TAVR Without Predilatation

Study Overview
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Brief Summary
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The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.

Official Title
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Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - patients undergoing TAVR via transfemoral or rascoarotid access Exclusion criteria: - others access (subclavian, apical, transaortic)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR<br>all comers study including all transfemoral or transcarotid TAVR procédures. direct implantation is the default strategy usually used in our enter as in may centers | Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis<br>* The procedure is performed via transfemoral or transcarotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of the direct implantation | success of the direct implantation defined as failure of crossing with the THV after 3 attemps and absence of complication related to the direct crossing | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indidence of post dilatation | Indidence of post dilatation | 1 day | 
| Underexpansion of the Edwards SAPIEN 3 THV | Underexpansion of the Edwards SAPIEN 3 THV | 1 day | 
| risks factors of failure of crossing | risks factors of failure of crossing : femoral vs carotid access, type of THV , vascular tortuosities, biscuipid valve, calcification, tight stenosis, horizontal aorta, small annulus | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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direct implanation, TAVR, Balloon prediltation, success of crossing the valve