Interventions for valvular disease and heart failure

Chronic haemodynamic performance of a biorestorative transcatheter heart valve in an ovine model

EuroIntervention 2021;17:e1009-e1018. DOI: 10.4244/EIJ-D-21-00386

Patrick Serruys
Patrick W. Serruys1,2,3, MD, PhD; Hideyuki Kawashima4, MD; Chun Chin Chang5, MD; Rodrigo Modolo6,4, MD; Rutao Wang1,7, MD; Robbert J. de Winter4, MD, PhD; Hadewych Van Hauwermeiren8, DVM, MLAS; Mohammed El-Kurdi9, PhD; Wian van den Bergh9, MSc; Martijn Cox9, PhD; Yoshinobu Onuma1, MD, PhD; William Flameng10, MD, PhD; Osama Soliman1,2, MD, PhD
1. Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland; 2. CÚRAM, the SFI Research Centre for Medical Devices, Galway, Ireland; 3. NHLI, Imperial College London, London, United Kingdom; 4. Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; 5. Division of Cardiology, Department of Internal Medicine, Taipei Veterans General Hospital, National Yang Ming University, Taipei, Taiwan; 6. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 7. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands; 8. Medanex Clinic B.V., Preclinical CRO, Diest, Belgium; 9. Xeltis B.V., Eindhoven, the Netherlands; 10. Department of Cardiac Surgery, Katholieke Universiteit (K.U) Leuven, Leuven, Belgium

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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