Development of an intraluminal device for the treatment of aortic regurgitation: prototype and in vitro testing system.

OBJECTIVES Development of an intraluminal device to reduce aortic regurgitation could provide a strategy intermediate between medical treatment and aortic valve replacement. An initial prototype and a testing system have been designed. METHODS Aortic valves obtained from heart transplant recipients were explanted and assessed in a mock circulatory loop with resistive and capacitive elements, including pressure-flow characteristics, similar to those of a normal arterial system. Normal heart function was simulated by a pulsatile ventricular-assist device. Pressure on each side of the valve and flow through the valve were recorded, allowing the calculation of regurgitant fractions and transvalvular gradients. Six solid geometrically differing obturators were tested. RESULTS All six designs resulted in significant reduction in aortic regurgitation (p < 0.0001), ranging from 15% to 38% improvement compared with control values. Small increases in transvalvular gradients (from 0 to 7 mm Hg) were also noted. DISCUSSION Initial results suggest that an intraluminally placed obturator can reduce aortic regurgitation without creating clinically significant transvalvular gradients. These initial in vitro experiments demonstrate the feasibility of an intraluminal device for the treatment of aortic valve disease, and further investigation is warranted.