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. 2024 Aug;32(7-8):270-275.
doi: 10.1007/s12471-024-01869-5. Epub 2024 Apr 23.

Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial

Maxim J P Rooijakkers  1 , Geert A A Versteeg  1 , Kimberley I Hemelrijk  2 , Hugo M Aarts  2 , Daniël C Overduin  3 , Dirk-Jan van Ginkel  3 , Pieter J Vlaar  4 , Marleen H van Wely  1 , Lokien X van Nunen  1 , Robert Jan van Geuns  1 , Leen A F M van Garsse  5 , Guillaume S C Geuzebroek  5 , Michel W A Verkroost  5 , Laura Rodwell  6 , Robin H Heijmen  5 , Pim A L Tonino  4 , Jurrien M Ten Berg  3   7 , Ronak Delewi  2 , Niels van Royen  8
Affiliations

Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial

Maxim J P Rooijakkers et al. Neth Heart J. 2024 Aug.

Abstract

Background: During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking.

Trial design: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium‑3 criteria.

Conclusion: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Keywords: Aortic stenosis; Bleeding complications; Complications; Pacemaker; Transcatheter aortic valve implantation; Valve Academic Research Consortium 3.

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Conflict of interest statement

M.H. van Wely has been a proctor and consultant for Abbott Vascular. R.H. Heijmen has been a consultant for Medtronic. P.A.L. Tonino and R. Delewi are Associate Editors of the Netherlands Heart Journal. N. van Royen has received research funding from Abbott, Philips, Medtronic and Biotronik, has served as a consultant for RainMed, Castor and Medtronic and has received speaker fees from Abbott and Bayer. M.J.P. Rooijakkers, G.A.A. Versteeg, K.I. Hemelrijk, H.M. Aarts, D.C. Overduin, D.-J. van Ginkel, P.J. Vlaar, , L.X. van Nunen, R.J. van Geuns, L.A.F.M. van Garsse, G.S.C. Geuzebroek, M.W.A. Verkroost, L. Rodwell and J.M. ten Berg declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the TAVI XS trial. BARC Bleeding Academic Research Consortium, QuickDASH Quick Disabilities of Arm, Shoulder and Hand, LEFS Lower Extremity Functional Scale, TAVI transcatheter aortic valve implantation, VARC Valve Academic Research Consortium
Fig. 2
Fig. 2
a–g Procedural steps in temporary pacing lead placement in an upper arm vein. a Positioning of the upper arm. b, c Ultrasound-guided visualisation of the upper arm vein. Arrow indicates the upper arm vein. d Guidewire entering the upper arm vein. Arrow indicates the guidewire. e 6F sheath inserted in the upper arm vein. f Fixation of 5F temporary pacing lead inserted through a 6F sheath in the upper arm vein. g Angiographic visualisation of the temporary pacing lead trajectory from a left upper arm vein to right ventricular apex
See this image and copyright information in PMC

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