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Clinical Trials/NCT02956915
NCT02956915
Completed
N/A

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

University Hospital, Rouen5 sites in 1 country300 target enrollmentMay 22, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Symptomatic Aortic Stenosis
Sponsor
University Hospital, Rouen
Enrollment
300
Locations
5
Primary Endpoint
Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 22, 2017
End Date
February 23, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days

Time Frame: 30 days after TF TAVI procedure

Secondary Outcomes

  • Incidence of early discharge/prolonged hospitalization in the overall study population(30 days after TF TAVI procedure)
  • Safety of early discharge(30 days after TF TAVI procedure)
  • Predictors of early discharge success or failure by multivariate analysis(30 days after TF TAVI procedure)

Study Sites (5)

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