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

Abstract

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. The TAVI XS trial is amulticentre, randomised, open-label clinical trial with blinded evaluation of endpoints. Atotal 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) type2, 3or 5bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type2, 3or 5bleeding, and early safety at 30days according to Valve Academic Research Consortium‑3 criteria. The TAVI XS trial is the first randomised trial comparing an upper extremity approach to alower 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.