title: 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.
abstract: BACKGROUND
  To 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.
  
  
  METHODS
  Twenty 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±4.7years). Four sizes of prosthesis were used for annular size up to 21 mm (n=1), 23mm (n=2), 25mm (n=10) and 27mm (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.
  
  
  RESULTS
  TAVI 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 mmHg, P<0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9±1mmHg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation.
  
  
  CONCLUSIONS
  Trans-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.
authors.affiliation: Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.
authors.forename: Da
authors.initials: D
authors.lastname: Zhu
authors.affiliation: Department of Cardiology, West China hospital, Sichuan University, Chengdu, Sichuan, PR China.
authors.forename: Yucheng
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China. Electronic address: drguoyq@qq.com.
authors.forename: Yingqiang
authors.initials: Y
authors.lastname: Guo
authors.affiliation: Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.
authors.forename: Jia
authors.initials: J
authors.lastname: Hu
authors.affiliation: JC Medical Inc. Redwood City, CA, USA.
authors.forename: Ji
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, West China hospital, Sichuan University, Chengdu, Sichuan, PR China.
authors.forename: Xin
authors.initials: X
authors.lastname: Wei
authors.affiliation: Department of Cardiology, West China hospital, Sichuan University, Chengdu, Sichuan, PR China.
authors.forename: Hong
authors.initials: H
authors.lastname: Tang
authors.affiliation: Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.
authors.forename: Yingkang
authors.initials: Y
authors.lastname: Shi
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery; D000082882:Bicuspid Aortic Valve Disease; D015331:Cohort Studies; D004452:Echocardiography / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006330:Heart Defects, Congenital / Q000401:mortality / Q000601:surgery*; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000706:statistics & numerical data*; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D012307:Risk Factors; D012449:Safety; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*; D016896:Treatment Outcome
keywords: Aortic regurgitation; Aortic stenosis; J-Valve™ system; Second-generation TAVI device; Transcatheter aortic valve implantation (TAVI)