title: A personalized approach to interventional treatment of tricuspid regurgitation: experiences from an acute animal study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Amerini
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Nima
authors.initials: N
authors.lastname: Hatam
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Margarita
authors.initials: M
authors.lastname: Malasa
authors.affiliation: Applied Medical Engineering, Helmholtz Institute Aachen, Aachen, Germany.
authors.forename: Desiree
authors.initials: D
authors.lastname: Pott
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Lachmandath
authors.initials: L
authors.lastname: Tewarie
authors.affiliation: Department of Radiology, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Isfort
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Goetzenich
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Hildinger
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Autschbach
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany jspillner@ukaachen.de.
authors.forename: Jan
authors.initials: J
authors.lastname: Spillner
mesh_terms: D000497:Alloys; D000818:Animals; D006328:Cardiac Catheterization / Q000295:instrumentation; D017076:Computer-Aided Design; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D008422:Materials Testing; D023421:Models, Animal; D057285:Precision Medicine; D011474:Prosthesis Design; D015607:Stents; D013552:Swine; D014057:Tomography, X-Ray Computed; D014261:Tricuspid Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D014262:Tricuspid Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014463:Ultrasonography
chemical_list: D000497:Alloys; C013616:nitinol
keywords: Heart valve prosthesis; Tricuspid valve