TY - JOUR JO - EuroIntervention TI - Preclinical evaluation of a transcatheter aortic valve replacement system for patients with rheumatic heart disease AB - <p><strong>Aims:</strong> 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.</p> <p><strong>Methods and results:</strong> 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&plusmn;13.0%) during the implantation period, mean transvalvular gradients increased from 3.08&plusmn;1.95 mmHg to 8.50&plusmn;5.38 mmHg (p=0.044) after five months.</p> <p><strong>Conclusions:</strong> 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.</p> AU - Scherman Jacques AU - Ofoegbu Chima AU - Myburgh Adriaan AU - Swanevelder Justiaan AU - van Breda Braden AU - Appa Harish AU - Human Paul AU - Williams David AU - Bezuidenhout Deon AU - Zilla Peter VL - 15 IS - 11 Y1 - 06/12/2019 Y1 - 2019 DOI - 10.4244/EIJ-D-18-01052 SP - e975 EP - e982 KW - aortic regurgitation KW - preclinical research KW - tavi PB - Europa Digital & Publishing SE - Interventions for valvular disease and heart failure UR - https://eurointervention.pcronline.com/article/preclinical-evaluation-of-a-transcatheter-aortic-valve-replacement-system-for-patients-with-rheumatic-heart-disease SN - 1774-024X ER -