Aims: We report our initial experience with the Freestyle aortic bioprosthesis.
Methods: This prosthesis was implanted in 40 patients between February 1993 and December 1998. Operative indications were aortic stenosis in 32 patients (80%), aortic regurgitation in seven patients (18%) and a combined lesion in one (3%). The mean patient age was 71.4+/-9.7 (SD) years, with 29 (72%) females. Pre-operative New York Heart Association (NYHA) class was III or IV in 28 (70%). Left ventricular systolic function was impaired in four (10%). Six (15%) patients had undergone previous cardiac surgery. Concomitant procedures were carried out in 21 patients (53%).
Results: Early mortality was zero. Early morbidity included three re-operations for bleeding, one cerebrovascular event, one haemorrhagic complication and one case of valve dysfunction. At follow up (range 4.6 to 75.6 months, mean 29.5+/-25.5) there has been one (3%) late death which was non valve related, one (3%) episode of study-valve endocarditis, and three (8%) thromboembolic episodes. NYHA Class was I or II in all but one survivor. Echocardiographic follow-up has shown no further instances of valve dysfunction with satisfactory haemodynamic parameters at 24-months post-operation, and a significant and sustained regression of left ventricular mass.
Conclusions: The initial experience with the Freestyle valve is that it results in good clinical and haemodynamic performance, suggesting it as an ideal bioprosthesis for this patient group.