A personalized approach to interventional treatment of tricuspid regurgitation: experiences from an acute animal study

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.