[Artificial heart valves: state of the art].
In the past major problems with artificial valves occurred partially due to the absence of a specific legislation in Belgium. In order to prevent some of those incidents new heart valve prosthesis need to be evaluated by specific tests before being allowed to appear on the Belgian market. Done by: in the following order 1. In vitro testing. At least three samples will be tested in vitro (in the aortic and in the mitral position) in a pulse-duplicator system under static and dynamic conditions. Results of durability testing over long period of time will not be repeated if provided by the companies. 2. Preclinical in vivo testing. Using an experimental animal model. Three different prostheses implanted in an international approved animal model for a minimum period of 5 months. After explanation the valves will be examined (macroscopically, radiographically and pathologically) and compared to the standard prostheses results. 3. Clinical testing. Initially done in heart centers with a large experience of heart valve operations. A minimum of 20 valves, divided over at least 2 centers, will be evaluated over a minimum period of 1 year with strict follow up and report of all complications. Long-term studies will give even more information. 4. Evaluation of the tests. All results will be screened by experts of the Evaluation Committee for Medical Implants (in office since 04/04/2002). If positive the valves will be admitted on the Belgian market to be provided with a fair reimbursement price.
van Nooten
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Dienst Cardiochirurgie-Vakgroep Heelkunde Faculteit Geneeskunde en Gezondheidswetenschappen-UZ Gent De Pintelaan 185-B 9000 Gent.
D000818:Animals; D001021:Aortic Valve; D001530:Belgium; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D008943:Mitral Valve; D023421:Models, Animal; D011183:Postoperative Complications; D013318:Stroke Volume