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BACE: New Alterative to Heart Valve Repair and Replacement
The Mardil device, called BACE (Basal Annuloplasty of the Cardia Externally), represents a novel modality to treating functional mitral valve regurgitation because it addresses the root cause of the condition: a heart muscle that is enlarged and weakened. In many cases, the mitral valve itself is structurally normal, but the muscle that supports the valve is weakened and stretched.
To support the weakened muscle, the BACE Device is implanted around the heart using conventional median sternotomy. The device is secured by sutures both on the atrial side as well as on the ventricular side of the atrio-ventricular groove. The device serves as a tension band that encircles and supports the exterior of the heart, in particular the left ventricular wall and the mitral valve annulus. Gentle pressure and support from the BACE Device allow the leaflets of the mitral valve to close properly, thereby preventing blood from leaking backward when the heart pumps.
BACE is designed to be far less invasive than heart valve repair or replacement because the device sits outside the heart, avoiding the need for open-heart surgery. BACE can be placed around the heart while it is beating to avoid the use of a heart-lung bypass machine. Because the device is placed outside the heart, there is no direct contact with blood flow, thus limiting the risk of thrombosis, stroke and infection that commonly occur with devices implanted within the heart.
Because the device is placed on a beating heart, its impact can immediately be assessed in real time with an echocardiogram. If the patient requires more or less pressure to support the mitral valve, the device can be easily adjusted by adding or removing saline from four inflatable chambers built into the tension band. The chambers can be remotely accessed after surgery through subcutaneous ports under the skin that funnel saline to and from the chambers.
Clinical Data on BACE
BACE is currently undergoing clinical trials in a pilot study being conducted in India. The initial prototype of the BACE Device was clinically validated in a pilot study involving 12 patients in Australia. Follow-up data have indicated significant improvements in the patients’ functional status and quality of life as measured by New York Heart Association (NYHA) scores (from 3.1 to 1.2) as well as ejection fractions (from 25 to 44.5), along with a significant drop in the degree of mitral regurgitation (2.8 to 0.3).
The device has been improved and enhanced based on feedback from the Mardil Scientific Advisory Board, and the upgraded device is currently being used in the pilot study in India. A percutaneous approach to implant the BACE Device is also under development.
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BACE device is investigational and not currently available in the United States or in any other country.
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