Evidence map›Paper›PMID 29017461›Full record

Trial reportBMC cardiovascular disorders2017

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

Marco Barbanti, Jan Baan, Mark S Spence, Fortunato Iacovelli, Gian Luca Martinelli, Francesco Saia, Alessandro Santo Bortone, Frank van der Kley, Douglas F Muir, Cameron G Densem and 6 more

Registry-linked trialAbstract readClinical TrialMulticenter StudyObservational Study
In one paragraph

Trial report in BMC cardiovascular disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02404467 (Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation The FAST-TAVI Study), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02404467 completednot on this map

Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation The FAST-TAVI Study

Typeobservational_patient_registrySponsorInstitut für Pharmakologie und Präventive MedizinRan2015 to 2019Enrolled502ConditionsAortic StenosisArmsTF TAVI
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Changes in demographics, treatment and outcomes in a consecutive cohort who underwent transcatheter aortic valve implantation between 2005 and 2020.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2022
    Article
  6. Article
  7. Article
  8. Observational
  9. Observational
  10. Review
  11. The history of transcatheter aortic valve implantation: The role and contribution of an early believer and adopter, the Netherlands.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Marco BarbantiCatania Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Salvatore Citelli 6, Catania, Italy. mbarbanti83@gmail.com.
Jan BaanDepartment of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
Mark S SpenceCardiology Department, Royal Victoria Hospital, Belfast, UK.
Fortunato IacovelliInterventional Cardiology Service, "Montevergine" Clinic, Mercogliano, Italy.
Gian Luca MartinelliNovara Department of Cardiac Surgery, Clinica San Gaudenzio, Novara, Italy.
Francesco SaiaCardiovascular and Thoracic Department, S. Orsola-Malpighi University Hospital, Bologna, Italy.
Alessandro Santo BortoneDepartment of Interventional Cardiology, University of Bari "Aldo Moro", Bari, Italy.
Frank van der KleyDepartment of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Douglas F MuirCardiothoracic Division, The James Cook University Hospital, Middlesbrough, UK.
Cameron G DensemDepartment of Interventional Cardiology, Papworth Hospital, Cambridge, UK.
Marije VisDepartment of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
Martijn S van MourikDepartment of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
Lenka SeilerovaEdwards Lifesciences, Prague, Czech Republic.
Claudia M LüskeInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Peter BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.ORCID http://orcid.org/0000-0002-4121-6866
Corrado TamburinoCatania Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Salvatore Citelli 6, Catania, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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

Indexed as

Feasibility StudiesFemoral ArteryHumansItalyNetherlandsPatient DischargePostoperative ComplicationsProspective StudiesRegistriesTime FactorsTranscatheter Aortic Valve ReplacementUnited KingdomAortic stenosisCost-effectivenessHospitalisationLength of staySAPIENTransfemoral

Identifiers

PMID29017461
PMCPMC5635502

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.