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Pre-implantation balloon-aortic valvuloplasty before transcatheter aortic valve implantation: is this still needed?

ABSTRACT: Balloon aortic valvuloplasty (BAV) has historically been recommended prior to transcatheter aortic valve implantation (TAVI). Pre-implantation BAV (pBAV) creates fractures at the level of calcified leaflets, thereby facilitating delivery of the transcatheter valve system across the diseased aortic valve and, enhances prosthesis implantation and expansion within the calcified aortic valve annulus. New device designs, lower profile delivery systems and increasing operator experience have enabled direct-TAVI (without pBAV), and its appeal amongst TAVI operators enhanced the dissemination of a direct TAVI approach across many centres. In this review, we discuss contemporary evidence that inform the debate on the need for routine pBAV for TAVI candidates and present a framework that may assist operators in selecting patients for pBAV.

SUBMITTER: Kotronias RA

PROVIDER: S-EPMC6242918 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Pre-implantation balloon-aortic valvuloplasty before transcatheter aortic valve implantation: is this still needed?

Kotronias Rafail A RA Teitelbaum Michael M Bagur Rodrigo R

Journal of thoracic disease 20181101 Suppl 30

Balloon aortic valvuloplasty (BAV) has historically been recommended prior to transcatheter aortic valve implantation (TAVI). Pre-implantation BAV (pBAV) creates fractures at the level of calcified leaflets, thereby facilitating delivery of the transcatheter valve system across the diseased aortic valve and, enhances prosthesis implantation and expansion within the calcified aortic valve annulus. New device designs, lower profile delivery systems and increasing operator experience have enabled d ...[more]

PMID: 30505541

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Project description:BackgroundIn 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/designTherefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning.DiscussionData provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis.Trial registrationClinicalTrials.gov Identifier: NCT02127580.

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