Severe Symptomatic Aortic Stenosis
Conditions
Keywords
Transcatheter aortic valve implantation, SAPIEN-3 prostheses, Length of stay, Aortic stenosis
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.
Interventions
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.
Sponsors
University Hospital, Rouen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of length of stay and reasons for prolonged hospitalization beyond 3 days | 30 days after TF TAVI procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early discharge/prolonged hospitalization in the overall study population | 30 days after TF TAVI procedure | Length of stay will be calculated from TAVI procedure (day 0) to discharge |
| Safety of early discharge | 30 days after TF TAVI procedure | Combined endpoint of mortality or rehospitalization at 30-days after TF-TAVI procedure |
| Predictors of early discharge success or failure by multivariate analysis | 30 days after TF TAVI procedure | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHélène ELTCHANINOFF, Pr
University Hospital, Rouen
Outcome results
None listed