Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT).

ABSTRACT:

Background

In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required.

Methods/design

Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed

SUBMITTER: Bramlage P 

PROVIDER: S-EPMC4247728 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature