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

NCT ID: NCT04274751

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transaxillary

TAVI, transaxillary approach

Transcatheter aortic valve implantation

Intervention Type DEVICE

Transcatheter aortic valve implantation

Transfemoral

TAVI, transfemoral approach

Transcatheter aortic valve implantation

Intervention Type DEVICE

Transcatheter aortic valve implantation

Interventions

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Transcatheter aortic valve implantation

Transcatheter aortic valve implantation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Ignacio J. Amat Santos

OTHER

Sponsor Role lead

Responsible Party

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Ignacio J. Amat Santos

Head of Interventional Cardiology Unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Spain

References

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Brennan JM, Holmes DR, Sherwood MW, Edwards FH, Carroll JD, Grover FL, Tuzcu EM, Thourani V, Brindis RG, Shahian DM, Svensson LG, O'Brien SM, Shewan CM, Hewitt K, Gammie JS, Rumsfeld JS, Peterson ED, Mack MJ. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014 Dec;98(6):2016-22; discussion 2022. doi: 10.1016/j.athoracsur.2014.07.051. Epub 2014 Oct 29.

Reference Type BACKGROUND
PMID: 25443009 (View on PubMed)

Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

Reference Type BACKGROUND
PMID: 12473543 (View on PubMed)

Kurra V, Schoenhagen P, Roselli EE, Kapadia SR, Tuzcu EM, Greenberg R, Akhtar M, Desai MY, Flamm SD, Halliburton SS, Svensson LG, Sola S. Prevalence of significant peripheral artery disease in patients evaluated for percutaneous aortic valve insertion: Preprocedural assessment with multidetector computed tomography. J Thorac Cardiovasc Surg. 2009 May;137(5):1258-64. doi: 10.1016/j.jtcvs.2008.12.013.

Reference Type BACKGROUND
PMID: 19380001 (View on PubMed)

Caceres M, Braud R, Roselli EE. The axillary/subclavian artery access route for transcatheter aortic valve replacement: a systematic review of the literature. Ann Thorac Surg. 2012 Mar;93(3):1013-8. doi: 10.1016/j.athoracsur.2011.10.056. Epub 2012 Jan 5.

Reference Type BACKGROUND
PMID: 22226233 (View on PubMed)

Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V, Kasimir MT, Doss M, Borger MA, Schuler G, Glogar D, Fehske W, Wolner E, Mohr FW, Mack M. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation. 2007 Sep 11;116(11 Suppl):I240-5. doi: 10.1161/CIRCULATIONAHA.106.677237.

Reference Type BACKGROUND
PMID: 17846311 (View on PubMed)

Bapat V, Khawaja MZ, Attia R, Narayana A, Wilson K, Macgillivray K, Young C, Hancock J, Redwood S, Thomas M. Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):733-40. doi: 10.1002/ccd.23276. Epub 2011 Sep 26.

Reference Type BACKGROUND
PMID: 21805602 (View on PubMed)

Modine T, Sudre A, Delhaye C, Fayad G, Lemesle G, Collet F, Koussa M. Transcutaneous aortic valve implantation using the left carotid access: feasibility and early clinical outcomes. Ann Thorac Surg. 2012 May;93(5):1489-94. doi: 10.1016/j.athoracsur.2012.01.030. Epub 2012 Mar 28.

Reference Type BACKGROUND
PMID: 22464036 (View on PubMed)

Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7.

Reference Type BACKGROUND
PMID: 24814495 (View on PubMed)

Schofer N, Deuschl F, Conradi L, Lubos E, Schirmer J, Reichenspurner H, Blankenberg S, Treede H, Schafer U. Preferential short cut or alternative route: the transaxillary access for transcatheter aortic valve implantation. J Thorac Dis. 2015 Sep;7(9):1543-7. doi: 10.3978/j.issn.2072-1439.2015.07.27.

Reference Type BACKGROUND
PMID: 26543600 (View on PubMed)

Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.

Reference Type BACKGROUND
PMID: 22019110 (View on PubMed)

Amat-Santos IJ, Rojas P, Gutierrez H, Vera S, Castrodeza J, Tobar J, Goncalves-Ramirez LR, Carrasco M, Catala P, San Roman JA. Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):935-944. doi: 10.1002/ccd.27485. Epub 2018 Jan 3.

Reference Type BACKGROUND
PMID: 29314570 (View on PubMed)

Garcia DC, Benjo A, Cardoso RN, Macedo FY, Chavez P, Aziz EF, Herzog E, Alam M, de Marchena E. Device stratified comparison among transfemoral, transapical and transubclavian access for Transcatheter Aortic Valve Replacement (TAVR): a meta-analysis. Int J Cardiol. 2014 Mar 15;172(2):e318-21. doi: 10.1016/j.ijcard.2013.12.162. Epub 2014 Jan 9. No abstract available.

Reference Type BACKGROUND
PMID: 24485611 (View on PubMed)

Schafer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck KH, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol. 2017 Apr 1;232:247-254. doi: 10.1016/j.ijcard.2017.01.010. Epub 2017 Jan 7.

Reference Type BACKGROUND
PMID: 28118931 (View on PubMed)

Amat-Santos IJ, Santos-Martinez S, Conradi L, Taramasso M, Poli A, Romaguera R, Pan M, Bagur R, Del Valle R, Nombela-Franco L, Bhadra OD, Aparisi A, Redondo A, Gutierrez H, Gomez I, Roman JAS. Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E291-E298. doi: 10.1002/ccd.29423. Epub 2020 Dec 14.

Reference Type RESULT
PMID: 33315296 (View on PubMed)

Other Identifiers

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CASVE PI-19-1428

Identifier Type: -

Identifier Source: org_study_id