Department of Cardiology, University of Cologne Heart Center, Cologne, Germany.
Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019.
Severe aortic stenosis (AS) is one of the most common and most serious valve diseases. Without timely intervention with surgical aortic valve replacement or transcatheter aortic valve replacement, patients have an estimated survival of 2-3 years. Guidelines for the treatment of AS have been developed, but studies suggest that as many as 42% of patients with AS are not treated according to these recommendations.The aims of this registry are to delineate the caseload of patients with AS, outline the management of these patients and determine appropriateness of treatments in participating centres with and without onsite access to surgery and percutaneous treatments.
METHODS/DESIGN: The IMPULSE enhanced registry is an international, multicentre, prospective, observational cohort registry conducted at four central full access centres (tertiary care hospitals) and at least two satellite centres per hub (primary/secondary care hospitals). An estimated 800 patients will be enrolled in the registry and patient follow-up will last for 12 months.
In addition to the primary aims determining the caseload management and outcome of patients with AS in primary, secondary and tertiary care settings, the registry will also determine a time course for the transition from asymptomatic to symptomatic status and the diagnostic steps, treatment decisions and the identification of decision-makers in tertiary versus primary/secondary care hospitals. The last patient will be enrolled in the registry in 2018 and results of the registry are anticipated in 2019.
NCT03112629.
严重的主动脉瓣狭窄（AS）是最常见和最严重的瓣膜疾病之一。如果没有及时进行手术主动脉瓣置换或经导管主动脉瓣置换，患者的估计生存率为 2-3 年。已经制定了 AS 的治疗指南，但研究表明，多达 42%的 AS 患者未按照这些建议进行治疗。该注册研究的目的是描述 AS 患者的病例数，概述这些患者的管理，并确定参与中心是否具有手术和经皮治疗的能力，治疗的适宜性。
方法/设计：IMPULSE 增强型注册研究是一项国际性、多中心、前瞻性、观察性队列注册研究，在四个中心（三级保健医院）和每个中心至少两个卫星中心（一级/二级保健医院）进行。预计将有 800 名患者参加该注册研究，患者随访时间为 12 个月。
除了确定初级、二级和三级保健环境中 AS 患者的病例管理和结局的主要目标外，该注册研究还将确定从无症状到有症状状态的时间过程，以及诊断步骤、治疗决策以及确定在三级与一级/二级保健医院的决策者。该注册研究将于 2018 年纳入最后一名患者，预计将于 2019 年公布注册研究结果。
NCT03112629。
