Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device

Background: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR. Objectives: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve). Methods: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm). Results: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days. Conclusions: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.