Amerini Andrea, Hatam Nima, Malasa Margarita, Pott Desiree, Tewarie Lachmandath, Isfort Peter, Goetzenich Andreas, Hildinger Martin, Autschbach Rüdiger, Spillner Jan
Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
Applied Medical Engineering, Helmholtz Institute Aachen, Aachen, Germany.
Interact Cardiovasc Thorac Surg. 2014 Sep;19(3):414-8. doi: 10.1093/icvts/ivu143. Epub 2014 Jun 10.
Interventional treatment of tricuspid valve disease has so far received little attention due to the anatomical challenges in a thrombogenic surrounding. In the present study, we present an imaging-based, personalized interventional approach to the therapy of tricuspid regurgitation.
In our porcine model, we used rapid prototyping to build a matrix reproducing the geometry of the right atrium that was previously derived from computer tomography (CT) scans. Over this matrix, a braided nitinol device fitting almost completely the right atrium was crafted. An additional tubular stent component was developed to carry a tissue valve prosthesis. This part was designed to be connectable to the annular portion of the main device. In our feasibility study, the crimped device was implanted via jugular access into the right atrium of 12 pigs and expanded subsequently. Following isolated implantation of the device without the valve-carrying component, further procedures included implantation of the whole composite device, including the mentioned tissue valve. Representing a only feasibility study, all implantations were performed under full bypass and direct sight. On-site visualization was performed by both echocardiography and fluoroscopy. Additional imaging was realized by postoperative CT scans.
Following implantation, 9 of 12 animals were weaned from cardiopulmonary bypass. Correct positioning of the device and orthodromic blood flow as maintained by the valve prosthesis were demonstrated by echocardiography and fluoroscopy. Postoperative contrast CT evaluation demonstrated proper fitting of the device into the right-sided heart cavities without obstruction of the outflow tract. Autopsy additionally confirmed its correct positioning without major trauma to surrounding structures.
We demonstrated the feasibility in principle of a personalized interventional treatment for tricuspid regurgitation using a braided stent, based on individual cardiac imaging, with anchoring forces mainly exerted on the venae cavae and on the inner surface of the right atrium. The design process of this device is a good indicator of the growing potential of an imaging-based personalized simulation and production approach for the treatment of tricuspid valve disease.
由于在具有血栓形成风险的环境中存在解剖学挑战，三尖瓣疾病的介入治疗迄今为止很少受到关注。在本研究中，我们提出了一种基于成像的、针对三尖瓣反流治疗的个性化介入方法。
在我们的猪模型中，我们使用快速成型技术构建了一个基质，该基质再现了先前从计算机断层扫描（CT）扫描获得的右心房几何形状。在这个基质上，制作了一个几乎完全贴合右心房的编织镍钛诺装置。还开发了一个额外的管状支架部件来承载组织瓣膜假体。这部分设计为可连接到主要装置的环形部分。在我们的可行性研究中，将卷曲的装置通过颈静脉途径植入12头猪的右心房，随后进行扩张。在单独植入不带瓣膜承载部件的装置后，进一步的操作包括植入整个复合装置，包括上述组织瓣膜。作为一项仅为可行性研究，所有植入操作均在完全体外循环和直视下进行。通过超声心动图和荧光透视进行现场可视化。术后CT扫描实现了额外的成像。
植入后，12只动物中有9只成功脱离体外循环。超声心动图和荧光透视显示装置定位正确，瓣膜假体维持正向血流。术后对比CT评估显示装置正确贴合右侧心腔，未阻塞流出道。尸检进一步证实其定位正确，对周围结构无重大创伤。
我们证明了基于个体心脏成像，使用编织支架对三尖瓣反流进行个性化介入治疗在原则上是可行的，其锚固力主要作用于腔静脉和右心房内表面。该装置的设计过程很好地表明了基于成像的个性化模拟和生产方法在治疗三尖瓣疾病方面的巨大潜力。
