CardioMEMS心力衰竭系统治疗慢性心力衰竭-欧洲视角。

IF 2.9 3区 医学 Q3 ENGINEERING, BIOMEDICAL Expert Review of Medical Devices Pub Date : 2023-05-01 DOI:10.1080/17434440.2023.2196400
Sumant P Radhoe, Pascal R D Clephas, Hamraz Mokri, Jasper J Brugts
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引用次数: 0

摘要

慢性心力衰竭(HF)的特点是住院率高。CardioMEMSTM心衰系统是一种肺动脉压力传感器,用于远程血流动力学监测,以减少心衰住院。该设备已获得FDA批准和CE认证,但CardioMEMS系统的临床证据主要基于美国的研究。由于美国和欧洲在心衰治疗方面的结构性差异,在常规心衰治疗和当代治疗的基础上,研究CardioMEMS在欧洲的疗效是很重要的。欧洲已经进行了几项观察性研究,但对随机临床试验的需求尚未得到满足。涵盖领域:本综述主要关注CardioMEMS远程血流动力学监测在欧洲HF设置中的安全性和有效性数据,并讨论了重要的即将开展的研究。专家意见:安全性方面,欧洲研究数据与美国研究数据一致。减少心衰住院的疗效似乎很有希望,但这仅仅是基于比较植入前后事件发生率的观察性研究。首个欧洲随机临床试验(MONITOR HF)将提供与当代心衰治疗的高质量医疗保健系统中实际标准治疗相比的疗效数据,并将为其他欧洲国家提供重要的可推广信息。
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The CardioMEMS Heart Failure System for chronic heart failure - a European perspective.

Introduction: Chronic heart failure (HF) is characterized by high hospital admission rates. The CardioMEMSTM HF System is a pulmonary artery pressure sensor developed for remote hemodynamic monitoring to reduce HF hospitalizations. The device is FDA approved and CE marked, but clinical evidence for the CardioMEMS system is mainly based upon U.S. studies. Because of structural differences in HF care between the U.S. and Europe, it is important to study CardioMEMS efficacy in European setting on top of usual HF care and contemporary therapy. Several observational studies have been performed in Europe, but there is an unmet need for randomized clinical trials.

Areas covered: This review focuses on safety and efficacy data for CardioMEMS remote hemodynamic monitoring in European HF setting, and discusses important upcoming studies.

Expert opinion: For safety, data from European studies are in line with U.S. studies. Efficacy with regard to reduction of HF hospitalizations seems promising, but is merely based upon observational studies comparing pre- and post-implantation event rates. The first European randomized clinical trial (MONITOR HF) will provide efficacy data compared to actual standard care in a high-quality healthcare system with contemporary HF treatment and will provide important generalizable information to other European countries.

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来源期刊
Expert Review of Medical Devices
Expert Review of Medical Devices 医学-工程:生物医学
CiteScore
5.90
自引率
3.20%
发文量
69
审稿时长
6-12 weeks
期刊介绍: The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.
期刊最新文献
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