A novel percutaneous mitral valve repair system was safe and effective in a small study of patients with symptomatic HF and functional mitral regurgitation.
In the prospective, nonrandomized MAVERIC study, researchers evaluated the catheter-based ARTO system (MVRx Inc.), which was designed to modify the mitral annulus to improve leaflet coaptation in patients with functional mitral regurgitation (MR).
The study included patients with systolic HF, NYHA class II to IV, functional MR grade 2+ or higher, left ventricular ejection fraction 40% or less, and LV end-diastolic diameter more than 50 mm and 75 mm or less.
The primary safety endpoint was major adverse events at 30 days and the primary efficacy endpoints were MR reduction, LV volumes and functional status.
No procedural adverse events were reported.
From baseline to 30 days, the data demonstrated decreases in effective regurgitant orifice area (30.3 mm2 to 13.5 mm2), regurgitant volume (45.4 mL to 19.5 mL) and mitral annular anteroposterior diameter (45 mm to 38.7 mm). The researchers also observed improvements in LV end-systolic volume (77.5 mL/m2 to 68.5 mL/m2) and LV end-diastolic volume index (118.7 mL/m2 to 103.9 mL/m2). At baseline, 81.8% of patients had NYHA class III or IV HF and 18.2% had class I or II HF; at 30 days, 45.5% had class III or IV HF and 54.6% had class I to II HF.
Ninety percent of patients had functional MR grade 3 to 4+ at baseline. At 30 days, 82% of patients had functional MR grade 1 to 2+.
One pericardial effusion requiring surgical drainage and one case of asymptomatic device dislodgement were reported at 30 days
“This first-in-human study of the ARTO transcatheter mitral valve repair system demonstrates that the procedure can be safely performed with a favorable learning curve,” the researchers concluded. “These initial data are extremely promising, especially in terms of safety.” – by Rob Volansky
Disclosure: Two researchers report consulting for MVRx.