Author + information
- Received June 10, 2014
- Revision received September 8, 2014
- Accepted October 8, 2014
- Published online March 1, 2015.
- Toby Rogers, BM, BCh∗,
- Kanishka Ratnayaka, MD∗,†,
- Merdim Sonmez, PhD∗,
- Dominique N. Franson, BS∗,
- William H. Schenke, BA∗,
- Jonathan R. Mazal, MS∗,
- Ozgur Kocaturk, PhD∗,‡,
- Marcus Y. Chen, MD∗,
- Anthony Z. Faranesh, PhD∗ and
- Robert J. Lederman, MD∗∗ ()
- ∗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
- ‡Institute of Biomedical Engineering, Bogazici University, Istanbul, Turkey
- ↵∗Reprint requests and correspondence:
Dr. Robert J. Lederman, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 2c713, Bethesda, Maryland 20892-1538.
Objectives 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.
This work was supported by the Division of Intramural Research, NHLBI, NIH (Z01-HL006040). Dr. Rogers, Dr. Ratnayaka, Dr. Sonmez, Ms. Franson, Dr. Kocaturk, and Dr. Lederman are coinventors on patents, assigned to NIH, for TRAIPTA devices. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 10, 2014.
- Revision received September 8, 2014.
- Accepted October 8, 2014.
- 2015 American College of Cardiology Foundation