Objective : To evaluate the long-term clinical performance of the Tissuemed (Aspire) porcine bioprosthesis in the aortic position.
Methods : We reviewed 375 patients [224 males, 151 females; mean age 74+6 years], who received 375 aortic implants between 1991-2001. Pre-operatively 60% of patients were in NYHA class III or IV. Concomitant procedures were performed in 12% of patients. Follow-up was 99.6% complete with cumulative follow-up of 1772 patient years. Standard Edmunds guidelines were used for evaluation.
Results : The 30 day hospital mortality in this elderly population was 8% [95% confidence intervals, 6-12] with no early valve related deaths. Patient survival at 11 years was 56%+9 for those <70yrs and 14%+6 for those 70 years. Valve related complication rates expressed as percent per patient year (number of events) were as follows: (i) structural valve failure 0.2% (4); (ii) non-structural dysfunction nil; (iii) major, minor or fatal thrombo-embolism 1.6% (28); (iv) major or fatal bleeding 1.1% (19); (v) prosthetic valve endocarditis 0.2% (3); and (vi) re-operation 0.3% (5). At 11 years freedom from (i) structural failure was 89%+7 (ii) non-structural dysfunction was 100%, (iii) thrombo-embolism was 83%+4 (ii) bleeding was 83%+6; (iii) prosthetic valve endocarditis was 98%+1.5; and (iv) re-operation was 80%+9. At follow-up 95% of survivors were in NYHA class I or II.
Conclusions : There were no early valve related deaths whilst valve related complications have remained low. Our study suggests satisfactory clinical performance of the Tissuemed (Aspire) aortic porcine bioprosthesis at 11 years. Longer-term clinical evaluation is essential to complete the assessment.