Chitra heart valve: Results of a multicenter clinical study

Background and aim of the study: The Chitra tilting disc valve was develope d in India to meet the need for a low-cost cardiac valve. The valve has an integrally machined cobalt-based alloy cage, an ultrahigh molecular-weight polyethylene disc, and a polyester suture ring. An important feature of thi s valve is its soft closing sound, by virtue of a plastic occluder. Methods: Between December 1990 and January 1995, 306 patients underwent iso lated aortic MR, n = 101) or mitral valve replacement (MVR, n = 205) at six institutions in India. The early mortality rate was 6.9% (seven after AVR; 14 after MVR). A total of 285 survivors was followed up until September 19 98; total follow up was 1212 patient-years (pt-yr) (AVR, 445 pt-yr; MVR, 76 7 pt-yr). Results: There were 52 late deaths (4.3%/pt-yr; AVR 2.2%/pt-yr; MVR 5.5%/pt -yr). Thirty-five deaths were valve-related (23 were due to unknown causes) . One AVR patient (0.2%/pt-yr) and 12 MVR patients (1.6%/pt-yr) developed v alve thrombosis, and embolic episodes occurred in 25 patients (seven after AVR, 1.6%/pt-yr; 18 after MVR, 2.4%/pt-yr). Bleeding events and infectious endocarditis occurred infrequently (AVR 0.9 and 0.7%/pt-yr; MVR 0.4 and 0.5 %/pt-yr, respectively). There was no incidence of paravalvular leak or stru ctural dysfunction of the valve. Actuarial survival rates at seven. years w ere 82.4 +/- 4.0% for AVR and 65.2 +/- 5.0% for MVR. During the same interv al, thrombus-free and embolism-free survival after AVR and MVR occurred in 98.9 +/- 1.1% and 94.1 +/- 1.9%, and 92.3 +/- 2.8% and 82.1 +/- 5.7% of pat ients, respectively. Freedom from all valve-related mortality and morbidity at seven years was 81.5 +/- 4.1% after AVR, and 64.2 +/- 5.1% after MVR. Conclusion: The Chitra valve appears to be safe and to have performance com parable with that of other currently used tilting disc valves. This valve c osts substantially less than other valves, and is therefore within reach of a larger subset of Indian patients.