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Transapical implantation of a self‐expandable aortic valve prosthesis utilizing a novel designed positioning element
Author(s) -
Liu Xiaopeng,
Tang Yue,
Luo Fuliang,
Tian Yi,
Li Kai,
Sun Jiakang,
Jia Liujun,
Wang Wei
Publication year - 2017
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26429
Subject(s) - medicine , prosthesis , aortic valve , prosthesis implantation , aortic valve replacement , prosthesis design , cardiology , surgery , stenosis
Objectives To evaluate a new transapical system which utilizes a novel designed positioning element and a two‐step positioning mechanism for easy and accurate implantation of transcatheter valves. Background Transcatheter aortic valve implantation is an important treatment option for non‐surgical patients with severe aortic stenosis. However, accurate placement of the transcatheter valve remains challenging. Methods Self‐expandable aortic valve prosthesis with a flexibly connected, annulus‐like positioning element was implanted through a transapical approach in 12 pigs. The positioning element was separated and can be released independent of the valve prosthesis. During valve implantation, firstly, the positioning element was unsheathed and fixed into the aortic sinus. Then, the prosthetic valve was guided to an anatomically oriented position and deployed. Six animals were followed up to 180 days. Results With the help of the positioning element, all 12 valves were successfully deployed at the anticipated site. The valve release procedure took an average of 7.3 ± 2.5 min. The mean transvalvular pressure gradient was 2.8 ± 1.1 mm Hg at valve deployment. Of the six chronic animals, the mean transvalvular pressure gradient was 3.0 ± 1.0 mm Hg on day 7, and 2.9 ± 1.6 mm Hg on day 180 ( P = 0.91). No migration, embolization, or coronary obstruction was observed during surgery and at necropsy. Pathological examination showed anatomically correct positioning of the prosthetic valve without signs of thrombosis or calcification. Conclusions In this study, we confirmed the feasibility of the J‐Valve transapical system for transapical implantation through a two‐step process. Satisfactory hemodynamic and pathological performance during a follow‐up of 180 days was demonstrated. © 2016 Wiley Periodicals, Inc.