Evaluation of Length of Stay After TF-TAVI

Severe Symptomatic Aortic Stenosis Clinical Trial

— FAST-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956915
• Other study ID #: 2016/012/HP
• Status: Completed
• Start date: May 22, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: April 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Symptomatic Aortic Stenosis

Intervention

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.

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Jacques Cartier Private Hospital	Massy
France	AP-HP Bichat - Claude Bernard Hospital	Paris
France	Rennes University Hospital	Rennes
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days		30 days after TF TAVI procedure
Secondary	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
Secondary	Safety of early discharge	Combined endpoint of mortality or rehospitalization at 30-days after TF-TAVI procedure	30 days after TF TAVI procedure
Secondary	Predictors of early discharge success or failure by multivariate analysis		30 days after TF TAVI procedure