Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Freiburgstrasse, CH-3010 Bern, Switzerland.
Département de Cardiologie, Hospital La Cavale Blanche, La Cavale Blanche Hospital Boulevard Tanguy Prigent, 29200 Brest, France.
Eur Heart J. 2024 Apr 1;45(13):1104-1115. doi: 10.1093/eurheartj/ehae069.
Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care.
欧洲开展的研究推动了心血管医疗器械的创新。这包括但不限于经皮冠状动脉介入治疗、心脏成像、经导管心脏瓣膜植入以及心律失常和心力衰竭的器械治疗。未来医学进步的一个重要部分涉及医疗技术的发展以及人工智能和机器学习的持续发展。需要营造有利于医疗技术发展和验证的环境,以便欧洲能够继续在器械创新方面发挥重要作用,同时保持高标准的安全性。本文总结了欧洲心脏病学会心血管圆桌会议(一个进行高级别对话、讨论与欧洲心血管健康未来相关问题的战略论坛)就心血管医学器械创新主题的观点。医疗器械在其整个生命周期中通过迭代过程进行开发和改进。早期可行性研究证明了概念的可行性,并有助于优化器械设计。如果成功,理想情况下,应随后进行比较新型器械与现有标准治疗方法的随机临床试验,并通过登记处收集上市后真实世界证据。不幸的是,欧洲尚未为各种器械类别实施可行性研究的标准化程序。心血管成像可用于诊断和对患者进行分类,以改善介入治疗的效果,并在器械植入后长期进行监测。随机临床试验通常使用基于心脏成像的纳入标准,而较少使用随机分组来比较不同模式的诊断或预后价值。使用机器学习的应用越来越重要,但欧洲和美国仍在制定特定的监管标准和途径。还需要为支持器械驱动生物监测的智能设备和数字技术制定标准。欧盟引入的器械监管变化旨在提高临床证据、透明度和安全性,但可能会影响创新、可及性和可用性的速度。包括探讨未满足的需求和研究设计建议的器械开发计划必须由医生、试验人员、患者、监管机构、支付方和行业共同推动,以确保患者能够获得创新治疗。
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