Transcatheter Treatment of Native Aortic Regurgitation
- In a multicenter, observational, compassionate-use registry of 27 patients with severe, symptomatic native AR and high or extreme/prohibitive surgical risk, the J-Valve had a procedural success rate of 81%; and (with changes in valve design and inclusion criteria) a procedural success rate of 100% in the last 15 cases.
- At 30 days, 88% of 24 patients were NYHA class I-II and no patient had residual AR ≥ moderate.
- At 1 year, all 17 patients with available follow-up were NYHA class I-II, and available echocardiography in 14 of 17 documented < moderate AR in all but one patient.
What were the 30-day outcomes for the compassionate-use experience in North America with a transcatheter heart valve (THV) device dedicated to the treatment of aortic regurgitation (AR)?
The J-Valve (J.C. Medical, Burlingame, CA) is a THV device designed specifically for the treatment of AR, consisting of a self-expanding nitinol frame, bovine pericardial leaflets, and a valve locating feature; with five available sizes intended to treat annular diameters 18-33 mm/annular perimeters 57-109 mm. This study reports the results of an observational registry of the compassionate use of the J-Valve from five sites in North America between May 2018 and October 2022 among patients with severe, symptomatic native valve AR who were at high or extreme/prohibitive risk for surgical aortic valve replacement.
A total of 27 patients (median age 81 [72-85] years, 81% high surgical risk, 96% New York Heart Association [NYHA] functional class [FC] III-IV) with native valve AR were treated with the J-Valve during the study period. The aortic valve was bicuspid in one patient; access was transfemoral in 21 patients (78%), with the remainder subclavian (four patients), carotid (one patient), or transcaval (one patient). Procedural success (J-Valve delivered to the intended location without need for surgical conversion or a second THV) was 81% (22 of 27 patients) in the overall experience and 100% in the last 15 cases. Two cases in the early experience required conversion to surgery, leading to changes in valve design; and a finding of leaflet prolapse during surgery in one patient led to subsequent exclusion of patients with leaflet prolapse. At 30 days, there was one death, one stroke, and three new pacemakers (13%); 88% of 24 patients were NYHA FC I-II; and no patient had residual AR ≥ moderate. Of 24 patients successfully treated with J-Valve and discharged from the hospital, 1-year follow-up was complete in 17 (two deaths occurred between 30 days and 1 year, and five patients had not yet reached the 1-year follow-up window); all were NYHA FC I-II. Echocardiography at 1 year was available in 14 of 17 patients, with no or trace AR in nine patients, mild AR in four, and moderate AR in one.
The authors conclude that the J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated/prohibitive surgical risk.
Most currently available transcatheter aortic valve replacement (TAVR) devices are designed for the treatment of calcific aortic stenosis (AS), relying on a heavily calcified aortic valve annulus to provide reliable fixation of the device. A multicenter registry report from 2017 among patients with pure native AR found improved procedural outcomes associated with newer-generation devices (driven by lower rates of second valve implantation and post-procedural ≥ moderate AR); but procedural success still was only 81% (Yoon SH, et al., J Am Coll Cardiol 2017;70:2752-63). The Jena Valve currently is approved in Europe for the treatment of both AS and AR. The present study describes early results with another THV device for the treatment of native AR, albeit limited to compassionate use in only 27 patients, a change in valve design and in inclusion criteria during the study, and follow-up to 1 year only in 17 patients. Additional larger studies will be needed to help define the efficacy and relative risks and benefits of this device.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Pacemaker, Artificial, Patient Discharge, Prolapse, Stroke, Transcatheter Aortic Valve Replacement
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