AIMS: Cardiac surgery in middle-income countries differs significantly from that in high-income countries regarding prevailing heart valve pathologies and access to cardiac surgery. Typically, rheumatic aortic regurgitation in the absence of calcification by far outweighs stenosis. As such, entirely different transcatheter aortic valve implantation (TAVI) concepts are required for these regions. The aim of the study was to evaluate the five-month performance of the SAT (Strait Access Technologies, Cape Town, South Africa) pericardial TAVI system in the orthotopic aortic position of juvenile sheep. METHODS AND RESULTS: A self-homing, non-occlusive balloon-expandable TAVI system comprising a hollow balloon, stabilising locator trunks, a scalloped CoCr stent with elevating anchorage arms and decellularised, sandwich-crosslinked pericardium was compared with control surgical valves (Edwards PERIMOUNT) in sheep. The implantation period was five months. The tactile placement of the TAVI valves was accomplished without the need for rapid pacing. At termination, no structural degeneration was observed in either group. The TAVIs were well healed with the stent struts largely embedded in tissue. Correlating with sheep growth (weight gain of 40.4±13.0%) during the implantation period, mean transvalvular gradients increased from 3.08±1.95 mmHg to 8.50±5.38 mmHg (p=0.044) after five months. CONCLUSIONS: A single-stage, balloon-expandable, easy to place TAVI system with antigen-depleted and antigen-masked bioprosthetic leaflets promises to address the distinct needs of low- and middle-income countries with regard to TAVI better than conventional systems.
AIMS: Cardiac surgery in middle-income countries differs significantly from that in high-income countries regarding prevailing heart valve pathologies and access to cardiac surgery. Typically, rheumatic aortic regurgitation in the absence of calcification by far outweighs stenosis. As such, entirely different transcatheter aortic valve implantation (TAVI) concepts are required for these regions. The aim of the study was to evaluate the five-month performance of the SAT (Strait Access Technologies, Cape Town, South Africa) pericardial TAVI system in the orthotopic aortic position of juvenile sheep. METHODS AND RESULTS: A self-homing, non-occlusive balloon-expandable TAVI system comprising a hollow balloon, stabilising locator trunks, a scalloped CoCr stent with elevating anchorage arms and decellularised, sandwich-crosslinked pericardium was compared with control surgical valves (Edwards PERIMOUNT) in sheep. The implantation period was five months. The tactile placement of the TAVI valves was accomplished without the need for rapid pacing. At termination, no structural degeneration was observed in either group. The TAVIs were well healed with the stent struts largely embedded in tissue. Correlating with sheep growth (weight gain of 40.4±13.0%) during the implantation period, mean transvalvular gradients increased from 3.08±1.95 mmHg to 8.50±5.38 mmHg (p=0.044) after five months. CONCLUSIONS: A single-stage, balloon-expandable, easy to place TAVI system with antigen-depleted and antigen-masked bioprosthetic leaflets promises to address the distinct needs of low- and middle-income countries with regard to TAVI better than conventional systems.
Authors: Piotr P Buszman; Mateusz Kachel; Carlos Fernandez Ceballos; Karolina Łukasik; Wojciech Domaradzki; Maciej Pruski; Armando Tellez; Serge Rousselle; Marta Konopko; Michał Glanc; Paweł Kaźmierczak; Krzysztof P Milewski; Pawel E Buszman Journal: JACC Basic Transl Sci Date: 2022-05-11
Authors: Harish Appa; Kenneth Park; Deon Bezuidenhout; Braden van Breda; Bruce de Jongh; Jandré de Villiers; Reno Chacko; Jacques Scherman; Chima Ofoegbu; Justiaan Swanevelder; Michael Cousins; Paul Human; Robin Smith; Ferdinand Vogt; Bruno K Podesser; Christoph Schmitz; Lenard Conradi; Hendrik Treede; Holger Schröfel; Theodor Fischlein; Martin Grabenwöger; Xinjin Luo; Heather Coombes; Simon Matskeplishvili; David F Williams; Peter Zilla Journal: Front Cardiovasc Med Date: 2022-03-03
Authors: Markus Mach; Philipp Szalkiewicz; Thomas Poschner; Waseem Hasan; Martin Andreas; Bernhard Winkler; Ena Hasimbegovic; Theresia Steinkellner; Andreas Strouhal; Christopher Adlbrecht; Georg Delle-Karth; Martin Grabenwöger Journal: Eur J Clin Invest Date: 2021-05-06 Impact factor: 4.686