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


METHODS
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).


RESULTS
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).


CONCLUSIONS
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.
Triggiani
M
M
Institute for Cardiovascular and Respiratory Diseases, University of Milan, Italy.
D'Ancona
G
G
Nascimbene
S
S
Benussi
S
S
Donatelli
F
F
Paolini
G
G
Galli
L
L
Grossi
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001705:Bioprosthesis; D004696:Endocarditis / Q000453:epidemiology / Q000209:etiology; D004869:Equipment Safety; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D006439:Hemodynamics; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D011336:Probability; D011379:Prognosis; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D012307:Risk Factors; D016019:Survival Analysis; D013552:Swine; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology; D013997:Time Factors