Evaluation of Length of Stay After TF-TAVI

NCT02956915 | Completed

• 1 other identifier: 2016/012/HP
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Severe Symptomatic Aortic Stenosis

Keywords

Transcatheter aortic valve implantation; SAPIEN-3 prostheses; Length of stay; Aortic stenosis

Outcome Measures

Primary Outcomes (1)

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

  30 days after TF TAVI procedure

Secondary Outcomes (3)

• 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 Arms (1)

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.

Procedure: Transfemoral Transcatheter aortic valve implantation

Interventions

Transfemoral Transcatheter aortic valve implantation 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.

patients with severe symptomatic aortic stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing an elective TF-TAVI procedure with a SAPIEN-3 prosthesis at participating centers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (5)

Brest University Hospital

Brest, France

Location

Jacques Cartier Private Hospital

Massy, France

Location

AP-HP Bichat - Claude Bernard Hospital

Paris, France

Location

Rennes University Hospital

Rennes, France

Location

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Hélène ELTCHANINOFF, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: May 22, 2017
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)