Polymeric mitral valve replacement in rheumatic heart disease: hemodynamic and early clinical outcomes from a dedicated sub-analysis of the India Surgical Trial

Background Rheumatic heart disease (RHD) is a leading cause of cardiovascular morbidity in low- and middle-income countries (LMICs), disproportionately affecting young patients and women of childbearing age. Current valve options—mechanical and bioprosthetic—result in significant challenges in these populations, including the need for intensive anticoagulation monitoring or accelerated structural deterioration. This study evaluates a novel polymeric heart valve designed to overcome these limitations. Methods The India Mitral Surgical Trial (CTRI/2023/02/049837) was a prospective, multicenter, single-arm trial involving 67 adult patients requiring mitral valve replacement. Patients were implanted with the polymer surgical mitral valve and followed for one-year with safety and hemodynamic assessments. Vitamin K antagonists were administered for a target INR of 2.5. This subgroup analysis focuses on patients with RHD. Results The RHD subgroup, included 49 patients with a mean age of 39 years, of whom 33 (67%) were female. The trial achieved 100% technical success defined as successful implantation of the study valve with immediate satisfactory valve function and no intraoperative valve-related complications. At one-year, all-cause mortality for the RHD subgroup was 10.2% with no valve-related deaths and no incidence of structural valve deterioration or valve reintervention. The mitral inflow gradient decreased from 9.9 ± 5.1 mmHg at baseline to 4.2 ± 1.5 mmHg at discharge and 4.4 ± 1.7 mmHg at 1 year while the echo defined effective orifice area increased from 0.9 ± 0.5 cm 2 at baseline to 1.6 ± 0.6 cm 2 at discharge and remained stable at 1.5 ± 0.4 cm 2 at 1 year. Thromboembolic events were comparable to commercial valves in the setting of a high percentage of patients requiring anticoagulation for preoperative atrial fibrillation. Conclusion The polymeric valve demonstrated an acceptable safety profile and excellent hemodynamic stability at one-year. Further studies are needed to confirm durability and study anticoagulation reduction. Polymeric valves may be a promising option for patients with RHD.