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Outcome after transvascular transcatheter aortic valve implantation in 2016.

ABSTRACT: We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany.All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P?=?0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P?

SUBMITTER: Gaede L

PROVIDER: S-EPMC5837346 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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Outcome after transvascular transcatheter aortic valve implantation in 2016.

Gaede Luise L Blumenstein Johannes J Liebetrau Christoph C Dörr Oliver O Kim Won-Keun WK Nef Holger H Husser Oliver O Elsässer Albrecht A Hamm Christian W CW Möllmann Helge H

European heart journal 20180201 8

<h4>Aims</h4>We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany.<h4>Methods and results</h4>All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especiall ...[more]

PMID: 29228149

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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

Outcome after transvascular transcatheter aortic valve implantation in 2016.

Publications

Outcome after transvascular transcatheter aortic valve implantation in 2016.

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