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Bicarbon valve - European multicenter clinical evaluation |
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| Authors: | JB Borman WGB Brands L Camilleri M Cotrufo W Daenen I Gandjbakhch C Infantes A Khayat F Laborde A Pellegrini A Piwnica B Reichart R Sharony R Walesby H Warembourg |
| Institution: | a Bikur Cholim Hospital, Jerusalem, Israel b Hadassah University Hospital, Jerusalem, Israel c Medisch Centrum de Klokkenberg, Breda, The Netherlands d Centre Hospitalier Universitaire, Clermond Ferrand, France e Azienda Ospedaliera Ospedale Monaldi, Napoli, Italy f Gasthuisberg University Hospital, Leuven, Belgium g Hopital La Pitié Salpetrière, Paris, France h Hospital Virgin Macarena, Seville, Spain i Hôpital Côte de Nacre, Caen, France j L'Institut Mutualiste Montsouris, Paris, France k Ospedale Niguarda Ca Granda, Milan, Italy l Hôpital Lariboisière, Paris, France m Grosshadern Klinikum, Munich, Germany n Carmel Medical Center, Haifa, Israel o London Chest Hospital, London, UK p Hôpital Cardiologique, Lille, France |
| Abstract: | Objective: Fifteen collaborating centers in eight countries present their pooled experience with the new Bicarbon™ bileaflet valve. Methods: Between 4/90 and 4/96, 1351 patients, 806 males and 545 females, aged 10 to 83, mean 58.4±12.4, underwent valve implantation. Operations: AVR, 726; MVR, 475; DVR, 150. Additional procedures: CABG, 211; TV repair, 64; other, 152. Results: Mortality: 67 early (seven valve related) and 56 late (40 valve related). Valve thrombosis: six obstructive, three non-obstructive; embolism: nine major cerebral, 37 other. Major bleeding: 29. Hemolysis: two clinically significant. Non-structural dysfunction: 24 paravalvular leaks, one leaflet interference. No structural failure! Endocarditis: 24. Reoperation 48: 22 non-structural dysfunctions, 14 endocarditis, seven thrombosis and embolism, five other. Estimated 5-year freedom from valve-related deaths is 97.2% for AVR and 92.4% for MVR; 4-year freedom from valve related deaths for DVR is 90.5%. Mean calculated NYHA improvement is 1.24. Conclusions: The Bicarbon mechanical prosthesis is well designed, durable, has good hemodynamic features and an acceptably low incidence of complications. |
| Keywords: | Bicarbon valve Heart valve replacement Bileaflet hinged mechanical prosthesis Results |
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