Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation – rationale and design of the FAST-TAVI registry

BMC Cardiovascular Disorders

Study Protocol

Mark S. Spence¹  Douglas F. Muir²  Francesco Saia³  Corrado Tamburino⁴  Marco Barbanti⁴  Martijn S. van Mourik⁵  Jan Baan⁵  Marije Vis⁵  Frank van der Kley⁶  Cameron G. Densem⁷  Alessandro Santo Bortone⁸  Lenka Seilerova⁹  Peter Bramlage^1,10  Claudia M. Lüske^1,10  Fortunato Iacovelli^1,11  Gian Luca Martinelli^1,12 

[1] Cardiology Department, Royal Victoria Hospital, Belfast, UK;Cardiothoracic Division, The James Cook University Hospital, Middlesbrough, UK;Cardiovascular and Thoracic Department, S. Orsola-Malpighi University Hospital, Bologna, Italy;Catania Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Salvatore Citelli 6, Catania, Italy;Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands;Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands;Department of Interventional Cardiology, Papworth Hospital, Cambridge, UK;Department of Interventional Cardiology, University of Bari “Aldo Moro”, Bari, Italy;Edwards Lifesciences, Prague, Czech Republic;Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany;Interventional Cardiology Service, “Montevergine” Clinic, Mercogliano, Italy;Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples “Federico II”, Naples, Italy;Novara Department of Cardiac Surgery, Clinica San Gaudenzio, Novara, Italy;

关键词: Aortic stenosis;    Hospitalisation;    Length of stay;    Cost-effectiveness;    Transfemoral;    SAPIEN;   

DOI  :  10.1186/s12872-017-0693-0

 received in 2017-07-13, accepted in 2017-10-05,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThere 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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

【 授权许可】

CC BY   
© The Author(s). 2017