Clinical mid-term outcomes of the Chinese-made CL-V bileaflet mechanical heart valve in Chinese patients

Background The CL-V full-carbon bileaflet mechanical heart valve is a novel Chinese-made prosthetic valve. This study evaluated the mid-term outcomes of the CL-V bileaflet mechanical heart valve after implantation in Chinese patients. Methods This study retrospectively enrolled a total of 38 consecutive patients who underwent elective mechanical heart valve replacement (MHVR) with two different valve types from April 2004 and May 2010, including 18 patients with the CL-V bileaflet mechanical heart valve (44.4% male, mean age 47.4±6.2 years, mean body weight 64.7±11.9 kg) and 20 patients with the St. Jude mechanical heart valve (45.0% male, mean age 49.7±7.6 years, mean body weight 66.1±11.1 kg). All patients underwent follow-up clinical evaluations in the outpatient department at all-time points. Results No complications occurred during the mean 61.3 months follow-up time (range, 47-102 months). The cardiothoracic ratios (52.7%±4.5% vs. 50.1%±4.0%), left atrium diameter (46.5±7.6 vs. 44.8±9.3 mm), left ventricular diastolic diameter (47.6±4.9 vs. 48.2±8.5 mm) and left ventricular ejection fraction (65.4%±8.7% vs. 64.5%±8.0%) were not significantly different between the two groups (P>0.05). Transthoracic Doppler echocardiography showed that the hemodynamic indexes were not significantly different between the two groups at 1 year and 3 years (P>0.05). Furthermore, no significant differences were found between the two groups in hemocompatibility indexes at both 6 months and 3 years postoperatively (P>0.05). Conclusions The mid-term follow-up results of the CL-V bileaflet mechanical heart valve were similar to those of the St. Jude Medical heart valve, which showed stable hemodynamics and good blood compatibility. Chinese-made CL-V bileaflet mechanical heart valves can be a substitute for St. Jude Medical heart valves, and can be widely used in cardiac surgery. Trial registration Chinese Clinical Trial Registry ChiCTR2000034158.