Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation (FAST-TAVI)

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

The hypothesis behind this study is that there is a proportion of patients considered high or intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged early after the procedure (within the first 2-3 days) without additional risks. Therefore, when performed in safety, an early discharge may cut periprocedural TAVI costs significantly.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: TF TAVI

Detailed Description

TAVI (Transcatheter aortic valve Implantation) - A viable alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis.

Considered as being at unacceptable surgical risk. Despite its widespread utilization, there are procedure specific complications and hospitalization associated costs that limit TAVI expansion into patient populations with lower risk.

Cost-effectiveness of TAVI has been investigated either compared with standard therapy for patients who are not candidates for surgical valve replacement or with conventional surgical replacement in high-risk patients.

Formal economic evaluation in inoperable patients demonstrated that the benefits of TAVI were achieved at an acceptable incremental cost to society, at least in the context of the U.S. and U.K. health systems.

In patients with severe, symptomatic AS who are at high but not prohibitive surgical risk, the PARTNER A trial demonstrated that TAVI appeared to be an economically attractive strategy compared with aortic valve replacement, provided that patients are suitable for a transfemoral approach. On the other hand, results for trans-apical TAVI compared with surgical replacement were economically unfavorable.

• Study Type: Observational
• Enrollment (Actual): 502

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70121
    • Università degli Studi di Bari Aldo Moro
  • Bologna, Italy, 40138
    • University Hospital of Bologna, Policlinico S. Orsola-Malpighi (Pad.23)
  • Novara, Italy, 28100
    • Clinica San Gaudenzio di Novara
  • AV
    • Mercogliano, AV, Italy, 83013
      • Montevergine Clinic
  • Sicily
    • Catania, Sicily, Italy, 95124
      • Ferrarotto Hospital, University of Catania
• Netherlands
  • Leiden, Netherlands, 2333
    • LUMC - Leiden University Medical Center
  • AZ
    • Amsterdam, AZ, Netherlands, 1105
      • AMC - Academic Medical Center - University of Amsterdam
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Vicotria Hospital, Belfast Trust
  • Cambridge, United Kingdom, CB23 3RE
    • Papworth Hospital
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 500 consecutive patients with severe aortic stenosis selected for TF TAVI at the respective site will be enrolled. Beyond the applicable criteria of the IFU no further in- and exclusion criteria are defined.

Description

Inclusion Criteria:

• None

Exclusion Criteria:

• None
• Beyond the applicable criteria of the IFU no further in- and exclusion criteria are defined.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving transfermoral TAVI; TF TAVI	Device: TF TAVI; Follow-up Observation of patients having received a TF-TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and safety of early discharge after transfemoral (TF) TAVI (cumulative incidence of death, hospitalization, complications)	Cumulative incidence of a combination of all cause death, vascular Access related complications permanent Pacemaker Implantation, re-hospitalization due to cardiac reasons, and Major bleeding complications from day 4 to 30 after TAVI.	30 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stratified Analysis of the cumulative incidence of a combination of the Primary outcome measures according to Patient risk factors and discharge date	Cumulative incidence of a combination of the primary outcome from day 4 to 30 in the LR / LD, HR / ED and HR / LD strata. Cumulative incidence of a combination of the primary outcome from day 4 to 15 in all strata.	30 days after intervention
Length-of-Stay after TAVI in days		1 year
Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group		1 year

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Marco Barbanti, MD, Ferrarotto Hospital, University of Catania

Publications and helpful links

General Publications

• Barbanti M, Baan J, Spence MS, Iacovelli F, Martinelli GL, Saia F, Bortone AS, van der Kley F, Muir DF, Densem CG, Vis M, van Mourik MS, Seilerova L, Luske CM, Bramlage P, Tamburino C. Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation - rationale and design of the FAST-TAVI registry. BMC Cardiovasc Disord. 2017 Oct 10;17(1):259. doi: 10.1186/s12872-017-0693-0.
• Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, van der Kley F, Bramlage P, Vis M, Tamburino C. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019 Jun 20;15(2):147-154. doi: 10.4244/EIJ-D-18-01197.
• Spence MS, Baan J, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, Owens CG, van der Kley F, Vis M, van Mourik MS, Costa G, Sykorova L, Luske CM, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Tamburino C, Barbanti M. Prespecified Risk Criteria Facilitate Adequate Discharge and Long-Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2020 Aug 4;9(15):e016990. doi: 10.1161/JAHA.120.016990. Epub 2020 Jul 25.

Helpful Links

• registry on-line eCRF website

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: FAST-TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided