Brief Title
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation
Official Title
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study
Brief Summary
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
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.
Study Type
Observational
Primary Outcome
30-day death, stroke or embolic events, PVE or sepsis
Secondary Outcome
Short term complications related to the approach.
Condition
Aortic Valve Stenosis
Intervention
Transcatheter aortic valve implantation
Study Arms / Comparison Groups
Transaxillary
Description: TAVI, transaxillary approach
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
75
Start Date
July 1, 2019
Completion Date
June 30, 2020
Primary Completion Date
June 30, 2020
Eligibility Criteria
Inclusion Criteria: - Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019. Exclusion Criteria: -
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04274751
Organization ID
CASVE PI-19-1428
Responsible Party
Sponsor-Investigator
Study Sponsor
Ignacio J. Amat Santos
Collaborators
Boston Scientific Corporation
Study Sponsor
, ,
Verification Date
October 2021