Nomura Takahiro, Maeno Yoshio, Yoon Sung-Han, Abramowitz Yigal, Israr Sharjeel, Miyasaka Masaki, Kazuno Yoshio, Takahashi Nobuyuki, Kawamori Hiroyuki, Nakamura Mamoo, Jilaihawi Hasan, Makkar Raj R
Advanced Health Sciences Pavilion, Cedars-Sinai Heart Institute, 127 S. San Vicente Blvd, Third Floor, Suite A3600, Los Angeles, CA 90048 USA.
J Invasive Cardiol. 2018 Nov;30(11):421-427.
Transcatheter aortic valve replacement (TAVR) in cases with left ventricular outflow tract calcification (LVOT-CA) remains a challenging procedure. The aim of this study was to compare the early outcomes of patients undergoing TAVR in LVOT-CA with new-generation devices vs early-generation devices.
Between January 2014 and December 2016, a total of 433 patients with severe aortic stenosis who had a preprocedural multidetector computed tomography underwent TAVR in a LVOT-CA. After propensity matching, data from 119 patients in each group were analyzed. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2.
Compared with early-generation devices (Edwards Sapien/Sapien XT/CoreValve), new-generation devices (Sapien 3/Evolut R) had significantly lower incidence of mild-moderate paravalvular leak (PVL) (1.7% new vs 7.6% early; P=.03), tended to have lower incidence of moderate or severe PVL (5.0% new vs 11.8% early; P=.06), had no significant difference in device success (89.1% new vs 83.2% early; P=.19), and had a significantly higher early safety rate at 30 days (93.3% new vs 84.9% early; P=.04). For cardiac conduction disturbances, new-generation and early-generation devices had similarly high rates of new permanent pacemaker implantation (16.8% new vs 15.1% early; P=.72), whereas the number of patients who developed new-onset left bundle-branch block (LBBB) were significantly higher in those with new-generation devices (16.0% new vs 6.7% early; P=.03).
In the setting of LVOT-CA, patients with new-generation devices compared to those with early-generation devices had acceptable clinical outcomes except for cardiac conduction disturbances, especially in new-onset LBBB.
经导管主动脉瓣置换术(TAVR)用于左心室流出道钙化(LVOT-CA)的病例仍然是一项具有挑战性的手术。本研究的目的是比较使用新一代器械与早期器械进行TAVR的患者的早期结局。
在2014年1月至2016年12月期间,共有433例重度主动脉瓣狭窄且术前接受多排计算机断层扫描的患者在LVOT-CA中接受了TAVR。经过倾向匹配后,对每组119例患者的数据进行了分析。TAVR终点和不良事件根据瓣膜学术研究联盟-2进行定义。
与早期器械(爱德华兹Sapien/Sapien XT/ CoreValve)相比,新一代器械(Sapien 3/Evolut R)轻度至中度瓣周漏(PVL)的发生率显著更低(新一代为1.7%,早期为7.6%;P = 0.03),中度或重度PVL的发生率有降低趋势(新一代为5.0%,早期为11.8%;P = 0.06),器械成功率无显著差异(新一代为89.1%,早期为83.2%;P = 0.19),且30天时的早期安全率显著更高(新一代为93.3%,早期为84.9%;P = 0.04)。对于心脏传导障碍,新一代和早期器械的新永久性起搏器植入率相似(新一代为16.8%,早期为15.1%;P = 0.72),而新一代器械组发生新发左束支传导阻滞(LBBB)的患者数量显著更高(新一代为16.0%,早期为6.7%;P = 0.03)。
在LVOT-CA的情况下,与使用早期器械的患者相比,使用新一代器械的患者除心脏传导障碍外,尤其是新发LBBB,具有可接受的临床结局。