Fifteen-year results with the Hancock II valve: a multicenter experience.

Objectives: The purpose of this multi-institutional study was to review the 15-year outcome of patients who received isolated aortic or mitral valve replacement with the Hancock II bioprosthesis.

Methods: From 1983 through 2002, 1274 patients underwent 1293 isolated valve replacements, 809 aortic valve replacements and 484 mitral valve replacements, at hospitals in the Venetian area (Padova, Treviso, and Venice). Mean age was 68 +/- 8 years in patients undergoing aortic valve replacement and 66 +/- 9 years in patients undergoing mitral valve replacement; 52% of patients undergoing aortic valve replacement and 63% of patients undergoing mitral valve replacement were in New York Heart Association class III or greater. Coronary artery disease was present in 32% of patients who had undergone aortic valve replacement and 18% of patients who had undergone mitral valve replacement. Follow-up included 8520 patient-years, with a median of 12 years, and was 97% complete.

Results: Overall 15-year survival was 39.7% +/- 2.4%, similar in both the aortic and mitral positions. Multivariable analysis of late survival showed the incremental risk of male sex, higher New York Heart Association class, coronary artery disease, and mitral position. Freedom from embolism was higher in the aortic position (81% +/- 2.9% in aortic vs 72% +/- 4.7% in mitral valve replacements). Freedom from endocarditis was similar in the aortic and mitral position (95% +/- 1.2% vs 94% +/- 1.7%). Freedom from reoperation (82% +/- 3.7% vs 71% +/- 5.0%) and from valve-related morbidity-mortality (52% +/- 3.6% vs 36% +/- 4.4%) was higher in patients who had undergone AVR. Actual freedom from structural valve deterioration for patients 60 years and older who had undergone aortic valve replacement was 96.5% +/- 1.3% versus 88% +/- 3.2% for patients who had undergone mitral valve replacement and 70% +/- 7.5% versus 77.5% +/- 5.3%, respectively, in younger patients. Multivariable Weibull analysis showed structural valve deterioration related to younger age and preoperative valve incompetence and inversely related to coronary artery disease.

Conclusion: Optimal 15-year durability can be expected in male patients 60 years and older who have undergone aortic valve replacement and in male patients 65 years and older who have undergone mitral valve replacement, extending safely the age limits for the use of this valve.