Upper- vs Lower-Extremity Secondary Access During Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial
Importance
The upper-extremity method for secondary access during Transcatheter Aortic Valve Implantation (TAVI) may lower the risk of bleeding at the access site.
Objective
This study aimed to compare the safety and effectiveness of upper-extremity access versus lower-extremity access in patients receiving TAVI.
Study Overview
The TAVI XS trial was conducted from November 28, 2022, to November 15, 2023, across four centers in the Netherlands. Patients with severe aortic stenosis and no contraindications for either access method were invited to participate.
Intervention
Participants were randomly assigned to either:
- Upper-extremity approach: Access through the radial artery and temporary pacing via the upper-arm vein.
- Lower-extremity approach: Access through the femoral artery and temporary pacing via the femoral vein.
Main Outcomes
The primary goal was to measure clinically relevant bleeding. Secondary goals included overall bleeding, time to mobilization, length of hospital stay, access failure, and procedure duration.
Results
Out of 324 eligible patients, 238 underwent transfemoral TAVI. Key findings include:
- Clinically relevant bleeding occurred in 4.2% of the upper-extremity group compared to 13.4% in the lower-extremity group (P = .01).
- Overall bleeding was lower in the upper-extremity group (21.0% vs 34.5%; P = .02).
- Time to mobilization and hospital stay were similar for both groups.
- Access failure was higher in the upper-extremity group (11.8% vs 0.8%; P = .001).
- Procedure time was longer for the upper-extremity approach (60 minutes vs 48 minutes; P = .002).
Conclusion
The upper-extremity approach in TAVI was linked to significantly less bleeding compared to the lower-extremity method. This approach should be considered to minimize bleeding complications during the procedure.
Trial Registration
ClinicalTrials.gov Identifier: NCT05672823.
Value of Clinical Trials
Clinical trials play a vital role in developing safe and effective treatments. It is essential to integrate their findings into everyday medical practice.
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