BACKGROUND: A lifetime valve replacement strategy compels durable technology, superior hemodynamics, and an acceptable quality of life. A novel polymer valve demonstrates early clinical evidence to satisfy these requirements.
METHODS: A uniquely formulated, biostable, biocompatible polymer that resists calcification was incorporated into a mitral valve design and robotically manufactured to precisely meet the functional demands of a cardiac valve, which met pre-clinical metrics and entered early human clinical evaluation. Patients with regurgitant and/or stenotic mitral valve pathology, who met criteria for mitral valve replacement, underwent clinical evaluation and CT guided size verification. All patients, upon approval by a multidisciplinary, multinational screening committee, underwent comparable, isolated surgical mitral valve replacement via sternotomy. After 6 months of Coumadin anticoagulation, the protocol requires transition to novel oral anticoagulation with rigorous clinical and imaging follow-up.
RESULTS: Since April 2023, 67 patients at 8 India sites have undergone isolated mitral valve replacement with a polymer leaflet prosthesis. Data for first 35 patients includes 62% female and average age of 39 years with 72% having severe mitral stenosis due to rheumatic heart disease. Importantly, 60% of the females enrolled were less than 40 years old, considered women of childbearing potential. Thirty-five patients have reached 30-day outcomes evaluation with surgeons implanting the 27mm valve most commonly (45.7%). The estimated orifice area on transthoracic echocardiogram at 30 days was 1.96 mm2 with a mean transvalvular gradient of 4.1 mm Hg. Although there has been 1 death from a non-cardiovascular or valve related event, no patient has experienced stroke, thromboembolic, or bleeding complications.
CONCLUSIONS: This novel polymer mitral valve demonstrates promising early clinical success. Collective patient experience across all studies for this valve represent the most human clinical experience of any polymer valve. As the first ever polymer valve FDA approved for in-human clinical trials, more than 150 patients represent 161 patient-years with this implanted polymer valve. These early outcomes inspire validation of a lifetime valve management strategy that embodies a resilient technology, excellent hemodynamic performance, and potentially no anticoagulation requirement - a single valve procedure that lasts a lifetime.
