Transapical Mitral Implantation of the Tiara Bioprosthesis Pre-Clinical Results

被引:32
作者
Banai, Shmuel [1 ]
Verheye, Stefan [2 ]
Cheung, Anson [3 ]
Schwartz, Marc [4 ]
Marko, Alexei [4 ]
Lane, Randy [4 ]
Jolicoeur, E. Marc [5 ]
Garceau, Patrick [5 ]
Biner, Simon [1 ]
Tanguay, Jean-Francois [5 ]
Edelman, Elazer R. [6 ]
White, Christopher J. [7 ]
机构
[1] Tel Aviv Med Ctr & Sch Med, Dept Cardiol, IL-64239 Tel Aviv, Israel
[2] ZNA Middelheim Hosp, Dept Cardiol, Antwerp, Belgium
[3] St Pauls Hosp, Cardiac Surg Dept, Vancouver, BC V6Z 1Y6, Canada
[4] Neovasc Inc, Vancouver, BC, Canada
[5] Montreal Heart Inst, Dept Cardiol, Montreal, PQ H1T 1C8, Canada
[6] Harvard MIT, Ctr Biomed Engn, Cambridge, MA USA
[7] John Ochsner Heart & Vasc Inst, Med Ctr, Dept Cardiol, New Orleans, LA USA
关键词
mitral regurgitation; mitral valve; mitral valve implantation; transapical; transcatheter; DENIED SURGERY; HEART-DISEASE; VALVE REPAIR;
D O I
10.1016/j.jcin.2013.10.009
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives This study sought to describe the pre-clinical evaluation of transapical mitral implantation of the Tiara (Neovasc Inc, Vancouver, British Columbia, Canada) valve in preparation for first-in-man implantation. Background The Tiara is a transcatheter self-expanding mitral bioprosthesis, specifically designed for the complex anatomic configuration of the mitral apparatus. Methods Tiara valves were implanted in a short-term porcine model, in a long-term ovine model, and in human cadavers. Results Short-term and long-term evaluation demonstrated excellent function and alignment of the valves, with no left ventricular outflow tract obstruction, coronary artery obstruction, or transvalvular gradients. Long-term evaluation of 7 sheep demonstrated clinically stable animals. A mild degree of prosthetic valve regurgitation was seen in 2 of the 7 sheep. A mild-to-moderate degree of paravalvular leak, which was attributed to this animal model, was observed in 6 of these animals. Cardioscopy and macroscopic evaluation demonstrated stable and secure positioning of the Tiara valve with no evidence of injury to the ventricular or atrial walls. Pericardial leaflets were free and mobile without calcifications. Implantation of the Tiara valves in human cadaver hearts demonstrated, upon visual inspection, proper anatomic alignment and seating of the valve, both at the atrial and at the ventricular aspects of the native mitral apparatus. Conclusions In preparation for the first-in-man transcatheter mitral valve implantation, we report the successful pre-clinical evaluation of the Tiara transcatheter self-expanding mitral bioprosthetic valve. In porcine and ovine models without mitral regurgitation, transapical mitral implantation of the Tiara valve is technically feasible and safe, and results in a stable and well-functioning mitral bioprosthesis. (C) 2014 by the American College of Cardiology Foundation
引用
收藏
页码:154 / 162
页数:9
相关论文
共 10 条
[1]   Tiara: A Novel Catheter-Based Mitral Valve Bioprosthesis Initial Experiments and Short-Term Pre-Clinical Results [J].
Banai, Shmuel ;
Jolicoeur, E. Marc ;
Schwartz, Marc ;
Garceau, Patrick ;
Biner, Simon ;
Tanguay, Jean-Francois ;
Cartier, Raymond ;
Verheye, Stefan ;
White, Christopher J. ;
Edelman, Elazer .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2012, 60 (15) :1430-1431
[2]   Percutaneous Transcatheter Mitral Valve Repair A Classification of the Technology [J].
Chiam, Paul T. L. ;
Ruiz, Carlos E. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (01) :1-13
[3]   Decision-making in elderly patients with severe aortic stenosis:: why are so many denied surgery? [J].
Iung, B ;
Cachier, A ;
Baron, G ;
Messika-Zeitoun, D ;
Delahaye, F ;
Tornos, P ;
Gohlke-Bärwolf, C ;
Boersma, E ;
Ravaud, P ;
Vahanian, A .
EUROPEAN HEART JOURNAL, 2005, 26 (24) :2714-2720
[4]   A prospective survey of patients with valvular heart disease in Europe:: The Euro Heart Survey on Valvular Heart Disease [J].
Iung, B ;
Baron, G ;
Butchart, EG ;
Delahaye, F ;
Gohlke-Bärwolf, C ;
Levang, OW ;
Tornos, P ;
Vanoverschelde, JL ;
Vermeer, F ;
Boersma, E ;
Ravaud, P ;
Vahanian, A .
EUROPEAN HEART JOURNAL, 2003, 24 (13) :1231-1243
[5]   Transapical mitral valved stent implantation: A survival series in swine [J].
Lozonschi, Lucian ;
Bombien, Rene ;
Osaki, Satoru ;
Hu, Jian ;
Snell, Dolores ;
Edwards, Niloo M. ;
Cremer, Jochen ;
Lutter, Georg .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2010, 140 (02) :422-U241
[6]   Mitral valved stent implantation [J].
Lutter, Georg ;
Quaden, Rene ;
Iino, Kenji ;
Hagemann, Angelika ;
Renner, Jochen ;
Huemme, Tim ;
Cremer, Jochen ;
Lozonschi, Lucian .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2010, 38 (03) :350-355
[7]   Double-crowned valved stents for off-pump mitral valve replacement [J].
Ma, L ;
Tozzi, P ;
Huber, CH ;
Taub, S ;
Gerelle, G ;
von Segesser, LK .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2005, 28 (02) :194-198
[8]   Midterm results of edge-to-edge mitral valve repair without annuloplasty [J].
Maisano, F ;
Caldarola, A ;
Blasio, A ;
De Bonis, M ;
La Canna, G ;
Alfieri, O .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2003, 126 (06) :1987-1997
[9]   Congenital heart disease in the general population - Changing prevalence and age distribution [J].
Marelli, Ariane J. ;
Mackie, Andrew S. ;
Ionescu-Ittu, Raluca ;
Rahme, Elham ;
Pilote, Louise .
CIRCULATION, 2007, 115 (02) :163-172
[10]   What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? [J].
Mirabel, Mariana ;
Iung, Bernard ;
Baron, Gabriel ;
Messika-Zeitoun, David ;
Detaint, Delphine ;
Vanoverschelde, Jean-Louis ;
Butchart, Eric G. ;
Ravaud, Philippe ;
Vahanian, Alec .
EUROPEAN HEART JOURNAL, 2007, 28 (11) :1358-1365