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

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Transcatheter aortic valve implantation

• Registration Number: NCT04274751
• Lead Sponsor: Ignacio J. Amat Santos

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-02-16
• Study First Posted: 2020-02-18
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transaxillary	Transcatheter aortic valve implantation	TAVI, transaxillary approach
Transfemoral	Transcatheter aortic valve implantation	TAVI, transfemoral approach

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Short term complications related to the approach.	30-days	Short term complications related to the approach.
Mid term complications related to the approach.	1-year	Mid term complications related to the approach.

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain