Key result
Implantation of a new mitral valve device was successful in 100% of sheep (10/10), demonstrating normal left ventricular function, low pressure gradients, and no tissue damage at 3 months.
Why the study?
This study aimed to evaluate the usability, performance, and safety of an innovative mitral valve device featuring an intraventricular bridge for artificial chordae anchoring and/or direct posterior leaflet fixation in a chronic setting.
Does an innovative mitral valve device with an intraventricular bridge demonstrate usability, performance, and safety in a sheep model?
Does an innovative mitral valve device with an intraventricular bridge demonstrate usability, performance, and safety in a sheep model?
An innovative mitral valve device with an intraventricular bridge demonstrated safety, usability, and preserved valve function at 3 months in a sheep model, suggesting potential utility for complex degenerative mitral disease.
Answers are grounded in this paper and cite their sources.
Device success in sheep is hypothesis-generating; human trials needed before clinical translation.
OBJECTIVES: This study aimed to evaluate the usability, performance and safety of an innovative mitral valve device in the chronic setting characterized by an intraventricular bridge, which enables artificial chordae anchoring and/or direct posterior leaflet fixation. METHODS: Ten female sheep were employed and underwent device implantation. Any interference of the device with leaflet motion, ease of device use, correct chordae length estimation and implantation were evaluated. Post-procedural valve competence and device performance were verified by periodic postoperative echocardiograms and laboratory examinations. Following euthanasia, gross anatomy and histology evaluation of the hearts and valves were performed to detect tissue abnormalities and inflammation reaction related to the device. RESULTS: The procedure was successfully completed in all 10 sheep. Lengths of the 2 chordae implanted were 23 (21.5-24) mm and 23 (22.5-24) mm. The time required to suture both pairs of the artificial chordae was 2.7 ± 0.7 min. At the 3-month follow-up, left ventricular function was normal. The transvalvular peak pressure gradient was 9 (7.5-10) and the mean gradient was 4 (3.5-4) mmHg. Upon necropsy and histological evaluation, no damage to left ventricle wall, valve leaflets, chordae and papillary muscles and absence of thrombus formation and inflammatory reaction were observed. Radiological images showed neither fracture of the device nor calcifications. Laboratory tests showed no signs of haemolysis. CONCLUSIONS: In vivo late tests confirmed the ease of correct chordal length estimation prior to implantation, short operative time and usability in flailed anterior leaflet repair. The absence of negative impact of the device on mitral leaflets motion, function and structure and successful repair might suggest that the device would be useful in complex degenerative mitral disease.
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Zeitani et al. (2022) studied Degenerative mitral regurgitation (n=10). Innovative mitral valve device (intraventricular bridge) was evaluated on Usability, performance and safety (including procedure success, valve competence, and tissue abnormalities). Implantation of a new mitral valve device was successful in 100% of sheep (10/10), demonstrating normal left ventricular function, low pressure gradients, and no tissue damage at 3 months.
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