Long-term durability of the Hancock II porcine bioprosthesis☆

Abstract 

Background

Survival and prosthetic complications of patients receiving the Hancock II second-generation bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in the aortic, mitral, mitral-aortic, and tricuspid positions were analyzed at 15 years’ follow-up.

Methods

Between May 1983 and December 1993, 212 patients (104 men and 108 women; mean age, 63 ± 9 years; age range, 29-81 years) received 66 aortic, 114 mitral, 26 mitral-aortic, and 6 tricuspid Hancock II valves. Thirty-one percent of patients had previous valve operations, 15% had concomitant cardiac procedures, and 87% were in New York Heart Association class III or IV. Follow-up included 1704 patient-years and was 98% complete, with a median of 9 patient-years (range, 0.013-17.4 years). Forty-six patients were at risk at 14 to 15 years, and 30 were at risk after 15 years.

Results

One hundred twenty-two (57%) of 212 patients died, 20 of them perioperatively. Fifteen-year actuarial Kaplan-Meier survival was 35.2% ± 3.8%, and freedom from valve-related mortality was 84% ± 3.5%, with no difference on the basis of position or age (<65 or ≥65 years). Percentages for freedom from thromboembolism, anticoagulant-related hemorrhage, endocarditis, and paravalvular leak were, respectively, 78.2% ± 4%, 83.5% ± 3.6%, 95.7% ± 2%, and 97.3% ± 1.4%, with no significant difference between the aortic and mitral positions. Freedom from structural valve deterioration was 71.8% ± 5.6%: 88.9% ± 6.2% in the aortic position versus 59.5% ± 3.9% in the mitral position (P = .01) and 64.3% ± 3% in the mitral-aortic position. In patients younger than 65 years, actual freedom from structural valve deterioration was less than that seen in older patients (84.5% ± 3.5% vs 95% ± 3.0%) and was better in the aortic versus the mitral position (92% ± 4.5% vs 82% ± 4.2%).

Conclusion

The Hancock II porcine valve showed excellent 15-year durability. We recommend its use in patients 65 years of age, as well as in younger patients undergoing aortic replacement.

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