Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve™ for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up

BackgroundTo evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis (AS) or pure/dominant aortic regurgitation (AR) using the J-Valve™ system.MethodsTwenty patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for open-heart surgery were enrolled in this study. The mean Logistic Euro-SCORE I was 27.2 ± 8.2% (mean age 74.5 ± 4.7 years). Four sizes of prosthesis were used for annular size up to 21 mm (n = 1), 23 mm (n = 2), 25 mm (n = 10) and 27 mm (n = 7). Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. The primary endpoint was all-cause mortality. Secondary endpoints were procedural success, major adverse events as well as echocardiographic performance.ResultsTAVI with the J-Valve™ device was successfully performed in 19 patients (95%). Conversion to surgical valve replacement was necessary in one patient due to prosthesis embolization. No mortality occurred during 90 days follow-up. Pacemaker implantation for new onset conduction disorders was necessary in one patient (5%). For patient with severe AS, post-procedure TAVI resulted in favorable reduction of mean transvalvular gradients (55.3 ± 8.5 vs. 16.4 ± 13.3 mm Hg, P < 0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9 ± 1mm Hg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation.ConclusionTrans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery.