植入心脏转换器-除器与左心室射出分数在30%至35之间患者的死亡率之间的关联
Jason H Wasfy1, Aditya Achanta2, Michael K Hidrue3
1Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA JWASFY@mgh.harvard.edu.
Open heart
|August 25, 2023
概括
植入式心脏转移除器 (ICD) 对左心室喷射率 (LVEF) 接近35%的患者没有死亡益处. 需要进一步的试验来证实在这个LVEF范围内的初级预防的有效性.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 公共卫生 公共卫生
背景情况:
- 协商一致的指导方针建议植入心转除器 (ICD) 用于预防心肌病和左心室喷射率 (LVEF) ≤35%的患者突然心脏死亡的初级预防.
- 支持LVEF接近35%的患者的ICD疗效的证据由于过去的试验不足而有限.
- 未来对这一特定人群进行大规模试验不太可能.
研究的目的:
- 评估ICD植入与LVEF患者30%至35%之间的死亡率之间的关联.
- 评估ICD在初级预防中的有效性,在接近指南值的狭窄LVEF范围内.
- 为了对36%至40%之间的LVEF患者进行二次分析.
主要方法:
- 马萨诸塞州总医院 (2001-2020年) 的回顾性分析心声回声数据.
- 在没有先前ICD植入的情况下,识别30-35%的LVEF患者.
- 倾向性得分匹配和时间依赖的考克斯比例危险模型被用于评估ICD与死亡率的关联.
主要成果:
- 在应用纳入/排除标准后,分析队列包括6109名患者.
- 倾向性得分匹配显示,ICD植入和死亡率之间没有统计学上显著的关联 (HR 0.93,95% CI 0.75-1.15).
- 接受ICD治疗的患者更有可能是男性,白人,并且有心室动脉冲动或心肌梗塞病史.
结论:
- 在接近35%值的LVEF患者中,ICD治疗与降低死亡率无关.
- 研究结果与现有试验数据一致,但不能最终证明缺乏疗效.
- 需要一项强大的临床试验,以确定初级预防ICD在LVEF在30%至35%之间的患者中的有效性.
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