Neurosciences and Rehabilitation Department, University of Ferrara, Ferrara, Italy.
Cardiovascular Sciences Department, Agostino Gemelli Foundation Polyclinic IRCCS, Rome, Italy.
Interact Cardiovasc Thorac Surg. 2022 Jun 15;35(1). doi: 10.1093/icvts/ivac067.
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.
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.
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.
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.
本研究旨在评估一种创新性二尖瓣装置在具有室内桥结构的慢性环境中的可用性、性能和安全性，该结构可实现人工腱索锚固和/或直接后叶固定。
10 只雌性绵羊被用于装置植入。评估了装置对瓣叶运动的干扰、装置使用的便利性、正确腱索长度估计和植入。通过定期的术后超声心动图和实验室检查验证了术后瓣膜功能和装置性能。安乐死后，对心脏和瓣膜进行大体解剖和组织学评估，以检测与装置相关的组织异常和炎症反应。
10 只绵羊的手术均成功完成。植入的 2 根腱索长度分别为 23（21.5-24）mm 和 23（22.5-24）mm。缝合两对人工腱索所需的时间为 2.7±0.7 分钟。在 3 个月的随访中，左心室功能正常。跨瓣峰值压力梯度为 9（7.5-10）mmHg，平均梯度为 4（3.5-4）mmHg。尸检和组织学评估未见左心室壁、瓣叶、腱索和乳头肌损伤，无血栓形成和炎症反应。影像学图像未显示装置断裂或钙化。实验室检查未见溶血迹象。
体内晚期试验证实了在植入前正确估计腱索长度的便利性、手术时间短和在撕裂的前瓣叶修复中的可用性。装置对二尖瓣瓣叶运动、功能和结构没有负面影响，修复成功，这表明该装置在复杂退行性二尖瓣疾病中可能有用。
