title: Transatrial intrapericardial tricuspid annuloplasty.
abstract: OBJECTIVE
  This study sought to demonstrate transcatheter deployment of a circumferential device within the pericardial space to modify tricuspid annular dimensions interactively and to reduce functional tricuspid regurgitation (TR) in swine.
  
  
  BACKGROUND
  Functional TR is common and is associated with increased morbidity and mortality. There are no reported transcatheter tricuspid valve repairs. We describe a transcatheter extracardiac tricuspid annuloplasty device positioned in the pericardial space and delivered by puncture through the right atrial appendage. We demonstrate acute and chronic feasibility in swine.
  
  
  METHODS
  Transatrial intrapericardial tricuspid annuloplasty (TRAIPTA) was performed in 16 Yorkshire swine, including 4 with functional TR. Invasive hemodynamics and cardiac magnetic resonance imaging (MRI) were performed at baseline, immediately after annuloplasty and at follow-up.
  
  
  RESULTS
  Pericardial access via a right atrial appendage puncture was uncomplicated. In 9 naïve animals, tricuspid septal-lateral and anteroposterior dimensions, the annular area and perimeter, were reduced by 49%, 31%, 59%, and 24% (p < 0.001), respectively. Tricuspid leaflet coaptation length was increased by 53% (p < 0.001). Tricuspid geometric changes were maintained after 9.7 days (range, 7 to 14 days). Small effusions (mean, 46 ml) were observed immediately post-procedure but resolved completely at follow-up. In 4 animals with functional TR, severity of regurgitation by intracardiac echocardiography was reduced.
  
  
  CONCLUSIONS
  Transatrial intrapericardial tricuspid annuloplasty is a transcatheter extracardiac tricuspid valve repair performed by exiting the heart from within via a transatrial puncture. The geometry of the tricuspid annulus can interactively be modified to reduce severity of functional TR in an animal model.
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Toby
authors.initials: T
authors.lastname: Rogers
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland; Department of Cardiology, Children's National Medical Center, Washington, DC.
authors.forename: Kanishka
authors.initials: K
authors.lastname: Ratnayaka
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Merdim
authors.initials: M
authors.lastname: Sonmez
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Dominique N
authors.initials: DN
authors.lastname: Franson
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: William H
authors.initials: WH
authors.lastname: Schenke
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Mazal
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland; Institute of Biomedical Engineering, Bogazici University, Istanbul, Turkey.
authors.forename: Ozgur
authors.initials: O
authors.lastname: Kocaturk
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Marcus Y
authors.initials: MY
authors.lastname: Chen
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Anthony Z
authors.initials: AZ
authors.lastname: Faranesh
authors.affiliation: Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: lederman@nih.gov.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lederman
mesh_terms: D000818:Animals; D020517:Atrial Appendage; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D058385:Cardiac Valve Annuloplasty / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D004195:Disease Models, Animal; D005240:Feasibility Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006439:Hemodynamics; D008279:Magnetic Resonance Imaging; D011474:Prosthesis Design; D011677:Punctures; D013552:Swine; D013997:Time Factors; D014261:Tricuspid Valve / Q000503:physiopathology*; D014262:Tricuspid Valve Insufficiency / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*
keywords: annuloplasty; structural heart interventions; transcatheter repair; tricuspid regurgitation