Our experience with ball valve replacement of the mitral valve during the past decade is presented in terms that allow comparison with other techniques. The use of such prostheses is characterized by ease of implantation, with an overall operative mortality of 11 per cent for isolated mitral replacement and 13 per cent for multiple valve replacement. The operative mortality for isolated mitral valve replacement during 1969 and thus far in 1970 has been nil. The late mortality was 13 per cent for isolated mitral replacement and 20 per cent for multiple valve replacement. Forty-three per cent of the total late deaths were clearly unrelated to the prosthetic device itself.
The overall incidence of late infection and leak is less than 1 per cent and the immediate haemodynamic benefit is not altered by loss of structural integrity of the prosthesis.
The most serious problem after mitral valve replacement with the ball valve prosthesis is that of thromboembolic complications. While thrombotic stenosis of the prosthesis is a rarity, embolic episodes, usually cerebral in type, have been noted in 63 per cent of the patients surviving mitral valve replacement with the earliest model ball valve from August 1960 to February 1966. Improvements in valve design have resulted in a remarkable decrease in this incidence as examined by actuarial techniques and taking into account the duration of follow-up. The extension of the cloth sewing margins to the orifice of the valve while maintaining a metallic orifice and metallic cage (Model 6120) resulted in a drop of the thromboembolic rate to 17 per cent from April 1965 to April 1969.
The development of the totally cloth-covered prosthesis has further improved these results, with only one thromboembolic complication after isolated mitral valve replacement with the Model 6310 valve in a series of 66 consecutive patients. In clinical practice this has resulted in the avoidance of the use of anticoagulant therapy in patients in whom for a variety of reasons this carries an increased hazard. With further follow-up it may be possible to discontinue the routine use of anticoagulants.