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. Identifier: NCT02404467

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clinical researchfemoralmultidisciplinary Heart Team
Interventions for valvular diseaseTAVI
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