Veneziano Sara, Trippoli Sabrina, Messori Andrea, Calderone Vincenzo, Piragine Eugenia
Department of Pharmacy, University of Pisa, 56126 Pisa, Italy.
HTA Unit, Centro Operativo, Regione Toscana, 50136 Firenze, Italy.
Rev Cardiovasc Med. 2025 Aug 15;26(8):39915. doi: 10.31083/RCM39915. eCollection 2025 Aug.
Medical devices for tricuspid regurgitation have emerged as viable treatment options for patients who do not respond to drug therapy or who are unsuitable for open-heart surgery due to high surgical risk. Recently, numerous new medical devices have been proposed and approved for use. Therefore, comprehensive reviews of the literature on the current medical devices for tricuspid regurgitation are necessary. This paper subsequently describes all medical devices used for transcatheter tricuspid valve interventions, providing an updated overview of the current options for managing tricuspid regurgitation, a common valvular heart disease associated with changes in the configuration and function of the tricuspid valve. Over 70 million people worldwide suffer from tricuspid regurgitation, with an estimated mortality rate of 0.51 deaths per 10,000 person-years. However, delays in diagnosis and treatment frequently contribute to disease progression. Meanwhile, the growing health and economic burden of tricuspid regurgitation has led to the urgent need for new therapeutic strategies to overcome the limitations of pharmacological and surgical approaches. In this scenario, transcatheter tricuspid valve interventions represent a promising option for patients with severe tricuspid regurgitation, considered inoperable due to excessive surgical risk. Medical devices designed for these innovative approaches are classified into two main groups: transcatheter tricuspid valve repair and replacement systems. This review presents the technological characteristics of medical devices and the results of studies on their clinical efficacy and safety, thereby supporting the use of transcatheter tricuspid valve repair/replacement systems in clinical practice.
对于那些对药物治疗无反应或因手术风险高而不适合进行心脏直视手术的患者,用于治疗三尖瓣反流的医疗设备已成为可行的治疗选择。最近,许多新的医疗设备已被提出并批准使用。因此,有必要对当前用于三尖瓣反流的医疗设备的文献进行全面综述。本文随后描述了所有用于经导管三尖瓣介入治疗的医疗设备,提供了当前治疗三尖瓣反流(一种与三尖瓣结构和功能变化相关的常见瓣膜性心脏病)的最新选择概述。全球超过7000万人患有三尖瓣反流,估计死亡率为每10000人年0.51例死亡。然而,诊断和治疗的延迟常常导致疾病进展。与此同时,三尖瓣反流日益增加的健康和经济负担导致迫切需要新的治疗策略来克服药物和手术方法的局限性。在这种情况下,经导管三尖瓣介入治疗对于因手术风险过高而被认为无法手术的严重三尖瓣反流患者来说是一个有前景的选择。为这些创新方法设计的医疗设备主要分为两类:经导管三尖瓣修复和置换系统。本综述介绍了医疗设备的技术特点以及关于其临床疗效和安全性的研究结果,从而支持在临床实践中使用经导管三尖瓣修复/置换系统。