Chiariello Giovanni Alfonso, Kuci Saimir, Saitto Guglielmo, Massetti Massimo, Alfieri Ottavio, Zeitani Jacob
Cardiovascular Sciences Department, Agostino Gemelli Foundation Polyclinic IRCSS, Rome, Italy.
Catholic University of The Sacred Heart, Rome, Italy.
J Med Eng Technol. 2021 Apr;45(3):197-206. doi: 10.1080/03091902.2021.1891312. Epub 2021 Mar 23.
Mitral valve repair is typically performed by implanting a ring-like device at the valve annulus to reshape the annulus and to improve leaflet coaptation. In most cases, some additional procedures are needed, including leaflet resection and artificial chordae implantation. However, artificial chordae implantation could be technically challenging and postoperative left ventricular remodeling could increase the risk of recurrent mitral regurgitation. We propose an innovative annular device made of chromo-cobalt, finalized not only to reshape the annulus but also to enable anchoring of leaflets to a fixed intraventricular structure. Durability evaluation of the device was tested by applying eight radial force vectors equally spaced along the ring and related fatigue analysis. To evaluate the efficacy of the mitral valvuloplasty using the tested ring, the device was implanted in five adult swine hearts. Functional analysis of the ring was performed by measuring left ventricular pressure and fluid volume loss, following implantation in normal and dysfunctional mitral valve leaflets. Both fatigue and functional analysis showed satisfactory and promising results in terms of durability and efficacy of mitral valve repair. Because of its favorable durability and functional characteristics this device appears promising and provides good results in terms of valve competence, thus avoiding both manipulations of papillary muscles and interference in left ventricular hemodynamics. However, an test is mandatory to fully understand the impact of the device on subvalvular apparatus.
二尖瓣修复通常通过在瓣环处植入环形装置来重塑瓣环并改善瓣叶对合。在大多数情况下，还需要一些额外的操作，包括瓣叶切除和人工腱索植入。然而，人工腱索植入在技术上可能具有挑战性，并且术后左心室重塑可能会增加二尖瓣反流复发的风险。我们提出了一种由铬钴制成的创新环形装置，其不仅旨在重塑瓣环，还能使瓣叶锚定到固定的心室内结构。通过沿环等间距施加八个径向力向量并进行相关疲劳分析来测试该装置的耐久性。为了评估使用测试环进行二尖瓣成形术的效果，将该装置植入五头成年猪的心脏中。在正常和功能失调的二尖瓣叶植入后，通过测量左心室压力和液体量损失来对环进行功能分析。疲劳分析和功能分析在二尖瓣修复的耐久性和效果方面均显示出令人满意且有前景的结果。由于其良好的耐久性和功能特性，该装置似乎很有前景，并且在瓣膜功能方面提供了良好的结果，从而避免了对乳头肌的操作以及对左心室血流动力学的干扰。然而，必须进行进一步测试以充分了解该装置对瓣下结构的影响。
