Intermittent regurgitation caused by incomplete leaflet closure of the Medtronic ADVANTAGE bileaflet heart valve: Analysis of the underlying mechanism

Objective Clinical echocardiographic assessments of the Medtronic ADVANTAGE (Medtronic Inc, Minneapolis, Minn) prosthesis in the aortic position revealed a phenomenon identified as “intermittent regurgitation.” An in vitro investigation was initiated to identify the underlying mechanism. Methods In a pulse duplicator environment, 6 ADVANTAGE size 23 aortic valves were analyzed. Leaflet motion and flow through the valves were documented using echocardiography with color Doppler flow, digital high speed imaging, and flow meter assessment. Results Intermittent regurgitation could be reproduced in all 6 of the tested valves within limited ranges of flow, pressure, and valve orientation. By virtue of high-speed imaging, the mechanism underlying intermittent regurgitation was identified. During intermittent regurgitation, the leading edge of the second-to-close leaflet makes contact with the chamfer on the leading edge of the first-to-close leaflet. The fluid closing forces working on the first-to-close leaflet prevent it from shifting back so that the leading edge of the second-to-close leaflet remains positioned against the chamfer of the first-to-close leaflet. In this position, the major radius of the second-to-close leaflet does not reach the housing's major radius. Therefore, a crescent-shaped gap remains between the leaflet tip of the second-to-close leaflet and the housing major radius during all or part of diastole. The regurgitant fraction can increase from a normal range of 6% to 25% during an intermittent regurgitation beat. Conclusions In vitro intermittent regurgitation can be induced in the size 23 aortic ADVANTAGE valve under a limited range of conditions. To avoid possible misinterpretations, the phenomenon must be known in detail by all physicians dealing with patients with an ADVANTAGE valve.