1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve

BACKGROUND: Polymer leaflet material may extend the durability of surgical mitral valve replacement (SMVR) to provide stable long-term hemodynamics. The India Mitral Surgical Trial sought to evaluate the safety and performance of a novel polymer leaflet material as part of a surgical mitral valve (MV) prosthesis. OBJECTIVES: In this study, the authors sought to report 1-year outcomes in patients undergoing SMVR for MV disease using the Tria Mitral Valve (Foldax). METHODS: Adult patients requiring MV replacement were enrolled in a prospective single-arm multicenter trial at 8 clinical sites in India from April to November 2023. An independent physician screening committee reviewed each patient for study eligibility before enrollment. Safety events were adjudicated per standard Valve Academic Research Consortium 3 criteria guidelines, and valve performance was assessed by means of echocardiographic and computed tomographic imaging at 30 days and 1 year. Patients were maintained on a vitamin K antagonist (target international normalized ratio: 2.5). RESULTS: and 4.6 ± 1.7 mm Hg, respectively. There were 2 thrombotic events and 3 ischemic strokes, all in patients with subtherapeutic international normalized ratio. CONCLUSIONS: The polymer surgical MV demonstrated an acceptable safety profile and maintained stable hemodynamic performance through 1 year in patients undergoing MV replacement. Further study of this promising polymer leaflet technology is ongoing. (Clinical Investigation for the Foldax Tria Mitral Valve-India; NCT06191718).