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

Autor: Rooijakkers MJP; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands., Versteeg GAA; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands., Hemelrijk KI; Department of Cardiology, Amsterdam University Medical Centre, Amsterdam, The Netherlands., Aarts HM; Department of Cardiology, Amsterdam University Medical Centre, Amsterdam, The Netherlands., Overduin DC; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands., van Ginkel DJ; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands., Vlaar PJ; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., van Wely MH; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands., van Nunen LX; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands., van Geuns RJ; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands., van Garsse LAFM; Department of Cardiothoracic Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Geuzebroek GSC; Department of Cardiothoracic Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Verkroost MWA; Department of Cardiothoracic Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Rodwell L; Department of Health Sciences, Section Biostatistics, Radboud Institute for Health Sciences, Nijmegen, The Netherlands., Heijmen RH; Department of Cardiothoracic Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Tonino PAL; Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands., Ten Berg JM; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.; Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands., Delewi R; Department of Cardiology, Amsterdam University Medical Centre, Amsterdam, The Netherlands., van Royen N; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands. niels.vanroyen@radboudumc.nl.
Jazyk: angličtina
Zdroj: Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation [Neth Heart J] 2024 Aug; Vol. 32 (7-8), pp. 270-275. Date of Electronic Publication: 2024 Apr 23.
DOI: 10.1007/s12471-024-01869-5
Abstrakt: Background: 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.
Trial Design: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total 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) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium‑3 criteria.
Conclusion: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz: