An observational study in Aortic Valve Stenosis, sponsored by Ignacio J. Amat Santos. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Ignacio J. Amat Santos · Observational
Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 75 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Ignacio J. Amat Santos is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.
All-comers
Exclusion Criteria:
-
TAVI, transaxillary approach
Device: Transcatheter aortic valve implantation
TAVI, transfemoral approach
Device: Transcatheter aortic valve implantation
Transcatheter aortic valve implantation
30-day death, stroke or embolic events, PVE or sepsis
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.
Time frame: 30 day
1-year death, stroke or embolic events, PVE or sepsis
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.
Time frame: 1 year
Intraprocedural Vascular complications
Intraprocedural Vascular complications
Time frame: Intraprocedural
In-hospital Vascular complications
In-hospital Vascular complications
Time frame: 7-days
Short term complications related to the approach.
Short term complications related to the approach.
Time frame: 30-days
Mid term complications related to the approach.
Mid term complications related to the approach.
Time frame: 1-year
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Ignacio J. Amat Santos