Clinical experience with the miltonia valve: short-term performance of new bi-leaflet mechanical prosthesis in mitral valve replacement surgery.

Abstract

Purpose: This study evaluates the performance of the Miltonia bi-leaflet mechanical prosthesis for mitral valve replacement (MVR).

Methodology: Fifty patients were included in this study who underwent MVR using cardiopulmonary bypass (CPB) and mild hypothermia. After surgery, standard postoperative care was provided. Echocardiography was performed preoperatively, postoperatively at discharge, and at a 6-month follow-up to assess hemodynamic performance and detect adverse events.

Results: The mean age was 38.88 ± 9.51 years, with a predominance of female patients. The average hospital stay was 9.6 ± 3.8 days. Before surgery, 88% of patients were in New York Heart Association (NYHA) class III, 8% in class IV, and 4% in class II. Post-surgery, 92% improved to class I, 4% to class II (p < 0.001). Both mean and peak pressure gradients showed significant improvement post-procedure (p < 0.001) and at 6 months (p < 0.001) compared to pre-operative status. At the 6-month follow-up, there were no cases of prosthetic valve endocarditis, structural/non-structural valve deterioration, dysfunction, or paravalvular leaks, with a 4% mortality rate. Four patients were diagnosed with prosthetic heart valve thrombosis (PHVT) during follow-up period of 6 months.

Conclusion: The Miltonia valve showed excellent hemodynamic performance and significant improvement in NYHA functional class.