在医疗器械和手术试验中保留射血分数的心力衰竭的表型特征。

IF 3.7 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Kurdo Araz, Francesco Fioretti, Sara Ladak, Mohammed Obaidan, Javed Butler, Aamir Hameed
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引用次数: 0

摘要

目的:保留射血分数的心力衰竭(HFpEF)患病率接近所有心力衰竭病例的50%,通常与高龄、肥胖、心房颤动和高血压相关,医疗方法有限。本综述旨在确定治疗HFpEF的医疗器械或手术干预的潜力,并提出HFpEF的特定表型。方法和结果:采用各种临床试验数据库和系统评价和荟萃分析首选报告项目(PRISMA)指南进行系统评价,随后进行描述性分析和方法学质量评价。纳入标准包括有左心室射血分数(LVEF)≥50%和舒张功能不全症状的HFpEF患者的医疗器械或手术干预。我们确定了24项新颖的试验,涉及n = 1752名受试者:17医疗设备试验[3房分流设备试验(n = 1069), 1心房流量调节器(n = 41), 3迷走神经的神经刺激试验(n = 112), 1压力激活疗法试验(n = 21),心肌收缩性调制器1试验(n = 47), 6心脏再同步化治疗试验(n = 178)和2功能性电刺激治疗试验(n = 89)]和7外科干预试验(1)肾脏去神经试验(n = 25), 3大内脏神经消融试验(n = 111),2项导管消融试验(n = 55)和1项心包切开术试验(n = 4)。1项试验完成了3期试验,20项试验完成了1期试验,并进行了进一步的试验,5项试验完成了1期试验,但没有进行进一步的试验。结论:总的来说,24项试验中有16项至少证明了安全性和可行性。然而,尽管许多医疗设备或外科手术的试验证明了治疗HFpEF表型的概念,但它们没有提供足够的证据证明其长期益处。需要进行更强有力的基于表型的临床试验,以确保在HFpEF中开发基于证据的解决方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Phenotype characterization of heart failure with preserved ejection fraction in medical device and surgical trials.

Aims: Heart failure with preserved ejection fraction (HFpEF) prevalence is nearing 50% of all heart failure cases and is often associated with advanced age, obesity, atrial fibrillation and hypertension, and medical approaches are limited. This review aims to determine the potential of medical devices or surgical interventions in treating HFpEF and to propose specific phenotypes of HFpEF.

Methods and results: A systematic review was conducted using various clinical trial databases and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines followed by descriptive analysis and methodology quality assessment. Inclusion criteria included a medical device or surgical intervention involving HFpEF patients defined by a left ventricular ejection fraction (LVEF) ≥50% and signs of diastolic dysfunction. Twenty-four novel trials were identified involving n = 1752 participants: 17 medical device trials [3 interatrial shunt device trials (n = 1069), 1 atrial flow regulator trial (n = 41), 3 vagal nerve stimulation trials (n = 112), 1 baroreflex activation therapy trial (n = 21), 1 cardiac contractility modulator trial (n = 47), 6 cardiac resynchronization therapy trials (n = 178) and 2 functional electrical stimulation therapy trials (n = 89)] and 7 surgical intervention trials [1 renal denervation trial (n = 25), 3 greater splanchnic nerve ablation trials (n = 111), 2 catheter ablation trials (n = 55) and 1 pericardiotomy procedure trial (n = 4)]. One trial completed phase 3 trials, 20 trials completed phase 1 trials with further trials, and 5 trials completed phase 1 trials without further trials.

Conclusions: Overall, 16 out of 24 trials have at least demonstrated safety and feasibility. However, despite many trials of a medical device or surgical procedure showing proof of concept to treat HFpEF phenotypes, they do not provide sufficient evidence of long-term benefit. More robust and phenotype-based clinical trials are needed to ensure evidence-based solutions are developed in HFpEF.

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来源期刊
ESC Heart Failure
ESC Heart Failure Medicine-Cardiology and Cardiovascular Medicine
CiteScore
7.00
自引率
7.90%
发文量
461
审稿时长
12 weeks
期刊介绍: ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.
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