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Sheathless Transcaval Transcatheter Aortic Valve Implantation Through an Abdominal Aortic Graft.

ABSTRACT: An 82-year-old patient presented with severe symptomatic aortic stenosis, a high surgical risk profile, and a history of abdominal aortic replacement. Arterial access vessel conditions precluded transarterial transcatheter aortic valve implantation (TAVI). Transcaval access through the aortic graft was achieved; however, tortuosity and resistance at the graft entry site hampered insertion of the introducer sheath and delivery system. Transcaval TAVI without a sheath was contemplated with the expectation of aortocaval fistulous decompression of blood around the TAVI catheter. Hemodynamic measures remained stable, and the valve was successfully implanted. This case illustrates the feasibility of sheathless transcaval TAVI without relevant hemodynamic compromise.

SUBMITTER: Lanz J

PROVIDER: S-EPMC6437678 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Sheathless Transcaval Transcatheter Aortic Valve Implantation Through an Abdominal Aortic Graft.

Lanz Jonas J Pilgrim Thomas T Greenbaum Adam B AB Lederman Robert J RJ Windecker Stephan S

The Canadian journal of cardiology 20181016 12

An 82-year-old patient presented with severe symptomatic aortic stenosis, a high surgical risk profile, and a history of abdominal aortic replacement. Arterial access vessel conditions precluded transarterial transcatheter aortic valve implantation (TAVI). Transcaval access through the aortic graft was achieved; however, tortuosity and resistance at the graft entry site hampered insertion of the introducer sheath and delivery system. Transcaval TAVI without a sheath was contemplated with the exp ...[more]

PMID: 30527166

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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.

Project description:BACKGROUND:Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. OBJECTIVES:The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. METHODS:A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. RESULTS:Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. CONCLUSIONS:Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).

Dataset Information

Sheathless Transcaval Transcatheter Aortic Valve Implantation Through an Abdominal Aortic Graft.

Publications

Sheathless Transcaval Transcatheter Aortic Valve Implantation Through an Abdominal Aortic Graft.

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