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心脏再同步治疗除颤器(CRT-D)患者更换器械时的适当植入式心律转复除颤器干预:是否需要从 CRT-D 降级为 CRT-起搏器?DECODE CRT-D 分析中的真实临床实践见解。

Appropriate implantable cardioverter-defibrillator interventions in cardiac resynchronization therapy-defibrillator (CRT-D) patients undergoing device replacement: time to downgrade from CRT-D to CRT-pacemaker? Insights from real-world clinical practice in the DECODE CRT-D analysis.

机构信息

Department of Cardiovascular Sciences, Catholic University of Sacred Heart Rome, Via Largo Francesco Vito, 1, Rome, Italy.

Azienda Ospedaliero-Universitaria Policlinico Sant'Orsola Malpighi, Bologna, Italy.

出版信息

Europace. 2018 Sep 1;20(9):1475-1483. doi: 10.1093/europace/eux323.

Abstract

AIM

Ventricular tachycardia (VT)/ventricular fibrillation (VF) occurrence after cardiac resynchronization therapy-defibrillator (CRT-D) replacement is unknown; hence, there is no practical guideline to recommend either CRT-D or CRT-pacemaker at the time of device replacement. We observed the 1-year VT/VF occurrence after CRT-D replacement in a subanalysis of the Detect Long-term Complications after ICD Replacement (DECODE) registry.

METHODS AND RESULTS

A total of 332 consecutive patients who had undergone CRT-D replacement from 2013 to 2015 were enrolled in 36 Italian centres. The primary endpoint was the number of patients with any appropriate implantable cardioverter-defibrillator (ICD) interventions during 12-month follow-up. The secondary endpoint comprised death from any cause and appropriate ICD interventions. At replacement, 214 (64.5%) patients had a left ventricular ejection fraction ≤ 35% and 138 (41.6%) patients had a secondary prevention indication for ICD. Seventy (21.1%) patients had no longer indication to ICD therapy. During a median follow-up period of 406.5 (362-533) days, VT/VF requiring therapy delivery occurred in 57 (17%) patients, specifically in 7% of those who no longer had an ICD indication. On multivariate analysis, number of criteria for ICD replacement independently predicted appropriate ICD intervention during follow-up [hazard ratio (HR) = 1.62, 95% confidence interval (CI) 1.07-2.46; log-rank P = 0.02]. The combined endpoint of death from any cause or appropriate ICD therapy occurred in 76 (23%) patients. Only NYHA class remained associated with this combined endpoint (HR = 1.97, 95% CI 1.23-3.14; P = 0.005).

CONCLUSIONS

The DECODE registry showed the 'real-world' experience of CRT-D recipients approaching device replacement, in which 7% of patients who no longer had an indication for ICD therapy experienced appropriate ICD interventions.

摘要

目的

心脏再同步治疗除颤器(CRT-D)更换后发生室性心动过速(VT)/心室颤动(VF)的情况尚不清楚;因此,在更换设备时,没有实用的指南来推荐 CRT-D 或 CRT-起搏器。我们观察了在 ICD 更换后长期并发症检测(DECODE)登记处的亚分析中 CRT-D 更换后 1 年内 VT/VF 的发生情况。

方法和结果

共纳入 2013 年至 2015 年期间在 36 家意大利中心接受 CRT-D 更换的 332 例连续患者。主要终点是在 12 个月随访期间发生任何适当的植入式心脏复律除颤器(ICD)干预的患者人数。次要终点包括任何原因导致的死亡和适当的 ICD 干预。在更换时,214 例(64.5%)患者左心室射血分数≤35%,138 例(41.6%)患者有 ICD 二级预防适应证。70 例(21.1%)患者不再有 ICD 治疗适应证。在中位数为 406.5(362-533)天的随访期间,57 例(17%)患者发生需要治疗的 VT/VF,具体来说,在不再有 ICD 适应证的患者中,有 7%的患者发生这种情况。多变量分析显示,ICD 更换的标准数量独立预测了随访期间适当的 ICD 干预[风险比(HR)=1.62,95%置信区间(CI)1.07-2.46;对数秩 P=0.02]。因任何原因死亡或适当 ICD 治疗的联合终点发生在 76 例(23%)患者中。只有纽约心脏协会(NYHA)心功能分级与这一联合终点相关(HR=1.97,95%CI 1.23-3.14;P=0.005)。

结论

DECODE 登记处显示了 CRT-D 接受者接近设备更换的“真实世界”经验,其中 7%不再有 ICD 治疗适应证的患者经历了适当的 ICD 干预。

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