Abstract
BACKGROUND: Physical 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. METHODS: The 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). RESULTS: Lower-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). CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov identifier: NCT05672823.