Circulation:低射血分数初级预防患者使用皮下植入心脏复律除颤器的效果

2021-01-04 MedSci原创 MedSci原创

尽管与早期的S-ICD试验相比,并发症的发生率相对较高,但当代S-ICD装置和编程具有较高的疗效和安全性。

心律失常导致的心脏性猝死(SCD)是血管死亡的主要原因,占全球50%以上的心血管死亡事件。许多大型临床试验发现,埋藏式心脏转复除颤器(ICD)可降低特定人群的SCD死亡率。

通常,心脏除颤或心脏复律波形能量控制系统采用经静脉ICD或皮下S-ICD治疗心脏心律失常。但传统的经静脉ICD有经静脉导线的固有缺点,包括:置入导线时的风险–心脏穿孔、心包积液、心包填塞、血胸、气胸;以及装置寿命期限内的延迟风险–血管内导线感染、导线故障等。

据报道,经静脉ICD的并发症发生率为3%-6%另外,经静脉置入导线的延迟风险包括感染风险(发生率为9/1000装置-)和导线故障风险(根据导线类型,5年时故障率为5%-40%),两者均会导致再次手术率及并发症发生率增加。因此,S-ICD被越来越多的推荐以避免经静脉ICD植入相关的并发症。

N Engl J Med. 2020 Aug 6;383(6):526-536. doi: 10.1056/NEJMoa1915932.

去年8月,《新英格兰医学》(NEJM)杂志也开展了一项非劣效性对照研究,比较ICD皮下植入与静脉植入的疗效和安全性差异。结果发现对于需接受心脏复律除颤器植入的患者,接受皮下植入方式造成的设备相关并发症和异常电击风险与经静脉植入相当

那么,对于射血分数降低的初级预防患者使用S-ICD的效果如何呢?为此,一项前瞻性的跨国研究——UNTOUCHED 试验评估了在射血分数降低的初级预防患者中使用标准化编程和改进的传感算法S-ICD的疗效。结果发表在最新的《循环》(Circulation)杂志上。

 该研究纳入了左心室射血分数≤35%且无起搏指征的一级预防患者。植入第2代或第3S-ICD装置,并对速率≥250/分钟的治疗输送进行编程,对速率≥200/分钟和<250/分钟的治疗进行形态识别。对患者进行18个月的随访。

主要终点事件与91.6%的绩效目标相比的无错误放电(IAS)率(来源于MADIT-RIT研究[多中心自动除颤器植入-减少不当治疗试验])。进行Kaplan-Meier分析来评估IAS、全因性休克和并发症的发生率。

1116例患者植入S-ICD1111例患者进行了随访分析。平均年龄为55.8±12.4岁,25.6%为女性,23.4%为黑人,53.5%为缺血性心脏病,87.7%为症状性心力衰竭,平均左室射血分数为26.4±5.8%18个月的IAS自由度为95.9%

进一步分析发现,植入最新一代装置、使用3切口技术、无房颤病史和缺血原因了可以降低IAS发生率。此外,18个月无全因休克率为90.6%,达到了85.8%的预设目标。18个月无并发症率为92.7%

该研究表明,尽管与早期的S-ICD试验相比,并发症的发生率相对较高,但当代S-ICD装置和编程具有较高的疗效和安全性。

 

参考文献:

Gold MR, et al. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021 Jan 5;143(1):7-17. doi: 10.1161/CIRCULATIONAHA.120.048728.

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    2021-03-29 我要当大牛

    接受皮下植入ICD的患者出现不合适休克这种并发症的概率较大,这应该是一个可以随着技术改进能够解决的问题,由于皮下植入减少了经静脉植入所导致的严重感染等并发症,我认为经皮下植入ICD是未来发展的方向。

    0

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    2021-01-06 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

  7. 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    2021-01-06 zhouqu_8
  8. 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    2021-01-06 jiyangfei
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style='color:#2F92EE;'>#植入#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62645, encryptionId=7a736264553, topicName=植入)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=832411313664, createdName=jiyangfei, createdTime=Wed Jan 06 13:59:43 CST 2021, time=2021-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047258, encodeId=de0a104e25814, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Tue Jan 05 01:59:43 CST 2021, time=2021-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=913750, encodeId=0c03913e5019, content=心律失常导致的心脏性猝死(SCD)是心血管死亡的主要原因,占全球50%以上的心血管死亡事件。, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4gCIdSaEkahCNuUWZv4iaKmqvUKHyKnBiarBM9RStQKBeV5Lh6GYYFiamdV5KlSfbLvmAgZTLtq81XA/0, createdBy=13511650672, createdName=言西早, createdTime=Mon Jan 04 23:19:10 CST 2021, time=2021-01-04, status=1, ipAttribution=)]
    2021-01-05 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

  10. 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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Thu Feb 04 15:59:43 CST 2021, time=2021-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915018, encodeId=420691501844, content=<a href='/topic/show?id=5b9b10409926' target=_blank style='color:#2F92EE;'>#皮下植入心脏复律除颤器#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104099, encryptionId=5b9b10409926, topicName=皮下植入心脏复律除颤器)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 21:33:00 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914194, encodeId=444c91419434, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Wed Jan 06 21:51:07 CST 2021, time=2021-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1439175, encodeId=5f7a14391e5d9, content=<a href='/topic/show?id=8e3a98396f2' target=_blank style='color:#2F92EE;'>#除颤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98396, encryptionId=8e3a98396f2, topicName=除颤)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Wed Jan 06 13:59:43 CST 2021, time=2021-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520720, encodeId=a9651520e20b4, content=<a href='/topic/show?id=7a736264553' target=_blank style='color:#2F92EE;'>#植入#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62645, encryptionId=7a736264553, topicName=植入)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=832411313664, createdName=jiyangfei, createdTime=Wed Jan 06 13:59:43 CST 2021, time=2021-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047258, encodeId=de0a104e25814, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Tue Jan 05 01:59:43 CST 2021, time=2021-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=913750, encodeId=0c03913e5019, content=心律失常导致的心脏性猝死(SCD)是心血管死亡的主要原因,占全球50%以上的心血管死亡事件。, 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    2021-01-04 言西早

    心律失常导致的心脏性猝死(SCD)是心血管死亡的主要原因,占全球50%以上的心血管死亡事件。

    0