Evaluation of Length of Stay After TF-TAVI (FAST-TAVI)

Evaluation of Length of Stay and Predisposing Factors of Late Discharge After Transfemoral Transcatheter Aortic Valve Implantation Using the SAPIEN-3 Prosthesis: A French Multicenter Prospective Observational Trial

Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.

While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.

Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.

Study Overview

• Status: Completed
• Conditions: Severe Symptomatic Aortic Stenosis
• Intervention / Treatment: Procedure: Transfemoral Transcatheter aortic valve implantation

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Brest, France
    • Brest University Hospital
  • Massy, France
    • Jacques CARTIER Private Hospital
  • Paris, France
    • AP-HP Bichat - Claude Bernard Hospital
  • Rennes, France
    • Rennes University Hospital
  • Rouen, France
    • ROUEN university 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

patients undergoing an elective TF-TAVI procedure with a SAPIEN-3 prosthesis at participating centers

Description

Inclusion Criteria:

• Stable patients with severe symptomatic aortic stenosis
• Patient undergoing planned TF-TAVI with the SAPIEN-3 prosthesis,
• TF-TAVI using a minimalist approach of local anesthesia and conscious sedation

Exclusion Criteria:

• The use of other (than Edwards SAPIEN-3 or XT) transcatheter aortic valve devices.
• TF-TAVI requiring general anesthesia or surgical cut-down.
• TF-TAVI performed in unstable patients or on an urgent/emergent basis.
• Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc).
• Discharge back home impossible (including transfer in another hospital)
• Programmed transfer to another hospital

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with severe symptomatic aortic stenosis; Stable patients with severe symptomatic aortic stenosis undergoing planned Transfemoral Transcatheter aortic valve implantation with the SAPIEN-3 prosthesis will be included. TF-TAVI will be done using a minimalist approach of local anesthesia and conscious sedation.	Procedure: Transfemoral Transcatheter aortic valve implantation; Transcatheter aortic valve implantation (TAVI): The SAPIEN-3 prosthese are implanted without open heart surgery. The valve delivery system is inserted in the body via the femoral artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days	30 days after TF TAVI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of early discharge/prolonged hospitalization in the overall study population	Length of stay will be calculated from TAVI procedure (day 0) to discharge	30 days after TF TAVI procedure
Safety of early discharge	Combined endpoint of mortality or rehospitalization at 30-days after TF-TAVI procedure	30 days after TF TAVI procedure
Predictors of early discharge success or failure by multivariate analysis		30 days after TF TAVI procedure

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2017
• Primary Completion (ACTUAL): February 23, 2018
• Study Completion (ACTUAL): February 23, 2018

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (ESTIMATE): November 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Aortic stenosis; Length of stay; Transcatheter aortic valve implantation; SAPIEN-3 prostheses
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2016/012/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No