经股动脉导管主动脉瓣植入术后早期出院的可行性与安全性——FAST-TAVI注册研究的原理与设计
Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation - rationale and design of the FAST-TAVI registry.
作者信息
Barbanti Marco, Baan Jan, Spence Mark S, Iacovelli Fortunato, Martinelli Gian Luca, Saia Francesco, Bortone Alessandro Santo, van der Kley Frank, Muir Douglas F, Densem Cameron G, Vis Marije, van Mourik Martijn S, Seilerova Lenka, Lüske Claudia M, Bramlage Peter, Tamburino Corrado
机构信息
Catania Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Salvatore Citelli 6, Catania, Italy.
Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
出版信息
BMC Cardiovasc Disord. 2017 Oct 10;17(1):259. doi: 10.1186/s12872-017-0693-0.
BACKGROUND
There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes.
METHODS
The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge.
DISCUSSION
The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).
背景
经导管主动脉瓣植入术（TAVI）后住院时间缩短的趋势日益明显，尤其是对于经股动脉（TF）途径接受该手术的患者。初步数据表明，存在一部分患者在经股动脉TAVI术后可非常早期安全出院。然而，目前的证据仅限于少数回顾性研究，样本量相对较小。
方法
经股动脉TAVI术后早期出院的可行性与安全性（FAST-TAVI）注册研究是一项前瞻性观察性注册研究，将在意大利、荷兰和英国的10个地点开展。如果患者计划使用球囊扩张式SAPIEN 3经导管心脏瓣膜（THV；爱德华生命科学公司，加利福尼亚州欧文市）进行经股动脉TAVI，将被纳入研究。主要终点是出院后30天内发生的全因死亡率、血管通路相关并发症、永久性起搏器植入、中风、因心脏原因再次住院、肾衰竭和大出血的综合情况。患者将根据早期出院（≤3天）的高风险或低风险（根据预先指定的标准）以及是否早期出院进行分层。次要终点将包括主要结局及其各个组成部分的事件发生时间（Kaplan-Meier）分析、早期和晚期出院的相对成本分析以及短期和长期生活质量的变化。多因素逻辑回归将用于确定表明患者可能适合早期出院的因素。
讨论
FAST-TAVI注册研究收集的数据应有助于阐明经股动脉TAVI术后早期出院的安全性，并确定使早期出院成为安全且具有成本效益策略的患者和手术特征。
试验注册
ClinicalTrials.gov标识符：NCT02404467（首次注册于2015年3月23日）。
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