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Predilatation Prior to Transcatheter Aortic Valve Implantation: Is it Still a Prerequisite?

ABSTRACT: Predilatation has been historically considered a mandatory step before transcatheter aortic valve implantation (TAVI) since it facilitates valve crossing and prosthesis delivery, ensures optimal valve expansion and improves hemodynamic stability during valve deployment. However, as a result of procedural evolution over time, direct TAVI (without pre-implantation balloon aortic valvuloplasty) has emerged as an interesting option to simplify the procedure and to avoid potential valvuloplasty-related complications. Several real-world retrospective studies and one small randomised study have shown that direct TAVI (with both self-expanding and balloon-expandable prostheses) is feasible, safe and associated with outcomes similar to standard TAVI with pre-implantation balloon aortic valvuloplasty. In the absence of high-quality, robust evidence, the current review aims to discuss the advantages and disadvantages of omitting predilatation prior to TAVI.

SUBMITTER: Pagnesi M

PROVIDER: S-EPMC5808664 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Predilatation Prior to Transcatheter Aortic Valve Implantation: Is it Still a Prerequisite?

Pagnesi Matteo M Baldetti Luca L Del Sole Paolo P Mangieri Antonio A Ancona Marco B MB Regazzoli Damiano D Buzzatti Nicola N Giannini Francesco F Colombo Antonio A Latib Azeem A

Interventional cardiology (London, England) 20170901 2

Predilatation has been historically considered a mandatory step before transcatheter aortic valve implantation (TAVI) since it facilitates valve crossing and prosthesis delivery, ensures optimal valve expansion and improves hemodynamic stability during valve deployment. However, as a result of procedural evolution over time, direct TAVI (without pre-implantation balloon aortic valvuloplasty) has emerged as an interesting option to simplify the procedure and to avoid potential valvuloplasty-relat ...[more]

PMID: 29588739

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Project description:ObjectiveTranscatheter aortic valve implantation (TAVI) procedures are increasing rapidly, but the durability of tissue valve and periprocedural complications are not satisfactory. Immune reaction to the galactose-α-1,3 galactose β-1,4-N-acetylglucosamine (α-Gal) and conventional processing protocols of cardiac xenografts lead to calcification. Next-generation TAVI needs to be made with α-Gal-free xenografts by multiple anticalcification therapies to avoid immune rejection and enhance durability, and three-dimensional (3D) printing technology to improve the procedural safety.MethodsPorcine pericardia were decellularized and immunologically modified with α-galactosidase. The pericardia were treated by space filler, crosslinked with glutaraldehyde in organic solvent, and detoxified. The sheep-specific nitinol (nickel-titanium memory alloy) wire backbone was made from a 3D-printed model for ovine aortic root. After it passed the fitting test, we manufactured a self-expandable stented valve with the porcine pericardia mounted on the customized nitinol wire-based stent. After in vitro circulation using customized silicone aortic root, we performed TAVI in 9 sheep and obtained hemodynamic, radiological, immunohistopathological, and biochemical results.ResultsThe valve functioned well, with excellent stent fitting and good coronary flow under in vitro circulation. Sheep were sequentially scheduled to be humanely killed until 238 days after TAVI. Echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the aortic valve. The xenografts were well preserved without α-Gal immune reaction or calcification based on the immunological, radiographic, microscopic, and biochemical examinations.ConclusionsWe proved preclinical safety and efficacy for next-generation α-Gal-free TAVI with multiple anticalcification therapies and 3D-printing technology. A future clinical study is warranted based on these promising preclinical results.

Dataset Information

Predilatation Prior to Transcatheter Aortic Valve Implantation: Is it Still a Prerequisite?

Publications

Predilatation Prior to Transcatheter Aortic Valve Implantation: Is it Still a Prerequisite?

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