title: A New Transcatheter Aortic Valve Replacement System for Predominant Aortic Regurgitation Implantation of the J-Valve and Early Outcome.
abstract: OBJECTIVE
  This study introduces a newly designed transcatheter aortic valve system, the J-Valve system, and evaluates its application in patients with predominant aortic regurgitation without significant valve calcification. We also report the early results of one of the first series of transapical implantations of this device and aim to offer guidance on the technical aspects of the procedure.
  
  
  BACKGROUND
  Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification.
  
  
  METHODS
  Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50 ± 8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co., Ltd., Suzhou, China), a self-expandable porcine valve, in the aortic position at our institution. All patients were considered to be prohibitive or high risk for surgical valve replacement (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.15% to 44.44%; mean, 29.32 ± 7.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed.
  
  
  RESULTS
  Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00 ± 77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major post-operative complications or mortality during the follow-up.
  
  
  CONCLUSIONS
  Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Huan
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Liming
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Ye
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Jiayu
authors.initials: J
authors.lastname: Zheng
authors.affiliation: Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Kefang
authors.initials: K
authors.lastname: Guo
authors.affiliation: Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Luo
authors.affiliation: Department of Echocardiography, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Weipeng
authors.initials: W
authors.lastname: Zhao
authors.affiliation: Department of Medical Imaging, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Xue
authors.initials: X
authors.lastname: Yang
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: Aikebaier
authors.initials: A
authors.lastname: Maimaiti
authors.affiliation: Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wcs_heartsurgeon@126.com.
authors.forename: Chunsheng
authors.initials: C
authors.lastname: Wang
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D002681:China; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D008297:Male; D061330:Multidetector Computed Tomography; D011183:Postoperative Complications / Q000453:epidemiology*; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D013552:Swine; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*
keywords: aortic valve insufficiency; minimally invasive surgical procedures; transcatheter aortic valve replacement