Interventions for valvular disease and heart failure

Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial

EuroIntervention 2019;15:147-154. DOI: 10.4244/EIJ-D-18-01197

Marco Barbanti
Marco Barbanti1, MD; Martijn S. van Mourik2, MD; Mark S. Spence3, MD; Fortunato Icovelli4,5, MD; Gian Luca Martinelli6, MD; Douglas F. Muir7, MD; Francesco Saia8, MD; Alessandro Santo Bortone9, MD; Cameron G. Densem10, MD; Frank van der Kley11, MD; Peter Bramlage12, MD; Marije Vis2, MD; Corrado Tamburino1, MD
1. Department of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Catania, Italy; 2. Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; 3. Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom; 4. Department of Cardiology, “Montevergine” Clinic, Mercogliano, Italy; 5. Department of Cardiology, Department of Advanced Biomedical Sciences, University of Naples, Naples, Italy; 6. Department of Cardiac Surgery, Clinica San Gaudenzio, Novara, Italy; 7. Cardiothoracic Division, The James Cook University Hospital, Middlesbrough, United Kingdom; 8. Cardiovascular and Thoracic Department, S. Orsola-Malpighi University Hospital, Bologna, Italy; 9. Department of Cardiology, University of Bari “Aldo Moro”, Bari, Italy; 10. Department of Cardiology, Papworth Hospital, Cambridge, United Kingdom; 11. Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands; 12. Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany

Aims: Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set of risk criteria that allows a safe and timely discharge, to validate their appropriateness prospectively in different centres and multiple European countries, and to assess post-discharge outcomes.

Methods and results: We defined and validated the adequacy of a set of discharge criteria and its ability to predict timely and safe discharge properly after the intervention in a prospective, European, multicentre registry. A total of 502 unselected patients were enrolled at 10 sites in three countries. The primary endpoint, defined as 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 at 30 days, was reached in 12.9% of patients (95% CI: 11.3-16.5). The overall 30-day mortality was 1.1% (95% CI: 0.2-2.0), and the rates of stroke/TIA 1.7% (95% CI: -0.6 to 4.0), PPI 7.3% (95% CI: 5.8-8.9), major vascular complications 1.9% (95% CI: 0.7-3.1), major/life-threatening bleeding 2.4% (95% CI: 1.0-3.8) and cardiac re-hospitalisation 3.7% (95% CI: 1.4-6.0). Patients appropriately discharged early had a significantly lower risk of the primary endpoint (7.0 vs. 26.4%; p<0.001) which was reflected in some of its relevant components: stroke (0.0 vs. 2.8%; p=0.015), PPI (4.3 vs. 15.9%; p<0.001), major vascular complications (0.3 vs. 4.7%; p=0.004) and major/life-threatening bleeding (0.3 vs. 6.5%; p<0.001).

Conclusions: We validated the appropriateness of a pre-specified set of risk criteria that allows a safe and timely discharge. The rate of 30-day complications did not reveal any risk increase with this strategy compared with the reported outcomes in major TAVI trials and registries. ClinicalTrials.gov Identifier: NCT02404467

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

clinical researchfemoralmultidisciplinary Heart Team
Interventions for valvular diseaseTAVI
Read next article
Derivation and external validation of a simple risk tool to predict 30-day hospital readmissions after transcatheter aortic valve replacement

Latest news