Introduction: Over the years, significant evidences show that bileaflet mechanical heart valves perform better than previous designs in terms of transvalvular gradients, flow pattern distribution, and thrombogenic properties. Mechanical valves are made of carbon/titanium/ other sturdy materials making them long-lasting up-to patient’s life-time. 

Methodology: We performed a clinical trial to evaluate short-term clinical efficacy in terms of hemodynamic performance, valve-related morbidity and early & late mortality of MILTONIA bileaflet valve in mitral valve replacements. It was initiated after getting ethical approval. We enrolled 50 patients > 18 years, any gender that needed elective MVR, after written informed consent. All patients were operated using extracorporeal circulation and moderate hypothermia. Based on size of mitral annulus, appropriate sized valve was implanted. Standard postoperative-care was provided to all patients.  Transthoracic-echocardiography performed preoperatively & postoperatively at discharge, and 6-month follow-up. 

Results: Mean age was 38.88 ± 9.51 years, with F>M. Mean hospital stay was 14.26 days. Prior to surgery, 88% patients had NYHA functional class-III, while 8% & 4% had class-IV & class-II respectively. All patients had significant improvements in their NYHA functional class after surgery (92% for NYHA class-I and 4% for NYHA class-II, P <0.001). Mean pressure gradients showed a significant improvement (P <0.01) post-procedure and over 6-months (P<0.01) compared to pre-surgery. Peak pressure gradients showed significant improvement (P< 0.01) postoperatively which improved further over 6-months. Up until follow up, there were no incidents of re-exploration/AKI/valve thrombosis/ prosthetic valve endocarditis/ structural or non-structural valve deterioration/dysfunction/ mitral valve apparatus damage/dysfunction or paravalvular leak. No patient required permanent pacemaker implanted. 6-month follow-up showed only 4% mortality. 

Conclusion: MILTONIA valves showed short-term safety and efficacy based on good hemodynamic performance, low rate of mortality, complications and significant improvement of NYHA functional class. However, a larger study with longer follow-up is needed to establish its long-term safety and efficacy.