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 reg urgitation could provide a strategy intermediate between medical treat ment 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 circulator y 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 r ecorded, allowing the calculation of regurgitant fractions and transva lvular gradients, Six solid geometrically differing obturators were te sted, Results: All six designs resulted in significant reduction in ao rtic regurgitation (p < 0.0001), ranging from 15% to 38% improvement c ompared with control values. Small increases in transvalvular gradient s (from 0 to 7 mm Hg) were also noted. Discussion: initial results sug gest that an intraluminally placed obturator can reduce aortic regurgi tation 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 fu rther investigation is warranted.