Department of Cardiac Surgery, San Raffaele Hospital, Milan, Italy.
Eur J Cardiothorac Surg. 2012 Sep;42(3):524-9. doi: 10.1093/ejcts/ezs069. Epub 2012 Apr 4.
The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system.
Adult swines (n = 15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days.
All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12 ± 3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence.
Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.
本研究旨在评估一种经导管二尖瓣环成形术系统的技术可行性和性能。
15 头成年猪通过第 4-5 肋间行左开胸术。在心脏跳动的情况下，通过经心尖超声和透视引导，将一种经导管装置（CardioBand，Valtech-Cardio Ltd）经 18F 鞘管引入左心房，并将其固定于后前连合之间的瓣环上。使用可控输送系统将无缝线装置植入，以展开连续的固定元件。植入后，在心脏跳动下，根据超声心动图的指导，调整装置长度以减小瓣环的后前向和间隔侧向间距。最后，从工作鞘管中退出柔性调节工具并关闭心房荷包。除了 5 只动物以外，所有动物均因故意急性处死，其余动物在 90 天后处死。
所有动物均成功完成急性植入。1 只动物在术后第 3 天因出血死亡。所有动物均成功植入了二尖瓣环成形系统。平均植入 12±3 个固定元件。每个动物植入后瓣环长度减少 20%。尸检时，植入物的位置距瓣环几毫米（3.5±4mm）。在 3 只动物中，固定元件无意中植入瓣叶，但未观察到冠状动脉损伤。所有动物均成功完成急性植入。1 只动物在术后第 3 天因出血死亡。在 4 只长期存活的动物中，植入的二尖瓣环成形装置愈合良好，瓣环无裂开。
经导管微创、心脏跳动时植入可调式瓣环成形带在动物模型中是可行的。这种方法可能是高危患者替代开胸手术的一种选择。
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