Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Ignacio J. Amat Santos
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 30-day death, stroke or embolic events, PVE or sepsis
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ignacio J. Amat Santos
Head of Interventional Cardiology Unit
Hospital Clínico Universitario de Valladolid
Eligibility Criteria
Inclusion Criteria
- •Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
30-day death, stroke or embolic events, PVE or sepsis
Time Frame: 30 day
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.
1-year death, stroke or embolic events, PVE or sepsis
Time Frame: 1 year
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.
In-hospital Vascular complications
Time Frame: 7-days
In-hospital Vascular complications
Intraprocedural Vascular complications
Time Frame: Intraprocedural
Intraprocedural Vascular complications
Secondary Outcomes
- Short term complications related to the approach.(30-days)
- Mid term complications related to the approach.(1-year)