Evaluation of Length of Stay After TF-TAVI

Completed

• Conditions: Severe Symptomatic Aortic Stenosis
• Interventions: Procedure: Transfemoral Transcatheter aortic valve implantation

• Registration Number: NCT02956915
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2017-05-22
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with severe symptomatic aortic stenosis	Transfemoral Transcatheter aortic valve implantation	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days	30 days after TF TAVI procedure

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Rouen University Hospital; 🇫🇷 Rouen, France

Brest University Hospital; 🇫🇷 Brest, France

AP-HP Bichat - Claude Bernard Hospital; 🇫🇷 Paris, France

Rennes University Hospital; 🇫🇷 Rennes, France

Jacques Cartier Private Hospital; 🇫🇷 Massy, France