The performance of the Braunwald-Cutter aortic prosthetic valve.

Four hundred seventy-five patients underwent aortic valve replacement with the Braunwald-Cutter ball-valve prosthesis at two institutions. The early (30-day) hospital mortality was 4.7% for those with isolated aortic valve replacement and 6.9% for the entire group. For the former, 5-year actuarial survival of the hospital survivors was 72 +/- 5.7%; for the latter group it was 71 +/- 4.4%. Eleven patients (5 since the date of follow-up inquiry) have suffered poppet escape, 9 of whom died. The actuarial incidence of known poppet escape is 4 +/- 2.6% at 47 months; when the 5 patients suffering poppet escape since the date of follow-up inquiry are included, with certain assumptions, the incidence is 3.7 +/- 1.14%. The projected probability of poppet escape using all 11 patients is 12.2% at 5 years; the 70% confidence bands of projected probability of poppet escape separate from those of the risk of re-replacement at 61 months. This and other analyses indicate that in general, patients with the Braunwald-Cutter aortic prosthesis should have it replaced 4 1/2 to 5 years after its insertion.