The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Chronic Hemodynamic Performance of a Biorestorative Transcatheter Heart Valve in an Ovine Model

DOI: 10.4244/EIJ-D-21-00386

1. Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland and NHLI, Imperial College London, London, United Kingdom, London, United Kingdom
2. Department of Cardiology, National University of Ireland, Galway (NUIG)
3. Division of Cardiology, Department of Internal Medicine, Taipei Veterans General Hospital, National Yang Ming University, Taipei, Taiwan.
4. Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas (UNICAMP). Campinas, Brazil
5. Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
6. Medanex Clinic B.V., Preclinical CRO, Diest, Belgium
7. Xeltis B.V., Eindhoven, the Netherlands
8. Department of Cardiac Surgery, Katholieke Universiteit (K.U) Leuven, Leuven, Belgium.
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Background: The Xeltis biorestorative transcatheter heart valve (BTHV) leaflets are made from an eletrospun bioabsorbable supramolecular polycarbonate-urethane and are mounted on a self-expanding nitinol frame. Acute hemodynamic performance of this BTHV was favorable.

Aims: We sought to demonstrate preclinical feasibility of a novel BTHV by evaluating the hemodynamic performances of 5 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 was 10.0±2.8mmHg, 19.0±1.0mmHg, 8.0±1.7mmHg, 26.8±2.4mmHg, and 11.2±4.1mmHg, and effective orifice area was 0.7±0.3cm2, 1.1±0.3cm2, 1.5±1.0cm2, 1.5±0.6cm2, and 1.0±0.4cm2 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 potential to demonstrate endogenous tissue restoration in an aortic valve in-vivo. The most promising iteration showed intact leaflets and acceptable hemodynamic performance at 12 months, illustrating the potential of BTHV.

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