The AltaValve System, a novel atrial-fixation transcatheter mitral valve replacement (TMVR) device, showed high technical success with clinically significant reduction in mitral regurgitation (MR), new study data show. The early feasibility study (EFS) also showed sustained implant performance and notable improvements in New York Heart Association class at 30-day follow-up in patients symptomatic, severe MR. Vlasis Ninios, MD, of Interbalkan European Medical Center, Thessaloniki, Greece, presented these results Monday during a Late-Breaking Clinical Science session at Cardiovascular Research Technologies (CRT) 2024 in Washington, D.C. Current sub-valvular TMVR devices have limitations, including high screen-failure rates among potential patients, especially because they pose a higher risk of left ventricular outflow tract (LVOT) obstruction. The current EFS, therefore, evaluated the outcomes of the AltaValve device (4C Medical Technologies Inc.), which is designed to treat a larger range of patients and minimize the risk of LVOT obstruction. The prospective, multicenter, single-arm study evaluated safety and performance of the valve in 24 patients with symptomatic, severe MR who were deemed to be at high surgical risk. At baseline, the patients’ mean age was 77.0±6.4 years, and 71% were women. Of the enrolled patients, 24% had degenerative MR, 67% had functional MR, and 4% had mixed MR. Most patients had preserved left ventricular function, with a mean ejection fraction of 53.0% ± 8.5%. Most (79%) patients were New York Heart Association class III/ or IV. Technical success rate of the TMVR procedure with the device was 96%. Postprocedurally, no patients had MR or paravalvular leak (PVL). Post-procedure mean mitral valve gradient was 2.2±1.1 mmHg, and ejection fraction remained preserved. At 30-day follow-up, 95% of the patients had none/trace PVL, with one other patient having mild PVL. Also, 96% of the patients had NYHA class I/II. No patient had thrombus, embolization, erosion, new onset of atrial fibrillation or need for pacemaker placement. “The atrial-fixation TMVR technology of AltaValve may help reduce risk of LVOT obstruction and increase patient eligibility,” Ninios concluded. He added that a large pivotal study is being designed to further the device’s longer-term safety and The EFS was sponsored by 4C Medical Technologies Inc. Photo Credit: Bailey Salimes/CRTonline.org Photo Caption: Vlasis Ninios, MD, presents findings from a study of the AltaValve transcatheter mitral valve replacement device on Monday at CRT 2024 in Washington, D.C.