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Randomized Controlled Trial
. 2024 Oct 1;7(10):e2438578.
doi: 10.1001/jamanetworkopen.2024.38578.

Upper- vs Lower-Extremity Secondary Access During Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial

Geert A A Versteeg  1 , Maxim J P Rooijakkers  1 , Kimberley I Hemelrijk  2 , Pieter J Vlaar  3 , Daniël C Overduin  4 , Marleen H van Wely  1 , Hugo M Aarts  2 , Dirk-Jan van Ginkel  4 , 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 , Aysun Cetinyurek-Yavuz  6 , Robin H Heijmen  5 , Jurrien M Ten Berg  4   7 , Pim A L Tonino  3 , Ronak Delewi  2 , Niels van Royen  1
Affiliations
Randomized Controlled Trial

Upper- vs Lower-Extremity Secondary Access During Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial

Geert A A Versteeg et al. JAMA Netw Open. .

Abstract

Importance: An upper-extremity approach for secondary access during transfemoral transcatheter aortic valve implantation (TAVI) may reduce clinically relevant secondary access site-related bleeding.

Objective: To investigate the safety and efficacy of an upper-extremity approach compared with a lower-extremity approach in patients undergoing TAVI.

Design, setting, and participants: The TAVI XS trial was a randomized clinical trial performed between November 28, 2022, and November 15, 2023, with a 30-day follow-up, in 4 TAVI centers in the Netherlands. Eligibility was determined first, and only those patients with severe aortic stenosis and no contraindication for upper- or lower-extremity secondary access were informed about the study and asked to participate.

Intervention: Participants were randomized 1:1 between the upper-extremity approach (radial artery diagnostic access and upper-arm vein for temporary pacing lead placement) and lower-extremity approach (femoral artery diagnostic access and femoral vein for temporary pacing lead placement) for secondary access during TAVI.

Main outcomes and measures: Primary end point was clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) of the randomized secondary access. Secondary end points included any clinically relevant bleeding, time to mobilization, duration of hospitalization, secondary access failure, and procedural time.

Results: Of a total of 324 eligible patients, 238 patients undergoing transfemoral TAVI (mean [SD] age, 79.4 [6.5] years; 150 male [63.0%]; median European System for Cardiac Operative Risk Evaluation II score, 2.2% [IQR, 1.5%-3.5%]) were included. The primary end point occurred in 5 of 119 patients (4.2%) in the upper-extremity group and 16 of 119 (13.4%) in the lower-extremity group (odds ratio [OR], 0.28 [95% CI, 0.10-0.80]; P = .01). Incidence of any clinically relevant bleeding was decreased in the upper-extremity group (25 of 119 [21.0%] vs 41 of 119 [34.5%] patients; OR, 0.51 [95% CI, 0.28-0.91]; P = .02). There was no difference in time to mobilization or duration of hospitalization. Secondary access failure (14 of 119 [11.8%] vs 1 of 119 [0.8%] patients; OR, 15.73 [95% CI, 2.03-121.69]; P = .001) and procedural time (60.0 [IQR, 39.0-88.0; 95% CI, 53.0-70.0] vs 48.0 [IQR, 34.0-64.0; 95% CI, 40.0-55.0] minutes; P = .002) were higher in the upper-extremity cohort.

Conclusion and relevance: In this randomized clinical trial of patients undergoing transfemoral TAVI, the upper-extremity approach for secondary access was associated with less clinically relevant access site-related bleeding compared with the conventional lower-extremity approach and should be considered to reduce periprocedural bleeding complications.

Trial registration: ClinicalTrials.gov Identifier: NCT05672823.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr van Wely reported receiving personal fees from Abbott Vascular and Boston Scientific Corporation outside the submitted work. Prof van Geuns reported receiving consulting and speaker’s fees from Abbott Vascular, AstraZeneca, Sanofi SA, Amgen Inc, and InfraRedx Inc and receiving institutional research grant funding from Amgen Inc, InfraRedx Inc, AstraZeneca, and Sanofi SA. Dr ten Berg reported receiving grant funding from ZonMw (Dutch government) and Daichi Sankyo Company Limited outside the submitted work. Dr Tonino reported receiving grant funding from Opsens and Biosensors International and personal fees from Medtronic PLC outside the submitted work. Dr Delewi reported receiving grant funding from Abiomed Inc, Boston Scientific Corporation, Edwards Lifesciences, and Novartis AG outside the submitted work. Dr van Royen reported receiving grant funding from Abbott Vascular, Koninklijke Philips NV, and Biotronik and speaker’s fees from Abbott Vascular, Suzhou Rainmed Medical Technology Co Ltd, MicroPort, and Bayer AG outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flowchart
Figure 2.
Figure 2.. Bleeding End Points
Primary bleeding end points consisted of clinically relevant bleeding of the randomized secondary access; secondary bleeding end points, any clinically relevant bleeding.
Figure 3.
Figure 3.. Main Secondary and Efficacy End Points
Procedural time (median [IQR]), fluoroscopy time (mean [95% CI]), and time to mobilization (median [IQR]) for the total cohort and for only the 47 patients with a pacing lead in place after the transcatheter aortic valve implantation procedure.
See this image and copyright information in PMC

Comment in

References

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