The Medtronic-Hall valve: a design in 1977 to improve the results of valve replacement.

The prototype Medtronic-Hall valve was developed from improvements to the Lillehei-Kaster and Björk-Shiley valves. The housing was constructed of a single piece of titanium and the disc was composed of pyrolytic carbon; both materials had shown no structural breakdown in previous clinical use. The valve was tested with pulse simulator and electromagnetic flow meter studies and yielded a high effective orifice area. Results in 110 patients were significantly better with the Medtronic-Hall valve than with either of the previous valves. In the 21-mm aortic valve the peak-peak gradient was 12 mmHg; it was 9.2 mmHg in the 23-mm, 3.8 mmHg in the 25-mm, and 2.5 mmHg in the 27-mm. Studies found 5% of forward flow regurgitation in the aortic position and more than desired regurgitation through the mitral valve. After the opening angle of the mitral valve was reduced to 70 degrees, regurgitation reached an acceptable level and the improved hemodynamics resulted in lower transvalvular gradients than in previous mechanical valves. Some patients are naturally more prone to thromboembolism regardless of valve type or anticoagulant therapy; thus the human factor plays a large role in a valve's success. More randomized studies are needed for accurate valve comparison, in addition to investigations of sewing ring factors. Nevertheless, the Medtronic-Hall valve has been used successfully for 15 years and has exhibited no housing fractures.