CLINICAL-EVALUATION OF THE ST-JUDE-MEDICAL HEART-VALVE PROSTHESIS - A 2-YEAR FOLLOW-UP OF 150 PATIENTS

  • 1 January 1984
    • journal article
    • research article
    • Vol. 88  (3) , 432-438
Abstract
To evaluate the clinical performance of the St Jude Medical bileaflet heart valve prosthesis, 150 consecutive patients (95 male and 55 female patients, mean age 54 yr, range 1-74 yr) were followed for an average of 24 mo. These included 74 patients with aortic, 56 patients with mitral, and 20 patients with multiple valve replacement. During the 2 yr follow-up, there were a total of 4 perioperative and 7 late deaths, 2 of which were prosthesis related. Reoperation was necessary in 4 patients because of paravalvular leaks in 2 patients with mitral and 1 patient with aortic prostheses in addition to leaflet dislodgment in 1 patient with a mitral prosthesis, a postoperative complication that was not reported previously. The thromboembolic rate/100 patient-yr 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 4 complications of anticoagulant therapy (3 minor and 1 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 vs. 1.3 .+-. 0.6 postoperatively. In patients with angina, it was 2.6 .+-. 0.6 preoperatively vs. 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 vs. 0.9 .+-. 0.1 m/s in the aortic position; 1.1 .+-. 0.3 vs. 0.8 .+-. 0.3 m/s in the mitral position).

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