Clinical evaluation of the St. Jude Medical heart valve prosthesis. A two-year follow-up of 150 patients.

To evaluate the clinical performance of the St Jude Medical bileaflet heart valve prosthesis, we followed 150 consecutive patients (95 male and 55 female patients, mean age 54 years, range 1 to 74 years) for an average of 24 months. These included 74 patients with aortic, 56 patients with mitral, and 20 patients with multiple valve replacement. During the 2 year follow-up, there were a total of four perioperative and seven late deaths, two of which were prosthesis related. Reoperation was necessary in four patients, because of paravalvular leaks in two patients with mitral and one patient with aortic prostheses and because of leaflet dislodgment in one patient with a mitral prosthesis, a postoperative complication that has not been reported previously. The thromboembolic rate per 100 patient-years was 2.6 in aortic and 2.9 in mitral valve replacement, the symptoms being reversible in all patients. All patients were receiving anticoagulant therapy. A total of four complications of anticoagulant therapy (three minor and one fatal) were observed. Significant hemolysis was observed in none of the patients. In patients with dyspnea, the New York Heart Association functional classification was 2.7 +/- 0.8 preoperatively versus 1.3 +/- 0.6 postoperatively. In patients with angina, it was 2.6 +/- 0.6 preoperatively versus 1.03 +/- 0.2 postoperatively. Noninvasive Doppler measurements revealed excellent flow characteristics, values being close to those obtained in natural valves (mean +/- standard deviation of maximal flow velocity: 1.5 +/- 0.5 versus 0.9 +/- 0.1 m/sec in the aortic position; 1.1 +/- 0.3 versus 0.8 +/- 0.3 m/sec in the mitral position).