Carpentier-Edwards Porcine Bioprostheses: Clinical Performance Assessed by Actual Analysis
W. R. E. Jamieson MD, Robert T. Miyagishima MD, Lawrence H. Burr MD, Samuel V. Lichtenstein MD, Guy J. Fradet MD, Michael T. Janusz MD

The clinical performance of porcine bioprostheses for valve replacement surgery has been evaluated for over 30 years by actuarial analysis. Actual or cumulative incidence analysis provides a complementary method to determine valve-related complications due to structural valve deterioration. Here, valve-related mortality and reoperation of porcine bioprostheses for aortic and mitral valve replacement were compared by actuarial and actual methodology. Carpentier-Edwards porcine bioprostheses were implanted in 2,237 aortic valve replacements (AVR) and 1,582 mitral valve replacements (MVR). Fatal valve-related complications occurred in 7.6% of AVR and 11.3% of MVR. The cumulative follow up was 14,810 patient-years (mean 6.6 years) for AVR, and 9,718 patient-years (mean 6.1 years) for MVR. Patient survival, and actuarial and actual freedom from valve-related mortality and valve-related reoperation was reported at 15 years. The actual freedom from valve-related mortality and reoperation (primarily from structural valve deterioration), provides further evidence to consider porcine bioprostheses for AVR in patients aged >60 years, and for MVR in patients aged >70 years. Freedom from valve-related mortality supports the use of porcine bioprostheses for MVR in patients aged 61-70 years. Patient survival is influenced to the greatest extent by factors other than valve-related mortality.

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