First All-Carbon Mitral Valve Replacement

Abstract

Arthur Beall, Jr., MD, a colleague of DeBakey, converted his existing Beall mitral prosthesis with a Dacron-covered sewing cuff, struts covered with Teflon tubing, and a Teflon occluder, into a prosthesis with carbon-coated struts and a carbon-coated occluder. The new valve Model 105 was tested in calves for 12 months. After clinical trials in humans, in 1973, it was announced that the prosthesis was ready for general use. The federal legislation of medical devices had not yet been enacted.. Subsequently, two deaths were caused by fracture of the struts releasing the occluders into the ventricular cavity. It was concluded that the coatings had been cracked during handling. Strict restrictions on handling and packaging were initiated, and as a precaution, the thickness of the carbon coating on the struts was increased. The improved valve was labeled Model 106. There were no further episodes of structural fracture. A long-term report exists of a Beall Model 106 mitral valve that had remained implanted for 30 years. The woman received the valve in 1976 at age 21. Thirty years later at 51 years (2006), the valve was explanted due to pannus encroachment and replaced with an On-X Life Technologies mitral prosthesis. At her last reported visit, January 2010, she was asymptomatic.