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

Abstract

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).

Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies

“…Taken together, we observed significantly reduced bleeding rates and a dramatic decrease in vascular complications for newer generation devices. This superior safety profile with regard to access site complications is an important prerequisite for an early discharge after the TAVR procedure being cost effective 29 , increases patient comfort, and the mental and emotional aspects that affect the recovery after the procedure 30 .…”

Transcatheter management of severe aortic stenosis during the COVID-19 pandemic

“…42 In a different group of 120 patients that underwent TAVI at a single centre, 55% of patients were discharged on either the same day as the procedure, the following day or within 72 hours of their intervention. 43 These preliminary studies have provided supportive evidence that early discharge after TAVI is safe and feasible and indeed now that median length of stay in the UK is down to 3 days, it should certainly be feasible during the pandemic (table 1).…”

The history of transcatheter aortic valve implantation: The role and contribution of an early believer and adopter, the Netherlands

“…5). In conjunction with the experience gained and improved catheter and valve Total number of publications (n) per year are subdivided by the journal Impact Factor (2019) using the following categories: ≥15, 10-15 and 0-10 technology, a program of early discharge was instituted [18][19][20][21]. The Netherlands also played an important role in the adoption and evaluation of the use of cerebral protection devices for the prevention of perioperative stroke [22].…”