The Medtronic Intact xenograft: an analysis of 342 patients over a seven-year follow-up period.

Three hundred forty-two patients from December 1985 to January 1993 received 352 Medtronic Intact porcine xenograft valves (zero-pressure glutaraldehyde-fixed with toluidine blue anticalcification agent). The follow-up was 99.4% complete with a mean of 3.14 years (3 months to 7.9 years). The mean patient age was 64 years (range, 16 to 82 years) and the median age was 67 years. There were 14 aortic valve replacement patients (11.9%) and 62 mitral valve replacement patients (29.2%) who preoperatively were in New York Heart Association class IV to V. The hospital mortality was 8.4% +/- 2.9% (aortic valve replacement, 5.9%; mitral valve replacement, 9.4%; tricuspid valve replacement, 7.6%). Actuarial patient survival at 7 years was 65% +/- 5% (aortic valve replacement, 77% +/- 5%; mitral valve replacement, 63% +/- 5%). At 7 years, the freedom from thromboembolism was 74% +/- 4%, freedom from endocarditis 93% +/- 2%, and freedom from reoperation 90% +/- 3%. Reoperation was required for endocarditis (7 patients), periprosthetic leak (6), and 2 of 3 cases of structural deterioration. The actuarial freedom from structural deterioration at 5 years was 97% +/- 3%. The combined incidence of all important morbid valve-related events was analyzed with an actuarial freedom at 7 years of 63% +/- 3%. The durability of the Medtronic Intact is at least equal to that of other porcine bioprostheses. The relevant important time-frame of 7 to 12 years of follow-up has just begun, and possibly the reoperation rate for intrinsic value failure and the low incidence of calcification in the elderly patient may be showing improved characteristics of this valve. No stronger inferences are possible at this stage of the 7-year follow-up.

An analysis of risk factors for death and mode-specific death after aortic valve replacement with allograft, xenograft, and mechanical valves.

From September 1967 to January 1990, a total of 2100 patients underwent 2366 aortic valve replacements with a variety of allograft, xenograft, and mechanical valves. Concomitant procedures were performed in 764 patients. Actuarial survival at 12 years was 59.6% (70% confidence limits 57.8% to 61.4%). Hazard function for death was highest immediately after operation, falling to merge with a slowly rising phase of risk at approximately 3 months. Actuarial freedom from sudden death at 12 years was 88.0% (70% confidence limits 86.7% to 89.3%). The shape of the hazard function for sudden death was similar to that for death. Actuarial freedom from death with cardiac failure at 12 years was 87.9% (70% confidence limits 86.5% to 89.2%). The shape of the hazard function for death with cardiac failure was also similar to that for death. Risk factor analysis revealed the important deleterious impact on long-term survival resulting from impaired left ventricular structure and function because of aortic valve disease. No current-era valve used in this study (allograft, xenograft, or mechanical) was a risk factor for death. Both aortic wall disease and endocarditis necessitating aortic valve replacement substantially decreased long-term patient survival. Aortic valve replacement is advisable much earlier in the natural history of aortic valve disease before secondary left ventricular damage occurs.