Key result
The Xeltis biorestorative transcatheter heart valve iteration D demonstrated intact leaflets, 0% moderate or greater aortic regurgitation, and a mean transvalvular gradient of 11.2±4.1 mmHg at 12 months in an ovine model.
Why the study?
Following favorable acute haemodynamic performance, preclinical feasibility and haemodynamic performances of five pilot biorestorative transcatheter heart valve designs required evaluation up to 12 months in a chronic ovine model.
Does the Xeltis biorestorative transcatheter heart valve demonstrate acceptable haemodynamic performance and endogenous tissue restoration up to 12 months in an ovine model?
Does the Xeltis biorestorative transcatheter heart valve demonstrate acceptable haemodynamic performance and endogenous tissue restoration up to 12 months in an ovine model?
Iteration D of the Xeltis biorestorative transcatheter heart valve demonstrated acceptable haemodynamic performance and intact leaflets with advanced tissue coverage at 12 months in an ovine model, illustrating its potential for endogenous tissue restoration.
No immediate clinical implications; leaves open translation of biorestorative THV performance to human trials.
BACKGROUND: The Xeltis biorestorative transcatheter heart valve (BTHV) leaflets are made from an electrospun bioabsorbable supramolecular polycarbonate-urethane and are mounted on a self-expanding nitinol frame. The acute haemodynamic performance of this BTHV was favourable. AIMS: We sought to demonstrate the preclinical feasibility of a novel BTHV by evaluating the haemodynamic performances of five pilot valve designs up to 12 months in a chronic ovine model. METHODS: Five design iterations (A, B, B', C, and D) of the BTHV were transapically implanted in 46 sheep; chronic data were available in 39 animals. Assessments were performed at implantation, 3, 6, and 12 months including quantitative aortography, echocardiography, and histology. RESULTS: At 12 months, greater than or equal to moderate AR on echocardiography was seen in 0%, 100%, 33.3%, 100%, and 0% in the iterations A, B, B', C, and D, respectively. Furthermore, transprosthetic mean gradients on echocardiography were 10.0±2.8 mmHg, 19.0±1.0 mmHg, 8.0±1.7 mmHg, 26.8±2.4 mmHg, and 11.2±4.1 mmHg, and effective orifice area was 0.7±0.3 cm2, 1.1±0.3 cm2, 1.5±1.0 cm2, 1.5±0.6 cm2, and 1.0±0.4 cm2 in the iterations A, B, B', C, and D, respectively. On pathological evaluation, the iteration D demonstrated generally intact leaflets and advanced tissue coverage, while different degrees of structural deterioration were observed in the other design iterations. CONCLUSIONS: Several leaflet material iterations were compared for the potential to demonstrate endogenous tissue restoration in an aortic valve in vivo. The most promising iteration showed intact leaflets and acceptable haemodynamic performance at 12 months, illustrating the potential of the BTHV.
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A 2021 study studied Preclinical evaluation of transcatheter heart valve (n=46). Xeltis biorestorative transcatheter heart valve (BTHV) was evaluated on Aortic regurgitation severity and transprosthetic mean gradients at 12 months. The Xeltis biorestorative transcatheter heart valve iteration D demonstrated intact leaflets, 0% moderate or greater aortic regurgitation, and a mean transvalvular gradient of 11.2±4.1 mmHg at 12 months in an ovine model.
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