Evaluation of Length of Stay After TF-TAVI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-22

Study Completion Date

2018-02-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Symptomatic Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Transfemoral Transcatheter aortic valve implantation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No