ABSTRACT 99

Mitral Valve Anulus Decalcification with Calcium Demineralization Solution May Enhance Technical Ease of Mitral Valve Operations

Authors: B.R.Constantz, PhD., Corazon Technologies, Menlo Park, CA, USA; R.D. Poser#, J.J.Akin#, K. R. Hankermeyer#, T.E. Brandner#, J.A. Bravo#, L.B. Lin#, & M.Mack+.

Background:
Calcified arterial plaque is similar to bone in that it is composed of mineral embedded in organic matrix. Nearly 40% of non-diabetic and 75% of diabetic peripheral arterial occlusive disease (PAOD) patients have moderate to severe calcification of atheromatous lesions in peripheral arteries. If treatable at all, these complex lesions are prone to poor clinical outcomes.  We evaluated the safety of a novel demineralization solution and catheter delivery platform for dissolution of these problematic calcified lesions.

Methods:
14 canines underwent bilateral femoral cutdowns and catheterization for controlled comparison of vascular and systemic response to demineralization system. The system entails anovel trilumenal catheter system accommodating CDS solution delivery, buffering (H2CO3) and aspiration of effluent. Treatment times ranged 10 to 30 minutes; CDS volume range 80 to 230 ml. Treatment segments were isolated and harvested at multiple survival points. Vascular and systemic response(hemolysis, thrombogenicity, end organ function) were evaluated by vascular histology, serum indicators of organ function and gross pathology inspection of end organs.

Results:
Preliminary results indicate no abnormal systemic abnormalities, hemolysis or thrombosis. No difference was detected between control and treatment groups.

Conclusions:
Corazon CDS is safe in healthy canine arteries. If the treatment is demonstrated to be efficacious,this platform may demonstrate a significant contribution treatment of complex arterial disease.