Aspire porcine bioprosthesis: ten years' experience

Abstract

Background and aim of the study: Clinical results of this multicenter study of the Aspire porcine valve were reported previously at eight years; the present report provides an update of valve performance to 10 years postoperatively.

Methods: A total of 749 patients (60% males; mean age 73+/-7 years) underwent implantation with the Aspire (Tissuemed) porcine bioprosthesis between 1991 and 2002, at three institutions. Follow up was complete for 98% of the cohort. The mean follow up period was 51.6+/-39.6 months (range: 0-181 months); total follow up was 3,159 patient-years (pt-yr).

Results: There were 617 aortic valve replacements (AVR), 96 mitral valve replacements (MVR) and 32 double valve replacements. There were 62 deaths (8.3%), one of which was valve-related. The late mortality rate was 9.3% per pt-yr (1.2%/pt-yr valve-related). Actuarial freedom from complications at 10 years was: thromboembolism 76+/-4% (2.6%/pt-yr); hemorrhage 73+/-4% (2.8%/pt-yr); structural valve deterioration (SVD) 96+/-2% (0.2%/pt-yr); non-structural deterioration 99+/-1% (0.1%/pt-y); prosthetic valve endocarditis 97+/-1% (0.3%/pt-yr); and reoperation 97+/-1% (0.4%/pt-yr). In patients aged >70 years, the 10-year actuarial freedom from SVD was 98+/-2% for AVR and 93+/-7% for MVR. Preoperative atrial fibrillation (AF) was a significant predictor of late mortality (p <0.001), thromboembolism (p = 0.05) and hemorrhage (p = 0.01).

Conclusion: The Aspire porcine bioprostheses is a reliable choice for a tissue valve, for both the aortic and mitral positions, especially in patients aged >70 years. In elderly patients the presence of AF is a significant predictor of early and late mortality and morbidity.