Mechanical heart valves: are two leaflets better than one?

Abstract Objective We sought to compare the long-term clinical outcomes of patients who underwent isolated aortic valve replacement with single-disc and bileaflet mechanical heart valves. Methods From May 1975 through October 2001, 590 single-disc valves (7 models) were used for isolated valve replacement, and from November 1980 through July 2002, 1283 bileaflet valves (10 models) were used for isolated valve replacement. Detailed follow-up was performed to a maximum of 27.4 and 21.9 years with a total of 6872 and 5811 patient-years for single-disc valves and bileaflet valves, respectively. Survival and valve-related events were analyzed. Results Single-disc valves were mainly implanted from 1975 through 1995, whereas bileaflet valves were mainly implanted from 1987 through 2002; thus the years of concurrent use were 1987 through 1995. The bileaflet valve had a significantly lower explantation rate, whereas the single-disc valve had a significantly lower thromboembolism rate. No significant differences were detected in early mortality, long-term survival, and other valve-related complications. When limiting the comparison to the concurrent period of 1987 through 1995, no significant difference was detected in survival or in any valve-related complication. Conclusion Single-disc and bileaflet valves provide similar clinical performance. The predominant use of bileaflet valves is not based on clinical outcomes.