Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.

Detailed Description
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Aortic stenosis (AS) is the most frequently treated heart valve disease in our society. Transcatheter aortic valve implantation (TAVI) was originally described through an antegrade transeptal route by Cribier and colleagues in 2002. Because of the complexity of the procedure and risks of damaging the mitral apparatus, this approach was abandoned in favor of less challenging alternatives, with transfemoral (TF) route as primary option. Nevertheless, the TF approach is not feasible or of high risk in between 15 and 35% of the patients and vascular complications have been shown to be an independent predictor of death warranting alternative access techniques for TAVI. In this regard, the transapical, direct aortic, transcarotid, transcaval, and transubclavian/transaxillary (TSc) implantation routes currently serve as alternative access options. The TSc approach was initially used in selected cases. However, recent series suggest that TSc may provide better outcomes than alternative routes when TF is inadequate. Additionally, same studies suggest that, as compared to TF approach, TSc TAVI may present lower rate of vascular complications with comparable rates of other major outcomes despite the worse baseline profile of patients who are considered inappropriate for TF procedures. Moreover, fully-percutaneous TSc approach can be successfully performed with low rate of complications as was recently proposed by some authors. However, comparisons have been based in small series of cases, most of them with former iteration of TAVI devices, and a formal prospective comparison has never been performed. Therefore, our aim is to gather all cases of fully-percutaneous TSc and TF approaches for TAVI in Spain and Portugal and compare the standardized safety and efficacy endpoints through a matched analysis.

Official Title
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Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Transcatheter aortic valve implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019. Exclusion Criteria: -

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 |
| --- | --- |
| Transaxillary<br>TAVI, transaxillary approach | Device: Transcatheter aortic valve implantation<br>* Transcatheter aortic valve implantation<br>|
| Transfemoral<br>TAVI, transfemoral approach | Device: Transcatheter aortic valve implantation<br>* Transcatheter aortic valve implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day death, stroke or embolic events, PVE or sepsis | Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up. | 30 day | 
| 1-year death, stroke or embolic events, PVE or sepsis | Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up. | 1 year | 
| Intraprocedural Vascular complications | Intraprocedural Vascular complications | Intraprocedural | 
| In-hospital Vascular complications | In-hospital Vascular complications | 7-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term complications related to the approach. | Short term complications related to the approach. | 30-days | 
| Mid term complications related to the approach. | Mid term complications related to the approach. | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve Implantation (TAVI), Transaxillary approach