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).

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

Division of Cardiology Department of Advanced Biomedical Sciences University of Naples Federico 2 Naples Italy

Edwards Lifesciences Prague Czech Republic

Institute for Pharmacology and Preventive Medicine Cloppenburg Germany

Interventional Cardiology Service Montevergine Clinic Mercogliano Italy

Novara Department of Cardiac Surgery Clinica San Gaudenzio Novara Italy

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A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study

Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry

Prespecified Risk Criteria Facilitate Adequate Discharge and Long-Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation

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ClinicalTrials.gov
NCT02404467