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 cm2 at baseline to 1.6 ± 0.6 cm2 at discharge and remained stable at 1.5 ± 0.4 cm2 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.