NCT04274751

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Ignacio J. Amat Santos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve implantation	Transcatheter aortic valve implantation

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2020-02-18
• Last updated: 2021-10-26

Locations

1 site across 1 country: Spain