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
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
复制标题
DOI：
10.1016/j.ijcard.2015.07.037
复制
发表时间：
2015-11-15
影响因子：
3.5
通讯作者：
Shi, Yingkang
中科院分区：
文献类型：
--
作者：
Zhu, Da;Chen, Yucheng;Shi, Yingkang
背景资料：目的：评价J-Valve（TM）系统经导管主动脉瓣植入术（TAVI）治疗主动脉瓣狭窄（AS）或单纯/显性主动脉瓣返流（AR）的安全性和有效性。平均Logistic Euro-SCORE I为27.2 ± 8.2%（平均年龄74.5 ± 4.7岁）。瓣环尺寸分别为21 mm（n = 1）、23 mm（n = 2）、25 mm（n = 10）和27 mm（n = 7），使用了4种尺寸的假体。在基线、术后和随访时进行临床和超声心动图评价。主要终点为全因死亡率。次要终点是手术成功率，主要不良事件以及超声心动图performance.Results：19例患者（95%）成功进行了TAVI与J-Valve T装置。1例患者因人工瓣膜栓塞需要转为外科瓣膜置换术。随访90天无死亡病例。1例患者（5%）因新发传导障碍需要植入起搏器。对于重度AS患者，术后TAVI导致平均跨瓣压差有利降低（55.3 +/- 8.5 vs. 16.4 +/- 13.3 mm Hg，P < 0.01）。瓣膜植入后AR患者的平均跨瓣压差也有利（6.9 +/- 1 mm Hg）。大多数患者没有或轻微瓣周返流（17/19），而没有中度或重度瓣周返流。结论：经心尖TAVI使用J阀T假体是一个潜在的有效的治疗方案，为患者AS或纯/显性AR在心脏直视手术的高风险。(C)2015爱思唯尔爱尔兰有限公司版权所有。
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 (TM) 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 +/- 4.7 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.Results: TAVI with the J-Valve T 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 +/- 1 mm Hg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation.Conclusion: Trans-apical TAVI using the J-Valve T prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery. (C) 2015 Elsevier Ireland Ltd. All rights reserved.