Clinical trial NCT04274751: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter aortic valve Implantation (TAVI)
Transaxillary approach
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2020-02-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.

All-comers

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: 30-day death, stroke or embolic events, PVE or sepsis
timeFrame: 30 day
measure: 1-year death, stroke or embolic events, PVE or sepsis
timeFrame: 1 year
measure: Intraprocedural Vascular complications
timeFrame: Intraprocedural
measure: In-hospital Vascular complications
timeFrame: 7-days
Secondary outcomes:
measure: Short term complications related to the approach.
timeFrame: 30-days
measure: Mid term complications related to the approach.
timeFrame: 1-year
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
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