Mitral valve replacement: randomized trial of St. Jude and Medtronic Hall prostheses

Abstract

Background. This study was designed to better define the merits of the bileaflet and tilting-disc valves. Methods. We prospectively randomized 156 patients (mean age, 59 years) to receive either the St. Jude (n = 80) or the Medtronic Hall (n = 76) mitral valve prosthesis between September 1986 and December 1997. The two groups were not significantly different with respect to preoperative New York Heart Association class, left ventricular ejection fraction, incidence of mitral stenosis or insufficiency, extent of coronary artery disease, completeness of revascularization, or cross-clamp or bypass time. Results. The operative mortality (11.2% versus 13.1%, St. Jude versus Medtronic Hall, respectively) and late mortality (27% versus 22%, St. Jude versus Medtronic Hall, respectively) were not significantly different. Follow-up was complete in all hospital survivors with a mean of 60.7 months (range, 1 to 133 months). The analysis of 10-year actuarial survival and freedom from valve-related events demonstrated no significant differences between the cohorts. Freedom from reoperation was higher in the St. Jude group ( p < 0.01). Comparisons of patient functional status and echocardiographic hemodynamic parameters obtained at the time of follow-up demonstrated no significant differences between the two prostheses. Conclusions. This study suggests that there is no difference between the St. Jude and Medtronic Hall prostheses with respect to late clinical performance or hemodynamic results and therefore does not support the preferential selection of either prosthesis.