and irregular exercise is controversial. The aim of this research is to assess the role of regular training in the incidence of SCD and to identify risk factors among patients with CCS participating in a long-term training program.

Methods: Data of risk factors, therapy, and participation were collected retrospectively for a 10-year period, assessing the length and regularity of participation. The incidence of SCD and related mortality was registered. ANOVA, χ2 test, and multinominal logistic regression and stepwise analysis were performed.

Results: The Incidence of chronic kidney disease (CKD) was higher (p < 0.01) and taking beta-blockers (BBs) was lower (p = 0.04) in the SCD group. Irregular training, lack of BBs, smoking, and CKD increased the risk of SCD, while female sex, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers (ACEI/ARBs), and BBs decreased the risk of SCD.

Conclusions: Taking ACEI/ARBs and BBs proved to be a protective factor, emphasizing the use of optimal medical therapy. Assessment of cardiac risk factors and control of comorbidities also proved to be important. The occurrence of SCD was connected to irregular physical activity, probably relating to the adverse effects of ad hoc exercising.

引言:建议慢性冠状动脉综合征(CCS)患者定期进行体育活动。然而,剧烈的体育锻炼是心脏性猝死(SCD)的一个危险因素。短期和不定期锻炼的效果是有争议的。本研究的目的是评估定期训练在SCD发生率中的作用,并确定参与长期训练计划的CCS患者的风险因素。方法:回顾性收集10年的危险因素、治疗和参与的数据,评估参与的时间和规律。记录SCD的发生率和相关死亡率。方差分析、χ2检验、多元逻辑回归和逐步分析。结果:慢性肾脏病(CKD)的发病率较高(p 结论:服用ACEI/ARBs和BBs被证明是一个保护因素,强调使用最佳的药物治疗。心脏危险因素的评估和合并症的控制也被证明是重要的。SCD的发生与不规律的体育活动有关,可能与临时锻炼的不良影响有关。
{"title":"Evaluation of Incidence and Risk Factors of Sudden Cardiac Death in Patients with Chronic Coronary Syndrome Attending Physical Training.","authors":"Gergely Galos, Eszter Szabados, Miklos Rabai, Rita Szalai, Luca Anna Ferkai, Ildiko Papp, Kalman Toth, Barbara Sandor","doi":"10.1007/s40119-023-00331-8","DOIUrl":"10.1007/s40119-023-00331-8","url":null,"abstract":"<p><strong>Introduction: </strong>Regular physical activity is recommended to patients with chronic coronary syndrome (CCS). However, vigorous physical exercise occurs as a risk factor of sudden cardiac death (SCD). The effect of short-term and irregular exercise is controversial. The aim of this research is to assess the role of regular training in the incidence of SCD and to identify risk factors among patients with CCS participating in a long-term training program.</p><p><strong>Methods: </strong>Data of risk factors, therapy, and participation were collected retrospectively for a 10-year period, assessing the length and regularity of participation. The incidence of SCD and related mortality was registered. ANOVA, χ<sup>2</sup> test, and multinominal logistic regression and stepwise analysis were performed.</p><p><strong>Results: </strong>The Incidence of chronic kidney disease (CKD) was higher (p < 0.01) and taking beta-blockers (BBs) was lower (p = 0.04) in the SCD group. Irregular training, lack of BBs, smoking, and CKD increased the risk of SCD, while female sex, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers (ACEI/ARBs), and BBs decreased the risk of SCD.</p><p><strong>Conclusions: </strong>Taking ACEI/ARBs and BBs proved to be a protective factor, emphasizing the use of optimal medical therapy. Assessment of cardiac risk factors and control of comorbidities also proved to be important. The occurrence of SCD was connected to irregular physical activity, probably relating to the adverse effects of ad hoc exercising.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10703744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41107516","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
Real-World Insights into Evolocumab Use in Patients with Hyperlipidemia Across Five Countries: Analysis from the ZERBINI Study. 五个国家高脂血症患者使用Evolocumab的真实世界见解:来自ZERBINI研究的分析。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-10-07 DOI: 10.1007/s40119-023-00334-5
Milan Gupta, Rajvi J Wani, Khalid Al Faraidy, Jean Bergeron, Eduardo Contreras, Angel Alberto Garcia Peña, G B John Mancini, Francisco Padilla, Abel Alberto Pavia Lopez, Kiran Philip, Johnny Wu, Erin S Mackinnon

Introduction: This study characterizes patients receiving evolocumab in clinical practice and assesses treatment effectiveness, safety and persistence outcomes across five countries.

Methods: This retrospective and prospective observational study enrolled patients initiated on evolocumab during August 2017 to July 2019 at 49 sites across Canada, Mexico, Colombia, Saudi Arabia and Kuwait. Medical records data were extracted within 6 months prior to (baseline) and every 3 months for 12 months post evolocumab initiation and reported as available.

Results: A total of 578 patients were enrolled (40.1% female, median age 60 [interquartile range (IQR) 51-68] years); 83.7% had atherosclerotic cardiovascular disease and/or familial hypercholesterolemia. Median low-density lipoprotein cholesterol (LDL-C) at baseline was 3.4 (IQR 2.7-4.2) mmol/L (131.5 [IQR 104.4-162.4] mg/dL), with 75.6% of patients receiving a statin (59.2% high intensity). Compared to baseline, the median lowest LDL-C was reduced by 70.2% and remained stable over 12 months of treatment. Guideline-recommended LDL-C thresholds < 1.8, < 1.4 and < 1.0 mmol/L (< 70, < 55 and < 40 mg/dL) were achieved by 75.3%, 63.6% and 47.4% of patients. LDL-C outcomes were consistent across high- and very high-risk patients. Background lipid-lowering therapy remained relatively stable. No serious treatment-emergent adverse events were reported, and persistence to evolocumab was 90.2% at 12 months.

Conclusion: These findings provide real-world evidence that evolocumab use is in accordance with its international guideline-recommended place in dyslipidemia therapy, as well as confirmation of its effectiveness and safety in a heterogeneous population. Evolocumab can address a healthcare gap in the management of dyslipidemia by increasing the proportion of patients achieving LDL-C goals recommended to lower cardiovascular risk.

引言:这项研究描述了在临床实践中接受埃沃洛单抗的患者,并评估了五个国家的治疗有效性、安全性和持久性结果。方法:这项回顾性和前瞻性观察性研究招募了2017年8月至2019年7月期间在加拿大、墨西哥、哥伦比亚、沙特阿拉伯和科威特的49个地点开始使用埃沃洛单抗的患者。医疗记录数据在(基线)前6个月内提取,在evolocomab启动后12个月内每3个月提取一次,并报告为可用。结果:共有578名患者入选(40.1%为女性,中位年龄60[四分位间距(IQR)51-68]岁);83.7%患有动脉粥样硬化性心血管疾病和/或家族性高胆固醇血症。基线时的中位低密度脂蛋白胆固醇(LDL-C)为3.4(IQR 2.7-4.2)mmol/L(131.5[IQR 104.4-162.4]mg/dL),75.6%的患者接受他汀类药物治疗(59.2%高强度)。与基线相比,中位最低LDL-C降低了70.2%,并在治疗的12个月内保持稳定。指南推荐的LDL-C阈值 结论:这些发现提供了现实世界的证据,证明埃沃洛单抗的使用符合其国际指南在血脂异常治疗中的推荐位置,并证实了其在异质人群中的有效性和安全性。Evolocumab可以通过增加实现LDL-C目标的患者比例来解决血脂异常管理方面的医疗差距,以降低心血管风险。
{"title":"Real-World Insights into Evolocumab Use in Patients with Hyperlipidemia Across Five Countries: Analysis from the ZERBINI Study.","authors":"Milan Gupta, Rajvi J Wani, Khalid Al Faraidy, Jean Bergeron, Eduardo Contreras, Angel Alberto Garcia Peña, G B John Mancini, Francisco Padilla, Abel Alberto Pavia Lopez, Kiran Philip, Johnny Wu, Erin S Mackinnon","doi":"10.1007/s40119-023-00334-5","DOIUrl":"10.1007/s40119-023-00334-5","url":null,"abstract":"<p><strong>Introduction: </strong>This study characterizes patients receiving evolocumab in clinical practice and assesses treatment effectiveness, safety and persistence outcomes across five countries.</p><p><strong>Methods: </strong>This retrospective and prospective observational study enrolled patients initiated on evolocumab during August 2017 to July 2019 at 49 sites across Canada, Mexico, Colombia, Saudi Arabia and Kuwait. Medical records data were extracted within 6 months prior to (baseline) and every 3 months for 12 months post evolocumab initiation and reported as available.</p><p><strong>Results: </strong>A total of 578 patients were enrolled (40.1% female, median age 60 [interquartile range (IQR) 51-68] years); 83.7% had atherosclerotic cardiovascular disease and/or familial hypercholesterolemia. Median low-density lipoprotein cholesterol (LDL-C) at baseline was 3.4 (IQR 2.7-4.2) mmol/L (131.5 [IQR 104.4-162.4] mg/dL), with 75.6% of patients receiving a statin (59.2% high intensity). Compared to baseline, the median lowest LDL-C was reduced by 70.2% and remained stable over 12 months of treatment. Guideline-recommended LDL-C thresholds < 1.8, < 1.4 and < 1.0 mmol/L (< 70, < 55 and < 40 mg/dL) were achieved by 75.3%, 63.6% and 47.4% of patients. LDL-C outcomes were consistent across high- and very high-risk patients. Background lipid-lowering therapy remained relatively stable. No serious treatment-emergent adverse events were reported, and persistence to evolocumab was 90.2% at 12 months.</p><p><strong>Conclusion: </strong>These findings provide real-world evidence that evolocumab use is in accordance with its international guideline-recommended place in dyslipidemia therapy, as well as confirmation of its effectiveness and safety in a heterogeneous population. Evolocumab can address a healthcare gap in the management of dyslipidemia by increasing the proportion of patients achieving LDL-C goals recommended to lower cardiovascular risk.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10704010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41105472","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
Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial. 自制鼻内注射依他阿米治疗症状性阵发性室上性心动过速播客:RAPID试验。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-11-10 DOI: 10.1007/s40119-023-00335-4
Bruce S Stambler, James E Ip

Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etripamil is an investigational self-administered intranasal L-type CCB for unsupervised treatment of PSVT. In this podcast, we discuss the RAPID trial (NCT03464019), which was a phase 3 study that evaluated the safety and efficacy of etripamil in terminating PSVT episodes using a repeat-dosing regimen. RAPID was a multicenter, randomized trial that enrolled adults with electrocardiograph (ECG)-documented PSVT episodes lasting ≥ 20 min. Patients who tolerated test doses of etripamil were randomized 1:1 to receive either etripamil or placebo. Upon perceiving PSVT symptoms, patients began ECG monitoring and performed a vagal maneuver. If arrhythmia termination was unsuccessful, they self-administered 70 mg of etripamil or placebo, followed by an optional second dose after 10 min. The primary endpoint was time to conversion of PSVT to sinus rhythm within 30 min of the initial dose and sustained for ≥ 30 s. The safety group included all patients who self-administered the study treatment. Of 692 enrollees, 184 self-administered the study drug (99 etripamil, 85 placebo) for ECG-confirmed PSVT. Conversion of PSVT to sinus rhythm within 30 min was achieved in 64.3% of etripamil-treated subjects versus 31.2% of placebo-treated subjects. A significant threefold reduction in the median time to conversion of 17.2 min was observed in the etripamil group versus 53.5 min in the placebo group. Treatment-emergent adverse events were mild or moderate and primarily included transient nasal discomfort, nasal congestion, and rhinorrhea. If etripamil is approved by the US FDA, it can potentially address a significant unmet need for PSVT treatment outside a clinical setting, reducing the need for intravenous treatments that require medical supervision.Podcast available for this article.

阵发性室上性心动过速(PSVT)在临床实践中常见,对医疗系统和患者来说是一个重大负担。一线治疗包括钙通道阻滞剂(CCB),尽管它们是静脉注射的,需要医疗监督。依他阿米是一种用于无监督PSVT治疗的研究性自行给药的L型鼻内CCB。在本播客中,我们讨论了RAPID试验(NCT03464019),这是一项3期研究,评估了异搏定使用重复给药方案终止PSVT发作的安全性和有效性。RAPID是一项多中心随机试验,纳入了心电图(ECG)记录的持续PSVT发作的成年人 ≥ 20分钟。耐受试验剂量异搏定的患者被1:1随机分配接受异搏定或安慰剂。在发现PSVT症状后,患者开始心电图监测并进行迷走神经活动。如果心律失常终止不成功,他们自行给药70 mg异搏定或安慰剂,10分钟后任选第二次给药。主要终点是PSVT在初始剂量后30分钟内转变为窦性心律的时间,并持续 ≥ 30秒。安全组包括所有自行接受研究治疗的患者。在692名入选者中,184人自行服用研究药物(99 etripamil,85安慰剂)治疗心电图证实的PSVT。在接受异搏定治疗的受试者中,64.3%的人在30分钟内将PSVT转换为窦性心律,而接受安慰剂治疗的受受试者为31.2%。与安慰剂组的53.5分钟相比,异搏定组的中位转化时间显著缩短了三倍,为17.2分钟。治疗后出现的不良事件为轻度或中度,主要包括短暂的鼻腔不适、鼻塞和鼻漏。如果etripamil获得美国食品药品监督管理局的批准,它可能会解决临床环境之外对PSVT治疗的重大未满足需求,从而减少需要医疗监督的静脉注射治疗的需求。播客可用于本文。
{"title":"Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial.","authors":"Bruce S Stambler, James E Ip","doi":"10.1007/s40119-023-00335-4","DOIUrl":"10.1007/s40119-023-00335-4","url":null,"abstract":"<p><p>Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etripamil is an investigational self-administered intranasal L-type CCB for unsupervised treatment of PSVT. In this podcast, we discuss the RAPID trial (NCT03464019), which was a phase 3 study that evaluated the safety and efficacy of etripamil in terminating PSVT episodes using a repeat-dosing regimen. RAPID was a multicenter, randomized trial that enrolled adults with electrocardiograph (ECG)-documented PSVT episodes lasting ≥ 20 min. Patients who tolerated test doses of etripamil were randomized 1:1 to receive either etripamil or placebo. Upon perceiving PSVT symptoms, patients began ECG monitoring and performed a vagal maneuver. If arrhythmia termination was unsuccessful, they self-administered 70 mg of etripamil or placebo, followed by an optional second dose after 10 min. The primary endpoint was time to conversion of PSVT to sinus rhythm within 30 min of the initial dose and sustained for ≥ 30 s. The safety group included all patients who self-administered the study treatment. Of 692 enrollees, 184 self-administered the study drug (99 etripamil, 85 placebo) for ECG-confirmed PSVT. Conversion of PSVT to sinus rhythm within 30 min was achieved in 64.3% of etripamil-treated subjects versus 31.2% of placebo-treated subjects. A significant threefold reduction in the median time to conversion of 17.2 min was observed in the etripamil group versus 53.5 min in the placebo group. Treatment-emergent adverse events were mild or moderate and primarily included transient nasal discomfort, nasal congestion, and rhinorrhea. If etripamil is approved by the US FDA, it can potentially address a significant unmet need for PSVT treatment outside a clinical setting, reducing the need for intravenous treatments that require medical supervision.Podcast available for this article.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10703755/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72208468","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
Comparative Effectiveness of Various Radiofrequency Ablation Catheters in the Ablation of Typical Atrial Flutter. 不同射频消融导管在典型心房颤动消融中的疗效比较。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-10-20 DOI: 10.1007/s40119-023-00336-3
Asher Gorantla, Mahmoud Alsaiqali, Jonathan Francois, Shruthi Sivakumar, Leonell Freytes-Santiago, Ahmad Jallad, Adam S Budzikowski

Introduction: Although ablation of typical atrial flutter (AFL) can be easily achieved with radiofrequency energy (RF), no studies compare the effectiveness of different ablation catheters. Our study aimed to compare the efficacy of various types of ablation catheters in treating typical AFL.

Methods: We analyzed patients with AFL who underwent RF ablation by a single operator at our institution. Successful ablation was evidenced by a bidirectional conduction block (trans-isthmus conduction time ≥ 130 ms or double potentials ≥ 90 ms). Logistic regression was used to compare success rate and linear regression to compare lesion time.

Results: Out of 222 patients, only six did not meet the success criteria (2.7%). The catheters used were non-irrigated, large-tip, internally irrigated (Chili II Boston Scientific), and externally irrigated (non-force-sensing) catheters (Cool Path, Abbott). An externally irrigated force-sensing catheter (TactiCath, Abbott) was used with > 10 gm of force and (LPLD) setting (30 W- 45 °C- 60 s), and high-power short-duration (HPSD) setting (50 W- 43 °C - 12 s). No complications were encountered. The catheter type had no statistically significant association with ablation success. With the use of externally irrigated catheter with contract force-sensing and HPSD settings, statistically significantly shortening of lesion time was achieved 758.3 s, [CI - 1128.29, - 388.35 s] followed by LPLD by 419.0 s [CI - 808.49, - 29.47 s].

Conclusions: The typical atrial flutter radiofrequency ablation procedure had a high success rate, which was not influenced by the type of ablation catheter. Contact force ablation catheter and HPSD are associated with shorter total lesion time.

引言:尽管使用射频能量(RF)可以很容易地实现典型房扑(AFL)的消融,但没有研究比较不同消融导管的有效性。我们的研究旨在比较不同类型的消融导管治疗典型AFL的疗效。方法:我们分析了在我们机构由单一操作员进行射频消融的AFL患者。双向传导阻滞(经峡部传导时间 ≥ 130毫秒或双电位 ≥ 90ms)。Logistic回归用于比较成功率,线性回归用于比较病变时间。结果:在222名患者中,只有6名不符合成功标准(2.7%)。使用的导管为非灌注、大尖端、内部灌注(Chili II Boston Scientific)和外部灌注(非力敏)导管(Cool Path,Abbott)。使用外部冲洗的力感应导管(TactiCath,Abbott) > 10 gm的力和(LPLD)设置(30 W-45°C-60 s),以及高功率短持续时间(HPSD)设置(50 W-43°C-12 s)。未发现并发症。导管类型与消融成功率无统计学显著相关性。使用具有收缩力传感和HPSD设置的外部灌注导管,在统计学上显著缩短了病变时间758.3 s,[CI-1128.29,-388.35 s],随后LPLD缩短了419.0 s[CI-808.49,-29.47 s],其不受消融导管类型的影响。接触力消融导管和HPSD与较短的总损伤时间相关。
{"title":"Comparative Effectiveness of Various Radiofrequency Ablation Catheters in the Ablation of Typical Atrial Flutter.","authors":"Asher Gorantla, Mahmoud Alsaiqali, Jonathan Francois, Shruthi Sivakumar, Leonell Freytes-Santiago, Ahmad Jallad, Adam S Budzikowski","doi":"10.1007/s40119-023-00336-3","DOIUrl":"10.1007/s40119-023-00336-3","url":null,"abstract":"<p><strong>Introduction: </strong>Although ablation of typical atrial flutter (AFL) can be easily achieved with radiofrequency energy (RF), no studies compare the effectiveness of different ablation catheters. Our study aimed to compare the efficacy of various types of ablation catheters in treating typical AFL.</p><p><strong>Methods: </strong>We analyzed patients with AFL who underwent RF ablation by a single operator at our institution. Successful ablation was evidenced by a bidirectional conduction block (trans-isthmus conduction time ≥ 130 ms or double potentials ≥ 90 ms). Logistic regression was used to compare success rate and linear regression to compare lesion time.</p><p><strong>Results: </strong>Out of 222 patients, only six did not meet the success criteria (2.7%). The catheters used were non-irrigated, large-tip, internally irrigated (Chili II Boston Scientific), and externally irrigated (non-force-sensing) catheters (Cool Path, Abbott). An externally irrigated force-sensing catheter (TactiCath, Abbott) was used with > 10 gm of force and (LPLD) setting (30 W- 45 °C- 60 s), and high-power short-duration (HPSD) setting (50 W- 43 °C - 12 s). No complications were encountered. The catheter type had no statistically significant association with ablation success. With the use of externally irrigated catheter with contract force-sensing and HPSD settings, statistically significantly shortening of lesion time was achieved 758.3 s, [CI - 1128.29, - 388.35 s] followed by LPLD by 419.0 s [CI - 808.49, - 29.47 s].</p><p><strong>Conclusions: </strong>The typical atrial flutter radiofrequency ablation procedure had a high success rate, which was not influenced by the type of ablation catheter. Contact force ablation catheter and HPSD are associated with shorter total lesion time.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10703754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49674643","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
Contemporary Use of Coronary Physiology in Cardiology. 冠状动脉生理学在心脏病学中的当代应用。
IF 3.4 Q2 Medicine Pub Date : 2023-12-01 Epub Date: 2023-09-05 DOI: 10.1007/s40119-023-00329-2
Ayman Elbadawi, Ramy Sedhom, Mohamed Ghoweba, Abdelazeem Mohamed Etewa, Waleed Kayani, Faisal Rahman

Coronary angiography has a limited ability to predict the functional significance of intermediate coronary lesions. Hence, physiological assessment of coronary lesions, via fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR), has been introduced to determine their functional significance. An accumulating body of evidence has consolidated the role of physiology-guided revascularization, particularly among patients with stable ischemic heart disease. The use of FFR or iFR to guide decision-making in patients with stable ischemic heart disease and intermediate coronary lesions received a class I recommendation from major societal guidelines. Nevertheless, the role of coronary physiology testing is less clear among certain patients' groups, including patients with serial coronary lesions, acute coronary syndromes, aortic stenosis, heart failure, as well as post-percutaneous coronary interventions. In this review, we aimed to discuss the utility and clinical evidence of coronary physiology (mainly FFR and iFR), with emphasis on those specific patient groups.

冠状动脉造影在预测中度冠状动脉病变的功能意义方面能力有限。因此,通过分数血流储备(FFR)或瞬时无波比(iFR)对冠状动脉病变进行生理评估,以确定其功能意义。越来越多的证据证实了生理引导的血运重建术的作用,特别是在稳定性缺血性心脏病患者中。在稳定性缺血性心脏病和中度冠状动脉病变患者中,使用FFR或iFR来指导决策获得了主要社会指南的I级推荐。然而,冠状动脉生理测试在某些患者群体中的作用尚不清楚,包括一系列冠状动脉病变、急性冠状动脉综合征、主动脉狭窄、心力衰竭以及经皮冠状动脉介入治疗后的患者。在这篇综述中,我们的目的是讨论冠状动脉生理学(主要是FFR和iFR)的应用和临床证据,重点是那些特定的患者群体。
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Cardiology and Therapy
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