Six-and-half years' experience with the St. Jude BioImplant porcine prosthesis

In this study, we reviewed our experience in heart valve replacement with the St. Jude BioImplant heart valve, which is a low-profile, low-pressure glutaraldehyde-fixed porcine prosthesis mounted on a flexible Delrin stent.

During the period May 1989-January 1996, 117 patients were implanted with 132 BioImplant prostheses; three patients were lost to follow up and excluded from the series. Mean age was 67.5 +/- 9.8 years (range: 19 to 82 years); myocardial revascularization was performed in 22 (19.3%) patients. In-hospital mortality rate was 6% (7/117 patients). By January 1996, 114 patients (53 males, 61 females), in whom 59 aortic, 35 mitral, 15 mitro-aortic and five tricuspid prostheses had been implanted, were eligible for the analysis. Mean follow up was 40.4 +/- 21.7 months (range: 1 to 76 months).

The survival probability of survivors was 72.1 +/- 6.5 at 77 months. Seventeen patients died during follow-up. The mean NYHA class improved from 3.1 +/- 0.6 preoperatively to 1.4 +/- 0.6 postoperatively. The freedom probabilities were respectively 89.5 +/- 5.3% from thromboembolism, 93.2 +/- 3.7% from infective endocarditis, 84.5 +/- 10.3% from structural dysfunction, 99.1 +/- 0.9% from non-structural dysfunction, and 80.1 +/- 10.2% from reoperation. The freedom probability for valve-related events was respectively 75.3 +/- 12.3%, 98.0 +/- 1.9% and 67.2 +/- 17.2% for patients who underwent mitral, aortic and mitro-aortic heart valve replacement (p = 0.05 comparing only patients who underwent mitral or aortic replacement); moreover the freedom probability from valve-related events was 71.6 +/- 11.2% in patients aged < or = 65 years and 90.2 +/- 6.6% in patients aged > 65 years (p = 0.006).

The BioImplant heart valve, in our experience, seems to be a valuable device which shows a mid-term performance similar to that of other porcine prostheses.