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Daniel J. Goldstein
Daniel Burkhoff
Gerald M. Lemole
Mehmet C. Oz
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J Thorac Cardiovasc Surg 1996;112:979-983
© 1996 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

DEVELOPMENT OF AN INTRALUMINAL DEVICE FOR THE TREATMENT OF AORTIC REGURGITATION: PROTOTYPE AND IN VITRO TESTING SYSTEM

Robert C. Ashton, Jr., MDc, Daniel J. Goldstein, MDa, David D'Alessandro, BSa, Alan D. Weinberg, MSa, Daniel Burkhoff, MD b , Heinz D. Rosskothena, Gerald M. Lemole, MDd, Mehmet C. Oz, MDa

Received for publication Jan. 9, 1996 Revisions requested March 1, 1996; revisions received June 5, 1996 Accepted for publication June 7, 1996. Address for reprints: Mehmet C. Oz, MD, Columbia Presbyterian Medical Center, Milstein Hospital, Suite 7-435, 177 Ft. Washington Ave., New York, NY 10032.

Abstract

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. (J THORAC CARDIOVASC SURG 1996;112:979-83)






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