Bicarbon valve - European multicenter clinical evaluation

J. B. Borman*, W. G.B. 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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Fifteen collaborating centers in eight countries present their pooled experience with the new Bicarbon(TM) 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: aortic valve replacement (AVR), 726; mitral valve replacement (MVR), 475; double valve replacement (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 5year 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.

Original languageEnglish
Pages (from-to)685-693
Number of pages9
JournalEuropean Journal of Cardio-thoracic Surgery
Volume13
Issue number6
DOIs
StatePublished - Jun 1998
Externally publishedYes

Keywords

  • Bicarbon valve
  • Bileaflet hinged mechanical prosthesis
  • Heart valve replacement
  • Results

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