Authors
Marco Ancona, Ciro Salvatore Vella, Vittorio Romano, Luca Ferri, Filippo Russo, Barbara Bellini, Domitilla Gentile, Greca Zanda, Christos Papageorgiou, Eustachio Agricola, Antonio Esposito,
Matteo Montorfano.
Background
Valve-in-valve transcatheter aortic valve replacement (ViV TAVR) will rapidly increase in the next future, both with TAV-in-SAV (transcatheter aortic valve in surgical aortic valve) and TAV-in-TAV (transcatheter aortic valve in transcatheter aortic valve) procedures. Recrossing of degenerated bioprosthesis is usually more challenging than native aortic valve and, sometimes, could even be impossible. An effective ViV TAVR requires a safe and correct recrossing of the degenerated bioprosthesis.
AIMS
Methods
Results
Twenty patients were enrolled in the study (8 patients in THV group, 6 patients in degenerated surgical aortic bioprosthesis group, 6 patients in native aortic valve group). The primary endpoint of device safety was achieved in all the patients. No device-related complications occurred. According to secondary endpoint, technical success was achieved in all the study population. The overall effectiveness of crossing procedure with study device was different among the three study groups, ranging from 100% in the THV group to 16.6% in degenerated surgical bioprosthesis group.
Conclusions
The EasyCross catheter is the first device specifically developed to help aortic valve recrossing. In this first in human feasibility trial, the primary endpoint of safety of the EasyCross catheter was met in all the patients and the secondary endpoint of efficacy was promising. Further studies will be needed to prove the efficacy of the device in larger series.
Original Article
Read the original Article on Science Direct
