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(Circulation. 2003;108:II-134.)
© 2003 American Heart Association, Inc.

Surgery for Valvular Heart Disease

Introduction of a Flexible Polymeric Heart Valve Prosthesis With Special Design for Mitral Position

Sabine H. Daebritz, MD^*; Jörg S. Sachweh, MD^*; Benita Hermanns, MD; Bernd Fausten, MD; Andreas Franke, MD; Jan Groetzner, MD; Bernd Klosterhalfen, MD; Bruno J. Messmer, MD

From the Department of Cardiac Surgery, Ludwig-Maximilians-University, Munich, Germany; and Department of Thoracic- and Cardiovascular Surgery, Department of Pathology, and Department of Cardiology, University Hospital, 52057 Aachen, Germany

Correspondence to Sabine Daebritz, MD, Department of Cardiac Surgery, LMU, University Hospital Grosshadern, Marchioninistr. 15, D-81377 Munich, Germany. Phone: 49-89-7095-3451, Fax: 49-89-7095-3943, E-mail: sabine.daebritz{at}hch.med.uni-muenchen.de

Background— Current heart valve prostheses are constructed mimicking the native aortic valve. Special hemodynamic characteristics of the mitral valve such as a nonaxial central inflow with creation of a left ventricular vortex have so far not been taken into account. A new polycarbonaturethane (PCU) bileaflet heart valve prosthesis with special design for the mitral position is introduced, and results of animal testing are presented.

Methods and Results— After in vitro testing, 7 PCU-prostheses and 7 commercial bioprostheses (Perimount, n=4; Mosaic, n=3) were implanted in mitral position into growing Jersey calves (age 3–5 months, weight 60–97 kg) for 20 weeks. 2-Dimensional echocardiography was performed after implantation and before sacrification. Autopsy included histologic, radiographic, and electron microscopic examination of the valves. In vitro durability was proven for >15 years. After implantation 2-dimensional-echocardiography showed no relevant gradient or regurgitation of any prosthesis. Clinical course of the animals with PCU valves was excellent. In contrast, 5 of 7 calves with bioprostheses were sacrificed after 1–9 weeks because of congestive heart failure. 2-Dimensional echocardiography of the PCU valves after 20 weeks showed mild leaflet thickening with trivial regurgitation; mean gradient was 8.1±5.0 mm Hg (weight: 160–170 kg). The explanted PCU prostheses revealed mild calcification and no structural degeneration. All of the Perimount bioprostheses were severely calcified and degenerated after 11±7 weeks. One Mosaic bioprosthesis was thrombosed after 1 week, and 2 showed severe and mild-to-moderate degeneration after 4 and 22 weeks, respectively.

Conclusions— Polycarbonaturethane valve prostheses with special design for mitral position show excellent hemodynamic performance and durability in vivo. Calcification and structural changes are mild compared with bioprostheses. Controlled clinical studies are planned.

Key Words: heart valve prosthesis • mitral valve surgery • polyurethane • biodegradation