背景:心源性休克(CS)患者的治疗包括几种健康技术,包括Impella泵和静脉动脉体外膜氧合(VA-ECMO)。然而,虽然它们在临床实践中被广泛使用,与这些设备相关的资源使用和生活质量(QoL)信息很少。本研究的目的是,因此,收集并比较评估Impella与VA-ECMO治疗严重CS患者的临床和社会经济数据,最终进行成本效益(CEA)和预算影响(BIA)分析。
方法:这是一个前瞻性加回顾性研究,在SDABocconi管理学院健康与社会护理管理研究中心的科学协调下进行的多中心研究以及米兰CarattereScientific(IRCCS)SanRaffaeleScientificInstitute的临床协调。Impella网络是为了本研究的目的而建立的,包括从意大利北部到南部地区的17个意大利临床中心。意大利网络有资格成为国际Impella心脏外科手术注册的一个小组。使用Impella泵治疗的CS患者(CP,5.0或5.5)将被前瞻性招募,以及有关临床结果的信息,资源使用和QoL收集。经济数据将与接受VA-ECMO治疗的可比患者的数据进行回顾性匹配。CEA和BIA都将在意大利采用社会观点进行。这项研究将有助于产生新的社会经济证据,为未来的覆盖决策提供信息。
背景:截至2024年5月,大多数临床中心向其伦理委员会提交了文件(N=13;76%),六个中心获得了伦理批准,两个中心开始登记患者。研究结果将在同行评审的出版物中发表,并通过会议演示文稿进行传播。
BACKGROUND: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this
study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses.
METHODS: This is a prospective plus retrospective, multicentre
study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this
study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This
study will contribute to generate new socioeconomic evidence to inform future coverage decisions.
BACKGROUND: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients.
Study results will be published in peer-reviewed publications and disseminated through conference presentations.