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J Thorac Cardiovasc Surg 2009;138:718-724
© 2009 The American Association for Thoracic Surgery
Evolving Technology/Basic Science |
a INSERM, U 698, Cardiovascular Bioengineering, Bichat University Hospital, Paris, France
b Cardiovascular Surgery, Foch Hospital, Suresnes, France
c Vascular Surgery, Ambroise Paré University Hospital, Boulogne–Billancourt, France
d Cardiology, Marie Lannelongue Hospital, Le Plessis Robinson, France
e CORONEO, Inc, Montréal, Québec, Canada
f Institut Galilée, University Paris 13, Villetaneuse, France
g University of Orléans, Orléans, France
Received for publication February 23, 2009; revisions received April 13, 2009; accepted for publication May 17, 2009. * Address for reprints: Anne Meddahi-Pellé, MD, PhD, INSERM, U 698, Hemostasis, Bio-engineering and Cardiovascular Remodelling, Cardiovascular Bioengineering Team, Bichat University Hospital, 75018 Paris, France. (Email: anne.pelle{at}inserm.fr).
Objective: Dystrophic aortic insufficiency is characterized by dilation of the aortic annular base and sinotubular junction diameters preventing coaptation of thin and pliable cusps amenable to valve repair. An expansible aortic ring was designed to reduce dilated aortic root diameters to increase valvular coaptation height while maintaining root dynamics. The properties of the device were tested in vitro and in vivo in an ovine model.
Methods: Expansible rings were composed of an elastomer core covered by polyester fabric. After in vitro analysis of their mechanical properties, the rings were implanted in 6 sheep at both the level of the annular base and sinotubular junction (double subvalvular and supravalvular external aortic annuloplasty). Root dynamics were assessed by using intracardiac ultrasonography before surgical intervention and at 6 months. Histologic, scanning electron microscopic, and mechanical studies were then performed on explanted samples.
Results: The expansible ring produced a significant reduction of the aortic annular base and sinotubular junction diameters. Coaptation height was increased from 2.5 ± 0.7 mm to 6.2 ± 1.1 mm (P < .001). Mechanical testing on 6-month explanted samples revealed no significant differences in elastic modulus. Dynamics of the root were well preserved. Histomorphologic studies showed incorporation of the material without degradation.
Conclusions: Expansible aortic ring implantation produces a significant annuloplasty that increases coaptation height while preserving the dynamics of the aortic root. The effectiveness of the device in treating aortic insufficiency is currently being evaluated in the prospective Conservative Aortic Valve surgery for aortic Insufficiency and Aneurysm of the Aortic Root trial comparing conservative aortic valve surgery versus mechanical valve replacement.
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