Multicenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is also recommended in patients at intermediate risk, especially when a femoral approach (TF) is possible (Baumgartner et al. Eur Heart J. 2017). Currently, there is no recommendation regarding length of stay after TAVI and practices are extremely heterogeneous. Despite the growing experience of centers, better patient selection and a reduction in complications, the length of stay after TAVI remains very high in France. Faced with the great disparity observed between the centers, efforts are necessary to educate the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study is to evaluate the effectiveness of an intervention based on training teams to reduce the length of stay after TF-TAVI.

Official Title
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Etude Multicentrique évaluant l'efficacité d'Une Intervention Visant à réduire la durée de séjour après l'Implantation d'Une bioprothèse Aortique Par Voie transfémorale

Conditions
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Aortic Valve Stenosis, Cardiovascular Diseases

Intervention / Treatment
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* Other: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years of age; Patient hospitalized for TF-TAVI Patient affiliated or benefiting from a health insurance scheme Patient having read and understood the information letter and having signed the consent form. Exclusion Criteria: Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 1 Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study, there is a randomization of the participating centres in two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The randomized centres in this group will be follow a training dedicated on implementation of organizational and therapeutic measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI. | Other: Training<br>* Training dedicated on implementation of organizational and therapeutic measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.<br>|
| No Intervention: Control group<br>The randomized centres in this group will not change their practices. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of a multi-component organizational intervention | Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days. | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of the intervention | This outcome will be evaluated using : the average length of stay, the 30-day rehospitalization rate and the 30-day death rate. | Day 30 | 
| To evaluate the budgetary impact of the intervention | This outcome will be assessed using: the hospital costs from the point of view of the hospital and the financial gains for health insurance that would be associated with the generalization of the intervention in France. | Year 1 | 
| To evaluate the implementation of the intervention | This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires) | Year 1 | 
| To identify the factors associated with the effectiveness and safety of the intervention | This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days. | Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Aortic valve stenosis, Lenght-of-stay, Medico-economy