Transapical transcatheter aortic valve replacement with a novel transcatheter aortic valve replacement system in high-risk patients with severe aortic valve diseases.

OBJECTIVES: The clinical experience of a novel transapical transcatheter aortic valve replacement system, the J-Valve (JC Medical Inc, Burlingame, Calif), in high-risk patients with severe aortic valve diseases is limited.

METHODS: A total of 107 high-risk patients (mean age, 74.4 ± 5.2 years) underwent transcatheter aortic valve replacement with the J-Valve from March 2014 to July 2015, which included 63 patients with aortic stenoses and 44 patients with aortic regurgitation. Echocardiography and contrast-enhanced computed tomography were used to evaluate patients' baseline characteristics and their follow-up conditions.

RESULTS: The J-Valve was successfully implanted in 102 patients (95.3%). Five patients (4.7%) underwent conversion to open surgery. The overall mortality was 4.7% (n = 5) at both 30 days and 6 months, whereas subgroup mortality was 6.3% (n = 4) in the aortic stenosis group and 2.3% (n = 1) in the aortic regurgitation group. Permanent pacemakers were implanted in 5 patients (4.7%). In the aortic stenosis group, paravalvular regurgitation was observed as none or trace in 54.2% of patients (n = 32), mild in 42.4% of patients (n = 25), and moderate in 3.4% of patients (n = 2) postprocedure. The mean aortic gradient decreased from 56.7 ± 15.2 mm Hg to 14.4 ± 7.8 mm Hg (P < .01). The peak aortic valve velocity declined from 4.76 ± 0.6 m/s to 2.45 ± 0.57 m/s (P < .01). In the patients with aortic regurgitation, paravalvular regurgitation was none or trace in 74.4% (n = 32), mild in 23.3% (n = 10), and 2.3% (n = 1) after the procedure. Mean aortic gradient was 7.1 ± 2.9 mm Hg.

CONCLUSIONS: Transcatheter aortic valve replacement by the J-Valve is an adequate clinical option to treat high-risk patients with severe aortic stenosis or aortic regurgitation.