Frey Norbert, Steeds Richard P, Serra Antonio, Schulz Eberhard, Baldus Stephan, Lutz Matthias, Pohlmann Christiane, Kurucova Jana, Bramlage Peter, Messika-Zeitoun David
Department of Cardiology and Angiology, University of Kiel, Kiel, Germany.
Queen Elizabeth Hospital and Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.
BMC Cardiovasc Disord. 2017 Jan 5;17(1):5. doi: 10.1186/s12872-016-0439-4.
Severe aortic stenosis (AS) is a common, serious valve disease in which no effective medical therapy is available and, if not treated by intervention, has a 5-year survival of only 40-60%. Despite the availability of guidelines supporting the effective use of surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) to treat the majority of these patients, adherence to these guidelines in clinical practice is still unsatisfactory. Several recent studies have emphasised the necessity for improved communication between multidisciplinary teams, with the aim to ensure that severe AS patients receive appropriate treatment.
METHODS/DESIGN: IMPULSE is a prospective, multicentre, European registry designed to gather data over 12 months on the treatment decisions made by referring physicians for patients newly diagnosed with severe AS. Each patient has a follow-up of 3 months. The study will consist of two observational phases to assess the appropriateness and rate of referral based on current guidelines prior to and after an interventional phase aiming to determine whether a simple quality of care intervention improves patient management.
Data will be analysed firstly, to determine the appropriateness of treatment decisions for the management of severe AS in current European clinical practice, and secondly, to evaluate the effectiveness of facilitated data relay from a designated echocardiography department nurse to the referring physician early after diagnosis in improving quality of care. Additionally, variables will be identified that are associated with inappropriate decision-making. Collectively, the aim will be to design a clinical pathway that will improve the timely management of patients with newly diagnosed severe AS.
重度主动脉瓣狭窄（AS）是一种常见且严重的瓣膜疾病，目前尚无有效的药物治疗方法，若不进行干预治疗，5年生存率仅为40% - 60%。尽管有指南支持有效使用外科主动脉瓣置换术（SAVR）或经导管主动脉瓣植入术（TAVI）来治疗大多数此类患者，但临床实践中对这些指南的遵循情况仍不尽人意。最近的几项研究强调了多学科团队之间加强沟通的必要性，目的是确保重度AS患者得到适当治疗。
方法/设计：IMPULSE是一项前瞻性、多中心的欧洲注册研究，旨在收集转诊医生对新诊断为重度AS患者的治疗决策数据，为期12个月。每位患者随访3个月。该研究将包括两个观察阶段，以评估在一个旨在确定简单的护理质量干预措施是否能改善患者管理的干预阶段之前和之后，基于当前指南的转诊适宜性和转诊率。
首先将对数据进行分析，以确定当前欧洲临床实践中重度AS管理治疗决策的适宜性，其次评估在诊断后早期由指定的超声心动图科室护士向转诊医生进行便利的数据传递对改善护理质量的有效性。此外，还将确定与不适当决策相关的变量。总体目标是设计一条临床路径，以改善新诊断的重度AS患者的及时管理。
