1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve: Insights Into New Technology.

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

Sixty-seven patients, of whom 64% were female (48% of childbearing age), with a mean age of 42 years (range: 19-67 years), mean body mass index of 22.7 kg/m2, and body surface area of 1.6 cm2 were treated with SMVR with 100% technical success. Most patients (54%) were NYHA functional class III or IV at baseline. The mean Society of Thoracic Surgeons score was 1.4%. The etiology of MV disease was stenosis in 27%, regurgitation in 30%, and mixed in 43% of patients, primarily secondary to rheumatic heart disease. The 1-year rates for all-cause mortality, thromboembolic events, stroke, structural valve deterioration, and valve reintervention were 9.1%, 7.5%, 4.9%, 0%, and 0%, respectively. No death was valve related. One-year effective orifice area and mean inflow gradient were 1.4 ± 0.4 cm2 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).