JACC:评估一种新型自扩张经导管心脏瓣膜CENTERA-EU试验的1年结局

2019-04-04 xiangting MedSci原创

CENTERA-EU试验证明了CENTERA THV的中期安全性和疗效。

这项研究目的是报告CENTERA-EU试验的1年结局。

CENTERA经导管心脏瓣膜(THV)(爱德华兹生命科技,欧文,加利福尼亚)是一种小巧(14-F e鞘管兼容)、自扩张的镍钛合金瓣膜,具有可重新定位的机动输送系统。CENTERA-EU试验的30天结果证明了该瓣膜的短期安全性和疗效。

在欧洲、澳大利亚和新西兰的23个中心完成瓣膜植入。所有患者均使用经股动脉通路。由一个中心实验室判定基线、出院、30天、6个月和1年的超声心动图结果。由一个独立的临床事件委员会裁定主要不良临床事件。

2015年3月至2016年7月,203名严重症状性主动脉瓣狭窄的高危患者(年龄82.7±5.5岁,67.5%为女性,68.0%纽约心脏病学会功能分级III级或IV级,胸外科医师协会评分6.1±4.2%)接受使用CENTERA THV的经导管主动脉瓣置换术。该研究的主要终点是30天死亡率(1.0%)。1年时,总体死亡率为9.1%,血管死亡率为4.6%,致残性卒中为4.1%,6.5%的风险患者植入新的永久性心脏起搏器,心脏相关再住院率为6.8%。1年时的血流动力学参数稳定,平均主动脉瓣梯度为8.1±4.7mmHg,平均有效瓣口面积为1.7±0.42cm2,并且没有严重或中度主动脉瓣返流。

CENTERA-EU试验证明了CENTERA THV的中期安全性和疗效。在症状性主动脉瓣狭窄的高危患者中,CENTERA THV的死亡率低,血流动力学持续改善,并且永久起搏器植入率低。(爱德华兹CENTERA-EU自扩张经导管心脏瓣膜的安全性和性能[CENTERA-2]; NCT02458560)

原始出处:
Didier Tchétché. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC:Cardiovascular Interventions. 08 April 2019.

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    2020-01-03 hbwxf
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    2019-12-28 gous
  5. [GetPortalCommentsPageByObjectIdResponse(id=1738946, encodeId=82d71e38946f1, content=<a href='/topic/show?id=6e566913df' target=_blank style='color:#2F92EE;'>#ERA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6913, encryptionId=6e566913df, topicName=ERA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e36234488643, createdName=124988c7m106暂无昵称, createdTime=Mon Dec 16 19:34:00 CST 2019, time=2019-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1854352, encodeId=8c0818543521d, content=<a href='/topic/show?id=48351020537' target=_blank style='color:#2F92EE;'>#JACC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10205, encryptionId=48351020537, topicName=JACC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=55ce62, createdName=hbwxf, createdTime=Fri Jan 03 05:34:00 CST 2020, time=2020-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715955, encodeId=e95a1e1595547, content=<a href='/topic/show?id=2c375156e5f' target=_blank style='color:#2F92EE;'>#心脏瓣膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=51567, encryptionId=2c375156e5f, topicName=心脏瓣膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b6d32099965, createdName=jianjun77, createdTime=Fri Nov 01 01:34:00 CST 2019, time=2019-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1782824, encodeId=40381e82824e4, content=<a href='/topic/show?id=5af1448804' target=_blank style='color:#2F92EE;'>#CENTERA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4488, encryptionId=5af1448804, topicName=CENTERA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a9987, createdName=gous, createdTime=Sat Dec 28 11:34:00 CST 2019, time=2019-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1684783, encodeId=a3c51684e834e, content=<a href='/topic/show?id=794754e74f4' target=_blank style='color:#2F92EE;'>#扩张#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54774, encryptionId=794754e74f4, topicName=扩张)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=699d28086811, createdName=lsj637, createdTime=Tue Jun 18 17:34:00 CST 2019, time=2019-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1326173, encodeId=612613261e34d, content=<a href='/topic/show?id=96c71804b7' target=_blank style='color:#2F92EE;'>#ACC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1804, encryptionId=96c71804b7, topicName=ACC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Sat Apr 06 06:34:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1510215, encodeId=8588151021547, content=<a href='/topic/show?id=e9bce8254ef' target=_blank style='color:#2F92EE;'>#经导管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78254, encryptionId=e9bce8254ef, topicName=经导管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=93e010191378, createdName=lsj631, createdTime=Sat Apr 06 06:34:00 CST 2019, time=2019-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1583614, encodeId=33ba158361466, content=<a href='/topic/show?id=508d68e698c' target=_blank style='color:#2F92EE;'>#瓣膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68769, encryptionId=508d68e698c, topicName=瓣膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=58dc16986228, createdName=12498e5fm17(暂无昵称), createdTime=Sat Apr 06 06:34:00 CST 2019, time=2019-04-06, status=1, ipAttribution=)]
    2019-06-18 lsj637
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    2019-04-06 lsj631
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