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在真实世界的一级预防中,心脏除颤器治疗的适应证和结局。来自 IRIDE(意大利预防植入除颤器研究)研究的数据。

Indication to cardioverter-defibrillator therapy and outcome in real world primary prevention. Data from the IRIDE [Italian registry of prophylactic implantation of defibrillators] study.

机构信息

Azienda Ospedaliero Universitaria "S. Maria della Misericordia" and IRCAB Foundation, SOC Cardiologia, Udine, Italy.

出版信息

Int J Cardiol. 2013 Sep 30;168(2):1416-21. doi: 10.1016/j.ijcard.2012.12.042. Epub 2012 Dec 31.

Abstract

AIMS

Several trials demonstrated the life saving role of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD). The aim was to evaluate the clinical characteristics and 4-year outcome of consecutive patients treated in clinical practice by prophylactic ICD implantation on the basis of class I recommendations and up-to-date ICD programming.

METHODS AND RESULTS

IRIDE multi-center, prospective and observational study enrolled 604 consecutive patients (mean age: 66 ± 10 years) treated by ICD between 01/01/2006 and 30/06/2010. Main characteristics were similarly distributed among the inclusion criteria of MADIT II (24%), SCD-HeFT (24%), COMPANION (26%) and MADIT-CRT (18%) trials, while a small number of patients met the MUSTT and MADIT (7%) inclusion criteria. Single-chamber ICDs were implanted in 168 (28%) patients, dual-chamber in 167 (28%) and biventricular in 269 (43%) patients. ATP programming was activated in 546 (90%) patients. Overall survival and rate of appropriate ICD intervention by ATP and/or shock at 12-24-36-48 months of follow-up were 94%, 89%, 80%, 75% and 16%, 28%, 37% and 50%, respectively. No difference in mortality rate between the groups who received or did not receive appropriate ICD interventions was demonstrated (p=ns).

CONCLUSIONS

The IRIDE study confirms the effectiveness in real world practice of ICD implantation in patients at risk of SCD. The life saving role of ICD therapy increases as the duration of follow-up is prolonged and the survival benefit is similar in patients who received or did not receive appropriate device treatment, thus suggesting a beneficial effect of up-to-date device programming.

摘要

目的

几项试验证明了植入式心脏复律除颤器(ICD)在预防心脏性猝死(SCD)方面的救生作用。目的是评估根据 I 类推荐和最新 ICD 编程,在临床实践中对预防性 ICD 植入治疗的连续患者的临床特征和 4 年结果。

方法和结果

IRIDE 多中心、前瞻性和观察性研究纳入了 2006 年 1 月 1 日至 2010 年 6 月 30 日期间接受 ICD 治疗的 604 例连续患者(平均年龄:66±10 岁)。主要特征在 MADIT II(24%)、SCD-HeFT(24%)、COMPANION(26%)和 MADIT-CRT(18%)试验的纳入标准中分布相似,而少数患者符合 MUSTT 和 MADIT(7%)纳入标准。单腔 ICD 植入 168 例(28%),双腔 ICD 植入 167 例(28%),双室 ICD 植入 269 例(43%)。546 例(90%)患者激活 ATP 编程。12、24、36 和 48 个月随访时的总体生存率和 ATP 和/或电击的适当 ICD 干预率分别为 94%、89%、80%、75%和 16%、28%、37%和 50%。未发现接受或未接受适当 ICD 干预的患者死亡率存在差异(p=ns)。

结论

IRIDE 研究证实了 ICD 植入在 SCD 风险患者中的实际应用效果。随着随访时间的延长,ICD 治疗的救生作用增加,接受或未接受适当设备治疗的患者的生存获益相似,因此表明最新设备编程具有有益作用。

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