hvsa
Home
Courses
Course Objectives
Programs
CME Credits
Cases and Abstract Submissions
venue and accomodations
HVSA
Directors and Faculty
Videos
Register

 

New York City Conference

Back to 2014 Annual Meeting Abstracts


Long Term Durability of a Sutureless Aortic Valve: In Vitro and In Vivo Evidences
Luc BEHR, Dr., Nicolas Borenstein, Dr., François LABORDE, Pr..
IMM RECHERCHE, Paris, France.

OBJECTIVE: The aim of this extensive in vitro and in vivo testing program was to provide evidence of the long term durability of the Perceval sutureless aortic valve (Sorin Group Italia Srl, Saluggia Italy). This collapsible valve is based on a highly innovative design leveraging on well proven biomaterials and processes, such as bovine pericardium treated with glutaraldehyde and homocysteic acid.
METHODS:
In vitro
evaluation consisted of bench tests: 1- accelerated leaflet wear testing (N= 52 bioprosthesis, all sizes) simulating normotensive and hypertensive conditions, in regular and irregular anatomic setting; 2- accelerated stent fatigue testing (N= 50 nitinol stents, all sizes) in hypertensive conditions; 3- histological evaluation of the pericardial valve leaflets after device collapsing.
In vivo
evaluation consisted of 5 months orthotopic implantation in juvenile sheep (N=6) with echographic, angiographic and histopathological assessment.
RESULTS:
In vitro
tests: Accelerated wear testing at 600 million cycles, i.e. 15 years of equivalent life, showed no Perceval valve failure and all samples had acceptable functional performance (EOA and regurgitation). All stents undergoing accelerated fatigue testing survived the 600 million cycles under hypertensive loading conditions. Histological evaluation of the valve leaflets after collapsing showed well preserved collagen structure.
In vivo
tests: echographic and angiographic assessment of peak (11 +/- 10 mm Hg), mean (6 +/- 5 mm Hg) transvalvular gradient, EOA (1.3 +/- 0.3 cm2) and regurgitation showed good haemodynamic performances. Explant examination showed proper integration by endothelial coverage of the valve components in contact with the aortic root. Neither alteration of the leaflets (i.e. tear, perforation) nor of the stent (i.e. deformation, fracture) were observed. Semi-quantitative and quantitative inorganic Ca and P analysis demonstrated low levels of calcification.
CONCLUSIONS: Long term durability represents the main concern for surgeons when implanting a newly developed cardiac valve prosthesis. The results we are reporting demonstrate the good performance of the Perceval sutureless valve in in vitro bench tests, and as well as in the in vivo study, where the sheep is recognized as the most severe model in predicting the risk of valve degeneration.


Back to 2014 Annual Meeting Abstracts

     

Home | Courses | Objectives | Program | CME Credit | Cases & Abstracts | Venu & Accomodations | HVSA | Committee & Faculty | Register | Privacy Policy