Long-term clinical outcomes of the Toronto stentless porcine valve: 15-year results from dual centers.

Background and aim of the study The purpose of this study is to examine the long-term durability of the Toronto stentless porcine valve (SPV) in the aortic position (St Jude Medical, Minneapolis, MN). Methods We assessed the long-term clinical outcomes of 515 patients with aortic valve replacement (AVR) with the Toronto SPV from 1987 to 2001 at two centers, excluding early (<30 days) death. Median follow-up was 11.5 years (maximum 19.0 years). Results Average age was 64.2 +/- 10.8 years, and females were 34% (173/515). The incidence of prosthesis-patient mismatch was low, 10.9%. Overall survival was 90.7 +/- 1.3%, 75.4 +/- 2.0%, and 56.8 +/- 3.2% at 5, 10, and 15 years, respectively after surgery. Over the follow-up duration, 116 patients (23%) underwent repeated AVR: 90 for structural valve deterioration (SVD), 12 for endocarditis, 10 nonstructural valve dysfunction (10 aortic regurgitation due to aorta dilatation), and four for other reasons. The cumulative incidence of repeated AVR with death as a competing risk was 1.4% (95% confidence interval [CI], 0.6-2.7), 11.1% (95% CI, 8.4-14.2), and 34.4% (95% CI, 28.8-40.2) at 5, 10, and 15 years, respectively. Reoperative mortality was 5.2% (6/116). In SVD, the regurgitation type was dominant (82%). Conclusions The Toronto SPV is associated with excellent survival and durability during the first decade of follow-up. However, regurgitation type of SVD increases from 10 years after operation with acceptable reoperative mortality. These findings may assist with prosthesis selection and reintervention strategy for failing stentless bioprosthesis.