BACKGROUND AND AIM OF THE STUDY: There is renewed interest in the pericardial heart valve as an alternative to the porcine bioprosthesis. The long-term results of a randomized trial comparing a second-generation pericardial valve against a well-tested porcine bioprosthesis are presented. Seven-year follow up has been reported previously. Production of the Bioflo pericardial prosthesis used in this trial was discontinued due to fears related to bovine spongiform encephalopathy. METHODS:Between February 1987 and March 1990, 170 patients undergoing aortic (AVR) or mitral (MVR) valve replacement were assigned randomly to receive either the Bioflo pericardial bioprosthesis or the Carpentier-Edwards (CE) supra-annular porcine bioprosthesis. Eighty-five patients received 93 Bioflo valves (46 AVR, 31 MVR, eight AVR+MVR), and the remaining 85 received 99 CE valves (48 AVR, 23 MVR, 14 AVR+MVR). Mean patient age was 61.0 years (range: 38-77 years) for the Bioflo group and 62.1 years (range: 41-77 years) for the CE group. Current follow up is 100% complete and totals 1,391 patient-years; mean +/- SD follow up was 8.2 +/- 3.4 years (maximum 12.2 years). RESULTS: The operative mortality rate was 4.12%. There were 70 patients still at risk at 11 years (31 Bioflo, 39 CE); of these, 91.4% were in NYHA classes I/II. No significant difference in survival or valve-related complications was seen between the groups. Mean (+/- SEM) survival at 11 years was 41.4 +/- 6.8% in the Bioflo group and 55.3 +/- 6.8% in the CE group (p = 0.15). There were 16 valve-related deaths (nine in the Bioflo group, seven in the CE group). At 11 years, freedom from valve-related mortality was 89.5 +/- 3.9% for the Bioflo group and 91.0 +/- 3.5% for the CE group (p = 0.4). Valve position had no impact on survival. At 11 years, freedom from structural valve deterioration was 83.9 +/- 5.4% and 87.5 +/- 4.2% in the Bioflo and CE groups, respectively (p = 0.9). CONCLUSION: Over the 11-year period of follow up, clinical performance of the Bioflo pericardial valve was comparable with that of the Carpentier-Edwards supra-annular porcine bioprosthesis. No difference was apparent between the two valve types when implanted in either the aortic or the mitral position.
RCT Entities:
BACKGROUND AND AIM OF THE STUDY: There is renewed interest in the pericardial heart valve as an alternative to the porcine bioprosthesis. The long-term results of a randomized trial comparing a second-generation pericardial valve against a well-tested porcine bioprosthesis are presented. Seven-year follow up has been reported previously. Production of the Bioflo pericardial prosthesis used in this trial was discontinued due to fears related to bovine spongiform encephalopathy. METHODS: Between February 1987 and March 1990, 170 patients undergoing aortic (AVR) or mitral (MVR) valve replacement were assigned randomly to receive either the Bioflo pericardial bioprosthesis or the Carpentier-Edwards (CE) supra-annular porcine bioprosthesis. Eighty-five patients received 93 Bioflo valves (46 AVR, 31 MVR, eight AVR+MVR), and the remaining 85 received 99 CE valves (48 AVR, 23 MVR, 14 AVR+MVR). Mean patient age was 61.0 years (range: 38-77 years) for the Bioflo group and 62.1 years (range: 41-77 years) for the CE group. Current follow up is 100% complete and totals 1,391 patient-years; mean +/- SD follow up was 8.2 +/- 3.4 years (maximum 12.2 years). RESULTS: The operative mortality rate was 4.12%. There were 70 patients still at risk at 11 years (31 Bioflo, 39 CE); of these, 91.4% were in NYHA classes I/II. No significant difference in survival or valve-related complications was seen between the groups. Mean (+/- SEM) survival at 11 years was 41.4 +/- 6.8% in the Bioflo group and 55.3 +/- 6.8% in the CE group (p = 0.15). There were 16 valve-related deaths (nine in the Bioflo group, seven in the CE group). At 11 years, freedom from valve-related mortality was 89.5 +/- 3.9% for the Bioflo group and 91.0 +/- 3.5% for the CE group (p = 0.4). Valve position had no impact on survival. At 11 years, freedom from structural valve deterioration was 83.9 +/- 5.4% and 87.5 +/- 4.2% in the Bioflo and CE groups, respectively (p = 0.9). CONCLUSION: Over the 11-year period of follow up, clinical performance of the Bioflo pericardial valve was comparable with that of the Carpentier-Edwards supra-annular porcine bioprosthesis. No difference was apparent between the two valve types when implanted in either the aortic or the mitral position.