title: Transcatheter treatment of tricuspid regurgitation by caval valve implantation--experimental evaluation of decellularized tissue valves in central venous position.
abstract: BACKGROUND
  Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR.
  
  
  RESULTS
  Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54-98 kg; median 74.5 kg, n = 8) of severe TR. The devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, device function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves.
  
  
  CONCLUSIONS
  In the venous circulation in severe TR, decellularized valves show superior functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with evidence of less degradation in dTV. © 2014 Wiley Periodicals, Inc.
authors.affiliation: Department of Internal Medicine I (Cardiology, Angiology, Pneumology, Intensive Care Medicine), University Heart Center, Friedrich-Schiller-University, Jena, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Lauten
authors.forename: Adrian
authors.initials: A
authors.lastname: Laube
authors.forename: Harald
authors.initials: H
authors.lastname: Schubert
authors.forename: Sabine
authors.initials: S
authors.lastname: Bischoff
authors.forename: Sandor
authors.initials: S
authors.lastname: Nietzsche
authors.forename: Kim
authors.initials: K
authors.lastname: Horstkötter
authors.forename: Bhawana
authors.initials: B
authors.lastname: Poudel-Bochmann
authors.forename: Marcus
authors.initials: M
authors.lastname: Franz
authors.forename: Artur
authors.initials: A
authors.lastname: Lichtenberg
authors.forename: Hans R
authors.initials: HR
authors.lastname: Figulla
authors.forename: Payam
authors.initials: P
authors.lastname: Akhyari
mesh_terms: D000497:Alloys; D000818:Animals; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D002908:Chronic Disease; D004195:Disease Models, Animal; D005260:Female; D005786:Gene Expression Regulation; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D006439:Hemodynamics; D011474:Prosthesis Design; D020127:Recovery of Function; D012720:Severity of Illness Index; D012756:Sheep; D015607:Stents; D013997:Time Factors; D014261:Tricuspid Valve / Q000000981:diagnostic imaging / Q000378:metabolism / Q000503:physiopathology / Q000648:ultrastructure; D014262:Tricuspid Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014463:Ultrasonography; D014682:Vena Cava, Inferior; D014683:Vena Cava, Superior
chemical_list: D000497:Alloys; C013616:nitinol
keywords: decellularized valves; tricuspid regurgitation