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Transcatheter aortic valve implantation economics: a grisly reality.

ABSTRACT: Transcatheter aortic valve implantation (TAVI), an established treatment for inoperable and high-risk operable symptomatic patients with severe aortic stenosis with growing numbers of procedures and expanding indications, is an expensive therapy. Cost-effectiveness analyses rely on the value of the incremental cost-effectiveness ratio (ICER), which is the difference in cost between two possible interventions, divided by the difference in their effect. Several analyses have demonstrated that TAVI is cost-effective with an acceptable ICER for the inoperable patient alone and only via the iliofemoral route, while TAVI is more costly and is either less or equally effective as surgery in high-risk operable patients. When use of TAVI is extended to include a larger number of patients suitable for surgery, the overall results become less favorable. Acceptable ICERs should practically equate to the value of the gross domestic product (GDP) per capita in each country; however, the cost of the TAVI kit alone already exceeds the GDP per capita of all moderate- and low-income countries. An overview of the current cost-efficacy issues of TAVI is presented and this grisly reality is discussed, which may hopefully be improved in the future.

SUBMITTER: Manolis AS

PROVIDER: S-EPMC5639228 | biostudies-other | 2017 Sep

REPOSITORIES: biostudies-other

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Transcatheter aortic valve implantation economics: a grisly reality.

Manolis Antonis S AS

Annals of cardiothoracic surgery 20170901 5

Transcatheter aortic valve implantation (TAVI), an established treatment for inoperable and high-risk operable symptomatic patients with severe aortic stenosis with growing numbers of procedures and expanding indications, is an expensive therapy. Cost-effectiveness analyses rely on the value of the incremental cost-effectiveness ratio (ICER), which is the difference in cost between two possible interventions, divided by the difference in their effect. Several analyses have demonstrated that TAVI ...[more]

PMID: 29062748

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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

Transcatheter aortic valve implantation economics: a grisly reality.

Publications

Transcatheter aortic valve implantation economics: a grisly reality.

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