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Diagnosis of cardiac murmurs in children 儿童心脏杂音的诊断
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.105
P. Rao
Heart murmurs are frequently heard, and the murmurs are the usual cause for uncovering heart defects in pediatric patients. The murmurs are grouped into systolic murmurs, diastolic murmurs, and continuous murmurs. Cautious assessment of the murmur and associated abnormalities in physical examination are likely to produce correct diagnosis of the cause of the murmur. Sometimes it may be necessary to utilize noninvasive and invasive (rarely) investigations to achieve an accurate diagnosis. Nonetheless, such diagnostic studies may frequently be required for quantification, and before intervention either by transcatheter methods or by surgery.
心脏杂音是经常听到的,并且杂音通常是发现儿科患者心脏缺陷的原因。杂音分为收缩期杂音、舒张期杂音和持续性杂音。仔细评估杂音和体格检查中相关的异常可能会对杂音的病因做出正确的诊断。有时可能需要使用非侵入性和侵入性(很少)检查来获得准确的诊断。尽管如此,在经导管方法或手术干预之前,这种诊断研究可能经常需要量化。
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引用次数: 1
Daily atrial fibrillation issues: the view-point of a practicing surgeon 日常房颤问题:一个执业外科医生的观点
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.118
T. Bilfinger
Atrial Fibrillation (AF) is encountered daily by the cardiac surgeon. How to deal with a patient with pre existing AF who is on anticoagulation taking into account urgency, type of anticoagulation and procedure planned are some of the daily considerations encountered. When to start anticoagulation and other pharmacotherapy after the occurrence of post-op atrial fibrillation and the use of ablative therapies in view of bleeding and other complications are daily judgement calls made by surgeons. Whom to offer combined interventions are decisions the surgeon faces daily. While guidelines help in broad strokes, there is little help for individual situations which is due to structural problems and absence of universal definitions resulting in the lack of granular data needed for practical individualized daily decision making.
心脏外科医生每天都会遇到心房颤动(AF)。如何处理已经存在的房颤患者,并考虑到紧急情况,抗凝类型和程序计划是一些日常需要考虑的问题。术后房颤发生后何时开始抗凝等药物治疗,以及考虑到出血等并发症是否采用消融治疗是外科医生的日常判断。向谁提供联合干预是外科医生每天都要面对的决定。虽然指导方针有广泛的帮助,但由于结构性问题和缺乏普遍定义,导致缺乏实际个性化日常决策所需的细粒度数据,对个人情况几乎没有帮助。
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引用次数: 0
Management of chronic type B aortic dissection 慢性B型主动脉夹层的处理
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.125
J. Trahanas, O. Jarral, Chandler Long, G. Hughes, Frank W. Sellke
The standard of care first-line therapy for uncomplicated acute type B aortic dissection is medical therapy. As a result, many of these dissections progress to become chronic type B aortic dissections (CTBAD). In the following manuscript, we will outline the natural history of these lesions and review what constitutes a CTBAD by anatomy and chronology. We will also describe the long-term medical management and surveillance of these lesions, what constitutes high-risk features, and when intervention should be considered. Endovascular, open and hybrid management strategies, potential complications, and subsequently required surveillance will also be discussed. With proper medical management, surveillance, and intervention, CTBAD can be managed effectively and downstream morbidity minimized.
无并发症急性B型主动脉夹层的标准护理一线治疗是药物治疗。因此,许多此类夹层进展为慢性B型主动脉夹层(CTBAD)。在下面的手稿中,我们将概述这些病变的自然历史,并通过解剖学和年代学回顾什么构成CTBAD。我们还将描述这些病变的长期医疗管理和监测,哪些构成高风险特征,以及何时应考虑干预。血管内、开放和混合管理策略、潜在并发症以及随后需要的监测也将被讨论。通过适当的医疗管理、监测和干预,CTBAD可以得到有效管理,并将下游发病率降至最低。
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引用次数: 1
Disclosing the cardiomyopathic substrate within the heart muscles in amyloidosis by cardiac magnetic resonance: diagnostic and prognostic implications 通过心脏磁共振揭示淀粉样变性患者心肌内的心肌病底物:诊断和预后意义
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.81
S. Pica, M. Lombardi
The use of cardiac magnetic resonance (CMR) for accurate morphological assessment of cardiomyopathies is well described. CMR tissue characterization with late gadolinium enhancement and parametric mapping is highly promising in differentiating key etiologies of left ventricular hypertrophy, diagnosing cardiac involvement in systemic amyloidosis, detecting early disease, and tracking changes over time, as well as providing valuable prognostic information. This review focuses on the typical imaging findings in cardiac amyloidosis by CMR, highlighting its potentials with respect to traditional imaging techniques. Furthermore, the diagnostic and prognostic role of CMR parameters and the future perspectives related to the newest applications are addressed.
使用心脏磁共振(CMR)准确形态学评估心肌病是很好的描述。晚期钆增强的CMR组织特征和参数定位在鉴别左心室肥厚的关键病因、诊断系统性淀粉样变性的心脏受累、发现早期疾病、跟踪随时间的变化以及提供有价值的预后信息方面非常有希望。本文综述了CMR在心脏淀粉样变性中的典型影像学表现,并强调了其相对于传统成像技术的潜力。此外,还讨论了CMR参数的诊断和预后作用以及与最新应用相关的未来前景。
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引用次数: 0
Reduced myocardial perfusion is common among subjects with ischemia and no obstructive coronary artery disease and heart failure with preserved ejection fraction: a report from the WISE-CVD continuation study. 心肌灌注减少在心肌缺血、无阻塞性冠状动脉疾病和射血分数保留型心力衰竭患者中很常见:WISE-CVD 持续研究报告。
Pub Date : 2022-01-01 Epub Date: 2022-03-05 DOI: 10.20517/2574-1209.2021.103
Haider Aldiwani, Michael D Nelson, Behzad Sharif, Janet Wei, T Jake Samuel, Nissi Suppogu, Odayme Quesada, Galen Cook-Wiens, Edward Gill, Lidia S Szczepaniak, Louise E J Thomson, Balaji Tamarappoo, Anum Asif, Chrisandra Shufelt, Daniel Berman, C Noel Bairey Merz

Aim: Women with evidence of ischemia and no obstructive coronary artery disease (INOCA) have an increased risk of major adverse cardiac events, including heart failure with preserved ejection fraction (HFpEF). To investigate potential links between INOCA and HFpEF, we examined pathophysiological findings present in both INOCA and HFpEF.

Methods: We performed adenosine stress cardiac magnetic resonance imaging (CMRI) in 56 participants, including 35 women with suspected INOCA, 13 women with HFpEF, and 8 reference control women. Myocardial perfusion imaging was performed at rest and with vasodilator stress with intravenous adenosine. Myocardial perfusion reserve index was quantified as the ratio of the upslope of increase in myocardial contrast at stress vs. rest. All CMRI measures were quantified using CVI42 software (Circle Cardiovascular Imaging Inc). Statistical analysis was performed using linear regression models, Fisher's exact tests, ANOVA, or Kruskal-Wallis tests.

Results: Age (P = 0.007), Body surface area (0.05) were higher in the HFpEF group. Left ventricular ejection fraction (P = 0.02) was lower among the INOCA and HFpEF groups than reference controls after age adjustment. In addition, there was a graded reduction in myocardial perfusion reserve index in HFpEF vs. INOCA vs. reference controls (1.5 ± 0.3, 1.8 ± 0.3, 1.9 ± 0.3, P = 0.02), which was attenuated with age-adjustment.

Conclusion: Reduced myocardial perfusion reserve appears to be a common pathophysiologic feature in INOCA and HFpEF patients.

目的:有缺血迹象但无阻塞性冠状动脉疾病(INOCA)的女性发生重大心脏不良事件(包括射血分数保留型心力衰竭(HFpEF))的风险增加。为了研究 INOCA 和 HFpEF 之间的潜在联系,我们研究了 INOCA 和 HFpEF 的病理生理学发现:我们对 56 名参与者进行了腺苷负荷心脏磁共振成像(CMRI)检查,其中包括 35 名疑似 INOCA 患者、13 名 HFpEF 患者和 8 名参照对照组女性。心肌灌注成像在静息状态下和静脉注射腺苷进行血管扩张应激时进行。心肌灌注储备指数被量化为应激时心肌对比度上升与静息时心肌对比度上升的比值。所有 CMRI 测量均使用 CVI42 软件(Circle Cardiovascular Imaging Inc)进行量化。统计分析采用线性回归模型、费雪精确检验、方差分析或 Kruskal-Wallis 检验:结果:HFpEF 组的年龄(P = 0.007)、体表面积(0.05)更高。经年龄调整后,INOCA 组和 HFpEF 组的左心室射血分数(P = 0.02)低于参照对照组。此外,HFpEF组与INOCA组相比,心肌灌注储备指数呈分级下降趋势(1.5 ± 0.3、1.8 ± 0.3、1.9 ± 0.3,P = 0.02),经年龄调整后,下降趋势有所减弱:结论:心肌灌注储备减少似乎是 INOCA 和 HFpEF 患者的共同病理生理特征。
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引用次数: 0
Amiodarone and postoperative atrial fibrillation 胺碘酮与术后房颤的关系
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.115
Stephen D. Waterford, Lindsey M Prescher, Michal Ad, L. A. Santore, Cordell Spellman, N. Ad
New-onset postoperative atrial fibrillation (POAF) develops in 10%-50% of patients after cardiac surgery. In this review, we focus on risk factors associated with POAF and the different pharmacological strategies used for prophylaxis, with special attention to amiodarone. The use of amiodarone will be discussed both as a prophylactic regimen used before and following cardiac surgery, but also as a rhythm control treatment in patients who develop POAF. Finally, we conclude by reviewing gaps in the literature on amiodarone and further studies which could close these gaps.
10%-50%的心脏手术后患者会出现术后新发心房颤动(POAF)。在这篇综述中,我们关注与POAF相关的危险因素以及用于预防的不同药物策略,特别关注胺碘酮。胺碘酮的使用将在心脏手术前后作为预防方案进行讨论,但也可作为POAF患者的心律控制治疗。最后,我们回顾了文献中关于胺碘酮的空白,并进行了进一步的研究,以弥补这些空白。
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引用次数: 0
Improving future postoperative atrial fibrillation care: a 30,000-foot viewpoint 改善未来的术后房颤护理:3万英尺的观点
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.120
Daniel F Pardo, F. Grover, Jessica Y. Rove, A. Shroyer
Aim: In the United States (US), post-operative atrial fibrillation (POAF) is the most common complication following cardiac surgery. In order to understand the opportunities to improve POAF patients’ care, this “30,000 foot” review evaluated the professional society POAF database/registry definitions and guideline recommendations. Methods: All US-based professional society organizations with an interventional cardiac database/registry and/or cardiac care guidelines were identified; from these, the POAF database definitions and guideline recommendations were evaluated using a content analysis approach. Results: The Society of Thoracic Surgeons (STS) POAF definition was the most frequently referenced definition (21% of key references). Only 50% (n = 5/10) US cardiac surgery databases/registries included any POAF definition; compared to STS, the other five definitions required substantially more detailed documentation. Across eight guidelines, three different types of POAF recommendations were found: risk assessment (n = 3); prevention (n = 7); and management (n = 8). As a common feature, the risk assessment strategies tended to focus on advanced age (n = 6). Beta-blockers (n = 5) and amiodarone (n = 6) were common prevention approaches. Uniformly, anti-coagulation was the only management strategy (n = 8) recommended, barring any contraindications. Conclusion: Across ten professional societies, 50% had no POAF definition; of the remaining five, no POAF definitional consistency was found. Across the eight US-based professional society POAF-related guidelines, only anticoagulation was uniformly recommended. Given these “big picture” findings, professional societies are urged to work collaboratively to harmonize these divergent POAF definitions and consolidate their evidence-based guideline recommendations to improve future POAF patients’ quality of care.
目的:在美国,术后心房颤动(POAF)是心脏手术后最常见的并发症。为了了解改善POAF患者护理的机会,这篇“30,000英尺”的综述评估了专业协会POAF数据库/注册表的定义和指南建议。方法:确定所有具有介入性心脏数据库/登记和/或心脏护理指南的美国专业协会组织;根据这些,使用内容分析方法对POAF数据库定义和指南建议进行评估。结果:胸外科学会(Society of Thoracic Surgeons, STS) POAF定义是最常被引用的定义(占关键参考文献的21%)。只有50% (n = 5/10)的美国心脏外科数据库/登记处包括任何POAF定义;与STS相比,其他五个定义需要更详细的文件。在八项指南中,发现了三种不同类型的POAF建议:风险评估(n = 3);预防(n = 7);作为一个共同特征,风险评估策略倾向于关注高龄患者(n = 6), β受体阻滞剂(n = 5)和胺碘酮(n = 6)是常见的预防方法。除任何禁忌症外,抗凝治疗是唯一推荐的治疗策略(n = 8)。结论:在10个专业学会中,50%没有POAF定义;其余5个,没有发现POAF定义的一致性。在美国8个专业协会的poaf相关指南中,只有抗凝被统一推荐。鉴于这些“大图景”的发现,我们敦促专业协会合作协调这些不同的POAF定义,并巩固他们的循证指南建议,以提高未来POAF患者的护理质量。
{"title":"Improving future postoperative atrial fibrillation care: a 30,000-foot viewpoint","authors":"Daniel F Pardo, F. Grover, Jessica Y. Rove, A. Shroyer","doi":"10.20517/2574-1209.2021.120","DOIUrl":"https://doi.org/10.20517/2574-1209.2021.120","url":null,"abstract":"Aim: In the United States (US), post-operative atrial fibrillation (POAF) is the most common complication following cardiac surgery. In order to understand the opportunities to improve POAF patients’ care, this “30,000 foot” review evaluated the professional society POAF database/registry definitions and guideline recommendations. Methods: All US-based professional society organizations with an interventional cardiac database/registry and/or cardiac care guidelines were identified; from these, the POAF database definitions and guideline recommendations were evaluated using a content analysis approach. Results: The Society of Thoracic Surgeons (STS) POAF definition was the most frequently referenced definition (21% of key references). Only 50% (n = 5/10) US cardiac surgery databases/registries included any POAF definition; compared to STS, the other five definitions required substantially more detailed documentation. Across eight guidelines, three different types of POAF recommendations were found: risk assessment (n = 3); prevention (n = 7); and management (n = 8). As a common feature, the risk assessment strategies tended to focus on advanced age (n = 6). Beta-blockers (n = 5) and amiodarone (n = 6) were common prevention approaches. Uniformly, anti-coagulation was the only management strategy (n = 8) recommended, barring any contraindications. Conclusion: Across ten professional societies, 50% had no POAF definition; of the remaining five, no POAF definitional consistency was found. Across the eight US-based professional society POAF-related guidelines, only anticoagulation was uniformly recommended. Given these “big picture” findings, professional societies are urged to work collaboratively to harmonize these divergent POAF definitions and consolidate their evidence-based guideline recommendations to improve future POAF patients’ quality of care.","PeriodicalId":75299,"journal":{"name":"Vessel plus","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67654843","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: 1
Heart transplantation in cardiac amyloidosis 心脏淀粉样变性的心脏移植
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.126
C. Di Nora, S. Sponga, C. Nalli, M. Driussi, I. Vendramin, G. Benedetti, G. Guzzi, M. Imazio, U. Livi
It is known that the prognosis of patients affected by light-chain (AL) or transthyretin-related (TTR) amyloidosis is poor. TTR amyloidosis has usually shown a slower progression than AL amyloidosis, both hereditary TTR amyloidosis, where there is an inherited mutation in the DNA, and wild-type TTR amyloidosis, which usually affects the elderly. In this paper, the current literature about heart transplantation on cardiac amyloidosis patients is extensively reviewed. The two most frequent types of cardiac amyloidosis have been considered for heart transplantation: AL amyloidosis and wild-type TTR amyloidosis. According to this analysis, it is reasonable that heart transplantation may represent a valuable option in carefully selected patients. Moreover, it could improve prognosis, enabling autologous stem cell transplantation in the AL amyloidosis subgroup. In our humble opinion, it is mandatory to define a multidisciplinary approach to help select candidates to obtain the most effective results.
已知轻链(AL)或转甲状腺素相关(TTR)淀粉样变患者预后较差。TTR淀粉样变通常比AL淀粉样变进展缓慢,两者都是遗传性TTR淀粉样变(DNA遗传突变)和野生型TTR淀粉样变(通常影响老年人)。本文对目前有关淀粉样变性患者心脏移植的文献进行综述。两种最常见的心脏淀粉样变性被认为是心脏移植的淀粉样变性:AL淀粉样变性和野生型TTR淀粉样变性。根据这一分析,在精心挑选的患者中,心脏移植可能是一个有价值的选择是合理的。此外,它可以改善预后,使AL淀粉样变性亚组的自体干细胞移植成为可能。在我们的拙见中,必须定义一个多学科的方法来帮助选择候选人以获得最有效的结果。
{"title":"Heart transplantation in cardiac amyloidosis","authors":"C. Di Nora, S. Sponga, C. Nalli, M. Driussi, I. Vendramin, G. Benedetti, G. Guzzi, M. Imazio, U. Livi","doi":"10.20517/2574-1209.2021.126","DOIUrl":"https://doi.org/10.20517/2574-1209.2021.126","url":null,"abstract":"It is known that the prognosis of patients affected by light-chain (AL) or transthyretin-related (TTR) amyloidosis is poor. TTR amyloidosis has usually shown a slower progression than AL amyloidosis, both hereditary TTR amyloidosis, where there is an inherited mutation in the DNA, and wild-type TTR amyloidosis, which usually affects the elderly. In this paper, the current literature about heart transplantation on cardiac amyloidosis patients is extensively reviewed. The two most frequent types of cardiac amyloidosis have been considered for heart transplantation: AL amyloidosis and wild-type TTR amyloidosis. According to this analysis, it is reasonable that heart transplantation may represent a valuable option in carefully selected patients. Moreover, it could improve prognosis, enabling autologous stem cell transplantation in the AL amyloidosis subgroup. In our humble opinion, it is mandatory to define a multidisciplinary approach to help select candidates to obtain the most effective results.","PeriodicalId":75299,"journal":{"name":"Vessel plus","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67654959","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
Global variation in the incidence of new-onset postoperative atrial fibrillation after cardiac and non-cardiac surgery: a systematic review 心脏和非心脏手术后新发房颤发生率的全球变化:系统回顾
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.146
Daniel F Pardo, A. L. Shroyer, T. Bilfinger
Aim: In the US, postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery and a frequent complication after non-cardiac surgery, causing excess patient length of stay and costs. After a comprehensive review looking for validated statistically significant data sets, too few data, particularly from outside of the US and Europe, could be found to perform a conclusive analysis, but there is enough data for a well-informed, educated opinion. Methods: A systematic review analyzing 28 international and US studies of POAF hospital length of stay were identified; from this excess and % excess along with total patient length of stay were calculated, where excess patient length of stay is defined as the difference in post-operative stay between POAF and non-POAF patients in days. Geographic variabilities were calculated using chi-square analyses for US regions and international comparisons for a variety of surgical procedures with POAF. Results: Geographic variability analyses when corrected for total hospital stay showed a 325% longer excess patient length of stay (days) in the US vs. Europe (3.4 days vs. 0.8 days) for coronary artery bypass grafting (CABG). It also showed a 27.3% longer excess patient length of stay (days) in the US vs. Europe (4.2 days vs. 3.3 days) for lung resections. These were both statistically significant at P < 0.001. Conclusion: There appear to be substantial variations in POAF-related care practices worldwide. In all practice settings, POAF causes increased patient length of stay. Europeans appear to do better than the US in POAF patients’ length of stay for CABG but not for lung resections. POAF is a worldwide problem where international cooperation in research and development of best practice guidelines would be particularly fruitful.
目的:在美国,术后心房颤动(POAF)是心脏手术后最常见的并发症,也是非心脏手术后最常见的并发症,导致患者住院时间延长和费用增加。经过全面审查,寻找经过验证的统计显著数据集后,可以找到的数据太少,特别是来自美国和欧洲以外的数据,无法进行结论性分析,但有足够的数据可以形成一个知情的、受过教育的观点。方法:系统回顾分析28项国际和美国关于POAF住院时间的研究;从这一超额和%超额以及患者总住院时间进行计算,其中超额住院时间定义为POAF和非POAF患者术后住院天数的差异。使用卡方分析计算美国地区的地理变异,并对各种POAF手术进行国际比较。结果:对总住院时间进行校正后的地理变异性分析显示,美国冠状动脉旁路移植术(CABG)的多余患者住院时间(天)比欧洲(3.4天对0.8天)长325%。它还显示,在美国,肺切除术患者的额外住院时间(天)比欧洲(4.2天对3.3天)长27.3%。P < 0.001,均有统计学意义。结论:在世界范围内,与poaf相关的护理实践似乎存在实质性差异。在所有的实践设置中,POAF导致患者住院时间增加。在POAF患者CABG的住院时间方面,欧洲人似乎比美国人做得好,但在肺切除术方面则不然。POAF是一个世界性的问题,在研究和制定最佳做法准则方面的国际合作将特别富有成果。
{"title":"Global variation in the incidence of new-onset postoperative atrial fibrillation after cardiac and non-cardiac surgery: a systematic review","authors":"Daniel F Pardo, A. L. Shroyer, T. Bilfinger","doi":"10.20517/2574-1209.2021.146","DOIUrl":"https://doi.org/10.20517/2574-1209.2021.146","url":null,"abstract":"Aim: In the US, postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery and a frequent complication after non-cardiac surgery, causing excess patient length of stay and costs. After a comprehensive review looking for validated statistically significant data sets, too few data, particularly from outside of the US and Europe, could be found to perform a conclusive analysis, but there is enough data for a well-informed, educated opinion. Methods: A systematic review analyzing 28 international and US studies of POAF hospital length of stay were identified; from this excess and % excess along with total patient length of stay were calculated, where excess patient length of stay is defined as the difference in post-operative stay between POAF and non-POAF patients in days. Geographic variabilities were calculated using chi-square analyses for US regions and international comparisons for a variety of surgical procedures with POAF. Results: Geographic variability analyses when corrected for total hospital stay showed a 325% longer excess patient length of stay (days) in the US vs. Europe (3.4 days vs. 0.8 days) for coronary artery bypass grafting (CABG). It also showed a 27.3% longer excess patient length of stay (days) in the US vs. Europe (4.2 days vs. 3.3 days) for lung resections. These were both statistically significant at P < 0.001. Conclusion: There appear to be substantial variations in POAF-related care practices worldwide. In all practice settings, POAF causes increased patient length of stay. Europeans appear to do better than the US in POAF patients’ length of stay for CABG but not for lung resections. POAF is a worldwide problem where international cooperation in research and development of best practice guidelines would be particularly fruitful.","PeriodicalId":75299,"journal":{"name":"Vessel plus","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67655138","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: 1
Perspective on the development of a bioengineered patch to treat heart failure: rationale and proposed design of phase I clinical trial 生物工程贴片治疗心力衰竭的发展前景:I期临床试验的基本原理和建议设计
Pub Date : 2022-01-01 DOI: 10.20517/2574-1209.2021.149
S. Goldman, J. Traverse, M. Zile, E. Juneman, B. Greenberg, R. Kelly, Jennifer W. Koevary, J. Lancaster
This perspective focuses on the development of tissue engineered (TE) cell-based therapies to treat left ventricular (LV) dysfunction and chronic heart failure (CHF). The development of induced pluripotent stem cells enabled investigators to seed or co-culture human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) alone and in combination with other cells onto bioengineered scaffolds applied to the epicardial surface of the damaged left ventricle. Using our work as an example, we show how a xenograft implant of a bioengineered scaffold embedded with human neonatal fibroblasts and seeded with hiPSC-CMs partially reversed maladaptive LV remodeling and improved LV systolic/diastolic function in an immune-competent rat model of CHF. The fibroblasts lay down an extracellular matrix and secrete growth factors that increase myocardial blood flow. This approach provides an improved cell payload that covers a larger area of the damaged left ventricle as opposed to direct cell injections into the heart or down the coronary arteries. These studies combined with ongoing studies in immune-competent Yucatan mini swine treated with the same xenograft led to the preliminary design of a proposed Phase I clinical trial that will be presented to the Federal Drug Administration. For the proposed Phase I clinical, this TE patch will be implanted onto the epicardial surface of non-immunosuppressed patients undergoing elective Coronary Artery Bypass Grafting with Ejection Fractions ≥ 20% and ≤ 45%. The primary endpoints will be adverse events/severe adverse events associated with placing the TE patch on the heart. While Phase I trials are primarily safety trials, this proposed trial is designed to obtain some potential efficacy endpoints to help with the design of future Phase II/III clinical trials. These endpoints include changes in LV remodeling that were seen in the pre-clinical animal models as well as including endpoints that focus on patient well-being.
这一观点的重点是发展组织工程(TE)细胞为基础的治疗左心室(LV)功能障碍和慢性心力衰竭(CHF)的疗法。诱导多能干细胞的发展使研究人员能够将人类诱导多能干细胞来源的心肌细胞(hiPSC-CMs)单独或与其他细胞联合播种或共培养到生物工程支架上,并应用于受损左心室的心外膜表面。以我们的工作为例,我们展示了生物工程支架的异种移植物植入人新生儿成纤维细胞并植入hiPSC-CMs,如何在免疫能力强的CHF大鼠模型中部分逆转不适应的左室重塑并改善左室收缩/舒张功能。成纤维细胞形成细胞外基质并分泌生长因子,增加心肌血流量。与直接将细胞注入心脏或冠状动脉相比,这种方法提供了更好的细胞负荷,覆盖了受损左心室的更大区域。这些研究与正在进行的对具有免疫能力的尤卡坦迷你猪进行相同异种移植物治疗的研究相结合,导致了拟议的I期临床试验的初步设计,该试验将提交给联邦药物管理局。对于拟议的I期临床,该TE贴片将被植入非免疫抑制患者的心外膜表面,这些患者接受选择性冠状动脉旁路移植术,射血分数≥20%和≤45%。主要终点将是与将TE贴片放置在心脏上相关的不良事件/严重不良事件。虽然I期试验主要是安全性试验,但这项拟议的试验旨在获得一些潜在的疗效终点,以帮助设计未来的II/III期临床试验。这些终点包括在临床前动物模型中观察到的左室重塑的变化,以及关注患者福祉的终点。
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引用次数: 1
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