Chitra Heart Valve: Results of a Multicenter Clinical Study
R. Sankarkumar MCh, G. S. Bhuvaneshwar PhD, R. Magotra MS, S. Muralidharan MCh, R. S. Rajan MCh, D. Saha FRCS, K. S. V. K. Subba Rao MCh, M. S. Valiathan ChM, S. Radhakrishna PhD, A. V. Ramani BSc, Chem Tech

The Chitra heart valve (CHV) was developed in India to meet the need for a low-cost cardiac valve prosthesis. It is a tilting disc prosthesis with an integrally machined cobalt alloy cage, an ultra-high molecular-weight polyethylene disc, and a polyester suture ring. Between December 1990 and January 1995, 306 patients underwent isolated aortic (AVR; n = 101) or mitral valve replacement (MVR; n = 205) at six institutions in India. A total of 285 survivors was followed up until September 1998; total follow up was 1212 patient-years (AVR 445 pt-yr; MVR 767 pt-yr). There were 52 late deaths (4.3%/pt-yr; AVR 2.2%/pt-yr; MVR 5.5%/pt-yr). Valve-related mortality occurred in 35 patients; 23 deaths were from unknown causes. Thrombosis was seen at 0.2%/pt-yr in AVR cases and 1.6%/pt-yr in MVR cases. Embolic events occurred at 1.6%/pt-yr after AVR and 2.4%/pt-yr after MVR. Incidences of bleeding events (0.9% for AVR; 0.4% for MVR) and infective endocarditis (0.7% for AVR; 0.5% for MVR) were very low. Neither paravalvular leak nor structural dysfunction of the valve were reported. Actuarial survival at seven years was 82.4% and 65.2% for AVR and MVR, respectively. These results show the CHV to be safe, and to have comparable performance with other, currently used valves of similar design.