Clinical trial NCT02956915: Evaluation of Length of Stay After TF-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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Symptomatic Aortic Stenosis
Keywords: Transcatheter aortic valve implantation
SAPIEN-3 prostheses
Length of stay
Aortic stenosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing an elective TF-TAVI procedure with a SAPIEN-3 prosthesis at participating centers

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days
timeFrame: 30 days after TF TAVI procedure
Secondary outcomes:
measure: Incidence of early discharge/prolonged hospitalization in the overall study population
timeFrame: 30 days after TF TAVI procedure
measure: Safety of early discharge
timeFrame: 30 days after TF TAVI procedure
measure: Predictors of early discharge success or failure by multivariate analysis
timeFrame: 30 days after TF TAVI procedure
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Massy
country: France
facility: Jacques Cartier Private Hospital
city: Paris
country: France
facility: AP-HP Bichat - Claude Bernard Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Hélène ELTCHANINOFF, Pr
role: PRINCIPAL_INVESTIGATOR
References: