Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2026
Extremity Function After Transfemoral Transcatheter Aortic Valve Implantation: A TAVI XS Sub-Study.
Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05672823 (Minimally-Invasive Upper Extremity Approach Versus Lower Extremity Approach for Transcatheter Aortic Valve Implantation), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Minimally-Invasive Upper Extremity Approach Versus Lower Extremity Approach for Transcatheter Aortic Valve Implantation (TAVI) Accessory Access Sites; A Prospective, Multicenter, Investigator-Initiated, Randomized Clinical Trial
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21 authors.
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Abstract
backgroundPhysical decline after transcatheter aortic valve implantation (TAVI) is associated with worse outcomes. However, data on post-TAVI extremity function are limited. This sub-study of the TAVI XS trial aimed to assess extremity function after transfemoral TAVI, evaluate functional decline, compare outcomes between upper-and lower-extremity secondary access approaches and identify predictors of functional decline after TAVI.
methodsThe TAVI XS was a randomized clinical trial comparing upper- and lower-extremity secondary access during TAVI. Patients were assessed for extremity function at baseline and at 30 days using the Lower Extremity Function Scale (higher score indicating better function) and the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (higher score indicating worse function).
resultsLower-extremity (45.0 [IQR 35.0-57.0] to 52.0 [39.0-63.0]; p < 0.001), and upper-extremity function (11.4 [2.3-25.0] to 6.8 [0-22.7]; p = 0.003) improved after TAVI. Relevant decline in lower-extremity function occurred in 20 (8.4%) patients, and in upper-extremity function in 19 (8.0%) patients. No differences in post-TAVI function were observed between upper- or lower-extremity secondary access (lower-extremity: 10.1% vs. 6.7%; p = 0.35, upper-extremity: 7.6% vs. 8.4%; p = 0.81). Predictors (OR [95% CI]) of clinically relevant decline were baseline use of dual antiplatelet therapy/oral anticoagulants (4.17 [1.39-12.49]; p = 0.01) for lower-extremity function and multiple punctures (4.05 [1.46-11.24]; p = 0.007) for upper-extremity function. Age inversely affected lower- (0.92 [0.85-0.99/year]; p = 0.02) and upper-extremity function (0.93 [0.86-0.99/year]; p = 0.04).
conclusionsThe incidence of clinically relevant decline in extremity function after TAVI is low. No differences in reported extremity function were observed between the upper- and lower-extremity secondary access approach. Predictors of decline were antithrombotic therapy and multiple punctures.
trial registrationClinicalTrials.gov identifier: NCT05672823.
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